{
    "info": {
        "nct_id": "NCT00171873",
        "official_title": "Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut",
        "inclusion_criteria": "* Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut\n* curative surgery impossible\n* two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)\n* Age ≥ 18\n* Karnofsky-index > 60\n* written informed consent\n* proliferation index for Ki67\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* hypersensitivity to octreotide\n* poorly differentiated or small cell neuroendocrine tumors\n* primary tumor outside of the midgut\n* prior treatment with somatostatin-analogue > 4 weeks\n* prior treatment with alpha-interferon, chemotherapy, or chemoembolisation\n* participation in any other clinical trial\n* pregnancy or lactation\n* no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years\n* severe decompensated organ malfunction (heart-, liver- insufficiency)\n\nOther protocol-defined exclusion criteria may apply.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* curative surgery impossible",
                "criterions": [
                    {
                        "exact_snippets": "curative surgery impossible",
                        "criterion": "curative surgery",
                        "requirement": {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "curative surgery impossible",
                        "criterion": "curative surgery",
                        "requirement": {
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                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥ 18",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Karnofsky-index > 60",
                "criterions": [
                    {
                        "exact_snippets": "Karnofsky-index > 60",
                        "criterion": "Karnofsky-index",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Karnofsky-index > 60",
                        "criterion": "Karnofsky-index",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* proliferation index for Ki67",
                "criterions": [
                    {
                        "exact_snippets": "proliferation index for Ki67",
                        "criterion": "Ki67",
                        "requirement": {
                            "requirement_type": "proliferation index",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "proliferation index for Ki67",
                        "criterion": "Ki67",
                        "requirement": {
                            "requirement_type": "proliferation index",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "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": {
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                    {
                        "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": "* hypersensitivity to octreotide",
                "criterions": [
                    {
                        "exact_snippets": "hypersensitivity to octreotide",
                        "criterion": "hypersensitivity to octreotide",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "hypersensitivity to octreotide",
                    "criterion": "hypersensitivity to octreotide",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* poorly differentiated or small cell neuroendocrine tumors",
                "criterions": [
                    {
                        "exact_snippets": "poorly differentiated ... neuroendocrine tumors",
                        "criterion": "neuroendocrine tumors",
                        "requirement": {
                            "requirement_type": "differentiation",
                            "expected_value": "poorly differentiated"
                        }
                    },
                    {
                        "exact_snippets": "small cell neuroendocrine tumors",
                        "criterion": "neuroendocrine tumors",
                        "requirement": {
                            "requirement_type": "cell type",
                            "expected_value": "small cell"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "poorly differentiated ... neuroendocrine tumors",
                        "criterion": "neuroendocrine tumors",
                        "requirement": {
                            "requirement_type": "differentiation",
                            "expected_value": "poorly differentiated"
                        }
                    },
                    {
                        "exact_snippets": "small cell neuroendocrine tumors",
                        "criterion": "neuroendocrine tumors",
                        "requirement": {
                            "requirement_type": "cell type",
                            "expected_value": "small cell"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* primary tumor outside of the midgut",
                "criterions": [
                    {
                        "exact_snippets": "primary tumor outside of the midgut",
                        "criterion": "primary tumor location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "outside of the midgut"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "primary tumor outside of the midgut",
                    "criterion": "primary tumor location",
                    "requirement": {
                        "requirement_type": "location",
                        "expected_value": "outside of the midgut"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* prior treatment with somatostatin-analogue > 4 weeks",
                "criterions": [
                    {
                        "exact_snippets": "prior treatment with somatostatin-analogue > 4 weeks",
                        "criterion": "prior treatment with somatostatin-analogue",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "prior treatment with somatostatin-analogue > 4 weeks",
                    "criterion": "prior treatment with somatostatin-analogue",
                    "requirement": {
                        "requirement_type": "duration",
                        "expected_value": {
                            "operator": ">",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* prior treatment with alpha-interferon, chemotherapy, or chemoembolisation",
                "criterions": [
                    {
                        "exact_snippets": "prior treatment with alpha-interferon",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "alpha-interferon"
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with ... chemotherapy",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with ... chemoembolisation",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "chemoembolisation"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "prior treatment with alpha-interferon",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "alpha-interferon"
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with ... chemotherapy",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with ... chemoembolisation",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "chemoembolisation"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* participation in any other clinical trial",
                "criterions": [
                    {
                        "exact_snippets": "participation in any other clinical trial",
                        "criterion": "participation in other clinical trials",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
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                    "criterion": "participation in other clinical trials",
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                    }
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                        "criterion": "pregnancy",
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                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactation",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "pregnancy",
                        "criterion": "pregnancy",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactation",
                        "criterion": "lactation",
                        "requirement": {
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* severe decompensated organ malfunction (heart-, liver- insufficiency)",
                "criterions": [
                    {
                        "exact_snippets": "severe decompensated organ malfunction (heart-",
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                        }
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                    {
                        "exact_snippets": "severe decompensated organ malfunction (heart-",
                        "criterion": "heart malfunction",
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                            "requirement_type": "compensation",
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                    },
                    {
                        "exact_snippets": "severe decompensated organ malfunction (heart-, liver-",
                        "criterion": "liver malfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
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                        "exact_snippets": "severe decompensated organ malfunction (heart-, liver-",
