{
    "info": {
        "nct_id": "NCT00490360",
        "official_title": "Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria: - Age > 18 years\n\n* Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head\n* WHO-performance status 0-2\n* Written informed consent\n* Discussion in an intrdisciplinary conference\n\nExclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min)\n\n* Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul)\n* Uncorrectable coagulopathy\n* Severe cholestasis (bilirubin >100mmol/l)\n* Distant metastases in liver, lungs or other organs\n* Peritoneal carcinomatosis\n* Unresectable tumor (s. 4.2.)\n* Contraindication for Whipple procedure\n* Uncontrolled infection\n* Neurotphil count > °2\n* Estimated life experience < 6 months\n* HIV Infection\n* Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent\n* Female patients in child-bearing age without adequate contraception"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Inclusion criteria: - Age > 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age > 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age > 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed",
                        "criterion": "ductal adenocarcinoma confirmation method",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "resectable",
                        "criterion": "ductal adenocarcinoma resectability",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ductal adenocarcinoma",
                        "criterion": "ductal adenocarcinoma presence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pancreatic head",
                        "criterion": "location of ductal adenocarcinoma",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "pancreatic head"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically or cytologically confirmed",
                                "criterion": "ductal adenocarcinoma confirmation method",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "resectable",
                                "criterion": "ductal adenocarcinoma resectability",
                                "requirement": {
                                    "requirement_type": "resectability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "ductal adenocarcinoma",
                                "criterion": "ductal adenocarcinoma presence",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "pancreatic head",
                                "criterion": "location of ductal adenocarcinoma",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "pancreatic head"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* WHO-performance status 0-2",
                "criterions": [
                    {
                        "exact_snippets": "WHO-performance status 0-2",
                        "criterion": "WHO-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": "WHO-performance status 0-2",
                        "criterion": "WHO-performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Discussion in an intrdisciplinary conference",
                "criterions": [
                    {
                        "exact_snippets": "Discussion in an intrdisciplinary conference",
                        "criterion": "interdisciplinary conference discussion",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Discussion in an intrdisciplinary conference",
                        "criterion": "interdisciplinary conference discussion",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Exclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min)",
                "criterions": [
                    {
                        "exact_snippets": "Insufficient renal function (calculated creatinin clearance < 60ml(min)",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Insufficient renal function (calculated creatinin clearance < 60ml(min)",
                    "criterion": "renal function",
                    "requirement": {
                        "requirement_type": "creatinine clearance",
                        "expected_value": {
                            "operator": "<",
                            "value": 60,
                            "unit": "ml/min"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul)",
                "criterions": [
                    {
                        "exact_snippets": "neutrophil count <1'000/ul",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "/ul"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets < 100'000/ul",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "/ul"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "neutrophil count <1'000/ul",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "/ul"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets < 100'000/ul",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "/ul"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Uncorrectable coagulopathy",
                "criterions": [
                    {
                        "exact_snippets": "Uncorrectable coagulopathy",
                        "criterion": "coagulopathy",
                        "requirement": {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Severe cholestasis (bilirubin >100mmol/l)",
                "criterions": [
                    {
                        "exact_snippets": "Severe cholestasis",
                        "criterion": "cholestasis",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "bilirubin >100mmol/l",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmol/l"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Distant metastases in liver, lungs or other organs",
                "criterions": [
                    {
                        "exact_snippets": "Distant metastases in liver",
                        "criterion": "distant metastases in liver",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Distant metastases in ... lungs",
                        "criterion": "distant metastases in lungs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Distant metastases in ... other organs",
                        "criterion": "distant metastases in other organs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Peritoneal carcinomatosis",
                "criterions": [
                    {
                        "exact_snippets": "Peritoneal carcinomatosis",
                        "criterion": "peritoneal carcinomatosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Unresectable tumor (s. 4.2.)",
                "criterions": [
                    {
                        "exact_snippets": "Unresectable tumor",
                        "criterion": "tumor",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Contraindication for Whipple procedure",
                "criterions": [
                    {
                        "exact_snippets": "Contraindication for Whipple procedure",
                        "criterion": "Whipple procedure",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled infection",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Neurotphil count > °2",
                "criterions": [
                    {
                        "exact_snippets": "Neurotphil count > °2",
                        "criterion": "neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Estimated life experience < 6 months",
                "criterions": [
                    {
                        "exact_snippets": "Estimated life experience < 6 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* HIV Infection",
                "criterions": [
                    {
                        "exact_snippets": "HIV Infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Severe medical or psychatric comorbidities",
                        "criterion": "medical or psychiatric comorbidities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "interefere with the participation in this trial",
                        "criterion": "interference with trial participation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "interefere with ... the informed consent",
                        "criterion": "interference with informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Female patients in child-bearing age without adequate contraception",
                "criterions": [
                    {
                        "exact_snippets": "Female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "child-bearing age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing"
                        }
                    },
                    {
                        "exact_snippets": "without adequate contraception",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}