{
    "info": {
        "nct_id": "NCT02284529",
        "official_title": "Evaluate the Safety of Combination of Orectalip® (Oxaliplatin), Fluorouracil and Leucovorin as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\n1. Subject must have World Health Organization performance status score less than 1.\n2. Subject must have WBC more than 4,000 cells, platelet count more than 100,000, absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg, serum creatinine level less than1.5mg\n\nExclusion Criteria\n\n1. Subject who has received oxaliplatin treatment\n2. Subject who has history of allergy to platinum derivates agents\n3. Subject who has decompensated liver function(ALT、 AST and alkaline phosphatase more than 2.5 times of upper limit of normal range).\n4. Subject has serious concomitant illness preceding the entry into the study.\n5. Female subject who is pregnant or breast feeding.\n6. Female subject who is going to be pregnant within 6 months during treatment."
    },
    "inclusion_lines": [
        {
            "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Subject must have World Health Organization performance status score less than 1.",
            "criterions": [
                {
                    "exact_snippets": "World Health Organization performance status score less than 1",
                    "criterion": "World Health Organization performance status score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject must have WBC more than 4,000 cells, platelet count more than 100,000, absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg, serum creatinine level less than1.5mg",
            "criterions": [
                {
                    "exact_snippets": "WBC more than 4,000 cells",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4000,
                                "unit": "cells"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count more than 100,000",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count more than 1,500",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum bilirubin level less than1.5mg",
                    "criterion": "serum bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine level less than1.5mg",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Subject who has received oxaliplatin treatment",
            "criterions": [
                {
                    "exact_snippets": "received oxaliplatin treatment",
                    "criterion": "oxaliplatin treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject who has history of allergy to platinum derivates agents",
            "criterions": [
                {
                    "exact_snippets": "history of allergy to platinum derivates agents",
                    "criterion": "allergy to platinum derivates agents",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject who has decompensated liver function(ALT、 AST and alkaline phosphatase more than 2.5 times of upper limit of normal range).",
            "criterions": [
                {
                    "exact_snippets": "decompensated liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "compensation",
                            "expected_value": "decompensated"
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT ... more than 2.5 times of upper limit of normal range",
                    "criterion": "ALT level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... more than 2.5 times of upper limit of normal range",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase more than 2.5 times of upper limit of normal range",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subject has serious concomitant illness preceding the entry into the study.",
            "criterions": [
                {
                    "exact_snippets": "serious concomitant illness",
                    "criterion": "concomitant illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Female subject who is pregnant or breast feeding.",
            "criterions": [
                {
                    "exact_snippets": "Female subject who is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Female subject who is going to be pregnant within 6 months during treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female subject",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "going to be pregnant within 6 months during treatment",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 6 months during treatment"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ]
}