{
"info": {
"nct_id": "NCT00522262",
"official_title": "Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial",
"inclusion_criteria": "* Female\n* Age 50-74 at baseline\n* Postmenopausal\n* Moderately sedentary lifestyle\n* Live in Calgary or Edmonton, Alberta, Canada\n* English-speaking\n* Willing to be randomized\n* Body-mass index 22.0-40.0\n* Breast tissue density >=0%\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 50 Years\nMust have maximum age of 74 Years",
"exclusion_criteria": "* Previous invasive cancer in last 5 years\n* Major co-morbidities\n* Unable to participate in exercise program\n* Current smoker\n* Current excessive drinker\n* Hormone replacement therapy use in previous 2 years\n* Drugs that may influence one or more study outcomes",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Female",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "* Age 50-74 at baseline",
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{
"exact_snippets": "Age 50-74",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 50,
"unit": "years"
},
{
"operator": "<=",
"value": 74,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"criterion": "age",
"requirement": {
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"expected_value": {
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"value": 50,
"unit": "years"
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{
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"value": 74,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Postmenopausal",
"criterions": [
{
"exact_snippets": "Postmenopausal",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Postmenopausal",
"criterion": "menopausal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
}
]
}
},
{
"identified_line": {
"line": "* Moderately sedentary lifestyle",
"criterions": [
{
"exact_snippets": "Moderately sedentary lifestyle",
"criterion": "lifestyle",
"requirement": {
"requirement_type": "activity level",
"expected_value": "moderately sedentary"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Moderately sedentary lifestyle",
"criterion": "lifestyle",
"requirement": {
"requirement_type": "activity level",
"expected_value": "moderately sedentary"
}
}
]
}
},
{
"identified_line": {
"line": "* Live in Calgary or Edmonton, Alberta, Canada",
"criterions": [
{
"exact_snippets": "Live in Calgary or Edmonton, Alberta, Canada",
"criterion": "residence location",
"requirement": {
"requirement_type": "location",
"expected_value": [
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"Edmonton"
]
}
},
{
"exact_snippets": "Live in Calgary or Edmonton, Alberta, Canada",
"criterion": "residence location",
"requirement": {
"requirement_type": "region",
"expected_value": "Alberta, Canada"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Live in Calgary or Edmonton, Alberta, Canada",
"criterion": "residence location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"Calgary",
"Edmonton"
]
}
},
{
"exact_snippets": "Live in Calgary or Edmonton, Alberta, Canada",
"criterion": "residence location",
"requirement": {
"requirement_type": "region",
"expected_value": "Alberta, Canada"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* English-speaking",
"criterions": [
{
"exact_snippets": "English-speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "English"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "English-speaking",
"criterion": "language",
"requirement": {
"requirement_type": "proficiency",
"expected_value": "English"
}
}
]
}
},
{
"identified_line": {
"line": "* Willing to be randomized",
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"exact_snippets": "Willing to be randomized",
"criterion": "willingness to be randomized",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Willing to be randomized",
"criterion": "willingness to be randomized",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Body-mass index 22.0-40.0",
"criterions": [
{
"exact_snippets": "Body-mass index 22.0-40.0",
"criterion": "body-mass index",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 22.0,
"unit": ""
},
{
"operator": "<=",
"value": 40.0,
"unit": ""
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Body-mass index 22.0-40.0",
"criterion": "body-mass index",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 22.0,
"unit": ""
},
{
"operator": "<=",
"value": 40.0,
"unit": ""
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Breast tissue density >=0%",
"criterions": [
{
"exact_snippets": "Breast tissue density >=0%",
"criterion": "breast tissue density",
"requirement": {
"requirement_type": "density",
"expected_value": {
"operator": ">=",
"value": 0,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Breast tissue density >=0%",
"criterion": "breast tissue density",
"requirement": {
"requirement_type": "density",
"expected_value": {
"operator": ">=",
"value": 0,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 50 Years",
"criterions": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 50 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 50,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 74 Years",
"criterions": [
{
"exact_snippets": "maximum age of 74 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 74,
"unit": "Years"
}
}
}
]
},
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"exact_snippets": "maximum age of 74 Years",
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"value": 74,
"unit": "Years"
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}
}
]
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}
],
"exclusion_lines": [
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Previous invasive cancer in last 5 years",
"criterion": "previous invasive cancer",
"requirement": {
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"expected_value": {
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"value": 5,
"unit": "years"
}
}
}
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"requirement": {
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"expected_value": {
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"value": 5,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Major co-morbidities",
"criterions": [
{
"exact_snippets": "Major co-morbidities",
"criterion": "co-morbidities",
"requirement": {
"requirement_type": "severity",
"expected_value": "major"
}
}
]
},
"logical_structure": {
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"criterion": "co-morbidities",
"requirement": {
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"expected_value": "major"
}
}
}
},
{
"identified_line": {
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{
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"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
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"criterion": "smoking status",
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}
}
]
},
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"criterion": "smoking status",
"requirement": {
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Current excessive drinker",
"criterion": "alcohol consumption",
"requirement": {
"requirement_type": "status",
"expected_value": "excessive"
}
}
]
},
"logical_structure": {
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"criterion": "alcohol consumption",
"requirement": {
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}
}
}
},
{
"identified_line": {
"line": "* Hormone replacement therapy use in previous 2 years",
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{
"exact_snippets": "Hormone replacement therapy use in previous 2 years",
"criterion": "hormone replacement therapy use",
"requirement": {
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}
}
]
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}
}
}
},
{
"identified_line": {
"line": "* Drugs that may influence one or more study outcomes",
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{
"exact_snippets": "Drugs that may influence one or more study outcomes",
"criterion": "drugs",
"requirement": {
"requirement_type": "influence on study outcomes",
"expected_value": true
}
}
]
},
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"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}