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39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Methods | Methods Design and oversight endTB is an international, multicenter, open-label Phase III, non-inferiority trial conducted by the endTB consortium (see Supplement ). Full design ( Figure S1 ) and implementation details are published 9 and available at NEJM.org. The study was approved by institutional/ethics review bo... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Design and oversight | Design and oversight endTB is an international, multicenter, open-label Phase III, non-inferiority trial conducted by the endTB consortium (see Supplement ). Full design ( Figure S1 ) and implementation details are published 9 and available at NEJM.org. The study was approved by institutional/ethics review boards tha... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Participants | Participants Individuals aged 15 years or older who had fluoroquinolone-susceptible, pulmonary RR-TB confirmed by WHO-endorsed rapid tests were enrolled at 12 sites, which were run by endTB partners ( Table S2 ), in Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa, with the goal of ensuring represe... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Randomization and treatment | Randomization and treatment Treatment assignment was made by Bayesian randomization, adapted monthly by interim treatment response: 8-week culture and 39-week efficacy. Details have been previously published. 7 , 8 Assignment occurred through a centralized interactive randomization system. Experimental regimens were 3... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Procedures | Procedures Clinical, safety, and mycobacteriologic assessments occurred weekly until week 12, every 4 weeks until week 47, and every 6-8 weeks thereafter ( Table S9 ). Standardized mycobacteriology tests were performed in designated, quality-controlled, trial-site laboratories; the Institute of Tropical Medicine suppor... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Outcomes | Outcomes Favorable outcome at week 73 was the primary efficacy endpoint. It was established by the absence of an unfavorable outcome and either 1) two consecutive, negative cultures (one between weeks 65 and 73); or 2) favorable bacteriological, radiological, and clinical evolution. Unfavorable outcomes were: death (fr... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Analysis populations | Analysis populations Modified intention-to-treat (mITT) and per-protocol (PP) were co-primary analysis populations. The mITT population included all randomized participants who took at least one dose of study treatment (safety population) and who had a pre-randomization culture positive for M. tuberculosis . It exclud... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Statistical Analysis | Statistical Analysis Sample size assumptions included: week 73 favorable outcomes in 75% of participants in experimental groups, 70% of participants in the control, and relapse in 10%; 11% ineligible for mITT and 10% more ineligible for PP. A sample size of 750 afforded 80% power for non-inferiority (one-sided type I e... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Results | Results Trial populations and baseline characteristics Between February 2017 and October 2021, 1542 individuals underwent screening and 754 were randomized. Nine participants were excluded from the safety population (N=745) and 46 from the mITT population, which comprised 699 participants. The PP population included 56... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Trial populations and baseline characteristics | Trial populations and baseline characteristics Between February 2017 and October 2021, 1542 individuals underwent screening and 754 were randomized. Nine participants were excluded from the safety population (N=745) and 46 from the mITT population, which comprised 699 participants. The PP population included 562 partic... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Efficacy results | Efficacy results In the primary, unadjusted outcome analysis of the control group, favorable outcomes occurred in 80.7% (95% CI, 72.4 to 87.3) in the mITT and in 95.9% (95%CI, 88.6 to 99.2) in the PP populations. Ordered comparison revealed that four experimental groups (9BCLLfxZ, 9BLMZ, 9BDLLfxZ, and 9DCMZ) were non-i... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Safety results | Safety results We report the number of participants in the safety population who experienced at least one of each safety event by Week 73 after randomization. The number with at least one Grade 3 or higher AE ranged from 54.8% (9BLMZ) to 61.4% (9BDLLfxZ) in experimental groups and was 62.7% in the control. SAE frequenc... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Discussion | Discussion Consistent results across all analyses support the non-inferior efficacy of three regimens (9BLMZ, 9BCLLfxZ, and 9BDLLfxZ) compared to the standard of care. These three regimens each produced favorable outcomes in more than 85% of participants at week 73; this represents an improvement over global averages a... | 22 | false | true |
