Clinical trials

This is a type-2 hybrid effectiveness-implementation study of brief culturally adapted behavioral activation for adults with depression in primary care setting. This clinical trial has two parallel aims: 1) to understand if brief culturally adapted behavioral activation therapy delivered by psychologist in primary care in individual face-to-face session is effective to reduce depressive symptoms among adult patients in Primary Healthcare Centers and 2) to test the outcome of clinical training and supervision on acceptability, feasibility, appropriateness, and fidelity of implementation of brief culturally adapted behavioral activation therapy in Primary Healthcare Centers. The main questions it aims to answer is: 1\) Is brief culturally adapted behavioral activation intervention delivered by primary care psychologist effective in reducing depressive symptoms among adult patients with depression in primary care settings and 2) Are training and supervision effective in enhancing acceptability, feasibility, appropriateness and fidelity of implementation of brief culturally adapted behavioral activation therapy for adults with depression in primary care settings?

The aim of this research is to analyze the effect of a Lactiplantibacillus plantarum Dad-13 supplementation on the gut microbiota profile and performance of adolescent athletes.

This mixed-methods study develops and evaluates a mobile health (mHealth) application for smoking cessation among Indonesian adolescents aged 13-15 years. The study uses a sequential exploratory approach with three phases: (1) qualitative research to inform app design; (2) app development using Rapid Application Development (RAD) model; and (3) a single-blind, two-arm randomized controlled trial comparing the mHealth intervention to paper-based materials. The intervention is grounded in the Unified Theory of Acceptance and Use of Technology (UTAUT2) and Transtheoretical Model (TTM). Primary outcome is smoking abstinence at 1-, 3-, and 6-month follow-ups measured through self-report questionnaires.

The goal of this clinical trial is to compare the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing elective cesarean delivery. The study also aims to evaluate hemodynamic stability and procedure-related side effects associated with both techniques. The main questions it aims to answer are: 1. What is the difference in the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing cesarean section? 2. Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery? 3. What procedure-related side effects occur with each anesthetic technique? Researchers will compare epidural anesthesia with dural puncture epidural (DPE) to determine which technique achieves a faster and more effective sensory block while maintaining maternal hemodynamic stability. Participants will: 1. Be randomly assigned to receive either epidural anesthesia or DPE anesthesia 2. Undergo elective cesarean delivery under regional anesthesia 3. Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively

The goal of this clinical trial is To evaluate the benefit of levofloxacin prophylaxis in prolonging the median time to first febrile neutropenia in pediatric ALL patients during induction phase. It will also learn about the safety of levofloxacin during induction treatment. The main questions it aims to answer are: * Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo? * What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo? Researchers will compare oral levofloxacin to a placebo (a look-alike substance with no active drug) to see if levofloxacin is effective in preventing infection during induction chemotherapy. Participants will: * Be children aged 1 to 18 years with ALL undergoing induction chemotherapy. * Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase. * Have regular checkups, physical exams, and laboratory tests during induction. * Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality. * Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.

Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Treatment for sore nipples and breast engorgement is mostly focused on medication. There is very little research that focuses on the impact of interventions regarding breastfeeding techniques carried out during the antenatal period to prevent sore nipples. Knowing the effect of breastfeeding position and attachment education through clinical demonstration in third-trimester primigravida pregnant women to prevent sore nipples and engorgement. This research uses quasi-experiments. The population in this research is a third-trimester pregnant woman in the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis Community Health Centers. The number of samples in this study was 100 divided into 2, namely 50 intervention groups and 50 control groups. breastfeeding education will be provided to pregnant women at 34-35 weeks of gestation, as led by a lactation counselor. The first session will take place at a puskesmas (public health center), where mothers will receive an e-booklet, followed by 40 minutes of hands-on clinical skills training for those in the intervention group. A second session will take place two weeks after the first session in the form of a home visit only for those in the intervention group. The outcome of this research is position, attachment, effective sucking, nipple pain, sore nipples, and engorgement. T-test and chi-square will be used to test differences and similarities between study groups.

* The objective of this research is to determine the accuracy of different types of lung transthoracal needle aspiration (TTNA) i.e. jabbing-then-suction, suction-with-jabbing, and suction-only TTNA in patients with suspected lung cancer. * Researchers will compare these techniques to determine whether there are any quality differences in the obtained tumor samples

This is a pilot study of culturally adapted behavioral activation for adults with depression in primary care setting. As a pilot study following systematic cultural adaptation process, the purpose of this clinical trial is to understand if brief culturally adapted individual intervention based on behavioral activation, can be an acceptable, feasible, and appropriate intervention to reduce depressive symptoms among adults with depression in primary care setting. The main question it aims to answer is: Is brief culturally adapted behavioral activation intervention delivered by primary care psychologist acceptable, feasible, and appropriate as an evidence based treatment for reducing depressive symptoms among adults with depression in primary care setting?

The goal of this trial is to learn if the Yoga Asana Chandra Harmoni intervention can improve psychological well-being and learning readiness in medical students. The main questions it aims to answer are: Does Yoga Asana Chandra Harmoni improve psychological well-being (specifically, reduce stress, anxiety, and depression) in medical students? Does Yoga Asana Chandra Harmoni enhance self-directed learning readiness in medical students? Researchers will compare a group receiving the Yoga Asana Chandra Harmoni intervention to a control group to see if the intervention leads to significant improvements in psychological well-being and self-directed learning readiness. Participants will: Complete baseline questionnaires assessing psychological well-being, sleep quality, self-directed learning readiness, and self-efficacy. Participate in 3 weekly Yoga Asana Chandra Harmoni sessions for 4 weeks (intervention group). Continue with their usual activities (control group). Complete follow-up questionnaires at post-test (end of week 4) and at a 2-week follow-up to assess changes in the outcome measures. Engage in additional online audio guided practices 5 times/week for 20-30 minutes, including breathing exercises (weeks 1-2) and body scans (weeks 3-4) (intervention group).

