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NCT ID: NCT05818943 Recruiting - Clinical trials for GRIN-related Disorders

Evaluation of Radiprodil in Children With GRIN-related Disorder

Start date: March 7, 2023
Phase: Phase 1
Study type: Interventional

Study RAD-GRIN-101 is a phase 1B trial to assess safety, tolerability, PK, and potential efficacy of radiprodil for the treatment of GRIN-related disorder in children with a Gain-of-Function (GoF) genetic variant. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A. After the end of part A, all participants who are still eligible can choose to continue to receive radiprodil as part of an open-label long-term treatment period (Part B).

NCT ID: NCT05818774 Recruiting - Neck Pain Clinical Trials

End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves

EndPaRL
Start date: March 10, 2023
Phase: N/A
Study type: Interventional

Aim of the EndPaRL study is to compare the efficacy and effectiveness of the two techniques utilizing sharp straight conventional radiofrequency needle with a trident needle for radiofrequency neurotomy of Cervical Medial Branch Nerves (CMBNs), in patients presenting with chronic, moderate-to-severe, neck pain due to cervical zygapophyseal joint osteoarthritis, as diagnosed by positive responses to two consecutive diagnostic blocks with local anesthetic of the CMBN.

NCT ID: NCT05818358 Recruiting - Arterial Stiffness Clinical Trials

Postprandial Effects of Bean and Whole Grain Consumption on Arterial Stiffness

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This is a single site, single-blinded, controlled randomized crossover clinical trial designed to compare the effects of black beans or whole grains or white rice at breakfast on postprandial vascular responses in males and females with arterial stiffness (n=10). Eligible participants will be asked to attend 3 in-person visits for comparative testing of black beans versus whole grains versus white rice.

NCT ID: NCT05818150 Recruiting - Knee Osteoarthritis Clinical Trials

GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA

MOTION
Start date: January 16, 2024
Phase: N/A
Study type: Interventional

This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.

NCT ID: NCT05816811 Recruiting - Stroke Clinical Trials

Power Exercise for Stroke Recovery: The POWER Feasibility Trial

POWER-F
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Post-stroke deficits are highly common and functional impairment persists throughout life after stroke. Skeletal muscle mass and strength are fundamental contributors to mobility throughout the adult life course. Stroke-related muscle atrophy contributes to loss of strength, and declines in lower extremity function, cardiorespiratory fitness, and walking independence and post-stroke sarcopenia. Improving the quantity and function of skeletal muscle needs to be an important therapeutic target after stroke. Resistance exercise training (RET) has been shown to increase skeletal muscle mass, strength and power, reduce oxidative stress, improve cardiac function, and better regulate lipids after stroke. However, the feasibility and the effects of a power focused RET program for individuals with stroke need to be examined.

NCT ID: NCT05816122 Recruiting - Multiple Sclerosis Clinical Trials

MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect

MS-DETECT
Start date: September 22, 2023
Phase: N/A
Study type: Interventional

The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS). The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution. A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients. Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL). Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression. The study will include 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

NCT ID: NCT05815433 Recruiting - Clinical trials for Microbial Colonization

Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants

PPDHM
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum antibiotic prophylaxis (IAP) therapy during labour. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups. The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and high breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.

NCT ID: NCT05814705 Recruiting - Healthy Clinical Trials

The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

There are times in life when people cannot use their muscles, such as during illness or injury. Muscle and mitochondria (the 'energy factory' in cells) health decline very quickly when people cannot use their muscles, but certain foods can help reduce these declines. Recent research suggests that Urolithin A, which is a natural compound that can be produced after eating pomegranates, nuts, and berries, improves muscle health. In this study, the investigators aim to investigate if a protein beverage (standard care during disuse) with or without Urolithin A can reduce or prevent the loss of muscle health while wearing a knee brace (muscle disuse).

NCT ID: NCT05814627 Recruiting - Clinical trials for Rheumatoid Arthritis

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

SELECT- SWITCH
Start date: June 15, 2023
Phase: Phase 3
Study type: Interventional

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05814471 Recruiting - Gonarthrosis Clinical Trials

Validation orthèse Pour Gonarthrose

Start date: March 30, 2023
Phase: N/A
Study type: Interventional

A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.