{
"info": {
"nct_id": "NCT03705429",
"official_title": "A Multi-Centre Randomized Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer",
"inclusion_criteria": "* Patients with HER-2 positive early stage breast cancer for whom TC-H or weekly P-H is being considered.\n* Able to provide verbal consent.\n* Willing to complete study related-questionnaires\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Unable to give informed consent or complete questionnaires",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients with HER-2 positive early stage breast cancer for whom TC-H or weekly P-H is being considered.",
"criterions": [
{
"exact_snippets": "HER-2 positive",
"criterion": "HER-2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "early stage breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "early"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "HER-2 positive",
"criterion": "HER-2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "early stage breast cancer",
"criterion": "breast cancer stage",
"requirement": {
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"expected_value": "early"
}
}
]
},
{
"or_criteria": [
{
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"criterion": "treatment consideration",
"requirement": {
"requirement_type": "consideration",
"expected_value": "TC-H"
}
},
{
"exact_snippets": "weekly P-H",
"criterion": "treatment consideration",
"requirement": {
"requirement_type": "consideration",
"expected_value": "weekly P-H"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Able to provide verbal consent.",
"criterions": [
{
"exact_snippets": "Able to provide verbal consent.",
"criterion": "verbal consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to provide verbal consent.",
"criterion": "verbal consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
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"criterions": [
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"exact_snippets": "Willing to complete study related-questionnaires",
"criterion": "willingness to complete questionnaires",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Willing to complete study related-questionnaires",
"criterion": "willingness to complete questionnaires",
"requirement": {
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"expected_value": true
}
}
]
}
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{
"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": "* Unable to give informed consent or complete questionnaires",
"criterions": [
{
"exact_snippets": "Unable to give informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Unable to ... complete questionnaires",
"criterion": "ability to complete questionnaires",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
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]
},
"logical_structure": {
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"criterion": "informed consent",
"requirement": {
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"expected_value": true
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},
{
"exact_snippets": "Unable to ... complete questionnaires",
"criterion": "ability to complete questionnaires",
"requirement": {
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"expected_value": true
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}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}