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NCT ID: NCT04577404 Completed - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Start date: October 29, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

NCT ID: NCT04577352 Completed - Friedreich Ataxia Clinical Trials

A Study to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Participants With Friedreich Ataxia

MOVE-FA
Start date: December 17, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy (using the modified Friedreich Ataxia Rating Scale [mFARS]) and safety of vatiquinone in participants with Friedreich ataxia (FA).

NCT ID: NCT04576988 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.

NCT ID: NCT04576689 Completed - Clinical trials for Diabetic Macular Oedema

Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - A Sustained, Low Dose Dexamethasone Therapy

Start date: October 30, 2020
Phase: Phase 2
Study type: Interventional

This trial is a phase II, multi-center, single-masked (assessors) dose-ranging study designed to evaluate the comparative safety and preliminary efficacy of two dosage regimens of the IBE-814 IVT Dexamethasone Implant in patients with DMO and RVO.

NCT ID: NCT04576117 Recruiting - Clinical trials for Recurrent WHO Grade 2 Glioma

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

Start date: February 16, 2021
Phase: Phase 3
Study type: Interventional

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

NCT ID: NCT04576026 Not yet recruiting - Ketosis Clinical Trials

Exogenous Ketone Supplementation and Cognitive Function During Exercise

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

15 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Ketone esters supplementation and iso-caloric carbohydrate. The purpose of this study is to evaluate the effect of ketone esters on cognitive function during exercise after induced mental fatigue

NCT ID: NCT04575883 Recruiting - Clinical trials for Congenital Heart Disease

HIIT in Youth With Congenital Heart Disease (MedBIKE)

Start date: November 22, 2022
Phase: N/A
Study type: Interventional

Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life. Cardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.

NCT ID: NCT04575831 Completed - Clinical trials for Advanced Lung Cancer

Exercise, Nutrition, and Palliative Care in Advanced Lung Cancer (ENPAL)

ENPAL
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Background: Evidence supports exercise and nutrition as beneficial for enhancing QOL in earlier stages of lung cancer; however, there is minimal research of either intervention - and none with combined interventions - in advanced lung cancer patients. In addition to a multimodal intervention approach that includes nutrition and exercise, consideration of advanced cancer care symptom management is crucial for optimizing the potential benefits of either intervention. Objectives: Primary outcome measure of this study is feasibility, including recruitment (% who participate from those eligible), attendance (weekly group class), assessment completion, safety (adverse event reporting), attrition rates, and qualitative themes generated from one-on-one participant interviews. The secondary outcome to be measured is the impact of the intervention on PROs, including QOL, fatigue and symptom burden, as well as self-reported physical activity levels and physical function assessed in-person. Methods: The proposed exercise intervention will include a centre-based group exercise program plus home-based exercises, and behaviour change support for advanced non-small cell lung cancer (NSCLC) patients, classified as stage III or IV with self-reported symptom burden. Eligible participants must be cleared by the health care professionals (HCP) to engage in mild to moderate levels of physical activity (PA). Using a prospective, mixed-methods design (supported by the Medical Research Council guidance for the evaluation of complex interventions), the quantitative component of this pilot study will measure feasibility and exploratory outcome measures, with an embedded qualitative component to examine participant perspectives about study tolerability/feasibility of the intervention. A subset of participants and instructors will be recruited for qualitative interviews using purposive sampling to achieve maximum variation based on factors that may lead to different viewpoints (e.g., age, gender, lung cancer type/stage, treatment). Relevance: The proposed work will inform the design of a future pragmatic trial for this population. The goal is to build a patient-focused model of care that delivers wellness resources for advanced lung cancer care that will ultimately improve the patients' health and QOL. This approach is novel, patient-focused, and will build a tailored approach within existing resources to deliver optimal care.

NCT ID: NCT04575597 Completed - Clinical trials for Coronavirus Disease (COVID-19)

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

Start date: October 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29

NCT ID: NCT04575584 Terminated - Clinical trials for Coronavirus Disease (COVID-19)

Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

Start date: October 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.