Presidente Prudente

Researchers are evaluating a combination therapy of finerenone plus empagliflozin compared to usual care in patients hospitalized with heart failure. This international, randomized, controlled, open-label trial aims to assess the effectiveness and safety of this early, intensive treatment approach in managing heart failure during and after hospitalization. Participants will either receive the combination of oral finerenone and empagliflozin or continue with usual care management. The study is designed to compare these two approaches to determine their impact on clinical outcomes. The trial includes a treatment period with these medications given alongside usual management during hospitalization and follow-up. During the study, participants will be monitored over six months for clinical benefits and safety outcomes such as serious adverse events and adverse events leading to discontinuation. Researchers will assess heart failure events, symptom changes using the Kansas City Cardiomyopathy Questionnaire, and time to death or heart failure events. Study visits and evaluations will track participant health and response to treatment over this period.

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

Researchers are evaluating the disease-free survival in participants with high-risk non-muscle-invasive bladder cancer HR-NMIBC who have previously received Bacillus Calmette-Gurin BCG treatment. This Phase 3 trial compares a new treatment called TAR-210 with the investigators choice of intravesical chemotherapy. The study focuses on participants with specific fibroblast growth factor receptor FGFR alterations and aims to find out which treatment better prevents cancer recurrence or progression after BCG therapy. Participants are randomly assigned to one of two groups. Group A will have TAR-210 inserted into the bladder starting on Day 1 and continuing for about 2 years. Group B will receive either mitomycin C or gemcitabine chemotherapy, chosen by the investigator, given once weekly for 4 to 6 weeks induction, followed by monthly maintenance doses for up to 1 year, with a possible second year of maintenance at the investigators discretion. All treatments are delivered directly into the bladder intravesically. During the study, participants will be monitored for up to 5 years to track disease-free survival and other outcomes such as recurrence-free survival, time to next intervention, disease worsening, progression, and overall survival. Researchers will also assess side effects, laboratory and vital sign changes, and quality of life using specific questionnaires. The study includes regular evaluations and safety monitoring throughout the participation period, which may last several years.

Researchers are evaluating the effects of therapeutic-dose heparin compared to usual care pharmacological thromboprophylaxis in patients hospitalized with community-acquired pneumonia CAP. This international, open-label, randomized controlled trial aims to understand if higher doses of heparin can improve outcomes by addressing inflammatory and thrombotic processes that contribute to respiratory, cardiac, and organ complications in CAP. The study builds on findings from COVID-19 patients, where therapeutic-dose heparin showed benefits in non-critically ill patients. Participants are randomly assigned to one of two groups. One group receives a daily therapeutic dose of low molecular-weight heparin LMWH or unfractionated heparin UFH for up to 14 days or until hospital discharge. The other group receives usual care with thromboprophylactic dose anticoagulation following local protocols, with doses not exceeding half the therapeutic level. The investigational arm prefers LMWH but may use UFH, especially in cases of renal compromise, with dosing tailored to patient weight and local standards. During the study, participants will be monitored for survival over 30 days as the primary outcome. Secondary outcomes include bleeding events, heparin-induced thrombocytopenia HIT, thrombotic events, invasive mechanical ventilation, mortality at multiple time points, hospital-free days, and health-related quality of life. The study involves hospital assessments, close monitoring of safety and clinical status, and tracking of various health measures up to 180 days, ensuring comprehensive evaluation of the treatments under study.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating how blood flow restriction BFR techniques may help improve recovery after intense resistance exercise. The study involves healthy adults aged 18 to 35 years and aims to compare different BFR pressures to understand their effects on muscle recovery, pain, strength, and function following maximal muscle stress. This controlled clinical trial explores accessible recovery methods to optimize physiological adaptation and reduce fatigue from high-intensity training. Forty men and forty women will be randomly assigned to one of four groups BFR at 80% of total occlusion pressure, BFR at 60% of total occlusion pressure, BFR at 10 mmHg pressure, or a control group resting without BFR. Each participant will complete initial assessments, undergo a muscle stress protocol, then receive their assigned intervention continuously for 20 minutes. Follow-up assessments will occur immediately, and then at 24, 48, and 72 hours after exercise. Participants will be evaluated on muscle pain using a Numerical Rating Scale, recovery and discomfort via Likert scales, exertion with the Borg scale, and muscle cellular integrity using bioelectrical impedance analysis. Muscle tone, stiffness, elasticity, strength, and power will also be measured with specialized devices and functional tests. The study includes monitoring for safety and consent procedures, and all data will be handled confidentially over the course of the trial.

Researchers are evaluating the effects of combining active recovery AR and blood flow restriction BFR on post-exercise recovery in healthy amateur male runners aged 18 to 40 years who run faster than 530 minkm. The study aims to determine if using both techniques together offers better recovery outcomes compared to active recovery alone or complete rest after exercise. Participants will be randomly assigned to one of three groups active recovery with blood flow restriction using a pneumatic cuff at 60% occlusion pressure for 10 minutes, active recovery without restriction for 10 minutes, or passive rest without movement for 10 minutes. All participants will complete baseline assessments and a muscle stress protocol before applying their assigned recovery method. During the study, researchers will assess heart rate variability, muscle soreness, recovery perception, discomfort, effort, cellular integrity, pain threshold, muscle tone, stiffness, elasticity, muscle power, plantar flexor strength, and aerobic capacity at baseline and at intervals up to 96 hours after exercise. Participants will provide informed consent and may allow data sharing with universities or regulatory authorities. The study includes follow-up evaluations immediately and at 24, 48, 72, and 96 hours post-exercise.

This observational study investigates how lifestyle habits and health characteristics, such as physical activity and excess weight, relate between parents and their children aged six years and older. Researchers aim to understand whether these habits and health factors are connected across different physical activity domains and intensities, including work or school activities, leisure time, and active commuting. The study also explores links between other habits like smoking, eating disorders, anxiety, depression, chronic diseases, and overweight status, considering the parents physical activity levels. The study involves no intervention or treatment instead, it observes children, adolescents, and at least one of their biological parents. Researchers collect data on physical activity using both objective and subjective measures, focusing on different intensities and domains. The study includes assessments of various health and lifestyle factors such as sedentary behavior, blood pressure, body measurements, bone density, mental health symptoms, quality of life, sleep quality, and eating habits, all measured at baseline. Participants will be evaluated through questionnaires, physical measurements, and health assessments. These include monitoring physical activity patterns, sedentary time, cardiovascular function, and psychological well-being. The primary outcomes are objective and subjective measures of physical activity. Secondary outcomes cover a broad range of health and lifestyle indicators. The studys duration and follow-up details are not specified, with data mainly collected at baseline to analyze the relationships between parents and childrens lifestyles and health.