Belleville

Researchers are evaluating the safety and effectiveness of LY4268989 combined with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis. This phase 2 study aims to understand if the combination can better manage the condition. The study is sponsored by Eli Lilly and Company and involves a randomized, double-blind design with parallel groups. Participants receive either LY4268989 orally along with mirikizumab given intravenously and then subcutaneously, or mirikizumab with a placebo pill matching LY4268989. Responders to treatment will be re-randomized for a second study period. Treatment lasts approximately 104 weeks with up to 21 visits planned throughout the study. During the study, participants undergo assessments including clinical remission evaluation using the modified Mayo Score at weeks 12, 24, and 48, endoscopic improvement, and symptomatic remission measurements. Safety and response are closely monitored through scheduled visits. Overall participation lasts about 118 weeks, allowing researchers to gather long-term data on the treatments being studied.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the long-term safety, performance, and functional outcomes of the Indigo Aspiration System for treating pulmonary embolism PE. This observational study focuses on patients with acute PE and aims to gather real-world data on how well the device works and its safety over time. Participants receive frontline treatment with the Indigo Aspiration System as part of their standard care for acute PE. The study monitors patients for safety events within 48 hours after the procedure and assesses heart function by measuring the right ventricle to left ventricle ratio. Quality of life and functional outcomes are evaluated at 90 days, along with longer-term monitoring for serious device-related events and mortality up to one year and 30 days respectively. During the study, participants will undergo diagnostic imaging and clinical assessments to track their recovery and the effects of the device. Researchers will collect data on adverse events, quality of life questionnaires, exercise capacity tests, and symptom scales. The total participation lasts up to several months, including follow-up visits to ensure comprehensive monitoring of safety and function after treatment.