Brookhaven

This trial investigates MZE829 capsules in adults with proteinuric chronic kidney disease who also carry the APOL1 high risk genotype, specifically G1G1, G2G2, or G1G2 variants. The study aims to evaluate the safety, tolerability, and impact on albuminuria, a marker of kidney damage, in this population. It is an open-label Phase 2 trial, meaning all participants receive the study drug and results will help determine its effects and safety profile. Participants receive MZE829 capsules orally in a single-group design. The study includes two cohorts one with chronic kidney disease alongside diabetes, and another with chronic kidney disease without diabetes. The treatment and monitoring occur over a 12-week period, during which the study team assesses drug safety and effects on albuminuria levels. During the trial, participants will be monitored for adverse events and tolerability from baseline through week 12. Researchers will also measure changes in urine albumin-to-creatinine ratio UACR to evaluate kidney function. Blood samples will be taken to assess plasma drug concentrations. The total participation time is approximately 12 weeks, focusing on safety and biological effects of MZE829.

This trial investigates whether middle meningeal artery embolization MMAE can be a safe and effective alternative to conventional open surgery for patients with moderately symptomatic chronic subdural hematoma CSDH. The study aims to determine if MMAE reduces the need for additional rescue surgery or deaths compared to standard surgery and to assess the safety of both treatments in this patient group. Participants will be randomly assigned to receive either MMAE, which involves particle embolization of the middle meningeal artery using specialized devices, or conventional surgery through burr holes or craniotomy to drain the hematoma. Treatments are delivered soon after randomization, and participants in both groups are monitored closely for outcomes. During the study, participants will share medical history, undergo physical exams, blood tests, and head CT scans. They will also complete questionnaires and report any adverse events. Researchers will follow participants for about 180 to 210 days after treatment to measure the need for rescue surgery or death and evaluate treatment safety. This process includes regular evaluations to track progress and health status.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are evaluating an experimental procedure of delivering verapamil directly into arteries for patients who have had an acute ischemic stroke. This study focuses on testing the safety of intra-arterial verapamil, a drug commonly used to treat blood vessel spasms, and how it affects recovery after stroke. The trial is limited to patients who have already received a mechanical thrombectomy as part of their standard care. Participants are randomly assigned to receive one of two doses of verapamil 10 mg or 20 mg administered intra-arterially following the mechanical thrombectomy procedure. This randomized, interventional study compares these two treatment groups to explore how the different doses impact patient outcomes and safety. During the study, participants will be monitored for bleeding complications and serious adverse events, including death, over a three-month period. Functional outcomes will be assessed at 30 and 90 days, and neuroimaging will be performed at 180 and 365 days. Researchers will track recovery progress and safety through these evaluations, with an overall follow-up period extending up to one year.