Mont De Marsan

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

Myeloproliferative Neoplasms (MPN) are blood cancers linked with a higher risk of blood clots, involving platelets, red blood cells, white blood cells, and blood vessel cells. Some studies have looked at the JAK2V617F gene mutation in white blood cells to predict clot risk, but results have been mixed. This research aims to study the amount of this mutation in different blood cell types and blood vessel cells to find patterns that may relate to clot risk in MPN patients. The study will include 120 patients with polycythemia vera (PV) or essential thrombocythemia (ET) who have the JAK2V617F mutation. Blood samples will be taken to isolate platelets, red blood cells, granulocytes, and endothelial cells. The mutation level will be measured in these cells using digital PCR technology. Researchers will explore how these patterns connect to clot history at diagnosis, MPN type, clot risk scores, and clot types. Participants will undergo a special blood draw alongside routine tests. The study will analyze the mutation levels in different cells and their association with clot risk and disease characteristics. The main measurement is the history of thrombosis when the disease is diagnosed. Safety and consent procedures are followed, and patients will be included at diagnosis or within one year without prior cytoreductive treatment, with consent and registry inclusion.

Researchers are evaluating the effect of early sitting out of bed in an arm-chair position on the functional recovery of patients in intensive care who are on mechanical ventilation. The study focuses on patients with ICU-acquired weakness and aims to determine if this early mobilization technique improves functional and muscular recovery compared to a conservative strategy of sitting in bed. The research hypothesis is that early armchair positioning enhances functional recovery. Participants will be placed in a chair once awake with a Richmond Agitation-Sedation Scale (RASS) score between -1 and +1 for more than 12 hours. They will be seated daily for at least 30 minutes until discharge from intensive care or day 28, whichever comes first, unless there are temporary contraindications. If patients cannot communicate their wish to stop, their tolerance will be checked, and the chair session will not exceed 4 hours. During the study, researchers will assess participants' functional levels at discharge from intensive care or day 28, whichever occurs first. Patients will be monitored throughout their stay, and adherence to the intervention will be tracked. The total participation duration varies depending on the length of stay in intensive care, with functional recovery as the primary outcome measure.

Researchers are conducting a phase 3, multicenter, open-label, randomized study to evaluate new treatments for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation (ASCT). The study aims to compare the effectiveness and safety of a combination of elranatamab and lenalidomide as a replacement for standard chemotherapy during the consolidation phase, and to assess elranatamab alone versus standard care during maintenance therapy. Participants will first receive standard induction therapy with four cycles of a drug combination called D-VRd. After this, they will be randomly assigned to either receive standard consolidation therapy involving high-dose chemotherapy and ASCT followed by D-VRd consolidation (Arm A), or elranatamab combined with lenalidomide for consolidation (Arm B). Upon completing consolidation, patients will be re-randomized to receive maintenance treatment with either lenalidomide alone (Arm C) or elranatamab alone (Arm D). During the study, participants will be monitored for treatment effects including minimal residual disease negativity at the end of consolidation, progression-free survival, and overall survival. The study involves various assessments including clinical evaluations, laboratory tests, and monitoring for disease progression or side effects. The entire treatment and follow-up period may last up to several years, allowing researchers to evaluate long-term outcomes and safety.

Researchers are investigating the safety, effectiveness, and cost-efficiency of the LUMINOR4 Drug Eluting Balloon (DEB) for treating new and recurring lesions in the superficial femoral artery and popliteal artery. This study particularly focuses on complex cases such as calcified, long lesions, or occlusions, where the use of additional debulking devices may improve treatment outcomes. The registry includes a wide range of patients with peripheral arterial disease and follows them for up to five years. Participants will be treated with the LUMINOR4 paclitaxel eluting balloon, which is designed to open narrowed or blocked arteries while delivering medication to prevent re-narrowing. The study allows the use of crossing devices, laser treatment, or atherectomy if needed during the initial procedure. If the balloon treatment is insufficient, bailout stenting is permitted. The treatment targets lesions starting from just below the common femoral bifurcation to the popliteal artery, ensuring at least one patent outflow artery to the ankle. During the study, participants will be monitored for up to 36 months to assess both the primary efficacy endpoint—measured by the artery's openness via ultrasound at 12 months—and overall medical safety. Follow-up includes imaging, clinical evaluation, and safety assessments to track the durability of the treatment. The total participation involves long-term monitoring to evaluate outcomes and potential risks associated with the device and procedure.

Researchers are conducting a French prospective observational study to understand how patients aged 18 years and older with moderate to severe atopic dermatitis (AD) are managed when eligible for or currently receiving systemic therapy. The study aims to describe treatment patterns, including previous and current therapies, and monitor drug survival and compliance over time. Experienced dermatologists in hospital and office settings will participate, ensuring treatment decisions reflect real-world clinical practice. Patients will be followed for one year under routine care, with systemic treatment decisions made solely by their physicians independent of study enrollment. The study does not involve specific interventions or changes in treatment but observes the use and management of systemic therapies for AD, including topical corticosteroid use and other systemic options. Participants will complete questionnaires and undergo assessments at baseline, six months, and twelve months. Researchers will collect data on previous and current treatments, therapeutic management of atopic comorbidities, drug survival changes, and treatment adherence. The study focuses on gathering real-life information on systemic therapy use and patient outcomes over the 12-month follow-up period.

