Creteil

Researchers are evaluating the effects of early apneic ventilation compared to usual care with ultra-protective lung ventilation in patients with severe acute respiratory distress syndrome (ARDS) who require venovenous extracorporeal membrane oxygenation (ECMO). This Phase 3, open-label, multicenter trial aims to examine whether early apneic ventilation can reduce lung injury, shorten ECMO duration, and lower mortality at 60 days in this critically ill population. Participants are randomized to receive either ECMO plus near apneic ventilation or ECMO plus ultra-protective lung ventilation. Near apneic ventilation is applied during the first three days of ECMO using BIPAP/APRV or pressure-controlled ventilation, with specific settings to maintain airway pressures and low respiratory rates. After three days, apneic ventilation may continue or standard ultra-protective ventilation is used. The ultra-protective lung ventilation group receives low tidal volume and pressure ventilation settings until ECMO weaning. Prone positioning during ECMO is allowed at the physician's discretion in both groups. Throughout the study, researchers monitor mortality, need for lung transplantation, ongoing ECMO support, and days alive without ECMO up to day 60. Participants undergo clinical assessments and ventilator management according to the assigned strategy. Consent procedures accommodate emergency inclusion with surrogate consent when needed, and follow-up includes evaluation of lung recovery and survival outcomes over the 60-day period.

Fibromyalgia is a chronic pain condition affecting the muscles and bones, causing widespread pain and sensitivity. Patients often experience fatigue, anxiety, depression, and a reduced quality of life. Current treatments have limited effectiveness and many side effects. Previous research (EXOFIB-1 study) using the Exopulse Mollii suit showed promising benefits in reducing pain, fatigue, and improving quality of life, though the effects were small to medium. Extending the treatment to six months may improve outcomes further. The study evaluates the effects of the EXOPULSE MOLLII SUIT, a full-body garment with 58 electrodes that provides low-frequency electrical stimulation to muscles. The suit aims to reduce pain through a gentle electric current based on the gate control theory, which blocks pain signals. Participants receive either active stimulation for one hour daily or a sham stimulation for one minute with similar settings. The device is easy to wear and its pain relief effects can last 24 hours or more. Participants aged 18 to 75 with fibromyalgia will be assessed before and after each stimulation session at four visits over 45 days. Researchers will measure changes in functional disability using the Fibromyalgia Impact Questionnaire. Throughout the study, patients will be monitored for symptoms, medication changes, and any side effects. The study looks to confirm if longer use of the suit can provide greater relief of fibromyalgia symptoms.

Researchers are studying acute pyelonephritis (AP), a common bacterial kidney infection in children, focusing on those aged 1 month to less than 3 years without prior urological malformations. The study compares a short 3-day intravenous (IV) antibiotic treatment alone to a 3-day IV treatment followed by 7 days of oral antibiotics. The goal is to see if the shorter IV-only treatment is as effective at preventing infection recurrence and long-term kidney scarring, while possibly reducing antibiotic resistance and preserving gut microbiota diversity. Participants receive either IV ceftriaxone and/or amikacin once daily for 3 days, or the same 3-day IV treatment followed by 7 days of oral cotrimoxazole or cefixime. The study includes procedures like procalcitonin testing and fecal or rectal swabs collected at several points during and after treatment (day 0, 3, 10 or 17, and 31 or 38) to monitor bacterial presence and gut microbiota changes. Treatment begins after initial confirmation of infection and favorable early response. During the study, children are closely monitored for infection recurrence 28 days after completing antibiotics. Assessments include clinical evaluations, urine cultures, and monitoring for any adverse effects. The total participation covers treatment and follow-up periods to ensure safety and measure outcomes such as infection recurrence and bacterial resistance. This is a Phase 4 open-label randomized trial conducted across multiple centers.

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This study aims to collect real-world medical data on the device's effectiveness and safety over a period of 12 and 36 months after implantation. The study is a multicenter, prospective, non-interventional follow-up involving urologists experienced with the device. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and treat male stress urinary incontinence caused by intrinsic sphincter deficiency. Participants receive the device through surgical implantation, and their progress is tracked during routine clinical visits. Follow-up visits occur around baseline (preoperative and implantation), between 1 and 3 months post-operation, and at 12 months. Afterward, annual questionnaires are mailed for two more years to continue monitoring. Participants are involved in routine clinical care with additional questionnaires to assess their condition. Researchers evaluate patient-reported improvement and monitor any adverse events at 12 months. The total study duration includes follow-up up to three years post-implantation, allowing long-term observation of device performance and safety in a real-world setting.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are evaluating the safety and tolerability of Sacituzumab Tirumotecan when administered directly into the bladder for people with intermediate-risk non-muscle invasive bladder cancer (NMIBC). The study aims to find the highest dose that patients can take without experiencing serious problems and to select a dose level for future studies to assess how well the drug works. This is a Phase 1/2 open-label clinical trial focused on safety and efficacy in this specific bladder cancer population. Participants receive Sacituzumab Tirumotecan through intravesical administration, meaning the drug is given directly into the bladder. The study allows the use of rescue medications and supportive care to manage side effects such as stomatitis, oral mucositis, ocular surface toxicity, and other adverse events. Rescue medications may include antihistamines, steroids, antiemetics, antifungals, analgesics, and growth factors as deemed necessary by the investigator. During the study, researchers monitor participants closely for dose limiting toxicities, adverse events, and treatment discontinuations due to side effects, with primary outcomes assessed up to approximately 6 to 10 weeks. Participants undergo evaluations to assess safety and tolerability throughout the treatment period. The total duration and detailed follow-up procedures are designed to understand the drug’s safety profile and identify the optimal dose for further research.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.