{
"info": {
"nct_id": "NCT03882866",
"official_title": "3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study",
"inclusion_criteria": "* Age: 18-80 years\n* Cytologically or histologically confirmed pancreatic adenocarcinoma\n* Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)\n* Single tumor size≤ 6 cm\n* Karnofsky performance score (KPS)≥60\n* Estimated survival ≥3 months\n* Without other several comorbidity\n* Participants must have adequate organ function:\n\n * WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L\n * Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal\n * Albumin≥3g/dL\n * Total bilirubin ≤3mg/dL\n * PT≤3 × institutional upper limit of normal or INR≤2.3\n * Creatinine ≤1.5 × institutional upper limit of normal\n* Ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Patients with other malignant tumors\n* History of other anti-cancer therapy, including surgery,radiation, ablation and so on\n* Pregnant or lactating women\n* Patients with Immunodeficiency disease\n* Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure,active coronary heart disease and severe arrhythmia\n* Uncontrolled hypertension\n* Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)\n* Active tuberculosis\n* Chronic renal insufficiency\n* Other organ failure\n* History of organ transplantation\n* History of severe mental illness",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age: 18-80 years",
"criterions": [
{
"exact_snippets": "Age: 18-80 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age: 18-80 years",
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"operator": ">=",
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"unit": "years"
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"value": 80,
"unit": "years"
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}
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}
},
{
"identified_line": {
"line": "* Cytologically or histologically confirmed pancreatic adenocarcinoma",
"criterions": [
{
"exact_snippets": "Cytologically or histologically confirmed pancreatic adenocarcinoma",
"criterion": "pancreatic adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"cytologically",
"histologically"
]
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Cytologically or histologically confirmed pancreatic adenocarcinoma",
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"requirement": {
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"expected_value": [
"cytologically",
"histologically"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)",
"criterions": [
{
"exact_snippets": "Inoperable locally advanced pancreatic cancer",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "operability",
"expected_value": "inoperable"
}
},
{
"exact_snippets": "Inoperable locally advanced pancreatic cancer",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
},
{
"exact_snippets": "based on American Joint Committee on Cancer (AJCC) staging system (8th ed)",
"criterion": "staging system",
"requirement": {
"requirement_type": "system",
"expected_value": "American Joint Committee on Cancer (AJCC) 8th edition"
}
},
{
"exact_snippets": "without distant metastasis",
"criterion": "distant metastasis",
"requirement": {
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"expected_value": false
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Inoperable locally advanced pancreatic cancer",
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"expected_value": "inoperable"
}
},
{
"exact_snippets": "Inoperable locally advanced pancreatic cancer",
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}
}
]
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"exact_snippets": "based on American Joint Committee on Cancer (AJCC) staging system (8th ed)",
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"requirement": {
"requirement_type": "system",
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}
}
]
},
{
"exact_snippets": "without distant metastasis",
"criterion": "distant metastasis",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Single tumor size≤ 6 cm",
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{
"exact_snippets": "Single tumor size≤ 6 cm",
"criterion": "tumor size",
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "cm"
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}
}
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"exact_snippets": "Single tumor size≤ 6 cm",
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"operator": "<=",
"value": 6,
"unit": "cm"
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{
"identified_line": {
"line": "* Karnofsky performance score (KPS)≥60",
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{
"exact_snippets": "Karnofsky performance score (KPS)≥60",
"criterion": "Karnofsky performance score",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 60,
"unit": "N/A"
}
}
}
]
},
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"exact_snippets": "Karnofsky performance score (KPS)≥60",
"criterion": "Karnofsky performance score",
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"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Estimated survival ≥3 months",
"criterions": [
{
"exact_snippets": "Estimated survival ≥3 months",
"criterion": "estimated survival",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Estimated survival ≥3 months",
"criterion": "estimated survival",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Without other several comorbidity",
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{
"exact_snippets": "Without other several comorbidity",
"criterion": "comorbidity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"exact_snippets": "Without other several comorbidity",
"criterion": "comorbidity",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Participants must have adequate organ function:",
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"exact_snippets": "adequate organ function",
"criterion": "organ function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
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"exact_snippets": "adequate organ function",
"criterion": "organ function",
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"expected_value": true
}
}
]
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},
{
"identified_line": {
"line": "* WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L",
"criterions": [
{
"exact_snippets": "WBC≥3×109/L",
"criterion": "white blood cell count (WBC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "×10^9/L"
}
}
},
{
"exact_snippets": "HGB≥90g/dL",
"criterion": "hemoglobin (HGB)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "PLT≥50×109/L",
"criterion": "platelet count (PLT)",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 50,
"unit": "×10^9/L"
}
}
}
]
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{
"exact_snippets": "WBC≥3×109/L",
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"operator": ">=",
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"unit": "×10^9/L"
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"exact_snippets": "HGB≥90g/dL",
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"unit": "g/dL"
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"line": "* Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal",
"criterions": [
{
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"unit": "institutional upper limit of normal"
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"exact_snippets": "alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal",
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"line": "* Albumin≥3g/dL",
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"exact_snippets": "Albumin≥3g/dL",
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"unit": "g/dL"
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"identified_line": {
"line": "* Total bilirubin ≤3mg/dL",
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"exact_snippets": "Total bilirubin ≤3mg/dL",
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"operator": "<=",
"value": 3,
"unit": "mg/dL"
}
}
}
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"exact_snippets": "Total bilirubin ≤3mg/dL",
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"unit": "mg/dL"
