Tegucigalpa

Researchers are evaluating an investigational vaccine called vYF to determine if it is safe and helps the body develop antibodies against yellow fever compared to two licensed vaccines, Stamaril and YF-VAX. The study also looks at how vYF works when given together with the measles, mumps, and rubella MMR vaccine in infants aged 11 to 15 months. This Phase III trial aims to provide important information about the immune response and safety of these vaccines in young children. Eligible children from 9 months to 5 years old will be randomly assigned to receive one dose of either vYF, Stamaril, or YF-VAX vaccine. A special group of infants aged 11 to 15 months will receive vYF together with the MMR vaccine during the same visit. About three years after the first dose, a smaller group of participants aged 9 to 24 months will be invited to receive a booster dose of the vaccine they initially received, followed by an additional 6 months of observation for these participants. Participants will be involved for about three years, during which their immune response will be measured at several time points, including before vaccination, days 11, 15, 29, 6 months, and yearly up to 3 years. Safety will be closely monitored through reports of side effects and medical assessments after each vaccination. Blood samples and other tests will be used to track antibody levels and vaccine effects, helping researchers understand how well the vaccines work and their safety profiles over time.

This research aims to evaluate the immune response and safety of an investigational chickenpox vaccine VNS Vaccine compared to an already approved vaccine called Varivax VV. The study focuses on healthy children who have not previously had chickenpox or received a chickenpox vaccine, and takes place when the second dose is given three months after the first dose, which is administered between 12 and 15 months of age. Participants are randomly assigned to one of three groups one group receives two doses of the Varivax vaccine another group receives two doses of the investigational VNS vaccine and the third group receives a first dose of Varivax followed by a second dose of the VNS vaccine. Additional vaccines including measles, mumps, and rubella MMR, hepatitis A HAV, and pneumococcal conjugate vaccine PCV are given on the first day. In some countries, a second dose of MMR is also given between 15 and 18 months according to national guidelines. During the study, researchers will monitor immune responses by measuring specific antibodies against the chickenpox virus after the second dose, particularly 43 days post-vaccination. They will also track any local or systemic side effects following each vaccine dose, recording adverse events up to nearly nine months after the first dose. The total participation includes multiple visits over this time, ensuring detailed safety and immune response assessment for each child.

Researchers are evaluating the pain relief effects and obstetric outcomes of tramadol, paracetamol, and placebo in first-time pregnant women during active labor. This randomized, double-blind, placebo-controlled trial aims to compare how these treatments affect the duration of active labor and other important birth-related factors. The study focuses on nulliparous women and examines both maternal and newborn safety during labor and delivery. Participants receive a single intravenous dose of either tramadol 100 mg, paracetamol 1 g, or a saline placebo at the start of active labor, defined as cervical dilation of at least 4 cm with regular contractions. The study is carefully designed to keep patients and care providers unaware of the assigned treatment to ensure unbiased results. The treatments are administered by trained medical personnel following strict protocols. During the study, researchers collect data on labor duration, delivery type, use of oxytocin, and any side effects experienced by the mother or newborn. Pain levels are also measured before and after treatment. Safety monitoring continues up to 48 hours after birth. The trial includes regular assessments of labor progress and newborn health, with a total participation period covering labor through immediate postpartum. The study is funded and overseen by Universidad Nacional Autnoma de Honduras and conducted at Hospital Escuela in Tegucigalpa.

Researchers are evaluating two different management protocols for children aged 1 to 12 years with severe traumatic brain injury sTBI in Latin America. The study aims to determine if using a treatment approach guided by invasive intracranial pressure ICP monitoring leads to better outcomes compared to a protocol based solely on imaging and clinical exams. This trial builds on previous adult studies and addresses the unique needs of pediatric patients to improve care and guide global clinical practice. The study randomly assigns children to one of two treatment groups. One group receives care following a protocol that uses invasive ICP monitoring to guide management decisions, based on recommendations from the Brain Trauma Foundation Guidelines. The other group follows the CREVICE protocol, which manages sTBI using imaging and clinical examination without ICP monitoring. Both protocols focus on aggressive management of sTBI. The trial is conducted in eight pediatric intensive care units in Latin America, aiming to strengthen research skills among local pediatric intensivists. Participants will be closely monitored during their hospital stay, with the study measuring outcomes such as quality of life using the Pediatric Quality of Life Inventory PedsQL at three and six months, functional recovery with the Glasgow Outcome Scale - Extended Pediatric GOS-E Peds, mortality rates, brain-specific treatments, and length of stay in intensive care. Data will be collected for up to six months after injury to assess the effects of the two management strategies on recovery and complications.

