{
"info": {
"nct_id": "NCT05043220",
"official_title": "COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von Gynäkologisch Onkologischen Patientinnen Unter Onkologischer Systemtherapie - CO-SI-ONKO-Studie",
"inclusion_criteria": "* gynecological cancer\n* indication for systemic cancer therapy\n* patients who are legally competent and able to understand and follow instructions of the study staff\n* present informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* no use if internet or applications\n* persons who are in a dependency or employment relationship with the study center\n* positive proof of COVID-19\n* affection of the external auditory canal",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* gynecological cancer",
"criterions": [
{
"exact_snippets": "gynecological cancer",
"criterion": "gynecological cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "gynecological cancer",
"criterion": "gynecological cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* indication for systemic cancer therapy",
"criterions": [
{
"exact_snippets": "indication for systemic cancer therapy",
"criterion": "systemic cancer therapy",
"requirement": {
"requirement_type": "indication",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "indication for systemic cancer therapy",
"criterion": "systemic cancer therapy",
"requirement": {
"requirement_type": "indication",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* patients who are legally competent and able to understand and follow instructions of the study staff",
"criterions": [
{
"exact_snippets": "patients who are legally competent",
"criterion": "legal competence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "able to understand and follow instructions of the study staff",
"criterion": "ability to understand and follow instructions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "patients who are legally competent",
"criterion": "legal competence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "able to understand and follow instructions of the study staff",
"criterion": "ability to understand and follow instructions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* present informed consent",
"criterions": [
{
"exact_snippets": "present informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "present informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"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 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"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* persons who are in a dependency or employment relationship with the study center",
"criterions": [
{
"exact_snippets": "persons who are in a dependency or employment relationship with the study center",
"criterion": "relationship with the study center",
"requirement": {
"requirement_type": "type",
"expected_value": [
"dependency",
"employment"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "persons who are in a dependency or employment relationship with the study center",
"criterion": "relationship with the study center",
"requirement": {
"requirement_type": "type",
"expected_value": [
"dependency",
"employment"
]
}
}
]
}
},
{
"identified_line": {
"line": "* positive proof of COVID-19",
"criterions": [
{
"exact_snippets": "positive proof of COVID-19",
"criterion": "COVID-19",
"requirement": {
"requirement_type": "proof",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "positive proof of COVID-19",
"criterion": "COVID-19",
"requirement": {
"requirement_type": "proof",
"expected_value": "positive"
}
}
}
},
{
"identified_line": {
"line": "* affection of the external auditory canal",
"criterions": [
{
"exact_snippets": "affection of the external auditory canal",
"criterion": "external auditory canal",
"requirement": {
"requirement_type": "affection",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "affection of the external auditory canal",
"criterion": "external auditory canal",
"requirement": {
"requirement_type": "affection",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* no use if internet or applications",
"criterions": [
{
"exact_snippets": "no use if internet or applications",
"criterion": "use of internet or applications",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "no use if internet or applications",
"criterion": "use of internet",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no use if internet or applications",
"criterion": "use of applications",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
}
],
"failed_miscellaneous": []
}