{
    "info": {
        "nct_id": "NCT00308165",
        "official_title": "A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors",
        "inclusion_criteria": "* Single primary malignant brain tumor\n* Previous treatment with external beam radiation\n* Tumor is stereotactically accessible\n* Karnofsky Performance Score of at least 60\nHealthy volunteers allowed\nMust have minimum age of 1 Year",
        "exclusion_criteria": "* Diffuse subependymal or Cerebrospinal fluid (CSF) disease\n* Tumor involves brainstem, cerebellum or both hemispheres\n* Active infection\n* Systemic disease associated with unacceptable anesthetic/operative risk\n* Previous treatment with topotecan\n* Unable to receive MRI scans",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Single primary malignant brain tumor",
            "criterions": [
                {
                    "exact_snippets": "Single primary malignant brain tumor",
                    "criterion": "primary brain tumor",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "single"
                        },
                        {
                            "requirement_type": "malignancy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous treatment with external beam radiation",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with external beam radiation",
                    "criterion": "external beam radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor is stereotactically accessible",
            "criterions": [
                {
                    "exact_snippets": "Tumor is stereotactically accessible",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "stereotactic accessibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky Performance Score of at least 60",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Score of at least 60",
                    "criterion": "Karnofsky Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 1 Year",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 1 Year",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Year"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Diffuse subependymal or Cerebrospinal fluid (CSF) disease",
            "criterions": [
                {
                    "exact_snippets": "Diffuse subependymal",
                    "criterion": "subependymal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Cerebrospinal fluid (CSF) disease",
                    "criterion": "Cerebrospinal fluid (CSF) disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor involves brainstem, cerebellum or both hemispheres",
            "criterions": [
                {
                    "exact_snippets": "Tumor involves brainstem",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "brainstem"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor involves ... cerebellum",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "cerebellum"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor involves ... both hemispheres",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "both hemispheres"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic disease associated with unacceptable anesthetic/operative risk",
            "criterions": [
                {
                    "exact_snippets": "Systemic disease associated with unacceptable anesthetic/operative risk",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "unacceptable anesthetic/operative risk"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous treatment with topotecan",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with topotecan",
                    "criterion": "treatment with topotecan",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to receive MRI scans",
            "criterions": [
                {
                    "exact_snippets": "Unable to receive MRI scans",
                    "criterion": "MRI scan",
                    "requirements": [
                        {
                            "requirement_type": "ability to receive",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}