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NCT ID: NCT03941119 Terminated - Dementia Clinical Trials

Evaluating the Impact of VR-therapy on BPSD and QoL of Individuals With Dementia Admitted to Hospital

VRx-RCT
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Behavioural and Psychological Symptoms of Dementia (BPSD) (such as aggression, restlessness, agitation, wandering, anxiety, depression) are common to most people with dementia at some point during their illness and represent an aspect of dementia particularly difficult to manage. There is growing attention to the therapeutic effects of natural environments on people's health. Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to enhance wellbeing, reduce depression, anxiety and stress levels, and decrease hospital length-of-stay for inpatients. Virtual Reality (VR) is a novel technology that uses a Head Mounted Display (HMD) to generate simulated immersive experiences that elicit perceptions and behaviors similar to those in real life and can make one feel as though they are truly present in another place. Based on scientific research, previous studies, and expert consultation, we created a library of VR experiences depicting calming nature scenes designed specifically for people with dementia. The objectives of this RCT are 1) to evaluate the effects of VR-therapy on BPSD and the hospital care experience of in-patients with dementia and/or delirium admitted to an acute care hospital, 2) to determine the usability, tolerability, and safety of VR-therapy for patients with dementia and/or delirium admitted to acute care, 3) determine the effect of VR-therapy on quality of life for patients with dementia and/or delirium admitted to acute care and 4) to explore a framework for introducing non-pharmacological therapies in acute care hospitals. Our hypotheses are 1) VR-therapy helps manage BPSD (e.g. decrease anxiety, aggression, depression, violent behaviors, incidents of wandering), and may decrease the amount and/or frequency of sedatives and anti-depressant medication administered and/or the number of incidents that require restraints, and the number of falls, in people with dementia and/or delirium admitted to an acute care hospital. 2) VR-therapy will improve the quality of life for individuals with dementia and/or delirium admitted to an acute care hospital (operationalized through conducting a validated instrument to measure quality of life for people with dementia). 3) VR-therapy is safe and feasible to administer to individuals with dementia and/or delirium admitted to an acute care hospital (with assistance from their circle of care members and/or caregivers).

NCT ID: NCT03938545 Terminated - Clinical trials for Graves' Ophthalmopathy (GO)

ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )

Start date: July 23, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the current study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG

NCT ID: NCT03924154 Terminated - Clinical trials for Pulmonary Arterial Hypertension

A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)

Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension (PAH).

NCT ID: NCT03923478 Terminated - Clinical trials for Ulcerative Colitis Chronic Moderate

ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

Start date: June 24, 2019
Phase: Phase 1
Study type: Interventional

Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.

NCT ID: NCT03920254 Terminated - Clinical trials for Ulcerative Colitis (UC)

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

Start date: July 23, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

NCT ID: NCT03917719 Terminated - Clinical trials for Duchenne Muscular Dystrophy

An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

GalaxyDMD
Start date: March 14, 2019
Phase: Phase 3
Study type: Interventional

The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

NCT ID: NCT03915535 Terminated - Healthy Athletes Clinical Trials

Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold

Start date: September 19, 2019
Phase: Phase 4
Study type: Interventional

he objective of this study is to compare the effects two different formulations of fish oil monoglycerides on the mitochondrial functions and on the lactate threshold of athletes during a high intensity exercise. Twenty four (24) subjects will be enrolled in the study and followed for a period of 90 days. A first visit will capture all the baseline parameters and will be followed by two subsequent visits (at day 45 and at day 90) where the same measurements will be done. The subjects will be divided in two parallel groups. Subjects of group A will receive a constant daily dose of 4,3g eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) whereas subjects of group B will receive a constant daily dose of 4,4g of EPA only. Subjects will be treated from day 1 to day 90 without interruption or modification to their regimen.

NCT ID: NCT03907072 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy

DYSTANCE 51
Start date: September 4, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping intervention (DYSTANCE 51)

NCT ID: NCT03896295 Terminated - Clinical trials for Generalized Myasthenia Gravis

An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

Start date: August 6, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)

NCT ID: NCT03891823 Terminated - Clinical trials for Ventricular Remodeling, Left

Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)

EVOLVE-MR
Start date: March 8, 2019
Phase: N/A
Study type: Interventional

The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation.