Ajaccio

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Researchers are conducting an international, multicenter, prospective, non-randomized post-market clinical follow-up PMCF study to confirm and support the clinical safety and performance of the Coroflex4 ISAR NEO coronary stent system, which is a sirolimus-eluting stent. This study includes all consecutive patients treated with this stent in a real-world, non-selected population under daily clinical practice to meet EU Medical Device Regulation requirements. Participants receive treatment with the Coroflex4 ISAR NEO coronary stent system as intended by the manufacturer during their standard care for coronary artery disease or ischemic heart disease. The study observes patients treated with this device without randomization or control groups, focusing on its use in routine medical settings. During the study, participants will be monitored for safety and efficacy outcomes, including freedom from target lesion failure within 7 days after the procedure. Additional safety measures during percutaneous coronary intervention PCI will be tracked, such as avoiding stent dislodgement, balloon rupture, hypotube rupture, coronary perforation, coronary dissection, no reflow, and coronary thrombosis. The study involves informed consent and follows patients outcomes under normal clinical conditions until study completion.

This research aims to study people who have had their first episode of symptomatic deep vein thrombosis DVT in their lower limbs to understand the risk and severity of post-thrombotic syndrome PTS, the most common long-term complication of DVT. The study focuses on evaluating how the amount of thrombosis blood clot burden measured by the Venous Volumetric Index VVI on ultrasound relates to the development and severity of PTS assessed by the Villalta scale over 6 months. Participants will be followed at multiple times around 1 week, 1 month, 3 months, and 6 months after diagnosis. At each visit, doctors will assess symptoms and signs to calculate the Villalta score and perform venous ultrasounds to measure thrombosis burden using the VVI. Blood samples will be collected at several visits to study inflammation, coagulation, and clot breakdown factors. Quality of life questionnaires will also be completed at 3 and 6 months. During the study, symptom assessments, ultrasound exams, blood tests, and questionnaires will help researchers understand how the thrombosis burden at baseline and over time relates to the occurrence and severity of PTS. The study ends with the 6-month visit. Researchers will monitor the presence of moderate to severe PTS and changes in clot burden to identify important prognostic factors that may guide future prevention and treatment strategies.

Researchers are evaluating early fluid removal strategies in Intensive Care Unit ICU patients with acute kidney injury AKI who are receiving renal replacement therapy RRT and have fluid overload. Fluid overload in these patients is linked to increased complications and higher risk of death. The study compares two fluid removal approaches to see if a moderate removal rate guided by tissue blood flow monitoring can improve kidney, heart, and lung outcomes compared to a low removal rate that stabilizes fluid without such monitoring. Participants are randomly assigned to one of two groups. The experimental group will have fluid removed at a rate of 2 ml per kilogram per hour, adjusted based on tolerance and blood flow, aiming to reach their original body weight. If this target is not met within 24 hours, the rate can be increased. The control group will have fluid removal set between 0 and 1 mlkgh to maintain body weight stability, with adjustments as needed. Fluid removal may be paused temporarily if signs of poor blood flow or intolerance occur. During the study, participants will be closely monitored with assessments of organ function, kidney recovery, heart rhythm, and respiratory support needs for up to 30 days. The main measure is the number of days without needing organ support by day 30. Other evaluations include mortality, time off mechanical ventilation and vasopressors, ICU stay length, and complications such as strokes or intestinal ischemia. The trial aims to determine if a guided moderate fluid removal improves overall health outcomes in this critical patient group.

Cancer treatment often involves surgery, chemotherapy, and radiotherapy, which can cause acute and chronic pain, including neuropathic pain that is hard to predict and treat. Many cancer patients experience chronic pain that significantly affects their quality of life. This research aims to validate a predictive tool to assess the risk of neuropathic pain and pain chronicity in cancer patients, considering factors like preoperative pain, opioid use, age, sleep, psychological state, and social vulnerability. The study involves 500 cancer patients with breast, gynecological, lung, or colorectal cancers, along with 125 healthy volunteers as controls. Participants will undergo assessments of cognitive, emotional, and pain-related factors through questionnaires. Data collection occurs at baseline, 6 months, and 12 months to evaluate pain intensity, neuropathic pain signs, cognitive function, emotional status, social vulnerability, quality of life, sleep quality, disease perception, and analgesic use. Participants will complete various validated questionnaires and scales at these time points to help researchers measure their pain trajectories and related factors. The primary outcome is the CANoPy score, assessed at baseline and during follow-up visits. The study tracks these measures over one year to understand pain development and its impact, aiming to improve predictive abilities for neuropathic pain in cancer management.