{
    "info": {
        "nct_id": "NCT05256576",
        "official_title": "KORE-INNOVATION: a Prospective, Multi-site Clinical Trial to Implement and Analyse the Effects of an Innovative Perioperative Care Pathway to Reduce Complications for Patients with Ovarian Cancer",
        "inclusion_criteria": "* Women with primary diagnosis of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages)\n* women with first recurrence of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages)\n* patients who have given and signed informed consent-forms\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* inoperable situs\n* neoadjuvant chemotherapy\n* simultaneous diagnosis of secondary primary tumors (except for breast cancer)\n* dementia or other psychological diseases, that impair comprehence and compliance\n* pregnancy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* women with first recurrence of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages)",
                "criterions": [
                    {
                        "exact_snippets": "women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "first recurrence of ovarian, fallopian tube or peritoneal cancer",
                        "criterion": "cancer type and recurrence",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": "first"
                        }
                    },
                    {
                        "exact_snippets": "first recurrence of ovarian, fallopian tube or peritoneal cancer",
                        "criterion": "cancer type and recurrence",
                        "requirement": {
                            "requirement_type": "cancer type",
                            "expected_value": [
                                "ovarian",
                                "fallopian tube",
                                "peritoneal"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "primary surgical treatment",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "primary surgical"
                        }
                    },
                    {
                        "exact_snippets": "all histological subgtypes",
                        "criterion": "histological subtype",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": "all"
                        }
                    },
                    {
                        "exact_snippets": "all FIGO-stages",
                        "criterion": "FIGO stage",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": "all"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "women",
                                                        "criterion": "gender",
                                                        "requirement": {
                                                            "requirement_type": "value",
                                                            "expected_value": "female"
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "first recurrence of ovarian, fallopian tube or peritoneal cancer",
                                                        "criterion": "cancer type and recurrence",
                                                        "requirement": {
                                                            "requirement_type": "recurrence",
                                                            "expected_value": "first"
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "first recurrence of ovarian, fallopian tube or peritoneal cancer",
                                                "criterion": "cancer type and recurrence",
                                                "requirement": {
                                                    "requirement_type": "cancer type",
                                                    "expected_value": [
                                                        "ovarian",
                                                        "fallopian tube",
                                                        "peritoneal"
                                                    ]
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "primary surgical treatment",
                                        "criterion": "treatment type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "primary surgical"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "all histological subgtypes",
                                "criterion": "histological subtype",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": "all"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "all FIGO-stages",
                        "criterion": "FIGO stage",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": "all"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* patients who have given and signed informed consent-forms",
                "criterions": [
                    {
                        "exact_snippets": "patients who have given and signed informed consent-forms",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "patients who have given and signed informed consent-forms",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "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": "* inoperable situs",
                "criterions": [
                    {
                        "exact_snippets": "inoperable situs",
                        "criterion": "situs",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "inoperable situs",
                        "criterion": "situs",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* neoadjuvant chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "neoadjuvant chemotherapy",
                        "criterion": "neoadjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* simultaneous diagnosis of secondary primary tumors (except for breast cancer)",
                "criterions": [
                    {
                        "exact_snippets": "simultaneous diagnosis of secondary primary tumors (except for breast cancer)",
                        "criterion": "secondary primary tumors",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "simultaneous diagnosis of secondary primary tumors (except for breast cancer)",
                        "criterion": "secondary primary tumors",
                        "requirement": {
                            "requirement_type": "simultaneity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "simultaneous diagnosis of secondary primary tumors (except for breast cancer)",
                        "criterion": "secondary primary tumors",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": "breast cancer"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "simultaneous diagnosis of secondary primary tumors (except for breast cancer)",
                                "criterion": "secondary primary tumors",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "simultaneous diagnosis of secondary primary tumors (except for breast cancer)",
                                "criterion": "secondary primary tumors",
                                "requirement": {
                                    "requirement_type": "simultaneity",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "simultaneous diagnosis of secondary primary tumors (except for breast cancer)",
                            "criterion": "secondary primary tumors",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": "breast cancer"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* dementia or other psychological diseases, that impair comprehence and compliance",
                "criterions": [
                    {
                        "exact_snippets": "dementia",
                        "criterion": "dementia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other psychological diseases",
                        "criterion": "psychological diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "impair comprehence and compliance",
                        "criterion": "comprehension and compliance",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "dementia",
                                "criterion": "dementia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "impair comprehence and compliance",
                                "criterion": "comprehension and compliance",
                                "requirement": {
                                    "requirement_type": "impairment",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other psychological diseases",
                                "criterion": "psychological diseases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "impair comprehence and compliance",
                                "criterion": "comprehension and compliance",
                                "requirement": {
                                    "requirement_type": "impairment",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* pregnancy",
                "criterions": [
                    {
                        "exact_snippets": "pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "criterion": "pregnancy",
                    "requirement": {
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                        "expected_value": false
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Women with primary diagnosis of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages)",
                "criterions": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "primary diagnosis of ovarian, fallopian tube or peritoneal cancer",
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                            "expected_value": [
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                                "fallopian tube cancer",
                                "peritoneal cancer"
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                    },
                    {
                        "exact_snippets": "primary surgical treatment",
                        "criterion": "treatment type",
                        "requirement": {
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                        }
                    },
                    {
                        "exact_snippets": "all histological subgtypes",
                        "criterion": "histological subtype",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "all"
                        }
                    },
                    {
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                        "criterion": "FIGO stage",
                        "requirement": {
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                            "expected_value": "all"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Women",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": "female"
                                }
                            },
                            {
                                "or_criteria": [
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                                        "exact_snippets": "primary diagnosis of ovarian, fallopian tube or peritoneal cancer",
                                        "criterion": "primary cancer diagnosis",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": "ovarian cancer"
                                        }
                                    },
                                    {
                                        "exact_snippets": "primary diagnosis of ovarian, fallopian tube or peritoneal cancer",
                                        "criterion": "primary cancer diagnosis",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": "fallopian tube cancer"
                                        }
                                    },
                                    {
                                        "exact_snippets": "primary diagnosis of ovarian, fallopian tube or peritoneal cancer",
                                        "criterion": "primary cancer diagnosis",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": "peritoneal cancer"
                                        }
                                    }
                                ]
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                        ]
                    },
                    {
                        "exact_snippets": "primary surgical treatment",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "value",
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                        }
                    },
                    {
                        "exact_snippets": "all histological subgtypes",
                        "criterion": "histological subtype",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "all"
                        }
                    },
                    {
                        "exact_snippets": "all FIGO-stages",
                        "criterion": "FIGO stage",
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                            "expected_value": "all"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}