Researchers are evaluating the safety and effectiveness of three different doses of frexalimab compared to a placebo in people with newly diagnosed Type 1 Diabetes (T1D) who are already receiving insulin treatment. This is a Phase 2, randomized, double-blind study with a 52-week blinded extension and an optional open-label extension, aiming to preserve the pancreatic beta-cell function in adults and adolescents aged 12 to 35 years. The study assesses changes in C-peptide concentration over 52 weeks as a primary outcome measure to understand how well the pancreas continues to produce insulin. Participants receive frexalimab or placebo starting with an intravenous infusion on Day 1, followed by subcutaneous injections from Week 2 to Week 102. Insulin therapy continues alongside, with doses adjusted by the investigator. The study includes a screening period of 3 to 5 weeks, a main double-blind treatment period lasting 52 weeks, a 52-week blinded extension, and an optional 104-week open-label extension. After treatment, participants undergo up to 26 weeks of safety follow-up. Throughout the study, participants will have regular assessments including mixed meal tolerance tests to measure C-peptide levels, along with monitoring of safety and efficacy. Researchers will collect data on insulin usage, adverse events, and other health parameters over the total study duration of up to 135 weeks. This comprehensive follow-up helps evaluate the long-term effects of frexalimab on insulin secretion and participant health.

Ventilator-associated pneumonia (VAP) is a common and serious infection in intensive care units, often leading to prolonged mechanical ventilation and excessive antibiotic use. This trial evaluates two strategies for starting antibiotic therapy in patients with suspected non-severe VAP: immediate antibiotic treatment after sampling versus waiting for microbiological confirmation before starting treatment. The study aims to balance the risks of unnecessary antibiotic exposure against the dangers of delaying therapy in infected patients, considering concerns about antibiotic resistance and patient outcomes. Participants are randomly assigned to one of two groups. The control group receives immediate empiric antibiotic therapy within one hour of randomization, based on clinical judgment and local protocols; treatment is stopped if respiratory samples are negative or continued for seven days if VAP is confirmed. The conservative strategy group waits for respiratory sample culture and/or PCR results before starting antibiotics; if results are negative, no antibiotics are given, and if positive, treatment is started promptly and continued for seven days without waiting for susceptibility testing. Throughout the study, participants are monitored for death or continued use of invasive mechanical ventilation up to 28 days. Researchers record the proportion of patients who die or remain on ventilation at 28 days as the primary outcome. The study involves patients who have been mechanically ventilated for more than 48 hours and meet specific clinical criteria for suspected VAP without signs of severe illness, with informed consent obtained from patients or their representatives.

Kidney cancer accounts for 2 to 3% of solid cancers in adults, with around 431,288 new cases worldwide yearly. In France alone, 13,500 patients undergo total or partial nephrectomy annually. Advances in minimally invasive surgery and enhanced recovery programs have shortened hospital stays, but this has changed the care experience for kidney tumor patients, often leading to feelings of decreased care quality and disrupted medical follow-up. The study aims to evaluate a new approach to coordinate perioperative care for patients having nephrectomy for kidney tumors across several French centers, focusing on benefits for patients, caregivers, and the healthcare system. The study is assessing the UroConnect remote monitoring medical device, which includes a patient interface with self-questionnaires and educational materials, and a caregiver interface designed to improve nurse coordination during the perioperative period. This device supports the formalization of a nurse coordinator role that is tailored to the needs of oncological surgery. The intervention involves implementing UroConnect to optimize patient support and nursing coordination throughout the surgical care pathway. Participants will be monitored for 30 days after surgery, with researchers measuring the number of unplanned and uncoordinated healthcare visits during this time. The study collects data through the device and nursing coordination activities to assess its impact on care quality. This approach aims to improve the surgical care pathway for kidney tumor patients by digitizing nursing coordination and enhancing support during recovery.

Researchers are investigating the potential preventive effect of clopidogrel on the development of systemic sclerosis (SSc), a serious autoimmune disease involving immune dysfunction, blood vessel damage, and tissue scarring. This trial focuses on people who show early signs of the disease, including the presence of specific autoantibodies and Raynaud phenomenon, which together indicate a high risk of progressing to full SSc within five years. The study is designed as a Phase II/III double-blind, randomized, placebo-controlled trial to evaluate whether clopidogrel can reduce this risk. Participants will be randomly assigned to receive either clopidogrel 75 mg or a matching placebo daily for two years. The treatment phase lasts 24 months, during which participants will take the study medication orally each day. After finishing treatment, they will be followed for an additional 36 months without study medication, making the total study duration five years. The study compares the frequency of developing SSc according to established criteria between the two groups over this period. Throughout the study, participants will have clinical examinations, blood tests, and patient-reported outcome assessments every six months. These evaluations will monitor disease progression, treatment effects, and safety. The main outcome measured is how often participants develop systemic sclerosis within five years. The study includes long-term follow-up to assess the lasting impact of clopidogrel on disease prevention and participant health.