{
    "info": {
        "nct_id": "NCT05095831",
        "official_title": "Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.",
        "inclusion_criteria": "* Neoplasia group: high suspicion of pancreas neoplasia based on computed tomography and/or nuclear magnetic resonance.\n* Inflammatory group: high suspicion of acute or chronic pancreatitis based on computed tomography and/or nuclear magnetic resonance.\n* Control group: patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia).\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 79 Years",
        "exclusion_criteria": "* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with important impact on cardiac risk assessment (NHYA III/IV);\n* Impossibility of EUS-guided biopsy (only for neoplasia or inflammatory group);\n* Pregnancy or nursing;\n* Refuse to participate in the study and/or to sign corresponding informed consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Neoplasia group: high suspicion of pancreas neoplasia based on computed tomography and/or nuclear magnetic resonance.",
            "criterions": [
                {
                    "exact_snippets": "high suspicion of pancreas neoplasia based on computed tomography",
                    "criterion": "pancreas neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "suspicion level",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "diagnostic method",
                            "expected_value": [
                                "computed tomography",
                                "nuclear magnetic resonance"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inflammatory group: high suspicion of acute or chronic pancreatitis based on computed tomography and/or nuclear magnetic resonance.",
            "criterions": [
                {
                    "exact_snippets": "high suspicion of acute or chronic pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "based on computed tomography",
                    "criterion": "computed tomography",
                    "requirements": [
                        {
                            "requirement_type": "basis for suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "based on ... nuclear magnetic resonance",
                    "criterion": "nuclear magnetic resonance",
                    "requirements": [
                        {
                            "requirement_type": "basis for suspicion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Control group: patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia).",
            "criterions": [
                {
                    "exact_snippets": "without a history of any type of solid or hematologic malignancy",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without a history of ... hepato-pancreato-biliary disease (including fatty liver and pancreas disease)",
                    "criterion": "history of hepato-pancreato-biliary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without a history of ... tobacco/alcohol habits",
                    "criterion": "history of tobacco/alcohol habits",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without a history of ... morbid obesity with bariatric surgery criteria",
                    "criterion": "history of morbid obesity with bariatric surgery criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "require EUS evaluation",
                    "criterion": "EUS evaluation requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 79 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 79 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 79,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with important impact on cardiac risk assessment (NHYA III/IV);",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "kidney/liver failure",
                    "criterion": "kidney failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "kidney/liver failure",
                    "criterion": "liver failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any comorbidity with important impact on cardiac risk assessment (NHYA III/IV)",
                    "criterion": "comorbidity impacting cardiac risk assessment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "important"
                        },
                        {
                            "requirement_type": "classification",
                            "expected_value": "NHYA III/IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Impossibility of EUS-guided biopsy (only for neoplasia or inflammatory group);",
            "criterions": [
                {
                    "exact_snippets": "Impossibility of EUS-guided biopsy",
                    "criterion": "EUS-guided biopsy",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "only for neoplasia or inflammatory group",
                    "criterion": "group",
                    "requirements": [
                        {
                            "requirement_type": "membership",
                            "expected_value": [
                                "neoplasia",
                                "inflammatory"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or nursing;",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refuse to participate in the study and/or to sign corresponding informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Refuse to participate in the study",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign corresponding informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}