Osasco

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are investigating a treatment approach for patients hospitalized with community-acquired pneumonia (CAP), a condition with high rates of illness and death. This phase 3 trial compares therapeutic-dose heparin versus usual care pharmacological thromboprophylaxis to see if it improves patient outcomes. The study focuses on preventing complications caused by blood clots and inflammation that can worsen respiratory and organ function in CAP patients. Previous findings in COVID-19 pneumonia suggest heparin might reduce disease progression and mortality, but its effects in non-COVID-19 CAP are unknown. Participants will receive either therapeutic-dose heparin, preferably a low molecular weight heparin (LMWH) like enoxaparin, dalteparin, or tinzaparin, dosed by patient weight unless contraindicated. Intravenous unfractionated heparin (UFH) may be used instead, especially for those with kidney issues, with dosing adjusted to specific blood clotting targets. The trial is open-label and randomized, with adaptive rules to monitor progress. Usual care pharmacological thromboprophylaxis is the comparator. Treatment and monitoring occur during hospital admission, anticipated to last at least 72 hours after randomization. During the study, patients are assessed for survival at 30 days and monitored for complications related to CAP. Researchers collect clinical data including oxygen use, laboratory tests, and adverse events, tracking safety and effectiveness. The study excludes patients with active COVID-19, recent bleeding, contraindications to anticoagulation, or those receiving critical care interventions. Overall participation depends on hospital stay length and clinical status, with follow-up to evaluate the primary outcome of survival within a month.

Researchers are studying the effectiveness and safety of Finlândia hair lotion association in treating androgenetic alopecia, a common form of hair loss affecting men. This phase III clinical trial focuses on men aged 18 to 60 with specific grades of hair loss classified by the modified Norwood-Hamilton scale. Participants have been using 5% minoxidil for at least three months and agree to maintain consistent hair style, length, and color throughout the study. Participants are randomly assigned to receive either the Finlândia hair lotion association plus a finasteride placebo or a combination of minoxidil hair lotion and finasteride 1 mg. The trial uses a double-blind, double-dummy design to compare these two treatments. The study evaluates changes in hair density over a six-month period to assess treatment effects. During the study, participants are monitored regularly for hair density changes and any safety concerns. Researchers collect data over six months to measure the primary outcome of hair density improvement from the baseline. Safety and tolerability are also closely observed, with participants maintaining their usual hair care routines as specified. The total participation duration aligns with the six-month treatment and observation period.

Researchers are evaluating a new cosmetic serum formula (2039125 03) to treat facial hyperpigmentation caused by three different conditions: mild to moderate melasma, mild to moderate acne-induced post-inflammatory hyperpigmentation (PIHP), and solar lentigo. Hyperpigmentation results from excess melanin production and can be triggered by genetic, hormonal, inflammatory, or ultraviolet factors. This open-label study aims to assess the serum's effectiveness, cosmetic acceptability, and impact on social stigmatization over three months in adult patients. Participants apply the serum twice daily, once in the morning and once in the evening, to their face for three months. The study includes three groups, each representing one of the hyperpigmentation conditions. The treatment is used under normal conditions, and measurements are taken before and after the treatment period to evaluate changes. During the study, patients will undergo assessments that include scoring their pigmentation using scales specific to their condition, such as the Investigator's Global Assessment (IGA) score for melasma and acne PIHP, the modified Melasma Area and Severity Index (mMASI), the Post-Acne Hyperpigmentation Index (PAHPI), and the solar lentigo pigmentation scale. These scores will be compared from the start of treatment to Day 84 to assess improvement. Safety and tolerability are monitored descriptively. The total participation time is three months of treatment with regular evaluations.

Researchers are evaluating the safety and topical effectiveness of a scar gel over 90 days of continuous use. The study compares the investigational scar gel with a benchmark product to prevent hypertrophic scars and improve scar appearance. It also looks at effects on skin hydration, itching, discomfort, and scar pigmentation normalization. Participants will use either the investigational scar gel or the benchmark scar gel. Both are health care products applied topically to scars. The study focuses on scars from cesarean sections, breast implants, or blunt cut injuries. The treatment period lasts 90 days with continuous application to assess the products' effects. During the study, participants will attend scheduled visits for evaluations. Researchers will assess clinical outcomes, participant perceptions, and instrumental measures related to scar appearance and skin condition. Safety and efficacy will be monitored throughout the 90-day period, providing comprehensive data on the scar gels' performance.