{
    "info": {
        "nct_id": "NCT02379520",
        "official_title": "HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers",
        "inclusion_criteria": "PROCUREMENT\n\n1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample\n2. Cancer is:\n\n   * recurrent or persistent after standard therapy\n   * OR patient is unable to receive standard therapy\n3. Karnofsky score ≥ 50%\n4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent\n\nTREATMENT\n\n1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample\n2. Cancer is:\n\n   * recurrent or persistent after standard therapy\n   * OR patient is unable to receive standard therapy\n3. Life expectancy ≥ 6 weeks.\n4. Age ≥ 18 years.\n5. Karnofsky score ≥ 50%\n6. Bilirubin < 3 × upper limit of normal (ULN), AST < 5 × ULN, Hgb ≥ 7.0 g/dL\n7. Pulse oximetry of > 90% on room air.\n8. GFR > 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent\n9. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent\n10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "PROCUREMENT\n\n1. Known HIV positivity.\n\nTREATMENT\n\n1. Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.\n2. Severe intercurrent infection.\n3. Pregnancy or lactation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "PROCUREMENT",
            "criterions": [
                {
                    "exact_snippets": "PROCUREMENT",
                    "criterion": "PROCUREMENT",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "PROCUREMENT"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of a cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of a high risk HPV type",
                    "criterion": "high risk HPV type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented in a biopsy sample",
                    "criterion": "biopsy sample documentation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Cancer is:",
            "criterions": [
                {
                    "exact_snippets": "Cancer is:",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* recurrent or persistent after standard therapy",
            "criterions": [
                {
                    "exact_snippets": "recurrent",
                    "criterion": "disease recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "persistent",
                    "criterion": "disease persistence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after standard therapy",
                    "criterion": "prior standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* OR patient is unable to receive standard therapy",
            "criterions": [
                {
                    "exact_snippets": "patient is unable to receive standard therapy",
                    "criterion": "ability to receive standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Karnofsky score ≥ 50%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky score ≥ 50%",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. 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",
                    "requirements": [
                        {
                            "requirement_type": "explanation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient/guardian given copy of informed consent",
                    "criterion": "informed consent copy",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "TREATMENT",
            "criterions": [
                {
                    "exact_snippets": "TREATMENT",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of a cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of a high risk HPV type",
                    "criterion": "high risk HPV type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented in a biopsy sample",
                    "criterion": "biopsy sample documentation",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Cancer is:",
            "criterions": [
                {
                    "exact_snippets": "Cancer is",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* recurrent or persistent after standard therapy",
            "criterions": [
                {
                    "exact_snippets": "recurrent",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recurrent"
                        }
                    ]
                },
                {
                    "exact_snippets": "persistent",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "persistent"
                        }
                    ]
                },
                {
                    "exact_snippets": "after standard therapy",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": "standard therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* OR patient is unable to receive standard therapy",
            "criterions": [
                {
                    "exact_snippets": "patient is unable to receive standard therapy",
                    "criterion": "ability to receive standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Life expectancy ≥ 6 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 6 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Karnofsky score ≥ 50%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky score ≥ 50%",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Bilirubin < 3 × upper limit of normal (ULN), AST < 5 × ULN, Hgb ≥ 7.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 3 × upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST < 5 × ULN",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hgb ≥ 7.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pulse oximetry of > 90% on room air.",
            "criterions": [
                {
                    "exact_snippets": "Pulse oximetry of > 90%",
                    "criterion": "pulse oximetry",
                    "requirements": [
                        {
                            "requirement_type": "oxygen saturation",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. GFR > 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent",
            "criterions": [
                {
                    "exact_snippets": "GFR > 30 mL/min",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent",
                    "criterion": "GFR calculation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "Cockcroft-Gault",
                                "MDRD study",
                                "CKD-EPI creatinine equations",
                                "equivalent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. 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",
                    "requirements": [
                        {
                            "requirement_type": "explanation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient/guardian given copy of informed consent",
                    "criterion": "informed consent copy",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.",
            "criterions": [
                {
                    "exact_snippets": "Sexually active patients",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to utilize one of the more effective birth control methods",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 6 months after the study is concluded",
                    "criterion": "duration of birth control use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 6 months after the study is concluded"
                        }
                    ]
                },
                {
                    "exact_snippets": "The male partner should use a condom",
                    "criterion": "male partner condom use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "PROCUREMENT",
            "criterions": [
                {
                    "exact_snippets": "PROCUREMENT",
                    "criterion": "PROCUREMENT",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "PROCUREMENT"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Known HIV positivity.",
            "criterions": [
                {
                    "exact_snippets": "Known HIV positivity.",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "TREATMENT",
            "criterions": [
                {
                    "exact_snippets": "TREATMENT",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "TREATMENT"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving any investigational agents",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have received any tumor vaccines ... within previous 4 weeks",
                    "criterion": "tumor vaccines",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have received any ... T cell antibodies within previous 4 weeks",
                    "criterion": "T cell antibodies",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Severe intercurrent infection.",
            "criterions": [
                {
                    "exact_snippets": "Severe intercurrent infection",
                    "criterion": "intercurrent infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pregnancy or lactation.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}