Santa Maria

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating how long adult participants with KRASNRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer remain disease-free when treated with different combinations of drugs. The study compares amivantamab combined with chemotherapy regimens mFOLFOX6 or FOLFIRI versus cetuximab combined with the same chemotherapy regimens. This phase 3 trial aims to understand which treatment approach may better delay cancer progression. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles consisting of 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin or irinotecan hydrochloride, repeated every 28 days. The other group receives cetuximab combined with the same chemotherapy regimens, also in 28-day cycles. Treatments continue until imaging shows disease progression or other criteria require stopping. During the study, participants will undergo regular assessments including radiographic imaging to monitor disease status and treatment effects. Researchers will measure progression-free survival for up to over 4 years, along with other outcomes such as overall survival, response rates, duration and time to response, and quality of life using validated questionnaires. Safety will be monitored through adverse event reporting and laboratory tests, with follow-up continuing for several years to capture long-term results.

This trial investigates the safety and efficacy of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Participants must have specific tumor characteristics including PD-L1 and HER2 status, and measurable disease according to established criteria. The study is a blinded, randomized phase 23 trial sponsored by Bristol-Myers Squibb. Participants will receive either Pumitamig or Nivolumab alongside chemotherapy regimens such as Folfox or Capox, with dosing given on specified days. The study uses a parallel design with multiple experimental arms to evaluate these combinations. Treatments and assessments will continue over several months following randomization. During the study, participants will undergo regular evaluations including tumor response assessments by RECIST criteria, survival monitoring, and safety checks. Researchers will measure objective response rates, progression-free survival, and overall survival up to several years after treatment starts. The trial includes long-term follow-up to monitor outcomes and safety over time, with the primary outcome tracked for up to two years after the last participant is randomized.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

Researchers are evaluating the effects of therapeutic-dose heparin compared to usual care pharmacological thromboprophylaxis in patients hospitalized with community-acquired pneumonia CAP. This international, open-label, randomized controlled trial aims to understand if higher doses of heparin can improve outcomes by addressing inflammatory and thrombotic processes that contribute to respiratory, cardiac, and organ complications in CAP. The study builds on findings from COVID-19 patients, where therapeutic-dose heparin showed benefits in non-critically ill patients. Participants are randomly assigned to one of two groups. One group receives a daily therapeutic dose of low molecular-weight heparin LMWH or unfractionated heparin UFH for up to 14 days or until hospital discharge. The other group receives usual care with thromboprophylactic dose anticoagulation following local protocols, with doses not exceeding half the therapeutic level. The investigational arm prefers LMWH but may use UFH, especially in cases of renal compromise, with dosing tailored to patient weight and local standards. During the study, participants will be monitored for survival over 30 days as the primary outcome. Secondary outcomes include bleeding events, heparin-induced thrombocytopenia HIT, thrombotic events, invasive mechanical ventilation, mortality at multiple time points, hospital-free days, and health-related quality of life. The study involves hospital assessments, close monitoring of safety and clinical status, and tracking of various health measures up to 180 days, ensuring comprehensive evaluation of the treatments under study.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

Researchers are conducting the BRAVO study, a multicenter observational research project focused on adults aged 18 and over living with HIVAIDS across Brazil. The study aims to gather detailed information about chronic non-communicable diseases NCDs, mental health, and quality of life in this population to help develop better health policies. It includes participants from various regions in Brazil and emphasizes the importance of understanding cardiometabolic health, mental health, and other risk factors among people living with HIVAIDS. The study collects a wide range of data including sociodemographic details, risk factors for main NCDs, physical examination results, and biological samples for biochemical and metabolic testing. It uses validated tools and some project-developed questionnaires to assess conditions such as depression, anxiety, substance use, and quality of life through the WHOQOL-BREF survey. Data are managed using REDCap software and cover clinical lab tests, physical measures, respiratory function, renal, hepatic, and bone health, as well as sexually transmitted infections and cancer risk assessments. Participants will provide informed consent and undergo a cross-sectional baseline assessment during 2025 and 2026. Researchers will measure the prevalence of chronic diseases, mental disorders, metabolic and behavioral risk factors, antiretroviral therapy adherence, and quality of life at baseline and one year later. The study plans subgroup analyses for specific populations and ensures confidentiality and ethical compliance. Participation involves data collection through questionnaires, exams, and sample collection, with a target of 743 participants to ensure reliable results.

Researchers are evaluating two different chemotherapy regimens following long-course chemoradiation therapy for patients with distal rectal cancer. The study aims to compare fluoropyrimidine alone versus fluoropyrimidine combined with oxaliplatin in consolidation chemotherapy to determine their effect on tumor response and the potential for organ preservation through a Watch and Wait strategy. This multi-center trial focuses on patients with MRI-defined distal rectal tumors classified as mrT2-3N0-1 and assesses tumor response after 12 weeks from radiotherapy completion. Participants receive 54 Gy of radiotherapy with daily capecitabine during treatment, followed by consolidation chemotherapy starting one week after radiotherapy ends. One group receives fluoropyrimidine alone, while the other receives fluoropyrimidine plus oxaliplatin, with dosing schedules of either mFOLFOX6 or CAPOX over approximately 12 weeks. Tumor response is centrally reviewed at 12 and 18 weeks, with decisions about continuing organ preservation or proceeding to surgery made by a central committee blinded to treatment assignment. Throughout the study, participants undergo clinical exams, endoscopic assessments, and high-resolution MRI to monitor tumor changes and response. The primary outcome is the decision to proceed with the Watch and Wait approach based on clinical complete response at 18 weeks post-radiotherapy. Secondary outcomes include surgery-free survival, total mesorectal excision-free survival, distant metastases-free survival, local regrowth-free survival, and colostomy-free survival assessed over three years. The study includes ongoing safety monitoring and follow-up to evaluate long-term outcomes.

Researchers are evaluating the requirements for four essential amino acids isoleucine, leucine, valine, and tryptophan in neonates who receive total parenteral nutrition TPN. This study will take place at two hospitals in Brazil and aims to better understand how much of each amino acid these stable, TPN-fed preterm babies need. The research uses the Carbon Oxidation method to measure amino acid oxidation and determine the babies nutritional requirements. Each baby will receive one or two levels of either isoleucine, leucine, valine, or tryptophan over a two-day period. On the first day, the baby will receive a standard pediatric amino acid solution along with a labeled bicarbonate to measure carbon dioxide production. On the second day, the baby will receive a test TPN solution with varying amounts of the specific amino acid being studied, including a small amount of labeled phenylalanine to track amino acid oxidation. Breath, urine, and blood samples will be collected to analyze amino acid use and plasma concentrations. During the study, breath and urine samples will be collected to measure amino acid oxidation, and blood samples will be taken alongside routine clinical blood work to assess plasma amino acid levels. The main outcome measured is amino acid oxidation over 48 hours. The study will include stable preterm neonates born at or after 28 weeks gestation, up to 28 days old, who are fully TPN fed. Participation involves close monitoring in the NICU with sample collections coordinated to minimize discomfort.

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.