{
"info": {
"nct_id": "NCT01458457",
"official_title": "Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study",
"inclusion_criteria": "* diagnosed breast cancer\n* current usual care treatment\n* willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group\n* informed consent\nHealthy volunteers allowed\nMust be FEMALE",
"exclusion_criteria": "* complementary treatment at the Hospital Meran in the last 6 months\n* no German or Italian language ability\n* participation in other study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
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{
"exact_snippets": "diagnosed breast cancer",
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"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "breast cancer",
"requirement": {
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"expected_value": true
}
}
]
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{
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"criterion": "usual care treatment",
"requirement": {
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}
}
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"logical_structure": {
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{
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{
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"criterion": "duration of refraining from complementary treatment",
"requirement": {
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"expected_value": {
"operator": "=",
"value": 6,
"unit": "months"
}
}
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{
"exact_snippets": "randomization into the usual care group",
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"requirement": {
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}
}
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"requirement": {
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"expected_value": true
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{
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"value": 6,
"unit": "months"
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"else_criteria": null
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{
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"criterion": "informed consent",
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}
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}
],
"exclusion_lines": [
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "complementary treatment at the Hospital Meran in the last 6 months",
"criterion": "complementary treatment at the Hospital Meran",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
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"criterion": "complementary treatment at the Hospital Meran",
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"expected_value": {
"operator": "<=",
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"unit": "months"
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}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "no German ... language ability",
"criterion": "German language ability",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "no ... Italian language ability",
"criterion": "Italian language ability",
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"expected_value": false
}
}
]
},
"logical_structure": {
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"criterion": "German language ability",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "no ... Italian language ability",
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"requirement": {
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"expected_value": false
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}
]
}
},
{
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"requirement": {
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"criterion": "participation in other study",
"requirement": {
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"expected_value": false
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
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"requirement": {
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{
"identified_line": {
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{
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"criterion": "gender",
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}
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],
"failed_exclusion": [],
"failed_miscellaneous": []
}