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NCT ID: NCT02637687 Active, not recruiting - Clinical trials for Solid Tumors Harboring NTRK Fusion

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

SCOUT
Start date: December 16, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.

NCT ID: NCT02636686 No longer available - Clinical trials for Duchenne Muscular Dystrophy

Extension Study of Drisapersen in DMD Subjects

Start date: n/a
Phase: N/A
Study type: Expanded Access

This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

NCT ID: NCT02634359 Active, not recruiting - Reproduction Clinical Trials

Evaluation of EarlySense for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment

Start date: December 2015
Phase: N/A
Study type: Interventional

The study objective is to collect data to assess the accuracy and reliability of Earlysense fertility cycle monitoring performance vs. acceptable known reference methods such as blood tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms.

NCT ID: NCT02634281 Completed - Smoking Cessation Clinical Trials

Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?

Start date: February 2016
Phase: Phase 4
Study type: Interventional

SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control. Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule. Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD. Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months. Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects). Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate. Expected benefits: This study might contribute to optimize the current use of varenicline.

NCT ID: NCT02633644 Terminated - Heart Failure Clinical Trials

Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)

Start date: September 2015
Phase: Phase 2
Study type: Interventional

The purpose of the ENDO-HF study is to determine the safety & performance of the Harmony System for the treatment of heart failure

NCT ID: NCT02632786 Completed - AL Amyloidosis Clinical Trials

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis

PRONTO
Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

NCT ID: NCT02632409 Active, not recruiting - Clinical trials for Various Advanced Cancer

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

CheckMate 274
Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

NCT ID: NCT02631785 Not yet recruiting - Clinical trials for Pediatric Anxiety Disorders

Fear Conditioning, Extinction and Its Recall in Anxious Youth

FCPA
Start date: February 2016
Phase: N/A
Study type: Interventional

The proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety. The study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations between brain functioning and response to exposure intervention in anxious children.

NCT ID: NCT02629939 Completed - Clinical trials for Cardiopulmonary Resuscitation

Basic Knowledge of CPR Among Close Relatives of Heart Patients-check Status Quo and Attemp to Establish a Potential Plan to Implement This Knowledge

Start date: September 2016
Phase: N/A
Study type: Interventional

Cardiac arrest is a public health problem and is the leading cause of death in many parts of the world. Cardiac arrest can occur inside the hospital and outside it. In the United States and Canada occur in approximately 350,000 cases of cardiac arrest a year , who receive CPR , Half of them outside the hospital. Treatment of cardiac arrest is performing Cardio Pulmonary Resuscitation (CPR) and early defibrillation. Performing compressions is the essential part of performing CPR until the arrival of defibrillation. Efforts are being made to simplify the implementation of basic CPR and make it accessible to everyone. Method "hands only CPR" offers CPR with compressions only without ventilations, Studies have shown a similar survival rate between" hands only CPR" method and CPR with ventilations. Patient's chances of survival are higher if a bystander begins performing CPR until trained medical staff arrives. Chances of survival decreases by 7-10% every passing minute past moment of collapse if not performed CPR. MDA survey carried out in 1984-5 reported at the start of CPR by a bystander at 8% Another survey in 2000 reported 14%, In a recent study in Jerusalem found a rate of only 15% of performing compressions by bystanders- A very low rate compared to 33% reported in the United States 41.3% in Japan and 44.9% in Denmark. The average time of arrival of the medical team in Israel is 10.3 minutes, so it is very important to begin performing CPR by those present before the arrival of medical staff. Most cases of cardiac arrest were the result of a previous cardiac disease, Therefore patients with cardiac disease are at higher risk of cardiac arrest and cardiac death. Place cardiac arrest is 72% percent of the time at home, and the likely presence of family members. The general population should know basic resuscitation to save a life, knowledge is needed especially among families of heart patients who are way more likely that such an event will occur in their presence. Therefore, one can relate to families of heart patients dedicated to increasing population as a basic knowledge of CPR. There is no other organized plan to study family members of patients with heart disease basic knowledge of CPR Despite the importance of it Attempts have been published in previous studies from around the world to create a focus group study of CPR among close relatives of heart patients. An attempt was made to incorporate as part of the proposed cardiac rehabilitation patients after MI Through self-study kit given at discharge from the hospital and more Difficult to evaluate the success of these efforts over the long term, but short-term study of short workshops yielded sufficient knowledge about basic CPR This study should serve as a catalyst as a first step towards building a suitable program nationwide and hopefully save many lives

NCT ID: NCT02629861 Completed - Migraine Clinical Trials

Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

Start date: March 23, 2016
Phase: Phase 3
Study type: Interventional

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine