UMB Data Catalog

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Results Found: 4
  • UMB Dataset

    Assessing Muscle-Related Adverse Events in Randomized Trials of Statins

    Authors
    Peter Doshi
    Kyungwan Hong
    Sarah Tanveer
    Tom Jefferson
    Description

    This study examined randomized trials of statins to investigate the reporting of muscle-related adverse events (MRAEs). The study highlights the importance of critical appraisal of trial design and data collection methods from clinical study reports. Internal company trial documents were requested from the European Medicines Agency and Health Canada for all clinical trials of atorvastatin, rosuvastatin,...

    Subject
    Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
    Access Rights
    Unrestricted access
  • UMB Dataset

    Sleep, circadian rhythms and fatigue in children with CNS tumors hospitalized for high dose chemotherapy

    Authors
    Valerie E. Rogers
    Belinda Mandrell
    Description

    This study tested a sleep promotion intervention (randomized controlled trial) in children with recently diagnosed central nervous system tumors admitted to the hospital for high dose chemotherapy in preparation for autologous stem cell rescue. We hypothesized that disturbed sleep of hospitalized pediatric oncology patients would be reduced by altering the hospital sleep environment. Therefore, a randomized,...

    Subject
    Central Nervous System/Cancer
    Sleep Wake Disorders
    Access Rights
    Unrestricted access
  • UMB Dataset

    Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

    Authors
    Joseph Fraiman
    Juan Erviti
    Mark Jones
    Sander Greenland
    3 more author(s)...
    Description

    An adapted version of the Brighton Collaboration priority list was used to evaluate serious adverse events (SAE) of special interest observed in mRNA Covid-19 vaccine trials. In December of 2020, reviewers searched journal publications and trial data on the FDA’s and Health Canada’s websites to locate SAE results tables for these trials. For each trial, blinded SAE tables were prepared. Using these...

    Subject
    COVID-19/prevention & control
    Vaccines
    Timeframe
    2020
    Access Rights
    Unrestricted access
  • UMB Dataset

    Dataset (data extraction spreadsheet) of an Exploratory Review of Clinical Study Reports of Randomised Controlled Trials

    Authors
    Peter Doshi
    Tom Jefferson
    Description

    This dataset (data extraction spreadsheet) is associated with an exploratory evaluation of pharmaceutical industry clinical study reports (CSR) for possible use in evidence synthesis and systematic reviews. 78 CSRs from public sources were selected for data extraction. The report dates range from 1991 through 2011, inclusive, and represent 90 randomized controlled trials of 14 pharmaceuticals. The...

    Subject
    Drug Industry
    Access Rights
    Unrestricted access