{
"info": {
"nct_id": "NCT04116827",
"official_title": "Analysis of Sleep and Activity Patterns in Pre-menopausal Breast Cancer Patients After Taking Tamoxifen Using a Wrist-worn Internet of Things Device",
"inclusion_criteria": "* diagnosed of unilateral breast cancer (stage 0 ~III)\n* underwent proper cancer treatment including surgery, chemotherapy, radiation therapy\n* age : 18 ~ 45\n* scheduled for applying tamoxifen and goserelin\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 45 Years",
"exclusion_criteria": "* need CPAP device during sleep due to sleep apnea\n* under medication for restless leg syndrome\n* previous history of tamoxifen\n* irregular bedtime due to shift work\n* diagnosed of recurrent or metastatic cancer\n* have difficulty understanding and conducting surveys and verbal instructions due to severe cognitive, communication and perception problems\n* refuse to participate\n* has musculoskeletal system and neurological damage and lesions",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* diagnosed of unilateral breast cancer (stage 0 ~III)",
"criterions": [
{
"exact_snippets": "diagnosed of unilateral breast cancer",
"criterion": "unilateral breast cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "stage 0 ~III",
"criterion": "breast cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* underwent proper cancer treatment including surgery, chemotherapy, radiation therapy",
"criterions": [
{
"exact_snippets": "underwent proper cancer treatment including surgery",
"criterion": "cancer treatment",
"requirements": [
{
"requirement_type": "type",
"expected_value": "surgery"
}
]
},
{
"exact_snippets": "underwent proper cancer treatment including ... chemotherapy",
"criterion": "cancer treatment",
"requirements": [
{
"requirement_type": "type",
"expected_value": "chemotherapy"
}
]
},
{
"exact_snippets": "underwent proper cancer treatment including ... radiation therapy",
"criterion": "cancer treatment",
"requirements": [
{
"requirement_type": "type",
"expected_value": "radiation therapy"
}
]
}
]
},
{
"line": "* age : 18 ~ 45",
"criterions": [
{
"exact_snippets": "age : 18 ~ 45",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 45,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* scheduled for applying tamoxifen and goserelin",
"criterions": [
{
"exact_snippets": "scheduled for applying tamoxifen",
"criterion": "tamoxifen treatment",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": true
}
]
},
{
"exact_snippets": "scheduled for applying ... goserelin",
"criterion": "goserelin treatment",
"requirements": [
{
"requirement_type": "scheduled",
"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 be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 45 Years",
"criterions": [
{
"exact_snippets": "maximum age of 45 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 45,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* need CPAP device during sleep due to sleep apnea",
"criterions": [
{
"exact_snippets": "need CPAP device during sleep",
"criterion": "CPAP device usage",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
},
{
"exact_snippets": "due to sleep apnea",
"criterion": "sleep apnea",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* under medication for restless leg syndrome",
"criterions": [
{
"exact_snippets": "under medication for restless leg syndrome",
"criterion": "restless leg syndrome",
"requirements": [
{
"requirement_type": "medication status",
"expected_value": "under medication"
}
]
}
]
},
{
"line": "* previous history of tamoxifen",
"criterions": [
{
"exact_snippets": "previous history of tamoxifen",
"criterion": "tamoxifen",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* irregular bedtime due to shift work",
"criterions": [
{
"exact_snippets": "irregular bedtime due to shift work",
"criterion": "bedtime regularity",
"requirements": [
{
"requirement_type": "cause",
"expected_value": "shift work"
}
]
}
]
},
{
"line": "* diagnosed of recurrent or metastatic cancer",
"criterions": [
{
"exact_snippets": "diagnosed of recurrent or metastatic cancer",
"criterion": "cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": [
"recurrent",
"metastatic"
]
}
]
}
]
},
{
"line": "* have difficulty understanding and conducting surveys and verbal instructions due to severe cognitive, communication and perception problems",
"criterions": [
{
"exact_snippets": "difficulty understanding and conducting surveys and verbal instructions",
"criterion": "understanding and conducting surveys and verbal instructions",
"requirements": [
{
"requirement_type": "difficulty",
"expected_value": true
}
]
},
{
"exact_snippets": "severe cognitive, communication and perception problems",
"criterion": "cognitive, communication and perception problems",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
}
]
},
{
"line": "* refuse to participate",
"criterions": [
{
"exact_snippets": "refuse to participate",
"criterion": "willingness to participate",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* has musculoskeletal system and neurological damage and lesions",
"criterions": [
{
"exact_snippets": "musculoskeletal system",
"criterion": "musculoskeletal system",
"requirements": [
{
"requirement_type": "damage",
"expected_value": true
}
]
},
{
"exact_snippets": "neurological damage",
"criterion": "neurological system",
"requirements": [
{
"requirement_type": "damage",
"expected_value": true
}
]
},
{
"exact_snippets": "lesions",
"criterion": "lesions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}