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Found 15 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are studying the effectiveness of a tetravalent dengue vaccine TDV in reducing hospital stays due to dengue in children and adolescents aged 6 to 12 years living in Southeast Asian countries with high dengue transmission, including Thailand, Indonesia, and Malaysia. This observational study focuses on participants in a community-based cohort who may or may not receive the vaccine as part of a pilot public vaccination program where TDV is already approved. The study particularly aims to assess the vaccines effectiveness against less common dengue virus types DENV-3 and DENV-4. The study includes a nested case-control design with two groups cases who are hospitalized children or adolescents with confirmed dengue infection, and matched controls who live in the same neighborhood but have not been hospitalized with dengue. Participants are followed individually for up to 3 years within the cohort. The study is non-interventional, observing outcomes based on vaccination status within the existing vaccination program. Participants will be monitored through active hospital surveillance to identify dengue hospitalizations confirmed by laboratory testing. Data collected includes blood samples for RT-PCR testing, clinical diagnosis, and hospitalization records. Researchers will measure the rate of hospitalization due to dengue virus infections by serotype and baseline dengue immune status. The primary outcome is dengue-related hospitalization up to 36 months. Parents or legal representatives provide consent and assent for participants, including agreement for blood sample collection and follow-up over the study period.
Actively Recruiting
Researchers are evaluating a phase I clinical trial using autologous natural killer NK cell therapy for patients with liver cancer, specifically hepatocellular carcinoma HCC classified as Child-Pugh A and Barcelona Clinic Liver Cancer BCLC stages B or C. The study aims to find the appropriate treatment dosage, monitor side effects, and determine the average progression-free survival time. Participants include liver cancer patients treated at Cipto Mangunkusumo Hospital between May and December 2022 who meet specific health criteria. The treatment involves harvesting NK cells from the patients own body and infusing them back intravenously. Dosages are personalized based on each patients condition and response. The treatment duration varies and may take several weeks to fully assess effectiveness and potential impacts. The study also uses the CliniMACS Plus device to isolate the NK cells using specialized technology. Participants will be monitored for up to six months to determine the optimal dosage and evaluate tumor shrinkage, immune responses, and blood health. Progression-free survival will be tracked for up to two years or until disease progression or death. The study includes regular assessments and lab tests to understand treatment effects and safety during this period.
Actively Recruiting
Researchers are evaluating the functional outcomes of patients who have experienced a rupture of the anterior cruciate ligament ACL and undergone reconstruction surgery using hamstring grafts. The study compares two surgical techniques the all-inside technique and the complete tibial tunnel technique. The hamstring graft, taken from the patients posterior thigh, replaces the torn ligament during reconstruction to restore knee stability. Patients will be randomly assigned to receive ACL reconstruction surgery using either the all-inside technique, which creates shorter bone sockets secured with adjustable-loop suspensory fixation, or the complete tibial tunnel technique, which involves full-length bone tunnels and fixation with a bio-interference screw and fixed-loop suspensory device. Both methods use hamstring grafts, and surgeries will be performed under double-blind conditions. Participants will be followed up at 3, 6, 9, and 12 months after surgery at an outpatient orthopedic clinic. Evaluations will include measurements of tibial translation, pain severity using a visual analogue scale, International Knee Documentation Committee IKDC scores, and Tegner-Lysholm knee scoring scales. The diameter of the hamstring graft will also be recorded during surgery. These assessments aim to compare knee function and recovery between the two surgical techniques over one year.
