{
    "info": {
        "nct_id": "NCT01205334",
        "official_title": "Phase I/II Administration of CMV (Cytomegalovirus)-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme (COGLI)",
        "inclusion_criteria": "Healthy volunteers allowed",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "INCLUSION CRITERIA:\n\n* Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) in remission (Group A) or with active disease (Group B).\n* CMV-positive GBM\n* CMV seropositive\n* Life expectancy 6 weeks or greater\n* Karnofsky/Lansky score 50 or greater\n* Patient or parent/guardian capable of providing informed consent\n* Bilirubin less than 1.5x upper limit of normal, AST less than 3x upper limit of normal, serum creatinine less than 1.5x normal and Hgb 8.0 g/dL or greater\n* Pulse oximetry of 90% or greater on room air\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.\n* Patients should have been off other investigational antineoplastic therapy for one month prior to entry in this study.\n* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.\n\nEXCLUSION CRITERIA:\n\n* Severe intercurrent infection\n* Known HIV positivity\n* Pregnant or lactating\n* History of hypersensitivity reactions to murine protein-containing products."
    },
    "inclusion_lines": [
        {
            "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
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) in remission (Group A) or with active disease (Group B).",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Histopathological verification of glioblastoma multiforme"
                        ],
                        "criterion": "glioblastoma multiforme",
                        "requirement_type": "verification",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "glioblastoma multiforme (GBM: WHO grade IV)"
                        ],
                        "criterion": "glioblastoma multiforme",
                        "requirement_type": "grade",
                        "expected_value": "WHO grade IV"
                    },
                    {
                        "exact_snippets": [
                            "glioblastoma multiforme",
                            "in remission"
                        ],
                        "criterion": "glioblastoma multiforme",
                        "requirement_type": "disease status",
                        "expected_value": "remission"
                    },
                    {
                        "exact_snippets": [
                            "glioblastoma multiforme",
                            "with active disease"
                        ],
                        "criterion": "glioblastoma multiforme",
                        "requirement_type": "disease status",
                        "expected_value": "active disease"
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Histopathological verification of glioblastoma multiforme"
                                ],
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                                "requirement_type": "verification",
                                "expected_value": true
                            },
                            {
                                "exact_snippets": [
                                    "glioblastoma multiforme (GBM: WHO grade IV)"
                                ],
                                "criterion": "glioblastoma multiforme",
                                "requirement_type": "grade",
                                "expected_value": "WHO grade IV"
                            },
                            {
                                "exact_snippets": [
                                    "glioblastoma multiforme",
                                    "in remission"
                                ],
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                                "requirement_type": "disease status",
                                "expected_value": "remission"
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Histopathological verification of glioblastoma multiforme"
                                ],
                                "criterion": "glioblastoma multiforme",
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                                "expected_value": true
                            },
                            {
                                "exact_snippets": [
                                    "glioblastoma multiforme (GBM: WHO grade IV)"
                                ],
                                "criterion": "glioblastoma multiforme",
                                "requirement_type": "grade",
                                "expected_value": "WHO grade IV"
                            },
                            {
                                "exact_snippets": [
                                    "glioblastoma multiforme",
                                    "with active disease"
                                ],
                                "criterion": "glioblastoma multiforme",
                                "requirement_type": "disease status",
                                "expected_value": "active disease"
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CMV-positive GBM",
                "criterions": [
                    {
                        "exact_snippets": [
                            "CMV-positive"
                        ],
                        "criterion": "CMV",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "GBM"
                        ],
                        "criterion": "GBM",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "CMV-positive"
                        ],
                        "criterion": "CMV",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "GBM"
                        ],
                        "criterion": "GBM",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CMV seropositive",
                "criterions": [
                    {
                        "exact_snippets": [
                            "CMV seropositive"
                        ],
                        "criterion": "CMV",
                        "requirement_type": "serostatus",
                        "expected_value": "positive"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "CMV seropositive"
                        ],
                        "criterion": "CMV",
                        "requirement_type": "serostatus",
                        "expected_value": "positive"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy 6 weeks or greater",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Life expectancy 6 weeks or greater"
                        ],
                        "criterion": "life expectancy",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 6
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Life expectancy 6 weeks or greater"
                        ],
                        "criterion": "life expectancy",
                        "requirement_type": "duration",
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                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 6
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Karnofsky/Lansky score 50 or greater",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Karnofsky/Lansky score"
                        ],
                        "criterion": "Karnofsky/Lansky score",
                        "requirement_type": "value",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 50
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Karnofsky/Lansky score"
                        ],
                        "criterion": "Karnofsky/Lansky score",
                        "requirement_type": "value",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 50
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient or parent/guardian capable of providing informed consent",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Patient or parent/guardian capable of providing informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "capability",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Patient or parent/guardian capable of providing informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "capability",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin less than 1.5x upper limit of normal, AST less than 3x upper limit of normal, serum creatinine less than 1.5x normal and Hgb 8.0 g/dL or greater",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Bilirubin less than 1.5x upper limit of normal"
                        ],
                        "criterion": "bilirubin",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<",
                                    "value": 1.5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "AST less than 3x upper limit of normal"
                        ],
                        "criterion": "AST",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<",
                                    "value": 3
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "serum creatinine less than 1.5x normal"
                        ],
                        "criterion": "serum creatinine",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<",
                                    "value": 1.5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "Hgb 8.0 g/dL or greater"
                        ],
                        "criterion": "Hgb",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 8.0
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Bilirubin less than 1.5x upper limit of normal"
                                ],
                                "criterion": "bilirubin",
                                "requirement_type": "quantity",
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                                        {
