Belleville

Researchers are evaluating the safety and effectiveness of LY4268989 when given together with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on adults aged 18 to 80 years who have had UC diagnosed for at least 3 months and have active symptoms confirmed by specific clinical scores and endoscopic evidence. The study aims to assess clinical remission using the Modified Mayo Score at 12 weeks. Participants will receive either LY4268989 by mouth combined with mirikizumab administered first intravenously and then by subcutaneous injection, or mirikizumab alone with a placebo pill. The entire study treatment period will last about 104 weeks, with up to 21 visits planned for monitoring. Treatment schedules and dosing are designed to compare the combination therapy to mirikizumab alone. During the study, participants will undergo regular assessments including clinical evaluations, endoscopy, and monitoring of symptoms and safety. Researchers will track the percentage of participants achieving clinical remission by week 12 using the Modified Mayo Score. Participants will be followed closely throughout the study duration, which totals approximately 118 weeks from start to finish, including treatment and follow-up visits.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are studying the long-term safety, functional outcomes, and performance of the Indigo Aspiration System in treating pulmonary embolism (PE), a condition where blood clots block arteries in the lungs. This study aims to assess real-world results and gather data on how well this device works and its safety profile over time. The study uses the Indigo Aspiration System as a frontline endovascular treatment for patients with acute PE who meet specific criteria, such as having symptoms for 14 days or less and a right ventricle to left ventricle (RV/LV) ratio of 0.9 or higher. Participants must be at least 18 years old and receive treatment according to the device's instructions for use. The primary outcomes include measuring major adverse events and changes in the RV/LV ratio within 48 hours after the procedure. Participants will be evaluated through clinical assessments and imaging tests like computed tomographic angiography or echocardiograms to monitor heart function and treatment safety. Researchers will collect data on adverse events and the device's performance shortly after treatment. The study involves informed consent and follows ethical guidelines, with ongoing monitoring to understand long-term effects and safety.