39879593 | PMC7617355 | 10.1056/NEJMoa2400327 | Oral regimens for rifampin-resistant, fluoroquinolone-susceptible tuberculosis | Supplementary Material | Supplementary Material Supplement | 22 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Methods | Methods Trial Design and Objectives This randomized, placebo-controlled, observer-blind, phase 2b trial enrolled participants at 5 sites in South Africa: Worcester, Cape Town, and Mbekweni in Western Cape; Durban in KwaZulu-Natal; and Johannesburg in Gauteng Province. The primary objective was to demonstrate the effica... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Trial Design and Objectives | Trial Design and Objectives This randomized, placebo-controlled, observer-blind, phase 2b trial enrolled participants at 5 sites in South Africa: Worcester, Cape Town, and Mbekweni in Western Cape; Durban in KwaZulu-Natal; and Johannesburg in Gauteng Province. The primary objective was to demonstrate the efficacy of BC... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Participants | Participants Eligible participants were ≥10 and ≤18 years old and tested negative for HIV and QFT. Detailed eligibility criteria are described in the Supplement and protocol at nejm.org . | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Outcomes and assessments | Outcomes and assessments The primary endpoint was sustained QFT conversion based on positive QFT results using the manufacturer’s (Qiagen ® , Germany) assay threshold of 0.35 IU/mL IFNγ. Sustained Mtb infection was defined as sustained QFT conversion from a negative to a positive test, with initial conversion at any ... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Trial oversight | Trial oversight An independent data monitoring committee reviewed unblinded safety data every three months during enrollment and every six months thereafter, as well as the outcomes of the primary analyses. The trial was conducted in accordance with the International Council for Harmonization of Technical Requirements ... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Statistical analysis | Statistical analysis The trial was designed to provide 90% power with a 1-sided alpha of 2.5% for the primary endpoint analysis. Assuming a true VE of 45%, at least 118 sustained QFT conversion events were required to demonstrate VE with a lower bound of zero, where VE is calculated as 1 – HR(BCG/Placebo). The modified... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Results | Results Baseline characteristics and disposition From 16 Oct 2019 to 22 July 2021, 3653 participants were screened and 1836 were randomized 1:1 to BCG and placebo groups ( Figure 1B ). Table S1 shows the representativeness of trial participants. At primary analysis (data cutoff: June 30, 2023), 1752 participants were... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Baseline characteristics and disposition | Baseline characteristics and disposition From 16 Oct 2019 to 22 July 2021, 3653 participants were screened and 1836 were randomized 1:1 to BCG and placebo groups ( Figure 1B ). Table S1 shows the representativeness of trial participants. At primary analysis (data cutoff: June 30, 2023), 1752 participants were in tria... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Efficacy | Efficacy The mITT population included 871 and 849 participants in the BCG and placebo groups, respectively ( Figure 1B ). Thirty-eight (4.1%) and 58 (6.3%) participants were excluded from the mITT population due to positive QFT at D71; 9 (1.0%) and 8 (0.9%) were excluded due to missing D71 and no negative result at the... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Safety | Safety Solicited local AEs were reported by 77.8% participants in the BCG group and 38.1% in the placebo group; 40.5% and 34.3% reported any solicited systemic AEs, respectively ( Table 2 ). Swelling was the most common solicited local AE, and tiredness was the most common solicited systemic AE. Unsolicited non-serious... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Immunogenicity | Immunogenicity BCG revaccination increased the frequencies of antigen-specific CD4 T cells expressing any combination of IFN-γ, TNF, IL-2, IL-17, and IL-22, compared to placebo, which remained higher than baseline, 6 months after vaccination ( Figures 3 , S2 and S3 ). Th1 responses (CD4 T cells expressing IL-2, IFN-... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Discussion | Discussion This trial was conducted to assess the findings of an earlier trial that reported a significant reduction in sustained QFT conversion rates following BCG revaccination of QFT-negative, HIV-negative adolescents 3 , assuming that a confirmatory prevention of sustained Mtb infection result and supportive corr... | 9 | false | true |
40334156 | PMC12061034 | 10.1056/NEJMoa2412381 | BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection | Supplementary Material | Supplementary Material Supp | 9 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Evidence before this study | Evidence before this study Before undertaking this study, we conducted a systematic review on the economic evaluation of using targeted next-generation sequencing (tNGS) to diagnose drug-resistant tuberculosis (DR-TB). Our search, conducted on Aug 14, 2024, included databases such as PubMed, EMBASE, and SCOPUS, without... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Added value of this study | Added value of this study This study is the first to conduct a cost-effectiveness analysis of tNGS for the detection of DR-TB in low- and middle-income countries (LMICs). It provides essential economic evidence that has informed the World Health Organization (WHO) in making recommendations regarding the adoption of thi... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Implications of all the available evidence | Implications of all the available evidence Our study suggests that tNGS can be a cost-effective tool for DR-TB diagnosis, particularly in settings where comprehensive drug susceptibility testing (DST) is not routinely performed. The findings underscore the importance of considering existing DST practices and healthcare... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Introduction | Introduction Drug-Resistant Tuberculosis (DR-TB) has become growing public health threat, with incidence increasing and only one third of people with multi-drug resistance (MDR)/Rifampicin resistant (RR) -TB diagnosed and enrolled in treatment annually. 1 DR-TB is more difficult to diagnose as it requires bacteriologi... