Laval

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

This research aims to compare the effectiveness of a carbon medical device ankle foot orthosis AFO versus a standard plastic AFO in helping patients with walking difficulties due to foot drop. Foot drop is a problem often seen in various nerve and muscle diseases that affects walking ability, autonomy, and quality of life. The study focuses on how well patients can achieve their personal goals related to walking function while using these devices. Participants will use two types of ankle foot orthoses alternately in four phases over 12 weeks starting with the standard plastic AFO, then switching to the carbon medical device AFO, followed again by the standard plastic AFO, and finishing with the carbon AFO. Each participant serves as their own comparison. The treatments are worn regularly during this period as part of four study phases. Throughout the study, participants will be assessed at five visits from day 0 to week 12. Researchers will evaluate goal achievement using the Goal Attainment Scaling GAS three times a week, along with measures of mobility, walking distance, fatigue, stability, disability, pain, gait, balance, tolerance, and satisfaction. This comprehensive monitoring helps understand how each device impacts walking function and overall patient experience.

Researchers are investigating a new care pathway using Automated Dynamic Laximetry ADL to diagnose knee sprains with suspected cruciate ligament damage. Currently, magnetic resonance imaging MRI is the standard method to confirm diagnosis and assess severity, but studies suggest ADL performs similarly. This study aims to evaluate if starting care with ADL immediately after an emergency room visit can shorten diagnosis time, reduce immobilization, and lower care costs compared to the usual MRI-based approach. Participants will be randomly assigned to one of two groups one receiving the ADL-based care pathway and the other following the standard MRI pathway. In the ADL group, patients use a Zimmer splint to immobilize the injured limb and see a sports physician for ADL confirmation. In the MRI group, patients also use the Zimmer splint but receive an MRI scan and then follow usual care with their chosen doctor. MRI will be reserved for specific cases like surgery scheduling. During the study, participants will complete questionnaires such as the KOOS and EQ-5D-5L at multiple time points up to 12 months. Researchers will track recovery, return to work and sports, treatment timing, costs, and quality of life. The study involves follow-up visits to monitor progress and assess the benefits of the new care pathway over a year after injury.

Researchers are evaluating discomfort, pain, and skin condition changes in patients with reduced or very reduced mobility who use bedpans during hospital stays. This observational study focuses on patients over 18 years old who are bedridden and require bedpans, aiming to collect patient and caregiver opinions about current bedpan designs and their effects. The goal is to better understand pain and discomfort linked to bedpan use in typical hospital departments. Participants will be followed for 48 hours during their hospital stay, with data collected from two pelvis fittings every 24 hours, each fitting involving installation and removal of the bedpan. The study gathers information through patient questioning during hygiene care, which takes about 15 minutes total over two days. Caregivers also observe skin condition for redness or pressure sores while assessing pain and discomfort related to bedpan use. During the study, patients will have four pain assessments within 48 hours, along with evaluations of discomfort, skin condition changes, caregiver pain during bedpan handling, and factors influencing pain onset. The study also measures bedpan stability and difficulty of positioning or removal. Researchers will monitor how time spent on the bedpan affects pain, skin changes, and discomfort, with all data collected during the 48-hour follow-up period.

Calciphylaxis, also called uremic calcifying arteriolopathy UCA, is a rare condition causing painful skin lesions due to small blood vessel calcification and clotting. This disease mainly affects patients with end-stage renal disease ESRD who require hemodialysis. Researchers are evaluating the safety and effectiveness of adding rheopheresis, a special blood filtration treatment, to the standard care for calciphylaxis in these patients through a prospective randomized controlled trial. In this study, participants will be randomly assigned to one of two groups. The experimental group will receive rheopheresis in addition to standard care, involving an induction phase of 3 sessions in the first week followed by 2 sessions weekly for 3 weeks, then a maintenance phase with 1 session per week up to week 11. The comparator group will receive sham-apheresis sessions on the same schedule, which mimics the procedure without actual filtration. Rheopheresis uses a machine to remove certain high molecular weight proteins from plasma to help treat microcirculation problems. Participants will be followed for 12 weeks during treatment with regular assessments of wound healing, pain levels, quality of life, antibiotic usage, hospital discharge days, survival, and inflammatory protein changes. The primary outcome is the percentage of patients achieving complete healing of calciphylaxis lesions after 12 weeks. Secondary outcomes include partial healing, new lesion occurrence, pain and analgesic use, and overall survival at 12 weeks and one year. Safety and efficacy data will help determine the added value of rheopheresis in calciphylaxis care.

Researchers are evaluating the use of immersive virtual reality VR technology as part of a functional restoration program FRP for patients with chronic low back pain CLBP. This pilot study aims to assess how acceptable and usable the VR headset is for both healthcare providers and patients within a group rehabilitation setting. Chronic low back pain is a major cause of disability affecting quality of life, and while VR has shown promise in reducing pain and improving motor abilities, its role in group rehabilitation for CLBP is still being explored. Participants will receive the standard FRP, which includes physiotherapy, hydrotherapy, occupational therapy, adapted physical activity, and educational workshops. In addition to this, patients will use a wireless, immersive VR headset three times a week for 20-minute sessions over four to five weeks. The VR sessions involve pre-programmed exercises focusing on trunk movements like flexion, extension, and rotation, designed to enhance motor skills and reduce pain. Healthcare providers will assist patients in using the device in a dedicated room and monitor for any side effects. Throughout the study, patients will complete questionnaires assessing pain, kinesiophobia fear of movement, motor imagery ability, and functional disability at the start and end of the program. Pain levels will be recorded before and after each VR session. Adherence to the VR program will also be monitored weekly. The main measure is how well the VR system is accepted and used by participants by the end of the five-week program. This research will provide important information on integrating VR into group rehabilitation for chronic low back pain and inform future larger trials.