{
    "info": {
        "nct_id": "NCT00409994",
        "official_title": "A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and Phase II Study",
        "inclusion_criteria": "* Histologically proven rectum cancer\n* UICC TNM I-III\n* WHO performance status 0-2\n* Less than 10% weight loss the last 6 months\n* No recent (< 3 months) severe cardiac disease\n* Normal serum bilirubin and serum creatinin\nHealthy volunteers allowed",
        "exclusion_criteria": "* Concurrent chemotherapy with radiation\n* History of prior pelvis radiotherapy\n* Recent (<3 months) myocardial infarction\n* Uncontrolled infectious disease\n* Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically proven rectum cancer",
                "criterions": [
                    {
                        "exact_snippets": "Histologically proven rectum cancer",
                        "criterion": "rectum cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically proven rectum cancer",
                        "criterion": "rectum cancer",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* UICC TNM I-III",
                "criterions": [
                    {
                        "exact_snippets": "UICC TNM I-III",
                        "criterion": "UICC TNM stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "UICC TNM I-III",
                        "criterion": "UICC TNM stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "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": "* Less than 10% weight loss the last 6 months",
                "criterions": [
                    {
                        "exact_snippets": "Less than 10% weight loss the last 6 months",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Less than 10% weight loss the last 6 months",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "time period",
                            "expected_value": "last 6 months"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Less than 10% weight loss the last 6 months",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Less than 10% weight loss the last 6 months",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "time period",
                            "expected_value": "last 6 months"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No recent (< 3 months) severe cardiac disease",
                "criterions": [
                    {
                        "exact_snippets": "No recent (< 3 months) severe cardiac disease",
                        "criterion": "severe cardiac disease",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No recent (< 3 months) severe cardiac disease",
                        "criterion": "severe cardiac disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "No recent (< 3 months) severe cardiac disease",
                            "criterion": "severe cardiac disease",
                            "requirement": {
                                "requirement_type": "recency",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 3,
                                    "unit": "months"
                                }
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "No recent (< 3 months) severe cardiac disease",
                            "criterion": "severe cardiac disease",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Normal serum bilirubin and serum creatinin",
                "criterions": [
                    {
                        "exact_snippets": "Normal serum bilirubin",
                        "criterion": "serum bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal ... serum creatinin",
                        "criterion": "serum creatinin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Normal serum bilirubin",
                        "criterion": "serum bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal ... serum creatinin",
                        "criterion": "serum creatinin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
            }
        },
        {
            "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"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Concurrent chemotherapy with radiation",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent chemotherapy with radiation",
                        "criterion": "chemotherapy with radiation",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Concurrent chemotherapy with radiation",
                    "criterion": "chemotherapy with radiation",
                    "requirement": {
                        "requirement_type": "concurrency",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of prior pelvis radiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "History of prior pelvis radiotherapy",
                        "criterion": "prior pelvis radiotherapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of prior pelvis radiotherapy",
                    "criterion": "prior pelvis radiotherapy",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Recent (<3 months) myocardial infarction",
                "criterions": [
                    {
                        "exact_snippets": "Recent (<3 months) myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Recent (<3 months) myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirement": {
                        "requirement_type": "recency",
                        "expected_value": {
                            "operator": "<",
                            "value": 3,
                            "unit": "months"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled infectious disease",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled infectious disease",
                        "criterion": "infectious disease",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Uncontrolled infectious disease",
                    "criterion": "infectious disease",
                    "requirement": {
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent medication known as inhibitors of CYP3A4",
                        "criterion": "concurrent medication",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "inhibitors of CYP3A4"
                        }
                    },
                    {
                        "exact_snippets": "susceptible to increase Rapamycin blood concentrations",
                        "criterion": "effect on Rapamycin blood concentrations",
                        "requirement": {
                            "requirement_type": "susceptibility",
                            "expected_value": "increase"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Concurrent medication known as inhibitors of CYP3A4",
                        "criterion": "concurrent medication",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "inhibitors of CYP3A4"
                        }
                    },
                    {
                        "exact_snippets": "susceptible to increase Rapamycin blood concentrations",
                        "criterion": "effect on Rapamycin blood concentrations",
                        "requirement": {
                            "requirement_type": "susceptibility",
                            "expected_value": "increase"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}