{
    "info": {
        "nct_id": "NCT00176631",
        "official_title": "A Phase II Trial of Licorice Root and Docetaxel in Patients With Hormone Refractory Prostate Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of prostate adenocarcinoma\n\n  * Metastatic disease\n* Must have failed initial hormonal therapy and have disease progression after at least one chemotherapy regimen*, meeting any of the following criteria:\n\n  * Progressive PSA ≥ 5 ng/mL, as evidenced by 2 separate measurements taken ≥ 2 weeks apart with the second PSA measurement greater than the first one and PSA measurement at screening greater than the first one\n  * Progressive measurable disease (e.g., changes in the size of lymph nodes or parenchymal masses or appearance of new lesions on physical examination or x-ray/CT scan) with a PSA level at screening ≥ 5 ng/mL\n  * Progressive bone metastasis (e.g., presence of new lesions on a bone scan) with a PSA level at screening ≥ 5 ng/mL NOTE: *Prior chemotherapy must include a taxane therapy, but disease progression does not have to follow taxane therapy\n* Patients must maintain primary androgen ablation (hormonal) therapy AND experience disease progression while not receiving antiandrogen therapy\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* Life expectancy ≥ 6 months\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* WBC ≥ 3,500/mm^3\n* Bilirubin ≤ 1.2 mg/dL\n* Creatinine ≤ 1.5 mg/dL\n* SGOT or SGPT ≤ 1.5 times upper limit of normal\n* No other prior malignancy unless treated with curative intent and free of disease for the time period considered appropriate for the specific cancer\n* No uncontrolled hypertension\n* No active infections\n* No known HIV positivity\n* No uncontrolled medical condition that would preclude study therapy\n* No diagnosis of major depression or suicidal ideation\n* No problems with oral absorption\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 4 weeks since prior surgery or radiotherapy and recovered\n* At least 4 weeks since prior flutamide\n* At least 6 weeks since prior bicalutamide\n* No prior or concurrent herbal supplements or thiazide diuretics\n* No other concurrent investigational or commercial agents or therapies"
    },
    "inclusion_lines": [
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            "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",
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                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
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                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be MALE",
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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",
                        "criterion": "age",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
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                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 120 Years",
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                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Diagnosis of prostate adenocarcinoma",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of prostate adenocarcinoma",
                        "criterion": "prostate adenocarcinoma",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Diagnosis of prostate adenocarcinoma",
                        "criterion": "prostate adenocarcinoma",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Metastatic disease",
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                    {
                        "exact_snippets": "Metastatic disease",
                        "criterion": "metastatic disease",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Metastatic disease",
                        "criterion": "metastatic disease",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have failed initial hormonal therapy and have disease progression after at least one chemotherapy regimen*, meeting any of the following criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Must have failed initial hormonal therapy",
                        "criterion": "initial hormonal therapy",
                        "requirement": {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "disease progression after at least one chemotherapy regimen",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "after chemotherapy regimens",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must have failed initial hormonal therapy",
                        "criterion": "initial hormonal therapy",
                        "requirement": {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "disease progression after at least one chemotherapy regimen",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "after chemotherapy regimens",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Progressive PSA ≥ 5 ng/mL, as evidenced by 2 separate measurements taken ≥ 2 weeks apart with the second PSA measurement greater than the first one and PSA measurement at screening greater than the first one",
                "criterions": [
                    {
                        "exact_snippets": "Progressive PSA ≥ 5 ng/mL",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Progressive PSA ≥ 5 ng/mL",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "2 separate measurements taken ≥ 2 weeks apart",
                        "criterion": "PSA measurement interval",
                        "requirement": {
                            "requirement_type": "interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "second PSA measurement greater than the first one",
                        "criterion": "PSA measurement comparison",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": "second > first"
                        }
                    },
                    {
                        "exact_snippets": "PSA measurement at screening greater than the first one",
                        "criterion": "PSA screening comparison",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": "screening > first"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Progressive PSA ≥ 5 ng/mL",
                                                "criterion": "PSA level",
                                                "requirement": {
                                                    "requirement_type": "progression",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "Progressive PSA ≥ 5 ng/mL",
                                                "criterion": "PSA level",
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                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 5,
                                                        "unit": "ng/mL"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "2 separate measurements taken ≥ 2 weeks apart",
                                        "criterion": "PSA measurement interval",
                                        "requirement": {
                                            "requirement_type": "interval",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "second PSA measurement greater than the first one",
                                "criterion": "PSA measurement comparison",
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                                    "requirement_type": "comparison",
                                    "expected_value": "second > first"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "PSA measurement at screening greater than the first one",
                        "criterion": "PSA screening comparison",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": "screening > first"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Progressive measurable disease (e.g., changes in the size of lymph nodes or parenchymal masses or appearance of new lesions on physical examination or x-ray/CT scan) with a PSA level at screening ≥ 5 ng/mL",
                "criterions": [
                    {
                        "exact_snippets": "Progressive measurable disease (e.g., changes in the size of lymph nodes or parenchymal masses or appearance of new lesions on physical examination or x-ray/CT scan)",
                        "criterion": "progressive measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PSA level at screening ≥ 5 ng/mL",
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                        "requirement": {
                            "requirement_type": "quantity",
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                                "operator": ">=",
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                                "unit": "ng/mL"
                            }
                        }
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Progressive measurable disease (e.g., changes in the size of lymph nodes or parenchymal masses or appearance of new lesions on physical examination or x-ray/CT scan)",
