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NCT ID: NCT04346901 Completed - Melasma Clinical Trials

Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma

Start date: August 1, 2019
Phase: Phase 1
Study type: Interventional

Study's objectives are to determine proportion of melasma cases in hyperthyroid patients and to compare severity of melasma before and after medications of three months hyperthyroid therapy using modified melasma area and severity index (mMASI) score. A quasi experimental (pre-post intervention) study was conducted in Jakarta in August 2019-February 2020.

NCT ID: NCT04340609 Completed - Clinical trials for Acute Myocardial Infarction

Stem Cell in Acute Myocardial Infarction

AMI
Start date: March 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.

NCT ID: NCT04331782 Completed - Depression Clinical Trials

Integration of Mental Health in HIV Clinic to Increase the Success of ARV Treatment in PLWHA in Hospitals

Start date: July 22, 2019
Phase:
Study type: Observational

Integration of mental health in HIV clinics is needed in order to accelerate fast track 90-90-90 for controlling HIV. Symptoms of depression are sometimes difficult to recognize. In people living with HIV (PLWHA), depression that fails to be recognized and uncontrolled increases the risk of unsuccessful antiretroviral treatment and mortality. The main purpose of this study is to estimate the proportion of depressive disorders in people living with HIV. The study included adult HIV patients aged ≥18 years, both men and women, who had received ARV treatment for at least six months, with no history of being diagnosed with depression.

NCT ID: NCT04329663 Completed - ADHD Clinical Trials

Effectiveness of the Indonesian Computer-based Game

Start date: November 7, 2017
Phase: N/A
Study type: Interventional

The aim of this study was to develop an Indonesian computer-based game prototype that targets the clinical symptoms of ADHD as well as executive function and to investigate effectiveness through fMRI BOLD examination. This was a mix-method study design; the first step was an exploratory qualitative study using focused group discussion. The second step was 'the one group pre- and post-test design study' without any control. Ten primary school children who were drug-naïve and had a diagnosis of ADHD with no other mental or physical disorders participated in the study. Clinical improvement was measured by the CATPRS, BRIEF, and fMRI BOLD examination that focused on DLPFC-Hippocampus functional connectivity before and after 20 sessions of the Indonesian computer-based game prototype training. Data were analyzed using the paired t test and Pearson's correlation in SPSS for Mac version 21, and fMRI BOLD functional analysis was performed using SPM software version 12 and CONN Toolbox version 17. The hypothesis was: the Indonesian computer-based game prototype had an effect towards ADHD clinical symptoms and executive function that correlated with DLPFC-Hippocampus functional connectivity.

NCT ID: NCT04325438 Completed - Tuberculosis Clinical Trials

The Impact of Pharmacists' Interventions on the Quality of Life of HIV-TB Co-infection Outpatients in Indonesia

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Rationale: The co-infection of human immunodeficiency virus (HIV) and tuberculosis (TB) diseases presents further problems to patient's adherence due to high pill burden and adverse effects in the drug combination therapy. This situation is also a risk of the increase of multi-drug resistant TB and may affect the quality of life of patients. However, the prevalence of non-adherence has not been studied much in these patients in Indonesia, especially in West Java with several HIV patients who are still struggling with TB as their opportunistic infection. Pharmacist interventions in several studies have resulted in a better outcome of patients' therapy, especially in patients who need long-term adherence and compliance with drug treatment. It is hypothesized that patients' quality of life of HIV-TB co-infection patients will be improved with the intervention conducted by the pharmacist. Objective: In general, the study aimed to evaluate the utility of study participants with specific aims to describe the number of DRP and interventions applied, to describe drug concentration in selected participants (TB drugs: Rifampicin and Pyrazinamide), to compare changes of CD4+ cell counts and plasma HIV RNA (viral load) between baseline and after of intervention, to assess participants compliance and persistence to medication therapy, and descriptive analysis on the direct and indirect costs. Study design: This is a prospective, cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention with calculation after the start of inclusions within 6-months follow-up in 3 different clinics in Indonesia (Bekasi City Public Hospital, Persahabatan Public Hospital Jakarta and Cipto Mangunkusumo general hospital). Intervention: Interventions are given by a pharmacist as a drug consultant is an intervention concerning the drug treatment of HAART and anti-TB. Monthly, patients will have a discussion regarding their medication and drug-related problems they experience. The pharmacist will identify drug-related problems before and during treatment and solve the problems. Main study parameters/endpoints: change from baseline utility (quality of life) at 6 months Secondary endpoints: changes from baseline in CD4+, VL, adherence, persistence at 6 months and total costs.

NCT ID: NCT04315025 Completed - Clinical trials for Retinitis Pigmentosa

Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa

RP
Start date: October 7, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The study will perform UC-MSCs and CM transplantation. The first group will be injected by UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by CM. Each group consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6 months.

NCT ID: NCT04313829 Completed - Clinical trials for Type 2 Diabetes Mellitus

Pharmacist Counseling on the Health-related Quality of Life of Patients With Type 2 Diabetes Mellitus

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The quality of life (QoL) of patients with type 2 diabetes mellitus (T2DM) is a measure of the successful outcomes of therapy. The program of management of chronic diseases "Program Pengelolaan Penyakit Kronis" (Prolanis) among patients with hypertension and T2DM is a new strategy of the Badan Penyelenggara Jaminan Sosial (BPJS), which is the Indonesian national health insurance system. The impact of pharmacist counseling interventions on health-related QoL (HRQoL) was analyzed in Prolanis T2DM patients.

NCT ID: NCT04312347 Completed - ER+ Breast Cancer Clinical Trials

Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels

Start date: September 6, 2019
Phase: N/A
Study type: Interventional

The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.

NCT ID: NCT04303507 Completed - COVID19 Clinical Trials

Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting

COPCOV
Start date: April 29, 2020
Phase: N/A
Study type: Interventional

The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period. This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.

NCT ID: NCT04298333 Completed - Clinical trials for Metastatic Breast Cancer

Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer

Start date: June 27, 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients.