South Jakarta City

Researchers are evaluating the efficacy and safety of BGM0504 compared to semaglutide when added to metformin treatment in patients with type 2 diabetes in Indonesia. This Phase 3, randomized, open-label trial focuses on adults aged 18 to 75 years who have type 2 diabetes with specific blood sugar control levels. The study aims to see how these treatments affect blood sugar control measured by Hemoglobin A1c (HbA1c) over 24 weeks. Participants will receive either BGM0504 or semaglutide, both given by subcutaneous injection once weekly, in addition to their stable dose of metformin. The study compares these two drugs to assess their effects as add-ons rather than standalone treatments. The treatment period lasts 24 weeks, during which participants continue their current metformin dose. During the trial, participants will undergo regular monitoring, including blood tests to measure HbA1c changes from the start to week 24. Researchers will assess safety and treatment effects throughout the study. Participants are expected to maintain stable weight and metformin dosing. The total study duration for each participant is 24 weeks of treatment and observation.

Researchers are conducting a phase I/II randomized, double-blind, positive-controlled study to evaluate the safety and immune response of a virus-like particle (VLP) based polio vaccine (VLP-Polio) in healthy infants aged 6 weeks to 2 months and toddlers aged 12 to 18 months. The study compares different dosing levels of the investigational vaccine to a control vaccine, aiming to understand how well the vaccine works and how safe it is in these young age groups. In the phase I toddler group, participants receive one dose of either a high dose VLP-Polio vaccine or a control vaccine in a 3:1 ratio. Infants in phase I and phase II are assigned to one of four groups to receive either low-adjuvant, medium, or high doses of the VLP-Polio vaccine or a control vaccine, also in a 3:1 ratio. Infant participants receive three doses spaced 28 days apart, with a booster dose administered when they reach between 12 and 18 months of age. Enrollment proceeds from older to younger age groups and from lower to higher dosing levels. Participants will provide blood and mucosal samples throughout the study to assess immune responses. Researchers will monitor for any adverse events within seven days after each vaccination. The main outcomes include the rate of side effects and the development of neutralizing antibodies against poliovirus types 1, 2, and 3. The study also includes follow-up visits to evaluate safety and immune response over time, with participants and their caregivers required to comply with study procedures and maintain contact for follow-up.

Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. The study aims to show that V181 is safe, well tolerated, and reduces the frequency of dengue infections caused by any of the four dengue virus types, regardless of whether the child had previous exposure to dengue before vaccination. This is a phase 3, randomized, double-blind, placebo-controlled trial involving healthy participants within this age range. Participants will be randomly assigned to receive either a single 0.5 mL subcutaneous dose of the V181 vaccine or a placebo on Day 1. A subset of about 3,600 participants will be closely followed for immune response and safety for 28 days after vaccination. From this group, around 620 participants will be randomly selected to have their long-term immune response evaluated at selected times for up to 5 years after vaccination. Throughout the study, children will undergo medical history reviews and physical exams to confirm health status. Safety will be monitored by recording adverse events, including those requiring medical attention up to 6 months post-vaccination and serious events up to 5 years. The study also tracks injection site reactions and systemic side effects shortly after vaccination, and measures vaccine effectiveness by monitoring dengue infection rates up to 3 years after vaccination. Immune response tests will be done at planned intervals to assess how well the vaccine works over time.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are studying the immediate effects of apple cider vinegar on oxidative stress after meals in adults with obesity. The focus is on how apple cider vinegar influences post-meal levels of plasma malondialdehyde (MDA), a marker of lipid peroxidation and oxidative damage related to cardiometabolic risk. This study is a preliminary, randomized, open-label clinical trial aimed at understanding whether apple cider vinegar can reduce oxidative stress in this population. Participants will be randomly assigned to one of two groups: one group will consume a single dose of 15 mL apple cider vinegar diluted in 250 mL of water before a standardized meal, while the control group will consume 250 mL of water without apple cider vinegar. The vinegar or control drink is consumed within 5 minutes, followed by the meal within 30 minutes, starting 15 minutes after the beverage. Prior to the intervention, participants will follow a one-week run-in period with diet education and restrictions on antioxidant supplements and strenuous exercise to minimize factors affecting oxidative stress. Participants will provide blood samples while fasting and again three hours after the meal to measure changes in plasma MDA using high-performance liquid chromatography. The study also includes dietary and lifestyle instructions 24 hours before the intervention and overnight fasting prior to the study visit. The goal is to evaluate whether apple cider vinegar can acutely affect postprandial lipid peroxidation and contribute to lowering oxidative stress in adults with obesity.

