[96a5a0]: / output / allTrials / logical / NCT06855680_logical.json

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{
"info": {
"nct_id": "NCT06855680",
"official_title": "The EMIRATES Study - Development and Evaluation of Thyroid Cancer Patient Decision Aid (PDA-TC) - Pilot Study",
"inclusion_criteria": "* Aged over 18\n* Both genders\n* Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:\n\n 1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or\n 2. Confirmed following diagnostic hemithyroidectomy\n* Able to communicate in spoken and written English\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology)\n* Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion.\n* Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases\n* Patients who are diagnosed with thyroid cancer which is of a familial disease\n* Patient who is either Pregnant or breast-feeding\n* Patient with hyper- or hypothyroidism who is a candidate for surgery\n* Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease\n* Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.\n* Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent\n* Patient who is not able to read write and speak English",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Aged over 18",
"criterions": [
{
"exact_snippets": "Aged over 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Aged over 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Both genders",
"criterions": [
{
"exact_snippets": "Both genders",
"criterion": "gender",
"requirement": {
"requirement_type": "allowed_values",
"expected_value": [
"male",
"female"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Both genders",
"criterion": "gender",
"requirement": {
"requirement_type": "allowed_values",
"expected_value": [
"male",
"female"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:",
"criterions": [
{
"exact_snippets": "diagnosed of low-risk well-differentiated thyroid carcinoma",
"criterion": "thyroid carcinoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "low-risk well-differentiated"
}
},
{
"exact_snippets": "papillary thyroid carcinoma or follicular carcinoma",
"criterion": "thyroid carcinoma type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"papillary",
"follicular"
]
}
},
{
"exact_snippets": "size of 1-4cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "cm"
},
{
"operator": "<=",
"value": 4,
"unit": "cm"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "diagnosed of low-risk well-differentiated thyroid carcinoma",
"criterion": "thyroid carcinoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "low-risk well-differentiated"
}
},
{
"exact_snippets": "papillary thyroid carcinoma or follicular carcinoma",
"criterion": "thyroid carcinoma type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"papillary",
"follicular"
]
}
}
]
},
{
"exact_snippets": "size of 1-4cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "cm"
},
{
"operator": "<=",
"value": 4,
"unit": "cm"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or",
"criterions": [
{
"exact_snippets": "Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC)",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": "fine-needle aspiration cytology (FNAC)"
}
},
{
"exact_snippets": "Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC)",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "timing",
"expected_value": "pre-operatively"
}
},
{
"exact_snippets": "Thy5 grade",
"criterion": "Thy classification",
"requirement": {
"requirement_type": "grade",
"expected_value": "Thy5"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC)",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": "fine-needle aspiration cytology (FNAC)"
}
},
{
"exact_snippets": "Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC)",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "timing",
"expected_value": "pre-operatively"
}
}
]
},
{
"exact_snippets": "Thy5 grade",
"criterion": "Thy classification",
"requirement": {
"requirement_type": "grade",
"expected_value": "Thy5"
}
}
]
}
},
{
"identified_line": {
"line": "2. Confirmed following diagnostic hemithyroidectomy",
"criterions": [
{
"exact_snippets": "Confirmed following diagnostic hemithyroidectomy",
"criterion": "diagnostic hemithyroidectomy",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Confirmed following diagnostic hemithyroidectomy",
"criterion": "diagnostic hemithyroidectomy",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Able to communicate in spoken and written English",
"criterions": [
{
"exact_snippets": "Able to communicate in spoken and written English",
"criterion": "English communication",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to communicate in spoken and written English",
"criterion": "English communication",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology)",
"criterions": [
{
"exact_snippets": "diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "adverse features",
"criterion": "adverse features",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "poor differentiated cytology",
"criterion": "poor differentiated cytology",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "tall cell, columnar cell, Hurthle cell, and solid variant cytology",
"criterion": "cytology type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"tall cell",
"columnar cell",
"Hurthle cell",
"solid variant"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "adverse features",
"criterion": "adverse features",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "poor differentiated cytology",
"criterion": "poor differentiated cytology",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "tall cell, columnar cell, Hurthle cell, and solid variant cytology",
"criterion": "cytology type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"tall cell",
"columnar cell",
"Hurthle cell",
"solid variant"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion.",
