{
    "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": [
        {
            "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
                }
            ]
        },
        {
            "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"
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy ≥ 3 months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "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
                    }
                }
            ]
        },
        {
            "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
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Diagnosis of brainstem glioma",
            "criterions": [
                {
                    "exact_snippets": [
                        "Diagnosis of brainstem glioma"
                    ],
                    "criterion": "brainstem glioma",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            ]
        },
        {
            "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
                }
            ]
        },
        {
            "line": "* Pre-existing uncontrolled diarrhea",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pre-existing uncontrolled diarrhea"
                    ],
                    "criterion": "diarrhea",
                    "requirement_type": "control status",
                    "expected_value": "uncontrolled"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}