Wikidata:WikiProject Medicine/Data models/Trials

From Wikidata
Jump to: navigation, search

Home

 

Properties

 

Data models

 

Items and Queries

 

Literature

 


Lists

 


This page is to facilitate the elaboration and curation of a data model for clinical trial (Q30612) in Wikidata.

See also the standard from CDISC https://en.wikipedia.org/wiki/Clinical_Data_Interchange_Standards_Consortium: Clinical Trial Registry XML (CTR-XML) https://www.cdisc.org/standards/foundational/ctr-xml CTR-XML-1-0-Specification.pdf

Background[edit]

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. 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.

Rank Wikidata property 1 2 3 4 5 6 7 8 9
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
Recruitment  ? Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting Recruiting
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
Gender  ? Male Both Both Female Both Male Both Female Both
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
Phases  ? Phase 1
Enrollment  ? 20 2220 200 10000 600 15 120 90 3000
Funded Bys  ? Other Other NIH Other|NIH Other|NIH Other|Industry NIH Industry Other
Study Types  ? Observational Observational Observational Observational Observational Interventional Interventional Observational Observational
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
Acronym  ? null ZIKA-DFA-BB null null Zik01 ZIKSPERM null null CARBO
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

See also[edit]