Ajaccio

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are evaluating the Coroflex4 ISAR NEO coronary stent system, a sirolimus-eluting stent, in patients with coronary artery disease and ischemic heart disease. This international, multicenter, prospective, non-randomized post-market clinical follow-up study aims to confirm and support the device's clinical safety and performance in a real-world, unselected patient population, following daily clinical practice. The study complies with the European Union Medical Device Regulation requirements for post-market clinical follow-up. The study involves patients who have been treated or planned to be treated with the Coroflex4 ISAR NEO coronary stent system as intended by the manufacturer. The device is used in patients undergoing percutaneous coronary intervention (PCI) following the latest European Society of Cardiology recommendations. Eligible patients have novel lesion lengths of 2-4 mm. The study collects data from consecutive patients treated with the stent to evaluate outcomes in routine clinical settings without randomization. Participants will be monitored for safety and efficacy outcomes, including freedom from target lesion failure within 7 days after treatment. The research team will follow patients' clinical status and device performance as part of standard care. Informed consent is required, and patients will be observed to confirm the stent's safety and effectiveness under everyday medical practice conditions. The study does not specify a maximum age limit and includes adult patients aged 18 and older.

Post-thrombotic syndrome (PTS) is a frequent long-term complication of deep vein thrombosis (DVT) that significantly affects patients' quality of life and increases healthcare costs. This research aims to study how the extent of blood clot burden in the veins, measured by a special ultrasound score called the Venous Volumetric Index (VVI), can predict the likelihood and severity of PTS six months after a first episode of symptomatic DVT in the lower limbs. Understanding these predictive factors could help guide better treatment strategies for patients at risk of developing PTS. The study is a multicenter prospective cohort design involving patients diagnosed with a first episode of symptomatic lower limb DVT confirmed by ultrasound. Participants will be followed with clinical assessments and ultrasound scans at one week (only for those in biological research), one month, three months, and six months after diagnosis. Blood samples will be collected at baseline, one week, one month, and three months to examine inflammation and blood clotting factors. Quality of life questionnaires will be completed at three and six months. The VVI score will be calculated from ultrasound data to quantify the clot burden, and the Villalta scale will be used to assess PTS severity over the six-month follow-up period. During each visit, symptoms and clinical signs related to PTS will be evaluated, and color Doppler ultrasound of the lower limbs will be performed. Blood tests will help explore biological markers linked to PTS development. Patients will complete questionnaires about their quality of life to assess the impact of symptoms. The study concludes with the six-month visit, at which point researchers will analyze the association between initial clot burden and PTS outcomes. This comprehensive follow-up aims to improve the prediction and understanding of PTS after DVT.

Researchers are investigating the effects of different fluid removal rates during renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) who experience fluid overload. Fluid overload in these patients is linked to increased complications and death, and reducing it through ultrafiltration (UFnet) may improve outcomes. The study compares a moderate rate of fluid removal to a lower rate to see if targeting both fluid balance and tissue perfusion improves kidney, heart, and lung health. The study involves two main treatment approaches during RRT. One group will receive a higher UFnet rate of 2 ml/kg/h, adjusted for tolerance and tissue perfusion, aiming to reduce excess fluid to the patient's normal body weight. If needed, the rate may increase to 3 ml/kg/h. The other group will have a lower UFnet rate between 0 and 1 ml/kg/h, adjusted as necessary to stabilize fluid balance. If intolerance or tissue hypoperfusion occurs, ultrafiltration will be paused temporarily. Participants will be closely monitored throughout the study. Researchers will assess organ function, fluid balance, tissue perfusion, and safety measures including hemodynamic tolerance. The primary outcome is the number of days without needing organ replacement therapy over 30 days. This approach aims to determine whether a moderate fluid removal strategy guided by tissue perfusion can improve overall and kidney-specific recovery in critically ill patients with fluid overload undergoing RRT.

Neuropathic pain related to cancer and its treatments such as surgery, chemotherapy, and radiotherapy can cause acute and chronic pain that affects quality of life. Around 58% of cancer patients experience chronic neuropathic pain, which is often hard to treat and can persist after cancer remission. Many factors like preoperative pain intensity, opioid use, age, sleep problems, and psychological vulnerability influence chronic pain development, but there is currently no simple tool to predict individual risk before treatment begins. This research collects cognitive-emotional and pain-related data through questionnaires to validate a predictive tool that helps estimate the risk of neuropathic pain in cancer patients. The focus is on patients with breast, gynecological, colorectal, or lung cancer who are about to undergo anticancer therapies such as chemotherapy, surgery, hormonal therapy, radiotherapy, or targeted therapy. The study aims to optimize treatment by identifying patients more vulnerable to developing chronic neuropathic pain. Participants provide data through assessments of cognitive-emotional states and pain parameters. The main outcomes measured are CANoPy scores at baseline, 6 months, and 12 months to track pain progression. Patients must understand and cooperate with study requirements and give oral consent. The study also includes healthy volunteers for comparison. Participants are monitored throughout the study to evaluate the predictive tool's ability to identify those at risk of chronic neuropathic pain.