{"study_desc":{"title_statement":{"idno":"FRESH-PEF78-en","IDno":{"metadata_no":[{"agency":"PEF","code":"78"},{"agency":"FReSH","code":"FRESH-PEF78"}]},"title":"The Global Hypopituitary Control and Complications Study (HypoCCS)-A Global Observational Research Program","alternate_title":"HypoCCS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"SIREN","uri":"180089385"},{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"Somatotrope deficiency"},{"keyword":"adult"},{"keyword":"treatments"},{"keyword":"tolerance"},{"keyword":"quality of life"}],"topics":[{"topic":"Endocrinology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"D004704"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Primary objective: long-term follow-up of the clinical change and of the tolerance in patients with a somatotrope deficiency whether or not treated with somatropin (Umatrope\u00ae)","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Madagascar","abbreviation":"mg","extLink":{"vocab":"ISO","vocabURI":"mg"}},{"name":"C\u00f4te d'ivoire","abbreviation":"ci","extLink":{"vocab":"ISO","vocabURI":"ci"}},{"name":"Mali","abbreviation":"ml","extLink":{"vocab":"ISO","vocabURI":"ml"}},{"name":"Guinea","abbreviation":"gn","extLink":{"vocab":"ISO","vocabURI":"gn"}},{"name":"Bangladesh","abbreviation":"bd","extLink":{"vocab":"ISO","vocabURI":"bd"}},{"name":"Lebanon","abbreviation":"lb","extLink":{"vocab":"ISO","vocabURI":"lb"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Adult patients suffering from growth hormone deficiency secondary to a hypothalamic  or pituitary disease appearing in adulthood or suffering from a growth hormone deficiency since childhood, - having terminated their growth (epiphyseal closure), - having no contraindications to the treatment such as are specified in the summary of product characteristics.\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Function testing','Biological data','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\r\nQuality of life\/health perception"}]},"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":"[1000-10000[ individuals","response_rate":"recruitment closed"},"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\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"14-12-2010","lastUpdatedManual":"09-01-2013","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/Pubmed-HYPOCCS"}],"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":"Data collection notebook and questionnaire","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"international"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"IGF-I, lipidic and glycemic profile, hormone assays (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"}