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:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT01129492
Eligibility Criteria:
Inclusion Criteria:
* Patients previously diagnosed with hypothyroidism induced by chronic autoimmune thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography criteria were applied to diagnose CAT.
* Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or thyroglobulin (TgAb) autoantibodies
* Ultrasonography results consistent with CAT
* Patients undergoing LT4 treatment
* Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4 and thyrotropin (TSH)
Exclusion Criteria:
* Use of immunosuppressants, immunostimulants, or other drugs that could interfere with the production, metabolism and transport of thyroid hormones
* CAT with normal thyroid function
* CAT with subclinical hypothyroidism
* Thyroid nodules
* Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after gestation)
* History of Graves' disease
* Thyrotropin receptor antibody (TRAb) detectable
* Prior treatment with radioiodine
* Tracheal stenosis
* Pregnancy
* History of ionizing irradiation and/or neoplasia in the cervical area
* Previous surgical intervention in the thyroid
* Thyroid hypoplasia
* Ectopic thyroid
* Serious illness (cancer, ischemic coronary artery disease, stroke, kidney or liver failure, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT01129492
Study Brief:
Protocol Section:
NCT01129492