                        "criterion": "progressive measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PSA level at screening ≥ 5 ng/mL",
                        "criterion": "PSA level",
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                            "requirement_type": "quantity",
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                                "operator": ">=",
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                                "unit": "ng/mL"
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        },
        {
            "identified_line": {
                "line": "* Progressive bone metastasis (e.g., presence of new lesions on a bone scan) with a PSA level at screening ≥ 5 ng/mL NOTE: *Prior chemotherapy must include a taxane therapy, but disease progression does not have to follow taxane therapy",
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                    {
                        "exact_snippets": "Progressive bone metastasis (e.g., presence of new lesions on a bone scan)",
                        "criterion": "progressive bone metastasis",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
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                        "exact_snippets": "PSA level at screening ≥ 5 ng/mL",
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                            "requirement_type": "quantity",
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                                "operator": ">=",
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                                "unit": "ng/mL"
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                    },
                    {
                        "exact_snippets": "Prior chemotherapy must include a taxane therapy",
                        "criterion": "prior chemotherapy",
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                            "requirement_type": "inclusion",
                            "expected_value": "taxane therapy"
                        }
                    }
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            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "Progressive bone metastasis (e.g., presence of new lesions on a bone scan)",
                                "criterion": "progressive bone metastasis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "PSA level at screening ≥ 5 ng/mL",
                                "criterion": "PSA level",
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                    {
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                        "criterion": "prior chemotherapy",
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                            "requirement_type": "inclusion",
                            "expected_value": "taxane therapy"
                        }
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                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must maintain primary androgen ablation (hormonal) therapy AND experience disease progression while not receiving antiandrogen therapy",
                "criterions": [
                    {
                        "exact_snippets": "Patients must maintain primary androgen ablation (hormonal) therapy",
                        "criterion": "primary androgen ablation therapy",
                        "requirement": {
                            "requirement_type": "maintenance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "experience disease progression while not receiving antiandrogen therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "while not receiving antiandrogen therapy"
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must maintain primary androgen ablation (hormonal) therapy",
                        "criterion": "primary androgen ablation therapy",
                        "requirement": {
                            "requirement_type": "maintenance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "experience disease progression while not receiving antiandrogen therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "while not receiving antiandrogen therapy"
                        }
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            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status 0-1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 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 performance status 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": "* Life expectancy ≥ 6 months",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy ≥ 6 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
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                        "exact_snippets": "Life expectancy ≥ 6 months",
                        "criterion": "life expectancy",
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                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count ≥ 1,500/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
                        "criterion": "absolute neutrophil count",
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                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count ≥ 100,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mm^3",
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                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
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        },
        {
            "identified_line": {
                "line": "* Creatinine ≤ 1.5 mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine ≤ 1.5 mg/dL",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
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                    {
                        "exact_snippets": "Creatinine ≤ 1.5 mg/dL",
                        "criterion": "creatinine level",
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                                "operator": "<=",
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                ]
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        },
        {
            "identified_line": {
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                "criterions": [
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                        }
                    },
                    {
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                        }
                    }
                ]
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                    }
                },
                "then_criteria": null,
                "else_criteria": {
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                        {
                            "exact_snippets": "unless treated with curative intent",
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                                "requirement_type": "intent",
                                "expected_value": "curative"
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                        },
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                            "exact_snippets": "free of disease for the time period considered appropriate for the specific cancer",
                            "criterion": "disease-free period",
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                                "requirement_type": "duration",
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                            }
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                    ]
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        {
            "identified_line": {
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                        "exact_snippets": "No uncontrolled hypertension",
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                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* No active infections",
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                        "exact_snippets": "No active infections",
                        "criterion": "active infections",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "No active infections",
                        "criterion": "active infections",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No known HIV positivity",
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                    {
                        "exact_snippets": "No known HIV positivity",
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                        }
                    }
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                    {
                        "exact_snippets": "No known HIV positivity",
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}