There are about 1167 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.
The utilization of tamoxifen is considerably high in Indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. It is metabolized by the enzyme CYP2D6, resulting in its active metabolite, endoxifen, which has been proven to be effective in the prevention and treatment of breast cancer. Studies showed the CYP2D6 gene has more than 100 variants; some of which are linked with reduced drug activity, while others do not have any pathological implications. The metabolizer profile of these variants is generally grouped into Ultra-rapid, Normal, Intermediate, and Poor Metabolizers (UM, NM, IM, and PM, respectively). In our previous study (NCT04312347), the investigators recruited 150 breast cancer patients who were taking adjusted dose of tamoxifen daily based on their CYP2D6 phenotype. Although the investigators have measured the endoxifen level of the patients with adjusted treatment, the clinical outcomes of the study are not yet conclusive.
This clinical study will compare the effectivity and safety of combination cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad, and Zinc PCA as adjuvant therapy for acne vulgaris patients. These combination cream will be tested by mild to moderate acne vulgaris patients. Participants will be female patients aged 15-50 years old and divided into three groups. The control group (Group 1) will use Adapalene 0.1% cream only every night. Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning.
Background: The elderly are a vulnerable group for health problems as they age. Safe care is essential when caring for the elderly at home because adverse events can happen there, such as falls, pressure ulcers, injuries, or dangers caused by medication errors. Safety culture for the elderly at home needs to be developed so that they can avoid unexpected events. This study aimed to develop the model for safety culture among the elderly called Aging Safe from the Risk (ASRi) to improve the safety culture in elderly care at home. Methods: This exploratory sequential mixed methods study will consist of three stages. Stage 1, a qualitative descriptive study, will be conducted to explore the perceptions of families, nurses, and school administrators for the elderly regarding the safety of the elderly at home. Data will be collected by interviews and focus group discussions. Stage II will involve developing The ASRi model using the modified Delphi method. The list of elderly safety culture indicators will be assessed by experts and then further developed into a model. In stage III, a model test will be conducted with a non-equivalent control group using a quasi-experimental design. The investigators will provide interventions in the form of education and training to families regarding the safety culture for the elderly at home. Findings: There is a crucial need for studies assessing the safety culture in elderly care by empowering families at home to improve safety for the elderly. The results of this study will help fill the knowledge gap in this research and can aid in developing public health policy and programs for the elderly. .
A Phase 1 study to evaluate safety, tolerability, and immunogenicity of SARS-CoV-2 variant mRNA vaccines which are used to prevent COVID-19 caused by SARS-CoV-2 infection. this study is conducted during Indonesian subjects aged 18 years and older who have not received SARS-CoV-2 vaccines.
Study will be done by consortium of pediatrician from Indonesia, Japan, and Germany. This team will act as leaders while the field assistant will consist of nutritionist and general practitioner. The chosen primary endpoint is the improvement of weight for age (grams) of the sample after one month of intervention. Participants are weight faltering babies aged 6-12 months at study entry, with the weight increments below P 15th of WHO weight increments tables whose parents agreed to be included in the study by providing written informed consent.
This is a randomized clinical trial to measure the effect of tidal volume (group 6 ml/kg vs 10 ml/kg) on diaphragm dysfunction on mechanically ventilated critical patient.
The purpose of this study is to assess the efficacy of treating children with severe acute malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or without rice bran.
The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.
To fast respond the coronavirus disease of 2019 (COVID-19) pandemic, the Indonesian government has launched "Vaksinasi Gotong Royong" (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (The Indonesian Ministry of Health, 2021). Vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated vaccines produced by Sinopharm. The Indonesian National Agency of Drug and Food Control (NADFC) has issued an Emergency Use Authorization (EUA) for several COVID-19 vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (NADFC, 2021). Following EUA, Kimia Farma Indonesia as the holder of EUA has the obligation to monitor the safety and effectiveness in Indonesian population.
A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older