Greenfield

Researchers are evaluating patient outcomes and functional scores before and after an all-arthroscopic Brostrom repair for lateral ankle ligament injuries. This trial compares the use of a suture anchor construct alone versus suture anchors combined with the BioBrace Implant to understand differences in recovery and function. The study is prospective, randomized, and single-center, focusing on early postoperative results and safety. Participants will be assigned to one of two groups a control group receiving the standard arthroscopic Brostrom repair using suture anchors only, and a treatment group receiving the same repair augmented with the BioBrace Implant. The procedures are performed using an all-arthroscopic Brostrom technique. Clinical evaluations are scheduled preoperatively and at multiple points postoperatively, including 1, 3, and 6 weeks, and 3, 6, and 12 months. During the study, participants will complete various patient-reported outcome measures to assess pain, function, activity levels, and safety following surgery. These assessments include the American Orthopedic Foot and Ankle Society score, Foot Function Index, Visual Analog Scale, and Karlsson-Peterson score at all scheduled visits. The study involves close monitoring from before surgery through one year after the procedure to track recovery and outcomes.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.