{
"info": {
"nct_id": "NCT03221920",
"official_title": "Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care",
"inclusion_criteria": "* Diagnosed as colorectal adenocarcinoma pathologically\n* Decided by a digestive surgery consultant to be managed with best supportive care\n* More than 17 years old and capable of making informed consent\n* Karnofsky score > 50% or ECOG performance status <=2\n* No clinical signs of infection, with one or more of these criteria : fever, leukocytosis, local sign of infection (eg.abscess,ulcer)\n* AST < 2 times normal limit\n* ALT < 2 times normal limit\n* Serum Creatinine < 1,5 times normal limit\n* Not pregnant (for women)\n* Able to understand and willing participate and to sign informed consent form\n* No Diabetes Mellitus\n* No fat intolerance\n* No severe malnutrition or cancer cachexia\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "* Patient is still on other therapy for the tumour\n* Patient with coexisting diseases which prohibits the patient to follow the study protocols",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Diagnosed as colorectal adenocarcinoma pathologically",
"criterions": [
{
"exact_snippets": "Diagnosed as colorectal adenocarcinoma pathologically",
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}
},
{
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}
}
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},
"logical_structure": {
"and_criteria": [
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"unit": "years"
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"line": "* Karnofsky score > 50% or ECOG performance status <=2",
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"value": 50,
"unit": "%"
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"exact_snippets": "ECOG performance status <=2",
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"value": 2,
"unit": "N/A"
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"unit": "%"
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{
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{
"exact_snippets": "local sign of infection (eg.abscess,ulcer)",
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"identified_line": {
"line": "* AST < 2 times normal limit",
"criterions": [
{
"exact_snippets": "AST < 2 times normal limit",
"criterion": "AST",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 2,
"unit": "times normal limit"
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}
}
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"and_criteria": [
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"exact_snippets": "AST < 2 times normal limit",
"criterion": "AST",
"requirement": {
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"operator": "<",
"value": 2,
"unit": "times normal limit"
}
}
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{
"identified_line": {
"line": "* ALT < 2 times normal limit",
"criterions": [
{
"exact_snippets": "ALT < 2 times normal limit",
"criterion": "ALT",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 2,
"unit": "times normal limit"
}
}
}
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"exact_snippets": "ALT < 2 times normal limit",
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"value": 2,
"unit": "times normal limit"
}
}
}
]
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},
{
"identified_line": {
"line": "* Serum Creatinine < 1,5 times normal limit",
"criterions": [
{
"exact_snippets": "Serum Creatinine < 1,5 times normal limit",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "times normal limit"
}
}
}
]
},
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"exact_snippets": "Serum Creatinine < 1,5 times normal limit",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "times normal limit"
}
}
}
]
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},
{
"identified_line": {
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"criterions": [
{
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"criterion": "pregnancy",
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"expected_value": false
}
}
]
},
"logical_structure": {
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]
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},
{
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"expected_value": true
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},
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{
"exact_snippets": "sign informed consent form",
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"line": "* No fat intolerance",
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"exact_snippets": "No fat intolerance",
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"expected_value": false
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"criterion": "malnutrition",
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}
},
{
"exact_snippets": "No ... cancer cachexia",
"criterion": "cancer cachexia",
"requirement": {
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"expected_value": false
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},
{
"exact_snippets": "No ... cancer cachexia",
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},
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"identified_line": {
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"unit": "Years"
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},
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"identified_line": {
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{
"exact_snippets": "maximum age of 65 Years",
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"unit": "Years"
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"value": 65,
"unit": "Years"
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}
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}
],
"exclusion_lines": [
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"line": "* Patient is still on other therapy for the tumour",
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"exact_snippets": "Patient is still on other therapy for the tumour",
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}
}
}
},
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"identified_line": {
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"requirement": {
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}
]
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}
]
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* No Diabetes Mellitus",
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{
"exact_snippets": "No Diabetes Mellitus",
"criterion": "Diabetes Mellitus",
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"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "No Diabetes Mellitus",
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}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}