{
"info": {
"nct_id": "NCT03499782",
"official_title": "A Multi-center Study:Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Non-primary gallbladder or cholangiocarcinoma\n* With distant metastasis (M1 phase)\n* Incomplete follow-up data\n* Died within 30 days after surgery.",
"miscellaneous_criteria": "Inclusion Criteria:\n\n* Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results\n* Must be able to undergo surgery\n* Undergoing radical surgery for biliary malignancy (R0 or R1 resection)\n* Not complicated with other malignancy\n* No other treatments before and during surgery, such as radiotherapy and chemotherapy."
},
"inclusion_lines": [
{
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Non-primary gallbladder or cholangiocarcinoma",
"criterions": [
{
"exact_snippets": "Non-primary gallbladder",
"criterion": "gallbladder cancer",
"requirement": {
"requirement_type": "primary status",
"expected_value": false
}
},
{
"exact_snippets": "Non-primary ... cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
"requirement": {
"requirement_type": "primary status",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Non-primary gallbladder",
"criterion": "gallbladder cancer",
"requirement": {
"requirement_type": "primary status",
"expected_value": false
}
},
{
"exact_snippets": "Non-primary ... cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
"requirement": {
"requirement_type": "primary status",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* With distant metastasis (M1 phase)",
"criterions": [
{
"exact_snippets": "distant metastasis (M1 phase)",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "phase",
"expected_value": "M1"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "distant metastasis (M1 phase)",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "phase",
"expected_value": "M1"
}
}
]
}
},
{
"identified_line": {
"line": "* Incomplete follow-up data",
"criterions": [
{
"exact_snippets": "Incomplete follow-up data",
"criterion": "follow-up data",
"requirement": {
"requirement_type": "completeness",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Incomplete follow-up data",
"criterion": "follow-up data",
"requirement": {
"requirement_type": "completeness",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Died within 30 days after surgery.",
"criterions": [
{
"exact_snippets": "Died within 30 days after surgery.",
"criterion": "death after surgery",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 30,
"unit": "days"
}
]
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Died within 30 days after surgery.",
"criterion": "death after surgery",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 30,
"unit": "days"
}
]
}
}
}
}
}
],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results",
"criterions": [
{
"exact_snippets": "Clinical diagnosis of biliary malignancy",
"criterion": "biliary malignancy",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "gallbladder carcinoma",
"criterion": "gallbladder carcinoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "verified by pathological results",
"criterion": "pathological verification",
"requirement": {
"requirement_type": "verification",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "gallbladder carcinoma",
"criterion": "gallbladder carcinoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "cholangiocarcinoma",
"criterion": "cholangiocarcinoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Clinical diagnosis of biliary malignancy",
"criterion": "biliary malignancy",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
{
"exact_snippets": "verified by pathological results",
"criterion": "pathological verification",
"requirement": {
"requirement_type": "verification",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Must be able to undergo surgery",
"criterions": [
{
"exact_snippets": "Must be able to undergo surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be able to undergo surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Undergoing radical surgery for biliary malignancy (R0 or R1 resection)",
"criterions": [
{
"exact_snippets": "Undergoing radical surgery for biliary malignancy",
"criterion": "surgery for biliary malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "radical"
}
},
{
"exact_snippets": "R0 or R1 resection",
"criterion": "resection margin status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"R0",
"R1"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Undergoing radical surgery for biliary malignancy",
"criterion": "surgery for biliary malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "radical"
}
},
{
"exact_snippets": "R0 or R1 resection",
"criterion": "resection margin status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"R0",
"R1"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Not complicated with other malignancy",
"criterions": [
{
"exact_snippets": "Not complicated with other malignancy",
"criterion": "other malignancy",
"requirement": {
"requirement_type": "complication",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Not complicated with other malignancy",
"criterion": "other malignancy",
"requirement": {
"requirement_type": "complication",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* No other treatments before and during surgery, such as radiotherapy and chemotherapy.",
"criterions": [
{
"exact_snippets": "No other treatments before and during surgery, such as radiotherapy",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other treatments before and during surgery, such as ... chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No other treatments before and during surgery, such as radiotherapy",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other treatments before and during surgery, such as ... chemotherapy",
"criterion": "chemotherapy",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Inclusion Criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}