Wikidata:WikiProject Medicine/Data models/Trials
This page is to facilitate the elaboration and curation of a data model for clinical trial (Q30612) in Wikidata.
Clinical Data Interchange Standards Consortium (Q571067) have created a CTR-XML-1-0-Specification.pdf Clinical Trial Registry XML (CTR-XML) based on their CDISC Operational Data Model (ODM), itself based on the 20 items in the Trial Registration Data Set (TRDS) compiled by the World Health Organization (Q7817).
The purpose of CTR-XML is to 'support a "write once, use many times" solution', i.e. collecting information on clinical trials in one place in a way that it can be used in multiple places. While the clinical trial registries International Clinical Trials Registry Platform (Q29867940), EudraCT (Q1279829) and ClinicalTrials.gov (Q5133746) are what they had primarily in mind, the approach also provides a good basis for modeling clinical trials on Wikidata.
Clinical trials on Wikidata
To get things started, below is a set of metadata about clinical trials. It was obtained in CSV format from ClinicalTrials.gov on September 4, 2016, with little awareness of the above background information. The CSV was then transposed and converted to Mediawiki table format. The first column represents the fields available at ClinicalTrials.gov, and the respective headers are linked to a corresponding section on the talk page where this field can be discussed. The second column was added to allow for a quick overview of relevant Wikidata properties for which a direct mapping to the ClinicalTrials.gov fields has been established. The first row is a remnant of the search result sorting on the ClinicalTrials.gov site, but kept here to allow to link to the corresponding Wikidata items.
|NCT Number||ClinicalTrials.gov Identifier (P3098)||NCT02733796||NCT02810210||NCT02794181||NCT02856984||NCT02831699||NCT02874456||NCT02840487||NCT02741882||NCT01099852|
|Title||title (P1476)?||Persistence of Zika Virus in Semen After Acute Infection||Zika Virus Infection's Neonatal and Pediatric Consequences in French Department of America||Zika Virus and Related Arbovirus Infections in Deferred Blood Donors (ZVADD)||Zika in Infants and Pregnancy (ZIP)||The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico||Pilot Study to Detect Zika Virus in Sperm||Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults||Zika and Microcephaly: Case-control Study||Cohort of Patients Infected by an Arbovirus|
|Study Results||?||No Results Available||No Results Available||No Results Available||No Results Available||No Results Available||No Results Available||No Results Available||No Results Available||No Results Available|
|Conditions||?||Zika Virus|Zika Virus Disease|Virus Shedding|Transmission||Zika Virus Infection on Fetus and Child During the Pregnancy||Zika Virus|Dengue Virus|Chikungunya Virus Infections||Zika Virus Disease (Disorder)||Zika Virus Disease (Disorder)|Dengue|Chikungunya||Viruses||Prevention of Zika Infection|Zika-Specific Immune Response||Microcephaly||Fever|Dengue|Chikungunya|Zika|
|Interventions||?||Other: fundus examination|Other: Head ultrasound||Other: virus detection||Biological: VRC-ZKADNA085-00-VP||Other: Questionary||Other: biological sample collection|Other: quality of life questionnaire EuroQol®|Other: Health Assessment Questionnaire - MDHAQ and RAPID3|
|Sponsor/Collaborators||sponsor (P859)||Institute of Tropical Medicine, Belgium||Institut National de la Santé Et de la Recherche Médicale, France||National Institutes of Health Clinical Center (CC)||RTI International|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|National Institute of Allergy and Infectious Diseases (NIAID)|National Institute of Environmental Health Sciences (NIEHS)|Fundacao Oswaldo Cruz Foundation (FIOCRUZ)||Mexican Emerging Infectious Diseases Clinical Research Network|Secretaria de Salud, Mexico|National Institute of Allergy and Infectious Diseases (NIAID)||University Hospital, Toulouse|Centre Hospitalier Universitaire de Pointe-a-Pitre|Institut Pasteur||National Institute of Allergy and Infectious Diseases (NIAID)|National Institutes of Health Clinical Center (CC)||Laboratório Sabin||University Hospital Center of Martinique|Institut National de la Santé Et de la Recherche Médicale, France|Clinique Antilles-Guyane|
