Pelotas

Researchers are evaluating the safety and effectiveness of new drug combinations, including rilvegostomig with standard platinum-based chemotherapy, with or without ramucirumab, for treating advanced or metastatic non-small cell lung cancer NSCLC. This study is open-label and multicenter, involving participants with confirmed stage IV NSCLC. It includes a sub-study with safety run-in and expansion parts to find the best dose and assess treatment activity. Participants receive treatments infused intravenously, including rilvegostomig, ramucirumab, and chemotherapy drugs like cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. Non-squamous NSCLC participants are randomly assigned to either rilvegostomig plus chemotherapy with ramucirumab or rilvegostomig plus chemotherapy alone, while squamous NSCLC participants receive rilvegostomig plus chemotherapy and ramucirumab. The study includes initial safety evaluation and dose expansion phases. During the study, participants undergo tumor tissue collection, disease measurements, and regular assessments of side effects, tumor response, and survival. Researchers monitor blood samples for drug levels and antibodies and track progression and overall survival over approximately 46 months. Safety, tolerability, and anti-tumor effects are closely followed throughout the treatment and observation periods.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are evaluating the effects of Dato-DXd combined with osimertinib or Dato-DXd alone compared to platinum-based doublet chemotherapy in people with EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC whose disease progressed after prior osimertinib treatment. This Phase III, open-label, randomized study aims to compare progression-free survival among these treatments to better understand options for this condition. Participants are randomly assigned to one of three groups Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd is given as an intravenous infusion every 3 weeks, osimertinib is taken orally daily, and chemotherapy involves pemetrexed combined with carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance pemetrexed. Treatments continue until disease progression, unacceptable side effects, or other reasons to stop. Throughout the study, participants undergo regular assessments including radiological scans to monitor tumor response using RECIST v1.1 criteria, safety evaluations, and health status measurements. After stopping treatment, an end-of-treatment visit occurs within 35 days, followed by safety follow-up 28 days after the last dose. The study primarily measures progression-free survival over up to 2.5 years, with additional outcomes including overall survival, response rates, quality of life, and pharmacokinetics monitored for up to 3.5 years.

Researchers are investigating the effects of aquatic aerobic exercise combined with cognitive tasks on cognitive function and other health outcomes in older women aged 60 to 75. The study aims to determine whether adding cognitive tasks to aquatic exercise provides additional cognitive benefits compared to conventional aquatic exercise alone or no intervention. This randomized, single-blinded, three-arm trial is sponsored by the Federal University of Pelotas and focuses on aging-related changes in cognition and physical health. Participants are randomly assigned to one of three groups an aquatic aerobic exercise program with cognitive tasks, a conventional aquatic aerobic exercise program, or a control group. The exercise programs last 12 weeks with two sessions per week on non-consecutive days. The aquatic aerobic exercises involve interval training using movements such as butt kick, frontal kick, cross-country skiing, and stationary running with intensity guided by a perceived exertion scale. The cognitive tasks target various cognitive domains and are performed during active recovery phases in the combined group. During the study, participants undergo assessments at the start, after the 12-week intervention, and again at a 12-week follow-up. These include tests measuring cognitive function like the Digit Span Test and Controlled Oral Word Association Test, as well as evaluations of physical function, cardiovascular health, and psychosocial factors such as depressive symptoms and quality of life. The study tracks adherence to exercise intensity and progression in cognitive tasks. The goal is to evaluate whether both exercise programs improve health outcomes compared to no intervention, with added cognitive benefits expected from combining exercise with cognitive tasks.

Researchers are conducting a Phase 3b, randomized, double-blind for ages 60-79 and open-label for ages 40-59, multicenter study to evaluate the safety and immune response of the Butantan Dengue vaccine in adults aged 40 to 79 years. The study compares the humoral immune response of elderly participants 60-79 years to that of adults aged 40 to 59 years, including those with or without previous dengue exposure. The goal is to assess whether the vaccines immune response in the elderly is not inferior to that in younger adults. Participants receive a single dose of the Dengue 1,2,3,4 attenuated vaccine or placebo, with three study groups elderly receiving vaccine, adults receiving vaccine, and elderly receiving placebo. The vaccine dose contains an approximate concentration of 103.0 PFU of each attenuated dengue serotype virus. The study will last one year to evaluate immune response duration and monitor adverse events. Surveillance for dengue, chikungunya, and Zika virus infections will occur throughout the study. Participants will undergo blood tests to measure antibody responses at Day 1, Day 42 7 days, and Day 364 28 days after vaccination. Safety will be monitored through reports of adverse reactions up to Day 22 3 days and throughout the study. Participants will be contacted periodically by phone, electronic means, and home visits. Researchers will analyze neutralizing antibody seroconversion and track serious adverse events, ensuring participants health and vaccine safety over the year-long follow-up.

Researchers are comparing two methods for assessing the risk of dental caries tooth decay in children aged 7 to 11 years. The study aims to evaluate whether an elaborate, individualized risk assessment using the International Caries Classification and Management System ICCMS provides better guidance for treatment and follow-up than a simpler method based only on past dental caries experience. This is a randomized, double-blind clinical trial conducted over two years at the Pediatric Dentistry Clinic of the Federal University of Pelotas. Participants will be randomly assigned to one of two groups one group will receive dental caries treatment and maintenance guided by the multivariate ICCMS risk assessment, while the other group will be treated based on their caries experience alone using WHO criteria. Treatments and follow-up intervals will be tailored according to the initial risk assessment method assigned. The study includes evaluations at baseline, 12 months, and 24 months. During the study, parents will complete questionnaires about their childs diet, general and oral health quality of life, and medical history. Children will undergo clinical exams to assess caries presence and activity using the simplified ICDAS system. Researchers will track new caries lesions requiring operative intervention as the primary outcome and will also assess quality of life changes from baseline to the end of treatment. Data will be analyzed to compare the two risk assessment approaches over the 24-month period.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

This research aims to map breast and prostate cancer in patients treated through the Brazilian Unified Health System by performing complete sequencing of tumor somatic and germline exomes. It focuses on understanding molecular variants in tumors, which can affect treatment response and disease prognosis. The project also seeks to identify hereditary genetic syndromes and collect data on the populations ancestry for the Brazilian Ministry of Healths National Precision Genomics and Health Program, Genomas Brasil. The study includes two groups 745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by surgery, and 137 patients with metastatic prostate cancer. Sequencing involves somatic and germline whole exome analysis for prostate and HER2-positive breast cancer, and somatic whole exome with germline whole genome sequencing for triple-negative breast cancer. Participants will provide tumor tissue and blood samples for genomic analysis. Researchers will characterize complete somatic and germline exomesgenomes within 12 months, identify genetic variants related to tumor prognosis and treatment response, and count patients with mutations in cancer-predisposing genes. The study runs until 2026 and data will support precision oncology efforts in Brazil.