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Article
Open AccessOrganizational contextual factors that predict success of a quality improvement collaborative approach to enhance integrated HIV-tuberculosis services: a sub-study of the Scaling up TB/HIV Integration trial
A quality improvement (QI) collaborative approach to enhancing integrated HIV-Tuberculosis (TB) services may be effective in scaling up and improving the quality of service delivery. Little is known of the rol...
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Article
Open AccessToxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status
The phase III REMoxTB study prospectively enrolled HIV-positive (with CD4+ count > 250 cells, not on anti-retroviral therapy) and HIV-negative patients. We investigated the incidence of adverse events and cure...
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Article
Sequential chemical separations and multiple ion counting ICP-MS for 241Pu–241Am–237Np dating of environmental collections on a single aliquot
We have developed a combined sequential chemical separation procedure and multiple ion counting ICP-MS measurement method for isotopic measurements of Am in environmental samples. This, in conjunction with est...
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Article
Open AccessToxicity associated with tuberculosis chemotherapy in the REMoxTB study
The incidence and severity of tuberculosis chemotherapy toxicity is poorly characterised. We used data available from patients in the REMoxTB trial to provide an assessment of the risks associated with the sta...
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Article
Open AccessLiver toxicity associated with tuberculosis chemotherapy in the REMoxTB study
Drug-induced liver injury (DILI) is a common complication of tuberculosis treatment. We utilised data from the REMoxTB clinical trial to describe the incidence of predisposing factors and the natural history i...
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Article
Open AccessA comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens
Tuberculosis kills more people than any other infectious disease, and new regimens are essential. The primary endpoint for confirmatory phase III trials for new regimens is a composite outcome that includes ba...
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Article
Open AccessSpot sputum samples are at least as good as early morning samples for identifying Mycobacterium tuberculosis
The use of early morning sputum samples (EMS) to diagnose tuberculosis (TB) can result in treatment delay given the need for the patient to return to the clinic with the EMS, increasing the chance of patients ...
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Article
Open AccessErratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials
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Article
Open AccessLimited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials
Despite recent increased clinical trials activity, no regimen has proved able to replace the standard 6-month regimen for drug-sensitive tuberculosis. Understanding the relationship between microbiological mar...
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Article
Open AccessEvaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial
In contrast to drug-sensitive tuberculosis, the guidelines for the treatment of multi-drug-resistant tuberculosis (MDR-TB) have a very poor evidence base; current recommendations, based on expert opinion, are ...
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Article
Open AccessThe value of the pragmatic-explanatory continuum indicator summary wheel in an ongoing study: the bullous pemphigoid steroids and tetracyclines study
The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool is intended to be used in the design phase of trials to help investigative teams design trials in-line with their purpose. Our team applied t...
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Open AccessAlternative approaches to tuberculosis treatment evaluation: the role of pragmatic trials
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Open AccessThe evolution of and challenges in defining the clinical endpoint in tuberculosis treatment trials with non-inferiority designs