{
"info": {
"nct_id": "NCT02858804",
"official_title": "EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial",
"inclusion_criteria": "* age≤65 years\n* diagnosis with mantle cell lymphoma\n* Ann Arbor stage II,III or IV\n* ECOG≤1 or if ECOG≥2 but recover after pretreatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "* with centre neural system involvement\n* serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician\n* HIV positive or active HBV infection or other uncontrolled systematic infection\n* clinical central nervous dysfunction\n* serious surgery within 30 days\n* pregnancy or baby nursing period or un-contracepted child bearing period woman.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
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{
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"criterion": "age",
"requirement": {
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"value": 65,
"unit": "years"
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"unit": "years"
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"expected_value": true
}
}
]
},
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"III",
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]
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"expected_value": {
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"value": 1,
"unit": "N/A"
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"expected_value": {
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"value": 2,
"unit": "N/A"
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"criterion": "ECOG performance status",
"requirement": {
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"expected_value": true
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"value": 1,
"unit": "N/A"
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"criterion": "ECOG performance status",
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
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},
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{
"identified_line": {
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}
},
{
"identified_line": {
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"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
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}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 65 Years",
"criterions": [
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"exact_snippets": "maximum age of 65 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 65,
"unit": "Years"
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}
}
]
},
"logical_structure": {
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"value": 65,
"unit": "Years"
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"exclusion_lines": [
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"identified_line": {
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"criterions": [
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"criterion": "central nervous system involvement",
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"expected_value": true
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},
{
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"criterions": [
{
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"criterion": "diabetes",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "serious complications such as ... gastric ulcer",
"criterion": "gastric ulcer",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "serious complications such as ... other serious angiocardiopathy",
"criterion": "angiocardiopathy",
"requirement": {
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"expected_value": "serious"
}
}
]
},
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"expected_value": false
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{
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"requirement": {
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}
}
]
}
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{
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"criterion": "central nervous dysfunction",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "central nervous dysfunction",
"requirement": {
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"expected_value": true
}
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}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "serious surgery within 30 days",
"criterion": "serious surgery",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
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"value": 30,
"unit": "days"
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"expected_value": false
}
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"requirement": {
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"expected_value": false
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"expected_value": false
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"failed_inclusion": [],
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"failed_miscellaneous": []
}