There are about 1183 clinical studies being (or have been) conducted in Indonesia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
A condition of decreased serum T3 level in children after cardiac surgery using cardiopulmonary bypass has been commonly recognized as euthyroid sick syndrome (ESS). This syndrome has been closely associated with low cardiac output syndrome after heart surgery. The unique characteristics of pediatric patients with congenital heart disease (CHD) in Indonesia have caused ESS to arise in the population even before surgical managements. Thyroid hormones increase cardiac function, respiration and diuresis. Increased myocardial function occurred through the improvement of mitochondrial effectiveness as the body energy source by utilizing effective energy substrates, lactate and pyruvate. Prevention of decreased serum thyroid hormones level by T3 supplementation could be clinically beneficial. Intravenous T3 unit dose is very expensive and inapplicable for daily use. In adult studies, oral T3 was found to be effective for the prevention of decreased serum T3 levels; similar study on pediatric population, however, has not been elucidated.
This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets.
Condition: Non segmental and active vitiligo of adulthood. Main objective: To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB compared to UVB alone in active vitiligo after 6 months of treatment. Methods: Prospective interventional bicentric study with evaluation blinded to the treatment received. Inclusion criteria: Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the apparition or the modification of vitiligo lesions with the past 3 months and under Wood's lamp examination hypochromic borders and/or spotty depigmentation. Interventions: After central randomization - Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice weekly narrowband UVB treatment for 6 months. - Arm B: with twice weekly narrowband UVB treatment for 6 months. Evaluation: Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease of VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and biological tolerance. Variation of CXCL10 levels in the serum. Length of the study: Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and drafting the article: 6 months. Total length: 24 months.
This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. It is the aim of this observational cohort study to further characterize the effectiveness of dienogest in improving quality of life and long-term safety in routine clinical practice setting. Endometriosis is chronic and progressive disease and there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be good option for long-term treatment, however, experience with Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and safety of Visanne would support the long-term treatment strategy for Endometriosis management in the clinical practice.
The incidence of atopic dermatitis has increased dramatically in this years. Atopic dermatitis occurs due to complex interactions between genetic and environmental factors. One of the genes that consistenly linked with AD occurences is filaggrin gene (FLG gene). Mutation on the gene can induce disruption in epidermal cytoskeleton aggregation which serves to form protein-lipid, thereby disrupting the skin permeability to water and outside particles such as allergens.8-14 Several attempts have been made to prevent the occurences and progressivity of AD, one of them is LCPUFA supplementation. Until now, the clinical and meta-analysis studies have shown inconsistent results, but LCPUFA intervention in early life gives more consistent and protective results. In this study investigators would like to know about the influence of FLG gene mutation to the occurrence of atopic dermatitis, to know the composition of LCPUFA in early life in order to see protective effects of several LCPUFA, to see the influences of FADS1 and FADS2 gene polymorphism towards LCPUFA concentration from umbilical artery and buccal swab in early life and at the time AD occurs, to know about the diet at the time of AD occurrence, and to know the role of the ratio of DHA towards AA level in the development of AD due to their antagonistic effects, and to see the interactions between FLG gene, FADS gene and LCPUFA level in the development of AD.
Hopefully this research can help to provide the optimal nutrition management from pregnancy so that the babies wiil born with better quality of health and reduce the morbidity and mortality. Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of probiotics supplementation on pregnant women to the baby especially from inflammation pathways. The investigators hope the result of this research can help reducing infant morbidity and mortality rate in Indonesia, also has a benefit for future research.
This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.
The objective of the study is to explore the impact of a combined intervention including a growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive abilities, mother-child- interaction and behavior in children of 3 to 5 years from less enriched home environments.
This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in Timika, Indonesia with a 42 day follow up period.
Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in Indonesian elderly. This study was aimed to define the risk factors and clinical outcomes of frailty transitional status in Indonesian elderly.