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Methods | Methods Study design We developed stochastic decision analysis model to assess the cost-effectiveness of introducing tNGS for the diagnosis of DR-TB for all three objectives. This study was done from healthcare system perspective and accounted for healthcare system costs to diagnose and treat TB. The primary outcome of... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Study design | Study design We developed stochastic decision analysis model to assess the cost-effectiveness of introducing tNGS for the diagnosis of DR-TB for all three objectives. This study was done from healthcare system perspective and accounted for healthcare system costs to diagnose and treat TB. The primary outcome of this st... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Model structure, intervention, and comparator | Model structure, intervention, and comparator Model structure The decision analysis model employed a decision tree framework to simulate the diagnostic and treatment pathways for individuals with DR-TB. Each decision tree captured the sequence of testing, treatment decisions, and health outcomes, including true positiv... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Model structure | Model structure The decision analysis model employed a decision tree framework to simulate the diagnostic and treatment pathways for individuals with DR-TB. Each decision tree captured the sequence of testing, treatment decisions, and health outcomes, including true positive and false negative diagnostic results, treat... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Epidemiological, diagnostic and programmatic parameters | Epidemiological, diagnostic and programmatic parameters We gathered epidemiological parameters–prevalence data, diagnostic accuracy data and health outcome data–that were essential for the model from various sources. A detailed list of those sources is included in Table 1 . The estimate and ranges for the prevalence o... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Cost parameters | Cost parameters We only included costs incurred by the health care system ( Table 1 ). Per unit test cost of tNGS were derived from a systematic review on the cost-effectiveness of tNGS and empirical costing done in consultation with manufacturers and FIND in preparation for the GDG meeting. The costs of the different ... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Incremental cost-effectiveness | Incremental cost-effectiveness This study measured outcomes in terms of total costs and DALYs, with the primary economic measure being incremental cost per DALY averted. When tNGS was used as a test for DST among person with RR, we analyzed the incremental cost per DALY averted of introducing tNGS, compared to universa... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Statistics | Statistics Uncertainty around included parameters and the impact of this uncertainty on model results were explicitly examined through probabilistic sensitivity analyses (PSA). The primary outcome of ICER were obtained from a Monte Carlo simulation with 10,000 replications with 95% uncertainty ranges reported as the 2.... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Sensitivity and scenario analysis | Sensitivity and scenario analysis One-way sensitivity analysis was conducted to understand the potential impact of key model inputs on the ICER. We evaluated each individual parameter value independently. Parameters that showed greater influence, such as per unit test cost, contamination rate, repeat test probability (... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Ethics | Ethics Ethical approval was obtained from the University of Ottawa Research Ethics Boards (H-07-22-8325–ANN1-8325). This analysis did not involve human subjects. | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Role of funding source | Role of funding source The funder itself had no role in the design, conduct, analysis or in the decision to submit for publication. | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Results | Results Cost-effectiveness of tNGS versus universal pDST for DST among persons with RR The cost-effectiveness results for using tNGS as a test for DST after detection of RR, replacing pDST without considering differences in time to results and potential impact on loss to follow-up is shown in Table 2 . In this hypothe... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Cost-effectiveness of tNGS versus universal pDST for DST among persons with RR | Cost-effectiveness of tNGS versus universal pDST for DST among persons with RR The cost-effectiveness results for using tNGS as a test for DST after detection of RR, replacing pDST without considering differences in time to results and potential impact on loss to follow-up is shown in Table 2 . In this hypothetical co... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Cost-effectiveness of tNGS versus in-country DST practice for DST among persons with RR | Cost-effectiveness of tNGS versus in-country DST practice for DST among persons with RR The incremental cost per DALYs averted of using tNGS as a test for DST after detection of RR, replacing in-country DST practice for South Africa and Georgia was $15,619 (95% UR: cost saving–$114,782) and $18,375 (95% UR: Cost saving... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Cost-effectiveness of tNGS as an initial test for TB drug resistance | Cost-effectiveness of tNGS as an initial test for TB drug resistance When tNGS was used as an initial test for TB drug resistance in the high DR TB setting of Georgia ( Table 2 ) it resulted in improved health gains leading to an ICER of $9261 per DALY averted (95% UR: $5258–$32,040). At WTP threshold of 3 times the co... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Sensitivity analysis | Sensitivity analysis In univariable sensitivity analyses key epidemiological and cost parameters were varied across expected ranges to understand the influence of each parameter on model results. All variables having more than 10% change in model results were presented as a tornado diagram. When tNGS was used as a test... