Osasco

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 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 the effectiveness of Finlndia hair lotion combined with oral treatment for men with androgenetic alopecia, a common form of hair loss. This Phase III clinical trial aims to compare this investigational lotion with a combination of minoxidil lotion and finasteride pills to understand which treatment better improves hair density. The study is sponsored by EMS and uses a randomized, double-blind, double-dummy design to ensure unbiased results. Participants will be assigned to one of two groups. One group will take an oral placebo pill and apply 1 mL of Finlndia hair lotion twice daily. The other group will take one oral finasteride pill daily and apply 1 mL of minoxidil lotion twice daily. This treatment period lasts six months, during which participants will follow these dosing schedules closely. During the study, participants hair density changes will be measured after six months to evaluate treatment effects. Researchers will also monitor and record any adverse events to assess safety. The study involves regular visits for assessments and adherence monitoring. The total participation time is six months, after which participants will complete the study evaluations.

Researchers are evaluating the safety and topical effectiveness of a scar gel used continuously for 90 days. The study compares this investigational scar gel to a benchmark product to see how well each prevents hypertrophic scars and improves scar appearance. The research also examines effects on skin hydration, itching, discomfort, and scar pigmentation normalization. Participants will be randomly assigned to use either the investigational scar gel or the benchmark scar gel. Both products are health care devices applied topically to recent scars. The study is double-blinded to ensure unbiased results. The treatment period lasts 90 days, during which participants apply the products as directed. During the study, participants will attend scheduled visits for evaluations to monitor scar appearance and skin condition. Researchers will collect clinical assessments and participant perceptions throughout the 90-day period. The main outcome measured is the clinical and perceived efficacy of the scar gels after 90 days of use. Safety and skin hydration will also be monitored to understand the overall effects of the products.