{
    "info": {
        "nct_id": "NCT03848182",
        "official_title": "Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine",
        "inclusion_criteria": "1. Histologically or cytologically confirmed adenocarcinoma of the pancreas\n2. Patients is a candidate for gemcitabine chemotherapy (adjuvant, metastatic, locally advanced, borderline resectable settings all permitted)\n3. Patients at least 18 years of age\n4. ECOG performance status 0-2\n5. Consent to donate 12 tubes of peripheral blood of 10 mL each\n6. Adequate organ function as defined as -neutrophil count ≥ 1200 -platelets ≥ 75,000 -hemoglobin ≥ 8.0 -bilirubin ≤ 2.0 -creatinine ≤2.0 or calculated GFR ≥ 30\n7. Ability to understand and willingness to sign a written informed consent document\n8. Prior chemotherapy permitted, as long as 60 days have lapsed since last dose. Prior radiation therapy permitted, as long as 28 days lapsed since last treatment.\n9. Patients may receive other concurrent chemotherapy, immunotherapy, or radiotherapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "1. Patients never been immunized with tetanus toxoid (TT). Patients with a history of adverse reaction to tetanus vaccine (with the exception of self-limited fever or local tissue reaction\n2. Patients may not be receiving any investigational agents\n3. Pregnant women\n4. Patients with HIV",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Histologically or cytologically confirmed adenocarcinoma of the pancreas",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the pancreas",
                        "criterion": "adenocarcinoma of the pancreas",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the pancreas",
                        "criterion": "adenocarcinoma of the pancreas",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients is a candidate for gemcitabine chemotherapy (adjuvant, metastatic, locally advanced, borderline resectable settings all permitted)",
                "criterions": [
                    {
                        "exact_snippets": "candidate for gemcitabine chemotherapy",
                        "criterion": "gemcitabine chemotherapy candidacy",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adjuvant, metastatic, locally advanced, borderline resectable settings all permitted",
                        "criterion": "treatment setting",
                        "requirement": {
                            "requirement_type": "permitted settings",
                            "expected_value": [
                                "adjuvant",
                                "metastatic",
                                "locally advanced",
                                "borderline resectable"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "candidate for gemcitabine chemotherapy",
                        "criterion": "gemcitabine chemotherapy candidacy",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adjuvant, metastatic, locally advanced, borderline resectable settings all permitted",
                        "criterion": "treatment setting",
                        "requirement": {
                            "requirement_type": "permitted settings",
                            "expected_value": [
                                "adjuvant",
                                "metastatic",
                                "locally advanced",
                                "borderline resectable"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patients at least 18 years of age",
                "criterions": [
                    {
                        "exact_snippets": "Patients at least 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients at least 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. ECOG performance status 0-2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Consent to donate 12 tubes of peripheral blood of 10 mL each",
                "criterions": [
                    {
                        "exact_snippets": "Consent to donate 12 tubes of peripheral blood",
                        "criterion": "donation of peripheral blood",
                        "requirement": {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "12 tubes of peripheral blood of 10 mL each",
                        "criterion": "amount of peripheral blood",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 12,
                                "unit": "tubes"
                            }
                        }
                    },
                    {
                        "exact_snippets": "12 tubes of peripheral blood of 10 mL each",
                        "criterion": "amount of peripheral blood",
                        "requirement": {
                            "requirement_type": "volume per tube",
                            "expected_value": {
                                "operator": "=",
                                "value": 10,
                                "unit": "mL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Consent to donate 12 tubes of peripheral blood",
                        "criterion": "donation of peripheral blood",
                        "requirement": {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "12 tubes of peripheral blood of 10 mL each",
                                "criterion": "amount of peripheral blood",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "=",
                                        "value": 12,
                                        "unit": "tubes"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "12 tubes of peripheral blood of 10 mL each",
                                "criterion": "amount of peripheral blood",
                                "requirement": {
                                    "requirement_type": "volume per tube",
                                    "expected_value": {
                                        "operator": "=",
                                        "value": 10,
                                        "unit": "mL"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Adequate organ function as defined as -neutrophil count ≥ 1200 -platelets ≥ 75,000 -hemoglobin ≥ 8.0 -bilirubin ≤ 2.0 -creatinine ≤2.0 or calculated GFR ≥ 30",
                "criterions": [
                    {
