{
"info": {
"nct_id": "NCT04916262",
"official_title": "Correlation Between TCM Syndrome Factors and TSH Changes of Thyroid Hormone Withdrawal Before Iodine Therapy in Postoperative Patients With Thyroid Cancer",
"inclusion_criteria": "1. Study time: June 1, 2021, to January 1, 2022;\n2. Study site: The First Affiliated Hospital of Shandong First Medical University;\n3. 18-75 years old (including upper and lower limits), male or female;\n4. Patients with differentiated thyroid carcinoma diagnosed pathologically after total thyroidectomy\n5. Patients with oral levothyroxine tablets ≥ 4 weeks after operation\n6. Patients who have stopped taking levothyroxine tablets and whose TSH < 4.2uIU/ml at the time of withdrawal\n7. Patients who meet the 131I treatment criteria\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "1. Pregnant or lactating women\n2. Patients with various mental disorders, unconscious, etc.\n3. Cases with inaccurate information collection",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Study time: June 1, 2021, to January 1, 2022;",
"criterions": [
{
"exact_snippets": "Study time: June 1, 2021, to January 1, 2022",
"criterion": "study time",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1622505600,
"unit": "timestamp"
},
{
"operator": "<=",
"value": 1640995200,
"unit": "timestamp"
}
]
}
}
]
}
]
},
{
"line": "2. Study site: The First Affiliated Hospital of Shandong First Medical University;",
"criterions": [
{
"exact_snippets": "Study site: The First Affiliated Hospital of Shandong First Medical University",
"criterion": "study site",
"requirements": [
{
"requirement_type": "location",
"expected_value": "The First Affiliated Hospital of Shandong First Medical University"
}
]
}
]
},
{
"line": "3. 18-75 years old (including upper and lower limits), male or female;",
"criterions": [
{
"exact_snippets": "18-75 years old (including upper and lower limits)",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "male or female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "inclusion",
"expected_value": [
"male",
"female"
]
}
]
}
]
},
{
"line": "4. Patients with differentiated thyroid carcinoma diagnosed pathologically after total thyroidectomy",
"criterions": [
{
"exact_snippets": "differentiated thyroid carcinoma",
"criterion": "differentiated thyroid carcinoma",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "diagnosed pathologically",
"criterion": "pathological diagnosis",
"requirements": [
{
"requirement_type": "method",
"expected_value": "pathological"
}
]
},
{
"exact_snippets": "after total thyroidectomy",
"criterion": "total thyroidectomy",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": "completed"
}
]
}
]
},
{
"line": "5. Patients with oral levothyroxine tablets ≥ 4 weeks after operation",
"criterions": [
{
"exact_snippets": "Patients with oral levothyroxine tablets ≥ 4 weeks after operation",
"criterion": "oral levothyroxine tablets",
"requirements": [
{
"requirement_type": "duration since operation",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "6. Patients who have stopped taking levothyroxine tablets and whose TSH < 4.2uIU/ml at the time of withdrawal",
"criterions": [
{
"exact_snippets": "Patients who have stopped taking levothyroxine tablets",
"criterion": "levothyroxine tablets",
"requirements": [
{
"requirement_type": "status",
"expected_value": "stopped"
}
]
},
{
"exact_snippets": "TSH < 4.2uIU/ml at the time of withdrawal",
"criterion": "TSH",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 4.2,
"unit": "uIU/ml"
}
}
]
}
]
},
{
"line": "7. Patients who meet the 131I treatment criteria",
"criterions": [
{
"exact_snippets": "131I treatment criteria",
"criterion": "131I treatment criteria",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "met"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Pregnant or lactating women",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating women",
"criterion": "lactation status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "2. Patients with various mental disorders, unconscious, etc.",
"criterions": [
{
"exact_snippets": "Patients with various mental disorders",
"criterion": "mental disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "unconscious",
"criterion": "consciousness",
"requirements": [
{
"requirement_type": "state",
"expected_value": "unconscious"
}
]
}
]
},
{
"line": "3. Cases with inaccurate information collection",
"criterions": [
{
"exact_snippets": "inaccurate information collection",
"criterion": "information collection",
"requirements": [
{
"requirement_type": "accuracy",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}