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NCT ID: NCT04944784 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

COURAGE-ALS
Start date: August 16, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

NCT ID: NCT04943731 Completed - Laryngectomy Clinical Trials

Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Start date: July 26, 2021
Phase: N/A
Study type: Interventional

Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range of HMEs". The main purpose of this study is to find out if participants experience any differences in the amount of coughing and mucus problems when using the new range of Provox Life™ HMEs (and attachment devices) following an optimal Day/Night regimen. The study is sponsored by Atos Medical. Study Design: Participants will use the new Provox Life™ HME range and their attachments during two (2) observation phases (Phase 1, Phase 2). In Phase 1 (6 week study phase), participants will use the new Provox Life™ HMEs in a similar way as they currently use their existing HME devices. In the Phase 2 (6 week study phase), they will use the Provox Life™ HME devices following an optimal Day/Night regimen - with the aim to achieve the best possible humidification at all times. Prior to each study phase, participants will meet with their speech pathologist to learn about the new devices and how to use them. Once comfortable using them they will commence each observation phase. Data Collection: Experiences using their existing HMEs (prior to study) and then using the new HMEs in Phase 1 and Phase 2 will be collected via a series of questionnaires. These will be completed 5 times in total - at baseline before Phase 1 starts, and then at both week 2 and week 6 of Phase 1 and 2. Questionnaires relate to their use of the HMEs, coughing and mucus problems, skin integrity, overall experiences of using the new devices and any impacts on sleep and quality of life. Participants will complete some of the questionnaires at home (approx. 30mins) and the others during an interview session with one of the study team (approx. 30mins). The interview session can be conducted via telephone, videoconferencing or in person - depending on the patients preferences and any COVID restrictions.

NCT ID: NCT04940624 Completed - Clinical trials for Dravet Syndrome (DS)

A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome

Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.

NCT ID: NCT04939935 Recruiting - Clinical trials for Autosomal Dominant Polycystic Kidney Disease

Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)

Start date: November 29, 2022
Phase: Phase 3
Study type: Interventional

This study will investigate if a medication (metformin) widely used in the treatment of diabetes could be re-purposed for the treatment of patients with a diagnosis of early stage ADPKD to slow the rate of kidney function decline, reducing morbidity and mortality and improving the quality of life for ADPKD patients.

NCT ID: NCT04939584 Terminated - Atrial Fibrillation Clinical Trials

Patient Perception of MultiPulse Therapy™ (MPT™)

Start date: November 19, 2021
Phase: N/A
Study type: Interventional

Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.

NCT ID: NCT04939116 Recruiting - Proteinuria Clinical Trials

Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease

Start date: December 24, 2021
Phase: Phase 2
Study type: Interventional

The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.

NCT ID: NCT04938830 Active, not recruiting - RSV Infection Clinical Trials

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

NCT ID: NCT04938817 Active, not recruiting - Clinical trials for Small Cell Lung Carcinoma

Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

Start date: August 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a rolling arm study of pembrolizumab in combination with investigational agents in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study.

NCT ID: NCT04938427 Completed - Clinical trials for Lennox Gastaut Syndrome (LGS)

A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome

Start date: November 8, 2021
Phase: Phase 3
Study type: Interventional

The aims of the study are: - to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. - to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.

NCT ID: NCT04936308 Recruiting - Clinical trials for Arthritis, Psoriatic

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

SOLSTICE
Start date: September 28, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.