{
    "info": {
        "nct_id": "NCT00147160",
        "official_title": "Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse",
        "inclusion_criteria": "* Age from 4th birthday and younger than 21st birthday\n* Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours\n* Measurable and evaluable disease by the imaging criteria (MRI)\n* Patient not previously treated by either of the two drugs\nHealthy volunteers allowed\nMust have minimum age of 4 Years\nMust have maximum age of 21 Years",
        "exclusion_criteria": "* Malignant brain stem tumours are excluded",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age from 4th birthday and younger than 21st birthday",
            "criterions": [
                {
                    "exact_snippets": "Age from 4th birthday and younger than 21st birthday",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 21,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours",
            "criterions": [
                {
                    "exact_snippets": "Histologically documented malignant glial tumour",
                    "criterion": "malignant glial tumour",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "WHO classification grade III and IV",
                    "criterion": "tumour grade",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "astrocytoma",
                    "criterion": "tumour type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "astrocytoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "oligodendroglioma",
                    "criterion": "tumour type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "oligodendroglioma"
                        }
                    ]
                },
                {
                    "exact_snippets": "oligoastrocytoma",
                    "criterion": "tumour type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "oligoastrocytoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "mixed tumours",
                    "criterion": "tumour type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "mixed tumours"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable and evaluable disease by the imaging criteria (MRI)",
            "criterions": [
                {
                    "exact_snippets": "Measurable ... disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging criteria (MRI)",
                    "criterion": "imaging criteria",
                    "requirements": [
                        {
                            "requirement_type": "modality",
                            "expected_value": "MRI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient not previously treated by either of the two drugs",
            "criterions": [
                {
                    "exact_snippets": "Patient not previously treated by either of the two drugs",
                    "criterion": "previous treatment with specific drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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 4 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 4 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Malignant brain stem tumours are excluded",
            "criterions": [
                {
                    "exact_snippets": "Malignant brain stem tumours are excluded",
                    "criterion": "malignant brain stem tumours",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}