Sao Carlos

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

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 evaluating whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. This Phase 3 study compares zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The goal is to see if the new combination improves progression-free survival. Participants receive treatments through intravenous infusions of study drugs including zilovertamab vedotin, rituximab or its biosimilar, cyclophosphamide, doxorubicin, and vincristine, along with oral prednisone or prednisolone as per approved guidelines. Some may receive rescue medication such as granulocyte colony-stimulating factor (G-CSF) if needed. The study is open-label and conducted across multiple centers. During the study, participants are closely monitored for how long they live without their disease worsening, with follow-up up to approximately 50 months. Assessments include imaging scans like PET to evaluate disease status, heart function tests, and regular evaluations of overall health and side effects. Safety is monitored throughout, and researchers measure progression-free survival as the primary outcome to determine the effectiveness of the treatments.

Researchers are studying the immediate effects of two types of photobiomodulation (PBM) therapies on blood pressure, blood vessel function, and artery flexibility in adults aged 40 to 60 years with hypertension. This randomized, double-blind, sham-controlled trial involves 48 participants who have been diagnosed with hypertension for at least 3 months and are on blood pressure medication. The goal is to compare full-body LED panel PBM and modified intravascular laser irradiation of blood (ILIB) to see their impact on these cardiovascular measures. Participants will be randomly assigned to one of four groups: full-body LED panel treatment, sham panel treatment, modified ILIB therapy, or sham ILIB therapy. Each participant receives a single session of treatment according to their group. The panel therapy uses low-intensity LEDs with specific light settings, while the modified ILIB uses a laser device. Sham groups receive inactive versions of these therapies to serve as controls. Before and after the treatment, participants will have their blood pressure, blood vessel function, arterial stiffness, blood nitrite levels, and skin temperature checked. After treatment, ambulatory blood pressure monitoring will also be conducted. The study includes careful statistical analysis to assess differences between groups, focusing on the acute effects observed up to 24 hours after the intervention.

Researchers are evaluating whether cognitive functional therapy is more effective than therapeutic exercises in reducing pain and disability in adults with chronic shoulder pain. This randomized controlled trial involves 148 participants aged 18 to 65 years who have experienced shoulder pain for at least three months. The study also examines the impact of these treatments on shoulder function, psychological factors, and quality of life. Participants will be randomly assigned to one of two groups: the cognitive functional therapy (CFT) group or the therapeutic exercise group. The CFT group will receive weekly sessions for four to eight weeks, focusing on changing pain beliefs, gradually increasing movement confidence, and promoting healthy lifestyle habits. The therapeutic exercise group will perform supervised exercises twice a week for eight weeks, targeting specific shoulder muscles with resistance bands to improve strength and function. Throughout the study, participants will have their pain intensity and shoulder disability measured at baseline, 4 weeks, at the end of treatment (8 weeks), and again at 12-week follow-up. Additional assessments will include shoulder function, fear of movement, self-efficacy, sleep quality, treatment expectations, perceived change, satisfaction, and exercise adherence. Safety and participant progress will be monitored to ensure adherence and manage any issues during and after treatment.

Children with spastic cerebral palsy (CP) often experience challenges with movement and coordination, especially in their upper limbs, which affect daily activities like dressing, reaching for objects, and standing up. This study investigates the effects of a task-specific training program called the INTERACT protocol, which combines individualized exercises with augmented reality (AR) games to improve upper limb function and daily activities in children aged 6 to 12 years with CP. The research compares this approach to conventional physiotherapy to determine its impact on motor skills and quality of life. The INTERACT protocol involves training sessions three times a week for four weeks, each lasting 1 hour and 20 minutes. The program uses AR games projected on a wall, where children perform reaching and standing movements tracked by a special camera, providing real-time interaction and motivation. The control group will continue their usual physiotherapy treatment for the same duration. Both treatments aim to improve motor control, functional reach, and postural balance through engaging and goal-directed activities. Participants will be assessed before the intervention, immediately after, and two months later. Researchers will measure manual reach movements, upper limb disabilities, and postural sway during sit-to-stand and standing reach tasks. They will use various evaluations, including kinematic analysis, the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, and postural tests to monitor progress. The study also tracks adherence and retention of motor learning to understand long-term benefits of the interventions.

Researchers are studying how light reflects off the skin during whole-body photobiomodulation therapy (PBMT) in adults aged 18 to 30 years. PBMT uses low-intensity light to affect biological tissues, but the amount of light reflected when the light is applied without skin contact, and how different skin types affect this reflection, is not well understood. The study divides participants into groups based on their skin phototype and sex to explore these differences. The intervention involves applying whole-body PBMT using red light (660 nm) and infrared light (850 nm) for a total of about 10 minutes, split evenly between the two wavelengths. The light is delivered from 20 cm away from the skin surface. Reflection of light will be measured with a power and energy analyzer at several body sites including the biceps, abdomen, lower back, thighs, and calves. Participants will undergo light reflection measurements during the therapy session itself. Researchers will analyze the light reflected from the skin and compare results across skin phototypes and sexes, using statistical methods with a significance level of 5%. The study focuses on acute measurement of light reflection during irradiation to better understand PBMT effects on different skin types.

