{"doc_desc":{"title":"Evaluation of Overall Compliance and Duration of Zomacton\u00ae Treatment With the Zomajet\u00ae Needle-free Device (ZOMAJET)","idno":"FRESH-PEF2526-en","producers":[{"name":"Farah BAHBAH","affiliation":"FERRING SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2526-en","IDno":{"metadata_no":[{"agency":"PEF","code":"2526"},{"agency":"FReSH","code":"FRESH-PEF2526"}]},"title":"Evaluation of Overall Compliance and Duration of Zomacton\u00ae Treatment With the Zomajet\u00ae Needle-free Device (ZOMAJET)","alternate_title":"ZOMAJET"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Farah;BAHBAH","firstname":"Farah","lastname":"BAHBAH","type":"investigator","extlink":[{"title":"SIREN","uri":"322624735","role":"organisation id"}],"email":"Farah.Bahbah@ferring.com","affiliationName":"FERRING SAS","PILabo":"FERRING","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"FERRING SAS","extlink":[{"title":"SIREN","uri":"322624735","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FERRING SAS","extlink":[{"title":"SIREN","uri":"322624735"}]}]},"distribution_statement":{"contact":[{"name":"Farah;BAHBAH","lastname":"BAHBAH","firstname":"Farah","type":"contact","email":"Farah.Bahbah@ferring.com","affiliationName":"FERRING SAS","contactPointLabo":"","extlink":[{"uri":"322624735","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Somatropin"},{"keyword":"zomacton"},{"keyword":"zomajet vision X"},{"keyword":"Zomajet 2 vision"}],"topics":[{"topic":"Endocrinology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Paediatrics","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Evaluate with sufficient precision the overall observance rate for the treatment over a maximum period of three years. The study is carried out at the request of the authorities.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\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\": \"All patients, meeting the criteria of the Therapeutic Information Sheet (growth hormone deficiency or Turner's syndrome), for whom is initiated a treatment with Zomacton\u00ae 4 mg with the Zomajet\u00ae 2 Vision transjector or with Zomacton\u00ae 10 mg with the Zomajet\u00ae Vision X transjector when the latter has received its marketing authorization.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Anthropometry']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services"}]},"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 individuals","response_rate":"90"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational 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":"For further information on the ZOMAJET study, please contact: Dr Philippe NIEZ","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":"29-03-2011","lastUpdatedAuto":null,"lastUpdatedManual":"27-03-2012","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Questionnaire at the initiation of the treatment (initiation visit): Identification of the questionnaire; visit date; inclusion criterion (Initial Therapeutic Information Sheet); patient data: sex, date of birth, height, weight, bone age (according to the Greulich-Pyle atlas), gain in size before treatment, pubertal stage (according to Tanner), antecedents; indication (deficit in GH or Turner's syndrome with karyotope), cause of the deficit in GH, exploration of the deficit in GH (IGF-1 if available, stimulation tests and results, associated hormonal or endocrine disruptions); Prescribed treatment; Dosage and methods of administration.Follow-up questionnaires (1 follow-up visit about every 3 to 6 months): Identification of the questionnaire; date of visit; height, weight, bone age, pubertal stage, fasting glucose and IGF-1 (if available); Treatment administered as prescribed (yes\/no) - if not, treatment administered by intermittence, stopping of the treatment and reason(s) for noncompliance; Treatment stopped by the physician (yes\/no) - if yes, date and reason(s) - if not, technical difficulties in using the pen (yes\/no); modification in the methods of administration (yes\/no): new dosage and\/or new posology and\/or new head for the transjector pen and reason(s). Local and general tolerance.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"National"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"IGF-1 if available","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}