{
    "info": {
        "nct_id": "NCT00404495",
        "official_title": "Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.",
        "inclusion_criteria": "* Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.\n* Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4)\n* Life expectancy ≥ 3 months\nHealthy volunteers allowed\nMust have minimum age of 6 Months\nMust have maximum age of 18 Years",
        "exclusion_criteria": "* Diagnosis of brainstem glioma\n* Concurrent administration of any other anti-tumor therapy\n* Pre-existing uncontrolled diarrhea",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Recurrent or refractory medulloblastoma"
                        ],
                        "criterion": "medulloblastoma",
                        "requirement_type": "status",
                        "expected_value": [
                            "recurrent",
                            "refractory"
                        ]
                    },
                    {
                        "exact_snippets": [
                            "current standard treatment approaches have failed"
                        ],
                        "criterion": "standard treatment",
                        "requirement_type": "outcome",
                        "expected_value": "failed"
                    },
                    {
                        "exact_snippets": [
                            "biopsy is not required for recurrent disease"
                        ],
                        "criterion": "biopsy",
                        "requirement_type": "requirement",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": [
                                "Recurrent or refractory medulloblastoma"
                            ],
                            "criterion": "medulloblastoma",
                            "requirement_type": "status",
                            "expected_value": [
                                "recurrent",
                                "refractory"
                            ]
                        },
                        {
                            "exact_snippets": [
                                "current standard treatment approaches have failed"
                            ],
                            "criterion": "standard treatment",
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": [
                        "biopsy is not required for recurrent disease"
                    ],
                    "criterion": "biopsy",
                    "requirement_type": "requirement",
                    "expected_value": false
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Newly-diagnosed"
                        ],
                        "criterion": "diagnosis status",
                        "requirement_type": "recency",
                        "expected_value": "newly-diagnosed"
                    },
                    {
                        "exact_snippets": [
                            "high-grade glioma"
                        ],
                        "criterion": "glioma",
                        "requirement_type": "grade",
                        "expected_value": "high-grade"
                    },
                    {
                        "exact_snippets": [
                            "World Health Organization [WHO] grade 3 or 4"
                        ],
                        "criterion": "glioma",
                        "requirement_type": "WHO grade",
                        "expected_value": [
                            "3",
                            "4"
                        ]
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Newly-diagnosed"
                        ],
                        "criterion": "diagnosis status",
                        "requirement_type": "recency",
                        "expected_value": "newly-diagnosed"
                    },
                    {
                        "exact_snippets": [
                            "high-grade glioma"
                        ],
                        "criterion": "glioma",
                        "requirement_type": "grade",
                        "expected_value": "high-grade"
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "World Health Organization [WHO] grade 3 or 4"
                                ],
                                "criterion": "glioma",
                                "requirement_type": "WHO grade",
                                "expected_value": "3"
                            },
                            {
                                "exact_snippets": [
                                    "World Health Organization [WHO] grade 3 or 4"
                                ],
                                "criterion": "glioma",
                                "requirement_type": "WHO grade",
                                "expected_value": "4"
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy ≥ 3 months",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Life expectancy ≥ 3 months"
                        ],
                        "criterion": "life expectancy",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 3
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Life expectancy ≥ 3 months"
                        ],
                        "criterion": "life expectancy",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 3
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
                        "criterion": "healthy volunteers",
                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
                        "criterion": "healthy volunteers",
                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 6 Months",
                "criterions": [
                    {
                        "exact_snippets": [
                            "minimum age of 6 Months"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 0.5
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "minimum age of 6 Months"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 0.5
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "maximum age of 18 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "maximum",
                        "expected_value": {
                            "operator": "<=",
                            "value": 18
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "maximum age of 18 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "maximum",
                        "expected_value": {
                            "operator": "<=",
                            "value": 18
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Diagnosis of brainstem glioma",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Diagnosis of brainstem glioma"
                        ],
                        "criterion": "brainstem glioma",
                        "requirement_type": "diagnosis",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "Diagnosis of brainstem glioma"
                    ],
                    "criterion": "brainstem glioma",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent administration of any other anti-tumor therapy",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Concurrent administration of any other anti-tumor therapy"
                        ],
                        "criterion": "anti-tumor therapy",
                        "requirement_type": "concurrent administration",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "Concurrent administration of any other anti-tumor therapy"
                    ],
                    "criterion": "anti-tumor therapy",
                    "requirement_type": "concurrent administration",
                    "expected_value": true
                }
            }
        },
        {
            "identified_line": {
                "line": "* Pre-existing uncontrolled diarrhea",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Pre-existing uncontrolled diarrhea"
                        ],
                        "criterion": "diarrhea",
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "Pre-existing uncontrolled diarrhea"
                    ],
                    "criterion": "diarrhea",
                    "requirement_type": "control status",
                    "expected_value": "uncontrolled"
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}