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}
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"unit": "× institutional upper limit of normal"
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"exact_snippets": "INR≤2.3",
"criterion": "international normalized ratio (INR)",
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"value": 2.3,
"unit": "N/A"
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"identified_line": {
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"operator": "<=",
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"unit": "× institutional upper limit of normal"
}
}
}
]
}
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"identified_line": {
"line": "* Ability to understand and the willingness to sign a written informed consent document",
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{
"exact_snippets": "Ability to understand",
"criterion": "cognitive ability",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
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}
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"exact_snippets": "Ability to understand",
"criterion": "cognitive ability",
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"expected_value": true
}
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"exact_snippets": "willingness to sign a written informed consent document",
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}
]
}
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"exact_snippets": "Healthy volunteers allowed",
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}
},
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"line": "Must have minimum age of 18 Years",
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"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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}
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}
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"identified_line": {
"line": "Must have maximum age of 80 Years",
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"exact_snippets": "maximum age of 80 Years",
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"operator": "<=",
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"exact_snippets": "maximum age of 80 Years",
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"unit": "Years"
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}
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"exclusion_lines": [
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"identified_line": {
"line": "* Patients with other malignant tumors",
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"exact_snippets": "Patients with other malignant tumors",
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"expected_value": true
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}
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"exact_snippets": "Patients with other malignant tumors",
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"exact_snippets": "History of other anti-cancer therapy, including surgery",
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"exact_snippets": "History of other anti-cancer therapy, including ... radiation",
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}
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"exact_snippets": "History of other anti-cancer therapy, including ... ablation",
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"line": "* Pregnant or lactating women",
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"exact_snippets": "Pregnant",
"criterion": "pregnancy",
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"expected_value": false
}
},
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"exact_snippets": "lactating women",
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"exact_snippets": "Pregnant",
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}
},
{
"exact_snippets": "lactating women",
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"requirement_type": "presence",
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}
}
]
}
},
{
"identified_line": {
"line": "* Patients with Immunodeficiency disease",
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{
"exact_snippets": "Immunodeficiency disease",
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}
]
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"exact_snippets": "Immunodeficiency disease",
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}
}
},
{
"identified_line": {
"line": "* Uncontrolled hypertension",
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{
"exact_snippets": "Uncontrolled hypertension",
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}
]
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"exact_snippets": "Uncontrolled hypertension",
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}
}
]
}
},
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"identified_line": {
"line": "* Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)",
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{
"exact_snippets": "Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)",
"criterion": "infection",
"requirement": {
"requirement_type": "status",
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]
}
},
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"exact_snippets": "Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)",
"criterion": "infection",
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"requirement_type": "severity",
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"operator": ">",
"value": 2,
"unit": "grade"
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}
}
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"and_criteria": [
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"and_criteria": [
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"exact_snippets": "Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)",
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"requirement": {
"requirement_type": "status",
"expected_value": [
"ongoing",
"active"
]
}
},
{
"exact_snippets": "Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)",
"criterion": "infection",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "grade"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Active tuberculosis",
"criterions": [
{
"exact_snippets": "Active tuberculosis",
"criterion": "tuberculosis",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Active tuberculosis",
"criterion": "tuberculosis",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
}
},
{
"identified_line": {
"line": "* Chronic renal insufficiency",
"criterions": [
{
"exact_snippets": "Chronic renal insufficiency",
"criterion": "chronic renal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Chronic renal insufficiency",
"criterion": "chronic renal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Other organ failure",
"criterions": [
{
"exact_snippets": "Other organ failure",
"criterion": "organ failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Other organ failure",
"criterion": "organ failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* History of organ transplantation",
"criterions": [
{
"exact_snippets": "History of organ transplantation",
"criterion": "organ transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "History of organ transplantation",
"criterion": "organ transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* History of severe mental illness",
"criterions": [
{
"exact_snippets": "History of severe mental illness",
"criterion": "severe mental illness",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "History of severe mental illness",
"criterion": "severe mental illness",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure,active coronary heart disease and severe arrhythmia",
"criterions": [
{
"exact_snippets": "New York Heart Association (NYHA) class III/IV congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "severity",
"expected_value": "New York Heart Association (NYHA) class III/IV"
}
},
{
"exact_snippets": "active coronary heart disease",
"criterion": "coronary heart disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "severe arrhythmia",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}