{
    "info": {
        "nct_id": "NCT04695262",
        "official_title": "EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study",
        "inclusion_criteria": "* Patients with GI SETs scheduled for EUS-FNB\n* Patients with age > 18 but <85 years\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "* Patients with GI SETs <15mm\n* severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma\n* severe cardiopulmonary diseases and severe chronic kidney disease defined as glomerular filtration rate (GFR) < 15 ml/min\n* known allergic disposition to SonoVue®\n* pregnancy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with GI SETs scheduled for EUS-FNB",
                "criterions": [
                    {
                        "exact_snippets": "Patients with GI SETs",
                        "criterion": "GI SETs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scheduled for EUS-FNB",
                        "criterion": "EUS-FNB",
                        "requirement": {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with GI SETs",
                        "criterion": "GI SETs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scheduled for EUS-FNB",
                        "criterion": "EUS-FNB",
                        "requirement": {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with age > 18 but <85 years",
                "criterions": [
                    {
                        "exact_snippets": "age > 18 but <85 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "age > 18 but <85 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "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 85 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 85 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 85 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with GI SETs <15mm",
                "criterions": [
                    {
                        "exact_snippets": "GI SETs <15mm",
                        "criterion": "GI SETs",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "GI SETs <15mm",
                        "criterion": "GI SETs",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma",
                "criterions": [
                    {
                        "exact_snippets": "severe coagulopathy",
                        "criterion": "severe coagulopathy",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "severe coagulopathy",
                        "criterion": "severe coagulopathy",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "abnormal prothrombin time (PT)",
                                "criterion": "prothrombin time (PT)",
                                "requirement": {
                                    "requirement_type": "abnormality",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "abnormal partial thromboplastin time (PTT)",
                                "criterion": "partial thromboplastin time (PTT)",
                                "requirement": {
                                    "requirement_type": "abnormality",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "does not normalize after administration of fresh frozen plasma",
                            "criterion": "normalization after administration of fresh frozen plasma",
                            "requirement": {
                                "requirement_type": "normalization",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* severe cardiopulmonary diseases and severe chronic kidney disease defined as glomerular filtration rate (GFR) < 15 ml/min",
                "criterions": [
                    {
                        "exact_snippets": "severe cardiopulmonary diseases",
                        "criterion": "cardiopulmonary diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe chronic kidney disease",
                        "criterion": "chronic kidney disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "glomerular filtration rate (GFR) < 15 ml/min",
                        "criterion": "glomerular filtration rate (GFR)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 15,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "severe cardiopulmonary diseases",
                                "criterion": "cardiopulmonary diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "severe chronic kidney disease",
                                "criterion": "chronic kidney disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "glomerular filtration rate (GFR) < 15 ml/min",
                        "criterion": "glomerular filtration rate (GFR)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 15,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* known allergic disposition to SonoVue®",
                "criterions": [
                    {
                        "exact_snippets": "known allergic disposition to SonoVue®",
                        "criterion": "allergic disposition to SonoVue®",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "known allergic disposition to SonoVue®",
                    "criterion": "allergic disposition to SonoVue®",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* pregnancy",
                "criterions": [
                    {
                        "exact_snippets": "pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}