Actively Recruiting
Healthy Volunteer
Researchers are investigating how probiotic supplementation combined with counseling on healthy eating, physical activity, and psychosocial stimulation affects overweight and obese adolescents nutritional status and antibody response to COVID-19 vaccination. The study focuses on adolescents aged 12 to 17 years who have been vaccinated with CoronaVac and aims to understand the gut-lung-axis and the role of gut microbiota in immunity and infection risk, especially in the context of SARS-CoV-2. This randomized clinical trial is taking place in Indonesia, with attention to COVID-19 preventive measures during face-to-face activities. Participants are randomly assigned to one of two groups one receives a combination of three probiotic strains Lactobacillus rhamnosus, Bifidobacterium animalis subsp. lactis, and Lactobacillus acidophilus along with counseling, while the other receives placebo probiotics maltodextrin and the same counseling. The intervention lasts 20 weeks, with follow-up and assessment periods at 5, 10, 15, and 20 weeks to monitor changes. Counseling covers healthy eating, physical activity, and psychosocial stimulation to support overall health. During the study, researchers measure participants BMI-for-age z-scores and specific antibody levels against SARS-CoV-2 at multiple time points. They also analyze gut microbiota diversity, antibody affinity, secretory immunoglobulin A, and dietary quality. The study includes regular monitoring and assessments to evaluate the impact of the intervention on both nutritional and immune outcomes over the 20-week period.
Actively Recruiting
Healthy Volunteer
Researchers are investigating how dietary habits and hair zinc levels relate to body composition, inflammation marker TNF-alpha, and blood pressure among women of reproductive age from various ethnic groups in Jakarta, Indonesia. This observational study focuses on women from Minangkabau, Sundanese, Javanese, Betawi, and Chinese backgrounds to understand nutritional and inflammatory influences in this population. Participants will complete dietary assessments including a semi-quantitative food frequency questionnaire and a 3-day food diary. Body composition will be measured using the BOD POD device to determine fat and lean mass. Blood pressure will be recorded, and blood and hair samples will be collected for laboratory analysis of TNF-alpha and zinc levels. This data will be collected once during the study. Women will undergo a single session involving dietary evaluation, body measurements, blood pressure check, and biospecimen collection. Researchers will assess dietary zinc intake, diet quality using several indexes, body composition, hair zinc concentration, blood pressure, and serum TNF-alpha at this baseline visit. The study aims to provide insight into how diet and zinc status affect body composition and inflammation in this diverse urban female population.
Actively Recruiting
This research aims to understand how sunlight exposure affects vitamin D levels in children aged 1 to 5 years who have cerebral palsy. It also studies whether sunlight exposure influences the frequency of acute respiratory tract infections and assesses the safety of this exposure in these children. Children with cerebral palsy often face a higher risk of vitamin D deficiency due to limited mobility, dietary challenges, and medications that affect vitamin D metabolism. Participants will be randomly assigned to two groups one receiving sunlight exposure and one continuing their usual sunlight habits. Those in the sunlight group will have 10 minutes of sun exposure three times a week between 1100 AM and 100 PM for 8 weeks, exposing about 30% of their body surface area. The control group will not undergo this structured exposure. Caregivers will track daily sunlight exposure, respiratory infection episodes, adverse effects, and diet during the study. Throughout the study, children will undergo baseline and post-intervention assessments including vitamin D levels, body measurements, dietary evaluations, and skin type assessment. Researchers will monitor safety by checking for any signs of discomfort during sun exposure and will ensure adherence through scheduled video calls. The primary outcome is vitamin D level changes after 8 weeks, with secondary outcomes including respiratory infections and any adverse effects. The study lasts 8 weeks with ongoing monitoring during this period.
Actively Recruiting
Researchers are evaluating two different methods for guiding intravenous fluid therapy during the first 6 hours in the ICU after major abdominal surgery. The study aims to determine which method, guided by Cardiac Index or Central Venous Pressure, leads to a more accurate and optimal amount of fluid administration. The goal is to compare total fluid volumes given, as well as outcomes like mortality, length of stay, relaparotomy, and reintubation to find the best fluid management strategy for postoperative ICU patients. Participants will be randomly assigned to one of two groups during the first 6 hours in the ICU following surgery. One group will receive fluid therapy targeting a Cardiac Index between 2.5 and 4.0 Lminm, while the other group will receive fluid therapy targeting a Central Venous Pressure of 8 to 12 mmHg. All patients will also receive maintenance fluids totaling 25 mLkg over 24 hours, combining parenteral and enteral nutrition. This therapy period focuses on precise fluid management in the early postoperative stage. During the study, researchers will monitor total intravenous fluid volume from ICU enrollment until ICU discharge, up to 30 days. They will also track secondary outcomes including ICU mortality, length of ICU stay, need for relaparotomy, and reintubation. The study involves detailed observation during the ICU stay to assess how each fluid guidance method affects recovery and clinical results after major abdominal surgery.
