{
"info": {
"nct_id": "NCT02930876",
"official_title": "Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients: a Phase II Trial",
"inclusion_criteria": "- histological diagnosis of cancer, incurable (stage IIIB/IV according to AJCC 2010).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* chemotherapy within 90 days prior to study enrollment\n* not having a baseline (pre-treatment) Computed Tomography of the Thorax Abdomen and Pelvis (CTTAP) and whole body dual x-ray absorptometry (DXA) (this is important because having an assessment of baseline muscle mass will allow us to control for baseline sarcopenia and calculate changes from baseline to post-intervention)\n* bone metastasis in risk of fracture\n* inability to comply with the intervention for any known reasons (including physical or mental impairment that limits the capacity to undertake the exercise program)\n* considered to be at cardiovascular risk (defined by a pre-exercise cardiologic evaluation with electrocardiogram (ECG) and echocardiogram when indicated (echocardiogram if >50 years old, NYHA class I, angor, cardiovascular risk factors and abnormal ECG)).",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
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{
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"requirement": {
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}
},
{
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"requirement": {
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]
}
},
{
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"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"requirement": {
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}
},
{
"and_criteria": [
{
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"criterion": "cancer stage",
"requirement": {
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"expected_value": [
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"IV"
]
}
},
{
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"criterion": "cancer stage",
"requirement": {
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"expected_value": false
}
}
]
}
]
}
},
{
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{
"exact_snippets": "Healthy volunteers allowed",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"value": 18,
"unit": "Years"
}
}
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}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* chemotherapy within 90 days prior to study enrollment",
"criterions": [
{
"exact_snippets": "chemotherapy within 90 days prior to study enrollment",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "chemotherapy within 90 days prior to study enrollment",
"criterion": "chemotherapy",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 90,
"unit": "days"
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}
}
]
}
},
{
"identified_line": {
"line": "* not having a baseline (pre-treatment) Computed Tomography of the Thorax Abdomen and Pelvis (CTTAP) and whole body dual x-ray absorptometry (DXA) (this is important because having an assessment of baseline muscle mass will allow us to control for baseline sarcopenia and calculate changes from baseline to post-intervention)",
"criterions": [
{
"exact_snippets": "not having a baseline (pre-treatment) Computed Tomography of the Thorax Abdomen and Pelvis (CTTAP)",
"criterion": "baseline CTTAP",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "not having a baseline (pre-treatment) ... whole body dual x-ray absorptometry (DXA)",
"criterion": "baseline DXA",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": true
}
}
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{
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"criterion": "baseline DXA",
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"expected_value": true
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* bone metastasis in risk of fracture",
"criterions": [
{
"exact_snippets": "bone metastasis",
"criterion": "bone metastasis",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "risk of fracture",
"criterion": "risk of fracture",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": "failed"
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},
{
"identified_line": {
"line": "* inability to comply with the intervention for any known reasons (including physical or mental impairment that limits the capacity to undertake the exercise program)",
"criterions": [
{
"exact_snippets": "inability to comply with the intervention",
"criterion": "compliance with intervention",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "physical or mental impairment that limits the capacity to undertake the exercise program",
"criterion": "physical or mental impairment",
"requirement": {
"requirement_type": "impact on exercise program",
"expected_value": false
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
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{
"identified_line": {
"line": "* considered to be at cardiovascular risk (defined by a pre-exercise cardiologic evaluation with electrocardiogram (ECG) and echocardiogram when indicated (echocardiogram if >50 years old, NYHA class I, angor, cardiovascular risk factors and abnormal ECG)).",
"criterions": [
{
"exact_snippets": "pre-exercise cardiologic evaluation with electrocardiogram (ECG)",
"criterion": "pre-exercise cardiologic evaluation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "echocardiogram if >50 years old",
"criterion": "age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "years"
}
}
},
{
"exact_snippets": "NYHA class I",
"criterion": "NYHA class",
"requirement": {
"requirement_type": "classification",
"expected_value": "I"
}
},
{
"exact_snippets": "angor",
"criterion": "angor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "cardiovascular risk factors",
"criterion": "cardiovascular risk factors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "abnormal ECG",
"criterion": "ECG",
"requirement": {
"requirement_type": "abnormality",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}