{
"info": {
"nct_id": "NCT03263520",
"official_title": "Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer",
"inclusion_criteria": "* Cancer patients above 18 years old.\n* Patients with tumors in the high gastro-intestinal, hepatobiliary and pancreatic tracts in palliation.\n* Patients able to undergo BIA.\n* Malnourished patients as per the subjective global assessment produced by the patient (ASG-PPP) and whose score is greater than nine.\n* Patients who agree to participate in the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients with malignant tumors of other metachronous or synchronous location except nonmelanoma skin tumor\n* Patients with chronic renal failure.\n* Patients on diuretics, recent or chronic.\n* Patients on appetite stimulants and anabolic agents.\n* Patients using pacemakers, which can interfere with the results of BIA",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Cancer patients above 18 years old.",
"criterions": [
{
"exact_snippets": "Cancer patients",
"criterion": "cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "above 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Patients with tumors in the high gastro-intestinal, hepatobiliary and pancreatic tracts in palliation.",
"criterions": [
{
"exact_snippets": "tumors in the high gastro-intestinal",
"criterion": "tumors in the high gastro-intestinal tract",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "tumors in the ... hepatobiliary",
"criterion": "tumors in the hepatobiliary tract",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "tumors in the ... pancreatic tracts",
"criterion": "tumors in the pancreatic tract",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "palliation",
"criterion": "palliation",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "palliation"
}
]
}
]
},
{
"line": "* Patients able to undergo BIA.",
"criterions": [
{
"exact_snippets": "Patients able to undergo BIA.",
"criterion": "BIA capability",
"requirements": [
{
"requirement_type": "capability",
"expected_value": true
}
]
}
]
},
{
"line": "* Malnourished patients as per the subjective global assessment produced by the patient (ASG-PPP) and whose score is greater than nine.",
"criterions": [
{
"exact_snippets": "Malnourished patients as per the subjective global assessment produced by the patient (ASG-PPP)",
"criterion": "malnutrition",
"requirements": [
{
"requirement_type": "assessment",
"expected_value": "subjective global assessment produced by the patient (ASG-PPP)"
}
]
},
{
"exact_snippets": "score is greater than nine",
"criterion": "ASG-PPP score",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 9,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Patients who agree to participate in the study.",
"criterions": [
{
"exact_snippets": "Patients who agree to participate in the study.",
"criterion": "study participation agreement",
"requirements": [
{
"requirement_type": "agreement",
"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": "* Patients with malignant tumors of other metachronous or synchronous location except nonmelanoma skin tumor",
"criterions": [
{
"exact_snippets": "malignant tumors of other metachronous or synchronous location",
"criterion": "malignant tumors",
"requirements": [
{
"requirement_type": "location",
"expected_value": "metachronous or synchronous"
}
]
},
{
"exact_snippets": "except nonmelanoma skin tumor",
"criterion": "nonmelanoma skin tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients with chronic renal failure.",
"criterions": [
{
"exact_snippets": "chronic renal failure",
"criterion": "chronic renal failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients on diuretics, recent or chronic.",
"criterions": [
{
"exact_snippets": "Patients on diuretics",
"criterion": "diuretic use",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "recent or chronic",
"criterion": "duration of diuretic use",
"requirements": [
{
"requirement_type": "duration",
"expected_value": [
"recent",
"chronic"
]
}
]
}
]
},
{
"line": "* Patients on appetite stimulants and anabolic agents.",
"criterions": [
{
"exact_snippets": "Patients on appetite stimulants",
"criterion": "appetite stimulants",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Patients on ... anabolic agents",
"criterion": "anabolic agents",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients using pacemakers, which can interfere with the results of BIA",
"criterions": [
{
"exact_snippets": "Patients using pacemakers",
"criterion": "pacemaker usage",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}