Villeneuve D Ascq

Researchers are evaluating the safety of KTX-1001, a new oral drug that selectively inhibits the MMSET enzyme involved in multiple myeloma, in adults with relapsed or refractory multiple myeloma RRMM. This Phase I study aims to find the best dose and understand how the drug works alone and combined with other therapies in patients with a specific genetic change called t414. The study has two parts a dose escalation phase where different doses of KTX-1001 are tested over 28-day cycles to find the recommended dose and maximum tolerated dose and a dose expansion phase where patients receive KTX-1001 alone or combined with Mezigdomide, dexamethasone, carfilzomib, or pomalidomide. Treatments are given orally or by infusion depending on the combination, with dexamethasone taken once weekly. Participants will be monitored for response to treatment, drug safety, and how their bodies process the drug through regular assessments during the study. The main outcomes include determining the recommended dose and initial effectiveness of KTX-1001 combinations. The study is expected to continue until June 2028, with ongoing evaluations throughout treatment cycles.

Researchers are evaluating the use of the iCover balloon-expandable covered stent as a bridging stent in fenestrated endovascular aortic repair fEVAR to treat complex abdominal aortic aneurysms. This European multicenter, prospective study aims to demonstrate the safety and performance of iCover when implanted in target vessels during fEVAR procedures, which are preferred for their benefits over open surgery, such as reduced renal dysfunction risk and faster recovery. Participants will receive the iCover stent implanted as a bridging stent during the fEVAR procedure. The iCover stent is designed to be placed in renal and visceral arteries with specific size and anatomical requirements. The study includes a treatment phase where the device is implanted, followed by regular follow-up visits at discharge, 6 months, and 12 months to monitor the stents patency, stability, and absence of complications like endoleaks or aneurysm growth. During the study, participants will undergo imaging tests such as CT angiography and other evaluations to assess stent function and aneurysm status at specified intervals. Researchers will track outcomes including stent patency, vessel stability, technical success of implantation, and any adverse events or mortality up to 12 months post-implant. Participants are expected to attend all follow-up visits and comply with study procedures over the course of approximately one year.

Researchers are evaluating two adapted physical activity programs for adolescent idiopathic scoliosis AIS, a condition affecting 2% of adolescents aged 10 to 16 and more common in girls. The study aims to compare the effectiveness of a supervised high-intensity interval training HIIT program delivered via tele-rehabilitation by an adapted physical activity APA teacher versus a self-guided home exercise program using specific booklets. The goal is to see if tele-rehabilitation helps maintain long-term physical activity benefits in AIS patients. Participants will be randomly assigned to one of two groups. The TELE-APA group will take part in a 12-week tele-rehabilitation program with three 45-minute HIIT sessions per week, supervised by an APA teacher. After this, they will continue with a 12-week home exercise program using a HIIT exercise booklet. The CONTROL group will perform the same home-based HIIT exercise program using booklets for two consecutive 12-week periods without supervision, encouraged to keep a diary to track adherence. During the study, participants will undergo multiple evaluations including physical performance on a rowing ergometer, muscle endurance tests, VO2 max estimation, posture analysis using a force platform, spine radiographs, and quality of life assessments at baseline, 12 weeks, and 24 weeks. Attendance and motivation will be monitored weekly, and safety and progress will be regularly checked. The entire participation lasts 24 weeks, including supervised and self-guided periods.

This research focuses on young people hospitalized for psychiatric disorders, aiming to evaluate whether a training program for psychiatric care teams improves discussions about sexual health. The study addresses the impact of psychiatric disorders and psychotropic medications on sexuality, emphasizing a positive and respectful approach to sexual health as defined by the World Health Organization. The goal is to increase conversations about sexual health during hospitalization in several psychiatric clinics. The study is non-interventional and conducted in three phases. First, a mixed-method assessment including a quantitative self-questionnaire and qualitative surveys gathers baseline information from patients and caregivers. Next, based on this data, training programs for psychiatric professionals and supportive tools for young people are developed and implemented. Finally, the initial quantitative survey is repeated one year after training to measure its impact. Participants take part by completing self-administered questionnaires during their psychiatric care visits at specific times before and after the caregiver training. Researchers collect and compare responses to assess changes in sexual health discussions. The study involves evaluations through surveys, and participation lasts through the phases needed to complete these assessments, with no additional treatments involved.

Researchers are evaluating the use of virtual reality as a method to reduce pain during the endovenous thermal treatment of superficial varicose veins. The study aims to see if virtual reality sedation can delay the need for neuroleptanalgesia when combined with local anesthesia by tumescence. This is a prospective, randomized, open-label study involving 200 patients, focused on comparing pain intensity during surgery. Participants are divided into two groups one group receives local anesthesia by tumescence plus the usual neuroleptanalgesia treatment, while the other group receives local anesthesia with virtual reality software for sedation. The study tests if virtual reality sedation is not inferior to traditional neuroleptanalgesia by measuring maximum intraoperative pain. The entire participation lasts up to 2 days. During the study, pain is assessed immediately after surgery using a numerical rating scale. Researchers will also evaluate pre- and post-operative anxiety, overall patient satisfaction, surgery duration, ICU and hospital stay length, and time to resume normal activities. Safety and treatment details are monitored throughout, with the primary outcome focused on pain intensity on the first day.