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NCT ID: NCT03397576 Recruiting - HIV/AIDS Clinical Trials

Adherence Through Home Education and Nursing Assessment, Indonesia

Start date: February 27, 2017
Phase: N/A
Study type: Interventional

Adherence to antiretroviral therapy (ART) drops sharply after prison release. Effective medication adherence training immediately before and after prison release may improve health outcomes and limit transmission of Human Immunodeficiency Virus (HIV). ATHENA (Adherence Through Home Education and Nursing Assessment) is an evidence-based medication adherence intervention, which is delivered in the patient's home by nurses and peer educators working in teams. In this study, researchers will examine the acceptability and feasibility of the ATHENA intervention through a 2-arm randomized controlled trial conducted with HIV-infected prisoners in Indonesia. Eligible subjects will be >18 years of age, HIV-infected, and may be treatment-experienced or treatment-naive. Subjects randomized to the intervention arm will participate in monthly medication adherence counseling sessions within prison and home visits up to four months after prison release. Subjects randomized to the control arm will receive standard care, which includes a referral for HIV care after prison release. The primary endpoint is the proportion of subjects demonstrating ART adherence >90% at 3 months after prison release. Secondary endpoints are: 1) retention in HIV care, 2) ART initiation, 3) HIV- RNA viral load, 4) CD4+ T-cell count, 5) quality of life, 6) hospitalization, 6) substance use and sexual risk behaviors at 3 months after prison release.

NCT ID: NCT03383653 Recruiting - Healthy Clinical Trials

Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

Start date: August 29, 2017
Phase: N/A
Study type: Observational [Patient Registry]

To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman

NCT ID: NCT03374150 Active, not recruiting - Low-Calorie Diet Clinical Trials

The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling

Start date: May 26, 2017
Phase: N/A
Study type: Interventional

The world prevalence of obesity in adult population in 2014 was nearly 13% while in Indonesia, it has reached 32.9% in the same year. Obesity is an established risk factors for cardiovascular diseases. A large proportion of people who had succeeded to reduce body weight failed to maintain it (weight cycling). Studies were inconclusive about the best composition in the diet for such people to have a better life quality and reduce risk factors from non-communicable disease. The purpose of this research was to evaluate the body composition changes, Inflammation marker and oxidative stress marker changes resulted from low calorie high protein and standard protein diet programme in obese people with history of weight cycling. This is an open-randomized clinical trial of weight loss program as a part of a larger study researching the effect of low calorie high protein diet to body composition, oxidative stress, inflammation marker and metabolic syndrome in obese with weight cycling. Subjects were assigned to low calorie diet and were randomly distributed into two intervention groups, namely high protein group (22-30 % of total calories intake) and standard protein group (12-20%). Anthropometry, body composition data, and blood sample (for inflammation marker (HsCRP) and oxidative stress (malondialdehyde and glutathione)) were taken at baseline and at the end of the study. Subjects were followed up to 8 weeks with daily reminder and weekly counselling

NCT ID: NCT03367195 Active, not recruiting - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Efficacy and Safety of DLBS2411 in the Management of GERD

Start date: November 21, 2017
Phase: Phase 3
Study type: Interventional

This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice daily, given before morning and evening meals, for an 8-week course of therapy. Subjects should avoid taking meals 2-3 hours before bedtime. The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation. Recent study of DLBS2411 which was conducted in healthy volunteers, demonstrated the effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is hypothesized to benefit patients with gastric acid disorders such as in gastroesophageal reflux disease (GERD).

