Bmc Med
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Transparency and reproducibility are expected to be normative practices in clinical trials used for decision-making on marketing authorisations for new medicines. This registered report introduces a cross-sectional study aiming to assess inferential reproducibility for main trials assessed by the European Medicines Agency. ⋯ Despite their results supporting decisions that affect millions of people's health across the European Union, most main studies used in EPARs lack transparency and their results are not reproducible for external researchers. Re-analyses of the few trials with available data showed very good inferential reproducibility.
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The temporal relationship between adiposity and gut microbiota was unexplored. Whether some gut microbes lie in the pathways from adiposity to insulin resistance is less clear. Our study aims to reveal the temporal relationship between adiposity and gut microbiota and investigate whether gut microbiota may mediate the association of adiposity with insulin resistance in a longitudinal human cohort study. ⋯ Our study identified one potentially beneficial microbe Lachnospiraceae bacterium 3 1 57FAA CT1, which might mediate the effect of adiposity on insulin resistance. The identified microbes are helpful for the discovery of novel therapeutic targets, as to mitigate the impact of adiposity on insulin resistance.
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Recent years have seen important improvements in available preventive treatment regimens for tuberculosis (TB), and research is ongoing to develop these further. To assist with the formulation of target product profiles for future regimens, we examined which regimen properties would be most influential in the epidemiological impact of preventive treatment. ⋯ As preventive treatment regimens against TB continue to improve, understanding the key drivers of epidemiological impact can assist in guiding further development. By meeting these key targets, future preventive treatment regimens could play a critical role in global efforts to end TB.
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Children and young persons are known to have a high number of close interactions, often within the school environment, which can facilitate rapid spread of infection; yet for SARS-CoV-2, it is the elderly and vulnerable that suffer the greatest health burden. Vaccination, initially targeting the elderly and vulnerable before later expanding to the entire adult population, has been transformative in the control of SARS-CoV-2 in England. However, early concerns over adverse events and the lower risk associated with infection in younger individuals means that the expansion of the vaccine programme to those under 18 years of age needs to be rigorously and quantitatively assessed. ⋯ Vaccination of 12-170-year-olds and 5-11-year-olds is projected to generate a reduction in infection, hospital admission and deaths for both the age groups involved and the population in general. For any decision involving childhood vaccination, these benefits needs to be balanced against potential adverse events from the vaccine, the operational constraints on delivery and the potential for diverting resources from other public health campaigns.
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Randomized Controlled Trial
Effectiveness of a digital intervention versus alcohol information for online help-seekers in Sweden: a randomised controlled trial.
The ubiquity of Internet connectivity, and widespread unmet needs, requires investigations of digital interventions for people seeking help with their drinking. The objective of this study was to test the effectiveness of a digital alcohol intervention compared to existing online resources for help seekers. ⋯ A digital alcohol intervention produced self-reported behaviour change among online help seekers in the general population. The internal and external validity of this trial is strong, subject to carefully considered study limitations arguably inherent to trials of this nature. Limitations include higher than anticipated attrition to follow-up and lack of blinding.