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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.
Actively Recruiting
Researchers are evaluating whether a self-administered Pap smear, done by the patient, is as accurate as the traditional Pap smear performed by a healthcare provider. This study focuses on women aged 21 to 65 who need routine cervical cancer screening, aiming to improve screening rates in rural Alabama where cervical cancer is a concern. Participants will perform a self-collected Pap smear before receiving the traditional Pap smear from a licensed healthcare professional such as a physician, nurse practitioner, or physician assistant. Both samples will be labeled and sent to a clinical laboratory, where they will be analyzed blindly so the pathologist does not know which sample was self-collected. This comparison will determine the accuracy of the self-administered test. Throughout the study, results from both Pap smears will be collected and participants will be informed of their results through standard clinical procedures. The main outcome measured is the accuracy of the self-collected Pap smear compared to the traditional method, with results evaluated from the start of the study through 14 days after sample collection.