This study aims to evaluate the discriminative capacity of the COLA-6 questionnaire in identifying individuals with chronic respiratory diseases (CRDs) who attend primary health care (PHC) services in Brasil, for the treatment of other long-term conditions (LTCs). To achieve this, the investigators will conduct a cross-sectional observational study enrolling 859 individuals with one or more existing LTCs who are receiving care in PHC services. The COLA-6 questionnaire will be administered, and its results will be compared to gold-standard post-bronchodilator spirometry. The performance of the case-finding tool will be assessed using the area under a receiver operating characteristic (ROC) curve. This study will be conducted in PHC services, including Basic Health units (BHUs) and Family Health Units (FHUs), located in the municipalities of São Carlos and São Paulo, both situated in the state of São Paulo, Brasil. The municipality of São Carlos has a population of 254,857 inhabitants and a gross domestic product (GDP) of R$55,044.88 per capita, with 34 PHC units. In contrast, São Paulo, the state capital, has a population of 11,451,999 inhabitants and a per capita GDP of R$66,872.84, and is served by 471 PHC units. Individuals will be recruited from PHC services, including BHUs and FHUs, located in the municipalities of São Carlos and São Paulo, Brasil. Eligible individuals with NCDs will be identified through three main strategies: (1) individuals attending BHUs/FHUs with an established LTC profile (e.g., scheduled consultations or monitoring for hypertension, diabetes, etc.); (2) individuals with LTCs identified by community health agents through proactive outreach; and (3) individuals with LTCs who attend PHC services and become aware of the study through passive recruitment methods such as posters, information shared by staff or other patients, and invitations extended during service days. Additionally, posters containing the research team's contact information will be displayed, and invitations will be extended during service days at the BHUs/FHUs. All recruitment procedures will be conducted in accordance with ethical principles, ensuring the protection of participants' rights to privacy and autonomy. Data collection will be conducted in a single visit by a member of the UFSCar research team. All eligible participants will provide written Informed Consent prior study procedures. The following procedures will be carried out: Initial assessment; Application of case-finding tools questionnaires: COLA-6 questionnaire; Symptom-Based questionnaire (SBQ); Exhaled fraction of nitric oxide (FeNO) measurement; Spirometry (pre- and post-bronchodilator); Application of disease-specific questionnaires: Chronic Airways Assessment Test (CAAT) for all individuals with abnormal spirometry; Asthma Control Questionnaire (ACQ-7) for individuals with isolated or overlapping asthma; provision of basic information on access to downstream healthcare services for diagnosis and treatment of participants identified with abnormal spirometry. Participants will be classified based on spirometry and FeNO results into two groups, primarily according to the recommendations of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the Global Initiative for Asthma (GINA): Abnormal Spirometry: Includes COPD, asthma, asthma-COPD overlap, PRISm, restriction patterns, asthma-PRISm overlap and asthma-restriction overlap. Normal Spirometry: Participants without lung function abnormalities. The sample size calculation was based on the performance of the COLA-6 questionnaire for diagnosing COPD in the investigators' previous GECo study where COPD prevalence was 9.4%. With these assumed values, a minimum sample size of n=859 individuals will allow the investigators to estimate the area under (AUC) the receiver operating characteristic (ROC) curve to within 4.5% (based on a 95% confidence interval). According to prevalence studies for CRDs in Brasil, the investigators calculate the ability to identify approximately N=146 individuals with COPD, N=77 with asthma, and N=86 with Preserved Ratio Impaired Spirometry (PRISm) in this study, therefore an estimated sample of N=309 with abnormal spirometry and N=550 with normal spirometry. The investigators will case-find in more people if the expected prevalence is lower to reach these targets. The investigators will summarise the demographic, and clinical characteristics of participants overall and by those with normal and abnormal spirometry. Based on spirometry results, the investigators will report the prevalence of COPD, asthma, PRISm and restriction, alone and in combination, with 95% confidence intervals. For the primary analysis, the investigators will calculate the AUC of the ROC curves for COLA-6 compared with the gold standard spirometry diagnosis separately for combined CRDs, asthma, COPD and PRISm. Using the previously published threshold for COLA-6 scores of ≥4, the investigators will also calculate sensitivity, specificity, and negative and positive predictive values. In addition, based on the ROC curve the investigators will identify the COLA-6 score threshold that achieves sensitivity of at least 90%. All estimates will be reported with 95% confidence intervals. Full ethical approval was obtained from the Ethics Committee of the Federal University of São Carlos and UNISA (reference number: MARES-1: 85805425.4.1001.5504) and UCL as described above. The MARES project is funded by the UK NIHR (project reference 303125) using UK international development funding from the UK Government to support global health research. The views expressed in this publication are those of the the investigators and not necessarily those of the NIHR or the UK government.

Researchers are conducting an observational study to create a registry of Brazilian patients with hereditary cardiovascular diseases by combining clinical data with genomic information. The study aims to identify which genes are most commonly affected and determine the frequency of these genetic changes in the population. Participants have hereditary cardiovascular conditions such as various types of cardiomyopathy, familial hypercholesterolemia, Marfan syndrome, and other related syndromes. Participants undergo whole genome sequencing using DNA collected from a buccal swab to analyze their genetic makeup. This sequencing serves as a diagnostic test to explore genetic diversity and variant frequency related to their conditions. The genetic information is collected as part of routine medical care visits at multiple centers within Brazil's Unified Health System. During the study, participants will be interviewed and provide clinical information for the registry. Researchers will measure outcomes including diagnostic yield, genetic diversity, and variant frequency 30 months after the study start. Participants must consent to genetic counseling and provide informed consent. The study focuses on collecting detailed clinical and genomic data to better understand hereditary cardiovascular diseases in Brazil.