{"doc_desc":{"title":"Cohort of children with isolated nocturnal enuresis : a study of the safety of Minirinmelt in actual prescription","idno":"FRESH-PEF185-en","producers":[{"name":"Martine MONDIET","affiliation":"FERRING SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF185-en","IDno":{"metadata_no":[{"agency":"PEF","code":"185"},{"agency":"FReSH","code":"FRESH-PEF185"}]},"title":"Cohort of children with isolated nocturnal enuresis : a study of the safety of Minirinmelt in actual prescription","alternate_title":"MENUI"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Philippe;NIEZ","PILabo":"Laboratoire FERRING S.A.S","affiliationName":"FERRING SAS","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"322624735","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.niez@ferring.com","isContact":"Yes"}],"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":"Philippe;NIEZ","email":"philippe.niez@ferring.com","type":"contact","affiliationName":"FERRING SAS","contactPointLabo":"","extlink":[{"uri":"322624735","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"desmopressin"},{"keyword":"Minirin\u00ae tablet"},{"keyword":"Minirinmelt\u00ae"}],"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":"Andrology and urology","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":"Nocturnal enuresis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1048673005","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Show that the two oral forms (tablet and lyophilisate) of desmopressin have a similar safety profile and in particular in terms of frequency of the symptoms of alarms of an intoxication via water, in actual prescription situations, i.e. at general practitioners.","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":"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 (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\": \"Criteria for inclusion:             -patient having an isolated nocturnal enuresis, defined by the number of wet nights per week,             -patient aged 6 to 18 years,             -patient in which the family doctor has decided to prescribe a treatment via desmopressin, or      Minirin\u00ae tablets or Minirinmelt\u00ae lyophilisate. \",\n    \"clusion_E\": \"patient who has already received prior treatment via desmopressin regardless of its form,-patient who has a treatment in progress via desmopressin,-patient participating in a therapeutic study.\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Quality of life\/health perception\r\nOthers"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"750"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","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":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"No","contributorName":"Philippe NIEZ","contributorAffiliation":"ASTRAZENECA (FRANCE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Data collected in a paper observation notebook by the doctor using the data from the patient's medical dossier and following the information collected during consultations of the child with his or her parents or legal guardian. Satisfaction of the parents and of the children as well as the information pertaining to the quality of life of the patients (supplemented by the children and by the parents) were collected during the consultations via the filling out of the self-questionnaires at inclusions and when the treatment was stopped for the study.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Natremia collected in the case of an undesirable event if this was requested by the doctor","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}