Actively Recruiting
Researchers are evaluating the effectiveness of postoperative care in two different hospital units the Post-Anesthesia Care Unit PACU and the High Care Unit HCU for patients undergoing elective surgery. The study focuses on comparing the length of hospital stay after surgery and the number of cases where patients need to be moved up to the Intensive Care Unit ICU or HCU for additional care within 30 days after surgery. This observational study is sponsored by Indonesia University and aims to understand how these postoperative care settings impact patient outcomes. Participants include adult patients aged 18 years and older who have elective surgeries in specific operating rooms. They are divided into two groups based on their postoperative observation location one group is observed directly in the HCU, and the other in the PACU. The study observes their postoperative progress without administering additional treatments, comparing the hospital stay duration and step-up cases between these groups. During the study, participants are monitored from the day of surgery until they are discharged or up to 30 days after surgery. Researchers track the length of hospital stay and any movement to higher care units like ICU or HCU. Participants are expected to provide informed consent, and data collected will help measure the primary outcomes related to postoperative care effectiveness and complications.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effects on gum health when participants switch from a toothpaste containing a gum-health active ingredient to a fluoride toothpaste without these actives. This study focuses on people with gingival problems, aiming to understand changes in gum condition, plaque levels, and bleeding over a total period of 17 weeks. The trial uses a double-blind, randomized, controlled design to compare two types of toothpaste in adults. Participants will be randomly assigned to use one of two toothpastes twice daily at home for 13 weeks one containing a gum-health active and fluoride, and the other a fluoride toothpaste without gum-health actives. After this period, all participants will switch to the fluoride toothpaste without gum-health actives for an additional 4 weeks. The study includes dental assessments and sample collections at baseline, 4, 13, and 17 weeks to evaluate gum health and oral bacteria. During the study, participants will undergo dental exams measuring gingival condition, plaque, and bleeding on probing. Samples of gingival crevicular fluid and plaque will be collected to assess biomarkers and microbial changes. They will also complete a questionnaire about oral health impact related to periodontal disease. The study monitors these outcomes to assess changes in gum health and oral condition over the 17-week period.
Actively Recruiting
Researchers are evaluating the effects of Umbilical Cord Mesenchymal Stem Cells UC-MSC and Secretome as additional treatments for patients with severe Acute Respiratory Distress Syndrome ARDS. This randomized, double-blind clinical trial compares three groups to assess their impact on lung injury and inflammation. The study aims to see if these therapies can reduce injury scores and improve laboratory markers related to inflammation and organ function. Participants are divided into three groups one receiving standard care plus a placebo, one receiving UC-MSC infusions plus placebo nasal drops, and one receiving UC-MSC infusions combined with Secretome nasal drops. The UC-MSC is given intravenously at a dose of 10 million cells per kg on days 2, 5, and 8, while nasal drops either Secretome or growth medium as placebo are administered on days 1, 4, and 7. This controlled experimental study compares the outcomes among these groups to evaluate treatment success. During the study, participants undergo multiple assessments including chest X-rays, hypoxemia and respiratory compliance scores, and laboratory tests such as complete blood count, D-dimer, Procalcitonin, CRP, and inflammatory factors IL-6, IL-12, and TNF-alpha. Lung injury and organ function scores are measured at several time points up to day 28. The study tracks changes in these markers to evaluate the effects of the treatments over the course of the trial, which is expected to continue until December 2026.
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