{
    "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": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "highly suspicious cancerous mass based on imaging and clinical signs",
                    "criterion": "cancerous mass",
                    "requirements": [
                        {
                            "requirement_type": "suspicion level",
                            "expected_value": "highly suspicious"
                        },
                        {
                            "requirement_type": "basis",
                            "expected_value": [
                                "imaging",
                                "clinical signs"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not indicative of a direct biopsy/cellular diagnosis preceding surgery",
                    "criterion": "biopsy/cellular diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "appropriate initial therapy",
                            "expected_value": "surgical biopsy or resection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status - ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance status - ECOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy not specified",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy not specified",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC greater than 2,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "WBC greater than 2,000/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count greater than 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count greater than 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine less than 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine less than 2.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance greater than 50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance greater than 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant cardiac disease that would preclude the safe use of general anesthesia",
            "criterions": [
                {
                    "exact_snippets": "No significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant pulmonary disease that would preclude the safe use of general anesthesia",
            "criterions": [
                {
                    "exact_snippets": "No significant pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception during and for 1 month after study",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception during and for 1 month after study",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 1 month after study"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "grade III",
                                "grade IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}