"criterions": [
{
"exact_snippets": "diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "multifocal",
"criterion": "multifocal",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "bilateral",
"criterion": "bilateral",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "extrathyroidal extension",
"criterion": "extrathyroidal extension",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "perineural invasion",
"criterion": "perineural invasion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "angioinvasion",
"criterion": "angioinvasion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "multifocal",
"criterion": "multifocal",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "bilateral",
"criterion": "bilateral",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "extrathyroidal extension",
"criterion": "extrathyroidal extension",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "perineural invasion",
"criterion": "perineural invasion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "angioinvasion",
"criterion": "angioinvasion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patient with hyper- or hypothyroidism who is a candidate for surgery",
"criterions": [
{
"exact_snippets": "Patient with hyper- or hypothyroidism",
"criterion": "thyroid condition",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"hyperthyroidism",
"hypothyroidism"
]
}
},
{
"exact_snippets": "candidate for surgery",
"criterion": "surgery candidacy",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patient with hyper- or hypothyroidism",
"criterion": "thyroid condition",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"hyperthyroidism",
"hypothyroidism"
]
}
},
{
"exact_snippets": "candidate for surgery",
"criterion": "surgery candidacy",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease",
"criterions": [
{
"exact_snippets": "concurrently diagnosed with any medullary",
"criterion": "medullary disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "concurrently diagnosed with any ... anaplastic",
"criterion": "anaplastic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "concurrently diagnosed with any ... lymphoma",
"criterion": "lymphoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "concurrently diagnosed with any ... parathyroid disease",
"criterion": "parathyroid disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "concurrently diagnosed with any medullary",
"criterion": "medullary disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "concurrently diagnosed with any ... anaplastic",
"criterion": "anaplastic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "concurrently diagnosed with any ... lymphoma",
"criterion": "lymphoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "concurrently diagnosed with any ... parathyroid disease",
"criterion": "parathyroid disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.",
"criterions": [
{
"exact_snippets": "previous thyroidectomy",
"criterion": "previous thyroidectomy",
"requirement": {
"requirement_type": "reason",
"expected_value": "other than diagnostic hemithyroidectomy for their recent cancer diagnosis"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "previous thyroidectomy",
"criterion": "previous thyroidectomy",
"requirement": {
"requirement_type": "reason",
"expected_value": "other than diagnostic hemithyroidectomy for their recent cancer diagnosis"
}
}
}
},
{
"identified_line": {
"line": "* Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent",
"criterions": [
{
"exact_snippets": "cognitively impaired",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "mental health condition",
"criterion": "mental health condition",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to give consent",
"criterion": "ability to give consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "cognitively impaired",
"criterion": "cognitive impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to give consent",
"criterion": "ability to give consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "mental health condition",
"criterion": "mental health condition",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to give consent",
"criterion": "ability to give consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patient who is not able to read write and speak English",
"criterions": [
{
"exact_snippets": "not able to read",
"criterion": "ability to read English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "not able to ... write",
"criterion": "ability to write English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "not able to ... speak English",
"criterion": "ability to speak English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "not able to read",
"criterion": "ability to read English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "not able to ... write",
"criterion": "ability to write English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
{
"exact_snippets": "not able to ... speak English",
"criterion": "ability to speak English",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases",
"criterions": [
{
"exact_snippets": "diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "clinically or radiologically involved nodes",
"criterion": "involved nodes",
"requirement": {
"requirement_type": "detection method",
"expected_value": [
"clinical",
"radiological"
]
}
},
{
"exact_snippets": "distant metastases",
"criterion": "distant metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients who are diagnosed with thyroid cancer which is of a familial disease",
"criterions": [
{
"exact_snippets": "diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "familial disease",
"criterion": "familial disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patient who is either Pregnant or breast-feeding",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}