{
"info": {
"nct_id": "NCT02586701",
"official_title": "Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients",
"inclusion_criteria": "* referred electively for resection of malignant, non metastasized, colorectal lesions.\n* French or English speaking\nHealthy volunteers allowed\nMust have minimum age of 45 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "* ASA class 4-5\n* co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)\n* cardiac abnormalities\n* severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine > 1.5mg/dl, and hepatic failure ALT and AST > 50% over the normal range)\n* Sepsis\n* Morbid obesity (BMI > 40)\n* Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* referred electively for resection of malignant, non metastasized, colorectal lesions.",
"criterions": [
{
"exact_snippets": "referred electively for resection",
"criterion": "referral for resection",
"requirements": [
{
"requirement_type": "elective",
"expected_value": true
}
]
},
{
"exact_snippets": "malignant, non metastasized, colorectal lesions",
"criterion": "colorectal lesions",
"requirements": [
{
"requirement_type": "malignancy",
"expected_value": true
},
{
"requirement_type": "metastasis",
"expected_value": false
}
]
}
]
},
{
"line": "* French or English speaking",
"criterions": [
{
"exact_snippets": "French or English speaking",
"criterion": "language",
"requirements": [
{
"requirement_type": "language",
"expected_value": [
"French",
"English"
]
}
]
}
]
},
{
"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 45 Years",
"criterions": [
{
"exact_snippets": "minimum age of 45 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 45,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 90 Years",
"criterions": [
{
"exact_snippets": "maximum age of 90 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* ASA class 4-5",
"criterions": [
{
"exact_snippets": "ASA class 4-5",
"criterion": "ASA class",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "N/A"
},
{
"operator": "<=",
"value": 5,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)",
"criterions": [
{
"exact_snippets": "co-morbid medical, physical and mental conditions",
"criterion": "co-morbid conditions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "dementia",
"criterion": "dementia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "disabling orthopedic and neuromuscular disease",
"criterion": "disabling orthopedic and neuromuscular disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "psychosis",
"criterion": "psychosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* cardiac abnormalities",
"criterions": [
{
"exact_snippets": "cardiac abnormalities",
"criterion": "cardiac abnormalities",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine > 1.5mg/dl, and hepatic failure ALT and AST > 50% over the normal range)",
"criterions": [
{
"exact_snippets": "severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV)",
"criterion": "cardiac failure",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "New York Heart Association classes I-IV"
}
]
},
{
"exact_snippets": "severe end-organ disease such as ... COPD",
"criterion": "COPD",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "severe end-organ disease such as ... renal failure (creatinine > 1.5mg/dl",
"criterion": "renal failure",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "creatinine level",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "mg/dl"
}
}
]
},
{
"exact_snippets": "severe end-organ disease such as ... hepatic failure ALT and AST > 50% over the normal range",
"criterion": "hepatic failure",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "ALT and AST levels",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "% over the normal range"
}
}
]
}
]
},
{
"line": "* Sepsis",
"criterions": [
{
"exact_snippets": "Sepsis",
"criterion": "sepsis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Morbid obesity (BMI > 40)",
"criterions": [
{
"exact_snippets": "Morbid obesity (BMI > 40)",
"criterion": "BMI",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "morbid obesity"
},
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 40,
"unit": "BMI"
}
}
]
}
]
},
{
"line": "* Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).",
"criterions": [
{
"exact_snippets": "Anemia (hematocrit < 30%",
"criterion": "hematocrit",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 30,
"unit": "%"
}
}
]
},
{
"exact_snippets": "Anemia ... haemoglobin < 10g/dl",
"criterion": "haemoglobin",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "g/dl"
}
}
]
},
{
"exact_snippets": "Anemia ... albumin < 25mg/dl",
"criterion": "albumin",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 25,
"unit": "mg/dl"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}