{
    "info": {
        "nct_id": "NCT00002262",
        "official_title": "A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\nPatients must have:\n\n* Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.\n* Minimum life expectancy of 3 months.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Clinically significant cardiac disease.\n* Known hemorrhagic diathesis or active bleeding disorder.\n* Clinically apparent vascular disease.\n* Known lipoprotein disorders.\n* History of seizure disorder or central nervous system (CNS) metastasis.\n* Additional malignancy.\n\nConcurrent Medication:\n\nExcluded:\n\n* Cardiac agents.\n* Anticoagulants.\n* Thrombolytic agents.\n* Nonsteroidal anti-inflammatory drugs.\n* Corticosteroids.\n* Aspirin.\n* Vasodilators.\n\nPatients with the following are excluded:\n\n* Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions.\n\nPrior Treatment:\n\nExcluded within 4 weeks of study entry:\n\n* Chemotherapy.\n* Radiotherapy.\n* Immunotherapy."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.",
            "criterions": [
                {
                    "exact_snippets": "Biopsy-proven Kaposi's sarcoma (KS)",
                    "criterion": "Kaposi's sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "biopsy-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "multiple cutaneous lesions",
                    "criterion": "cutaneous lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minimum life expectancy of 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Minimum life expectancy of 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Co-existing Condition:",
            "criterions": [
                {
                    "exact_snippets": "Co-existing Condition",
                    "criterion": "co-existing condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiac disease.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hemorrhagic diathesis or active bleeding disorder.",
            "criterions": [
                {
                    "exact_snippets": "Known hemorrhagic diathesis",
                    "criterion": "hemorrhagic diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically apparent vascular disease.",
            "criterions": [
                {
                    "exact_snippets": "Clinically apparent vascular disease",
                    "criterion": "vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical appearance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known lipoprotein disorders.",
            "criterions": [
                {
                    "exact_snippets": "Known lipoprotein disorders",
                    "criterion": "lipoprotein disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of seizure disorder or central nervous system (CNS) metastasis.",
            "criterions": [
                {
                    "exact_snippets": "History of seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "central nervous system (CNS) metastasis",
                    "criterion": "CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Additional malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Additional malignancy",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Concurrent Medication:",
            "criterions": [
                {
                    "exact_snippets": "Concurrent Medication",
                    "criterion": "concurrent medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac agents.",
            "criterions": [
                {
                    "exact_snippets": "Cardiac agents",
                    "criterion": "cardiac agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anticoagulants.",
            "criterions": [
                {
                    "exact_snippets": "Anticoagulants",
                    "criterion": "anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thrombolytic agents.",
            "criterions": [
                {
                    "exact_snippets": "Thrombolytic agents.",
                    "criterion": "thrombolytic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nonsteroidal anti-inflammatory drugs.",
            "criterions": [
                {
                    "exact_snippets": "Nonsteroidal anti-inflammatory drugs",
                    "criterion": "nonsteroidal anti-inflammatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "Corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspirin.",
            "criterions": [
                {
                    "exact_snippets": "Aspirin",
                    "criterion": "aspirin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vasodilators.",
            "criterions": [
                {
                    "exact_snippets": "Vasodilators",
                    "criterion": "vasodilator use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions.",
            "criterions": [
                {
                    "exact_snippets": "Additional malignancies",
                    "criterion": "additional malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other conditions listed in Patient Exclusion Co-Existing Conditions",
                    "criterion": "other conditions listed in Patient Exclusion Co-Existing Conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Prior Treatment:",
            "criterions": [
                {
                    "exact_snippets": "Prior Treatment",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Excluded within 4 weeks of study entry:",
            "criterions": [
                {
                    "exact_snippets": "Excluded within 4 weeks of study entry",
                    "criterion": "time since exclusion",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Patients must have:",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        },
        {
            "line": "Patients with the following conditions or symptoms are excluded:",
            "criterions": []
        },
        {
            "line": "Excluded:",
            "criterions": []
        },
        {
            "line": "Patients with the following are excluded:",
            "criterions": []
        }
    ]
}