{
"info": {
"nct_id": "NCT04200001",
"official_title": "Evaluation of Sexual Quality of Life in Women Less Than 51 Years Old, During Adjuvant Hormonal Therapy for Breast Cancer",
"inclusion_criteria": "* Female age ≥ 18 years old and less than 51 years old.\n* Patient with non-metastatic early breast cancer,\n* Patient undergoing adjuvant hormonal therapy for at least 2 years,\n* Patient who has been treated by surgery, with or without chemotherapy and/or radiotherapy.\n* Patient being currently sexually active.\n* Patient who agreed, after receiving information, to participate to the study.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 51 Years",
"exclusion_criteria": "* Patient who refused to participate to this study or is unable to fulfill a questionnaire,\n* Patient not affiliated to the French social security system,\n* Subject under tutelage, curatorship or safeguard of justice,\n* Patient in an emergency situation,\n* Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,\n* Pregnant and / or breastfeeding woman.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Female age ≥ 18 years old and less than 51 years old.",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "age ≥ 18 years old and less than 51 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<",
"value": 51,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "age ≥ 18 years old and less than 51 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<",
"value": 51,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient with non-metastatic early breast cancer,",
"criterions": [
{
"exact_snippets": "non-metastatic",
"criterion": "metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "early breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "early"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "non-metastatic",
"criterion": "metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "early breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "early"
}
}
]
}
},
{
"identified_line": {
"line": "* Patient undergoing adjuvant hormonal therapy for at least 2 years,",
"criterions": [
{
"exact_snippets": "Patient undergoing adjuvant hormonal therapy",
"criterion": "adjuvant hormonal therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "for at least 2 years",
"criterion": "duration of adjuvant hormonal therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient undergoing adjuvant hormonal therapy",
"criterion": "adjuvant hormonal therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "for at least 2 years",
"criterion": "duration of adjuvant hormonal therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient who has been treated by surgery, with or without chemotherapy and/or radiotherapy.",
"criterions": [
{
"exact_snippets": "treated by surgery",
"criterion": "surgery treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "with or without chemotherapy",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
},
{
"exact_snippets": "and/or radiotherapy",
"criterion": "radiotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "treated by surgery",
"criterion": "surgery treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "with or without chemotherapy",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
},
{
"exact_snippets": "and/or radiotherapy",
"criterion": "radiotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patient being currently sexually active.",
"criterions": [
{
"exact_snippets": "Patient being currently sexually active.",
"criterion": "sexual activity",
"requirement": {
"requirement_type": "current status",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient being currently sexually active.",
"criterion": "sexual activity",
"requirement": {
"requirement_type": "current status",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patient who agreed, after receiving information, to participate to the study.",
"criterions": [
{
"exact_snippets": "Patient who agreed, after receiving information, to participate to the study.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient who agreed, after receiving information, to participate to the study.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"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": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 51 Years",
"criterions": [
{
"exact_snippets": "maximum age of 51 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 51,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 51 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 51,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patient who refused to participate to this study or is unable to fulfill a questionnaire,",
"criterions": [
{
"exact_snippets": "Patient who refused to participate",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "unable to fulfill a questionnaire",
"criterion": "ability to fulfill a questionnaire",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"not_criteria": {
"exact_snippets": "Patient who refused to participate",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
},
{
"not_criteria": {
"exact_snippets": "unable to fulfill a questionnaire",
"criterion": "ability to fulfill a questionnaire",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient not affiliated to the French social security system,",
"criterions": [
{
"exact_snippets": "Patient not affiliated to the French social security system",
"criterion": "affiliation to the French social security system",
"requirement": {
"requirement_type": "affiliation",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient not affiliated to the French social security system",
"criterion": "affiliation to the French social security system",
"requirement": {
"requirement_type": "affiliation",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Subject under tutelage, curatorship or safeguard of justice,",
"criterions": [
{
"exact_snippets": "Subject under tutelage, curatorship or safeguard of justice",
"criterion": "legal status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"tutelage",
"curatorship",
"safeguard of justice"
]
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Subject under tutelage, curatorship or safeguard of justice",
"criterion": "legal status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"tutelage",
"curatorship",
"safeguard of justice"
]
}
}
}
},
{
"identified_line": {
"line": "* Patient in an emergency situation,",
"criterions": [
{
"exact_snippets": "Patient in an emergency situation",
"criterion": "emergency situation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patient in an emergency situation",
"criterion": "emergency situation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,",
"criterions": [
{
"exact_snippets": "regular monitoring is impossible for psychological ... reasons",
"criterion": "psychological reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
},
{
"exact_snippets": "regular monitoring is impossible for ... family ... reasons",
"criterion": "family reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
},
{
"exact_snippets": "regular monitoring is impossible for ... social ... reasons",
"criterion": "social reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
},
{
"exact_snippets": "regular monitoring is impossible for ... geographical reasons",
"criterion": "geographical reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "regular monitoring is impossible for psychological ... reasons",
"criterion": "psychological reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
},
{
"exact_snippets": "regular monitoring is impossible for ... family ... reasons",
"criterion": "family reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
},
{
"exact_snippets": "regular monitoring is impossible for ... social ... reasons",
"criterion": "social reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
},
{
"exact_snippets": "regular monitoring is impossible for ... geographical reasons",
"criterion": "geographical reasons",
"requirement": {
"requirement_type": "possibility of regular monitoring",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant and / or breastfeeding woman.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
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"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}