Scotland Neck

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating whether adding navtemadlin to ruxolitinib treatment provides more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have not responded well to ruxolitinib alone. This Phase 3, randomized, double-blind study focuses on patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis. Participants must be JAK inhibitor-naive and have a suboptimal response to ruxolitinib treatment during the initial run-in period. During the study, all subjects start by receiving ruxolitinib alone in a run-in period. Those showing a suboptimal response are then randomly assigned in a 2:1 ratio to receive either navtemadlin or a navtemadlin placebo as an add-on to their ongoing ruxolitinib treatment. The study is blinded, so neither the participants nor the doctors know who is receiving the navtemadlin or placebo. Navtemadlin is an investigational MDM2 inhibitor, while ruxolitinib is a janus kinase 1/2 inhibitor. Participants are involved in assessments to compare spleen volume reduction and total symptom score reduction between the two treatment groups over 24 weeks. Researchers monitor safety and efficacy through clinical evaluations, symptom tracking, and laboratory tests. The study includes screening for performance status, blast counts, and TP53 wild-type status, ensuring participants meet specific health criteria before randomization.