Data from "Obstacles to the Reuse of Study Metadata in ClinicalTrials.gov"

This fileset provides supporting data and corpora for the empirical study described in: <br><b>Laura Miron, Rafael S. Goncalves and Mark A. Musen. Obstacles to the Reuse of Metadata in ClinicalTrials.gov</b><br><i>Description of files</i><br><b>Original data files:</b>- AllPublicXml.zip contains the set of all public XML records in ClinicalTrials.gov (protocols and summary results information), on which all remaining analyses are based. Set contains 302,091 records downloaded on April 3, 2019.- public.xsd is the XML schema downloaded from ClinicalTrials.gov on April 3, 2019, used to validate records in AllPublicXML.<br><b>BioPortal API Query Results</b>- condition_matches.csv contains the results of querying the BioPortal API for all ontology terms that are an 'exact match' to each condition string scraped from the ClinicalTrials.gov XML. Columns={filename, condition, url, bioportal term, cuis, tuis}. - intervention_matches.csv contains BioPortal API query results for all interventions scraped from the ClinicalTrials.gov XML. Columns={filename, intervention, url, bioportal term, cuis, tuis}.<br><br><b>Analytical Results:</b>- EC_human_review.csv contains the results of a manual review of random sample eligibility criteria from 400 CT.gov records. Table gives filename, criteria, and whether manual review determined the criteria to contain criteria for "multiple subgroups" of participants.- completeness.xlsx contains counts and percentages of interventional records missing fields required by FDAAA801 and its Final Rule.- industry_completeness.xlsx contains percentages of interventional records missing required fields, broken up by agency class of trial's lead sponsor ("NIH", "US Fed", "Industry", or "Other"), and before and after the effective date of the Final Rule- location_completeness.xlsx contains percentages of interventional records missing required fields, broken up by whether record listed at least one location in the United States and records with only international location (excluding trials with no listed location), and before and after the effective date of the Final Rule<br>