Bauru

Researchers are evaluating whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens in men with metastatic castration-resistant prostate cancer mCRPC, a type of prostate cancer that continues to grow despite low hormone levels. This Phase 3 study compares pasritamig plus docetaxel against docetaxel alone to see if the combination improves radiographic progression-free survival rPFS, which is the time until disease progression or death as seen on scans. Participants are randomly assigned to receive either pasritamig together with docetaxel or docetaxel plus prednisoneprednisolone as background medication. Treatment continues until disease progression is confirmed by scans or other criteria are met. The study is open-label, meaning both participants and researchers know which treatment is given. During the trial, participants will have regular scans such as CT, MRI, or bone scans to monitor disease progression, assessed by independent review. Researchers will also evaluate overall survival, symptom progression, response rates, prostate-specific antigen PSA levels, quality of life measures, and safety by tracking adverse events and lab results. The study may last up to approximately 4 years and 5 months, with frequent assessments throughout.

Researchers are evaluating the clinical benefit of combining Navlimetostat BMS-986504, a selective MTA-cooperative inhibitor of PRMT5, with pembrolizumab and chemotherapy compared to placebo plus pembrolizumab and chemotherapy. This study focuses on participants with first-line metastatic non-small cell lung cancer NSCLC who have a homozygous MTAP deletion. The trial is a randomized Phase 23 study aimed at advancing treatment options for this specific lung cancer group. Participants will receive one of several combinations Navlimetostat plus pembrolizumab and chemotherapy, or placebo plus pembrolizumab and chemotherapy. Chemotherapy drugs involved may include cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on certain days. The study uses a quadruple-masked, parallel design with multiple treatment arms to compare these regimens. During the study, participants will be monitored for progression-free survival and overall survival up to five years. Researchers will assess tumor response, disease control, duration and time to response, and safety through adverse event reporting and laboratory tests. The study includes detailed follow-up to evaluate efficacy and safety outcomes over the long term, with a primary completion date in 2031.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 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 investigating the effects of heated water-based exercise compared to land-based exercise on blood pressure and various health measures in older adults with hypertension. This study focuses on individuals over 60 years old with hypertension, aiming to assess how these exercise types impact arterial stiffness, endothelial function, metabolic and inflammatory markers, and functional capacity. The goal is to understand if exercising in a heated swimming pool offers unique benefits over traditional land exercises for managing hypertension and related health factors. Participants will be randomly assigned to one of three groups heated water-based exercise HEx, land-based exercise LEx, or a control group that maintains usual physical activity without starting new exercise programs. Both exercise groups will train three times a week for 12 weeks. HEx sessions include warm-up, aerobic exercise, resisted exercises targeting various muscle groups, and stretching, all performed in a heated pool. LEx sessions follow a similar structure but use treadmills, exercise bikes, fitness machines, and free weights on land. The control group receives guidance to maintain their usual activity levels. Throughout the study, participants will undergo assessments at the start, after 12 weeks, and after 24 weeks. These evaluations include blood pressure measurements, arterial stiffness, vascular function tests, exercise capacity assessments, muscle strength, flexibility, balance, and endurance tests. Researchers will monitor adherence to exercise sessions and track any changes in medication or health status. The study aims to provide detailed insight into the physiological and functional effects of these exercise programs in older adults with hypertension.

Researchers are comparing antimicrobial photodynamic therapy aPDT combined with scaling and root planing to scaling and root planing alone for treating periodontal disease in patients with obesity. The study aims to find out if adding aPDT improves periodontal health and reduces inflammation, as well as to examine differences in the protein makeup of gingival fluid after treatment. This interventional trial is led by the University of Sao Paulo and involves adults aged 18 to 70 with periodontal disease and obesity. Participants are randomly assigned to one of two groups one receives scaling and root planing followed by aPDT using methylene blue and a red laser, while the other receives only scaling and root planing. Both treatments are non-surgical procedures performed to clean the teeth and gums. The study uses a double-blind design to reduce bias. Participants will be evaluated at the start of the study and then again at 1, 3, and 6 months after treatment. Assessments include measuring probing depth, clinical attachment level, bleeding on probing, and changes in gingival fluid proteins. These measures help researchers understand the impact of the treatments on periodontal health. The total follow-up period lasts six months, during which safety and treatment effects are monitored.

