{
    "info": {
        "nct_id": "NCT01550848",
        "official_title": "A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer",
        "inclusion_criteria": "* Female between 18 and 70 years old;\n* Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;\n* ECOG (Eastern Cooperative Oncology Group) 0~1;\n* Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;\n* Got ICF (Informed Consent Form) before enrollment;\n* Life expectancy more than 12 weeks\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Pregnant or breast-feeding women or positive serum pregnancy test;\n* Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;\n* Participation in any investigational drug study within 4 weeks preceding treatment start;\n* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;\n* Serious uncontrolled intercurrent infections;\n* Poor compliance",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Female between 18 and 70 years old;",
                "criterions": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "between 18 and 70 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "between 18 and 70 years old",
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                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;",
                "criterions": [
                    {
                        "exact_snippets": "histologic proved metastatic breast cancer",
                        "criterion": "metastatic breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unsuitable to be treated with surgery",
                        "criterion": "suitability for surgery",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologic proved metastatic breast cancer",
                        "criterion": "metastatic breast cancer",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unsuitable to be treated with surgery",
                        "criterion": "suitability for surgery",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG (Eastern Cooperative Oncology Group) 0~1;",
                "criterions": [
                    {
                        "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) 0~1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) 0~1",
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                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;",
                "criterions": [
                    {
                        "exact_snippets": "Normal functions with heart",
                        "criterion": "heart function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal functions with ... liver",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal functions with ... renal",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal functions with ... bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "WBC≥3.5×109/L",
                        "criterion": "white blood cell count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hb≥90 g/L",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "plt≥100×109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Normal functions with heart",
                                "criterion": "heart function",
                                "requirement": {
                                    "requirement_type": "functionality",
                                    "expected_value": "normal"
                                }
                            },
                            {
                                "exact_snippets": "Normal functions with ... liver",
                                "criterion": "liver function",
                                "requirement": {
                                    "requirement_type": "functionality",
                                    "expected_value": "normal"
                                }
                            },
                            {
                                "exact_snippets": "Normal functions with ... renal",
                                "criterion": "renal function",
                                "requirement": {
                                    "requirement_type": "functionality",
                                    "expected_value": "normal"
                                }
                            },
                            {
                                "exact_snippets": "Normal functions with ... bone marrow",
                                "criterion": "bone marrow function",
                                "requirement": {
                                    "requirement_type": "functionality",
                                    "expected_value": "normal"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "WBC≥3.5×109/L",
                        "criterion": "white blood cell count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hb≥90 g/L",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "plt≥100×109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Got ICF (Informed Consent Form) before enrollment;",
                "criterions": [
                    {
                        "exact_snippets": "Got ICF (Informed Consent Form) before enrollment",
                        "criterion": "informed consent form",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Got ICF (Informed Consent Form) before enrollment",
                        "criterion": "informed consent form",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy more than 12 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy more than 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy more than 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
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                            "expected_value": "healthy"
                        }
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                ]
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        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
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                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Must be FEMALE",
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                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
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            "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 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Pregnant or breast-feeding women or positive serum pregnancy test;",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding women",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "positive serum pregnancy test",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding women",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "positive serum pregnancy test",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with brain metastases must be locally treated",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "locally treated"
                        }
                    },
                    {
                        "exact_snippets": "the disease must be stable for at least one month",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Uncontrolled brain metastases",
                            "criterion": "brain metastases",
                            "requirement": {
                                "requirement_type": "control",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients with brain metastases must be locally treated",
                                    "criterion": "brain metastases",
                                    "requirement": {
                                        "requirement_type": "treatment",
                                        "expected_value": "locally treated"
                                    }
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                                    "exact_snippets": "the disease must be stable for at least one month",
                                    "criterion": "brain metastases",
                                    "requirement": {
                                        "requirement_type": "stability duration",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 1,
                                            "unit": "month"
                                        }
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                            ]
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Participation in any investigational drug study within 4 weeks preceding treatment start;",
                "criterions": [
                    {
                        "exact_snippets": "Participation in any investigational drug study within 4 weeks preceding treatment start",
                        "criterion": "participation in investigational drug study",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
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            "logical_structure": {
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                    "exact_snippets": "Participation in any investigational drug study within 4 weeks preceding treatment start",
                    "criterion": "participation in investigational drug study",
                    "requirement": {
                        "requirement_type": "time since last participation",
                        "expected_value": {
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                            "value": 4,
                            "unit": "weeks"
                        }
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                }
            }
        },
        {
            "identified_line": {
                "line": "* Serious uncontrolled intercurrent infections;",
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                    {
                        "exact_snippets": "Serious uncontrolled intercurrent infections",
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                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Serious uncontrolled intercurrent infections",
                        "criterion": "intercurrent infections",
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                            "requirement_type": "control",
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                        }
                    }
                ]
            },
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                        "exact_snippets": "Serious uncontrolled intercurrent infections",
                        "criterion": "intercurrent infections",
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                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Serious uncontrolled intercurrent infections",
                        "criterion": "intercurrent infections",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Poor compliance",
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                    {
                        "exact_snippets": "Poor compliance",
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                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    }
                ]
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                        "requirement_type": "quality",
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                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent other malignancy at other sites",
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                        }
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                    {
                        "exact_snippets": "previous other cancer within the last 5 years",
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                                "operator": ">",
                                "value": 5,
                                "unit": "years"
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                        }
                    },
                    {
                        "exact_snippets": "adequately treated in situ carcinoma of cervix uteri",
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                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequately treated ... basal or squamous cell carcinoma of the skin",
                        "criterion": "basal or squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequately treated ... contralateral breast cancer",
                        "criterion": "contralateral breast cancer",
                        "requirement": {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    }
                ]
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                            {
                                "and_criteria": [
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                                        "exact_snippets": "Concurrent other malignancy at other sites",
                                        "criterion": "concurrent malignancy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
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                                            "exact_snippets": "adequately treated ... contralateral breast cancer",
                                            "criterion": "contralateral breast cancer",
                                            "requirement": {
                                                "requirement_type": "treatment adequacy",
                                                "expected_value": true
                                            }
                                        }
                                    },
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "adequately treated in situ carcinoma of cervix uteri",
                                            "criterion": "in situ carcinoma of cervix uteri",
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                                            }
                                        }
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                                            "exact_snippets": "adequately treated ... basal or squamous cell carcinoma of the skin",
                                            "criterion": "basal or squamous cell carcinoma of the skin",
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                                                "requirement_type": "treatment adequacy",
                                                "expected_value": true
                                            }
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                        ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "previous other cancer within the last 5 years",
                                "criterion": "previous cancer",
                                "requirement": {
                                    "requirement_type": "time since last occurrence",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "adequately treated ... contralateral breast cancer",
                                    "criterion": "contralateral breast cancer",
                                    "requirement": {
                                        "requirement_type": "treatment adequacy",
                                        "expected_value": true
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "adequately treated in situ carcinoma of cervix uteri",
                                    "criterion": "in situ carcinoma of cervix uteri",
                                    "requirement": {
                                        "requirement_type": "treatment adequacy",
                                        "expected_value": true
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "adequately treated ... basal or squamous cell carcinoma of the skin",
                                    "criterion": "basal or squamous cell carcinoma of the skin",
                                    "requirement": {
                                        "requirement_type": "treatment adequacy",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}