{
"info": {
"nct_id": "NCT02221076",
"official_title": "Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study",
"inclusion_criteria": "* Patients scheduled for a colposcopy\n* Patients scheduled for a hysteroscopy\n* Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion\n* 18 years or older.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Allergy to fluorescein\n* Previous life-threatening allergic reactions and known hypersensitivity\n* Pregnancy or breast-feeding\n* History of cardio-pulmonary disease (including bronchial asthma)\n* Restricted renal function\n* Patients under a beta-blockers treatment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients scheduled for a colposcopy",
"criterions": [
{
"exact_snippets": "scheduled for a colposcopy",
"criterion": "colposcopy",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "colposcopy",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
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"criterions": [
{
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"criterion": "hysteroscopy",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"requirement": {
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"expected_value": true
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]
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "surgical treatment",
"requirement": {
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"expected_value": true
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},
{
"exact_snippets": "suspected cervix/ endocervix/ endometrium lesion",
"criterion": "lesion location",
"requirement": {
"requirement_type": "location",
"expected_value": [
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"endocervix",
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]
}
},
{
"exact_snippets": "suspected cervix/ endocervix/ endometrium lesion",
"criterion": "lesion location",
"requirement": {
"requirement_type": "suspicion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
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"criterion": "surgical treatment",
"requirement": {
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"expected_value": true
}
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{
"exact_snippets": "suspected cervix/ endocervix/ endometrium lesion",
"criterion": "lesion location",
"requirement": {
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"expected_value": [
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}
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{
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"criterion": "lesion location",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* 18 years or older.",
"criterions": [
{
"exact_snippets": "18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "18 years or older",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"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": [
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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}
},
{
"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": [
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"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
}
]
}
},
{
"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": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Allergy to fluorescein",
"criterions": [
{
"exact_snippets": "Allergy to fluorescein",
"criterion": "allergy",
"requirement": {
"requirement_type": "substance",
"expected_value": "fluorescein"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Allergy to fluorescein",
"criterion": "allergy",
"requirement": {
"requirement_type": "substance",
"expected_value": "fluorescein"
}
}
}
},
{
"identified_line": {
"line": "* Previous life-threatening allergic reactions and known hypersensitivity",
"criterions": [
{
"exact_snippets": "Previous life-threatening allergic reactions",
"criterion": "life-threatening allergic reactions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "known hypersensitivity",
"criterion": "hypersensitivity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Previous life-threatening allergic reactions",
"criterion": "life-threatening allergic reactions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "known hypersensitivity",
"criterion": "hypersensitivity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnancy or breast-feeding",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast-feeding",
"criterion": "breast-feeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
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"criterion": "breast-feeding",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* History of cardio-pulmonary disease (including bronchial asthma)",
"criterions": [
{
"exact_snippets": "History of cardio-pulmonary disease",
"criterion": "cardio-pulmonary disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "(including bronchial asthma)",
"criterion": "bronchial asthma",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of cardio-pulmonary disease",
"criterion": "cardio-pulmonary disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "(including bronchial asthma)",
"criterion": "bronchial asthma",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Restricted renal function",
"criterions": [
{
"exact_snippets": "Restricted renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "status",
"expected_value": "restricted"
}
}
]
},
"logical_structure": {
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"criterion": "renal function",
"requirement": {
"requirement_type": "status",
"expected_value": "restricted"
}
}
}
},
{
"identified_line": {
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"requirement": {
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"expected_value": true
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}
]
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}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}