[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584042":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":21,"armGroups":22,"interventions":17,"overallOfficials":17,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":65,"id":71,"slug":17,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":17,"enrollmentInfo":81,"targetDuration":17,"studyType":84,"phases":17,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":48,"whyStopped":17,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"German Federal Institute for Risk Assessment","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Concentration of plant protection substances\u002Fmetabolites in different matrices","The concentrations of the investigated substances\u002Ftheir metabolites will be analysed in urine, patches (to assess dermal exposure of the body), hand wipes (to assess dermal exposure of the hands), filters of an personal air sampler (to assess inhalation exposure), hair samples and gras samples","Operators: during the observed work with PPP and for urine up to 48 hours after; resident: during the observed application and for urine up to 48 hours after; workers: during work in the orchards and for urine up to 48 hours a; control: at one time point",{"measure":14,"description":15,"timeFrame":16},"Effect biomarkers in blood and metabolome in plasma","Defined effect biomarkers in blood as well as the metabolome in plasma will be analysed before and after application of plant protection products to observe possible early physiological changes.\n\nThe following effect biomarkers in the blood will be measured:\n\nc-reactive protein, fasting glucose, HbA1c, cortisol, oxidized LDL, complete blood count, thyrotropin (TSH), free T3 (fT3), free T4 (fT4), gamma GT, GOT (ASAT), GPT (ALAT), bilirubin, cystatin C, urea","enrollment until 7 days after application\u002Fwork in the apple orchards; for people from the control group at one time point",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","Users, residents and workers:\n\npeople from \"Altes Land\", a large apple-growing region in northern Germany\n\nControl: live at least 10 km and max. 150 km away from agricultural apple orchards",[23,26,29,32],{"label":24,"type":17,"description":25,"interventionNames":17},"Operators","People who apply plant protection products to apple crops.",{"label":27,"type":17,"description":28,"interventionNames":17},"Workers","People who do manual work in apple cultivation, like pruning or harvesting.",{"label":30,"type":17,"description":31,"interventionNames":17},"Residents","People whose place of residence is adjacent to the orchard under investigation.",{"label":33,"type":17,"description":34,"interventionNames":17},"Control","People whose place of residence is at least 10 km away from agricultural apple orchards and a maximum of 150 km away from the apple orchard under investigation.",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":17,"email":40},"Prof. Dr. Cornelia Weikert","CONTACT","+49 301841255000","cornelia.weikert@bfr.bund.de",{"name":42,"role":38,"phone":43,"phoneExt":17,"email":44},"Dr. Anna Lechner","+49 301841255015","anna.lechner@bfr.bund.de",[46],{"facility":47,"status":48,"city":49,"state":17,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Federal Institute for Risk Assessment","RECRUITING","Berlin","10589","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],13.41053,52.52437,{"lat":57,"lon":56},[60,61],{"name":37,"role":38,"phone":39,"phoneExt":17,"email":40},{"name":37,"role":62,"phone":17,"phoneExt":17,"email":17},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[66,69],{"name":67,"class":68},"Federal Ministry of Food and Agriculture","UNKNOWN",{"name":70,"class":68},"ESTEBURG Obstbauzentrum Jork Kompetenzzentrum für den norddeutschen Obstbau","100584042",false,"NCT06884189","Application of Plant Protection Products (PPP) in Apple Orchards","Pilot Study on the Exposure of Operators, Residents and Workers to Plant Protection Products Used in Apple Orchards and Possible Health Effects","aPPPle","Inclusion Criteria:\n\n* belonging to one of the defined study groups\n* over 18 years of age at the time of recruitment\n* person can understand the language and content of the study requirements\n* person is capable of consenting to participate in the study and has given written consent to participate in the aPPPle study\n* person has health insurance\n\nExclusion Criteria for residents and control:\n\nperson has direct professional contact with the tested substances acetamiprid, dithianon or dodine",true,"ALL","18 Years",{"count":82,"type":83},16,"ESTIMATED","OBSERVATIONAL","The aim of the aPPPle pilot study is to test feasibility and generate first results in preparation for a main study. The aPPPle study will investigate the exposure of operators, workers and residents to plant protection products (PPP) and potential physiological effects on blood biomarkers. The target plants are apple crops, as application occurs at higher altitudes and therefore higher drift\u002Fexposure is expected compared to ground-level application. The substances to be investigated are acetamiprid (an insecticide) and dithianon and dodine (two fungicides).",[87,88,89,90],"Dermal Exposure","Inhalative Exposure","Metabolites in Urine","Effekt Biomarker in Blood",[92,93,94,95],"exposure study","plant protection products","human biomonitoring","effect biomarker","2025-03-17",{"date":98,"type":99},"2025-03-19","ACTUAL",{"date":101,"type":99},"2025-03-11",{"date":103,"type":83},"2025-12-20",{"name":5,"class":6},1]