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.
Introduction: Most cases of Triple Negative Breast Cancer (TNBC) have a high proliferation rate. TNBC is associated with a poor prognosis, a high recurrence rate, and a high incidence of distant metastases. The Epithelial-Mesenchymal Transition process (EMT) plays an essential role in the metastatic process. EMT markers were also more abundant in TNBC and contributed to a poorer TNBC prognosis. As an important EMT marker, the increased expression of vimentin also contributed to the increase in TNBC aggressiveness and resistance to chemotherapeutic agents. Through the mechanism of action in inhibiting the mevalonate pathway, statins can help inhibit the EMT process in metastases. Notably, simvastatin promotes the down-regulation of vimentin in breast cancer cells. The combination of statins and neoadjuvant chemotherapy (NAC) improves the cancer patient's response. This study is expected to evaluate the role of a combination between NAC and simvastatin on therapeutic response in TNBC patients through vimentin expression. Methods: This study is a double-blind, randomized, placebo-controlled trial conducted in Dr. Cipto Mangunkusumo National Central General Hospital. An expected total of 26 TNBC patients will be assessed for eligibility and asked for informed consent. Patients with the plan to have ACT (Doxorubicin hydrochloride, Cyclophosphamide, Paclitaxel) chemotherapy regimen will receive either a combination of ACT-Simvastatin (40 mg/day) or ACT-Placebo. The biopsy will be taken pre-NAC to make the histopathological diagnosis and examine the expression of vimentin. Patients will be evaluated for adverse effects reaction every cycle and the clinical response after 8 cycles. The post-intervention biopsy will be conducted after the cycle finish. The pathological response and vimentin expression will be reviewed from the obtained samples.
This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. The cardiovascular parameters used include left ventricular hypertrophy, systolic and diastolic function, carotid intima-media thickness, myocardial circumferential strain, and strain rate.
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpoints in nasal adjuvant or intranasal immunomodulator studies. The aim of this study is assessing the safety and efficacy of AD17002 in treating patients with mild to moderate COVID-19. All participants will be 1:1:1 divided, randomly, and receive standard of treatment. In addition, participants will be given either placebo, 20 or 40 μg of AD17002 via intranasal route and clinical progresses will be compared.
Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.
There is an increasing number of elderly population, not only in Indonesia, but also in the world. With increasing of age, there is also an increasing number of elderly with sarcopenia and frailty. Both of the diseases can lead to dependency, decrease quality of life, and morbidity. Besides nutrition, physical activity, especially resistance training is proven to be beneficial in improving sarcopenia and frailty condition. Currently in Cipto Mangunkusumo National Hospital (RSCM), there is no comprehensive frailty prevention clinic in the geriatric inpatient clinics. This research can be the base of frailty and sarcopenia treatment in RSCM.
This study is a multicenter, randomized, double blind, controlled, phase III clinical trial (Immunobridging Study) to evaluate the immunogenicity and safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in healthy populations aged 18 years and above. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in human.
Introduction: Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support. Objective: To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA. Method: This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses. Alternative hypothesis: 1. There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA. 2. There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA
This study is a cohort study that aims to assess the relationship between Vitamin D Levels in infant and the risk of anemia, atopic dermatitis, diarrhea and cardiovascular disorders in newborn. The subjects of this study are 100 women who met the inclusion criteria, which are in their third trimester of pregnancy and agree to be included in this study. These subjects then will be examined for their weight using standardized CEBA digital scale, height, upper arm circumference, and blood sampling will also be done to these women to measure their vitamin D levels, calcium, parathyroid hormone, ferritin, Fe serum, IL-16, IL-10. When subjects give birth, the babies will also be included in this study. Anthropometric examination will also be done on the babies, to measure their birth weight, birth length, and head circumference. Blood samples will also be taken from their umbilical cord to assess their complete blood count, ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10. All subjects then will be monitored, and home visits will be done when the babies reach 3 months old and 6 months old. An assessment of the incidence of diarrhea, atopic dermatitis, and an assessment of cardiovascular disorders (checking pulse and blood pressure) will be carried out during the visit. At the end of the study, venous blood sampling will be taken to see levels of vitamin D, calcium, parathyroid hormone, routine complete blood count, serum Fe, and ferritin, then data analysis is performed.
Subject will be trained to do regular foot exercise during their visit to the clinic. We will evaluate foot sensitivity and peripheral perfussion after