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Found 4 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
This research aims to develop and improve a decision support system for patients experiencing chest pain before they reach the hospital. It focuses on evaluating how well a machine learning model can assist emergency medical services in assessing these patients. The study addresses the challenge of safely directing patients to the right level of care, balancing timely treatment for serious conditions like heart attacks or strokes with avoiding unnecessary hospital visits that may cause delays or overcrowding. Participants will be asked questions at the scene about their medical history and pain details, and a blood sample for troponin and glucose will be taken and analyzed immediately. The study collects routine medical record data and scene measurements to validate and further develop the decision support model. Participants will continue to receive standard care according to guidelines, typically transport to an emergency department if needed. Throughout the study, researchers will monitor clinical outcomes including time-sensitive conditions, deaths within seven days, and adverse events within 72 hours after ambulance service inclusion. Data from the initial assessment, blood tests, and medical records will help evaluate the models predictive performance. The study is observational, and participant involvement includes answering questions and consenting to data and sample collection. The total duration extends from emergency contact through hospital discharge and follow-up periods up to 100 days.
Actively Recruiting
Researchers are investigating whether adding physical exercise during neoadjuvant chemotherapy NACT can improve outcomes for patients with primary invasive breast cancer. This trial focuses on whether exercise can increase the rate of pathological complete response pCR, meaning no invasive tumor remains after chemotherapy. Secondary goals include evaluating cancer burden after treatment, tumor response through imaging, quality of life, physical activity levels, muscle strength, fitness, cognitive effects, treatment completion, and long-term sick leave. The study also explores how exercise may influence anti-tumor mechanisms. Participants will be randomly assigned to one of two groups usual care with routine information about physical activity or a supervised exercise program during chemotherapy. The exercise group will engage in two 60-minute sessions weekly of high-intensity interval and strength training, supported by a personalized mobile app and local physiotherapists. The program starts with a moderate warm-up and is tailored to each patients fitness and perceived exertion, continuing from the start of chemotherapy until surgery, about five months. Throughout the study, participants will be carefully monitored with questionnaires, physical tests, and device-based activity tracking. Assessments include quality of life surveys, physical activity reports, muscle strength tests, cognitive function scans, fitness evaluations, tumor imaging, chemotherapy completion rates, and sick leave data. The primary outcome, pathological complete response, is assessed around 5-6 months after starting chemotherapy. Follow-up and data collection continue for up to two years to evaluate long-term effects and safety.
Actively Recruiting
Researchers are evaluating the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction HFPEF. This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial RRCT involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.