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                            "requirement_type": "compensation",
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                        }
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                                "exact_snippets": "severe decompensated organ malfunction (heart-",
                                "criterion": "heart malfunction",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "severe decompensated organ malfunction (heart-",
                                "criterion": "heart malfunction",
                                "requirement": {
                                    "requirement_type": "compensation",
                                    "expected_value": "decompensated"
                                }
                            }
                        ]
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                    {
                        "and_criteria": [
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                                "exact_snippets": "severe decompensated organ malfunction (heart-, liver-",
                                "criterion": "liver malfunction",
                                "requirement": {
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                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "severe decompensated organ malfunction (heart-, liver-",
                                "criterion": "liver malfunction",
                                "requirement": {
                                    "requirement_type": "compensation",
                                    "expected_value": "decompensated"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Other protocol-defined exclusion criteria may apply.",
                "criterions": [
                    {
                        "exact_snippets": "Other protocol-defined exclusion criteria",
                        "criterion": "protocol-defined exclusion criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Other protocol-defined exclusion criteria",
                        "criterion": "protocol-defined exclusion criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut",
                "criterions": [
                    {
                        "exact_snippets": "Therapy-naive patients",
                        "criterion": "therapy-naive",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "histologically confirmed diagnosis",
                        "criterion": "histological confirmation",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "locally inoperable or metastasized",
                        "criterion": "tumor operability",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": "locally inoperable or metastasized"
                        }
                    },
                    {
                        "exact_snippets": "well-differentiated neuroendocrine tumor",
                        "criterion": "tumor differentiation",
                        "requirement": {
                            "requirement_type": "differentiation",
                            "expected_value": "well-differentiated"
                        }
                    },
                    {
                        "exact_snippets": "neuroendocrine tumor of the midgut",
                        "criterion": "tumor location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "midgut"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Therapy-naive patients",
                                "criterion": "therapy-naive",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "histologically confirmed diagnosis",
                                "criterion": "histological confirmation",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "locally inoperable or metastasized",
                                "criterion": "tumor operability",
                                "requirement": {
                                    "requirement_type": "operability",
                                    "expected_value": "locally inoperable"
                                }
                            },
                            {
                                "exact_snippets": "locally inoperable or metastasized",
                                "criterion": "tumor operability",
                                "requirement": {
                                    "requirement_type": "operability",
                                    "expected_value": "metastasized"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "well-differentiated neuroendocrine tumor",
                        "criterion": "tumor differentiation",
                        "requirement": {
                            "requirement_type": "differentiation",
                            "expected_value": "well-differentiated"
                        }
                    },
                    {
                        "exact_snippets": "neuroendocrine tumor of the midgut",
                        "criterion": "tumor location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "midgut"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)",
                "criterions": [
                    {
                        "exact_snippets": "two-dimensional tumor formation",
                        "criterion": "tumor formation",
                        "requirement": {
                            "requirement_type": "dimensionality",
                            "expected_value": "two-dimensional"
                        }
                    },
                    {
                        "exact_snippets": "assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)",
                        "criterion": "imaging modality",
                        "requirement": {
                            "requirement_type": "assessability",
                            "expected_value": [
                                "Computed Tomography (CT)",
                                "Magnetic Resonance Imaging (MRI)"
                            ]
                        }
                    }
                ]
            },
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                            "expected_value": "two-dimensional"
                        }
                    },
                    {
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                                "exact_snippets": "assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)",
                                "criterion": "imaging modality",
                                "requirement": {
                                    "requirement_type": "assessability",
                                    "expected_value": "Computed Tomography (CT)"
                                }
                            },
                            {
                                "exact_snippets": "assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)",
                                "criterion": "imaging modality",
                                "requirement": {
                                    "requirement_type": "assessability",
                                    "expected_value": "Magnetic Resonance Imaging (MRI)"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years",
                "criterions": [
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                        "exact_snippets": "no secondary malignancy in anamnesis",
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                        "requirement": {
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                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years",
                        "criterion": "manifestation of secondary malignancy after curative therapy",
                        "requirement": {
                            "requirement_type": "time since last manifestation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "years"
                                    }
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                            }
                        }
                    }
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                            "exact_snippets": "no secondary malignancy in anamnesis",
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                                "requirement_type": "presence",
                                "expected_value": true
                            }
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                            "criterion": "manifestation of secondary malignancy after curative therapy",
                            "requirement": {
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                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<",
                                            "value": 5,
                                            "unit": "years"
                                        }
                                    ]
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
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                    "criterion": "secondary malignancy in anamnesis",
                    "requirement": {
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                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        }
    ],
    "failed_miscellaneous": []
}