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NCT ID: NCT06298344 Recruiting - Clinical trials for Congenital Heart Disease

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

Start date: May 1, 2024
Phase: Early Phase 1
Study type: Interventional

Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions.

NCT ID: NCT06282692 Recruiting - COVID-19 Pandemic Clinical Trials

INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old

Start date: June 19, 2023
Phase: Phase 3
Study type: Interventional

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.

NCT ID: NCT06280599 Recruiting - Stroke Clinical Trials

Transitional Care Model for Patients With Stroke

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings.

NCT ID: NCT06273059 Recruiting - Diabetes Mellitus Clinical Trials

Genomic Study of Young-Onset Diabetes Mellitus

Start date: September 12, 2022
Phase:
Study type: Observational

Diabetes Mellitus (DM) has been a major contributor to health burden in Indonesia and currently its burden still continues to rise. This is a result of increasing DM prevalence in the country as well as high rates of chronic complications from DM. Findings in Indonesia show that there is a high proportion of young people with diabetes, and also a high risk of therapeutic failure and complications from DM occurring in the younger population. Young-onset DM has a wide clinical spectrum, including autoimmune DM, polygenic DM, and monogenic DM such as Mature Onset Diabetes of the Young (MODY). Identification and proper diagnosis of young-onset DM spectrum is crucial to treatment outcomes, as certain spectrums, such as some subtypes of MODY, may benefit from cost-efficient alternatives with better outcomes. However, proper diagnosis of young-onset DM in Indonesia is still a great challenge, as currently some examinations, including genetic testing, has not yet been feasibly done in the country. With current advances in genomics, genetic testing may prove to be fundamental in providing optimal and personalized treatment and care for DM patients. This study is a pilot project aimed to initiate genomic research in young-onset DM patients in Indonesia. In the short term, this study aims to identify genetic variants that may be able to increase diagnostic accuracy of the young-onset DM spectrum. In the long term, this study aims to identify new genetic variants of young-onset DM. The study also aims to identify genetic variants associated with risks of chronic complications.

NCT ID: NCT06268509 Recruiting - Preterm Birth Clinical Trials

Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta

MONAS
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services? 2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services? Participants in the intervention group will receive: - Fetomaternal ultrasound examination each trimester - Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination - Supplements: multivitamin, minerals, vitamin D, fatty acid - Intervention regarding any abnormal results of nutritional panel - All standard maternal health services according to Indonesian Ministry of Health protocol Participants in the control group will receive: - All standard maternal health services according to Indonesian Ministry of Health protocol

NCT ID: NCT06263764 Recruiting - Quality of Life Clinical Trials

The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life.

NCT ID: NCT06259578 Recruiting - COVID-19 Pandemic Clinical Trials

UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study)

Start date: January 29, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.

NCT ID: NCT06255509 Recruiting - Dengue Clinical Trials

Dengue Virus Infection Amongst Patients With Acute Febrile Illness

Start date: February 5, 2024
Phase:
Study type: Observational [Patient Registry]

A prospective observational study that will be conducted in Tangerang Regency, Indonesia with primary objective to determine the clinical characteristics, specific immune responses, and viral serotypes in patients with confirmed dengue virus infection in Tangerang District, Indonesia.

NCT ID: NCT06225791 Recruiting - Nutrient Deficiency Clinical Trials

Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia

Start date: December 25, 2023
Phase: N/A
Study type: Interventional

The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Indonesian national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to: - Examine different MMS delivery strategies (i.e., packaging strategies and behavior change communication (BCC) strategies) in relation to MMS adherence. - Assess acceptability, feasibility, fidelity, and coverage of MMS program implementation within antenatal care services (ANC)

NCT ID: NCT06221917 Recruiting - Teaching Method Clinical Trials

Live-streaming Vs Face-to-face Teaching Method Effectiveness in Training Surgical Clerkship

LS vs FTF
Start date: January 9, 2024
Phase: N/A
Study type: Interventional

The goal of this observational study is to assess objectively whether teaching for simple wound sutures via Live-Streaming (LS) using Go-pro® has the same effectiveness as the traditional Face-to-face (FTF) teaching. The main question it aims to answer is whether training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training. After initially doing pre-test, participants will be randomized into two groups: LS and FTF. After teaching exposure, the participants will be given 1 week period of self-training to master the skill (as such procedural skills require a period of self training before we examine the effect of teaching exposure). Afterwards, they underwent post-test again with the previously same examiner, using the same OSCE rubric to avoid bias. Researchers will compare if the LS and FTF groups to see if training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training.