Port Jefferson

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

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 performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.