Researchers are evaluating the safety and pharmacokinetics of ambulatory antibiotic treatments for newborns with "all-risk" asymptomatic congenital syphilis. This phase II, randomized, open-label study aims to understand how these treatments behave in the body and their safety profile in this vulnerable population. The study focuses on infants born to mothers with various levels of syphilis risk during pregnancy, including untreated or inadequately treated cases. The study compares three antibiotic treatments: a ten-day course of oral Linezolid at 10 mg/kg twice daily, a ten-day course of oral Amoxicillin at 50 mg/kg twice daily, and a single intramuscular dose of Benzathine Penicillin G at 50,000 IU/kg. Participants receive one of these treatments during the study period. Throughout the study, researchers will monitor the time the antibiotics remain above the minimum inhibitory concentration (MIC) in blood serum and cerebrospinal fluid over 10 days. Safety is assessed by tracking adverse events from enrollment through 24 weeks. Participants will be evaluated through clinical assessments and monitoring to ensure treatment tolerability and to collect relevant pharmacokinetic data.

Researchers are evaluating the DynamX Coronary Bioadaptor System in patients with coronary artery disease caused by new native coronary artery lesions. This registry aims to confirm the safety, effectiveness, and performance of this device in a real-world patient population. The study focuses on patients who require percutaneous coronary intervention (PCI) with stent implantation. All participants will receive at least one DynamX Novolimus-eluting Coronary Bioadaptor implant following the product's Instructions for Use. The treatment is provided in a commercial setting as part of routine clinical care. This registry collects additional data on the device's performance and safety over time in patients undergoing this procedure. Participants will be monitored for at least 12 months to assess device-oriented clinical outcomes. Researchers will collect data on safety and effectiveness during this period. Patient involvement includes providing informed consent and complying with study procedures. The total duration of participation is based on the 12-month follow-up for clinical endpoints.

Researchers are studying endometriosis, a chronic condition affecting 10-15% of women of childbearing age, focusing on pelvic pain as a main symptom. The trial evaluates the use of triptorelin, a medication approved in Indonesia for endometriosis treatment, to see if extending the dosing interval can reduce side effects and costs while maintaining effectiveness. This phase 3 study compares two dosing schedules of triptorelin in women aged 18 to 40 with endometriosis cysts. Participants are divided into two groups. The first group receives triptorelin 3.75 mg twice before surgery (at baseline and week 6) and once after surgery at week 12. The second group receives a single dose of 3.75 mg after surgery at week 12. The treatment period lasts for 18 weeks. Subjects visit the hospital every 6 weeks for treatment and assessments. During the study, researchers measure pain levels using a visual analogue scale at baseline, weeks 6, 12 (before surgery), and 18. Blood tests for Anti Mullerian Hormone (AMH) and estradiol levels are performed at baseline and week 12. The condition of the uterus and cysts is evaluated during surgery at week 12. These measures help assess the impact of triptorelin on symptoms and hormone levels throughout the study.

Researchers are studying the effect of intraoperative dexmedetomidine on early flap viability and microvascular health in adult cancer patients undergoing elective microvascular reconstructive surgery. This double-blinded randomized controlled trial aims to understand whether dexmedetomidine can improve early surgical outcomes by influencing inflammation, endothelial injury, thrombosis, and tissue perfusion, which are common challenges in these patients. The study involves 60 adult cancer patients aged 18 to 65 years. Participants are randomly assigned to receive either dexmedetomidine or a saline placebo during surgery. Both treatments begin after anesthesia induction with fentanyl and propofol, and continue as a continuous intravenous infusion throughout the surgery and for 48 hours postoperatively. The dexmedetomidine group receives a loading dose followed by maintenance infusion adjusted to maintain sedation and hemodynamic stability. The control group receives a matching saline infusion over the same period. Throughout the study, researchers assess flap viability within 48 hours after surgery using a standardized clinical scoring system that evaluates flap color, temperature, capillary refill, and tissue firmness. Secondary measures include blood and tissue analysis of biomarkers related to endothelial health, inflammation, thrombosis, oxidative stress, and angiogenesis. In addition, microcirculation is monitored in real time using Sidestream Dark Field imaging to evaluate blood flow quality in the flap. These assessments help determine the impact of dexmedetomidine on microvascular flap success and postoperative recovery.

Researchers are studying the protective effects of oral vitamin C on the corneal endothelial layer in patients undergoing phacoemulsification for hard cataracts. The study aims to find out if vitamin C taken before and after surgery helps protect the cornea better than taking it only before surgery or not at all. They will also examine how oxidative stress markers (MDA levels) in the eye fluid and blood change with vitamin C compared to a placebo. Participants will be assigned to take either 500 mg of oral vitamin C or a placebo three times a day, starting seven days before the cataract surgery and continuing for 28 days after. The main procedure, phacoemulsification, will be performed during the study. Participants will be monitored through several follow-up visits at 1, 7, 28, and 42 days after surgery. Throughout the study, participants will keep a log to record their medication intake and any side effects. Researchers will assess corneal endothelial cell loss from the start to six weeks after the intervention, along with measuring oxidative stress markers in eye fluid and blood. The total participation period covers about seven weeks, including treatment and follow-up evaluations.