Clinical trials

This Phase 1/2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding plasmid. Secondary objectives include the assessment of preliminary signals of biological and functional activity, including changes in skeletal muscle mass and performance.

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: * Birth defects (abnormal and problematic structures or functions, a child is born with) * Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) * Certain health problems of the child up to 12 months of age * Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.

The goal of this Phase III clinical trial is to evaluate the efficacy, safety, and acceptability of different treatment regimens for Trichuris trichiura infection in schoolchildren aged 6 to 15 years living in La Moskitia, Honduras, an area with a high burden of soil-transmitted helminth infections. The main questions it aims to answer are: * Are combination treatments of albendazole and ivermectin more effective than albendazole alone for treating Trichuris trichiura infection? * Does a fixed-dose combination (FDC) of albendazole and ivermectin achieve cure rates comparable to co-administration of the two drugs? * How effective are the different treatment regimens against other soil-transmitted helminths, including Strongyloides stercoralis? * What adverse events occur following treatment with the different regimens? * How acceptable are the different treatment regimens to children and their caregivers? Researchers will compare four treatment groups: placebo, albendazole alone, albendazole plus ivermectin, and a fixed-dose combination of albendazole plus ivermectin. Participants will: * Be randomly assigned to one of the four treatment groups. * Receive a single dose of the assigned treatment. * Provide stool samples before treatment and approximately 21 days after treatment. * Undergo laboratory testing using quantitative real-time PCR (qPCR) to detect and quantify helminth infections. * Be monitored for adverse events after treatment. * Complete acceptability assessments together with their caregivers. The study will provide evidence on the efficacy, safety, and acceptability of a fixed-dose combination of albendazole and ivermectin and its potential use as a simplified treatment strategy for the control of soil-transmitted helminth infections in endemic settings.

The goal of this study is to evaluate the safety and immunogenicity of an investigational varicella vaccine in children. Researchers will compare the investigational vaccine, NBP608, with licensed varicella vaccines. The study includes children aged 12 months to 12 years. Approximately 780 participants will take part in this study. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Some participants will receive two doses, while others will receive one dose, according to the assigned study group. Participants will: Receive two subcutaneous injections of a study vaccine, administered approximately three months apart (if applicable). Visit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.

This randomized, double-blind, placebo-controlled trial evaluates whether oral furosemide 40 mg, initiated 12 hours postpartum, reduces hospital length of stay compared to placebo (folic acid 5 mg) in postpartum women with severe preeclampsia. Secondary outcomes include need for rescue antihypertensive medications, weight reduction, and metabolic safety (hypokalemia, renal function). A total of 186 participants (93 per arm) will be enrolled across two hospitals in Honduras.

This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).

The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days

The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and when they are co-administered with Measles Mumps Rubella (MMR) vaccines in infants aged 11-15 months. Number of Participants: A total of 2440 participants is planned to be enrolled in VYF04 study. Study Arms and Duration: Eligible participants will be randomized in 2 independent groups (9-24 months, 2-5 years) to receive 1 dose of either vYF or Stamaril or YF-VAX in a 2:1:1 ratio within each age group. An additional group with participants of 11-15 months of age will also receive at the same vaccination visit vYF and a single dose of MMR vaccine. For the 2nd step (YF booster vaccine administration in a subset), at the Year (Y) 3 visit, a subset of 120 participants of the 9-24 months of age group who did receive a YF vaccine on Day(D) 01 will be invited to join a booster dose assessment (booster dose administered after the Y3 visit blood sample has been taken). Participants aged 11 to 15 months at the time of the concomitant administration of vYF and MMR will not be eligible for receiving a booster dose. The duration of each participation will be approximately 3 years for all participants (including participants co-administered on D01 with vYF and MMR), and 6 more months post-booster dose administration for the participants enrolled in the booster subset.

This is a Phase 1b randomized, double-blind, placebo-controlled study to assess the safety and tolerability of a proprietary aKLmRNA formulated in lipid nanoparticles. Approximately 21 subjects will be enrolled. Each subject will receive a total of two injections during the study. The cohort will consist of approximately 21 subjects, with each receiving 0.5 mg aKLmRNA (AKL003) or placebo. Subjects will be randomized in a 2:1 ratio (active treatment:placebo). The placebo will be saline, matching the active treatment in both appearance and volume.

This is a single-blind, randomized, parallel-group, superiority clinical trial. The study aims to determine whether a single intake of 30g of dark chocolate (≥80% cocoa) by pregnant women with a non-reactive fetal non-stress test (NST) increases the conversion rate to a reactive NST within 20 minutes, compared to observation with a sugar-free white chocolate placebo. A total of 190 singleton pregnant women at 36-41 weeks gestation with a non-reactive NST will be recruited at the Hospital General San Felipe, Tegucigalpa, Honduras. Participants will be randomly assigned to either the intervention group (dark chocolate) or the control group (placebo). The primary outcome is the proportion of NSTs that become reactive. Secondary outcomes include changes in specific cardiotocographic parameters, total monitoring time, need for additional tests, and maternal satisfaction.