|Age||?||18 Years to 80 Years (Adult, Senior)||up to 2 Years (Child)||18 Years and older (Adult, Senior)||15 Years and older (Child, Adult, Senior)||Child, Adult, Senior||18 Years to 45 Years (Adult)||18 Years to 35 Years (Adult)||16 Years and older (Child, Adult, Senior)||Child, Adult, Senior|
|Study Designs||?||Observational Model: Case-Only|Time Perspective: Prospective||Observational Model: Cohort|Time Perspective: Prospective||Time Perspective: Prospective||Observational Model: Cohort|Time Perspective: Prospective||Observational Model: Cohort|Time Perspective: Prospective||Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Basic Science||Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Prevention||Observational Model: Case Control|Time Perspective: Retrospective||Observational Model: Cohort|Time Perspective: Prospective|
|Other IDs||?||B300201628191||C16-19||160124|16-CC-0124||GN ZIKA||Zik01||16 7941 03||160148|16-I-0148||Zika and microcephaly||09/B/08|
|First Received||?||March 30, 2016||June 20, 2016||June 8, 2016||July 20, 2016||July 11, 2016||May 6, 2016||July 19, 2016||April 13, 2016||February 23, 2010|
|Start Date||start time (P580)?||March 2016||June 2016||May 2016||June 2016||June 2016||May 2016||July 2016||February 2016||June 2010|
|Completion Date||end time (P582)?||January 2017||September 2018||March 2018||June 2018||June 2018||April 2017||December 2018||August 2016||July 2021|
|Last Updated||?||April 5, 2016||August 29, 2016||August 31, 2016||August 15, 2016||August 8, 2016||August 16, 2016||August 31, 2016||June 16, 2016||February 29, 2016|
|Last Verified||?||April 2016||August 2016||August 2016||August 2016||August 2016||August 2016||August 2016||June 2016||February 2016|
|Results First Received||?||No Study Results Posted||No Study Results Posted||No Study Results Posted||No Study Results Posted||No Study Results Posted||No Study Results Posted||No Study Results Posted||No Study Results Posted||No Study Results Posted|
|Primary Completion Date||?||January 2017||September 2017||December 2017||June 2018||June 2018||December 2016||December 2017||June 2016||July 2018|
|Outcome Measures||?||Incidence rate of ZIKV persistence in semen|kinetics of ZIKV persistence in semen|replication fitness of ZIKV in semen|comparison of ZIKV sequences from semen vs. non-semen samples||Embryofoetopathy incidence within cohort 1 and 3|Comparison of congenital abnormality incidence rates between cohorts 1 and 3||Prevalence of ZIKV, DENV and CHIKV infection (RNA-positives) among travel-deferred adult blood donors in the study population.|Prevalence of ZIKV infection (RNApositives) among adult blood donors with a history of potential sexual exposure to ZIKV infection, in the study population.|24-week Natural History of ZIKV, DENV and CHIKV (RNA-positives).||Incidence of congenital malformations for ZIKV infected participants|Incidence of adverse fetal outcomes for ZIKV infected participants|Incidence of congenital malformations for ZIKV symptomatic participants|Incidence of adverse fetal outcomes for ZIKV symptomatic participants||The proportion of subjects that have confirmed Zika, Chikungunya, or Dengue (including co-infections) from the subjects presenting with fever and/or rash in southeastern Mexico.||presence of Zika virus on RNA by polymerase chain reaction||To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg.|To evaluate the magnitude and frequency of ZIKV-specific antibodyresponse as measured by neutralization assay.||Zika virus infection clinical outcomes during pregnancy|zika virus serology|Chikungunya virus serology|Dengue virus serology||Occurrence, during follow-up (for 12 weeks following symptom onset), of shock, internal bleeding, failure of one or several organs or systems (brain, heart, lung, liver, kidney, clotting system), or death.|Onset of dengue hemorrhagic fever (WHO criteria). Changes in quality of life, measured with the EuroQol® questionnaire 3 and 12 weeks after the onset of dengue fever symptoms.|
|URL||reference URL (P854)?||https://ClinicalTrials.gov/show/NCT02733796||https://ClinicalTrials.gov/show/NCT02810210||https://ClinicalTrials.gov/show/NCT02794181||https://ClinicalTrials.gov/show/NCT02856984||https://ClinicalTrials.gov/show/NCT02831699||https://ClinicalTrials.gov/show/NCT02874456||https://ClinicalTrials.gov/show/NCT02840487||https://ClinicalTrials.gov/show/NCT02741882||https://ClinicalTrials.gov/show/NCT01099852|