{
    "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": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pathological confirmation",
                    "criterion": "pathological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Receiving surgery as a primary treatment",
            "criterions": [
                {
                    "exact_snippets": "Receiving surgery as a primary treatment",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "primary"
                        }
                    ]
                }
            ]
        },
        {
            "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)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 15 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 15 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 90 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 90 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previously receiving chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previously receiving chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Renal insufficiency with serum creatinine > 2.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Renal insufficiency",
                    "criterion": "renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine > 2.5 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Liver function abnormality with total serum bilirubin > 3.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Liver function abnormality",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "total serum bilirubin > 3.0 mg/dL",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}