{
    "info": {
        "nct_id": "NCT00003282",
        "official_title": "Phase I Trial of EF5, an Agent for the Detection of Hypoxia",
        "inclusion_criteria": "* Histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery\n* Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection\n* Performance status - ECOG 0-2\n* Life expectancy not specified\n* WBC greater than 2,000/mm^3\n* Platelet count greater than 100,000/mm^3\n* Bilirubin less than 2.0 mg/dL\n* Creatinine less than 2.0 mg/dL\n* Creatinine clearance greater than 50 mL/min\n* No significant cardiac disease that would preclude the safe use of general anesthesia\n* No significant pulmonary disease that would preclude the safe use of general anesthesia\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 1 month after study\n* No history of grade III or IV peripheral neuropathy\n* See Disease Characteristics\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed tumor",
                        "criterion": "tumor",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "highly suspicious cancerous mass based on imaging and clinical signs",
                        "criterion": "cancerous mass",
                        "requirement": {
                            "requirement_type": "suspicion level",
                            "expected_value": "highly suspicious"
                        }
                    },
                    {
                        "exact_snippets": "highly suspicious cancerous mass based on imaging and clinical signs",
                        "criterion": "cancerous mass",
                        "requirement": {
                            "requirement_type": "basis",
                            "expected_value": [
                                "imaging",
                                "clinical signs"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "not indicative of a direct biopsy/cellular diagnosis preceding surgery",
                        "criterion": "biopsy/cellular diagnosis",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically confirmed tumor",
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                                    "expected_value": "histologically confirmed"
                                }
                            },
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                                    "criterion": "biopsy/cellular diagnosis",
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                                        "expected_value": false
                                    }
                                }
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                                "exact_snippets": "highly suspicious cancerous mass based on imaging and clinical signs",
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                                    "expected_value": "highly suspicious"
                                }
                            },
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                                "exact_snippets": "highly suspicious cancerous mass based on imaging and clinical signs",
                                "criterion": "cancerous mass",
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                                        "clinical signs"
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                            },
                            {
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                                    "criterion": "biopsy/cellular diagnosis",
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                                        "expected_value": false
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        },
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                "line": "* Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection",
                "criterions": [
                    {
                        "exact_snippets": "Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection",
                        "criterion": "clinical condition or physiologic status",
                        "requirement": {
                            "requirement_type": "appropriate initial therapy",
                            "expected_value": "surgical biopsy or resection"
                        }
                    }
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                        "exact_snippets": "Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection",
                        "criterion": "clinical condition or physiologic status",
                        "requirement": {
                            "requirement_type": "appropriate initial therapy",
                            "expected_value": "surgical biopsy or resection"
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        },
        {
            "identified_line": {
                "line": "* Performance status - ECOG 0-2",
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                        "exact_snippets": "Performance status - ECOG 0-2",
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                            "requirement_type": "scale",
                            "expected_value": "ECOG"
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                        "exact_snippets": "Performance status - ECOG 0-2",
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                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
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                        "exact_snippets": "Performance status - ECOG 0-2",
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                            "requirement_type": "scale",
                            "expected_value": "ECOG"
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                    },
                    {
                        "exact_snippets": "Performance status - ECOG 0-2",
                        "criterion": "performance status",
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                            "requirement_type": "range",
                            "expected_value": {
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                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
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                            }
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Life expectancy not specified",
                "criterions": [
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                        "exact_snippets": "Life expectancy not specified",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "specification",
                            "expected_value": false
                        }
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            "logical_structure": {
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                        "exact_snippets": "Life expectancy not specified",
                        "criterion": "life expectancy",
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                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    }
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        },
        {
            "identified_line": {
                "line": "* WBC greater than 2,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "WBC greater than 2,000/mm^3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "WBC greater than 2,000/mm^3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count greater than 100,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count greater than 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Platelet count greater than 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin less than 2.0 mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin less than 2.0 mg/dL",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bilirubin less than 2.0 mg/dL",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
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            "identified_line": {
                "line": "* Creatinine less than 2.0 mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine less than 2.0 mg/dL",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
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                        "exact_snippets": "Creatinine less than 2.0 mg/dL",
                        "criterion": "creatinine level",
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                            "requirement_type": "level",
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                                "operator": "<",
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                                "unit": "mg/dL"
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                ]
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        },
        {
            "identified_line": {
                "line": "* Creatinine clearance greater than 50 mL/min",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine clearance greater than 50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
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                        "exact_snippets": "Creatinine clearance greater than 50 mL/min",
                        "criterion": "creatinine clearance",
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                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
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            "identified_line": {
                "line": "* No significant cardiac disease that would preclude the safe use of general anesthesia",
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                        "exact_snippets": "No significant cardiac disease",
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* No significant pulmonary disease that would preclude the safe use of general anesthesia",
                "criterions": [
                    {
                        "exact_snippets": "No significant pulmonary disease",
                        "criterion": "pulmonary disease",
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                ]
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        },
        {
            "identified_line": {
                "line": "* Negative pregnancy test",
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                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy",
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                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    }
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                        "exact_snippets": "Negative pregnancy test",
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                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Fertile patients must use effective contraception during and for 1 month after study",
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                        "criterion": "fertility",
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                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    },
                    {
                        "exact_snippets": "must use effective contraception during and for 1 month after study",
                        "criterion": "contraception use",
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                            "requirement_type": "duration",
                            "expected_value": "during and for 1 month after study"
                        }
                    }
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                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
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                        "requirement_type": "status",
                        "expected_value": "fertile"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "must use effective contraception during and for 1 month after study",
                    "criterion": "contraception use",
                    "requirement": {
                        "requirement_type": "duration",
                        "expected_value": "during and for 1 month after study"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No history of grade III or IV peripheral neuropathy",
                "criterions": [
                    {
                        "exact_snippets": "No history of grade III or IV peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
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                    {
                        "exact_snippets": "No history of grade III or IV peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "grade III",
                                "grade IV"
                            ]
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "No history of grade III or IV peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of grade III or IV peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "grade III",
                                "grade IV"
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                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* See Disease Characteristics",
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                        "exact_snippets": "Disease Characteristics",
                        "criterion": "disease characteristics",
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                            "requirement_type": "N/A",
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                    }
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                            "requirement_type": "N/A",
                            "expected_value": "see disease characteristics"
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                            "requirement_type": "status",
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                        "exact_snippets": "Healthy volunteers allowed",
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                            "expected_value": "healthy"
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        },
        {
            "identified_line": {
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
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                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
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                ]
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        },
        {
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    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}