Castelnau Le Lez

Venous thromboembolism (VTE) and atherosclerotic cardiovascular disease often occur together and share similar risk factors. Managing these conditions requires antithrombotic treatments, including anticoagulant therapy (AC) to prevent VTE recurrence and antiplatelet therapy (AP) to prevent major cardiovascular and cerebrovascular events. The combination of AC and AP can increase the risk of side effects, especially bleeding, which is a leading cause of emergency admissions related to adverse drug reactions. This Phase 3 trial compares two treatment strategies in patients with acute VTE who are also taking antiplatelet therapy for atherosclerotic cardiovascular disease. One group receives full-dose anticoagulant therapy alone, while the other group receives combined full-dose anticoagulant therapy plus antiplatelet therapy (aspirin or clopidogrel). The anticoagulant choice is at the investigator's discretion following international guidelines. The study aims to evaluate which strategy better balances the risk of bleeding and cardiovascular events. Participants are monitored for clinically relevant bleeding events during up to 12 months of full-dose treatment. The study also assesses recurrent venous thromboembolism and major adverse ischemic cardiovascular and cerebrovascular events. Throughout the study, researchers collect data on safety and effectiveness to determine the net clinical benefit of each treatment approach. Participation involves regular evaluations and follow-up over the treatment period.

Researchers are studying patients with chronic kidney disease who are beginning dialysis to understand how certain bone mineral markers relate to the progression of vascular calcifications over two years. The study focuses on measuring levels of plasma osteoprotegerin and plasma fibroblast growth factor 23 at the start of dialysis and tracking changes in vascular calcification, which may impact cardiovascular risk. Participants will have their plasma osteoprotegerin and fibroblast growth factor 23 levels measured through blood tests. Vascular calcification will be assessed using X-ray imaging of the lateral abdominal aorta to determine calcification scores. These measurements will be taken at the beginning and followed up over a two-year period to monitor changes. During the study, participants will undergo blood tests and X-ray imaging to evaluate their vascular calcification status and bone mineral marker levels. Researchers will measure the progression of vascular calcifications and relate it to plasma osteoprotegerin levels at inclusion. The total follow-up duration for participants is two years, allowing for long-term assessment of cardiovascular risk factors in this patient group.

Researchers are studying the effectiveness and tolerance of a new anti-regurgitation infant formula designed to reduce regurgitation episodes in infants with gastroesophageal reflux. This randomized, controlled, double-blind trial compares the new formula thickened with fibers to a formula thickened with locust bean gum. The goal is to assess how well the new formula reduces regurgitation frequency and its effects on digestive tolerance. Participants will exclusively feed their infants either the experimental formula or the comparator formula during the study. The study lasts for 1 month and 2 days, beginning with a 2-day pre-selection period, followed by a 30-day follow-up period. There is an optional additional 2-month follow-up phase to further monitor the infants. During the study, parents and researchers will track the frequency of regurgitation on day 14 as the primary outcome. Other assessments include monitoring digestive tolerance and overall infant health. Parents provide informed consent and participate in feeding and observation activities throughout the study duration, which may last up to 3 months if the optional follow-up is added.

Researchers are evaluating treatment strategies to improve overall survival in younger adults aged 18 to 60 years with acute myeloid leukemia (AML). This phase II/III open-label multicenter trial uses risk-adapted approaches throughout different stages of AML treatment, including induction, consolidation, and hematopoietic stem cell transplantation (HSCT) when applicable. The study also assesses optimal graft versus host disease (GvHD) prevention after allogeneic stem cell transplant in first complete remission (CR), comparing different conditioning intensities and prophylaxis methods. Participants receive induction chemotherapy with either daunorubicin plus cytarabine or high-dose idarubicin plus cytarabine. Consolidation therapy compares high-dose versus intermediate-dose cytarabine, with additional options including vosaroxin, dexamethasone, and venetoclax at various dosing levels depending on phase and response. For patients undergoing allogeneic SCT, GvHD prophylaxis is evaluated using either standard cyclosporine plus methotrexate or cyclosporine with mycophenolic acid (MPA). Treatment schedules include specified dosing days and supportive care with granulocyte-colony stimulating factor (G-CSF) until blood recovery. Participants are closely monitored through assessments including bone marrow aspirates, laboratory tests, cardiac evaluations, and genetic mutation testing. Outcome measures include overall survival at 3 years, disease-free survival at 18 months, and incidence of acute GvHD within 100 days post-transplant. Safety and treatment response are tracked throughout induction, consolidation, and transplantation phases. The study includes consent procedures and contraception requirements for certain treatments, with total involvement potentially spanning multiple treatment cycles and follow-up periods.

Thrombotic Micro-angiopathy (TMA) is a serious condition that includes Haemolytic and Uraemic Syndrome (HUS), requiring quick diagnosis and treatment. This study evaluates a therapeutic orientation test designed to detect the involvement of the complement system in TMA diagnosis. The test measures complement deposits on endothelial cells in a lab setting and aims to improve early detection of complement activation, which is important for timely treatment with drugs like Eculizumab that block the complement pathway. The therapeutic orientation test is performed on blood samples collected at three points: at the start of the study, at one month, and at six months. The study compares the test results with patients' clinical outcomes and the presence of abnormalities in complement regulation. This approach helps to assess the test's sensitivity and specificity over an average follow-up period of three years. Participants will undergo diagnostic testing and clinical monitoring throughout the study. Researchers will evaluate how well the test predicts complement involvement and patient evolution, especially in relation to treatment with Eculizumab. The study will use blood tests and clinical data to measure outcomes, tracking participants' health over several years to determine the test’s accuracy and usefulness in managing TMA.