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NCT ID: NCT02931851 Terminated - Extended Family Clinical Trials

Family Information Management in the Intensive Care Unit

ICU-Families
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

Relatives in intensive care units (ICU) are important partners in decision-making in the treatment of critically ill patients and provide a significant resource in the care and recovery of patients. Therefore, a professional, educational intervention targeting these caregivers may have fundamental benefits with little risk. As in other fields, information is searched in the internet, but this unselected information is often overwhelming and of little use in this context. Symptoms of anxiety, stress and depression are common in affected relatives. The majority of family members report some level of anxiety, depression and stress, sometimes even resulting in post-traumatic stress disorder (PTSD). Importantly, an association between lack of information and post-traumatic stress disorder PTSD has been reported. The large number of potentially affected families poses a particular challenge to healthcare and may cause substantial secondary costs to national economy.

NCT ID: NCT02914600 Terminated - Crohn's Disease Clinical Trials

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

DIVERSITYLTE
Start date: March 17, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

NCT ID: NCT02907177 Terminated - Multiple Sclerosis Clinical Trials

Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

POINT
Start date: March 30, 2017
Phase: Phase 3
Study type: Interventional

This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).

NCT ID: NCT02906124 Terminated - Pregnancy Clinical Trials

Study to Evaluate the Safety of Repatha® in Pregnancy

Start date: January 12, 2017
Phase:
Study type: Observational

To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months

NCT ID: NCT02906020 Terminated - Parkinson's Disease Clinical Trials

A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation

MOVES-PD
Start date: December 15, 2016
Phase: Phase 2
Study type: Interventional

Primary Objectives: - Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants. - Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: - To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation. - To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation. Part 2: - To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo. - To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.

NCT ID: NCT02895373 Terminated - Clinical trials for Respiratory Distress Syndrome, Adult

PGE1 as Additive Anticoagulant in ECMO-Therapy

ECMO_PGE1
Start date: July 2016
Phase: Phase 2
Study type: Interventional

Bleeding complications and thromboembolic complications are frequent during extracorporeal membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing the bleeding risk. This randomized, double-blind trial aims to investigate the effects of PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.

NCT ID: NCT02872649 Terminated - Bleeding Clinical Trials

Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation. In this pilot single-center study, thirty LVAD patients with stable renal function were scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after implantation of a HeartWare HVAD system following an open-label balanced parallel group design.

NCT ID: NCT02857309 Terminated - Heart Failure Clinical Trials

Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure

IMPULSE-HF
Start date: February 2014
Phase: N/A
Study type: Interventional

The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM) in the heart failure population with ejection fraction ranging between 25 and 45%. The study is designed in an adaptive manner to ensure proper statistical significance and power of the primary efficacy evaluation.

NCT ID: NCT02855164 Terminated - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)

FLIGHT-FXR
Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

NCT ID: NCT02848911 Terminated - Leukemia, B-Cell Clinical Trials

Safety Study to Assess AFM11 in Patients With Relapsed or Refractory Adult B-precursor ALL

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the maximum tolerated dose (MTD) in patients with acute lymphoblastic leukemia (ALL) and to determine the safety and tolerability of increasing doses and different infusion times of AFM11 infusion in patients with adult B-precursor ALL