{
"info": {
"nct_id": "NCT02946918",
"official_title": "Levothyroxine Replacement With Liquid Gel Capsules or Tablets in Post-thyroidectomy Stage in Low Risk Differentiated Thyroid Cancer Patients",
"inclusion_criteria": "* Age > 18 years\n* Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II\n* Planned total or near-total thyroidectomy\n* Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively\n* Normal serum TSH within 12 months preceding surgery\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* AJCC Stage III or greater\n* Undifferentiated, Anaplastic or Medullary Thyroid Cancer\n* Planned postoperative TSH goal other than 0.1-0.5 mU/L\n* History of gastrointestinal malabsorption or gastric bypass surgery\n* Pregnancy\n* Use of medications that alter the absorption or metabolism of levothyroxine\n* Prior use of levothyroxine",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age > 18 years",
"criterions": [
{
"exact_snippets": [
"Age > 18 years"
],
"criterion": "age",
"requirement_type": "N/A",
"expected_value": {
"operator": ">",
"value": 18
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Age > 18 years"
],
"criterion": "age",
"requirement_type": "N/A",
"expected_value": {
"operator": ">",
"value": 18
}
}
]
}
},
{
"identified_line": {
"line": "* Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II",
"criterions": [
{
"exact_snippets": [
"AJCC (American Joint Committee on Cancer) tumor Stage I or II"
],
"criterion": "AJCC tumor stage",
"requirement_type": "stage",
"expected_value": [
"I",
"II"
]
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"AJCC (American Joint Committee on Cancer) tumor Stage I or II"
],
"criterion": "AJCC tumor stage",
"requirement_type": "stage",
"expected_value": [
"I",
"II"
]
}
]
}
},
{
"identified_line": {
"line": "* Planned total or near-total thyroidectomy",
"criterions": [
{
"exact_snippets": [
"Planned total or near-total thyroidectomy"
],
"criterion": "thyroidectomy",
"requirement_type": "type",
"expected_value": [
"total",
"near-total"
]
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Planned total or near-total thyroidectomy"
],
"criterion": "thyroidectomy",
"requirement_type": "type",
"expected_value": [
"total",
"near-total"
]
}
]
}
},
{
"identified_line": {
"line": "* Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively",
"criterions": [
{
"exact_snippets": [
"Planned goal TSH suppression"
],
"criterion": "TSH suppression",
"requirement_type": "planned goal",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0.1
},
{
"operator": "<=",
"value": 0.5
}
]
}
},
{
"exact_snippets": [
"for at least 18 weeks postoperatively"
],
"criterion": "duration of TSH suppression",
"requirement_type": "minimum duration",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Planned goal TSH suppression"
],
"criterion": "TSH suppression",
"requirement_type": "planned goal",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0.1
},
{
"operator": "<=",
"value": 0.5
}
]
}
},
{
"exact_snippets": [
"for at least 18 weeks postoperatively"
],
"criterion": "duration of TSH suppression",
"requirement_type": "minimum duration",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
},
{
"identified_line": {
"line": "* Normal serum TSH within 12 months preceding surgery",
"criterions": [
{
"exact_snippets": [
"Normal serum TSH"
],
"criterion": "serum TSH",
"requirement_type": "normality",
"expected_value": true
},
{
"exact_snippets": [
"within 12 months preceding surgery"
],
"criterion": "time since surgery",
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12
}
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Normal serum TSH"
],
"criterion": "serum TSH",
"requirement_type": "normality",
"expected_value": true
},
{
"exact_snippets": [
"within 12 months preceding surgery"
],
"criterion": "time since surgery",
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12
}
]
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* AJCC Stage III or greater",
"criterions": [
{
"exact_snippets": [
"AJCC Stage III or greater"
],
"criterion": "AJCC Stage",
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3
}
]
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"AJCC Stage III or greater"
],
"criterion": "AJCC Stage",
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3
}
]
}
}
}
},
{
"identified_line": {
"line": "* Undifferentiated, Anaplastic or Medullary Thyroid Cancer",
"criterions": [
{
"exact_snippets": [
"Undifferentiated"
],
"criterion": "thyroid cancer",
"requirement_type": "type",
"expected_value": "undifferentiated"
},
{
"exact_snippets": [
"Anaplastic"
],
"criterion": "thyroid cancer",
"requirement_type": "type",
"expected_value": "anaplastic"
},
{
"exact_snippets": [
"Medullary"
],
"criterion": "thyroid cancer",
"requirement_type": "type",
"expected_value": "medullary"
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": [
"Undifferentiated"
],
"criterion": "thyroid cancer",
"requirement_type": "type",
"expected_value": "undifferentiated"
},
{
"exact_snippets": [
"Anaplastic"
],
"criterion": "thyroid cancer",
"requirement_type": "type",
"expected_value": "anaplastic"
},
{
"exact_snippets": [
"Medullary"
],
"criterion": "thyroid cancer",
"requirement_type": "type",
"expected_value": "medullary"
}
]
}
},
{
"identified_line": {
"line": "* Planned postoperative TSH goal other than 0.1-0.5 mU/L",
"criterions": [
{
"exact_snippets": [
"Planned postoperative TSH goal other than 0.1-0.5 mU/L"
],
"criterion": "postoperative TSH goal",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 0.1
},
{
"operator": ">",
"value": 0.5
}
]
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Planned postoperative TSH goal other than 0.1-0.5 mU/L"
],
"criterion": "postoperative TSH goal",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 0.1
},
{
"operator": ">",
"value": 0.5
}
]
}
}
}
},
{
"identified_line": {
"line": "* History of gastrointestinal malabsorption or gastric bypass surgery",
"criterions": [
{
"exact_snippets": [
"History of gastrointestinal malabsorption"
],
"criterion": "gastrointestinal malabsorption",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"gastric bypass surgery"
],
"criterion": "gastric bypass surgery",
"requirement_type": "history",
"expected_value": true
}
]
},
"logical_structure": {
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"exact_snippets": [
"History of gastrointestinal malabsorption"
],
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"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"gastric bypass surgery"
],
"criterion": "gastric bypass surgery",
"requirement_type": "history",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "* Pregnancy",
"criterions": [
{
"exact_snippets": [
"Pregnancy"
],
"criterion": "pregnancy",
"requirement_type": "presence",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Pregnancy"
],
"criterion": "pregnancy",
"requirement_type": "presence",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* Use of medications that alter the absorption or metabolism of levothyroxine",
"criterions": [
{
"exact_snippets": [
"Use of medications that alter the absorption or metabolism of levothyroxine"
],
"criterion": "medications",
"requirement_type": "effect on levothyroxine",
"expected_value": "alter absorption or metabolism"
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Use of medications that alter the absorption or metabolism of levothyroxine"
],
"criterion": "medications",
"requirement_type": "effect on levothyroxine",
"expected_value": "alter absorption or metabolism"
}
}
},
{
"identified_line": {
"line": "* Prior use of levothyroxine",
"criterions": [
{
"exact_snippets": [
"Prior use of levothyroxine"
],
"criterion": "levothyroxine",
"requirement_type": "prior use",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Prior use of levothyroxine"
],
"criterion": "levothyroxine",
"requirement_type": "prior use",
"expected_value": true
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}