{
    "info": {
        "nct_id": "NCT04649372",
        "official_title": "EndoVE endosCopic Treatment for Oesophageal and Gastric canceR",
        "inclusion_criteria": "* Histologically verified oesophageal tumour\n* Men or women aged at least 18 years of age.\n* Patient has already received or been considered for surgery, and / or chemo-radiation.\n* Performance status (Karnofsky > 60% or ECOG/WHO <2).\n* Treatment free interval of at least 2 weeks after previously applied therapy.\n* Patients must be mentally capable of understanding the information given.\n* Patients must give written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Coagulation disorder.\n* Patients with a clinically manifested arrhythmia or with a pacemaker.\n* Patients with oesophageal stenosis that cannot be relieved via balloon dilation.\n* Oesophageal tumour treated with radiotherapy in the previous 4 weeks.\n* Patients with epilepsy.\n* Pregnancy or lactation/breastfeeding.\n* Patients known to be Hepatitis B/C or HIV positive.\n* Concurrent treatment with an investigational medicinal product or participation in another clinical study.\n* Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.\n* Highly ulcerated oesophageal tissue.\n* Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease.\n* Allergic reactions to bleomycin observed previously\n* If a bleomycin cumulative dose of 400 x103 IU has been exceeded",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically verified oesophageal tumour",
            "criterions": [
                {
                    "exact_snippets": "Histologically verified oesophageal tumour",
                    "criterion": "oesophageal tumour",
                    "requirements": [
                        {
                            "requirement_type": "verification",
                            "expected_value": "histologically verified"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men or women aged at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Men or women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "men",
                                "women"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has already received or been considered for surgery, and / or chemo-radiation.",
            "criterions": [
                {
                    "exact_snippets": "Patient has already received or been considered for surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "consideration or receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has already received or been considered for ... chemo-radiation",
                    "criterion": "chemo-radiation",
                    "requirements": [
                        {
                            "requirement_type": "consideration or receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status (Karnofsky > 60% or ECOG/WHO <2).",
            "criterions": [
                {
                    "exact_snippets": "Performance status (Karnofsky > 60%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status ... ECOG/WHO <2",
                    "criterion": "ECOG/WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment free interval of at least 2 weeks after previously applied therapy.",
            "criterions": [
                {
                    "exact_snippets": "Treatment free interval of at least 2 weeks after previously applied therapy.",
                    "criterion": "treatment free interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be mentally capable of understanding the information given.",
            "criterions": [
                {
                    "exact_snippets": "mentally capable of understanding the information",
                    "criterion": "mental capability",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must give written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients must give written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Coagulation disorder.",
            "criterions": [
                {
                    "exact_snippets": "Coagulation disorder",
                    "criterion": "coagulation disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a clinically manifested arrhythmia or with a pacemaker.",
            "criterions": [
                {
                    "exact_snippets": "clinically manifested arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pacemaker",
                    "criterion": "pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with oesophageal stenosis that cannot be relieved via balloon dilation.",
            "criterions": [
                {
                    "exact_snippets": "oesophageal stenosis",
                    "criterion": "oesophageal stenosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be relieved via balloon dilation",
                    "criterion": "relief via balloon dilation",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Oesophageal tumour treated with radiotherapy in the previous 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Oesophageal tumour",
                    "criterion": "oesophageal tumour",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "radiotherapy"
                        },
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with epilepsy.",
            "criterions": [
                {
                    "exact_snippets": "Patients with epilepsy.",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or lactation/breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation/breastfeeding",
                    "criterion": "lactation/breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients known to be Hepatitis B/C or HIV positive.",
            "criterions": [
                {
                    "exact_snippets": "Patients known to be Hepatitis B/C ... positive.",
                    "criterion": "Hepatitis B/C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients known to be ... HIV positive.",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent treatment with an investigational medicinal product or participation in another clinical study.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with an investigational medicinal product",
                    "criterion": "concurrent treatment with investigational medicinal product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participation in another clinical study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.",
            "criterions": [
                {
                    "exact_snippets": "any other clinical condition",
                    "criterion": "clinical condition",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Highly ulcerated oesophageal tissue.",
            "criterions": [
                {
                    "exact_snippets": "Highly ulcerated oesophageal tissue",
                    "criterion": "oesophageal tissue",
                    "requirements": [
                        {
                            "requirement_type": "ulceration",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease.",
            "criterions": [
                {
                    "exact_snippets": "Contraindications for bleomycin use",
                    "criterion": "bleomycin use",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute pulmonary infection",
                    "criterion": "acute pulmonary infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe pulmonary disease",
                    "criterion": "severe pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergic reactions to bleomycin observed previously",
            "criterions": [
                {
                    "exact_snippets": "Allergic reactions to bleomycin observed previously",
                    "criterion": "allergic reactions to bleomycin",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If a bleomycin cumulative dose of 400 x103 IU has been exceeded",
            "criterions": [
                {
                    "exact_snippets": "bleomycin cumulative dose of 400 x103 IU has been exceeded",
                    "criterion": "bleomycin cumulative dose",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 400000,
                                "unit": "IU"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}