{
"info": {
"nct_id": "NCT00378131",
"official_title": "A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia",
"inclusion_criteria": "* Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.\n* Involuntary loss of body weight greater than 5% within the past 6 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Presently hospitalized or in a nursing care facility.\n* Inability to increase food intake from secondary causes.\n* Liver disease\n* If female-pregnant, breast-feeding or of childbearing potential.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.",
"criterions": [
{
"exact_snippets": "Community-dwelling patients",
"criterion": "residence status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "community-dwelling"
}
]
},
{
"exact_snippets": "greater than 18 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "incurable, histologically diagnosed cancer",
"criterion": "cancer diagnosis",
"requirements": [
{
"requirement_type": "curability",
"expected_value": "incurable"
},
{
"requirement_type": "diagnosis method",
"expected_value": "histologically diagnosed"
}
]
}
]
},
{
"line": "* Involuntary loss of body weight greater than 5% within the past 6 months",
"criterions": [
{
"exact_snippets": "Involuntary loss of body weight greater than 5% within the past 6 months",
"criterion": "body weight loss",
"requirements": [
{
"requirement_type": "involuntary",
"expected_value": true
},
{
"requirement_type": "percentage",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "%"
}
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
}
]
},
{
"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": "* Presently hospitalized or in a nursing care facility.",
"criterions": [
{
"exact_snippets": "Presently hospitalized",
"criterion": "hospitalization status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "in a nursing care facility",
"criterion": "nursing care facility residency",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Inability to increase food intake from secondary causes.",
"criterions": [
{
"exact_snippets": "Inability to increase food intake",
"criterion": "food intake",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
},
{
"exact_snippets": "secondary causes",
"criterion": "secondary causes",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Liver disease",
"criterions": [
{
"exact_snippets": "Liver disease",
"criterion": "liver disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* If female-pregnant, breast-feeding or of childbearing potential.",
"criterions": [
{
"exact_snippets": "female-pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "female ... of childbearing potential",
"criterion": "childbearing potential",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}