European journal of internal medicine
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Eur. J. Intern. Med. · Jan 2020
Randomized Controlled TrialTreating periodontal disease in patients with myocardial infarction: A randomized clinical trial.
Periodontitis has been associated with coronary artery disease, but the impact of a periodontal treatment on the endothelial function of patients with a recent ST-segment elevation myocardial infarction (STEMI) was not investigated. ⋯ NCT02543502 (https://clinicaltrials.gov/ct2/show/NCT02543502?term=NCT02543502&rank=1).
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Eur. J. Intern. Med. · Jan 2020
Assessment of frequency and reporting of design changes among clinical drug trials published in influential medical journals.
Modifications of primary outcome measures after trial initiation can undermine their scientific validity. We aimed to quantify these changes and to characterize potential predictors in clinical drug trials published in high impact factor general medicine journals. ⋯ Approximately half of trials published in influential medical journals present changes to the design while patient accrual is ongoing, and two thirds of them are unreported. Justification for such modifications should be reported more clearly. Reviewers, editors and readers should consult ClinicalTrials.gov for a more comprehensive report of the evolution of key study methods.