{
    "info": {
        "nct_id": "NCT02591082",
        "official_title": "A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment With Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath™ RC120 Catheter",
        "inclusion_criteria": "* 18 years of age\n* Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology\n* Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure\n* Willing to provide informed consent and comply with the required follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment.\n* Currently participating in another active drug or device study or registry protocol that would interfere with this study.\n* Vulnerable populations: prisoners, pregnant or breastfeeding females.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* 18 years of age",
                "criterions": [
                    {
                        "exact_snippets": "18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure",
                "criterions": [
                    {
                        "exact_snippets": "Without current myelotoxicity",
                        "criterion": "myelotoxicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sufficient health status to undergo a catheterization procedure",
                        "criterion": "health status",
                        "requirement": {
                            "requirement_type": "sufficiency for procedure",
                            "expected_value": "catheterization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Without current myelotoxicity",
                        "criterion": "myelotoxicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sufficient health status to undergo a catheterization procedure",
                        "criterion": "health status",
                        "requirement": {
                            "requirement_type": "sufficiency for procedure",
                            "expected_value": "catheterization"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Willing to provide informed consent and comply with the required follow-up.",
                "criterions": [
                    {
                        "exact_snippets": "Willing to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "comply with the required follow-up",
                        "criterion": "compliance with follow-up",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willing to provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "comply with the required follow-up",
                        "criterion": "compliance with follow-up",
                        "requirement": {
                            "requirement_type": "willingness",
                            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Have received prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Have received prior ... radiation therapy",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Have received prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Have received prior ... radiation therapy",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently participating in another active drug or device study or registry protocol that would interfere with this study.",
                "criterions": [
                    {
                        "exact_snippets": "Currently participating in another active drug or device study or registry protocol",
                        "criterion": "participation in another study",
                        "requirement": {
                            "requirement_type": "interference with this study",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Currently participating in another active drug or device study or registry protocol",
                        "criterion": "participation in another study",
                        "requirement": {
                            "requirement_type": "interference with this study",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Vulnerable populations: prisoners, pregnant or breastfeeding females.",
                "criterions": [
                    {
                        "exact_snippets": "Vulnerable populations: prisoners",
                        "criterion": "vulnerable population",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "prisoners"
                        }
                    },
                    {
                        "exact_snippets": "Vulnerable populations: ... pregnant",
                        "criterion": "vulnerable population",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "pregnant females"
                        }
                    },
                    {
                        "exact_snippets": "Vulnerable populations: ... breastfeeding females",
                        "criterion": "vulnerable population",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "breastfeeding females"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Vulnerable populations: prisoners",
                        "criterion": "vulnerable population",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "prisoners"
                        }
                    },
                    {
                        "exact_snippets": "Vulnerable populations: ... pregnant",
                        "criterion": "vulnerable population",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "pregnant females"
                        }
                    },
                    {
                        "exact_snippets": "Vulnerable populations: ... breastfeeding females",
                        "criterion": "vulnerable population",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "breastfeeding females"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": [
                                "unresectable",
                                "borderline resectable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "confirmed by histology or cytology",
                        "criterion": "diagnosis confirmation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histology",
                                "cytology"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma",
                                "criterion": "pancreatic adenocarcinoma",
                                "requirement": {
                                    "requirement_type": "resectability",
                                    "expected_value": [
                                        "unresectable",
                                        "borderline resectable"
                                    ]
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "confirmed by histology or cytology",
                                        "criterion": "diagnosis confirmation method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "histology"
                                        }
                                    },
                                    {
                                        "exact_snippets": "confirmed by histology or cytology",
                                        "criterion": "diagnosis confirmation method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "cytology"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}