[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555454":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":27,"locations":36,"responsibleParty":59,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":87,"overallStatus":97,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,12,15,18,21,24],{"label":9,"type":10,"description":11,"interventionNames":10},"Transfusion-dependent thalassemia major (TDTM)",null,"Patients suffering from homozygous transfusion-dependent Thalassemia Major.",{"label":13,"type":10,"description":14,"interventionNames":10},"Thalassemia Minor","Patients suffering from heterozygous transfusion-independent Thalassemia Minor.",{"label":16,"type":10,"description":17,"interventionNames":10},"Healthy controls","Healthy adult controls without any prevalent substance use (nicotine, alcohol etc.).",{"label":19,"type":10,"description":20,"interventionNames":10},"Glioma patients","Adults with high\u002Flow-grade glioma, a tumor size \\> 3cm that require resection with access to the ventricular system without ventricular hemorrhage.",{"label":22,"type":10,"description":23,"interventionNames":10},"ICU patients","Adults with brain hemorrhage (intracranial, subdural, subarachnoidal), treated with a ventricular shunt.",{"label":25,"type":10,"description":26,"interventionNames":10},"Patients undergoing diagnostic lumbar-puncture (plastic-naive)","Adults that receive a diagnostic lumbar puncture in an outpatient setting.",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Lukas Wisgrill, MD, PhD","CONTACT","800-123-4567","lukas.wisgrill@meduniwien.ac.at",{"name":34,"role":30,"phone":31,"phoneExt":10,"email":35},"Harald Sitte, MD, PhD","harald.sitte@meduniwien.ac.at",[37],{"facility":5,"status":10,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Vienna","1090","Austria","AT",{"type":43,"coordinates":44},"Point",[45,46],16.37208,48.20849,{"lat":46,"lon":45},[49,50,54,56],{"name":29,"role":30,"phone":10,"phoneExt":10,"email":32},{"name":51,"role":30,"phone":52,"phoneExt":10,"email":53},"Michael Eigenschink, MD","0043-1-40400-38485","michael.eigenschink@meduniwien.ac.at",{"name":29,"role":55,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":57,"role":58,"phone":10,"phoneExt":10,"email":10},"Harald Sitte, Prof.","SUB_INVESTIGATOR",{"type":55,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Lukas Wisgrill","Principal Investigator, MD",[63],{"name":64,"class":6},"University of Vienna","100555454","plasticizer-exposure-and-its-consequences-on-health-100555454",false,"NCT06512298","Plasticizer Exposure and Its Consequences on Health","PEACH","TDTM:\n\n* Inclusion: Adult, homozygous ß-Thalassemia Major, transfusion dependency.\n* Exclusion: Plastic implants, chronic infectious disease, pregnancy.\n\nThalassemia Intermedia\u002FMinor:\n\n* Inclusion: Adult, homozygous\u002Fheterozygous ß-Thalassemia Intermedia\u002FMinor\n* Exclusion: Plastic implants, chronic infectious disease, pregnancy, transfusion dependency\n\nHealthy adults:\n\n* Inclusion: Adult\n* Exclusion: Chronic disease, plastic implants, infectious disease, pregnancy, anemia, medication-, drug-, or alcohol-abuse\n\nGlioma patients:\n\n* Inclusion: Adult, high\u002Flow-grade glioma, tumor larger then 3cm, resection with access to the ventricular system\n* Exclusion: Large intraventricular hemorrhage, plastic implants, infectious disease\n\nICU patients:\n\n* Inclusion: Adult, brain hemorrhage, external CSF drain from ventricle\n* Exclusion: intraventricular hemorrhage, plastic implants, ECMO, hemodialysis, infectious disease\n\nPatients undergoing diagnostic lumbar-puncture:\n\n* Inclusion: Adult, diagnostic CSF sampling, outpatient setting\n* Exclusion: Ventricular hemorrhage, plastic implants, infectious disease",true,"ALL","18 Years",{"count":76,"type":77},120,"ESTIMATED","OBSERVATIONAL","Plasticizers are chemicals commonly found in many everyday items, from food packaging to medical equipment. Although they are pervasive in our daily lives, researchers still don't have a clear picture of their long-term effects on human health. Evidence suggests that these substances might disrupt various biological functions such as the immune system, the balance of gut bacteria, hormone regulation, and brain processes. While some studies have linked plasticizer exposure to health issues, definitive data from human studies are still lacking.\n\nThe PEACH study aims to bridge these knowledge gaps by investigating how plasticizers affect human health. The study focuses on understanding how these chemicals are absorbed, distributed, and accumulated in the body across different groups of patients. The investigators are particularly interested in how plasticizers influence gut microbiota and the functionality of immune cells, as well as their effects on neurotransmitters involved in brain function.\n\nA combination of patient data, systems biology, and laboratory models will be used to thoroughly assess the biological impacts of plasticizers. Advanced techniques such as mass spectrometry will aid in studying toxicokinetic properties, sequencing technologies will be used to examine immune effects, and radiouptake assays will be employed to explore interactions with neurotransmitter transport. This comprehensive methodology will provide new insights into the effects of both short-term and long-term exposure to plasticizers.\n\nThe PEACH study introduces innovative methods to the field, aiming to create a robust model for understanding how plasticizer compounds behave in the human body. It employs state-of-the-art techniques to assess the dynamics of these chemicals, marking a significant advancement in environmental health research.",[81,82,83,84,85,86],"Beta-thalassemia","Glioma","Healthy Controls","Transfusion-dependent Beta-Thalassemia","Intracranial Hemorrhages","Toxicity",[88,89,90,91,92,93,94,95,96],"Plasticizer","Transfusion","Systems Biology","Immunology","Microbiome","Neuropharmacology","Pharmacokinetics","Pharmacodynamics","Exposomics","NOT_YET_RECRUITING","2024-07-22",{"date":100,"type":101},"2024-07-24","ACTUAL",{"date":103,"type":77},"2024-10-01",{"date":105,"type":77},"2027-09-30",{"name":5,"class":6},1]