This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies 1. Does ceftazidime work better than ciprofloxacin as a first-choice antibiotic for children with hematological malignancies who have high-risk fever from low neutrophil count? 2. Are there any specific factors that affect how children with hematological malignancies respond to ciprofloxacin or ceftazidime when treating high-risk fever? Participants in this study are children with hematological malignancies who have a high risk of fever due to low neutrophil count. Children, aged 0 to 18 years old, will be hospitalized between June and December 2025 at Sardjito General Hospital The study will involve: * Collecting patient history, conducting physical exams, and performing supporting tests. * Randomly assigning participants into two groups: one group will receive the standard treatment with intravenous ciprofloxacin, while the other group will receive the intervention treatment with intravenous ceftazidime. * Both groups will be monitored for various outcomes, including the length of fever, length of low white blood cell count, length of hospital stay, length of antibiotic use, any changes in antibiotics, and mortality.

The goal of this observational study is to evaluate the predictive value of diaphragmatic ultrasound compared to the Rapid Shallow Breathing Index (RSBI) in determining weaning success among mechanically ventilated patients in the ICU for more than 48 hours. The main question it aims to answer is: Which is more effective in predicting weaning success: diaphragmatic ultrasound (including Diaphragmatic Excursion \[DE\] and Diaphragm Thickening Fraction \[DTF\]) or RSBI, in patients ventilated \>48 hours in the ICU of Dr. Sardjito General Hospital, Yogyakarta? Participants will be adult ICU patients who are undergoing weaning from mechanical ventilation after more than 48 hours. Before extubation, each participant will undergo diaphragmatic ultrasound assessment to measure DE and DTF, along with RSBI measurement. The predictive accuracy of these parameters will be evaluated by comparing them with the actual weaning outcomes. Secondary objectives include: 1. Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI. 2. Evaluating the correlation between DE values and successful weaning. 3. Determining the optimal cutoff values of DE and DTF as predictors of weaning failure. 4. Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria. 5. Identifying DE and DTF thresholds that may help reduce the risk of reintubation.

The aim of this clinical trial is to determine whether home-based cardiac rehabilitation with a family empowerment approach can help acute coronary syndrome patients recover. The main questions to be answered are: \- Does home-based cardiac rehabilitation with a family approach effective in patients with acute coronary syndrome to improve health-related quality of life and peak Vo2? Researchers will compare with usual care to see if home-based cardiac rehabilitation with a family approach is more effective for improving health-related quality of life and peak Vo2 in ACS patients. Patient inclusion criteria 1. Patients with acute coronary syndrome who had undergone hospitalization, with a minimum home care time of 3 months and a maximum of 1 year, calculated from the day of discharge from the hospital until the time of the interview. 2. Aged 18-65 years old, participants were selected with age variations representing young adults, adults and the elderly. 3. Patients with first experience of SCA, participants were selected whether they had undergone PCI or not. 4. Patients living with family and family involved in the patient care process. 5. Physical condition allows for interviews. physical condition is evidenced by examination of stable vital signs (diastolic BP \>90, systolic \<150 mmhg; N: 60-100x/min; S: 36-380c, no pain). Psychological condition does not show symptoms of depression as measured by the Patient Health Questionnaire-9 instrument. 6. Willing to participate in the study. Participants will: For 12 weeks 1. Perform walking exercises as prescribed 2. Implement diets and stress management according to the module 3. Quit smoking 4. Medication compliance 5. visit the clinic to see a cardiologist, undergo a 6-minute walk test

To evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes.

The prevalence of obesity in children is increasing rapidly, Among children aged 5-12 years, 18.8% have severe overweight, comprising 10.8% who are obese and 8.8% who are over. The development of effective and sustainable intervention strategies to prevent childhood obesity in Indonesia is becoming increasingly important, particularly given the limited implementation of health-promoting schools in the country. The first Phase using qualitative exploration was a needs assessment will be using of social cognitive theory. The second Phase will be the development model intervention modification of the health promotion school WHO and "Health School". The third Phase is the quantitative stage using a Cluster Randomised Controlled Trial to analyse differences and test the effectiveness of the HPS model. This study will be conducted in 8 primary schools located in Makassar, South Sulawesi. School in Makassar city and schools from outside Makassar city, randomly selected for the trial. Then the selected schools are randomly divided into school for nutrition education and physical activity. Intervention, while school each for comprehensive intervention. The study will be target students in Grades 4 and 5 of primary school. Assessments for the primary objective (BMI Z score), and secondary objectives (change in knowledge, self-efficacy, and health literacy) in thirds study arm. The subsequent phase will assess the efficacy of the intervention in terms of reductions in BMI Z scores, improvements in knowledge, self-efficacy and health literacy. Concurrently, the exploration of parental and teacher knowledge and insights regarding health promotion in schools and its potential in reducing overweight and obesity in children will be conducted.

The current study aims to empower local cadres in providing care for metastatic breast cancer (mBC) patients in 2 provinces in Indonesia (Bali and Yogyakarta).