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Scenario analysis | Scenario analysis Table 3 shows the result of scenario analyses done to evaluate cost effectiveness of using tNGS. When tNTS was compared to pDST, the scenario where patients in the pDST arm were initiated on the least effective individualized treatment, compared to tNGS, pDST was no longer dominant over tNGS. In the ... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Discussion | Discussion In this economic evaluation, we evaluated the cost-effectiveness of using tNGS for DST and detection of DR TB in the settings of South Africa, Georgia and India. When tNGS was compared with universal pDST, for DST among people with RR and assuming a similar probability of LTFU between tNGS and pDST, our find... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Contributors | Contributors AZ and SS contributed to conceptualization of the project, data curation, modelling, formal analysis, and manuscript writing. In addition, AZ also provided supervision of overall project. CM and NI contributed to conceptualization of the project, and manuscript writing. AA contributed to data curation and ... | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Data sharing statement | Data sharing statement The authors confirm that all parameters used in the cost-effectiveness analysis are available within the article and its Supplementary Materials . No new data were generated for this study. | 6 | false | true |
39810935 | PMC11732181 | 10.1016/j.eclinm.2024.103003 | Cost-effectiveness of targeted next-generation sequencing (tNGS) for detection of tuberculosis drug resistance in India, South Africa and Georgia: a modeling analysis | Declaration of interests | Declaration of interests CM reports receiving funding from USAID to support the Global TB Programme staff at the WHO. All other authors declare no conflicts of interest. | 6 | false | true |
39836471 | PMC11957701 | 10.1172/JCI188016 | Mycobacterium tuberculosis resisters despite HIV exhibit activated T cells and macrophages in their pulmonary alveoli | Introduction | Introduction An estimated 7.5 million incident cases of tuberculosis (TB) were reported in 2022, making it the highest number of newly diagnosed cases since 1995 ( 1 ). Globally, 6.3% of incident cases were in people with HIV (PWH) ( 1 ). Relative to HIV-negative persons, PWH have a higher risk of developing clinical T... | 5 | false | true |
39836471 | PMC11957701 | 10.1172/JCI188016 | Mycobacterium tuberculosis resisters despite HIV exhibit activated T cells and macrophages in their pulmonary alveoli | Results | Results Cell-type distribution of BAL cells. Our study was restricted to PWH on long-term ART with controlled viral loads and no history of TB despite long-term exposure to Mtb in a high-transmission setting ( Figure 1A ). The 14 participants belonged to 2 well-defined phenotypic groups of equal size: participants cl... | 5 | false | true |
39836471 | PMC11957701 | 10.1172/JCI188016 | Mycobacterium tuberculosis resisters despite HIV exhibit activated T cells and macrophages in their pulmonary alveoli | Cell-type distribution of BAL cells. | Cell-type distribution of BAL cells. Our study was restricted to PWH on long-term ART with controlled viral loads and no history of TB despite long-term exposure to Mtb in a high-transmission setting ( Figure 1A ). The 14 participants belonged to 2 well-defined phenotypic groups of equal size: participants classified... | 5 | false | true |
39836471 | PMC11957701 | 10.1172/JCI188016 | Mycobacterium tuberculosis resisters despite HIV exhibit activated T cells and macrophages in their pulmonary alveoli | Characteristics of alveolar myeloid cells in the absence of ex vivo Mtb challenge. | Characteristics of alveolar myeloid cells in the absence of ex vivo Mtb challenge. To better define the differences in BAL cell subpopulations between resister and LTBI samples, we clustered the myeloid and lymphoid cells separately. Clustering was done with all the infected and noninfected samples and the 2 time point... | 5 | false | true |
39836471 | PMC11957701 | 10.1172/JCI188016 | Mycobacterium tuberculosis resisters despite HIV exhibit activated T cells and macrophages in their pulmonary alveoli | Characteristics of alveolar lymphoid cells in the absence of Mtb. | Characteristics of alveolar lymphoid cells in the absence of Mtb. Next, we annotated the subpopulations in the lymphocyte subset, where we identified 19 clusters ( Figure 4A , Supplemental Figure 2 , and Supplemental Table 3 ). The majority of lymphocyte clusters comprised T cells (CD3 + ), including CD4 + naive T c... | 5 | false | true |
39836471 | PMC11957701 | 10.1172/JCI188016 | Mycobacterium tuberculosis resisters despite HIV exhibit activated T cells and macrophages in their pulmonary alveoli | Alveolar myeloid cell response to ex vivo Mtb challenge. | Alveolar myeloid cell response to ex vivo Mtb challenge. Next, we compared the gene expression of Mtb -challenged samples from 6 hours and 24 hours after infection against the corresponding noninfected samples by group ( Figure 5, A and B , and Supplemental Tables 7 and 8 ). In both groups, upregulated genes at 6 hou... | 5 | false | true |
39836471 | PMC11957701 | 10.1172/JCI188016 | Mycobacterium tuberculosis resisters despite HIV exhibit activated T cells and macrophages in their pulmonary alveoli | Alveolar lymphoid cell response to ex vivo Mtb challenge. | Alveolar lymphoid cell response to ex vivo Mtb challenge. Given the low cell counts in LTBI lymphocyte clusters, we used the same approach as for the baseline expression comparison of lymphocytes. We investigated the gene expression of key genes at the level of the 19 lymphocyte subpopulations ( Figure 6, A and B , Su... | 5 | false | true |
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