                        "exact_snippets": "neutrophil count ≥ 1200",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1200,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ≥ 75,000",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥ 8.0",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bilirubin ≤ 2.0",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine ≤2.0",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated GFR ≥ 30",
                        "criterion": "calculated GFR",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "neutrophil count ≥ 1200",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1200,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ≥ 75,000",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥ 8.0",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bilirubin ≤ 2.0",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "creatinine ≤2.0",
                                "criterion": "creatinine",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.0,
                                        "unit": "N/A"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "calculated GFR ≥ 30",
                                "criterion": "calculated GFR",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "N/A"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Ability to understand and willingness to sign a written informed consent document",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Prior chemotherapy permitted, as long as 60 days have lapsed since last dose. Prior radiation therapy permitted, as long as 28 days lapsed since last treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Prior chemotherapy permitted, as long as 60 days have lapsed since last dose.",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior radiation therapy permitted, as long as 28 days lapsed since last treatment.",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior chemotherapy permitted, as long as 60 days have lapsed since last dose.",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior radiation therapy permitted, as long as 28 days lapsed since last treatment.",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Patients may receive other concurrent chemotherapy, immunotherapy, or radiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Patients may receive other concurrent chemotherapy",
                        "criterion": "concurrent chemotherapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients may receive other concurrent ... immunotherapy",
                        "criterion": "concurrent immunotherapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients may receive other concurrent ... radiotherapy",
                        "criterion": "concurrent radiotherapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patients may receive other concurrent chemotherapy",
                        "criterion": "concurrent chemotherapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients may receive other concurrent ... immunotherapy",
                        "criterion": "concurrent immunotherapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients may receive other concurrent ... radiotherapy",
                        "criterion": "concurrent radiotherapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 100 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 100 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 100 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patients never been immunized with tetanus toxoid (TT). Patients with a history of adverse reaction to tetanus vaccine (with the exception of self-limited fever or local tissue reaction",
                "criterions": [
                    {
                        "exact_snippets": "Patients never been immunized with tetanus toxoid (TT)",
                        "criterion": "tetanus toxoid immunization",
                        "requirement": {
                            "requirement_type": "immunization status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with a history of adverse reaction to tetanus vaccine",
                        "criterion": "adverse reaction to tetanus vaccine",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "with the exception of self-limited fever or local tissue reaction",
                        "criterion": "adverse reaction to tetanus vaccine",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": [
                                "self-limited fever",
                                "local tissue reaction"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients never been immunized with tetanus toxoid (TT)",
                                "criterion": "tetanus toxoid immunization",
                                "requirement": {
                                    "requirement_type": "immunization status",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients with a history of adverse reaction to tetanus vaccine",
                                "criterion": "adverse reaction to tetanus vaccine",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "with the exception of self-limited fever or local tissue reaction",
                            "criterion": "adverse reaction to tetanus vaccine",
                            "requirement": {
                                "requirement_type": "exception",
                                "expected_value": [
                                    "self-limited fever",
                                    "local tissue reaction"
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients may not be receiving any investigational agents",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not be receiving any investigational agents",
                        "criterion": "investigational agents",
                        "requirement": {
                            "requirement_type": "receiving",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients may not be receiving any investigational agents",
                    "criterion": "investigational agents",
                    "requirement": {
                        "requirement_type": "receiving",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Pregnant women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant women",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Patients with HIV",
                "criterions": [
                    {
                        "exact_snippets": "Patients with HIV",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients with HIV",
                    "criterion": "HIV status",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}