Cergy

This research investigates treatment options for patients with intermittent claudication due to long lesions (15-25 cm) in the superficial femoral artery, a condition affecting many active individuals over 60 years old. It addresses the lack of dedicated clinical trials comparing femoro-popliteal bypass surgery to endovascular procedures, the latter currently recommended as first-line despite limited evidence on their long-term success. Participants receive either femoro-popliteal bypass surgery using the best vascular substitute available, such as an inverted saphenous vein or vascular prosthesis, under general or local anesthesia, or an endovascular procedure performed under general, local anesthesia, or sedation involving balloon angioplasty followed by stent placement or drug-coated balloon angioplasty. Both treatments target restoring blood flow through the affected artery. Throughout the study, researchers monitor the primary outcome of artery patency at two years post-procedure. Participants undergo assessments to track treatment success and safety, with careful attention to eligibility, informed consent, and follow-up over this period. The study aims to clarify which approach better maintains artery openness in patients with symptomatic lower limb artery disease.

Researchers are evaluating two antibiotic treatments for adults with bronchiectasis who have an early infection of the airways with Pseudomonas aeruginosa (PA). This infection is linked to more frequent flare-ups, worsened quality of life, and higher risk of death. Current guidelines recommend antibiotic treatment upon the first detection of PA, but the best regimen is unclear. The study aims to compare regimens involving oral fluoroquinolones alone or combined with intravenous and inhaled antibiotics to find effective and manageable treatment options. The study includes two treatment groups over a 3-month period. One group receives a 14-day course of oral ciprofloxacin and inhaled sodium colistimethate followed by 2.5 months of inhaled sodium colistimethate alone. The other group receives a 14-day combination of intravenous ceftazidime, oral ciprofloxacin, and inhaled sodium colistimethate, then continues inhaled sodium colistimethate for 2.5 months. After treatment, both groups are followed for an additional 9 months to monitor outcomes, totaling 12 months of antibiotic therapy and follow-up. Participants will undergo assessments including respiratory sample testing to measure the rate of PA eradication at 6 months. The study will also monitor safety and quality of life during and after treatment. Follow-up visits are scheduled throughout the 12 months to track progress, treatment adherence, and any adverse events. This phase 2 trial aims to provide strong evidence to guide antibiotic use in this patient group, potentially improving medical care and reducing costs.

Researchers are evaluating the safety of home treatment compared to hospitalisation for patients with active cancer who have symptomatic or incidental pulmonary embolism (PE) without HESTIA criteria. This randomized, multisite study aims to show that treating these patients at home is not worse than hospital care in terms of a combined 14-day outcome, which includes recurrent venous thromboembolism (VTE), major or relevant bleeding, and death. Patients with active cancer have a higher risk of complications from PE, and while some may currently be treated at home, evidence on the safety of this approach is limited. Participants will be randomly assigned to one of two groups. Those in the home-treatment group will be discharged within 24 hours after randomization and receive a follow-up phone call from the local thrombosis team within 7 days. Patients in the hospitalisation group will stay in the hospital for at least 48 hours post-randomization, after which their physician may discharge them. Both groups will receive anticoagulant treatment according to local protocols, started promptly after PE diagnosis. During the study, patients will be followed up at 7, 14, 30, and 90 days to monitor clinical events such as VTE recurrence, bleeding, or death. Patient-centered outcomes and resource use will also be assessed through questionnaires. An independent committee blinded to treatment groups will review all clinical outcomes. This approach aims to determine the best and safest care strategy for cancer patients with PE, considering both medical safety and quality of life.

