36 research outputs found

    Descriptions and reporting of adverse events in randomized control trials.

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    <p>Abbreviations:</p>+<p> = adverse event not defined a priori,</p>*<p> = clinical endpoint defined a priori,</p>¥<p> = both follow-up duration and frequency defined a priori for adverse event, AE = adverse event, FBS = fetal bovine serum, GVHD = graft-versus-host disease.</p

    Descriptions and reporting of adverse events in clinical trials with no control group.

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    <p>Abbreviations:</p>¥<p> = both follow-up duration and frequency defined a priori for adverse event,</p>+<p> = adverse event not defined a priori,</p>*<p> = clinical endpoint defined a priori,</p>++<p> = only follow-up duration listed for all events a priori, follow-up frequency not listed, AE = adverse event, DMSO = dimethylsulfoxide, FBS = fetal bovine serum, GVHD = graft-versus-host disease.</p

    Frequency of adverse events in randomized controlled trials.

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    <p>Abbreviations: AE = adverse event, FBS = fetal bovine serum, GVHD = graft versus host disease, MRI = magnetic resonance imaging.</p

    Descriptions and reporting of adverse events in non-randomized controlled trials.

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    <p>Abbreviations:</p><p>− = not reported,</p>+<p> = adverse event not defined a priori,</p>*<p> = clinical endpoint defined a priori,</p>¥<p> = both follow-up duration and frequency defined a priori, AE = adverse event, GVHD = graft-versus-host disease,</p

    A Scoping Review of Pediatrics Clinical Trial Administering High Doses of Vitamin D.

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    <p>Poster presented at the at the <b>2015 American Academy of Pediatrics (AAP) National Conference & Exhibition</b>. Washington, DC, October 24th, 2015.</p><p><em>This data has been published, and the paper can be found at </em><i>https://doi.org/10.7717/peerj.1701</i></p><p><strong>ABSTRACT</strong></p><p><b>Background.</b> Due to inadequate UV exposure, intake of small quantities of vitamin D is recommended to prevent musculoskeletal disease. Both basic science and observational literature strongly suggest that higher doses may benefit specific populations and have non-musculoskeletal roles. Evaluating the evidence surrounding high dose supplementation can be challenging given a relatively large and growing body of clinical trial evidence spanning time, geography, populations and dosing regimens. Study objectives were to identify and summarize the clinical trial literature, recognize areas with high quality evidence, and develop a resource database that makes the literature more immediately accessible to end users.</p><p><b>Methods.</b> Medline (1946 to January 2015), Embase (1974 to January 2015), and Cochrane databases (January 2015), were searched for trials. All pediatric (0–18 years) trials administering doses higher than 400 IU (<1 year) or 600 IU (≥1 year) were included. Data was extracted independently by two of the authors. An online searchable database of trials was developed containing relevant extracted information (http://www.cheori.org/en/pedvitaminddatabaseOverview). Sensitivity and utility were assessed by comparing the trials in the database with those from systematic reviews of vitamin D supplementation including children.</p><p><b>Results.</b> A total of 2,579 candidate papers were identified, yielding 169 trials having one or more arms meeting eligibility criteria. The publication rate has increased significantly from 1 per year (1970–1979) to 14 per year (2010–2015). Although 84% of the total trials focused on healthy children or known high risk populations (e.g., renal, prematurity), this proportion has declined in recent years due to the rise in trials evaluating populations and outcomes not directly related to the musculoskeletal actions of vitamin D (27% in 2010s). Beyond healthy children, the only pediatric populations with more than 50 participants from low risk of bias trials evaluating a clinically relevant outcome were prematurity and respiratory illness. Finally, we created and validated the online searchable database using 13 recent systematic reviews. Of the 38 high dose trials identified by the systematic review, 36 (94.7%) could be found within the database. When compared with the search strategy reported in each systematic review, use of the database reduced the number of full papers to assess for eligibility by 85.2% (±13.4%).</p><p><b>Conclusion. </b>The pediatric vitamin D field is highly active, with a significant increase in trials evaluating non-classical diseases and outcomes. Despite the large overall number there are few high quality trials of sufficient size to provide answers on clinical efficacy of high-dose vitamin D. An open access online searchable data should assist end users in the rapid and comprehensive identification and evaluation of trials relevant to their population or question of interest.</p><p><br></p

    MOESM1 of Omega-3 supplementation in patients with sepsis: a systematic review and meta-analysis of randomized trials

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    Additional file 1: Table S1. Search Strategy—MEDLINE. Table S2. Search Strategy—EMBASE. Table S3. Search Strategy—Cochrane Library. Table S4. Contents of Brand-name Parenteral Formulations. Table S5. Contents of Brand-name Enteral Formulations. Figure S1. Subgroup Analysis for Mortality Outcome. Table S6. Sensitivity Analyses for Mortality Outcome. Table S7. Sensitivity Analyses for ICU Length of Stay Outcome. Table S8. Sensitivity Analyses for Duration of Mechanical Ventilation Outcome. Figure S2. Funnel Plot for Mortality Outcome. Figure S3. Funnel Plot for ICU Length of Stay Outcome. Table S9. PRISMA Checklist
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