Santo Domingo

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Researchers are evaluating the safety, systemic exposure, and potential effects on the hypothalamic-pituitary-adrenal (HPA) axis of a topical medication called IDP-122 lotion, which contains halobetasol propionate. This study focuses on children and teenagers aged 6 to 17 years with moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches. The study is a Phase 4, open-label trial aimed at understanding how the drug is absorbed and its impact on adrenal health in this pediatric population. Participants will apply IDP-122 lotion topically to areas affected by plaque psoriasis, excluding the face, scalp, underarms, and skin folds. The lotion is studied for its pharmacokinetics, including measuring the maximum concentration of the drug in plasma at various times after application. The study requires participants to avoid prolonged exposure to natural or artificial ultraviolet light during the treatment period. The trial does not include a placebo group and focuses solely on monitoring the topical treatment effects. During the study, children will undergo several evaluations including blood tests to measure drug levels in the plasma at multiple time points within 24 hours after dosing. Their adrenal function will be assessed through a stimulation test measuring serum cortisol. Researchers will also monitor the safety and any side effects related to the treatment. Participants will be carefully observed to ensure adherence to the treatment schedule and to track any changes in their psoriasis or overall health throughout the study period.

Researchers are evaluating the immune response and safety of a new varicella vaccine (VNS Vaccine) compared to an approved vaccine called Varivax (VV) in healthy children. This study focuses on children aged 12 to 15 months who have not had chickenpox or received a varicella vaccine before. The goal is to see how well the second dose of these vaccines works when given three months after the first dose, assessing the body's immune reaction to the virus. Participants receive either the investigational varicella vaccine or the marketed Varivax vaccine as a second dose, given subcutaneously. Some children may also receive other vaccines such as MMR, Hepatitis A, or different types of pneumococcal conjugate vaccines, depending on their country's immunization schedule. Vaccines are given either subcutaneously or intramuscularly according to local recommendations. The study is randomized and observer-blind to compare the effects fairly. During the study, children will be monitored for immune response by measuring specific antibodies against the varicella virus 43 days after the second dose. Researchers will also observe safety and any side effects. Parents or caregivers will provide consent and children will undergo health checks before and during the trial. The total participation is timed around the vaccination schedule with follow-ups to evaluate vaccine effectiveness and safety.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are conducting an international, multicenter observational study to understand acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The study focuses on the epidemiology, patient outcomes, and care processes for those with AKI-RRT. It also aims to identify how these factors vary across different Latin American countries and what demographic, clinical, and socioeconomic elements affect patient outcomes. The study collects a wide range of data including clinical details, laboratory results, treatments, care processes, and patient outcomes to create a comprehensive database. It includes adult patients admitted to intensive care units diagnosed with stage 3 acute kidney injury who begin renal replacement therapy within a specific timeframe relative to ICU admission. The study does not involve experimental treatments but observes current care practices across multiple sites. Participants are monitored from enrollment through hospital discharge or up to 90 days to track in-hospital mortality and other outcomes. The research helps compare care approaches and results between countries and supports further clinical research in AKI-RRT. The total participation duration depends on the patient's hospital stay or 90 days, whichever comes first.

This research aims to evaluate the safety, usability, and effectiveness of a new accommodating intraocular lens (IOL) called AAL-FAIOL in adults needing cataract surgery in both eyes. The study takes place in Central America and focuses on patients diagnosed with bilateral cataracts requiring lens removal by phacoemulsification, a surgical technique using ultrasound to remove the cloudy lens. The goal is to compare the new AAL-FAIOL lens with the standard BAL-FAIOL lens in the same participants. Participants will undergo cataract surgery in each eye separately, with one eye receiving the AAL-FAIOL and the other the BAL-FAIOL. The eye surgeries will be spaced 14 to 35 days apart. The AAL-FAIOL lens may be adjusted post-surgery using laser energy to improve vision for distance if needed. Both lenses are implantable devices designed for long-term use inside the eye's lens capsule. During the approximately one-year follow-up, participants will attend scheduled visits to monitor eye health and vision. Researchers will assess cumulative eye-related adverse events, including any secondary surgical interventions, from day of surgery up to 12 months. The study will track safety, lens performance, and any adjustments required to optimize vision over the course of the year.

The International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry is an ongoing global observational program tracking routine clinical outcomes in patients diagnosed with Gaucher disease. It includes patients regardless of their treatment status and aims to improve understanding of the variability, progression, and natural history of Gaucher disease. The Registry also seeks to support the medical community by developing monitoring recommendations, characterizing the patient population, and evaluating long-term treatment effectiveness of imiglucerase and eliglustat. The Registry involves no experimental treatments; patients receive clinical assessments and care as directed by their treating physicians. Additionally, there is a Gaucher Pregnancy Sub-registry that monitors pregnancy outcomes, complications, and infant growth up to 36 months postpartum for women with Gaucher disease. This Sub-registry collects medical and obstetric history and pregnancy data for participants who consent, without altering their standard care. Participants provide data through routine clinical visits, and researchers collect medical information to better understand patient outcomes and optimize care. The Registry tracks outcomes over long periods, including up to 42 years, to support ongoing care improvements. Women in the Pregnancy Sub-registry have additional data collected on pregnancy and infant growth, contributing to comprehensive monitoring of Gaucher disease impacts during and after pregnancy.

Researchers are conducting a long-term study to observe people with sickle cell anemia (SCA), focusing on how the medicine hydroxyurea affects their growth, puberty, fertility, and pregnancy outcomes. Hydroxyurea helps increase fetal hemoglobin, which can reduce serious SCA complications and improve overall health, especially in areas with limited access to safe blood transfusions. Despite its benefits, the long-term effects of hydroxyurea on development and reproductive health are still not fully understood. Participants will be followed over several years, visiting the clinic every few months for health check-ups and blood tests. Girls who have started menstruating will have pregnancy tests every six months, while boys may be asked to provide semen samples if they agree. Regular health and fertility questionnaires will also be completed by all participants. The study will track clinical outcomes from enrollment up to 10 years, monitoring growth, development, fertility, and reproductive health among adolescents and young adults with SCA. This ongoing observation aims to provide important information about the long-term effects of hydroxyurea treatment and pregnancy outcomes in this population.

Researchers are evaluating the safety and immune response of an investigational 21-valent pneumococcal conjugate vaccine (PCV21) compared with an existing 20-valent pneumococcal conjugate vaccine (20vPCV). This study focuses on children and adolescents aged 2 to 17 years with sickle cell disease, some of whom may have had previous pneumococcal vaccinations. The purpose is to see if PCV21 helps the body produce protective antibodies and to assess its safety profile. Participants will receive a single dose of either the investigational PCV21 vaccine or the licensed 20vPCV vaccine. The study is randomized, modified double-blind, and includes two parallel groups. Each participant will be followed for up to 6 months after vaccination. There are no additional treatments beyond the single vaccine dose. During the study, researchers will monitor for immediate reactions within 30 minutes after vaccination, local and systemic side effects up to 7 days, and any other adverse events within 30 days. Serious adverse events and special safety concerns will be tracked for up to 181 days. Antibody levels specific to the vaccine serotypes will be measured 30 days after vaccination. Participants will attend scheduled visits for safety assessments and blood sample collections throughout the study period.