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NCT ID: NCT06298344 Not yet 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: March 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: NCT06291844 Completed - COVID-19 Clinical Trials

Ocular Trauma and COVID-19 in Indonesia

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Moreover, the COVID-19 outbreak has introduced distinct factors into the management of ocular trauma. This research investigated the epidemiology of ocular injuries during the pandemic and offered observations on the distinctive hurdles and trends encountered.

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: NCT06281353 Completed - Anogenital Wart Clinical Trials

The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue

Start date: August 16, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include: - To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and - To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin. The main questions it aims to answer are: - Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)? - Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls? - Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW? Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW.

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: NCT06272253 Active, not recruiting - COVID-19 Pandemic Clinical Trials

UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects

Start date: September 19, 2023
Phase: Early Phase 1
Study type: Interventional

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months. The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.

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: NCT06265714 Completed - Stroke Clinical Trials

The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia

Start date: July 23, 2021
Phase:
Study type: Observational [Patient Registry]

Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients.

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.