NCT ID: NCT03366584 Recruiting - Clinical trials for Hyaline Membrane Disease

The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates

Start date: January 2017
Phase: Phase 4
Study type: Interventional

Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in high mortality rate in Indonesia. Cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and mortality rate of premature neonates. But there is still different outcomes and severity of disease in preterm newborn receiving the same dose of antenatal steroid therapy. This raises questions whether there are other factors influencing the development and maturity of lung and gut in preterm newborn, aside from steroid therapy. Vitamin A, D and zinc are already known for their function in fetal lung and gut development. To our best of knowledge, no study has evaluated the effect of these vitamins levels on HMD and feeding intolerance in premature neonates. Therefore, the aim of this study want to evaluate the effect of antenatal steroid therapy versus co-administered β-carotene, vitamin D3, zinc and antenatal steroid therapy on the presence and severity of HMD and feeding intolerance in premature neonates.

NCT ID: NCT03366454 Recruiting - Pneumonia Clinical Trials

Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia.

Start date: July 4, 2017
Phase: N/A
Study type: Observational

Participants who meet the inclusion and exclusion criteria will be enrolled and then having a daily follow up for maximum of 13 days' hospitalization. Next follow up will be taken time at day 14th after hospitalization date, either on ward or policlinic. The participations will be ended by day 30th after hospitalization date when the called follow up is done by investigator.

NCT ID: NCT03358524 Recruiting - Oxidative Stress Clinical Trials

Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia

Start date: September 28, 2017
Phase: Phase 4
Study type: Interventional

This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo

NCT ID: NCT03354299 Completed - Malnutrition Clinical Trials

Effect of Coconut Milk Supplementation to Improve Nutritional Status in Cirrhosis Patient

Start date: June 2014
Phase: N/A
Study type: Interventional

Liver cirrhosis still becomes a major issue in Indonesia. Malnutrition has been observed in liver cirrhosis patients as it deteriorates liver function and cirrhosis itself. Malnutrition in liver cirrhosis can increase morbidity and mortality rates. Patients with liver cirrhosis have increased energy expenditure and endogenous fat oxidation reaction which is used as the basic energy sources. Energy obtained from fat was accounted for 86% of the total energy sources in this population. Fatty acid is also known to be an efficient energy backup for hepatocytes and other cells because it generates higher adenosine triphosphate (ATP) than other sources. Supplementary diet for patients with liver cirrhosis is considered beneficial for preventing hypercatabolism. To fulfill their nutritional needs, patients with liver cirrhosis is advised to take an extra food, such as a late night snack (LNS) with a total carbohydrate of around 50 g (equivalent to 200 kkal). Considering that most of the energy source in patients with liver cirrhosis came from fat, so the additional sources of energy having a high fat content were considered to be potentially highly beneficial to address the patients' nutritional status, as well as to reduce the risk of hyperglycemia after a meal and hypoglycemia after a long night fasting period time. Coconut milk contains many saturated fatty acids belonging to the medium chain triacylglycerol (MCT) group. The characteristics of MCT are quite different from long chain triacylglycerol (LCT). MCTs are more easily absorbed than LCTs, and are mostly absorbed in the form of free fatty acids, in both healthy and liver cirrhosis populations. This study wants to investigate the effects of coconut milk supplementation on improving the nutritional status of patients with liver cirrhosis. The patients were divided into 2 groups, groups I received 25 g of sugar plus 50 cc of coconut milk (200 kkal) as late night snacks (LNS); and group II received 50 g of sugar alone (200 kkal) as LNS. Investigators think that the group who received coconut milk supplementation has better nutritional status than the other group.

NCT ID: NCT03352674 Recruiting - Diabetes Mellitus Clinical Trials

Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

Start date: September 2016
Phase: Phase 2
Study type: Interventional

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients

NCT ID: NCT03352206 Recruiting - Clinical trials for Lymphatic Filariases

Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

Start date: September 1, 2017
Phase: N/A
Study type: Observational

This study will assess the impact of 2-drug (DA) or 3-drug (IDA) regimens on lymphatic filariasis infection parameters in communities. Parameters measured will include: circulating filarial antigenemia (CFA) assessed with the Filariasis Test Strip (FTS), antifilarial antibodies tested with plasma and microfilaremia (assessed by night blood smears and microscopy).