{"doc_desc":{"title":"Case-Control Study of Children with Hypospadias","idno":"FRESH-PEF73141-en","producers":[{"name":"Nicolas KALFA","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73141-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73141"},{"agency":"FReSH","code":"FRESH-PEF73141"}]},"title":"Case-Control Study of Children with Hypospadias","alternate_title":""},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Nicolas;KALFA","PILabo":"Montpellier University Hospital","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"075645114","role":"pi id"},{"title":"SIREN","uri":"263400160","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"nicolaskalfa@gmail.com","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00mthsf17","role":"sponsor id"},{"title":"SIREN","uri":"263400160","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00mthsf17"},{"title":"SIREN","uri":"263400160"}]}]},"distribution_statement":{"contact":[{"name":"Nicolas;KALFA","email":"nicolaskalfa@gmail.com","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00mthsf17","role":"organisation id","title":"ROR"},{"uri":"263400160","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"sexual determination disorder"},{"keyword":"endocrine disrupting chemicals"},{"keyword":"birth defect"},{"keyword":"environment"},{"keyword":"profession"},{"keyword":"pesticides"},{"keyword":"hypospadias"}],"topics":[{"topic":"Glaucoma","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/499924848","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"The objective of the study is to identify the impact of occupational and environmental exposure to endocrine-disrupting chemicals on non-genetic, isolated hypospadias.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Occitanie']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Children with hypospadias (from birth to 12 years old);  Controls: Normal children (no congenital, urological, genital or renal malformation; no inguinal hernia or endocrine diseases). Reasons for hospital admission were mainly acute appendicitis, idiopathic intestinal invagination, minor abdominal trauma and pyloric stenosis.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"710"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Case-control study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-07-2015","lastUpdatedAuto":null,"lastUpdatedManual":"03-07-2016","isContributorPI":"No","contributorName":"Nicolas KALFA","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.sciencedirect.com.gate2.inist.fr\/science\/article\/pii\/S0302283815004091"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":"Yes"},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Questionnaire issued by the surgeon or endocrinologist.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Montpellier"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"No","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}