{
    "info": {
        "nct_id": "NCT03377660",
        "official_title": "The Effect of Clinical Treatment for Unintentional Weight Loss on Food Reward and Appetitive Behaviour in Patients Who Have Lost >10% of Their Body Weight After Undergoing Curative Surgery for Oesophageal Cancer",
        "inclusion_criteria": "1. History of esophagectomy with gastric conduit reconstruction\n2. Recurrence-free at least 12 months post-operatively\n3. Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation\n4. Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Pregnancy, breastfeeding\n2. Significant and persistent chemoradiotherapy and/or surgical complication\n3. Other active malignancy\n4. Exocrine pancreatic insufficiency detected using fecal elastase\n5. Uncontrolled diabetes mellitus\n6. Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent\n7. Severe dysphagia\n8. Other disease or medication which may impact gut hormone physiology\n9. History of significant food allergy, certain dietary restrictions\n10. Any definite contraindication to somatostatin analogue administration\n11. Claustrophobia, or any absolute contraindication to MRI scanning\n12. Metallic implants, precluding fMRI",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. History of esophagectomy with gastric conduit reconstruction",
            "criterions": [
                {
                    "exact_snippets": "History of esophagectomy",
                    "criterion": "esophagectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric conduit reconstruction",
                    "criterion": "gastric conduit reconstruction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Recurrence-free at least 12 months post-operatively",
            "criterions": [
                {
                    "exact_snippets": "Recurrence-free at least 12 months post-operatively",
                    "criterion": "recurrence-free",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation",
            "criterions": [
                {
                    "exact_snippets": "Weight loss ≥10% from premorbid weight",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring ongoing caloric supplementation",
                    "criterion": "caloric supplementation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine",
            "criterions": [
                {
                    "exact_snippets": "undergo clinical treatment for weight loss",
                    "criterion": "clinical treatment for weight loss",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "undergo"
                        }
                    ]
                },
                {
                    "exact_snippets": "Sandostatin",
                    "criterion": "Sandostatin",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Mirtazapine",
                    "criterion": "Mirtazapine",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "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": "1. Pregnancy, breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Significant and persistent chemoradiotherapy and/or surgical complication",
            "criterions": [
                {
                    "exact_snippets": "Significant and persistent chemoradiotherapy and/or surgical complication",
                    "criterion": "chemoradiotherapy complication",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant and persistent chemoradiotherapy and/or surgical complication",
                    "criterion": "surgical complication",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Other active malignancy",
            "criterions": [
                {
                    "exact_snippets": "Other active malignancy",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Exocrine pancreatic insufficiency detected using fecal elastase",
            "criterions": [
                {
                    "exact_snippets": "Exocrine pancreatic insufficiency detected using fecal elastase",
                    "criterion": "exocrine pancreatic insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "fecal elastase"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Uncontrolled diabetes mellitus",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Significant psychiatric disorder",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "cognitive decline",
                    "criterion": "cognitive decline",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "communication impairment",
                    "criterion": "communication impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "limiting capacity to provide informed consent",
                    "criterion": "capacity to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Severe dysphagia",
            "criterions": [
                {
                    "exact_snippets": "Severe dysphagia",
                    "criterion": "dysphagia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Other disease or medication which may impact gut hormone physiology",
            "criterions": [
                {
                    "exact_snippets": "Other disease ... which may impact gut hormone physiology",
                    "criterion": "other disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on gut hormone physiology",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other ... medication which may impact gut hormone physiology",
                    "criterion": "medication",
                    "requirements": [
                        {
                            "requirement_type": "impact on gut hormone physiology",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History of significant food allergy, certain dietary restrictions",
            "criterions": [
                {
                    "exact_snippets": "History of significant food allergy",
                    "criterion": "food allergy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "certain dietary restrictions",
                    "criterion": "dietary restrictions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Any definite contraindication to somatostatin analogue administration",
            "criterions": [
                {
                    "exact_snippets": "definite contraindication to somatostatin analogue administration",
                    "criterion": "contraindication to somatostatin analogue",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Claustrophobia, or any absolute contraindication to MRI scanning",
            "criterions": [
                {
                    "exact_snippets": "Claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any absolute contraindication to MRI scanning",
                    "criterion": "absolute contraindication to MRI scanning",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Metallic implants, precluding fMRI",
            "criterions": [
                {
                    "exact_snippets": "Metallic implants, precluding fMRI",
                    "criterion": "metallic implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}