This randomized, double-blind, placebo-controlled trial aims to compare the analgesic efficacy and obstetric effects of tramadol (100 mg IV) versus paracetamol (1 g IV) versus placebo (saline solution) in nulliparous women during active labor. The primary outcome is duration of active labor (minutes). Secondary outcomes include duration of expulsive phase, type of delivery, need for oxytocin augmentation, maternal adverse events (nausea, vomiting, somnolence, hypotension), and neonatal outcomes (Apgar scores at 1 and 5 minutes, NICU admission). The study hypothesizes that tramadol significantly reduces active labor duration compared to paracetamol and placebo, without compromising maternal or neonatal safety. A total of 300 nulliparous women (100 per group) will be enrolled at Hospital Escuela, Tegucigalpa, Honduras.

Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma

This experimental study aims to evaluate whether the application of obstetric lubricant gel during vaginal delivery can significantly reduce the duration of the second stage of labor, preserve perineal integrity, and decrease the need for episiotomies. The study hypothesis is that lubricant gel facilitates fetal passage through the birth canal by reducing friction, shortening the expulsion phase and reducing maternal-neonatal complications. Two groups will be included: with and without gel application. Follow-up will span from admission of the pregnant woman until immediate postpartum discharge.

The purpose of this study is to investigate the safety and efficacy of a gene therapy for Klotho, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of the Klotho gene therapy.

This randomized clinical trial aims to compare the effect of the left lateral decubitus position versus the supine position on the duration of the active phase of labor in nulliparous women. A total of 188 participants will be randomly assigned to one of two groups. The intervention group will be placed in the left lateral decubitus position, while the control group will remain in the supine position. Both positions will be maintained for 30-minute intervals with 5-minute rest periods, continuing until delivery. The primary outcome is the duration of the active phase of labor. Secondary outcomes include rates of cesarean section, use of oxytocin and analgesics, and maternal and neonatal complications.

This study aims to analyze whether there is a significant difference in the occurrence of postpartum hemorrhage between women who underwent umbilical cord drainage and those who did not. Variables such as estimated blood loss volume, drop in hemoglobin levels, and the need for additional maneuvers or treatments to control hemorrhage will be examined. The research will be conducted under a parallel-group clinical trial design at the Hospital Escuela Universitario. Post-birth umbilical cord drainage may contribute to a lower frequency of postpartum hemorrhage compared to not performing it.

This is a randomized, double-blind, crossover clinical trial to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapeutic intervention for reducing pain in women during the active phase of labor. Nulliparous women with term pregnancies will be randomly assigned to sequences involving TENS intervention and placebo (device off) periods, separated by a washout. The primary outcome is labor pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include duration of the active labor phase, maternal and neonatal safety profile, and childbirth experience satisfaction. The study will be conducted at the Hospital Escuela Universitario from feb 2026 to Ago 2026.

The purpose of this study is to investigate the safety and efficacy of a combination klotho and follistatin gene therapy, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of this gene therapy.

Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies. Acute lymphoblastic leukemia(ALL)/lymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare. This study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia/lymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.

The purpose of the research protocol is to evaluate the effectiveness of Cinnamomum verum extract for the initiation of labor. Cinnamaldehyde ((E)-3-Phenylprop-2-enal) is an α, β unsaturated aromatic aldehyde, derived from cinnamon (Cinnamomum Verum oil) used as a flavoring; It is a clear yellowish liquid substance, with a strong odor and flavor. It is the main component of cinnamon (63%), giving it its physicochemical properties. Cinnamon has been an element of empirical use for the beginning of labor, however, its effectiveness has not been demonstrated. Cinnamon has been reported for its ethnopharmacological properties in pregnancy, being used to facilitate childbirth, as a lactagogue and for postpartum recovery. In Honduras, its use has been reported to relieve nausea and vomiting during pregnancy, to reduce abdominal pain. , reduction of lower limb edema, to relieve anxiety during labor, as well as a lactagogue without convergent opinions.

In May 2018, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer. While this strategy seeks to achieve coverage of 70% in disease testing and 90% in treatment by 2030, it is estimated that these goals will not be achieved by most low- and middle- income (LMICs) countries until 2120 under existing conditions. Presently, more than 90% of worldwide cervical cancer cases occur in LMICs. To accelerate this timeline, there is an urgent need for accurate, affordable and rapid testing that can facilitate same-day screening-and-treatment of cervical precancer. The AmpFire® human papillomavirus (HPV) test (Atila Biosystems, CA) has the potential to meet these needs. The test has been adapted to classify HPV positive women into four categories according to their risk for cervical cancer development based on the specific HPV type found during the test. Moreover, results can be delivered in less than 20 minutes for the highest risk HPV type, and less than an hour for the remaining HPV types. This is a potential game changer for countries where treating all HPV positive women is unfeasible. A combination of HPV test with other image-based triage strategies can further reduce overtreatment while reaching the most at-risk women. The goal of this project is to evaluate the performance and feasibility of an innovative same-day screening-and-treatment strategy in Honduras based on the AmpFire® HPV test combined with imaging triage using artificial intelligence via the Automated Visual Evaluation (AVE). Additionally, the investigators will evaluate the cost-effectiveness of the proposed approach vs. the current strategy based on visual inspection with acetic acid (VIA). The investigators believe that the AmpFire® test will have the potential to detect at least 90% of women with cervical precancer (performance). Similarly, the investigators anticipate that combining AmpFire® with AVE triage in a same-day screening-and-treatment strategy will be feasible and acceptable to patients and providers. The successful completion of this project will provide crucial data on the effectiveness of a self-sample, same-day screening-and-treatment approach with the potential to increase early detection while reducing loss to follow-up, ultimately resulting in increased adoption of this technology.

The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism. The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events. As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications. The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.

Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.