Researchers are evaluating an optimized strategy to reduce complications related to emergency tracheal intubation in adults experiencing vital distress. The study focuses on combining three interventions: using rocuronium as a paralytic agent to ease intubation, providing bag face-mask ventilation before intubation, and systematically using a Gum Elastic Bougie (GEB) to assist the first intubation attempt. This approach aims to lower the risks and morbidity associated with emergency intubations, especially in out-of-hospital settings. The study compares two approaches for rapid sequence intubation (RSI). One group receives rocuronium at 1.2 mg/kg with bag-mask ventilation between induction and laryngoscopy, and GEB is used systematically on the first attempt. The other group follows standard recommendations using succinylcholine at 1 mg/kg without systematic bag-mask ventilation, and GEB is only used if intubation fails under direct laryngoscopy. Emergency physicians will record immediate outcomes after out-of-hospital care and hospital data will be collected on day 28 after inclusion. Participants will undergo medical history review and physical examination including measurements of arterial pressure, oxygen saturation, and heart rate. The main outcome measured is the occurrence of severe complications related to intubation during the first hour after the procedure. Data collection includes out-of-hospital and intra-hospital monitoring, with follow-up to 28 days. This trial seeks to assess whether the combined strategy can improve safety and reduce intubation-related complications in emergency situations.

Researchers are evaluating the use of Venetoclax combined with Azacitidine (VEN/AZA) in adults newly diagnosed with acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. This evaluation follows prior phase 1b and phase 3 studies and focuses on real-life treatment outcomes in France, where VEN/AZA became available through an early access program called the Temporary Utilization Authorization (ATU). The study aims to provide healthcare professionals with real-world data on the benefits and risks of this treatment approach. Venetoclax has been accessible in France since February 2021 via the ATU program and continues under a post-ATU scheme after marketing authorization. Between February and June 2021, over 230 patients began treatment through this program. All patients continued VEN/AZA treatment after the ATU period ended as part of the ongoing post-ATU phase. The treatment is given as part of routine clinical care in this setting. Participants will be monitored for up to 18 months from the start of their first treatment cycle to assess outcomes such as overall response rate, overall survival, and event-free survival. Data collection includes tracking how patients respond to VEN/AZA in real-life conditions, helping to better understand treatment effects and safety in this patient population.

Researchers are evaluating treatments for patients with relapsing-remitting multiple sclerosis (RRMS), an autoimmune disease affecting the central nervous system. This trial compares two medications, rituximab and ocrelizumab, to see if rituximab is not less effective than ocrelizumab in keeping active RRMS patients free from disease activity over two years. Both drugs target B cells, which play a role in MS, and rituximab has been used off-label with promising safety and effectiveness, while ocrelizumab is a newer, approved treatment. The study addresses the high cost difference between these therapies and aims to confirm if rituximab could be a more economical option. Participants receive either rituximab or ocrelizumab through infusion treatments following a typical schedule: at treatment start, after 15 days, and then every six months for two years. Two groups are compared to assess the percentage of patients without disease activity after this period. The study includes six follow-up visits aligned with treatment infusions, during which health and quality of life questionnaires are also completed. During the study, participants undergo brain MRI scans within six months before joining and regular assessments at each visit to monitor disease status, safety, and treatment effects. Researchers track the occurrence of relapses and new brain lesions to measure disease activity. Participants provide informed consent, and their health insurance coverage is confirmed. The total duration of participation is two years, with regular clinical and radiological evaluations to ensure safety and gather data on the treatments' effectiveness.

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.

Researchers are evaluating the effects of acetylsalicylic acid and atorvastatin on overall survival in male patients with castrate-resistant prostate cancer (CRPC) who are starting their first-line treatment for CRPC. This international, multicenter, open-label phase III clinical trial uses a 2x2 factorial randomized design to study whether these drugs improve survival outcomes in this patient population. Participants receive acetylsalicylic acid at a dose of 100 mg and atorvastatin at 80 mg as part of the trial interventions. The trial compares these treatments in different combinations to assess their impact on overall survival. The study does not specify additional treatment schedules or extension phases but focuses on the effects of these drugs during the initial treatment period for CRPC. During the study, participants are monitored for overall survival, calculated from the date of randomization until death, with follow-up extending up to 15 years. Eligibility assessments include confirming CRPC status with specific testosterone and PSA criteria, imaging for metastases, performance status evaluation, and kidney and liver function tests. Safety is monitored by excluding patients with certain liver conditions, drug contraindications, or serious medical issues, and patient adherence is supported through informed consent and clinical follow-up procedures.