{
    "info": {
        "nct_id": "NCT01124994",
        "official_title": "Endomicroscopy-targeted Endoscopic Mucosa Resection for Barrett's Oesophagus-associated Neoplasia",
        "inclusion_criteria": "* Patients referred to our department for endoscopic mucosal resection (EMR) of Barrett's mucosa with high grade intraepithelial neoplasia (HGIN) that has been detected during routine upper endoscopy or Barrett's surveillance endoscopy at our department or at another hospital.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
        "exclusion_criteria": "* patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )\n* patients presenting with contraindications to EMR (low platelet count, therapeutic anticoagulation, coagulation disorders)\n* refusal to participate in the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients referred to our department for endoscopic mucosal resection (EMR) of Barrett's mucosa with high grade intraepithelial neoplasia (HGIN) that has been detected during routine upper endoscopy or Barrett's surveillance endoscopy at our department or at another hospital.",
            "criterions": [
                {
                    "exact_snippets": "Patients referred to our department for endoscopic mucosal resection (EMR)",
                    "criterion": "referral for endoscopic mucosal resection (EMR)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Barrett's mucosa with high grade intraepithelial neoplasia (HGIN)",
                    "criterion": "Barrett's mucosa with high grade intraepithelial neoplasia (HGIN)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "detected during routine upper endoscopy or Barrett's surveillance endoscopy",
                    "criterion": "detection during endoscopy",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "routine upper endoscopy",
                                "Barrett's surveillance endoscopy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at our department or at another hospital",
                    "criterion": "location of detection",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "our department",
                                "another hospital"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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 90 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 90 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )",
            "criterions": [
                {
                    "exact_snippets": "patients allergic to one of the drug components",
                    "criterion": "allergy to drug components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... drugs used for conscious sedation like propofol or midazolam",
                    "criterion": "allergy to conscious sedation drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... fluorescein, the fluorescent dye used for CLE",
                    "criterion": "allergy to fluorescein",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patients presenting with contraindications to EMR (low platelet count, therapeutic anticoagulation, coagulation disorders)",
            "criterions": [
                {
                    "exact_snippets": "contraindications to EMR",
                    "criterion": "contraindications to EMR",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "low platelet count",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "therapeutic anticoagulation",
                    "criterion": "therapeutic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulation disorders",
                    "criterion": "coagulation disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* refusal to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "refusal to participate in the study",
                    "criterion": "participation in the study",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}