This research aims to assess cancer treatment outcomes in children, adolescents, and young adults aged 0 to 21 years living in low- and middle-income countries LMICs. It focuses especially on acute lymphoblastic leukemia ALL and lymphoblastic lymphoma LBL, which have poorer outcomes in these regions compared to high-income countries due to challenges like delayed diagnosis, limited access to therapies, and financial barriers. The study seeks to inform future efforts to improve care quality and reduce treatment failures through evidence-based strategies. The study involves a retrospective review of medical records from participating oncology centers in several LMICs, including Guatemala, Honduras, El Salvador, Armenia, and Tanzania. It includes patients with any cancer diagnosis, with particular attention to those diagnosed with ALL or LBL. Researchers will collect data on treatment failure incidence, therapy-related toxicities, and clinical outcomes over a three-year period following cancer diagnosis. No experimental treatments are administered the study uses existing medical records for analysis. Participants medical records will be reviewed to capture information on treatment failure, including relapse, progression, or abandonment, and therapy-related toxicities in the ALLLBL subgroup. Researchers will also analyze outcomes by cancer type, treatment regimen, age, and sociodemographic factors. The primary outcomes include incidence of treatment failure and toxicities within three years of diagnosis. This observational study will provide valuable data to guide improvements in cancer care for young patients in LMICs.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are evaluating whether a single intake of 30g of dark chocolate with at least 80% cocoa can improve the reactivity of the fetal non-stress test NST in pregnant women who currently have a non-reactive NST. This single-blind, randomized clinical trial focuses on pregnant women between 36 and 41 weeks gestation with singleton pregnancies. The goal is to see if dark chocolate can increase the rate of NSTs becoming reactive within 20 minutes compared to a sugar-free white chocolate placebo. This study also examines related heart rate patterns and maternal satisfaction. Participants will be randomly assigned to one of two groups one group will consume a single oral dose of 30g dark chocolate within 5 minutes after a baseline non-reactive NST, while the control group will receive a single oral dose of 30g sugar-free white chocolate as a placebo. The study tracks changes in fetal heart activity and time spent in monitoring, along with any maternal side effects. The trial is designed to assess the superiority of dark chocolate over placebo in converting NST status. During the study, participants will undergo a baseline NST followed by treatment intake and monitoring for up to 60 minutes. Researchers will measure the proportion of NSTs that become reactive within 20 minutes, changes in fetal heart rate accelerations and variability, total monitoring time, and the need for further fetal tests or urgent obstetric interventions within 24 hours. Maternal satisfaction and any adverse events will be evaluated shortly after intervention. Participants will be followed up by telephone or electronic device for safety within 24 hours. The trial is planned to last until September 2026.

Researchers are investigating the nutritional status and its impact on treatment outcomes in children and adolescents newly diagnosed with B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia. This observational study aims to create a biobank of clinical data and biological specimens from participants aged 3 to 18 years, enhancing understanding of cancer progression, prognosis, treatment toxicities, survivorship, and late effects, especially in low and middle income countries. Participants will have biological samples such as stool and blood collected at key treatment milestones including diagnosis, end of induction, beginning of maintenance, end of treatment, and one year post-treatment. Alongside, data on socioeconomic status, food security, diet, physical activity, and nutritional measurements like height, weight, and arm size will be gathered throughout the treatment period and follow-up. During the study, researchers will collect demographic, lifestyle, clinical, and nutritional information at various timepoints to accompany the biorepository. The main outcomes include establishing a multinational biobank and compiling comprehensive data on treatment-related toxicities, survival, and nutrition over seven years. Participant involvement includes multiple assessments and sample collections over the treatment course and one year after treatment ends.

This research aims to compare how the left lateral decubitus position versus the supine position affects the length of the active phase of labor in first-time mothers. The trial focuses on nulliparous women at term with a single baby in head-down position who are in active labor. It seeks to provide local evidence on whether maternal position can influence labor duration and potentially reduce cesarean sections and complications. Participants will be randomly assigned to either lie in the left lateral decubitus position or remain in the supine position. Each position will be maintained in cycles of 30 minutes with 5-minute rest intervals during the active labor phase until delivery. Two groups are compared the experimental group in the left lateral position and the control group in the supine position. During the study, maternity and newborn outcomes such as the active labor duration, cesarean rates, use of labor medications, maternal complications, and newborn Apgar scores will be recorded. Follow-up includes monitoring until hospital discharge and assessments shortly after birth. Participants are followed from active labor onset until delivery and postpartum recovery, with data collected on labor progression and maternal and neonatal health.

Researchers are evaluating the immune response and safety of three different lots of an investigational 21-valent pneumococcal conjugate vaccine PCV21 compared to a licensed 20-valent pneumococcal vaccine 20vPCV, Prevnar 201d in healthy infants aged approximately 2 months. This phase 3 randomized, modified double-blind study aims to determine if the immune responses generated by the three PCV21 lots are similar and safe in this young population. Participants will receive four doses of either one of the three PCV21 vaccine lots or the 20vPCV licensed vaccine at approximately 2, 4, 6, and 12 months of age. Doses are given by intramuscular injection and administered alongside routine pediatric vaccines as per local guidelines. Two cohorts are involved Cohort A includes randomization to three PCV21 groups or the 20vPCV comparator group, while Cohort B includes randomization only to the three PCV21 groups. During the study, participants will attend six visits spaced over the first year of life, with the last visit occurring about 30 days after the 12-month vaccine dose. Researchers will measure antibody levels IgG 30 days after the third vaccine dose to assess immune response. Safety is monitored through observation of adverse events immediately after vaccination and for up to six months after the last dose. The total participation duration per infant is approximately 17 months.