Pelotas

Researchers are evaluating the safety and effectiveness of various new drug combinations, including novel agents combined with standard treatments, for people with advanced or metastatic non-small cell lung cancer (NSCLC). This open-label, multicenter trial focuses on sub-study 2, which examines rilvegostomig combined with standard platinum-based chemotherapy, with or without ramucirumab, in participants with advanced NSCLC. The study aims to identify optimal doses and expand cohorts to better understand treatment safety and tumor response. The trial involves two parts: Part A includes safety run-in groups to test different dose levels of rilvegostomig and establish the recommended Phase 2 dose if not already known. Part B expands to larger groups to assess treatment effects. Rilvegostomig and other study drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, and ramucirumab are given by intravenous infusion according to the study protocol. Sub-study 1 was canceled and will not take place. Participants will undergo assessments including tumor tissue sampling, disease measurement scans, and laboratory tests to monitor organ function and treatment effects. Researchers will track adverse events, serious adverse events, dose-limiting toxicities, and tumor responses over approximately 46 months. Safety, tolerability, and anti-tumor activity are key outcomes, with follow-up to ensure participant well-being and gather comprehensive data on these novel treatment combinations.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

Researchers are investigating the safety and effectiveness of Dato-DXd combined with osimertinib or alone compared to platinum-based doublet chemotherapy in treating adults with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase III, open-label study includes participants whose disease has worsened despite prior osimertinib treatment. The goal is to evaluate progression-free survival (PFS) over up to 2.5 years. Participants are randomly assigned to one of three groups: Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd and chemotherapy drugs (pemetrexed, carboplatin, or cisplatin) are given by intravenous infusion, while osimertinib is taken orally. Treatment continues until the cancer progresses based on imaging, unacceptable side effects occur, or other reasons require stopping treatment. After stopping the study drugs, participants will have an end-of-treatment visit within 35 days and safety follow-up about one month later. During the trial, researchers will monitor participants with radiological scans and assess progression-free survival. Safety evaluations will continue after treatment ends to detect any side effects. The study includes adults aged 18 to 130 years with good performance status and adequate organ function who have progressed on prior osimertinib therapy. The total study duration includes treatment and follow-up periods to ensure thorough assessment of treatment effects and safety.

Researchers are investigating whether combining cognitive tasks with aquatic aerobic exercise can improve cognitive function and other health outcomes in older women aged 60 to 75 years. This study compares a water-based aerobic exercise program with added cognitive tasks to a conventional aquatic aerobic exercise program and a control group. The goal is to see if the combined approach offers greater benefits for brain function while maintaining similar improvements in physical fitness, cardiovascular health, and psychosocial factors. Participants are divided into three groups: one performs aquatic aerobic exercises combined with cognitive challenges, another completes the same aquatic exercises without cognitive tasks, and a control group does not participate in these exercises. The aquatic sessions include exercises like butt kicks, frontal kicks, cross-country skiing, and stationary running, using an interval training style guided by perceived exertion levels. The combined group performs cognitive activities such as memory, attention, and reasoning tasks during recovery periods. Both exercise groups meet twice a week for 12 weeks. During the study, cognitive function is assessed using tests like the Digit Span Test and the Controlled Oral Word Association Test at the start, after 13 weeks of intervention, and again 12 weeks later. Other measures include physical, cardiovascular, and psychosocial evaluations. Researchers monitor progress and adherence through these assessments, aiming to understand the lasting effects of these exercise programs on older adults' cognitive and overall health.

Researchers are evaluating the safety and immune response of the Butantan Dengue vaccine in two age groups: adults aged 40 to 59 years and elderly participants aged 60 to 79 years. This Phase 3b, randomized, double-blind study for the elderly group and open-label for adults, aims to determine whether the vaccine's immune response in older adults is not inferior to that in younger adults. Participants may have had previous exposure to dengue or be healthy as confirmed by clinical examination. Participants receive the Dengue 1,2,3,4 (attenuated) vaccine, which contains a lyophilized formulation with specified concentrations of four dengue virus types. The study includes three parallel groups and follows participants for one year to assess both the immune response and safety. The primary immune response is measured 42 days plus 7 days after vaccination, while safety monitoring for adverse reactions occurs up to 22 days post-vaccination. Surveillance for dengue and related infections continues throughout the study. During the study, participants provide blood samples for immune response testing and are monitored for any adverse events. Researchers collect information on symptoms, vaccine reactions, and serious events for one year after vaccination. Participants complete diaries and attend scheduled visits and contacts by telephone, electronic means, or home visits to support safety and immune response assessments. The study measures the proportion of participants developing neutralizing antibodies and the frequency and severity of adverse reactions.

Researchers are comparing two ways of assessing the risk of dental caries (tooth decay) in children aged 7 to 11 years. The study aims to see whether a detailed, personalized risk assessment method leads to different treatment and follow-up outcomes compared to a simpler method based only on past dental caries experience. This is done through a double-blind randomized clinical trial lasting two years, involving children attending a pediatric dentistry clinic at the Federal University of Pelotas. Participants will be randomly divided into two groups. One group will receive caries treatment and follow-up guided by an individualized, multivariate risk assessment using ICCMS criteria, while the other group's treatment will be based solely on their previous dental caries experience. Treatments and the timing of return visits will be set according to each child's risk assessment at the start. The study includes baseline assessments, followed by evaluations at 12 and 24 months. Throughout the study, parents will complete questionnaires about their child's health, diet, and quality of life related to oral health. Children will have clinical examinations to assess caries presence and activity using the International Caries Detection and Assessment System (ICDAS) in a simplified form. Researchers will measure new caries lesions developing over 24 months as the primary outcome. Quality of life changes and the number of dental surfaces needing treatment will also be monitored and compared between the two groups.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are investigating breast and prostate cancer in patients treated through the Brazilian Unified Health System. The study focuses on understanding molecular changes in tumors, including genetic mutations that arise during cancer development, which can influence treatment responses and disease outcomes. It also aims to identify hereditary genetic syndromes to improve cancer follow-up and risk prediction. This effort supports the Brazilian Ministry of Health's National Precision Genomics and Health Program, Genomas Brasil, while collecting data on the population's ancestry. The project involves detailed genetic testing using whole exome and whole genome sequencing. For prostate and HER2-positive breast cancer, both somatic and germline whole exome sequencing will be conducted. For triple-negative breast cancer, somatic whole exome and germline whole genome sequencing will be analyzed. These tests are performed on tumor tissue and blood samples to map genetic variations linked to these cancers. Participants will provide tumor tissue and blood samples for genetic analysis. The study will characterize the complete somatic and germline exomes and genomes over a 12-month period. Researchers will collect clinical and genomic data to better understand cancer genetics and ancestry. Consent is required before inclusion, and the study monitors the genetic profiles of breast and prostate cancer patients to support precision medicine efforts in Brazil.