Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT02491567
Eligibility Criteria:
Inclusion Criteria:
For HT:
A positive titers of antithyroid peroxidase (anti-TPO) or antithyroglobulin (anti-Tg) antibodies and at least one of:
* Abnormal thyroid function that requires substitution treatment with L-thyroxine (TSH \> 5 μIU/ml and decreased or normal levels of fT4 or fT3)
* Increased volume of thyroid gland (goiter)
* Morphological changes on ultrasound of the thyroid gland
For GD:
* A positive titers of thyroid stimulating antibodies (anti-TSI) and
* Decreased TSH levels and increased levels of fT4 or fT3
For Controls:
* Otherwise healthy children and adolescents, age- and gender-matched with patients
* Absence of previously known chronic disease of autoimmune aetiology or atopy (including those with a history of chronic treatment with antihistamines, anti-inflammatory, corticosteroids or anti-epileptic drugs)
* Absence of a family history of autoimmune disease in first-degree relatives
Exclusion Criteria:
* Not Caucasian origin or affinity among participants
* Age of diagnosis above 18 years
* Disease duration below 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT02491567
Study Brief:
Protocol Section:
NCT02491567