[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582518":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":72,"collaborators":12,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":12,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":12,"maxAge":82,"enrollmentInfo":83,"targetDuration":12,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":12,"overallStatus":55,"whyStopped":12,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Children's Hospital Basel","OTHER",[8,13,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group w\u002F Congenital Hypothyroidism","NO_INTERVENTION","Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment",null,{"label":14,"type":15,"description":11,"interventionNames":16},"OptiThyDose w\u002F Congenital Hypothyroidism","EXPERIMENTAL",[17],"Other: OptiThyDose",{"label":19,"type":10,"description":20,"interventionNames":12},"Control group w\u002F Graves' Disease","Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment",{"label":22,"type":15,"description":20,"interventionNames":23},"OptiThyDose w\u002F Graves' Disease",[17],[25],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"OptiThyDose","OptiThyDose is an iterative mathematical model applied at each patient visit, consisting of three components: (i) a disease-specific pharmacometrics (PMX) model, (ii) an empirical Bayesian estimation (EBE) component, and (iii) an optimal control theory (OCT) component. It calculates the optimal LT4 or CMZ\u002FMMZ dose to maintain Free Thyroxine (FT4) levels within the upper half of the age-specific reference range, integrating past clinical and lab data.\n\nDosing follows international guidelines, with physicians able to consult OptiThyDose for individualized dosing within recommended ranges. At each outpatient visit, the physician can either (A) prescribe a dose within OptiThyDose's suggested range or (B) choose a dose based on personal experience.",[14,22],[30],{"name":31,"affiliation":32,"role":33},"Gabor Szinnai, Prof. MD, PhD","Paediatric Endocrinology, UKBB","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":12,"email":38},"CONTACT","+41 61 704 29 22","Gabor.Szinnai@ukbb.ch",[40,53],{"facility":41,"status":42,"city":43,"state":12,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":12},"Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris","NOT_YET_RECRUITING","Paris","75015","France","FR",{"type":48,"coordinates":49},"Point",[50,51],2.3488,48.85341,{"lat":51,"lon":50},{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB)","RECRUITING","Basel","Canton of Basel-City","4031","Switzerland","CH",{"type":48,"coordinates":62},[63,64],7.57327,47.55839,{"lat":64,"lon":63},[67,68,69],{"name":31,"role":36,"phone":37,"phoneExt":12,"email":38},{"name":31,"role":33,"phone":12,"phoneExt":12,"email":12},{"name":70,"role":71,"phone":12,"phoneExt":12,"email":12},"Marc Pfister, Prof. MD, PhD","SUB_INVESTIGATOR",{"type":73,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100582518","prospective-evaluation-of-optithydose-100582518",false,"NCT06864351","Prospective Evaluation of OptiThyDose","Prospective Evaluation of OptiThyDose, a Mathematical Model for Calculating Appropriate Dose Ranges in Children With Thyroid Diseases","Inclusion Criteria:\n\nCongenital hypothyroidism (CH)\n\n* Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample\n\nGraves' disease (GD)\n\n* Children until 18 years with new diagnosis of GD, recurrence of GD, or insufficiently controlled GD under CMZ\u002FMMZ during follow-up according to:\n\n  * Pathological lab values (suppressed TSH, increased thyroid hormone levels, positive Anti-TSH-receptor antibodies)\n  * Typical clinical picture, if present (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood)\n\nCH and GD\n\n* The study participant must be accessible for scheduled visits, treatment and follow-up.\n* Signed Informed Consent form (ICF) obtained prior to any study related procedure. Written IC for study participation must be signed and dated by the patient and\u002For his\u002Fher legal representative(s) in accordance with national legal requirements\n\nExclusion Criteria:\n\nCH and GD\n\n* Exclusion of newborns from mothers with GD\n* Exclusion of patients in case of a life-threatening event\n\nGD\n\n* Exclusion of children with known other aetiologies of hyperthyroidism than GD without elevated Anti-TSH-receptor antibodies e.g.:\n\n  * known toxic thyroid nodules proven by ultrasound\u002Fscintigraphy\n  * known amiodarone induced hyperthyroidism\n  * known McCune Albright syndrome (based on clinical, laboratory, and genetic diagnosis) associated hyperthyroidism\n  * known genetically proven hyperthyroidism caused by activating mutations of the TSH receptor gene","ALL","18 Years",{"count":84,"type":85},150,"ESTIMATED","INTERVENTIONAL",[88],"NA","The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).",[91,92,93],"Thyroid Diseases","Congenital Hypothyroidism","Graves Disease","2025-09-01",{"date":96,"type":97},"2025-09-03","ACTUAL",{"date":99,"type":97},"2025-08-28",{"date":101,"type":85},"2029-02",{"name":5,"class":6},2]