{
    "info": {
        "nct_id": "NCT00546065",
        "official_title": "APE-Study: Tumor-free Survival After Ablation of Barrett's Mucosa Plus Esomeprazole vs. Surveillance Without Ablation in Patients Cured From Barrett's Cancer Combined With Randomization of Esomeprazole vs Placebo for Symptomatic Reflux Control After Successful Ablation of Barrett's Mucosa",
        "inclusion_criteria": "* Endoscopically and histologically complete remission of mucosal Barrett's cancer (endoscopic resection with or without thermal ablation of resection margins)\n* Initial length of Barrett's segment before cancer therapy > 3 cm (initially long-segment Barrett's esophagus)\n* Barrett's length after endoscopic therapy of Barrett's cancer > 2 cm\n* Informed consent of the patient\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Attempted ablation therapy before the trial\n* Treatment duration of early Barrett's cancer > 12 months\n* Duration between achievement of complete remission and attempted inclusion into the study > 24 months\n* The Barrett's cancer treated has already been a secondary lesion of earlier Barrett's cancer\n* Inadequate healing of endoscopic resection (ER) ulcers\n* No residual Barrett's mucosa observed after pretreatment with ER\n* No PPI compliance\n* Relevant comorbidity (e.g., malignancy)\n* Pregnancy\n* Age below 18 years\n* Patient not able to understand study characteristics\n* No written informed consent available\n* Allergy against esomeprazole or intolerance of medication ingredients",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Endoscopically and histologically complete remission of mucosal Barrett's cancer (endoscopic resection with or without thermal ablation of resection margins)",
            "criterions": [
                {
                    "exact_snippets": "Endoscopically and histologically complete remission of mucosal Barrett's cancer",
                    "criterion": "remission of mucosal Barrett's cancer",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "endoscopic",
                                "histologic"
                            ]
                        },
                        {
                            "requirement_type": "completeness",
                            "expected_value": "complete"
                        }
                    ]
                },
                {
                    "exact_snippets": "endoscopic resection with or without thermal ablation of resection margins",
                    "criterion": "endoscopic resection",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "endoscopic resection"
                        },
                        {
                            "requirement_type": "additional procedure",
                            "expected_value": "thermal ablation of resection margins"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initial length of Barrett's segment before cancer therapy > 3 cm (initially long-segment Barrett's esophagus)",
            "criterions": [
                {
                    "exact_snippets": "Initial length of Barrett's segment before cancer therapy > 3 cm",
                    "criterion": "initial length of Barrett's segment",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Barrett's length after endoscopic therapy of Barrett's cancer > 2 cm",
            "criterions": [
                {
                    "exact_snippets": "Barrett's length after endoscopic therapy of Barrett's cancer > 2 cm",
                    "criterion": "Barrett's length after endoscopic therapy",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent of the patient",
            "criterions": [
                {
                    "exact_snippets": "Informed consent of the patient",
                    "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": "* Attempted ablation therapy before the trial",
            "criterions": [
                {
                    "exact_snippets": "Attempted ablation therapy before the trial",
                    "criterion": "ablation therapy",
                    "requirements": [
                        {
                            "requirement_type": "attempted",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "before the trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment duration of early Barrett's cancer > 12 months",
            "criterions": [
                {
                    "exact_snippets": "Treatment duration of early Barrett's cancer > 12 months",
                    "criterion": "treatment duration of early Barrett's cancer",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Duration between achievement of complete remission and attempted inclusion into the study > 24 months",
            "criterions": [
                {
                    "exact_snippets": "Duration between achievement of complete remission and attempted inclusion into the study > 24 months",
                    "criterion": "duration since complete remission",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The Barrett's cancer treated has already been a secondary lesion of earlier Barrett's cancer",
            "criterions": [
                {
                    "exact_snippets": "Barrett's cancer treated ... secondary lesion of earlier Barrett's cancer",
                    "criterion": "Barrett's cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "secondary lesion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate healing of endoscopic resection (ER) ulcers",
            "criterions": [
                {
                    "exact_snippets": "Inadequate healing of endoscopic resection (ER) ulcers",
                    "criterion": "healing of endoscopic resection (ER) ulcers",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "inadequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No residual Barrett's mucosa observed after pretreatment with ER",
            "criterions": [
                {
                    "exact_snippets": "No residual Barrett's mucosa observed",
                    "criterion": "residual Barrett's mucosa",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No PPI compliance",
            "criterions": [
                {
                    "exact_snippets": "No PPI compliance",
                    "criterion": "PPI compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Relevant comorbidity (e.g., malignancy)",
            "criterions": [
                {
                    "exact_snippets": "Relevant comorbidity (e.g., malignancy)",
                    "criterion": "comorbidity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "relevance",
                            "expected_value": "relevant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age below 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age below 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient not able to understand study characteristics",
            "criterions": [
                {
                    "exact_snippets": "Patient not able to understand study characteristics",
                    "criterion": "understanding of study characteristics",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No written informed consent available",
            "criterions": [
                {
                    "exact_snippets": "No written informed consent available",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergy against esomeprazole or intolerance of medication ingredients",
            "criterions": [
                {
                    "exact_snippets": "Allergy against esomeprazole",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "esomeprazole"
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance of medication ingredients",
                    "criterion": "intolerance",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "medication ingredients"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}