{
    "info": {
        "nct_id": "NCT05043701",
        "official_title": "Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)",
        "inclusion_criteria": "* Recurrence of histologically verified glioblastoma\n* Adequate biopsy to generate enough live cells to allow functional screening\n* Must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Must be 18 to 70 years of age\n* Adequate bone marrow, liver and heart function\n* Must be competent to give consent\n* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice guidelines (ICH GCP), and national/local regulations.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Patients taking part in other clinical trials which could make inclusion or follow-up difficult\n* Any reason why, in the opinion of the investigator, the patient should not participate",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Recurrence of histologically verified glioblastoma",
                "criterions": [
                    {
                        "exact_snippets": "Recurrence of histologically verified glioblastoma",
                        "criterion": "glioblastoma",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Recurrence of histologically verified glioblastoma",
                        "criterion": "glioblastoma",
                        "requirement": {
                            "requirement_type": "verification",
                            "expected_value": "histologically"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Recurrence of histologically verified glioblastoma",
                        "criterion": "glioblastoma",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Recurrence of histologically verified glioblastoma",
                        "criterion": "glioblastoma",
                        "requirement": {
                            "requirement_type": "verification",
                            "expected_value": "histologically"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate biopsy to generate enough live cells to allow functional screening",
                "criterions": [
                    {
                        "exact_snippets": "Adequate biopsy to generate enough live cells",
                        "criterion": "biopsy",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "enough live cells to allow functional screening",
                        "criterion": "live cells",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": "enough"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate biopsy to generate enough live cells",
                        "criterion": "biopsy",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "enough live cells to allow functional screening",
                        "criterion": "live cells",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": "enough"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                "criterions": [
                    {
                        "exact_snippets": "Must be ambulatory",
                        "criterion": "ambulatory status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be ambulatory",
                        "criterion": "ambulatory status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must be 18 to 70 years of age",
                "criterions": [
                    {
                        "exact_snippets": "Must be 18 to 70 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be 18 to 70 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate bone marrow, liver and heart function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... heart function",
                        "criterion": "heart function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... heart function",
                        "criterion": "heart function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must be competent to give consent",
                "criterions": [
                    {
                        "exact_snippets": "Must be competent to give consent",
                        "criterion": "competence to give consent",
                        "requirement": {
                            "requirement_type": "competence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be competent to give consent",
                        "criterion": "competence to give consent",
                        "requirement": {
                            "requirement_type": "competence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice guidelines (ICH GCP), and national/local regulations.",
                "criterions": [
                    {
                        "exact_snippets": "Signed informed consent ... must be obtained and documented",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Signed informed consent ... must be obtained and documented",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "expected cooperation of the patients for the treatment and follow up",
                        "criterion": "patient cooperation",
                        "requirement": {
                            "requirement_type": "expectation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Signed informed consent ... must be obtained and documented",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "signed",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Signed informed consent ... must be obtained and documented",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "documentation",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "expected cooperation of the patients for the treatment and follow up",
                        "criterion": "patient cooperation",
                        "requirement": {
                            "requirement_type": "expectation",
                            "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 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"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Any reason why, in the opinion of the investigator, the patient should not participate",
                "criterions": [
                    {
                        "exact_snippets": "Any reason why, in the opinion of the investigator, the patient should not participate",
                        "criterion": "investigator's opinion on participation",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "no reason not to participate"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any reason why, in the opinion of the investigator, the patient should not participate",
                    "criterion": "investigator's opinion on participation",
                    "requirement": {
                        "requirement_type": "N/A",
                        "expected_value": "no reason not to participate"
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Patients taking part in other clinical trials which could make inclusion or follow-up difficult",
                "criterions": [
                    {
                        "exact_snippets": "Patients taking part in other clinical trials",
                        "criterion": "participation in other clinical trials",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients taking part in other clinical trials",
                        "criterion": "participation in other clinical trials",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}