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.
Anemia is one of the major global problems that continues to this day. According to World Health Organization (WHO) data, anemia is found in 1.62 billion people or equivalent to 24.8% of the world's population while, the prevalence of anemia in children under 6 years of age in Indonesia reached 38.4%. Anemia, if undiagnosed or untreated for a long period of time can lead to multiorgan failure. The cardiovascular system is the most commonly affected system in chronic anemia. Between one-third and two-thirds of patients with severe anemia have cardiomegaly and this will return to normal within a few weeks after the anemia is well managed. This abnormality can be evaluated on chest radiograph or echocardiography.
This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Quinine Sulfate as an add-on therapy in hospitalized adults with COVID-19. The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any changes would be accompanied by an updated sample size. Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory tests (CBC, SGOT, SGPT, Ureum, Creatinine, EKG, and PCR), clinical examination (clinical assessment, vital signs, accompanying drugs, and other medical conditions) and safety assessment (serious adverse events/ SAE) Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Quinine Sulfate
Meniscus injuries are a very common cause of knee pain. The meniscus is a semilunar fibrocartilage structure found on the medial and lateral sides of the knee. The meniscus serves to absorb impact and protect the articular cartilage during weight-bearing activities, joint stability, proprioception, and nutrition. This has a significant effect on knee biomechanics. After the menisci are injured, the biomechanics of the knee change so that degenerative changes occur more frequently in the tibiofemoral compartment. Improvement of tibiofemoral arthrosis after meniscectomy surgery has been demonstrated in several long-term clinical studies. With increasing awareness of the importance of the meniscus in knee biomechanics, various meniscus repair techniques have been developed. In addition, several adjuvants for healing have been proposed to enhance meniscus healing. However, a study showed the meniscal repair failure rate increased from 22% to 24% at 5 years. Study found the healing rate of meniscus repair, which was accompanied by ACL repair, had a greater healing rate, 93% vs. 50%. Hemarthrosis that occurs after bony tunneling during ACL reconstruction provides a fibrin clot and an environment rich in factors that promote healing of the newly repaired meniscus. The fibrin clot provides the structural foundation for meniscus healing. Transmission factors, such as fibronectin and growth factors, are also present. Microfracture is a common procedure used for the treatment of damage to the articular cartilage in the knee. This procedure is used to stimulate the production of fibrocartilage in areas of injured cartilage. Microfractures are performed by creating 1 or more small channels (1 to 3 mm in size) that pierce the subchondral bone and release bone-forming components into the joint. Microfractures serve to promote the formation of fibrocartilage over damaged cartilage. Research in 2016 used an animal model (Capra hircus) to investigate the effectiveness of the microfracture technique on meniscus tear healing rates. They found significant healing in meniscal repair accompanied by microfracture technique (65% vs 12%). However there is still not enough research regarding the efficacy of microfracture in meniscal healing, especially among Indonesian. Therefore, the investigators aim to investigate its efficacy.
The goal of this clinical trial is to investigate the effect of propolis administration on dysmenorrhea in endometriosis patient. the main questions it aims to answer are: - Does the propolis administration reduce symptoms of dysmenorrhea in endometriosis? - Does the propolis administration reduce the amount of oxidative stress biomarkers in endometriosis? - Does the propolis administration reduce the amount of Inflammatory biomarkers in endometriosis? Participants will be given an intervention in the form of propolis at a dose of 1 drop per 10 kilogram of body weight per administration, twice a day. there will be a control group that will be given an intervention in the form of a placebo containing 70% caramel alcohol dye solution.
The goal of this clinical trial is to compare the effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on nutritional status and inflammatory response in head and neck cancer patients receiving radiotherapy. The main questions it aims to answer are: - Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on the nutritional status? - Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on inflammatory response? Participants will participants will receive ONS in powder form ready to brew as much as 2 servings per day for 3 weeks. Researchers will compare the effect of giving ONS containing immunonutrients compared to standard ONS to see the effect on nutritional status and inflammatory response
The aim of this study is to evaluate the effects of oral administration of carbohydrate-electrolyte-containing fluid, compared to standard clear fluid during preoperative fasting on metabolic responses, preoperative anxiety and postoperative complications in paediatric patients. Subjects will be randomly allocated into 2 groups: the intervention group will receive carbohydrate- electrolyte fluid whilst the control group will receive clear fluid. Both groups will receive 50 ml/kg of their designated fluid one day prior to surgery, and are allowed to consume the fluid gradually until 1 hour before the induction of anaesthesia. Prior to induction, preoperative anxiety will be assessed. Metabolic responses will be assessed through the degree of insulin resistance (using the Homeostatic Model Assessment for Insulin Resistance - HOMA-IR) and inflammatory cytokine (Interleukin-6) level. The metabolic responses will be evaluated after the induction of anaesthesia and 24 hours following the surgery. Preoperative anxiety will be assessed before the surgery using the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF). Immediate post operative complications such as post operative nausea and vomiting (PONV), emergence delirium and postoperative pain will be assessed in the recovery room.
