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.
To investigate the effect of Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum as an adjuvant to methylprednisolone for non-infectious and idiopathic uveitis
A scientific research to prove the safety and effectiveness of TVS 0 - 4 mmHg as a target of resuscitation using furosemide, to improve Perfused Vessel Density (PVD) > 25 mm / mm2, AKI stage (based on KDIGO criteria), CI > 2.5 cc / min / m2 , prevent the incidence of intubation, reduce the duration of ventilator use <120 hours and reduce the length of ICU stay in patients with septic shock after resuscitation
Researchers will conduct a 2-arm pilot randomized controlled trial with HIV-infected index patients recruited from two all-male prisons in Indonesia to assess the acceptability and feasibility of provider-assisted HIV partner notification (provider referral) and examine its potential to increase the number of partners who are tested for HIV and subsequently linked to prevention and treatment services.
This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.
Chemical peeling is an applied procedure which creates controlled destruction of all layers of the epidermis or dermis, subsequently causes exfoliation followed by regeneration of layers with the final result of improved texture and appearance of the skin. Various indications of chemical peeling actions include damage to skin structure (skin aging, scars, pigmentation disorders), superficial tumors (seborrheic keratosis, lentigo, actinic keratosis), and inflammation such as acne vulgaris. Various chemicals commonly used for procedures in peeling include alpha hydroxy acid or alpha-hydroxy acids (AHA) such as Glycolic Acid (GA) 20−70%, lactic acid, malic acid, pyruvic acid; beta hydroxy acids / BHA (10-30% salicylic acid), carbon dioxide snow, Jessner solution, lipohydroxy acid, resorcinol, retinoic acid, trichloroacetic acid (TCA), phenols, Baker − Gordon formula. In this study, the investigators are using glycolic acid 35% solution. Based on its mechanism of action, glycolic acid (GA) is a keratolytic agents, in which it penetrates the stratum corneum and interfere with corneocyte adhesion by damaging the intercellular desmosome bonds. Until now, GA is a superficial peeling that is very popular and most widely used throughout the world . The advantages of GA peeling include odorless, colorless, painless, permanently effective, and minimal side effects. However, unlike non-AHA peeling materials, peels made from AHA cannot be neutralized by themselves. Without neutralization, AHA will penetrate deeper and may cause scars. Neutralization is the process of applying a base solution to stop the work of chemicals in peeling. In neutralization, liquids that can be used are alkaline liquids such as water, sodium bicarbonate, sodium hydroxide or ammonium saline solution to stop its work. In various literature, it is stated that water can be used as a neutralizing liquid in the chemical peels of AHA. It has also been mentioned in the literature that neutralization with sodium bicarbonate on the market does not provide any advantage over water use, as long as the acid is completely removed from the skin surface. The objective of this research is to look into the effectiveness, safety , and cost efficacy of water (H2O).
Effectiveness of Early Enteral Feeding With High Protein Polymeric Formula Versus Oligomeric Formula Versus 5% Dextrose Solution in Clinical Improvement and Malnutrition on Intensive Care Unit Patients Background : Critically ill patients are physiologically unstable, often have complex hypermetabolic responses to trauma. These patients are facing a high risk of death, multi-organ failure, and prolonged ventilator use. Nutrition is one of therapy for critical illness, however, patients often experience malnutrition caused by disease severity, delays in feeding, and miscalculation of calorie needs, therefore, appropriate management of enteral feeding formula should be done in preventing malnutrition and improve clinical outcome during intensive treatment. Objective: This study aims to evaluate clinical improvement and malnutrition in critically ill participants under two different early enteral feeding formulas versus parenteral feeding Methodology : A three-arm randomized trial is performed (parenteral (5% Dextrose), and enteral high-protein polymeric formula, and oligomeric formula.) at the Intensive Care Unit in Wahidin Sudirohusodo Hospital, Makassar, Indonesia. The enteral feedings are given through a nasogastric tube within 24-48 hours after intensive care unit (ICU) admission as well as the parenteral group. A meticulous record of the calories and protein of intake is maintained for 3 days follow up including clinical parameters. The changes between pre and post-intervention of clinical parameters and nutrition scoring are assessed as the outcome of the intervention Hypothesis : Enteral feeding with High Protein Formula provides a better clinical outcome and less malnutrition event in comparison to 5% Dextrose and Oligomeric Formula
