Saint Jean De Luz

Researchers are evaluating new drugs or combinations of drugs to treat relapsed or refractory peripheral T-cell lymphomas through a platform trial consisting of multiple sub-studies. The study aims to collect exploratory data to better identify patient populations and inform the design of future clinical trials. Phase 1 sub-studies focus on determining safety and tolerability of increasing doses, while phase 2 sub-studies aim to find drugs that significantly improve patient outcomes. The trial includes at least two sub-studies Origina-ly-T, an open-label phase 2 study assessing the efficacy and safety of roginolisib, and GolcAza, an open-label phase 1 study identifying the maximum tolerated dose of golcadomide combined with oral 5-azacitidine. Participants receive the study treatments daily until unacceptable side effects, disease progression, or withdrawal. Origina-ly-T requires 31 patients, and GolcAza requires at least 18 patients. Participants will be monitored through clinical visits and assessments including progression-free survival and dose tolerance over a maximum two-year period. Researchers will evaluate safety, response rates, clinical benefit, time to next treatment or death, overall survival, and transplantation rates following treatment. The study requires adherence to visit schedules and protocol requirements, with careful safety monitoring throughout the treatment and follow-up phases.

Researchers are evaluating the SING IMT prosthesis in patients aged 55 and older who have pseudophakic eyes eyes with implanted intraocular lenses and suffer from late-stage Age-Related Macular Degeneration AMD with moderate to profound bilateral central vision impairment. This international, randomized, multicenter study aims to expand the devices approved use and assess its safety and effectiveness in this specific patient group. The findings will support regulatory decisions, help clinical care, and may lead to label expansion for the device. The study involves two treatment approaches one where the SING IMT device replaces the existing intraocular lens IOL after removal Lens Exchange group, and another where the device is implanted in front of the existing IOL without removal Add-On group. Both procedures place the device in the sulcus area of the eye. Participants will be randomly assigned to one of these two groups. The trial includes multiple follow-up periods to assess outcomes after implantation. Participants will undergo vision tests and eye examinations at the start and then at 1, 3, and 6 months after the procedure. Key assessments include measuring the percentage of endothelial cell density ECD loss, visual acuity, and recording any surgical complications or adverse events. Patient-reported outcomes and the size of the incision needed for implantation will also be tracked. Participants are expected to engage in a postoperative training program for using the implant. The total study duration for each participant covers these assessments and monitoring visits.

Researchers are evaluating the safety and effectiveness of the SING IMT Smaller Incision New Generation Implantable Miniature Telescope 3X implant to improve vision in patients aged 55 years and older with central vision impairment caused by end-stage Age-related Macular Degeneration AMD. This is a prospective, multicenter, open-label study where all eligible patients receive the implant and are followed for one year. The study aims to determine how well the device works and its safety during this period. Participants who qualify will have the SING IMT 3X device implanted during routine cataract surgery. Eligibility is confirmed by testing vision improvement with an external telescope simulator before surgery. After implantation, patients will attend 6 to 10 vision training sessions with a low-vision specialist to help adapt to the device. Surgeons will also assess the usability and satisfaction of the implant during the study. Throughout the 12-month follow-up, participants will have regular eye exams to monitor vision and eye health in both eyes. The study will track any surgical complications, adverse events, and medication use from the start to the end of the study. Researchers will measure improvements in visual acuity and the safety of the implant system, including the delivery method used during surgery.

Researchers are evaluating the Transoral Endoscopic Thyroidectomy by Vestibular Approach TOETVA compared to the traditional Anterior Cervical thyroidectomy AC in patients needing lobectomy or total thyroidectomy without lymph node procedures. This study aims to assess whether TOETVA, a newer surgical technique avoiding neck scars, is as safe and effective as the standard AC method. The trial focuses on early and mid-term postoperative complications, quality of life, and pain levels after surgery. The study involves two groups one receiving the TOETVA procedure and the other undergoing the AC surgery. TOETVA uses an endoscopic approach through the mouth to access the thyroid gland, potentially reducing visible scarring and tissue dissection. The AC procedure is the conventional open surgery with a neck incision. The trial will compare outcomes such as complication rates and patient recovery between these two surgical methods. Participants will be monitored for complications during the first 24 hours and up to 30 days after surgery. Quality of life and pain will be assessed at one month and six months post-operation using validated measures. The study includes follow-up visits to evaluate healing and patient well-being. Participation lasts through the surgical treatment and follow-up assessments, ensuring thorough evaluation of both surgical techniques.