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Title of Study Summary and Purpose Field/Research Study Type Study Title of study Summary and Purpose Field/research Study type Study design Intervention Study location Sponsor, collaborator and Study population/condition Sample size Available source of investigator information (website, trial identity code) Video Directly Observed Therapy A novel mHealth application that allows patients to make Adherance and completion Interventional Allocation: Randomized Video Directly Observed Therapy, USA Sponsor: (VDOT) to Monitor Short-Course and send videos of each medication dose ingested that are in treatment Endpoint Classification: Efficacy In-Person DOT (Control) TB contacts and refugees in San LTBI Treatment watched by healthcare providers via a HIPAA-compliant Study University of California, San Diego Diego who are prescribed 3HP for website to remotely monitor LTBI treatment adherence Intervention Model: Parallel LTBI treatment by their physician 310 NCT02641106 (Video DOT [VDOT]) has been developed. This study will Assignment will be randomly assigned to be determine whether monitoring patients with VDOT achieves Masking: Open Label monitored for adherence via higher treatment completion rates and greater patient either VDOT or in-person DOT acceptability at lower cost than clinic-based in-person DOT. Quantiferon Gold Test for Detecting To compare the effectiveness of linking the Quantiferon-gold Performance of comercially Interventional Allocation: Randomized South Africa Sponsor: TB Infection in HIV/AIDS Patients in in-tube test (QGIT) with routine CD4 testing to the routine available immunotests Intervention Model: Parallel South Africa use of the tuberculin skin test (TST), the current standard of Assignment Johns Hopkins University care for diagnosing latent tuberculosis infection (LTBI) in Masking: Open Label South Africa. The investigators hypothesize that QGIT clinics Primary Purpose: Diagnostic Collaborators: will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher proportion of patients and in a significantly Device: QGIT National Institute of Allergy and 3000 NCT02119130 faster timeframe. The cost-effectiveness of linking QGIT Infectious Diseases (NIAID) with routine CD4 compared to routine TST will also be evaluated, University of Witwatersrand, South Africa Vitamin D Suplementation in TB The goal of this clinical trial is to investigate the preventive Treatment/intervention Phase 3, Allocation: Randomized •Dietary Supplement: Not provided Healthy children ages between Prevention role of vitamin D supplementation in school age children in a Intervention Model: Parallel cholecalciferol (vitamin D) 6 and 13 years, enrolled in high transmission setting. The investigators hypothesis is Interventional Assignment 14000 IU vitamin D3 weekly Sponsor: participating schools 8200 NCT02276755 that (1) vitamin D supplementation will reduce rate of Masking: Double Blind (Subject, Experimental group will receive Harvard School of Public Health Not currently TB infected. acquisition of LTBI, (2) vitamin D supplementation will lead Caregiver, Investigator, vitamin D supplement (Tishcon, to greater reductions in active TB incidence, and (3) children Outcomes Assessor) USA). Toward a Safe and Reachable Thewith incidence the lowest of vitamin TB in Taiwan D status has at gradually baseline declinedwill gain mostin Treatment/intervention Interventional PhasePrimary 3 Purpose: Allocation: Prevention Randomized Rifapentine and Isoniazid for 3 months Taiwan Preventive Therapy for LTBI: a recent 10 years. In order to maintain the trend of decreasing Endpoint Classification: versus Isoniazid for 9 months Multicenter Randomized Controlled in incidence, preventive therapy for LTBI become more and Safety/Efficacy Study Study in Taiwan more important. However, which is the best preventive Intervention Model: Parallel regimen for LTBI is still unknown. Therefore, we conduct the Assignment Sponsor: 322 NCT02208427 prospective randomized multicenter studies to compare the Masking: Open Label National Taiwan University Hospital treatment completion rate of two regimens in Taiwan. The Primary Purpose: Prevention first regimen is daily isoniazid for 9 months. The second is weekly rifapentine plus high-dose isoniazid for 3 months. Study based in Southern Ethiopia Purpose - to explore if Performance of comercially Observational Observational Model: Defined Not provided Ethiopia Sponsor: children in contact with adults with TB have positive acute available immunotests Population Liverpool School of Tropical Medicine reactants such as IFN-y and other cytokine responses; if Time Perspective: Longitudinal Children with suspicion of TB these responses discriminate between high and low risk of Collaborator: attending health centres will 500 