Tegucigalpa

Researchers are evaluating the safety and immune response of an investigational yellow fever vaccine called vYF compared to two licensed vaccines, Stamaril and YF-VAX, in children aged from 9 months to 5 years. The study also examines the co-administration of vYF with the Measles Mumps Rubella (MMR) vaccine in infants aged 11 to 15 months. This Phase III study aims to determine how well vYF helps the body develop protective antibodies against yellow fever and to assess its safety profile in these pediatric groups. Eligible participants are divided into two age groups: 9-24 months and 2-5 years. Within each group, children are randomly assigned to receive one dose of vYF, Stamaril, or YF-VAX in a 2:1:1 ratio. Additionally, infants aged 11 to 15 months receive vYF together with a single dose of the MMR vaccine at the same visit. A subset of 120 children from the younger age group who received a yellow fever vaccine will be invited to receive a booster dose approximately three years later. The booster group participants will be followed for an additional six months after the booster administration. Participants will be followed for about three years, with scheduled visits to monitor safety and immune response. Blood samples will be collected to measure the percentage of children who develop antibodies against yellow fever by 28 days after vaccination. Safety evaluations and medical assessments will be conducted throughout the study to monitor any adverse effects. Those in the booster subset will have extended follow-up to assess the response to the booster dose, ensuring comprehensive evaluation of both initial and booster vaccinations.

Researchers are evaluating the pain relief effects and birth outcomes of tramadol, paracetamol, and a placebo in women experiencing active labor for the first time. This phase 4 randomized, double-blind trial compares these treatments to understand their impact on the length of active labor and other obstetric and newborn health measures. The study is conducted at Hospital Escuela in Tegucigalpa, Honduras, enrolling 300 first-time pregnant women aged 15 to 45 with single, term pregnancies and head-down babies. Participants receive one of three intravenous treatments at the start of active labor: tramadol 100 mg, paracetamol 1 g, or a saline placebo. These drugs are given as a single dose by trained medical staff following strict protocols to ensure safety and blinding. The study monitors for side effects such as nausea, vomiting, dizziness, and low blood pressure. All women are observed closely during labor and delivery to assess outcomes. During the trial, researchers will collect data on labor durations, delivery types, need for labor-boosting drugs, maternal side effects, and newborn health including Apgar scores and NICU admissions. Pain levels are measured before and after treatment. Sociodemographic and obstetric information is also recorded. Safety is reviewed every three months by a monitoring board. The study runs from February to June 2026, aiming to improve pain management options during labor while ensuring safety for mother and baby.

Traumatic brain injury (TBI) is a major cause of death and disability among children worldwide, especially severe TBI in children and adolescents. This trial focuses on whether treatment guided by invasive intracranial pressure (ICP) monitoring improves outcomes compared to treatment based on imaging and clinical exams alone. Conducted in eight Latin American pediatric intensive care units, the study also aims to build research skills among pediatric intensivists in the region and inform global clinical practice for managing severe pediatric TBI. The study compares two management protocols for children aged 1 to 12 years with severe TBI. One group receives care guided by ICP monitoring, while the other group's treatment is based on imaging and clinical assessments without ICP monitoring. Children must be enrolled within 24 hours of injury or deterioration and meet specific neurological criteria. The trial is a randomized controlled design with 428 participants, conducted in hospitals equipped to provide high-quality trauma care. Participants will be followed for at least six months, during which researchers will measure quality of life using the Pediatric Quality of Life Inventory (PedsQL) as the primary outcome. Other assessments include mortality, global outcomes, complications, ICU length of stay, and brain-specific treatments. The study involves close monitoring of neurological status and treatment effects to understand the benefits and risks of ICP monitoring in severe pediatric TBI care.

Researchers are evaluating cancer treatment outcomes in children, adolescents, and young adults aged 0 to 21 years diagnosed with any type of cancer, focusing especially on acute lymphoblastic leukemia and lymphoblastic lymphoma. The study is set in low- and middle-income countries where challenges like delayed diagnosis, misdiagnosis, and limited access to care lead to poorer outcomes compared to high-income countries. This research aims to understand treatment failure and therapy-related toxicities to improve future care strategies. The study collects data by reviewing medical records retrospectively from pediatric, adolescent, and young adult cancer patients treated at oncology centers in Guatemala, Honduras, El Salvador, Armenia, and Tanzania. There are no new drugs or treatments given; instead, the study examines past treatments such as chemotherapy, surgery, radiation therapy, and immunotherapy. Data abstraction is used to assess treatment failure and toxicities over a three-year period from the date of cancer diagnosis. Participants' medical records will be reviewed to gather information on treatment outcomes, therapy-related toxicities, and clinical events within three years following diagnosis. The study monitors the incidence of treatment failure and toxicities by examining available medical records, with patients without events censored at their last contact within three years. This retrospective follow-up helps researchers understand cancer care quality in these settings and supports the development of evidence-based interventions.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are evaluating whether a single intake of 30g of dark chocolate (at least 80% cocoa) by pregnant women with a non-reactive fetal non-stress test (NST) can increase the rate of conversion to a reactive NST within 20 minutes. The study focuses on singleton pregnant women between 36 and 41 weeks gestation who have a non-reactive NST, which is a common clinical finding that can cause anxiety and lead to additional tests or interventions. This randomized, single-blind trial compares dark chocolate to a sugar-free white chocolate placebo to explore a safe, low-cost way to improve fetal monitoring outcomes. Participants will be randomly assigned to receive either 30g of dark chocolate or 30g of sugar-free white chocolate as a placebo, both taken orally within five minutes after a baseline non-reactive NST. The dark chocolate contains methylxanthines and flavonoids, which may stimulate fetal activity, while the placebo lacks significant theobromine or caffeine. The study will monitor the conversion of NSTs from non-reactive to reactive status and assess additional fetal heart rate parameters, total monitoring time, need for further tests, and maternal satisfaction. During the study, women will undergo an NST before and after the intervention, with the primary outcome measured 20 minutes post-intake. Researchers will also track the need for extra fetal surveillance or urgent obstetric care within 24 hours, as well as any maternal side effects like nausea or palpitations. Participants will complete satisfaction surveys, and safety follow-up will be conducted via telephone or electronic device. The overall assessment aims to provide detailed information on fetal well-being and maternal experience during the monitoring period.

