{
    "info": {
        "nct_id": "NCT00625742",
        "official_title": "An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia",
        "inclusion_criteria": "1. Are referred to the Cachexia Clinic with involuntary weight loss of >5% of their premorbid weight within the previous 6 months.\n2. Are 18 years of age or older\n3. Have a Karnofsky performance score of 60 or higher.\n4. Can maintain oral food intake during the study\n5. Can understand the study procedures and can sign an informed consent form.\n6. Are not currently taking melatonin.\n7. Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy.\n8. Have a calculated creatinine clearance of >/= 60 cc/min.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Have dementia or delirium (as determined by the palliative care specialist) at study entry.\n2. Are pregnant\n3. Have been taking corticosteroids for longer than 48 hours.\n4. Have pulmonary edema, ascites or pitting edema on clinical examination.\n5. Are unable to walk.\n6. Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.\n7. Have an ALT/AST>3x upper limit of normal.\n8. Patients on methotrexate.\n9. Patients taking melatonin receptor agonists (such as Rozerem® [ramelteon]).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Are referred to the Cachexia Clinic with involuntary weight loss of >5% of their premorbid weight within the previous 6 months.",
            "criterions": [
                {
                    "exact_snippets": [
                        "referred to the Cachexia Clinic"
                    ],
                    "criterion": "Cachexia Clinic referral",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "involuntary weight loss"
                    ],
                    "criterion": "weight loss",
                    "requirement_type": "type",
                    "expected_value": "involuntary"
                },
                {
                    "exact_snippets": [
                        "weight loss of >5% of their premorbid weight"
                    ],
                    "criterion": "weight loss",
                    "requirement_type": "percentage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "within the previous 6 months"
                    ],
                    "criterion": "weight loss",
                    "requirement_type": "time frame",
                    "expected_value": "previous 6 months"
                }
            ]
        },
        {
            "line": "2. Are 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": [
                        "18 years of age or older"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "3. Have a Karnofsky performance score of 60 or higher.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Karnofsky performance score",
                        "60 or higher"
                    ],
                    "criterion": "Karnofsky performance score",
                    "requirement_type": "minimum value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 60
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. Can maintain oral food intake during the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "maintain oral food intake"
                    ],
                    "criterion": "oral food intake",
                    "requirement_type": "maintenance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. Can understand the study procedures and can sign an informed consent form.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Can understand the study procedures"
                    ],
                    "criterion": "understanding of study procedures",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "can sign an informed consent form"
                    ],
                    "criterion": "signing informed consent form",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "6. Are not currently taking melatonin.",
            "criterions": [
                {
                    "exact_snippets": [
                        "not currently taking melatonin"
                    ],
                    "criterion": "melatonin",
                    "requirement_type": "current usage",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "7. Are taking megestrol acetate and continue to lose weight despite at least 2 weeks of therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "taking megestrol acetate"
                    ],
                    "criterion": "megestrol acetate",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "continue to lose weight despite at least 2 weeks of therapy"
                    ],
                    "criterion": "weight",
                    "requirement_type": "change",
                    "expected_value": "loss"
                }
            ]
        },
        {
            "line": "8. Have a calculated creatinine clearance of >/= 60 cc/min.",
            "criterions": [
                {
                    "exact_snippets": [
                        "calculated creatinine clearance of >/= 60 cc/min"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 60
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Have dementia or delirium (as determined by the palliative care specialist) at study entry.",
            "criterions": [
                {
                    "exact_snippets": [
                        "dementia"
                    ],
                    "criterion": "dementia",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "delirium"
                    ],
                    "criterion": "delirium",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Are pregnant",
            "criterions": [
                {
                    "exact_snippets": [
                        "Are pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Have been taking corticosteroids for longer than 48 hours.",
            "criterions": [
                {
                    "exact_snippets": [
                        "taking corticosteroids"
                    ],
                    "criterion": "corticosteroid use",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 48
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. Have pulmonary edema, ascites or pitting edema on clinical examination.",
            "criterions": [
                {
                    "exact_snippets": [
                        "pulmonary edema"
                    ],
                    "criterion": "pulmonary edema",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "ascites"
                    ],
                    "criterion": "ascites",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "pitting edema"
                    ],
                    "criterion": "pitting edema",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. Are unable to walk.",
            "criterions": [
                {
                    "exact_snippets": [
                        "unable to walk"
                    ],
                    "criterion": "ability to walk",
                    "requirement_type": "ability",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "6. Have a history of serious adverse gastrointestinal events (i.e., bleeding or perforation),history of a coagulopathy or current anti-coagulant use.",
            "criterions": [
                {
                    "exact_snippets": [
                        "history of serious adverse gastrointestinal events"
                    ],
                    "criterion": "serious adverse gastrointestinal events",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "bleeding or perforation"
                    ],
                    "criterion": "gastrointestinal events",
                    "requirement_type": "type",
                    "expected_value": [
                        "bleeding",
                        "perforation"
                    ]
                },
                {
                    "exact_snippets": [
                        "history of a coagulopathy"
                    ],
                    "criterion": "coagulopathy",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "current anti-coagulant use"
                    ],
                    "criterion": "anti-coagulant use",
                    "requirement_type": "current",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "7. Have an ALT/AST>3x upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": [
                        "ALT/AST>3x upper limit of normal"
                    ],
                    "criterion": "ALT/AST",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "ALT/AST>3x upper limit of normal"
                    ],
                    "criterion": "upper limit of normal",
                    "requirement_type": "reference",
                    "expected_value": "3x"
                }
            ]
        },
        {
            "line": "8. Patients on methotrexate.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients on methotrexate"
                    ],
                    "criterion": "methotrexate",
                    "requirement_type": "usage",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "9. Patients taking melatonin receptor agonists (such as Rozerem® [ramelteon]).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients taking melatonin receptor agonists"
                    ],
                    "criterion": "melatonin receptor agonists",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "such as Rozerem® [ramelteon]"
                    ],
                    "criterion": "Rozerem® [ramelteon]",
                    "requirement_type": "usage",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}