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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying patients with rotator cuff injuries who are undergoing arthroscopic rotator cuff repair surgery. This study collects real-world data on the outcomes of using the REGENETEN Bioinductive Implant System, a medical device designed to manage and protect rotator cuff tendon injuries where there has been no significant loss of tendon tissue. The registry involves multiple centers across the United Kingdom, Europe, and Australia and plans to enroll up to 400 patients. Participants will receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant as part of their standard medical care. The implant is intended to support tendon healing in either partial or full thickness tendon tears. This is a prospective, single-arm study without a comparison group, focusing on collecting data after surgery. Patients will be followed and evaluated at multiple time points up to two years after surgery. Assessments include quality of life, arm and shoulder function, shoulder pain levels, and overall shoulder evaluation using several validated scoring systems. Data will be collected at baseline before surgery and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery to monitor recovery and outcomes over time.
Actively Recruiting
The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant (ASCT). This phase III, open-label, randomized, controlled study aims to evaluate whether adding a proteasome inhibitor to the salvage ASCT conditioning improves the depth of response, and to assess the impact of consolidation and maintenance treatments on the durability of response. The study also looks at overall survival, progression time, quality of life, and treatment safety among participants with measurable disease and good performance status. All participants first receive re-induction therapy consisting of 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone (ITD) over 28-day cycles to achieve maximum disease control. Those who reach stable disease or better are randomized to receive either conventional ASCT using melphalan or augmented ASCT combining melphalan with ixazomib. Following this, participants who maintain minimal response or better undergo a second randomization to either receive consolidation therapy with 2 cycles of ITD followed by ixazomib maintenance until disease progression, or no further treatment. During the study, participants will undergo regular assessments including blood tests, disease response evaluations, and monitoring for adverse effects. The primary outcomes measured are overall response rate 100 days after ASCT and progression-free survival up to 10 years. Secondary evaluations include overall survival, time to disease progression, minimal residual disease status at various stages, engraftment kinetics, and quality of life. Follow-up continues with clinic visits every three months until disease progression is observed, enabling long-term monitoring of treatment effects and safety.