{
    "info": {
        "nct_id": "NCT00832520",
        "official_title": "INST 0816: Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight",
        "inclusion_criteria": "1. All patients, 18 years of age or older, with advanced cancer are eligible.\n2. Patients must have lost 10% in the last 6 months\n3. Patients must have a life expectancy of at least 12 weeks.\n4. Patients must have a Zubrod performance status of 0-3.\n5. Patients must sign an informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with symptomatic brain metastases are excluded from this study.\n2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.\n3. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.\n4. Patients with head and neck cancers and GI cancers who have functional problems that limits food intake or absorption of nutrients such as partial or complete bowel obstructions, and patients with skin cancers (except melanoma) are not eligible\n5. Patients who lost weight on a voluntary diet.\n6. Patients who are already taking an appetite stimulant or other anti-depressant, except for SSRI taken in the morning.\n7. Patients who had surgery in the last 6 months",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. All patients, 18 years of age or older, with advanced cancer are eligible.",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced cancer",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients must have lost 10% in the last 6 months",
            "criterions": [
                {
                    "exact_snippets": "lost 10% in the last 6 months",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "=",
                                "value": 10,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "last 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients must have a life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients must have a Zubrod performance status of 0-3.",
            "criterions": [
                {
                    "exact_snippets": "Zubrod performance status of 0-3",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients must sign an informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients must sign an informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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. Patients with symptomatic brain metastases are excluded from this study.",
            "criterions": [
                {
                    "exact_snippets": "symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing mothers",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients of child bearing potential must use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.",
            "criterions": [
                {
                    "exact_snippets": "severe medical problems such as uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe medical problems such as ... cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe medical problems such as ... active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with head and neck cancers and GI cancers who have functional problems that limits food intake or absorption of nutrients such as partial or complete bowel obstructions, and patients with skin cancers (except melanoma) are not eligible",
            "criterions": [
                {
                    "exact_snippets": "head and neck cancers",
                    "criterion": "head and neck cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "GI cancers",
                    "criterion": "GI cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "functional problems that limits food intake or absorption of nutrients such as partial or complete bowel obstructions",
                    "criterion": "functional problems limiting food intake or absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "skin cancers (except melanoma)",
                    "criterion": "skin cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients who lost weight on a voluntary diet.",
            "criterions": [
                {
                    "exact_snippets": "lost weight",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "voluntary diet"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients who are already taking an appetite stimulant or other anti-depressant, except for SSRI taken in the morning.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are already taking an appetite stimulant",
                    "criterion": "appetite stimulant usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are already taking ... other anti-depressant",
                    "criterion": "anti-depressant usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for SSRI taken in the morning",
                    "criterion": "SSRI usage",
                    "requirements": [
                        {
                            "requirement_type": "time of day",
                            "expected_value": "morning"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients who had surgery in the last 6 months",
            "criterions": [
                {
                    "exact_snippets": "Patients who had surgery in the last 6 months",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}