{"doc_desc":{"title":"Etude longitudinale sur des enfants atteints d'\u00e9nur\u00e9sie nocturne isol\u00e9e : \u00e9tude sur la s\u00e9curit\u00e9 d'emploi de Minirinmelt en situation r\u00e9elle de prescription","idno":"FRESH-PEF185-fr","producers":[{"name":"Martine MONDIET","affiliation":"FERRING SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF185-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"185"},{"agency":"FReSH","code":"FRESH-PEF185"}]},"title":"Etude longitudinale sur des enfants atteints d'\u00e9nur\u00e9sie nocturne isol\u00e9e : \u00e9tude sur la s\u00e9curit\u00e9 d'emploi de Minirinmelt en situation r\u00e9elle de prescription","alternate_title":"MENUI"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Philippe;NIEZ","firstname":"Philippe","lastname":"NIEZ","type":"investigator","extlink":[{"title":"SIREN","uri":"322624735","role":"organisation id"}],"email":"philippe.niez@ferring.com","affiliationName":"FERRING SAS","PILabo":"Laboratoire FERRING S.A.S","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"Philippe;NIEZ","lastname":"NIEZ","firstname":"Philippe","type":"contact","email":"philippe.niez@ferring.com","affiliationName":"FERRING SAS","contactPointLabo":"","extlink":[{"uri":"322624735","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"desmopressine"},{"keyword":"Minirin\u00ae comprim\u00e9"},{"keyword":"Minirinmelt\u00ae"}],"topics":[{"topic":"Endocrinologie","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":"P\u00e9diatrie","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":"Andrologie et urologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7341b8bd-fcb0-44c1-9ca9-8752b542ed59"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d90d8dbf-c4b3-46c0-bf2c-55a4a3d9ba8b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D033441"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D014572"}]},{"topic":"\u00c9nur\u00e9sie nocturne","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1048673005","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"D\u00e9montrer que les deux formes orales (comprim\u00e9 et lyophilisat ) de desmopressine ont un profil de s\u00e9curit\u00e9 d\u2019emploi similaire et notamment en termes de fr\u00e9quence des sympt\u00f4mes d\u2019alarmes d\u2019une intoxication par l\u2019eau, en situation r\u00e9elle de prescription, c\u2019est \u00e0 dire en pratique de ville.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d\u2019inclusion :             -patient pr\u00e9sentant une \u00e9nur\u00e9sie nocturne isol\u00e9e, d\u00e9finie par le nombre de nuits mouill\u00e9es par semaine,             -patient \u00e2g\u00e9 de 6 \u00e0 18 ans,             -patient chez lequel le m\u00e9decin traitant a d\u00e9cid\u00e9 de prescrire un traitement par desmopressine, soit      Minirin\u00ae comprim\u00e9 soit Minirinmelt\u00ae lyophilisat. \",\n    \"clusion_E\": \"patient ayant d\u00e9j\u00e0 re\u00e7u un traitement ant\u00e9rieur par la desmopressine quelle que soit sa forme,            -patient ayant un traitement en cours par la desmopressine,            -patient participant \u00e0 un essai th\u00e9rapeutique\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\u00e9 de vie\/sant\u00e9 per\u00e7ue\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"750"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":false,"contributorName":"Philippe NIEZ","contributorAffiliation":"ASTRAZENECA (FRANCE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"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":"Donn\u00e9es recueillies dans un cahier d'observation papier par le m\u00e9decin \u00e0 partir des donn\u00e9es du dossier m\u00e9dical du patient et suite aux informations recuillies lors des consultations de l'enfant avec ses parents ou son tuteur l\u00e9gal. La satisfaction des parents et des enfants ainsi que les informations relatives \u00e0 la qualit\u00e9 de vie des patients(compl\u00e9t\u00e9es par les enfants et par les parents) ont \u00e9t\u00e9 recueillies lors des consultations par le remplissage d'auto-questionnaires \u00e0 l'inclusion et lors de l'arr\u00eat du traitement \u00e0 l'\u00e9tude .","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Natr\u00e9mie recueillie en cas d'\u00e9v\u00e8nement ind\u00e9sirable si elle a \u00e9t\u00e9 demand\u00e9e par le m\u00e9decin","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}