Villeneuve D Ascq

Researchers are evaluating the safety of KTX-1001, a new oral drug that selectively inhibits the MMSET enzyme to block a specific protein modification, in adults with relapsed or refractory multiple myeloma (RRMM). This Phase 1 study aims to find the best dose and schedule for KTX-1001 and to explore its effects in combination with other anti-myeloma therapies, especially in patients with a specific genetic change called t(4;14). The study has two parts: dose escalation and dose expansion. In dose escalation, patients receive KTX-1001 orally for 28 days per cycle to determine the maximum tolerated dose and recommended Phase 2 dose. In dose expansion, patients with t(4;14) receive KTX-1001 alone or combined with Mezigdomide, dexamethasone, carfilzomib, or pomalidomide. Treatments continue until disease progression. Dexamethasone is given once weekly by mouth, carfilzomib is given intravenously once weekly for three weeks per cycle, and pomalidomide is taken orally for 21 days in each 28-day cycle. Participants will be closely monitored throughout the study, including during the first 28-day cycle for dose-limiting toxicities and ongoing safety and efficacy assessments. Researchers will collect data on antitumor effects and tolerability. The study involves multiple visits with laboratory tests, imaging, and clinical evaluations to measure disease status and side effects. The total duration depends on patient response and treatment continuation until progression or unacceptable toxicity.

Researchers are evaluating the use of the iCover balloon-expandable covered stent as a bridging stent during fenestrated endovascular aortic repair (fEVAR) procedures to treat complex abdominal aortic aneurysms. The study aims to assess the safety and performance of the iCover stent in this context, focusing on avoiding open surgery risks by using fenestrated stent grafts, which may reduce kidney problems, surgical trauma, and recovery time for high-risk patients. The iCover stent system is used as a bridging stent in fEVAR procedures, positioned to connect the fenestrated endograft to target arteries such as renal arteries, the superior mesenteric artery, or the celiac trunk. The study follows specific anatomical and device guidelines to ensure proper placement, including limits on vessel diameter, angulation, and landing zones. Up to two iCover stents may be used per fenestration if needed. Participants will be monitored over a 12-month period to measure stent patency and the stability of target vessels after implantation. Follow-up involves clinical evaluations and imaging to detect any vessel instability or complications. The study also records safety outcomes and adherence to specified timelines, with participants expected to have a life expectancy exceeding 12 months and to comply with follow-up visits as scheduled.

Researchers are investigating two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS), a condition affecting about 2% of adolescents aged 10 to 16, mostly girls. AIS can cause physical deformities, pain, respiratory issues, bone problems, and psychological effects like reduced self-esteem and anxiety. Conventional treatments include rehabilitation and braces, but many adolescents do not engage in regular physical activity, which is important for managing AIS complications. This study focuses on improving access to tailored physical activity through tele-rehabilitation using high-intensity interval training (HIIT). The trial compares two groups of non-athletic adolescent girls with AIS over a 12-week period. One group receives a tele-rehabilitation program with individualized HIIT sessions supervised weekly by an adapted physical activity (APA) teacher via video conferencing, with three 45-minute sessions each week. The control group follows a self-guided home program using an exercise booklet with HIIT exercises specific to AIS, also three 45-minute sessions per week. After this first 12-week phase, both groups continue with a 12-week period of the home-based program using the booklet alone. Participants will be monitored for adherence through session attendance records or diaries. Researchers will evaluate overall physical performance using an ergometer-rowing machine at the start and after 12 weeks. The study includes assessments of physical ability, exercise adherence, and safety, with follow-up extending through the 24-week total participation. The goal is to determine if supervised tele-rehabilitation improves physical function and maintains benefits long term compared to self-guided exercise.

Researchers are evaluating how psychiatric disorders and the use of psychotropic medications affect the sexual health of young people hospitalized for psychiatric care. The study aims to increase discussions about sexual health between care teams and young patients by providing training to psychiatric staff. This research focuses on adolescents and young adults aged 15 and older receiving care in clinics affiliated with the French Society for Child and Adolescent Psychiatry (FSEF). The study involves three main phases. First, a mixed-method evaluation is conducted, including a self-administered questionnaire offered to all psychiatric patients during a one-month assessment period and qualitative surveys involving young patients and caregivers. Next, training programs for healthcare professionals are developed and delivered based on initial findings, alongside interventions for young people conducted both individually and in groups. Finally, the original quantitative survey is repeated after the intervention to measure changes in how often sexual health topics are discussed. Participants will complete self-questionnaires during two separate one-month periods—before and after the training intervention—to assess the impact of the study. Qualitative feedback from young people and caregivers will also be collected. Researchers will compare questionnaire results from before and one year after the team training to evaluate changes in communication about sexual health related to psychiatric disorders and psychotropic treatments. The study includes monitoring of patient consent and ensures follow-up during hospitalization in the psychiatric care settings.

Researchers are evaluating the potential of virtual reality to reduce pain during the endovenous thermal treatment of superficial varicose veins. This study aims to see if digital sedation using a virtual reality device can delay the need for neuroleptanalgesia, compared to the usual sedation methods. The trial is a prospective, randomized, open-label study involving 200 patients with superficial venous insufficiency. Participants will be divided into two groups: one using a device with virtual reality software for sedation, and the other receiving the usual neuroleptanalgesic treatment along with local anesthesia by tumescence. The study compares pain intensity during surgery between these two methods, accepting a small margin of difference to test whether virtual reality sedation is not worse than standard sedation. The treatment and assessments take place during a single outpatient surgical procedure. Participants will be monitored for pain intensity immediately after surgery using a numerical rating scale. The entire participation lasts up to 2 days. Researchers will assess maximum intraoperative pain and safety outcomes. The study includes measures to ensure participant understanding and consent, with a focus on tolerability and effectiveness of the digital sedation approach.