Sanford

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the use of Derm-Maxx, an acellular human dermis graft, as an additional treatment for patients with diabetic foot ulcers that have not healed with standard care alone. This multicenter randomized open-label trial focuses on patients with Wagner grade 1 and 2 diabetic foot ulcers. The study aims to assess healing rates and wound closure over a 12-week treatment period, with at least half of the participants being 65 years or older. Participants will undergo a 2-week run-in period before being randomly assigned to receive either Derm-Maxx plus standard of care or standard of care alone. During the 12-week treatment phase, patients will have weekly visits to monitor ulcer healing, with additional dressing changes recorded as needed. Derm-Maxx is applied to ulcers that have been properly prepared and offloaded using a specific device. The study also evaluates pain and safety alongside healing outcomes. Throughout the study, participants will be closely monitored with assessments of ulcer size, wound closure, and circulation to the affected foot. Researchers will collect data through physical exams, wound measurements, and adherence to offloading protocols. Safety and pain levels will be tracked to ensure participant well-being. The total duration of participation includes screening, run-in, treatment, and follow-up visits over at least 12 weeks.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

This research aims to evaluate how the Safe Dates for Young Parents (SDYP) program affects sexual and reproductive health behaviors, quality of life, and attitudes about intimate partner relationships in adolescents and young adults assigned female sex at birth who are pregnant or parenting. It focuses on whether the SDYP intervention impacts sexual behaviors, helps prevent or reduce intimate partner violence, and changes beliefs about healthy relationships during the study period. Participants assigned to the SDYP intervention will attend ten group sessions, each lasting 50 minutes. These sessions include interactive discussions, role-plays, games, brainstorming, analysis of scenarios, a poster contest, and a theatrical play. Researchers will compare outcomes between participants who receive the SDYP intervention and those in the control group who do not. During the study, participants will complete three interviews over one year to assess their sexual behaviors, attitudes, and experiences with intimate partner violence. The main outcome measured is condomless vaginal or anal sex at three and twelve months. The study will monitor changes in behaviors and beliefs related to sexual and reproductive health and relationship quality throughout the year.

Researchers are evaluating the Shield blood test as a screening tool for colorectal cancer (CRC) in people aged 45 to 81 who are at average risk for CRC. This study aims to assess how well the Shield test performs during a second round of testing, using colonoscopy as the standard comparison. Colorectal cancer is a common and serious disease, especially in older adults, and early detection through screening can reduce mortality by catching cancer at earlier, more treatable stages. Participants will undergo the Shield blood test as part of their standard care. The study focuses on average-risk individuals who do not have symptoms or high-risk factors for CRC. The performance of the Shield test will be monitored over a period of 33 to 42 months after enrollment to evaluate its effectiveness compared to colonoscopy results. During the study, participants will follow study procedures and standard care assessments. Researchers will measure the performance of the Shield test in detecting colorectal cancer and its precursors during the second testing interval. This includes ongoing monitoring and data collection to understand the test's accuracy and reliability in a real-world setting, with a total follow-up period extending beyond two and a half years.