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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating the best length of prednisone treatment for patients with granulomatosis with polyangiitis GPA and microscopic polyangiitis MPA, serious autoimmune diseases that can relapse and cause damage despite current treatments. Rituximab is commonly used to maintain remission, but the ideal duration for prednisone therapy remains unclear. This trial is the first prospective study to compare longer versus shorter prednisone use as an add-on to remission maintenance in these conditions. Participants will receive either prednisone 5 mg per day or a placebo for 12 months, with dosing beginning on Day 1. Prednisone dosage will be tapered by 1 mg per week until complete withdrawal after 12 months. The study is randomized, double-blind, and placebo-controlled, evaluating the impact of extended prednisone use alongside rituximab maintenance therapy. During the 30-month study period, participants will be monitored for relapse-free survival, defined by a disease activity score BVAS greater than zero. Researchers will also assess serious adverse events, glucocorticoid-related complications like fractures and weight gain, vasculitis relapse rates, prednisone use, bone density, disease damage, functional disability, quality of life, and healthcare resource use. Assessments include clinical evaluations and standardized questionnaires to track disease status and treatment effects over time.

Age: 18Years +All GendersPhase Not Applicable
45 locations
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Actively Recruiting

Researchers are evaluating how an early and extended rehabilitation program that combines personalized nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for patients who have undergone invasive mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this tailored rehabilitation program to usual care, aiming to support recovery from critical illness. The study is a multicenter randomized controlled trial led by Nantes University Hospital. Participants will be assigned randomly to either the rehabilitation group or the usual care group. Those in the rehabilitation group receive a customized program starting early in the ICU and continuing through the post-ICU ward and at home for 12 weeks. This program involves goal-directed nutrition and physical activities adjusted to each patients progress, with support from dieticians, physiotherapists, and physical activity instructors. The usual care group receives standard nutritional support and physiotherapy based on local practices from day 0 to day 180. Throughout the study, participants will undergo various assessments including walking distance measured by a 6-minute walk test at 6 months, muscle strength, muscle mass, physical activity levels, calorie and protein intake, body weight, mortality rates, blood glucose monitoring, and quality of life surveys. These evaluations occur at multiple time points during and after hospitalization, up to one year. The study includes careful monitoring of mechanical ventilation duration, infections, hospital stay lengths, and other safety outcomes. Participant involvement spans from ICU admission through long-term follow-up.

Age: 18Years +All GendersPhase Not Applicable
52 locations
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Actively Recruiting

Researchers are studying patients with chronic obstructive pulmonary disease COPD who experience frequent exacerbations. The study aims to compare the effectiveness of remote monitoring using the Bora Care solution versus conventional follow-up care. The main goal is to see if remote monitoring reduces the total number of hospital days due to respiratory problems over one year. Participants are randomly assigned to either a control group or an experimental group. The control group receives conventional care, including two general practitioner visits and one pulmonologist visit per year. The experimental group receives the same conventional care plus the Bora Care remote monitoring system, which includes a wristband that measures vital signs at home, a platform for caregivers to view data, and an early detection score for COPD exacerbations. Nurses trained in the Bora Care system monitor patients daily, alert the pulmonologist if needed, and follow up on any alerts. During the study, participants will have clinical visits including a 12-month follow-up with a pulmonologist. Researchers will monitor hospitalizations, length of hospital stays, quality of life, device usage, care organization, and patient and caregiver satisfaction over one to three years. The study uses a randomized design without masking and will last until December 2027.

Age: 18Years +All GendersPhase Not Applicable
10 locations