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NCT ID: NCT02851797 Completed - Clinical trials for Duchenne Muscular Dystrophy

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Start date: June 6, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective The primary objective of the study was to establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects. Secondary Objectives The secondary objectives of this study were: - To assess the safety and tolerability of givinostat versus placebo administered chronically in DMD subjects - To evaluate the PK profile of givinostat administered chronically in DMD subjects - To evaluate the impact on quality of life (QoL) and activities of daily living of givinostat versus placebo administered chronically.

NCT ID: NCT02851407 Completed - Clinical trials for Veno-occlusive Disease

Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

Start date: September 1, 2016
Phase: Phase 3
Study type: Interventional

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

NCT ID: NCT02851342 Completed - Multiple Sclerosis Clinical Trials

GTA-MEG as a Biomarker for Cognition in MS

Start date: April 2016
Phase:
Study type: Observational

In this study, 100 persons with Multiple Sclerosis and 50 matched controls will be examined with magnetoencephalography (MEG), magnetic resonance imaging (MRI) and cognitive tests. The primary hypothesis for the study is: Interhemispheric connectivity, determined using graph theoretic analysis (GTA) on source-reconstructed MEG data, is a biomarker for cognitive deterioration in MS, which has value at the individual patient level.

NCT ID: NCT02849626 Completed - Clinical trials for Partial-Onset or Primary Generalized Tonic-Clonic Seizures

Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

Start date: November 16, 2016
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.

NCT ID: NCT02849080 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

PIONEER 7
Start date: September 20, 2016
Phase: Phase 3
Study type: Interventional

This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

NCT ID: NCT02847728 Completed - Lung Cancer Clinical Trials

Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

Start date: July 28, 2016
Phase:
Study type: Observational

This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.

NCT ID: NCT02846532 Completed - Thrombosis Clinical Trials

Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure

UNIVERSE
Start date: November 16, 2016
Phase: Phase 3
Study type: Interventional

The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.

NCT ID: NCT02845362 Completed - Dysphagia Clinical Trials

Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases

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

Measurements of dysphagia severity are important when making management decisions and in the objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a validated self-report inventory using a visual analogue scale. This questionnaire permits a quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia in different pathology. Opposed to largely used videofluoroscopy swallowing study and endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure and enables a readily available assessment. Validated French version is not yet available. In the first phase of the study the investigators will validated this translation in dysphagic patients and control. Secondly, the investigators will validate the SSQ in Neuromuscular patients.

NCT ID: NCT02841462 Completed - Bursitis Clinical Trials

Hydrothermal Ablation in Recurrent and Chronic Symptomatic Bursitis

VMT-001
Start date: May 1, 2016
Phase: N/A
Study type: Interventional

The overall objective of this trial is to explore the dose-tolerance (safety) and dose-response (efficacy) of single 3-minute intra-bursal perfusions of a physiological saline solution at increasing temperatures.

NCT ID: NCT02840721 Completed - Colitis, Ulcerative Clinical Trials

Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.

Start date: October 26, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.