Bauru

Researchers are evaluating whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens, compared to docetaxel alone. This study focuses on participants with metastatic castration-resistant prostate cancer, a form of prostate cancer that continues to grow despite low male hormone levels. The trial is a Phase 3, randomized, open-label study assessing radiographic progression-free survival as the main outcome. Participants in this study receive pasritamig, a T-cell-redirecting agent targeting human kallikrein 2, along with docetaxel, a chemotherapy drug. Prednisone is also administered as part of the treatment. The study compares this combination therapy against docetaxel alone to determine if the addition of pasritamig can improve outcomes. During the study, participants undergo regular scans to monitor cancer progression and other assessments to evaluate their health status. Researchers track how long participants live without the cancer worsening based on imaging results. The study includes ongoing monitoring of treatment effects and safety, lasting up to nearly two years to observe radiographic progression-free survival.

Researchers are evaluating the combination of BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in people with first-line metastatic non-small cell lung cancer who have a homozygous MTAP deletion. The study is a randomized phase 2/3 trial focused on assessing clinical benefits in this specific patient group. Participants will receive either BMS-986504 with pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on specified days. This treatment is administered as part of the first-line therapy for metastatic disease. During the study, researchers will monitor progression-free survival up to 2 and 5 years using RECIST v1.1 criteria and overall survival up to 5 years. Participants will be assessed regularly for disease progression and survival outcomes. The study includes detailed monitoring to evaluate the effects and safety of the treatment combination over time.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

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 evaluating the effects of heated water-based exercise compared to land-based exercise on blood pressure, arterial stiffness, endothelial function, metabolic, inflammatory, and functional variables in older adults with hypertension. This study focuses on individuals over 60 years old who have been diagnosed with hypertension for more than six months and are using antihypertensive medication. The goal is to understand how different exercise environments impact cardiovascular and physical health in this population. The study involves three groups: one performing exercise sessions in a heated swimming pool (HEx), another doing land-based exercise sessions (LEx), and a control group (CON) that maintains usual physical activity without starting new exercise programs. Both exercise groups will train three times per week for 12 weeks. The heated water-based exercise includes warm-up, aerobic activities, resistance exercises, and stretching. The land-based exercise includes similar components with aerobic work on a treadmill or exercise bike, resistance training using fitness machines and free weights, and stretching. Participants will be assessed before starting, after 12 weeks, and after 24 weeks of follow-up. Evaluations include blood pressure measurements, physical capacity, cardiovascular and musculoskeletal responses, and various biological and biochemical markers. Researchers will monitor adherence to the exercise sessions and track any changes in medication or treatment. The main outcome measured is the change in blood pressure at baseline, 3 months, and 6 months, providing insights into the effects of these exercise methods on older hypertensive adults.

Researchers are evaluating the effects of adding antimicrobial photodynamic therapy (aPDT) to standard scaling and root planing treatment for patients who have both periodontitis and obesity. The study aims to find out whether this combined treatment improves periodontal health and reduces inflammation better than scaling and root planing alone. It also investigates differences in the protein profile of gingival fluid after each treatment. Participants will receive either scaling and root planing followed by aPDT or scaling and root planing alone as the control. The treatments focus on cleaning and treating the gums and teeth non-surgically. The study will track changes over time at 1, 3, and 6 months after treatment. During the study, researchers will measure probing depth and clinical attachment level at baseline, 1 month, 3 months, and 6 months to assess periodontal health. These measures will help determine how well the gums respond to the treatments. The total follow-up period for each participant is 6 months, during which outcomes and inflammation levels will be monitored.

Researchers are studying the immediate effects of beetroot extract on older women aged 60 to 70 who have high blood pressure (hypertension). The study focuses on whether beetroot extract influences blood pressure and muscle oxygen levels during aerobic exercise, aiming to better understand its impact on cardiovascular health and exercise tolerance in this group. Participants will take two capsules of a nitrate-rich beetroot extract or a matching placebo in a randomized, double-blind crossover design. They will then perform a single aerobic exercise session on a treadmill, which includes a 7-minute warm-up followed by 30 minutes at 60-80% of their maximum heart rate, with exercise intensity monitored by perceived exertion ratings. In a control condition, participants will rest seated for 30 minutes while completing a dietary questionnaire. Throughout the study, blood pressure will be measured at several points: at rest, during exercise, immediately after, and during recovery. Researchers will also assess oxidative stress markers and muscle oxygen saturation using near-infrared spectroscopy. The study includes thorough monitoring of cardiovascular responses to better understand how beetroot extract might affect exercise stress in hypertensive older women.

Researchers are studying the effects of periodontal treatment combined with a tongue scraper versus the same treatment plus antimicrobial photodynamic therapy (aPDT) in people who have periodontal disease and type 2 diabetes. The study aims to find out if aPDT is more effective in reducing bad breath (halitosis) and improving gum health. The trial compares traditional treatment methods including scaling and root planing with the addition of aPDT to see if it offers extra benefits. Participants will receive mechanical cleaning of biofilm in periodontal pockets and the tongue through scaling and root planing. One group will also receive antimicrobial photodynamic therapy using conventional methylene blue applied to the periodontal pockets and tongue. These treatments will be done once a week for one month. After this active treatment phase, participants will attend monthly maintenance and control visits up to six months. During the study, participants will be monitored from enrollment until six months to assess changes in halitosis. They will have regular exams and treatments during the weekly visits in the first month and follow-up visits thereafter. Researchers will evaluate the effects of the treatments on bad breath and periodontal health throughout this period, ensuring ongoing observation and care.

This research aims to evaluate how high-intensity interval training (HIIT) compares to moderate-intensity continuous exercise (MICE), both performed in heated water, on blood pressure and other heart and blood vessel functions in older adults with hypertension. The study recognizes that hypertension is a leading cause of illness and death, especially in aging populations, and explores water-based exercise as a way to improve exercise adherence and health outcomes in this group. The trial focuses on people aged 60 and older with hypertension to understand both immediate and long-term effects of these exercise types. Participants will be randomly assigned to one of three groups: high-intensity interval exercise, moderate-intensity continuous exercise, or a control group with no exercise. Both exercise programs take place in heated water (30 to 32 6C), with participants submerged up to the chest. The HIIT sessions include a 4-minute warm-up followed by 21 minutes alternating between high-intensity jogging or running and slower walking. The MICE sessions consist of a 4-minute warm-up and 26 minutes of continuous walking at moderate intensity. The control group will be seated in heated water for 30 minutes without exercising. Exercise programs last 12 weeks, followed by a 12-week observation period. Throughout the study, researchers will assess participants' physical fitness, blood pressure, heart and blood vessel function, heart rate variability, and quality of life before and after the 12- and 24-week periods. Participants will also undergo detailed measurements of blood pressure and cardiovascular responses after single exercise sessions. The study will monitor the feasibility of the exercise programs and track changes in systolic and diastolic blood pressure as the primary outcome after 12 weeks of training.