{"doc_desc":{"title":"Cohorte de patients parkinsoniens avec une maladie de Parkinson idiopathique","idno":"FRESH-PEF60119-fr","producers":[{"name":"Olivier RASCOL","affiliation":"UNIVERSITE DE TOULOUSE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60119-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60119"},{"agency":"FReSH","code":"FRESH-PEF60119"}]},"title":"Cohorte de patients parkinsoniens avec une maladie de Parkinson idiopathique","alternate_title":"COPARK"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Olivier;RASCOL","PILabo":"","affiliationName":"UNIVERSITE DE TOULOUSE","extlink":[{"title":"ORCID","uri":"0000-0002-1410-6397","role":"pi id"},{"title":"IdRef","uri":"084129980","role":"pi id"},{"title":"SIREN","uri":"938271392","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"rascol@cict.fr","isContact":"Oui"}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : COLLABORATION PREVUES AVEC LA COHORTE PAQUID (PR DARTIGUES, BORDEAUX, AQUITAINE) , AVEC LA COHORTE DES MALADES PARKINSONIENS ATTEINTS DE FLUCTUATIONS MOTRICES PITIE-SALPETRIERE (DR JC CORVOL, PARIS)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LN PHARMA","extlink":[{"title":"SIREN","uri":"439632241","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109"},{"title":"SIREN","uri":"263100125"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"LN PHARMA","extlink":[{"title":"SIREN","uri":"439632241"}]},{"name":"ASSOCIATION DE MALADES","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Olivier;RASCOL","email":"rascol@cict.fr","type":"contact","affiliationName":"UNIVERSITE DE TOULOUSE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01ahyrz84","role":"organisation id","title":"ROR"},{"uri":"938271392","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"sympt\u00f4mes parkinsoniens"},{"keyword":"activit\u00e9s"},{"keyword":"vie quotidienne"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"traitements"},{"keyword":"mortalit\u00e9"}],"topics":[{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : L\u2019objectif de ce projet multidisciplinaire (neurologie, pharmacologie, \u00e9pid\u00e9miologie, etc..) est donc de recueillir prospectivement dans une population de malades parkinsoniens ambulatoires identifi\u00e9s au sein de r\u00e9seaux r\u00e9gionaux de neurologues hospitaliers et lib\u00e9raux la survenue et la progression des signes moteurs (tremblement, akin\u00e9sie, rigidit\u00e9, complications motrices, freezing, chutes, dysarthrie,\u2026) et non moteurs (douleur, sympt\u00f4mes anxieux et d\u00e9pressifs, dysautonomie, troubles du sommeil, d\u00e9mence, apathie, fatigue\u2026) de la MP \u00e0 l\u2019aide d\u2019\u00e9chelles valid\u00e9es. Nous recueillerons parall\u00e8lement dans cette population la qualit\u00e9 de vie, la prise en charge (recours aux soins et consommation de m\u00e9dicaments) et la morbi-mortalit\u00e9. Objectif secondaire : Mise en place dans un second temps d\u2019une biobanque s\u2019appuyant sur la caract\u00e9risation ph\u00e9notypique et pharmacologique d\u00e9taill\u00e9e de la population Copark","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine','Occitanie','Hauts-de-France','Pays de la Loire']","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\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Malades parkinsoniens avec une maladie de Parkinson idiopathique (crit\u00e8res UKPDBB) \u00c2g\u00e9s de plus de 18 ans, non institutionnalis\u00e9s, sans syndrome parkinsonien atypique, n\u2019ayant jamais subi d\u2019intervention neurochirurgicale, sans alt\u00e9ration des fonctions cognitives (MMSE inf\u00e9rieur \u00e0 24) , sans pathologie grave mettant en jeu le pronostic vital, ayant sign\u00e9 un consentement \u00e9clair\u00e9.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits de qualit\u00e9 internes 1 A 2 FOIS\/AN Autre(s) proc\u00e9dure(s) qualit\u00e9 : STUDY NURSING ET MONITORING ; PROCEDURES DE FORMATION A LA RECHERCHE ; PROCEDURES BPE APPLIQUEES A CETTE RECHERCHE Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"467"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Condition d&#x27;acc\u00e8s acces aux donnees pour les membres de la recherche et non membres contractualises apres approbation par le comite scientifique de la cohorte et selon les modalites regies par la charte liant les differents partenaires","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"13-08-2014","isContributorPI":"Non","contributorName":"Olivier RASCOL","contributorAffiliation":"UNIVERSITE DE TOULOUSE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28copark+AND+Rascol+O[Author]%29+OR+24839938[uid]"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Industrie","Priv\u00e9 \u00e0 but non lucratif","Industrie"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Autoquestionnaire : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle) avec double saisie Entretiens : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle) avec double saisie Examens cliniques : Etape manuscrite (Saisie manuelle) avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"4 REGIONS FRANCAISES (MIDI-PYRENEES, AQUITAINE, PAYS DE LOIRE, NORD PAS DE CALAIS)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les 18 moisInformations recueillies lors de l'examen clinique : - sur le plan socio-d\u00e9mographique (\u00e2ge, sexe, profession, \u00e2ge \u00e0 l\u2019arr\u00eat des \u00e9tudes, situation d\u2019aide) ;- sur le plan clinique : descriptif de la maladie de Parkinson (date du diagnostic, s\u00e9v\u00e9rit\u00e9 des troubles et prise en charge ;- sur le plan moteur (UPDRS, Hoehn & Yahr, Scwab et England) ;- sur les aspects cognitifs (MMSE, Bref) ;- sur l\u2019apathie (apathy inventory) ;- sur la douleur (Mc Gill et questionnaire \u00e9labor\u00e9 par nos soins) ;- relev\u00e9s des comorbidit\u00e9s, consommation des m\u00e9dicaments et le recours aux soins (acc\u00e8s au syst\u00e8me de sant\u00e9) - \u00e9labor\u00e9 par nos soins ;- relev\u00e9 de la morbi-mortalit\u00e9.","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}