Lancet
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Randomized Controlled Trial Multicenter Study
Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial.
Diabetic peripheral neuropathic pain (DPNP) is common and often distressing. Most guidelines recommend amitriptyline, duloxetine, pregabalin, or gabapentin as initial analgesic treatment for DPNP, but there is little comparative evidence on which one is best or whether they should be combined. We aimed to assess the efficacy and tolerability of different combinations of first-line drugs for treatment of DPNP. ⋯ National Institute for Health Research (NIHR) Health Technology Assessment programme.
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Randomized Controlled Trial
A telemedicine model for abortion in South Africa: a randomised, controlled, non-inferiority trial.
Telemedicine for medical abortion increases access to safe abortion but its use has not been described in a controlled trial. We aimed to investigate the effectiveness, adherence, safety, and acceptability of a modified telemedicine protocol for abortion compared with standard care in a low-resource setting. ⋯ Grand Challenges Canada and the Swedish Research Council.
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Randomized Controlled Trial Multicenter Study
Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone: a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial.
Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, reports of growth and neurodevelopmental dose-related side-effects suggest that the current dose (12 mg plus 12 mg, 24 h apart) might be too high. We therefore investigated whether a half dose would be non-inferior to the current full dose for preventing respiratory distress syndrome. ⋯ French Ministry of Health.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial.
Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability. ⋯ The UK National Institute for Health Research Health Technology Assessment Programme.
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Randomized Controlled Trial
Mepolizumab for urban children with exacerbation-prone eosinophilic asthma in the USA (MUPPITS-2): a randomised, double-blind, placebo-controlled, parallel-group trial.
Black and Hispanic children living in urban environments in the USA have an excess burden of morbidity and mortality from asthma. Therapies directed at the eosinophilic phenotype reduce asthma exacerbations in adults, but few data are available in children and diverse populations. Furthermore, the molecular mechanisms that underlie exacerbations either being prevented by, or persisting despite, immune-based therapies are not well understood. We aimed to determine whether mepolizumab, added to guidelines-based care, reduced the number of asthma exacerbations during a 52-week period compared with guidelines-based care alone. ⋯ US National Institute of Allergy and Infectious Diseases and GlaxoSmithKline.