                                            "operator": "<",
                                            "value": 1.5
                                        }
                                    ]
                                }
                            },
                            {
                                "exact_snippets": [
                                    "AST less than 3x upper limit of normal"
                                ],
                                "criterion": "AST",
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<",
                                            "value": 3
                                        }
                                    ]
                                }
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                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "serum creatinine less than 1.5x normal"
                                ],
                                "criterion": "serum creatinine",
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                                            "operator": "<",
                                            "value": 1.5
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                            {
                                "exact_snippets": [
                                    "Hgb 8.0 g/dL or greater"
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                                "criterion": "Hgb",
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                                        {
                                            "operator": ">=",
                                            "value": 8.0
                                        }
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                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pulse oximetry of 90% or greater on room air",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Pulse oximetry",
                            "90% or greater"
                        ],
                        "criterion": "pulse oximetry",
                        "requirement_type": "level",
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                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 90
                                }
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                    }
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            "logical_structure": {
                "and_criteria": [
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                        "exact_snippets": [
                            "Pulse oximetry",
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                                    "operator": ">=",
                                    "value": 90
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Sexually active patients"
                        ],
                        "criterion": "sexual activity",
                        "requirement_type": "status",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "must be willing to utilize one of the more effective birth control methods"
                        ],
                        "criterion": "birth control method",
                        "requirement_type": "willingness to use",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "for 6 months after the CTL infusion"
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                        "requirement_type": "duration of use",
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                    },
                    {
                        "exact_snippets": [
                            "The male partner should use a condom"
                        ],
                        "criterion": "condom use",
                        "requirement_type": "requirement",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": [
                        "Sexually active patients"
                    ],
                    "criterion": "sexual activity",
                    "requirement_type": "status",
                    "expected_value": true
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": [
                                "must be willing to utilize one of the more effective birth control methods"
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                            "criterion": "birth control method",
                            "requirement_type": "willingness to use",
                            "expected_value": true
                        },
                        {
                            "exact_snippets": [
                                "for 6 months after the CTL infusion"
                            ],
                            "criterion": "birth control method",
                            "requirement_type": "duration of use",
                            "expected_value": "6 months"
                        },
                        {
                            "exact_snippets": [
                                "The male partner should use a condom"
                            ],
                            "criterion": "condom use",
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients should have been off other investigational antineoplastic therapy for one month prior to entry in this study.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "off other investigational antineoplastic therapy for one month prior to entry"
                        ],
                        "criterion": "investigational antineoplastic therapy",
                        "requirement_type": "cessation period",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "off other investigational antineoplastic therapy for one month prior to entry"
                        ],
                        "criterion": "investigational antineoplastic therapy",
                        "requirement_type": "cessation period",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Informed consent explained to, understood by and signed by patient/guardian"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "signed",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Patient/guardian given copy of informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "copy given",
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                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Informed consent explained to, understood by and signed by patient/guardian"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "signed",
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                    },
                    {
                        "exact_snippets": [
                            "Patient/guardian given copy of informed consent"
                        ],
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                        "requirement_type": "copy given",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Severe intercurrent infection",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Severe intercurrent infection"
                        ],
                        "criterion": "intercurrent infection",
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "Severe intercurrent infection"
                    ],
                    "criterion": "intercurrent infection",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known HIV positivity",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Known HIV positivity"
                        ],
                        "criterion": "HIV",
                        "requirement_type": "positivity",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Known HIV positivity"
                        ],
                        "criterion": "HIV",
                        "requirement_type": "positivity",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or lactating",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "status",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "lactating"
                        ],
                        "criterion": "lactation",
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                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
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                        "requirement_type": "status",
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                    },
                    {
                        "exact_snippets": [
                            "lactating"
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of hypersensitivity reactions to murine protein-containing products.",
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                    {
                        "exact_snippets": [
                            "History of hypersensitivity reactions"
                        ],
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                        "requirement_type": "history",
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                    },
                    {
                        "exact_snippets": [
                            "murine protein-containing products"
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                    }
                ]
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            "logical_structure": {
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                            "History of hypersensitivity reactions"
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                    },
                    {
                        "exact_snippets": [
                            "murine protein-containing products"
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                ]
            }
        },
        {
            "identified_line": {
                "line": "INCLUSION CRITERIA:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "EXCLUSION CRITERIA:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}