[96a5a0]: / output / allTrials / identified / NCT03975491_identified.json

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{
"info": {
"nct_id": "NCT03975491",
"official_title": "The Exercise And Colorectal Cancer Treatment (EXACT) Trial",
"inclusion_criteria": "* Age ≥18 years\n* Histologically-confirmed stage I-III colorectal cancer\n* Completed surgical resection\n* Completed chemotherapy (if applicable)\n* Completed radiotherapy (if applicable)\n* Provide written approval by physician or other qualified healthcare provider\n* No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted)\n* Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)\n* Allow the collection and storage of specimens and data for future use\n* Willing to be randomized\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Evidence of metastatic colon cancer\n* Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers)\n* Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention\n* Current body mass greater than or equal to 181 kg\n* Unable to provide a baseline fasting blood sample\n* Unable or unwilling to give informed consent\n* Unable or unwilling to be randomized\n* Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age ≥18 years",
"criterions": [
{
"exact_snippets": "Age ≥18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Histologically-confirmed stage I-III colorectal cancer",
"criterions": [
{
"exact_snippets": "Histologically-confirmed",
"criterion": "colorectal cancer",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically"
}
]
},
{
"exact_snippets": "stage I-III colorectal cancer",
"criterion": "colorectal cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
}
]
},
{
"line": "* Completed surgical resection",
"criterions": [
{
"exact_snippets": "Completed surgical resection",
"criterion": "surgical resection",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
}
]
},
{
"line": "* Completed chemotherapy (if applicable)",
"criterions": [
{
"exact_snippets": "Completed chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
}
]
},
{
"line": "* Completed radiotherapy (if applicable)",
"criterions": [
{
"exact_snippets": "Completed radiotherapy (if applicable)",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
}
]
},
{
"line": "* Provide written approval by physician or other qualified healthcare provider",
"criterions": [
{
"exact_snippets": "written approval by physician or other qualified healthcare provider",
"criterion": "approval by healthcare provider",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted)",
"criterions": [
{
"exact_snippets": "No planned major surgery during the study period",
"criterion": "planned major surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "colostomy reversal",
"criterion": "colostomy reversal",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "chemotherapy infusion port removal is permitted",
"criterion": "chemotherapy infusion port removal",
"requirements": [
{
"requirement_type": "permission",
"expected_value": true
}
]
}
]
},
{
"line": "* Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)",
"criterions": [
{
"exact_snippets": "Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)",
"criterion": "readiness to exercise",
"requirements": [
{
"requirement_type": "determination method",
"expected_value": "modified version of the Physical Activity Readiness Questionnaire (PAR-Q)"
}
]
}
]
},
{
"line": "* Allow the collection and storage of specimens and data for future use",
"criterions": [
{
"exact_snippets": "collection and storage of specimens",
"criterion": "specimen collection and storage",
"requirements": [
{
"requirement_type": "permission",
"expected_value": true
}
]
},
{
"exact_snippets": "collection and storage of ... data",
"criterion": "data collection and storage",
"requirements": [
{
"requirement_type": "permission",
"expected_value": true
}
]
}
]
},
{
"line": "* Willing to be randomized",
"criterions": [
{
"exact_snippets": "Willing to be randomized",
"criterion": "willingness to be randomized",
"requirements": [
{
"requirement_type": "willingness",
"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": "* Evidence of metastatic colon cancer",
"criterions": [
{
"exact_snippets": "Evidence of metastatic colon cancer",
"criterion": "metastatic colon cancer",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": true
}
]
}
]
},
{
"line": "* Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers)",
"criterions": [
{
"exact_snippets": "Concurrently actively treated other cancer",
"criterion": "other cancer",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": "concurrently actively treated"
}
]
},
{
"exact_snippets": "except non-melanoma skin cancer",
"criterion": "non-melanoma skin cancer",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
},
{
"exact_snippets": "except ... in situ cancers",
"criterion": "in situ cancers",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "* Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention",
"criterions": [
{
"exact_snippets": "Currently enrolled in another clinical trial of weight loss",
"criterion": "enrollment in another clinical trial",
"requirements": [
{
"requirement_type": "intervention type",
"expected_value": "weight loss"
}
]
},
{
"exact_snippets": "Currently enrolled in another clinical trial of ... physical activity",
"criterion": "enrollment in another clinical trial",
"requirements": [
{
"requirement_type": "intervention type",
"expected_value": "physical activity"
}
]
},
{
"exact_snippets": "Currently enrolled in another clinical trial of ... dietary intervention",
"criterion": "enrollment in another clinical trial",
"requirements": [
{
"requirement_type": "intervention type",
"expected_value": "dietary intervention"
}
]
}
]
},
{
"line": "* Current body mass greater than or equal to 181 kg",
"criterions": [
{
"exact_snippets": "Current body mass greater than or equal to 181 kg",
"criterion": "body mass",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 181,
"unit": "kg"
}
}
]
}
]
},
{
"line": "* Unable to provide a baseline fasting blood sample",
"criterions": [
{
"exact_snippets": "Unable to provide a baseline fasting blood sample",
"criterion": "baseline fasting blood sample",
"requirements": [
{
"requirement_type": "ability to provide",
"expected_value": true
}
]
}
]
},
{
"line": "* Unable or unwilling to give informed consent",
"criterions": [
{
"exact_snippets": "Unable or unwilling to give informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
},
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Unable or unwilling to be randomized",
"criterions": [
{
"exact_snippets": "Unable ... to be randomized",
"criterion": "ability to be randomized",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "unwilling to be randomized",
"criterion": "willingness to be randomized",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)",
"criterions": [
{
"exact_snippets": "any other condition that may impede testing of the study hypothesis",
"criterion": "condition impeding hypothesis testing",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "any other condition that may ... make it unsafe to engage in the exercise program",
"criterion": "condition making exercise unsafe",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}