Versailles

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are studying Philadelphia-negative myeloproliferative neoplasms (MPN), which include Polycythemia Vera (PV), essential thrombocythemia (ET), and prefibrotic myelofibrosis (PreMF). These chronic blood cancers involve specific mutations like JAK2V617F and carry a high risk of blood clots that can cause serious health problems. Current treatments include low-dose aspirin to reduce arterial clots, but patients still face risks of thrombosis and bleeding. This trial explores whether direct oral anticoagulants (DOACs), such as Apixaban or Rivaroxaban, might better prevent these clotting events in patients with the JAK2V617F mutation. Participants will be randomly assigned to receive either a DOAC (Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once daily) or low-dose aspirin (100 mg once daily). The study focuses on high-risk MPN patients with JAK2V617F mutation and will compare the effectiveness and safety of DOACs versus aspirin for preventing blood clots. Treatment will continue with close monitoring throughout the study. During the study, researchers will track the time until any arterial or venous blood clots occur over a 24-month follow-up period. Participants will undergo regular assessments to monitor clotting events, bleeding risks, and overall health. The trial aims to gather detailed information on how well these treatments prevent thrombosis and their safety profiles, helping to guide future care for patients with these blood disorders.

This research aims to create the largest possible real-life group of patients with chronic myeloid leukemia (CML) to study their long-term health outcomes. The study focuses on collecting observational data to understand different patient subgroups based on their treatment responses, the effects of new medications used in everyday practice, treatment discontinuations, and how changes in medical recommendations impact patients. The study involves gathering clinical and biological information from patients with CML both prospectively and retrospectively, starting from diagnosis and continuing during long-term follow-up, even after treatment has stopped. There are no specific treatments or interventions being tested, as the study is observational and collects data from real-life patient experiences. Participants will have their clinical and biological data collected and monitored until death or the last follow-up visit, which may last up to 30 years. This allows researchers to observe how the disease and treatments evolve over time. The study does not involve procedures, but collects information to better understand CML in real-world settings and evaluate various outcomes related to patient care.

This research focuses on men with benign prostatic hyperplasia (BPH), a condition causing urinary symptoms due to prostate enlargement. It evaluates whether a modified surgical technique that preserves ejaculation can provide similar relief of urinary symptoms as the conventional surgery, potentially improving quality of life by maintaining sexual function. The study is a multicenter, single-blinded, randomized clinical trial comparing two surgical methods for BPH treatment. Participants will undergo either partial trans urethral resection of the prostate, which preserves the prostatic apex to maintain ejaculation, or conventional complete endoscopic resection of the prostate. Both procedures aim to relieve urinary symptoms caused by BPH. The study compares the functional outcomes of these two surgeries, including urinary flow, ejaculatory function, sexual life quality, and surgery-related complications. During the study, men will be evaluated before surgery and followed for at least 6 months afterward. Assessments include the International Prostatic Symptom Score (IPSS) to measure urinary symptoms, ejaculatory function, sexual life quality, urinary flow rates, and monitoring for any complications or need for retreatment. The primary outcome is the IPSS score at 6 months post-surgery, helping to determine if the ejaculation-preserving technique is as effective as the conventional surgery for improving symptoms.

Researchers are evaluating early brain damage assessment scores in adult patients admitted to intensive care after cardiac arrest. Despite successful return of spontaneous circulation, outcomes remain poor and survival rates vary widely depending on arrest circumstances and post-resuscitation care. The study aims to compare different scoring systems to identify the best way to predict patient outcomes and guide treatment decisions in the critical early period after cardiac arrest. The study involves calculating early prognosis scores at the time of intensive care unit admission using clinical and biological data. These scores will be compared to determine which system most accurately predicts brain damage and patient prognosis following cardiac arrest. Participants will be assessed upon intensive care admission, typically within about three hours after cardiac arrest, using the cerebral admission hospital prognosis (CAHP) score and other scoring models. Data from clinical evaluations and biological tests will be collected to calculate these scores. Researchers will use these measures to determine the area under the curve for each scoring system to evaluate their predictive accuracy for patient outcomes.

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.

Developmental and Epileptic Encephalopathy (DEE) includes a diverse group of neurodevelopmental disorders associated with epilepsy and its underlying causes, regardless of epileptiform activity. Researchers are creating a national database with retrospective follow-up data from many patients to improve understanding of specific biomarkers. This effort aims to enhance classification and knowledge of the natural progression of DEE based on its causes, which can support more personalized treatment approaches and the development of management recommendations currently lacking for these conditions. This study involves collecting and reusing clinical data from patients diagnosed with DEE of genetic origin. There are no treatment interventions or experimental therapies involved; rather, the focus is on analyzing existing clinical information to identify diagnostic and early predictive biomarkers that could inform prognosis and care. The study period covers data from 2002 through 2026. Participants' clinical data will be systematically gathered and analyzed to find biomarkers linked to the neurodevelopmental trajectory of DEE. Researchers will monitor disease progression and outcomes using this archived information. The study will provide insights that may improve future personalized therapeutic management and guide recommendations for patients with DEE based on their genetic causes and biomarker presence.

Researchers are evaluating the effects of early intravenous high-dose vitamin C combined with vitamin B1 in patients admitted to intensive care after an out-of-hospital cardiac arrest (OHCA) who develop post-cardiac arrest shock. This shock involves heart and blood circulation failure and can lead to multiple organ failure and early death in up to 35% of patients. The study is a phase II multicenter randomized controlled trial designed to assess if vitamin C and vitamin B1 can improve outcomes compared to standard care following OHCA. Participants are randomly assigned to one of two groups. The experimental group receives standard care plus intravenous high-dose vitamin C at 200 mg/kg per day, given as 50 mg/kg every 6 hours for 3 days, starting within one hour after randomization. They also receive intravenous thiamine (vitamin B1) 200 mg twice daily for 3 days. The control group receives standard care according to guidelines, with no high-dose vitamin C during the first 3 days. From day 4, standard vitamin C and thiamine supplementation at lower doses are allowed. During the 28-day participation, patients are monitored for recovery from the shock, including the need for blood pressure support medications (vasopressors). The primary outcome is the cumulative rate of weaning off vasopressors by day 3 after cardiac arrest. Researchers will also assess safety and recovery progress. The study plans to enroll 234 patients over 24 months, with follow-up lasting 28 days after enrollment.

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 evaluating the impact of a temporary accommodation program (HTSH) on the length of hospital stays for elderly patients in the Ile-de-France region. This observational, non-interventional study involves multiple hospital departments and nursing home or long-term care units. The program is designed to provide short-term nursing home stays for elderly people discharged from hospital who cannot immediately return home due to their stabilized but complex social or medical situations. The study is supported by the Regional Health Agency of Ile-de-France. The study does not involve investigational drugs or specific interventions but rather observes the medical and social care pathways for elderly patients using HTSH beds. These beds are grouped in dedicated units with specialized staff, funded and maintained by the Regional Health Agency. The program aims to assess whether HTSH improves patient care and facilitates decisions about returning home. Participants will be followed for up to 24 months to measure outcomes including the length of hospital stays in referring services. Data collection includes documentation of consent, evaluation of social and medical care, and follow-up on patients' return home plans. Caregivers and healthcare professionals involved in the HTSH circuit may also participate by providing information through questionnaires. The study observes real-life care processes without altering patient treatment.