Port Jefferson

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously (IV) or subcutaneously (SC). Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohn's Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.

Researchers are evaluating combination therapies involving adagrasib with pembrolizumab and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation and varying levels of PD-L1 expression. This Phase 2 open-label trial focuses on first-line treatment for patients with tumors showing PD-L1 tumor proportion scores (TPS) of 1% or higher, including those with TPS below 50%. The study aims to assess clinical responses and progression-free survival in this specific population. Participants receive adagrasib orally at 400 mg twice daily, combined with pembrolizumab given intravenously every three weeks, with treatment duration varying by cohort. Some cohorts also include chemotherapy agents such as pemetrexed, cisplatin, or carboplatin administered every three weeks. Treatment regimens differ across three cohorts, with some participants receiving adagrasib alone initially, followed by combination therapy, and others receiving concurrent combination treatments for up to 31 or 35 cycles. During the study, participants undergo evaluations including imaging to measure tumor response according to RECIST criteria, safety monitoring for adverse events, and pharmacokinetic assessments. The main outcomes measured are objective response rate and progression-free survival at six months, with additional monitoring of overall survival and duration of response. The study lasts up to 30 months, providing detailed data on treatment effects and safety in this patient group.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating the long-term performance and reliability of Medtronic's 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.

Researchers are gathering ongoing information on the safety and performance of Medtronic products that are already available on the market. This registry study aims to support patients, hospitals, clinicians, regulators, payers, and the medical industry by simplifying the process of monitoring these products and providing up-to-date performance data. The study involves collecting data on patients who have received or are planned to receive Medtronic medical devices or therapies. Enrollment includes both prospective and retrospective participants within a specific time frame related to their therapy start. There are no specific interventions assigned, as this is an observational registry. Participants provide written consent and are followed periodically, typically every 6 to 12 months depending on the therapy, to assess the safety and effectiveness of their Medtronic product. Researchers collect information from medical records and follow-up visits to monitor outcomes over time. Participants may be followed for many years, with the study currently planned through January 2040.