Longwood

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating a novel spectacle lens to control myopia progression in young children aged 6 to 8 years. This randomized, controlled, double-masked study aims to validate results from previous trials by comparing the new spectacle lens with a standard single vision, impact-resistant lens. The 12-month results will help predict the treatments effectiveness over three years. Participants are randomly assigned to one of two groups one group will wear the new experimental spectacle lenses, and the other will wear standard single vision lenses. Both types of lenses are impact-resistant. The study requires children to wear their assigned spectacles for at least 10 hours daily, except during sleep, swimming, or other activities where wearing glasses is unsafe or impractical. Children will be involved in the study for 24 months, during which their vision will be regularly checked through tests including spherical equivalent refraction, axial length measurement, and visual acuity assessments. The study monitors how well the lenses control myopia progression and ensures safety by tracking any ocular or systemic conditions. Parent or guardian consent is required for participation.

This trial focuses on adults aged 64 and older who have moderate-to-severe primary knee osteoarthritis, a condition where joint cartilage breaks down and causes chronic inflammation and pain. The study evaluates the effects of Allocetra, an immunomodulatory cell-based therapy, compared to a placebo. Allocetra consists of specially modified allogeneic blood cells designed to reprogram immune cells and potentially reduce inflammation in the knee joint. Participants are randomly assigned to receive either Allocetra or a placebo through three ultrasound-guided injections into the affected knee on Days 0, 14, and 28. The study lasts for 12 months, with follow-up visits to monitor outcomes over this period. The trial is double-blind, meaning neither participants nor researchers know who receives Allocetra or placebo during the study. During the trial, participants will have assessments including pain and function evaluations using the Western Ontario and McMaster Universities Arthritis Index WOMAC at 3 and 6 months. Safety monitoring will continue for six months. Other measures such as quality of life and daily pain scores will also be collected. The study aims to understand Allocetras impact on knee osteoarthritis symptoms and safety over one year of observation.

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.