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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 May 2024 |
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Main ID: |
NCT06391515 |
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Date of registration:
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29/04/2024 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Subacute Thyroiditis in the SARS-CoV-2 Era
SAT-COVID-19 |
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Scientific title:
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Subacute Thyroiditis in the SARS-CoV-2 Era: a Multicentre Prospective Study |
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Date of first enrolment:
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November 23, 2020 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06391515 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- clinical diagnosis of subacute thyroiditis
- age = 18 years
- willingness to sign an informed consent
Exclusion Criteria:
- ongoing pregnancy
- alcohol abuse.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thyrotoxicosis
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Subacute Thyroiditis
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SARS CoV 2 Infection
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Intervention(s)
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Diagnostic Test: Blood sample, CRF, thyroid ultrasound
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Primary Outcome(s)
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description of neck pain at diagnosis
[Time Frame: at diagnosis]
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quantification of neck pain at diagnosis
[Time Frame: at diagnosis]
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duration of neck pain at diagnosis
[Time Frame: at diagnosis]
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Secondary Outcome(s)
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anti-thyroid peroxidase antibodies (TPOAb) at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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quantification of neck pain at follow-up
[Time Frame: 1, 3, 6 and 12 months after diagnosis]
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thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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description of neck pain at follow-up
[Time Frame: 1, 3, 6 and 12 months after diagnosis]
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thyroglobulin (Tg) at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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thyroid inhomogeneity at ultrasound
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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free thyroxine (fT4) at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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thyroid stimulating hormone (TSH) serum levels at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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thyroglobulin antibodies (TgAb) at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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duration of neck pain at follow-up
[Time Frame: 1, 3, 6 and 12 months after diagnosis]
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thyroid function at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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free triiodothyronine (fT3) at diagnosis and follow-up
[Time Frame: at diagnosis and after1, 3, 6 and 12 months]
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Secondary ID(s)
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1104/2020
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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