Sao Carlos

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

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 whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Researchers are conducting a randomized, double-blind, sham-controlled clinical trial to compare the immediate effects of two types of photobiomodulation PBM therapies on blood pressure, endothelial function, and arterial stiffness in people with hypertension. The study includes participants aged 40 to 60 years who have been diagnosed with hypertension for at least 3 months and are using blood pressure medications. The goal is to better understand how these light-based therapies may influence cardiovascular measures in this population. Participants will be randomly assigned to one of four groups full-body PBM from an LED panel, sham panel treatment with the device turned off, modified intravascular laser irradiation of blood ILIB therapy, or sham ILIB treatment with the device turned off. Each participant will receive a single application of the assigned therapy. The LED panel uses a wavelength of 660 nm with specific energy and power settings, while the modified ILIB also uses 660 nm but with different energy and power characteristics. Before and after the intervention, participants will be assessed for blood pressure, endothelial function, arterial stiffness, blood nitrite levels, and skin thermography. Ambulatory blood pressure monitoring will be performed after the intervention to track blood pressure over 24 hours. The primary outcome is the diastolic blood pressure effect immediately and up to 24 hours post-treatment. Secondary outcomes include systolic and mean arterial pressure, endothelial function, arterial stiffness, and blood nitrite changes measured at specified times after the therapy. Data analysis will determine if the therapies have significant acute effects on these cardiovascular parameters.

Researchers are evaluating whether cognitive functional therapy is more effective than therapeutic exercises in reducing pain and disability for individuals with chronic shoulder pain. This randomized controlled trial includes 148 participants aged 18 to 65 years who have experienced shoulder pain for at least three months. The study aims to understand which treatment better improves pain, disability, function, and psychosocial factors related to shoulder pain. Participants will be randomly assigned to one of two groups. One group will receive cognitive functional therapy once a week for four to eight weeks, focusing on changing beliefs about pain, gradually exposing patients to movements, and promoting lifestyle changes. The other group will follow a therapeutic exercise program twice a week for eight weeks, targeting shoulder muscles with specific exercises using progressive resistance bands. Throughout the study, participants will undergo assessments at baseline, four weeks, eight weeks, and a 12-week follow-up. Researchers will measure pain intensity, shoulder disability, specific function, fear of movement, pain self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction, and exercise adherence. The study includes monitoring for safety, and participants may be discontinued if certain injuries or treatments occur during the trial.

Children with spastic cerebral palsy CP, a condition that affects movement and coordination, often struggle with daily activities such as dressing, reaching for objects, and standing up. These difficulties can reduce their quality of life. Researchers are studying the effects of a new treatment called the INTERACT protocol, which combines task-specific training with augmented reality AR games to improve upper limb function and daily activities in children with CP aged 6 to 12 years. The study will randomly assign children to two groups the INTERACT group and a control group. The INTERACT group will participate in training sessions using AR games that encourage movements like reaching, sitting to standing, and stepping. These sessions will last 1 hour and 20 minutes, three times a week, for 4 weeks. The control group will continue their usual physiotherapy during the same period. The AR games use special software and equipment to track movements and create interactive, motivating exercises. Participants will be evaluated before the intervention, immediately after, and two months later to measure improvements. Assessments include movement analysis, disability scales, postural control tests, and questionnaires about daily activities and motivation. Throughout the study, therapists will monitor progress and adherence. This research aims to provide new evidence on how combining task training with AR can support motor learning and improve life skills in children with spastic CP.

Researchers are studying how light reflects off human skin during whole-body photobiomodulation therapy PBMT, which uses low-intensity red and infrared light to affect biological tissues. The trial focuses on men and women aged 18 to 30 years and aims to understand how different skin phototypes influence light reflection when the therapy is applied without skin contact. This research is led by Universidade Federal de Sao Carlos. Participants will receive whole-body photobiomodulation therapy using a device that emits red light 660 nm and infrared light 850 nm for a total of about 10 minutes5 minutes for each wavelength. The light source will be held 20 cm from the skin during treatment. Participants will be grouped by skin phototype using the Fitzpatrick scale to compare light reflection across skin types. The reflection will be measured in multiple body areas including the brachial biceps, abdomen, lumbar region, front and back of the thighs, and calves. During the therapy session, light reflection will be measured using specialized sensors and a powermeter. This measurement will occur only during the light therapy irradiation on the day of the procedure. Researchers will analyze reflection data to see how skin type affects light interaction with the skin. The study involves healthy volunteers with normal to overweight BMI, and participation is expected to last for the duration of the single treatment session.

Researchers are investigating ways to identify people in Brasil who may have undiagnosed chronic respiratory diseases CRDs like asthma and chronic obstructive pulmonary disease COPD. This study focuses on adults who already have other long-term health conditions such as heart disease, diabetes, or high blood pressure and attend primary health care centers in the cities of Sao Carlos and Sao Paulo. The goal is to evaluate simple questionnaires that can help detect these lung conditions early in people with other health problems. Participants will complete two questionnaires called COLA-6 and the Symptom-Based Questionnaire SBQ, which are quick and easy to use. Each person will also undergo lung function tests including spirometry before and after using a bronchodilator, as well as a fractional exhaled nitric oxide FeNO test to confirm lung health. Additional questionnaires related to asthma and chronic airway symptoms will be given to those with abnormal lung tests. The study will classify participants based on lung test results following recognized guidelines to identify different types of lung issues. All assessments are done during a single visit with a research team member. Participants will provide consent and undergo initial evaluations, questionnaires, and lung tests. The study will analyze how well the questionnaires identify abnormal lung function compared to spirometry results. Researchers will also collect information about participants health and lung conditions to better understand lung disease detection in people with other chronic illnesses. The study plans to recruit 859 individuals and will be completed by mid-2027.

Researchers are developing a registry of Brazilian patients with hereditary cardiovascular diseases by combining clinical information and genetic data. The study aims to identify which genes are most commonly affected and the frequency of these genetic changes within this population. The registry will help advance understanding and healthcare for hereditary heart conditions in Brazils public health system. Participants will be interviewed during their routine medical visits, and their DNA will be collected using buccal swabs for whole genome sequencing. This observational study does not involve any treatment but focuses on gathering detailed genetic and clinical data to better characterize hereditary cardiovascular diseases. The study is planned to run for 30 months starting from April 2025. During the study, participants will provide information through interviews and give DNA samples for sequencing. Researchers will measure diagnostic yield, genetic diversity, and variant frequency over the 30 months. The study does not involve additional interventions beyond data and sample collection, and participants will continue their usual medical care throughout the study period.