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Prospective Evaluation of OptiThyDose

RecruitingNAAges any - 18 YearsAllUniversity Children's Hospital Basel
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Congenital hypothyroidism (CH) * Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample Graves' disease (GD) * Children until 18 years with new diagnosis of GD, recurrence of GD, or insufficiently controlled GD under CMZ/MMZ during follow-up according to: * Pathological lab values (suppressed TSH, increased thyroid hormone levels, positive Anti-TSH-receptor antibodies) * Typical clinical picture, if present (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood) CH and GD * The study participant must be accessible for scheduled visits, treatment and follow-up. * 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/or his/her legal representative(s) in accordance with national legal requirements Exclusion Criteria: CH and GD * Exclusion of newborns from mothers with GD * Exclusion of patients in case of a life-threatening event GD * Exclusion of children with known other aetiologies of hyperthyroidism than GD without elevated Anti-TSH-receptor antibodies e.g.: * known toxic thyroid nodules proven by ultrasound/scintigraphy * known amiodarone induced hyperthyroidism * known McCune Albright syndrome (based on clinical, laboratory, and genetic diagnosis) associated hyperthyroidism * known genetically proven hyperthyroidism caused by activating mutations of the TSH receptor gene
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What it tests

  • OptiThyDose
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Where

7 sites
Arabkir Medical Cente & Institute of child and adolescent Health LLC
Yerevan, Armenia
Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris
Paris, France
Paediatric Endocrinology and Diabetology, University Children's Hospital Basel (UKBB)
Basel, Switzerland
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Switzerland
Kinderspital Zentralschweiz (LUKS)
Lucerne, Switzerland
Ostschweizer Kinderspital (OKS)
Sankt Gallen, Switzerland
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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