{
    "info": {
        "nct_id": "NCT00004872",
        "official_title": "Phase I Study of Endostatin in Advanced Cancer Patients",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory solid tumor for which no curative therapy exists Bidimensionally measurable or evaluable disease accessible to biopsy No brain metastases or primary brain tumors\n\nPATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: No serious active infection Not pregnant or nursing Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified"
    },
    "inclusion_lines": [
        {
            "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",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            },
            "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 120 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 120 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified",
                "criterions": [
                    {
                        "exact_snippets": "At least 4 weeks since prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior radiotherapy and recovered",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior radiotherapy and recovered",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "At least 4 weeks since prior chemotherapy",
                                "criterion": "prior chemotherapy",
                                "requirement": {
                                    "requirement_type": "time since",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "At least 4 weeks since prior radiotherapy and recovered",
                                "criterion": "prior radiotherapy",
                                "requirement": {
                                    "requirement_type": "time since",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "At least 4 weeks since prior radiotherapy and recovered",
                                "criterion": "prior radiotherapy",
                                "requirement": {
                                    "requirement_type": "recovery",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory solid tumor for which no curative therapy exists Bidimensionally measurable or evaluable disease accessible to biopsy No brain metastases or primary brain tumors",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed advanced refractory solid tumor",
                        "criterion": "advanced refractory solid tumor",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "no curative therapy exists",
                        "criterion": "curative therapy",
                        "requirement": {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Bidimensionally measurable or evaluable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "bidimensionally measurable",
                                "evaluable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "disease accessible to biopsy",
                        "criterion": "disease accessibility to biopsy",
                        "requirement": {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... primary brain tumors",
                        "criterion": "primary brain tumors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "Histologically confirmed advanced refractory solid tumor",
                                                                "criterion": "advanced refractory solid tumor",
                                                                "requirement": {
                                                                    "requirement_type": "confirmation",
                                                                    "expected_value": "histologically confirmed"
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "no curative therapy exists",
                                                                "criterion": "curative therapy",
                                                                "requirement": {
                                                                    "requirement_type": "existence",
                                                                    "expected_value": false
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "or_criteria": [
                                                            {
                                                                "exact_snippets": "Bidimensionally measurable or evaluable disease",
                                                                "criterion": "disease measurability",
                                                                "requirement": {
                                                                    "requirement_type": "measurability",
                                                                    "expected_value": "bidimensionally measurable"
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "Bidimensionally measurable or evaluable disease",
                                                                "criterion": "disease measurability",
                                                                "requirement": {
                                                                    "requirement_type": "measurability",
                                                                    "expected_value": "evaluable"
                                                                }
                                                            }
                                                        ]
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "disease accessible to biopsy",
                                                "criterion": "disease accessibility to biopsy",
                                                "requirement": {
                                                    "requirement_type": "accessibility",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "No brain metastases",
                                        "criterion": "brain metastases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "No ... primary brain tumors",
                                "criterion": "primary brain tumors",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "No ... primary brain tumors",
                        "criterion": "primary brain tumors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: No serious active infection Not pregnant or nursing Fertile patients must use effective contraception",
                "criterions": [
                    {
                        "exact_snippets": "Age: Over 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "> 18"
                        }
                    },
                    {
                        "exact_snippets": "Performance status: ECOG 0-1",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "scale",
                            "expected_value": "ECOG 0-1"
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy: Not specified",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    },
                    {
                        "exact_snippets": "Hematopoietic: WBC at least 4,000/mm3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hematopoietic: ... Absolute neutrophil count at least 2,000/mm3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic: Bilirubin normal",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "AST/SGOT no greater than 2 times upper limit of normal (ULN)",
                        "criterion": "AST/SGOT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Renal: Creatinine no greater than 1.5 mg/dL",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine clearance greater than 60 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No serious active infection",
                        "criterion": "serious active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Not pregnant or nursing",
                        "criterion": "pregnancy or nursing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Fertile patients must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": "required for fertile patients"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}