Reducing NOX-2, MMP-9, and TGF-β1 Expression in Preventing Ventricular Remodelling Post Acute ST-Segment Elevation Myocardial Infarction using Colchicine (Post Late Reperfusion Percutaneous Coronary Intervention and Non-Reperfusion and In Vitro Study on Ischemic Rat Cardiomyocyte Culture Model). Coronary heart disease (CHD) is the most common cause of mortality and disability worldwide. The handling of reperfusion in Indonesia is still far below the required standard. Most STEMI patients in Indonesia arrive late to a health facility with symptoms that have been present for more than 12 hours (late-onset). Heart failure following a myocardial infarction is one of the long-term complications of STEMI. Patients with STEMU who do not receive reperfusion were more likely to develop this consequence. According to several studies, microtubules in cardiomyocytes have been identified as an essential regulator of cardiomyocytes' ability to respond to shear stress, which offers compression resistance and facilitates mitochondrial energy production. Microtubule densification, which occurs due to remodelling in heart failure, disrupts the microtubule network. The role of reactive oxygen species (ROS) produced by ischemic myocardium in this remodelling is thus inextricably linked. NADPH oxidase is one of the enzymes involved (NOX). NOX-2 levels have been reported to be higher in myocardial infarction and cardiac remodelling, and it has a close interaction with microtubule network, with damage of microtubule tissue increasing NOX-2 generation of reactive oxygen species. By eroding the ECM and triggering cytokines and chemokines to recruit inflammatory cells to eliminate necrotic cardiomyocytes, matrix metalloproteinase 9 (MMP-9) aids tissue rebuilding. Induction and activation of endogenous TGF-signaling pathways after myocardial infarction have also been discovered to play a function. TGF-β may play a role in the resolution of the inflammatory response in the early stages of infarct repair by inactivating macrophages and decreasing endothelial cell chemokine and cytokine production. TGF-β stimulates the fibrogenic pathway by causing extracellular matrix deposition and fibrosis later. Colchicine is a commonly prescribed anti-inflammatory medication with a low cost. the mechanism of colchicine is tubulin binding, which prevents microtubule assembly and polymerization. Colchicine inhibits microtubule development at low concentrations and promotes microtubule depolymerization at higher concentrations. Several studies have demonstrated that low-dose colchicine can help reduce severe cardiac outcomes such as cardiovascular mortality, stroke, and cardiac arrest following myocardial infarction. Colchicine is known to cause partial restoration of microtubule tissue in the perinuclear region. Colchicine has also been shown in earlier research to reduce the expression of MMP-9, NOX2, and TGF-β This study aims to evaluate whether colchicine could prevent ventricular remodelling in STEMI patients with delayed reperfusion and non reperfusion. The minor hypothesis of this study was colchicine can lower NOX-2, MMP-9, and TGF-β expression in the clinical situation of patients with delayed and non-reperfusion STEMI following PCI. Randomization with 1:1 allocation were used to classify the patients, each group include 41 patients with one group receiving colchicine therapy and standard therapy and the other receiving standard therapy only. Colchicine administration was the independent variable. STEMI patients with delayed and non-reperfusion IKP who met the inclusion criteria are included in this randomized clinical trial. Left ventricular end-diastolic volume (LVEDV) was the dependent variable while serum MMP-9, NOX-2, and TGF-β were the intermediate variables. In the treatment group, colchicine 1 mg is administered before PCI or admission to the ICCU, and colchicine is continued at 0.5 mg/day for a month. Within 24 to 36 hours of treatment initiation, the patient had echocardiography, NOX-2, MMP-9, and TGF-β levels evaluated. On days 4-5, a second NOX-2, MMP-9, and TGF-β screening were performed. The follow up two months after treatment initiation includes an assessment of drug compliance, symptoms, and echocardiography. Depending on the normality of the data distribution, the difference between groups is performed using the unpaired T-test or the Mann-Whitney test. The significant difference between the treatment groups is indicated by a p-value of 0.05.
The goal of this interventional study is to learn about the efficacy and safety of first line anti epileptic drugs (AEDs) as substitution therapy for children who are resistant to second-line AEDs. The main question to answer it aims are : how much the difference proportion of responders (responders are children who achieve the decrease of seizure frequencies by 50%) how much time it is needed to achieve the decrease of seizure frequencies by 50% The patients who are eligible for the study and have given their consent, will be enrolled, divided into 2 groups, the control and intervention. The participant should follow the 14 weeks of intervention that consists of 6 phases : baseline, initial dose, titration dose, maintenance dose, tapering-off dose, and new combination maintenance dose.
The goal of this observational study is to explore the possible associated factors of ovarian cancer and endometrial cancer in Indonesia and develop screening tools that could predict the risk of both types of cancer The specific objectives of the study are 1. Elaborating the situation of ovarian and endometrial cancer in Indonesia 2. Exploring the possible clinical, demography and laboratory predictors of these diseases 3. Develop artificial-intelligence-based screening tools for both type of cancer based on possible predictors This study will utilize the patient registry diagnosed with ovarian and endometrial cancer. We assumed that several demography, clinical, and laboratory predictors might possess good screening performance with higher sensitivity and specificity (>80%).
This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).