Campo Grande

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

Researchers are studying baricitinib to see if it can help preserve beta-cell function in children and adults aged 1 to 35 years who have been newly diagnosed with type 1 diabetes. This Phase 3 study aims to evaluate the treatments impact on preserving insulin production shortly after diagnosis. Participants will be followed for about 60 weeks to assess changes in key diabetes-related measures. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study compares these two groups to evaluate the effects of baricitinib on beta-cell function. The main measurement is the change in C-peptide area under the curve over 52 weeks, which indicates insulin production. Additional outcomes include changes in blood sugar control, insulin use, hypoglycemia events, and other health indicators. During the study, participants will attend visits for assessments and monitoring over approximately 60 weeks. Tests will include blood measurements like C-peptide and hemoglobin A1c, insulin dose tracking, and health surveys. Safety and drug levels will be monitored. Researchers will use these data to understand if baricitinib can help maintain beta-cell function in people newly diagnosed with type 1 diabetes.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are studying biperiden as a potential preventive treatment for post traumatic epilepsy PTE, a common neurological complication after moderate or severe traumatic brain injury TBI. This research aims to evaluate if biperiden can reduce the occurrence of PTE, assess its side effects, and analyze its cost-effectiveness. The trial focuses on adult patients with moderate or severe TBI, as PTE often develops within two years after injury and currently lacks effective prevention. Participants are randomly assigned to receive either 5 mg of biperiden intravenously every 6 hours for 10 days or a placebo with similar administration. The treatment starts within 18 hours of brain injury. The study includes a two-year follow-up period with regular visits to monitor for epileptic seizures and other outcomes. The trial also examines brain activity through electroencephalogram analyses, genetic markers, and various neuropsychological functions. During the study, participants will undergo multiple assessments including EEG tests at set intervals, neuropsychological evaluations at 6 and 24 months, and quality of life questionnaires. Researchers will track seizure development, side effects of biperiden, and health status over two years. This long-term monitoring helps determine the drugs safety and effects on epilepsy prevention after brain injury.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

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.

Researchers are conducting a phase III, randomized, multi-center clinical trial to evaluate whether intravenous Tenecteplase TNK treatment is better than a placebo for patients who have suffered a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours after they were last seen well. The study focuses on patients with evidence of salvageable brain tissue or a clinical-radiological mismatch on perfusion imaging. The goal is to determine if TNK can improve functional outcomes compared to placebo. Participants will be randomly assigned in a 11 ratio to receive either a single intravenous bolus injection of Tenecteplase at a dose of 0.25 mgkg maximum 25 mg or a placebo bolus injection over 5 seconds. The study uses a double-blind design, and randomization considers factors such as age, stroke severity, and timing since last seen well. The planned enrollment is 466 participants, split evenly between the TNK and placebo groups, with interim analyses to assess study progress. During the 90-day follow-up, participants will undergo assessments including modified Rankin Scale scoring to evaluate functional outcomes, brain imaging to measure infarct volume and reperfusion, and quality of life questionnaires at 3 months, 6 months, and one year. Safety outcomes like intracranial hemorrhage and mortality rates will also be monitored. These evaluations aim to measure the effectiveness and safety of TNK treatment compared to placebo after ischemic stroke.

Researchers are evaluating the efficacy of perioperative dostarlimab compared with the standard of care in participants with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability dMMRMSI-H. This phase 3, open-label, randomized study focuses on these specific colon cancer patients to assess if dostarlimab can improve outcomes compared to current treatments. Participants are randomly assigned to receive either dostarlimab before and after surgery or the standard of care treatments, which include FOLFOX or CAPEOX chemotherapy or post-surgery observation. Dostarlimab is given as monotherapy during the perioperative period. The study carefully monitors participants for up to approximately 5 years to evaluate long-term effects. During the trial, participants undergo regular assessments including event-free survival reviewed by blinded independent central review, overall survival, and pathological response evaluations. Safety is closely monitored by tracking adverse events, immune-related effects, and serum concentrations of dostarlimab across treatment cycles. The study involves frequent follow-ups to understand treatment impact and ensure participant well-being throughout the extended observation period.

Researchers are conducting an observational, prospective, multicenter cohort study to evaluate patients with severe and very severe Chronic Obstructive Pulmonary Disease COPD in Brazil. The study focuses on patients classified according to the GOLD 2024 guidelines, exploring how COPD severity relates to exacerbation rates, disease progression, complications, and mortality. This study aims to provide national data on this specific subgroup of COPD patients across different Brazilian regions with varying environmental exposures and genetic backgrounds. This non-interventional study will include patients from eight medical centers representing all five regions of Brazil, including teaching and tertiary hospitals. Participants will be enrolled consecutively and followed for 12 months. The study involves on-site visits at enrollment, 6 months, and 12 months, with tele-consults at 3 and 9 months to collect clinical data, especially regarding exacerbations. Participants will undergo evaluations during scheduled visits and tele-consults, with data collected and reviewed by the studys adjudication team. Researchers will measure outcomes such as the incidence of hospitalizations, exacerbations, mortality, vaccination rates, and lung neoplasia over approximately one year. The study emphasizes gathering comprehensive clinical information through direct and remote contacts to understand COPD progression and related health events.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.