Researchers are studying children and adolescents aged 3 to 18 years with newly diagnosed B- or T-cell acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia. This study aims to understand how nutritional status, which can be measured and changed, affects cancer progression, treatment toxicities, and long-term health outcomes. The study includes participants from various global centers to represent different nutritional and economic backgrounds. The study involves collecting and storing biological specimens such as stool and blood samples at key points during treatment: diagnosis, end of induction, beginning of maintenance, end of treatment, and one year after treatment ends. Alongside these, clinical data including disease details, treatment side effects, survival information, and nutritional measurements like height, weight, and arm size will be gathered. There is no treatment intervention in this study. Participants will provide demographic information, lifestyle data including diet and physical activity, and nutritional assessments at multiple times during their treatment and follow-up. The data collected will help build a biorepository to support future research on how nutrition and biology impact leukemia outcomes. The study will observe and collect this information over a total period of seven years to monitor changes and long-term effects.

This research aims to compare the effects of two different maternal positions during labor on how long the active phase lasts in women having their first baby. The study focuses on nulliparous women at term with a single baby in the head-down position, who are in the active phase of labor with cervical dilation of 6 cm or more. It is conducted to provide local evidence in Honduras about whether positioning affects labor progression and the duration of active labor, which may influence delivery outcomes and the overall childbirth experience. Participants will be randomly assigned to one of two groups. One group will be placed in the left lateral decubitus position for 30-minute intervals with 5-minute rest breaks, while the other group will remain in the supine position following the same timing. These positions will be maintained throughout the active phase of labor until the baby is delivered. The study will compare the duration of the active phase between these two groups. During the study, researchers will measure the time from when the active phase of labor is diagnosed until delivery, along with secondary outcomes such as cesarean section rates, use of labor medications like oxytocin and pain relief, and any complications for mother or baby. Participants will be monitored closely throughout labor, and outcomes will be recorded within the first 24 hours after active labor begins to understand the impact of maternal positioning on labor progress and safety.

Researchers are conducting a phase 3 randomized, modified double-blind study to evaluate three lots of the investigational 21-valent pneumococcal conjugate vaccine (PCV21) in healthy infants aged approximately 2 months. The study aims to compare the immune response, measured by antibody production, and safety of PCV21 to a licensed 20-valent pneumococcal vaccine (Prevnar 201). The goal is to confirm if the different lots of PCV21 produce a similar immune response and assess their safety in infants. Participants will receive four doses of either PCV21 or the licensed 20vPCV vaccine by intramuscular injection at around 2, 4, 6, and 12 months of age. The study includes two groups: Cohort A, which randomizes infants to three PCV21 groups or one 20vPCV comparator group, and Cohort B, which includes randomization to three PCV21 groups only. Routine pediatric vaccinations will also be given according to local recommendations. The study involves six visits over approximately 17 months, spaced between vaccination times and follow-up assessments. Researchers will collect blood samples to measure specific antibody levels 30 days after the third vaccine dose. Participant health will be monitored through medical evaluations and questionnaires. The study will assess vaccine safety and immune response consistency across the vaccine lots during this period.

Researchers are evaluating a new approach to prevent cervical cancer using a rapid, affordable HPV screening test called the modified AmpFire4. This study focuses on women in Honduras, a low- and middle-income country where cervical cancer is a leading cause of death and current screening coverage is low. The goal is to improve early detection and treatment by combining this test with advanced imaging triage using artificial intelligence (Automated Visual Evaluation, AVE) to reduce overtreatment and increase access to care. The study involves testing 4,000 women using both self-collected and provider-collected samples with the AmpFire4 HPV test, followed by visual inspection, AVE imaging, colposcopy, and biopsy for those testing positive or a subset of negatives. Women who test positive will be offered immediate ablation treatment if eligible. An additional 1,000 women will self-collect samples in a single-visit approach to assess feasibility, with HPV-positive women returning in one year for follow-up testing and evaluation. The study also plans to compare the cost-effectiveness of this new strategy against the current visual inspection method (VIA). Participants will undergo screening visits including consent, questionnaires, and sample collection, followed by diagnostic exams and treatment as needed. Researchers will track test accuracy, patient flow, provider and patient satisfaction, and potential barriers to implementation. Follow-up includes clinical assessments and telephone surveys to monitor side effects. The study will last up to two years and aims to provide data on the performance, feasibility, and economic impact of this innovative cervical cancer screening and treatment approach.