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NCT ID: NCT03038399 Completed - Clinical trials for Duchenne Muscular Dystrophy

Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

Start date: February 2, 2017
Phase: Phase 2
Study type: Interventional

This long-term extension study is an open-label, multiple-dose study to evaluate the long-term safety, tolerability, efficacy and PD of vamorolone administered once daily by liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who participated in the VBP15-002 Phase IIa and VBP15-003 Phase IIa extension core studies.

NCT ID: NCT03038191 Terminated - Epilepsy Clinical Trials

Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home

Start date: March 8, 2017
Phase:
Study type: Observational

Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication. In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.

NCT ID: NCT03038165 Completed - Clinical trials for Intradialytic Hypertension

Hemodynamic Parameters Changes in the Course of Hemodialysis Sessions in Patients With Intradialytic Hypertension

Start date: November 2016
Phase:
Study type: Observational

While the exact pathogenesis of Intradialytic hypertension remains to be determined, several mechanisms were proposed to be involved. The main factors to determine the arterial blood pressure are the peripheral vascular resistance and cardiac output. The assumption is that the increase of blood pressure is related to the increase in peripheral vascular resistance during the dialysis session, due to fluid removal and fast reduction of the intravascular volume reduction. Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients with intradialytic hypertension will be evaluated

NCT ID: NCT03038100 Completed - Ovarian Cancer Clinical Trials

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

IMagyn050
Start date: March 8, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

NCT ID: NCT03037801 Recruiting - Bronchiolitis Clinical Trials

Intrapulmonary Percussive Ventilation for Children With Bronchiolitis on Non-Invasive Ventilation Support

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation. The patient population will be divided into two groups, one group will receive conventional treatment and the other group will receive conventional treatment and three times a day of physiotherapy using Intrapulmonary Percussive Ventilation.

NCT ID: NCT03036852 Completed - Chronic Hepatitis C Clinical Trials

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

SOF/VEL ESRD
Start date: March 22, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.

NCT ID: NCT03036488 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

Start date: March 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.

NCT ID: NCT03036254 Recruiting - Diabetes Mellitus Clinical Trials

Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk

Start date: October 8, 2017
Phase: N/A
Study type: Interventional

An urgent need exists to identify effective interventions to arrest or reverse dementia and cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen therapy effects on cognition in diabetes. The potential to preserve, or even enhance, cognition in elderly at high risk of cognitive decline and dementia has major implications for the affected individuals and their support systems that bear the social and financial burdens of long-term caregiving.

NCT ID: NCT03036098 Active, not recruiting - Urothelial Cancer Clinical Trials

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

CheckMate901
Start date: March 24, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

NCT ID: NCT03034499 Completed - Clinical trials for Pelvic Organ Prolapse

Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse

Start date: March 20, 2017
Phase: N/A
Study type: Interventional

A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse: 1. Via single-port. 2. Via multi-port.