{
"info": {
"nct_id": "NCT01907529",
"official_title": "A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)",
"inclusion_criteria": "* Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)\n* Age 18-70\n* No evidence of distant metastasis\n* No previous therapy\n* Normal hematologic function\n* No abnormality of renal or liver function\n* Written informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* With allergic constitution or possible allergic reflection to drugs to be used in this study\n* Any concurrent uncontrolled medical or psychiatric disorder\n* History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease\n* Being pregnant or nursing",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)",
"criterions": [
{
"exact_snippets": "Histologically confirmed invasive breast cancer",
"criterion": "invasive breast cancer",
"requirement": {
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"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "core needle biopsy for breast cancer diagnosis",
"criterion": "breast cancer diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "core needle biopsy"
}
},
{
"exact_snippets": "fine needle aspiration for lymph node metastasis diagnosis",
"criterion": "lymph node metastasis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "fine needle aspiration"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed invasive breast cancer",
"criterion": "invasive breast cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "core needle biopsy for breast cancer diagnosis",
"criterion": "breast cancer diagnosis",
"requirement": {
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"expected_value": "core needle biopsy"
}
}
]
},
{
"exact_snippets": "fine needle aspiration for lymph node metastasis diagnosis",
"criterion": "lymph node metastasis diagnosis",
"requirement": {
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"expected_value": "fine needle aspiration"
}
}
]
}
},
{
"identified_line": {
"line": "* Age 18-70",
"criterions": [
{
"exact_snippets": "Age 18-70",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 70,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age 18-70",
"criterion": "age",
"requirement": {
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"expected_value": {
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"operator": ">=",
"value": 18,
"unit": "years"
},
{
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"value": 70,
"unit": "years"
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]
}
}
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},
{
"identified_line": {
"line": "* No evidence of distant metastasis",
"criterions": [
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"exact_snippets": "No evidence of distant metastasis",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No evidence of distant metastasis",
"criterion": "distant metastasis",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* No previous therapy",
"criterions": [
{
"exact_snippets": "No previous therapy",
"criterion": "previous therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No previous therapy",
"criterion": "previous therapy",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Normal hematologic function",
"criterions": [
{
"exact_snippets": "Normal hematologic function",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Normal hematologic function",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
}
},
{
"identified_line": {
"line": "* No abnormality of renal or liver function",
"criterions": [
{
"exact_snippets": "No abnormality of renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "abnormality",
"expected_value": false
}
},
{
"exact_snippets": "No abnormality of ... liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "abnormality",
"expected_value": false
}
}
]
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"criterion": "renal function",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "No abnormality of ... liver function",
"criterion": "liver function",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Written informed consent",
"criterions": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "form",
"expected_value": "written"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "form",
"expected_value": "written"
}
}
]
}
},
{
"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": {
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* With allergic constitution or possible allergic reflection to drugs to be used in this study",
"criterions": [
{
"exact_snippets": "allergic constitution",
"criterion": "allergic constitution",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "possible allergic reflection to drugs to be used in this study",
"criterion": "allergic reaction to study drugs",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "allergic constitution",
"criterion": "allergic constitution",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "possible allergic reflection to drugs to be used in this study",
"criterion": "allergic reaction to study drugs",
"requirement": {
"requirement_type": "possibility",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Any concurrent uncontrolled medical ... disorder",
"criterion": "medical disorder",
"requirement": {
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"expected_value": "uncontrolled"
}
},
{
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"criterion": "psychiatric disorder",
"requirement": {
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"expected_value": "uncontrolled"
}
}
]
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"criterion": "medical disorder",
"requirement": {
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"expected_value": "uncontrolled"
}
},
{
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"criterion": "psychiatric disorder",
"requirement": {
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"expected_value": "uncontrolled"
}
}
]
}
},
{
"identified_line": {
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"criterions": [
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"criterion": "congestive heart failure",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "History of severe heart diseases, including ... unstable angina",
"criterion": "unstable angina",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "History of severe heart diseases, including ... uncontrolled arrhythmia",
"criterion": "uncontrolled arrhythmia",
"requirement": {
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"expected_value": true
}
},
{
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"criterion": "myocardial infarction",
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"expected_value": true
}
},
{
"exact_snippets": "History of severe heart diseases, including ... uncontrolled high blood pressure",
"criterion": "uncontrolled high blood pressure",
"requirement": {
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"expected_value": true
}
},
{
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"criterion": "heart valve disease",
"requirement": {
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"expected_value": true
}
}
]
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"expected_value": true
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},
{
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"criterion": "unstable angina",
"requirement": {
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"expected_value": true
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{
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"expected_value": true
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},
{
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"expected_value": true
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{
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"criterion": "uncontrolled high blood pressure",
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{
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},
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"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
},
{
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"criterion": "nursing",
"requirement": {
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"expected_value": false
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}
]
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{
"exact_snippets": "Being pregnant",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "nursing",
"criterion": "nursing",
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"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}