Backgrounds Squamous cell carcinoma of the oral cancer (OSCC) is the sixth most common malignancy. Surgery is the mainstay of treatment for oral cancers. In locally advanced and unresectable oral cancer, surgery presents challenges primarily because the head and neck region have many critical structures that can be damaged by tumor or treatment. Damage to the critical structures can result in significant structural, cosmetic and functional deficits that negatively impact quality of life. Use of NC was found to achieve resectability in 39% of locally advanced unresectable oral cancers. Patil et al. reported response rate with the three drugs regimen (TPF) for NC was 32% and 27,37% for two drugs regimen (TP). The overall response rate in the TPF group was significantly higher than that in the PF group, both in the induction-chemotherapy phase and after locoregional therapy (33,3% vs 19,9%, p = 0,004). Chemoresistancy has become the challenge in OSCC treatment affecting tumor response to chemotherapy. Hypoxic microenvironment found in OSCC is marked by the high expression of HIF-1α. CD44 and CD133 as a cancer stem cells marker in head and neck (HNSCC) and miR-210 known as hypoxamiR has been reported to contribute chemoresistancy. As hypoxia inarguably one of the main causes of chemoresistancy, it is agreeable to use melatonin as an antioxidant to reduce the hypoxic condition in tumor microenvironment. Melatonin, a potent endogenous antioxidant agent is proven to have an oncostatic effect, was given in expect to reduce the tumor hypoxic condition so that it would increase the tumor response on NC. Majority of the clinical study use oral melatonin given once daily in 20 mg dose as the minimal dose to yield anti-tumor effects. The purpose of this study is to prove the effectiveness of melatonin to increase clinical response in locally advanced OSCC patients when treated with NC. The effect of melatonin in reducing tumor hypoxia will be seen through its effect in decreasing the gene expressions of HIF-1α, miR-210, CD44, and CD133. Methods Study Design This study is a double blind, randomized clinical trial using placebo as comparison running from June 2017 to July 2018 . Locally advanced OSSC (stage IVA and IVB) patients that will receive NC were included in the study. Fifty patients treated at two centres (RSCM and RSKD) were randomly allocated into two arms. Twenty-five patients received melatonin combined with three regiment NC (Taxane, Cisplatin, and 5-FU) and the other received placebo with NC. However only 25 out of 50 patients had completed the study protocol (13 patients in melatonin arm and 12 in placebo arm) Evaluation of Clinical Response The clinical response were assessed by evaluating pre-treatment and post treatment MRI with the aid of RECIST 1.1. First, it is necessary to estimate the overall tumor burden at baseline (target and non-target lesion) and use this as a comparator for subsequent measurement. The tumor response then being determined according to the definition criteria according to RECIST 1.1, as follows: Complete response (CR) is the disappearance of all target lesions. Partial response (PR) means there is at least 30% decrement in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) means there is at least a 20% increment in the sum of diameters of target lesions or an absolute increment of at least 5 mm. Stable disease (SD) is when there is neither a sufficient shrinkage nor sufficient increment of target lesion. Patients who categorized as PR and CR undergone surgery while those with SD and PD undergone core biopsy. Genes expression examination The primer for HIF-1α miR210, CD44, and CD133 genes amplification was design using a Primer Quest Tool IDT software. The total sequence of each gene attained from GenBank data source: National Centre for Biotechnology Information (NCBI). The steps of gene expression examination are RNA isolation, cDNA synthesis, and absolute quantification qPCR. qPCR result was analyzed based on the gene expression concentration compare to the pre-determined standard curve (positive control) of each genes. Statistical analysis The data was analysed with statistics software SPSS 20. Saphiro Wilk was used to test data normal distribution. Data with normal distribution and with p > 0,05 presented in mean +- standard deviation (SD). Data with abnormal data distribution presented in median (minimal and maximal value). The statistical difference of gene concentration level (numerical data) between melatonin and placebo was analysed using normality test of Saphiro Wilk. Data with normal distribution was tested using unpaired-T test, while data with abnormal distribution was tested using Mann Whitney. Statistically significant different stated as p < 0,05.
This study aimed to explore the effect of intravenous (IV) vitamin C on sequential organ failure assessment (SOFA) score among septic patients in intensive care unit (ICU).
Chronic wounds (CW) still represents a heavy burden to many patients and health care institution. Despite the most recent advances in wound management, up to 50% of chronic wounds still fail to heal. Conventional treatment of chronic wounds does not seem to work in several cases, consumes enormous amount of money and time, so it is necessary to develop different strategies. Previous studies have reported stem cells ability in tissue regenerations due mainly to its secreted paracrine factors, rather than its differentiation ability to become new cells. The factors is called secretomes, microvesicles, or exosomes, that can be found in the medium where the cells are growing, therefore it called conditioned medium (CM). Mesenchymal stem cells (MSCs) such as Wharton's Jelly Mesenchymal Stem Cells (WJ-MSC) appear to emerge as a promising wound healing therapy. To the best of investigator's knowledge, after conducted a pilot study using animal model to gain the preliminary data for the ulcer healing potential, this is the investigator's first clinical study to see the therapeutic potentials of Conditioned Medium Stem Cell as an additional growth factors in chronic skin ulcer healing and to compare the success of chronic ulcer healing in patients undergoing CM treatment and standard approach. The investigators will examine the therapeutic effect of human WJ-MSC-CM in wound healing on patients with chronic skin ulcer.
This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis. A double-blind randomized controlled trial with matching paired subject was conducted on 40 residents of a nursing home in Jakarta. Specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation. After a week of preconditioning, each subject received two different moisturizing creams to be applied on separate lower limbs.