{
"info": {
"nct_id": "NCT02321631",
"official_title": "Efficacy of EPA-enriched Supplement Compared With Standard Formula on Body Weight Changing in Malnourished Head and Neck Cancer Patients Undergone Surgery: A Randomized Study",
"inclusion_criteria": "1. Patients diagnosed as Head an Neck cancer with pathological confirmation\n2. Receiving surgery as a primary treatment\n3. Malnutrition screening tool(MST) is 2 or more\nHealthy volunteers allowed\nMust have minimum age of 15 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "1. Previously irradiated patient in the Head and Neck region\n2. Previously receiving chemotherapy\n3. Renal insufficiency with serum creatinine > 2.5 mg/dL\n4. Liver function abnormality with total serum bilirubin > 3.0 mg/dL\n5. Pregnancy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients diagnosed as Head an Neck cancer with pathological confirmation",
"criterions": [
{
"exact_snippets": "Patients diagnosed as Head an Neck cancer",
"criterion": "Head and Neck cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pathological confirmation",
"criterion": "pathological confirmation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients diagnosed as Head an Neck cancer",
"criterion": "Head and Neck cancer diagnosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pathological confirmation",
"criterion": "pathological confirmation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Receiving surgery as a primary treatment",
"criterions": [
{
"exact_snippets": "Receiving surgery as a primary treatment",
"criterion": "surgery",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "primary"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Receiving surgery as a primary treatment",
"criterion": "surgery",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "primary"
}
}
]
}
},
{
"identified_line": {
"line": "3. Malnutrition screening tool(MST) is 2 or more",
"criterions": [
{
"exact_snippets": "Malnutrition screening tool(MST) is 2 or more",
"criterion": "Malnutrition screening tool (MST)",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Malnutrition screening tool(MST) is 2 or more",
"criterion": "Malnutrition screening tool (MST)",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"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 15 Years",
"criterions": [
{
"exact_snippets": "minimum age of 15 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 15,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 15 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 15,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 90 Years",
"criterions": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Previously irradiated patient in the Head and Neck region",
"criterions": [
{
"exact_snippets": "Previously irradiated patient in the Head and Neck region",
"criterion": "irradiation in the Head and Neck region",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previously irradiated patient in the Head and Neck region",
"criterion": "irradiation in the Head and Neck region",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "2. Previously receiving chemotherapy",
"criterions": [
{
"exact_snippets": "Previously receiving chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Previously receiving chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Renal insufficiency with serum creatinine > 2.5 mg/dL",
"criterions": [
{
"exact_snippets": "Renal insufficiency",
"criterion": "renal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "serum creatinine > 2.5 mg/dL",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Renal insufficiency",
"criterion": "renal insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "serum creatinine > 2.5 mg/dL",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Liver function abnormality with total serum bilirubin > 3.0 mg/dL",
"criterions": [
{
"exact_snippets": "Liver function abnormality",
"criterion": "liver function",
"requirement": {
"requirement_type": "abnormality",
"expected_value": true
}
},
{
"exact_snippets": "total serum bilirubin > 3.0 mg/dL",
"criterion": "total serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 3.0,
"unit": "mg/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Liver function abnormality",
"criterion": "liver function",
"requirement": {
"requirement_type": "abnormality",
"expected_value": true
}
},
{
"exact_snippets": "total serum bilirubin > 3.0 mg/dL",
"criterion": "total serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 3.0,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Pregnancy",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}