Diagnosis of Active and Latent TB disease progression and whether these could be Thrasher Research Fund also be investigated NCT00456469 Infection With IFN-y Assays in incorporated into improved diagnostic approaches. African Children The Role of Apoptosis Associated The apoptosis-associated markers, including Fas ligand, Development of new tests Observational Observational Model: Case Not provided Taiwan Markers in Pathogenesis of Decoy-receptor 3, Lipoxin, and prostaglandin E2, are with improved performance Control 1.Patients with tuberculosis: Pulmonary Tuberculosis discriminative in patients with active TB from those with LTBI and biomarkers Time Perspective: Prospective microbiology or pathology and thus might predict the potential of being active TB from proven tuberculosis infection LTBI. To compare the serum apoptosis-associated markers 2.Patients with latent between patients with active TB and patients with LTBI To tuberculosis infection are defined by interferon-gamma evaluate the efficiency of apoptosis-associated markers to National Taiwan University Hospital 400 NCT01676155 differentiate potential of active TB from LTBI release assay 3.Patients without tuberculosis and latent tuberculosis are defi=ed by negative findings in above-mentioned results Prognostic Value of Interferon The objective of this study is to assess the efficacy of the two Programme management Observational Observational Model: Cohort Not provided United Kingdom Sponsor: Gamma Release Assays in Predicting current TB (tuberculosis) blood tests (Interferon Gamma Time Perspective: Prospective Active Tuberculosis Among Release Assays (IGRA)) compared with the standard skin test Public Health England Individuals With, or at Risk of, (Mantoux Tuberculin Skin Test (TST)), for predicting active Latent Tuberculosis Infection tuberculosis among those at increased risk of TB. Those at Collaborators: Those who are close contacts increased risk are defined as either newly arrived immigrants of active tuberculosis cases or or people who have been in contact with TB cases. The study Imperial College London those who have are new 10000 NCT01162265 will also provide information on the cost effectiveness of entrants to the UK from high different testing strategies, such as the two step testing Queen Mary University of London incidence countries approach recommended by NICE. (>40/100000). University College, London Brunel University University of Birmingham Study to Evaluate the Tolerability This is a double-blind, masked, compared with placebo Treatment/intervention Interventional Phase 1 Allocation: Dietary Supplement: Nyaditum Sponsor: and Immunogenicity of Nyaditum clinical trial in pediatric population in contact with Randomized, Endpoint resae ® 10e5 of heat-killed Resae ® Probiotic Administered to tuberculosis with or without tuberculosis infection. This trial Classification: Safety/Efficacy Mycobacterium manresensis Spain Manresana de Micobacteriologia, SL Pediatric Population in Contact aims to study the effect of the probiotic Nyaditum resae® at Study, Intervention Model: Other: Placebo With Tuberculosis With or Without the level of specific Treg memory cells eight weeks after the Parallel Assignment, Masking: Latent Tuberculosis Infection first administration, and the global tolerability of the Double Blind (Subject, Caregiver, Child between 2 and 17 years, treatment. Investigator), Primary Purpose: who have had contact with 24 NCT02581579 Nyaditum resae® is a preparation in the form of capsules Prevention tuberculosis containing heat-killed environmental mycobacteria Mycobacterium manresensis. The overall objective of the study is the effect of Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis. Immune Responses to To study how the immune system of people with latent Other (immunology, Observational United States Sponsor: National Institute of Allergy Mycobacterium Tuberculosis (Mtb) tuberculosis infection (LTBI) acts to prevent development of pathogenesis, co-infection) and Infectious Diseases (NIAID) in People With Latent Tuberculosis active TB. Also, to study how helminth infection might affect Infection With or Without this immune response. An exploratory objective is to The study will enrol Concomitant Helminth Infection evaluate if there are subsets of subjects within the LTBI 250 NCT02225158 participants with LTBI group (irrespective of helminth infection status) who have Study Design: stable pool of long lasting antigen-specific IL-2 only producing CD4+ central memory T cells and changes to this Time Perspective: Prospective pool after receiving LTBI treatment. Randomised controlled trial for cost- The aim of this study is to perform a multimodal comparison Programme management Interventional Randomised controlled trial A 12 dose course
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