Versailles

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

Researchers are creating the largest possible real-life group of patients with Chronic Myeloid Leukemia CML to collect long-term follow-up data. This observational study aims to analyze epidemiological trends, identify patient subgroups based on treatment response, evaluate new medications used in everyday care, study treatment discontinuations, and assess the effects of evolving treatment recommendations. The study collects clinical and biological information from CML patients both prospectively and retrospectively starting from diagnosis. Data gathering continues throughout the long-term follow-up period, even after treatment has stopped. There are no specific drugs or interventions administered in this observational study it focuses on monitoring and recording real-world patient experiences and responses. Participants provide data throughout their disease course, which may be collected for up to 30 years or until death or last follow-up. Researchers evaluate multiple outcomes including molecular and cytogenetic responses, treatment efficacy and tolerance, prognosis scores at diagnosis, body measurements, and medical history related to CML. This extensive monitoring helps better understand CML progression and treatment in real-life settings.

Researchers are studying men over 40 years old with benign prostatic hyperplasia BPH who need surgery to improve urinary symptoms. The trial compares two types of prostate surgery a conventional endoscopic resection and a newer partial surgery that aims to preserve ejaculation function. This study explores whether the partial surgery can maintain ejaculation without reducing the relief of urinary symptoms, which is important because ejaculatory dysfunction often lowers quality of life after surgery. Participants are randomly assigned to one of two surgical groups. One group undergoes conventional endoscopic resection of the prostate, while the other receives a partial endoscopic resection that preserves the apex area near the veru montanum. The study is single-blinded, meaning patients do not know which surgery they receive. The main focus is on symptom improvement measured by the International Prostatic Symptom Score IPSS six months after surgery. During the study, men will have evaluations at 1, 3, 6, 12, and 36 months after surgery. These assessments include urinary symptoms, ejaculation and overall sexual life, urinary flow rates, and any surgery-related complications. The trial tracks these outcomes to understand the benefits and effects of each surgical method over time. Patients are expected to comply with scheduled visits and provide informed consent before participating.

Researchers are studying adults who have experienced cardiac arrest and are admitted to intensive care while comatose. The study focuses on comparing different early brain damage scoring systems to identify which best predicts patient outcomes. This research aims to help doctors decide the best post-resuscitation treatments and provide accurate information to families. The sponsor of the study is AfterROSC. The study observes patients without assigning treatments. At intensive care unit admission, usually about 3 hours after cardiac arrest, researchers calculate early prognosis scores based on clinical and biological data. This scoring is done for all eligible patients without altering their care. The main focus is to evaluate the performance of the Cerebral Admission Hospital Prognosis CAHP score. Participants will be monitored starting from intensive care admission, with data collected on their condition and brain damage scores. Researchers use these scores to assess outcomes and compare scoring systems. The study does not specify treatment changes, focusing instead on diagnostic evaluation and prognosis. Participation involves no additional interventions beyond standard care and clinical data collection.

Researchers are studying adults with bronchiectasis who have a recent infection of Pseudomonas aeruginosa PA in their airways. This infection is linked to more frequent worsening of symptoms, lower quality of life, and a higher risk of death. The study compares two antibiotic treatment plans to find out if a simpler oral and inhaled antibiotic combination works as well as a more intensive treatment involving intravenous antibiotics. This research aims to provide clearer evidence to guide how these infections should be treated for better health and economic outcomes. The study tests two treatment approaches over a 3-month period. One group receives an oral fluoroquinolone antibiotic combined with inhaled colistimethate sodium, starting with 14 days of both followed by 2.5 months of inhaled antibiotic alone. The other group gets intravenous beta-lactam antibiotic plus the same oral and inhaled antibiotics in the initial 14 days, then continues inhaled treatment alone for 2.5 months. After treatment, participants are followed for 9 more months to monitor their health and infection status, totaling 12 months from the start of therapy. Participants will have regular check-ups during and after treatment to measure how well PA is eradicated and to track any return of infection or worsening symptoms. Questionnaires will assess quality of life and treatment burden at the start, 3 months, and 12 months. Researchers will also monitor antibiotic resistance, adverse events, and healthcare costs over one year. This comprehensive follow-up helps evaluate both the medical and economic impact of the two antibiotic regimens in managing early PA airway infection in bronchiectasis.

Developmental and Epileptic Encephalopathies DEE are a diverse group of neurodevelopmental disorders associated with epilepsy and their underlying causes. Researchers aim to create a large national database with retrospective follow-up of many patients to better understand specific biomarkers. This will help improve classification and knowledge of DEEs natural progression depending on their causes, allowing for more personalized care and development of management recommendations where none currently exist. This observational study includes patients diagnosed with DEE and control patients undergoing routine EEG exams without epilepsy diagnoses. Data from 2002 to 2026 will be reused to identify diagnostic and early predictive biomarkers, categorize patient subgroups with these biomarkers, and assess quality of life, adaptive behavior, behavioral disorders, and autism spectrum disorders. The study uses existing clinical data without administering new treatments. Participants data will be analyzed retrospectively to find markers linked to neurodevelopmental outcomes in DEE. The study will assess multiple aspects of patients lives and behaviors over time. No new interventions or visits are required, as the study relies on existing health records. The trial runs until the end of 2026, with the goal to improve understanding and personalized management of DEE.

Researchers are investigating the use of high-dose intravenous vitamin C combined with thiamine vitamin B1 to manage post-cardiac arrest shock in patients admitted to intensive care units after out-of-hospital cardiac arrest. This condition often leads to cardiac and circulatory failure, causing multi-organ failure and early death in a significant portion of patients. The study is a phase II, multicenter, randomized controlled trial comparing standard care with the addition of high-dose vitamin C and thiamine to assess potential benefits on shock recovery and neurological outcomes. Participants are randomly assigned to one of two groups the control group receiving standard post-cardiac arrest care according to international guidelines, and the experimental group receiving standard care plus high-dose intravenous vitamin C at 50 mgkg every 6 hours for 3 days, starting within an hour after randomization, along with intravenous thiamine 200 mg twice daily for 3 days. From day 4 onwards, standard vitamin C supplementation up to 1000 mg daily and thiamine are allowed in both groups. During the 28-day participation period, patients will be closely monitored for recovery from shock, neurological function, and organ failure. Assessments include measuring the time to stop vasopressors by day 3, survival rates related to shock by day 7, neurological status at day 28, maximum vasopressor doses within 3 days, changes in organ failure scores, and arterial lactate levels. Safety and effectiveness data will be collected throughout to evaluate the impact of the vitamin C and thiamine treatment alongside standard care.

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

Researchers are evaluating the impact of a temporary accommodation program called HTSH on elderly patients length of stay in hospital services. This observational, multicenter study involves elderly patients discharged from hospitals in the Ile-de-France region who require short-term accommodation in nursing homes or long-term care units. The study aims to assess how this program supports medical and social care and influences decisions about returning home after hospitalization. The study includes a prospective group of 258 subjects and a retrospective group using data from 2021 and 2022. Temporary accommodation beds are provided in dedicated units with specialized staff, physically grouped within establishments supported by the Regional Health Agency. The study compares hospital stay lengths before and after the programs implementation to evaluate its efficiency. Participants will be observed over 24 months with data collected on hospital stay length, patient pathways, profiles, discharge outcomes, quality of life, and caregiver benefits. Medical records and social evaluations are reviewed, and caregivers and professionals involved in the HTSH circuit may also participate. This non-interventional study monitors outcomes without changing usual care, with no specified maximum age and no healthy volunteers included.