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NCT ID: NCT03775460 Recruiting - Clinical trials for Erythema Nodosum Leprosum

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

MaPs
Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.

NCT ID: NCT03762746 Recruiting - Clinical trials for Hallucinations, Verbal Auditory

Transcranial Magnetic Stimulation (TMS) for Patients With Treatment Resistant Auditory Verbal Hallucination

TMS
Start date: February 1, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of repetitive transcranial magnetic stimulation (rTMS) in schizophrenia with treatment resistant auditory verbal hallucination

NCT ID: NCT03736915 Recruiting - Pain Clinical Trials

A Trial Comparing Pain During Local Tumesent Injection In Fingers Using Different Syringe-Needle Combinations

Start date: November 14, 2018
Phase: N/A
Study type: Interventional

Background: This study aims to obtain the most favorable syringe and needle combination, which causes the least pain during local anesthesia tumescent injection in the simulation of fully awake hand surgery. Methods: A randomized single-blinded controlled trial is designed for 30 adult male healthy subjects to compare the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. The injection will be SIMPLE block technique using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc. Subjects are required to rate two check-point of VAS at the timing of needle puncture and just right after the completion of the infiltration. Upon the completion of each finger, the subject is also asked to give response to seri of questions regarding the procedures and their preferences. At the end of all injections, subject is asked to rate his preference of syringe and needle combination.

NCT ID: NCT03692715 Recruiting - Nephrolithiasis Clinical Trials

Antibiotic Prophylaxis Before Shock Wave Lithotripsy

APPEAL
Start date: September 27, 2018
Phase: Phase 4
Study type: Interventional

This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

NCT ID: NCT03648970 Recruiting - Pre-Eclampsia Clinical Trials

Indonesia Pravastatin to Prevent Preeclampsia Study

INOVASIA
Start date: March 1, 2018
Phase: Phase 2
Study type: Interventional

BACKGROUND Preeclampsia is a major cause of maternal and neonatal morbidity worldwide. There is currently no cure for preeclampsia, the only definitive treatment is termination of pregnancy by induction of labour or caesarean section. Statin has been proposed to represent a new approach to improve disease outcome/prevent preeclampsia based on its multilayered activity toward pregnancy protection, including: protection of vascular endothelial cells survival, induce expression of heme oxygenase 1 (HO-1), inhibiting the release of soluble FMS-like tirosine kinase-1 (sFlt-1) and soluble endoglin (sEng), two main culprits in the pathophysiology of preeclampsia. OBJECTIVE The aim of this study is to observe the effect of pravastatin administration in patients with high risk of preeclampsia in order to reduce maternal and neonatal mortality and morbidity. METHODS This is a prospective randomized controlled clinical trial. The research will be held in 5 maternal fetal medicine centers in Indonesia (multicenter study). The recruitment will be done by permuted block random sampling methods, with sample size around 280 patients divides into two group. Patients with high risk of preeclampsia will be randomized either to get pravastatin 2 x 20 mg per oral and aspirin 1 x 80 mg (treatment group) or low dose aspirin only (control group). The patient will be followed regularly until delivery to obtain detailed maternal and neonatal outcome. OUTCOME Primary Outcomes: Maternal preeclampsia, severe preeclampsia, gestational hypertension, indicated preterm delivery less than 37 weeks, indicated preterm delivery less than 34 weeks, maternal complications, length of hospital stay, and any serious adverse event. Secondary Outcomes: Composite fetal/neonatal mortality and morbidity (stillbirth, neonatal death, respiratory distress syndrome, intracerebral hemorrhage, neonatal sepsis, intra uterine growth restriction [Small for Gestational Age (SGA) < 5th centile], and necrotizing enterocolitis), birthweight, birthweight percentile, level of care (well baby, intermediate, NICU), NICU length of stay, ventilator usage, and length of perinatal hospital stay. KEYWORDS: pravastatin, preeclampsia, neonatal mortality, neonatal morbidity

NCT ID: NCT03638609 Recruiting - Clinical trials for Post-Cardiac Arrest Syndrome

The Effect of IABP Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome

Start date: October 23, 2017
Phase: N/A
Study type: Interventional

The prevalence of cardiac arrests is still high worldwide. Despite the return of spontaneous circulation (ROSC), mortality and morbidity in post cardiac arrest patients is reported high. Comprehensive management is essential in treating patients with post cardiac arrest syndrome. Adequate circulatory stability is achieved with fluid therapy, vasoactive drug therapy, and consideration of mechanical support. Intra-Aortic Ballon Pump (IABP) is one of the most feasible and available mechanical support in developing countries including Indonesia. There are several benefits of IABP reported in acute myocardial infarction complicated with cardiogenic shock. Nevertheless, the IABP-SHOCK II study revealed contradictive result which is IABP support was not improving mortality in acute myocardial infarction complicated with cardiogenic shock after revascularization. Other study, Korean Acute Myocardial Infarction Registry (KAMIR), also reported no benefits of IABP support in cardiogenic shock patients. But, the study the investigators mentioned earlier is a registry study, attributed to selection bias and several confounding factors resulting mismatch in population. There are no consideration to IABP time of initiation and duration of use in both studies. The Investigator is aiming to prove the early insertion of IABP to a better outcome compared with the absence of early IABP. The objective of the study is to assess mortality in post cardiac arrest syndrome patients with early insertion of IABP support. A total of 102 subjects will be enrolled in this study, divided into IABP and non-IABP group. The primary outcome is in-hopital-mortality, and various indicators in the pathomechanisme of post cardiac arrest syndrome will be measured in 30 minutes and 6 hours after ROSC. Effective lactate clearance, IL-6, Beclin-1, Caspase-3, a-vO2 diff, and ScvO2, cardiac output, VTI, TAPSE and ejection fraction will be measured and analized between the two groups.

NCT ID: NCT03549754 Recruiting - Hypertension Clinical Trials

iCaReMe Global Registry

iCaReMe
Start date: February 17, 2018
Phase:
Study type: Observational [Patient Registry]

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

NCT ID: NCT03504631 Recruiting - Clinical trials for Breast Cancer Female

Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

Start date: October 1, 2017
Phase:
Study type: Observational

This study is an observational study to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

NCT ID: NCT03503058 Recruiting - Malaria Clinical Trials

Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria

Start date: May 7, 2022
Phase: Phase 2
Study type: Interventional

The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in healthy Indonesian soldiers deployed to eastern Indonesia.

NCT ID: NCT03495401 Recruiting - Stunting Clinical Trials

Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth

Start date: April 28, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of double fortification (iron and zinc) in synbiotic milk (L.plantarum Dad13 and fructooligosaccharides) on under 5 years stunted children growth, gut microbiota composition, blood zinc and hemoglobin level, and cognitive level.