Researchers are studying how beetroot extract affects blood pressure and muscle oxygen levels during exercise in older women with high blood pressure. This trial focuses on the immediate effects of beetroot extract supplementation to understand its impact on cardiovascular and metabolic responses during aerobic exercise. The study is important because hypertension is a major risk factor for heart disease in this group, and dietary nitrate from beetroot might improve exercise tolerance and vascular health. Participants will take part in four sessions in a random order resting with placebo, resting with beetroot extract, exercising with placebo, and exercising with beetroot extract. Each beetroot dose includes about 314 mg of dietary nitrate in two capsules. The exercise sessions include a 7-minute warm-up and 30 minutes of aerobic exercise on a treadmill at 60-80% of their maximum heart rate. Rest sessions include sitting for 30 minutes while completing a food questionnaire. There is a minimum of two days between sessions to allow washout. During the study, participants blood pressure will be measured at rest, during, immediately after, and after recovery from the sessions. Muscle oxygen saturation will be continuously monitored during exercise, and markers of oxidative stress will be checked before and right after each session. The study tracks how these measures change with beetroot extract compared to placebo, providing detailed insight into its effects on exercise stress in hypertensive older women.

Researchers are evaluating the effectiveness of periodontal treatment combined with a tongue scraper, compared with the same treatment plus antimicrobial photodynamic therapy aPDT, in reducing bad breath halitosis in people who have periodontal disease and type 2 diabetes. The trial aims to determine if adding aPDT to conventional treatment is more effective for treating halitosis and improving periodontal health. This study is a randomized clinical trial sponsored by the University of Sao Paulo. Participants will receive one of two treatments scaling and root planing with antimicrobial photodynamic therapy applied to periodontal pockets and the tongue, or scaling and root planing with a tongue scraper only. Treatments will be given once a week for one month. After this active treatment phase, participants will attend maintenance and control visits once a month for up to six months. During the study, participants will visit the clinic weekly during treatment and monthly during follow-up. Researchers will assess halitosis from enrollment through six months, along with periodontal health measurements such as probing depth and clinical attachment level. These evaluations will help determine the added effects of aPDT compared to conventional treatment. The total participation time covers one month of active treatment plus six months of follow-up.

Researchers are evaluating the effects of high-intensity interval training HIIT versus moderate-intensity continuous exercise MICE, both done in heated water, on blood pressure and other related heart and vessel functions in older adults with hypertension. The study focuses on understanding how these two types of exercise impact hemodynamic and autonomic responses in this population, who often face challenges in exercising due to comorbidities or injuries. This research aims to provide insight into effective exercise strategies for managing hypertension in older individuals. The trial includes 60 participants over 60 years old with hypertension, randomly assigned to one of three groups HIIT, MICE, or a control group with no exercise. Exercise sessions are conducted in heated water at 30 to 32 C, with participants submerged up to the chest level. The HIIT program involves a warm-up followed by intervals of jogging or running alternating with walking, while the MICE program consists of continuous walking or jogging at moderate intensity. The control group remains seated in heated water without exercising. The exercise programs last for 12 weeks, followed by a 12-week observation period without exercise. Participants undergo evaluations before, during, and after the intervention, including blood pressure, arterial stiffness, endothelial function, heart rate variability, and physical and functional capacity tests. Quality of life is also assessed using questionnaires. Researchers monitor adherence to the exercise programs and measure changes in these variables after 12 and 24 weeks. The primary outcome is the change in systolic and diastolic blood pressure after 12 weeks of exercise.