{
    "info": {
        "nct_id": "NCT00040391",
        "official_title": "A Phase II, Randomized, Open-label, Controlled, Dose-elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer",
        "inclusion_criteria": "* Age 18 years or older\n* Diagnosis of colorectal cancer or adenocarcinoma of the appendix\n* A tumor mass that can be measured\n* Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1\n* Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Women that are pregnant or lactating\n* Prior treatment with Irinotecan\n* Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication\n* Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization\n* Current enrollment in another clinical trial\n* Administration of any prior systemic anticancer therapy for metastatic colorectal cancer",
        "miscellaneous_criteria": "Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary."
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Age 18 years or older",
                "criterions": [
                    {
                        "exact_snippets": "Age 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosis of colorectal cancer or adenocarcinoma of the appendix",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of colorectal cancer",
                        "criterion": "colorectal cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adenocarcinoma of the appendix",
                        "criterion": "adenocarcinoma of the appendix",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Diagnosis of colorectal cancer",
                        "criterion": "colorectal cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adenocarcinoma of the appendix",
                        "criterion": "adenocarcinoma of the appendix",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A tumor mass that can be measured",
                "criterions": [
                    {
                        "exact_snippets": "A tumor mass that can be measured",
                        "criterion": "tumor mass",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "A tumor mass that can be measured",
                        "criterion": "tumor mass",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Women that are pregnant or lactating",
                "criterions": [
                    {
                        "exact_snippets": "Women that are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Women that are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with Irinotecan",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with Irinotecan",
                        "criterion": "Irinotecan treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior treatment with Irinotecan",
                        "criterion": "Irinotecan treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication",
                "criterions": [
                    {
                        "exact_snippets": "Partial or complete bowel obstruction",
                        "criterion": "bowel obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known chronic malabsorption",
                        "criterion": "chronic malabsorption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "total colectomy",
                        "criterion": "total colectomy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other major abdominal surgery ... substantial alteration in transit or absorption of oral medication",
                        "criterion": "major abdominal surgery affecting medication absorption",
                        "requirement": {
                            "requirement_type": "impact on medication absorption",
                            "expected_value": "substantial alteration"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Partial or complete bowel obstruction",
                                "criterion": "bowel obstruction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "known chronic malabsorption",
                                "criterion": "chronic malabsorption",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "total colectomy",
                                "criterion": "total colectomy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other major abdominal surgery ... substantial alteration in transit or absorption of oral medication",
                                "criterion": "major abdominal surgery affecting medication absorption",
                                "requirement": {
                                    "requirement_type": "impact on medication absorption",
                                    "expected_value": "substantial alteration"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization",
                "criterions": [
                    {
                        "exact_snippets": "Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization",
                        "criterion": "adjuvant therapy for colorectal cancer",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization",
                    "criterion": "adjuvant therapy for colorectal cancer",
                    "requirement": {
                        "requirement_type": "time since last dose",
                        "expected_value": {
                            "operator": "<=",
                            "value": 6,
                            "unit": "months"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Current enrollment in another clinical trial",
                "criterions": [
                    {
                        "exact_snippets": "Current enrollment in another clinical trial",
                        "criterion": "enrollment in another clinical trial",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "current"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Current enrollment in another clinical trial",
                    "criterion": "enrollment in another clinical trial",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "current"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Administration of any prior systemic anticancer therapy for metastatic colorectal cancer",
                "criterions": [
                    {
                        "exact_snippets": "Administration of any prior systemic anticancer therapy for metastatic colorectal cancer",
                        "criterion": "prior systemic anticancer therapy for metastatic colorectal cancer",
                        "requirement": {
                            "requirement_type": "administration",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Administration of any prior systemic anticancer therapy for metastatic colorectal cancer",
                    "criterion": "prior systemic anticancer therapy for metastatic colorectal cancer",
                    "requirement": {
                        "requirement_type": "administration",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1",
                "criterions": [
                    {
                        "exact_snippets": "Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1",
                        "criterion": "toxic effects of radiotherapy or surgical procedures",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTC grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures",
                "criterions": [
                    {
                        "exact_snippets": "Willingness and ability to comply with scheduled visits",
                        "criterion": "compliance with scheduled visits",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with scheduled visits",
                        "criterion": "compliance with scheduled visits",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with ... treatment plan",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with ... treatment plan",
                        "criterion": "compliance with treatment plan",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with ... laboratory tests",
                        "criterion": "compliance with laboratory tests",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with ... laboratory tests",
                        "criterion": "compliance with laboratory tests",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with ... other study procedures",
                        "criterion": "compliance with other study procedures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability to comply with ... other study procedures",
                        "criterion": "compliance with other study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "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": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "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": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}