{
"info": {
"nct_id": "NCT02381782",
"official_title": "Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment",
"inclusion_criteria": "* Patients should have reached the age of 70 or more at enrolment\n* Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible\n* Patients should be fluent in Dutch or French\n* Patients must receive their primary oncology care in the participating hospital\n* Patients should be cognitively capable of performing the audiology assessment\n* Patients should have signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 70 Years",
"exclusion_criteria": "* Patients who do not match the above inclusion criteria\n* Patients who are visiting the oncology clinic for a second opinion and do not wish to be treated in this clinic\n* Patients presenting with clinically diagnosed Ménière's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss\n* Patients who already have a hearing aid or a previously diagnosed hearing loss",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients should have reached the age of 70 or more at enrolment",
"criterions": [
{
"exact_snippets": "Patients should have reached the age of 70 or more",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients should have reached the age of 70 or more",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible",
"criterions": [
{
"exact_snippets": "Histologically confirmed diagnosis of solid cancer",
"criterion": "solid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "Histologically confirmed diagnosis of ... hematologic malignancy",
"criterion": "hematologic malignancy",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "All stages of cancer are eligible",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "all stages"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed diagnosis of solid cancer",
"criterion": "solid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "All stages of cancer are eligible",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "all stages"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed diagnosis of ... hematologic malignancy",
"criterion": "hematologic malignancy",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "All stages of cancer are eligible",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "all stages"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients should be fluent in Dutch or French",
"criterions": [
{
"exact_snippets": "fluent in Dutch",
"criterion": "language fluency",
"requirement": {
"requirement_type": "language",
"expected_value": "Dutch"
}
},
{
"exact_snippets": "fluent in ... French",
"criterion": "language fluency",
"requirement": {
"requirement_type": "language",
"expected_value": "French"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "fluent in Dutch",
"criterion": "language fluency",
"requirement": {
"requirement_type": "language",
"expected_value": "Dutch"
}
},
{
"exact_snippets": "fluent in ... French",
"criterion": "language fluency",
"requirement": {
"requirement_type": "language",
"expected_value": "French"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must receive their primary oncology care in the participating hospital",
"criterions": [
{
"exact_snippets": "Patients must receive their primary oncology care in the participating hospital",
"criterion": "primary oncology care location",
"requirement": {
"requirement_type": "location",
"expected_value": "participating hospital"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients must receive their primary oncology care in the participating hospital",
"criterion": "primary oncology care location",
"requirement": {
"requirement_type": "location",
"expected_value": "participating hospital"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients should be cognitively capable of performing the audiology assessment",
"criterions": [
{
"exact_snippets": "cognitively capable of performing the audiology assessment",
"criterion": "cognitive capability",
"requirement": {
"requirement_type": "capability",
"expected_value": "performing the audiology assessment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "cognitively capable of performing the audiology assessment",
"criterion": "cognitive capability",
"requirement": {
"requirement_type": "capability",
"expected_value": "performing the audiology assessment"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients should have signed informed consent",
"criterions": [
{
"exact_snippets": "signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"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 70 Years",
"criterions": [
{
"exact_snippets": "minimum age of 70 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 70 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients who do not match the above inclusion criteria",
"criterions": [
{
"exact_snippets": "do not match the above inclusion criteria",
"criterion": "inclusion criteria",
"requirement": {
"requirement_type": "compliance",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "do not match the above inclusion criteria",
"criterion": "inclusion criteria",
"requirement": {
"requirement_type": "compliance",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Patients who are visiting the oncology clinic for a second opinion and do not wish to be treated in this clinic",
"criterions": [
{
"exact_snippets": "Patients who are visiting the oncology clinic for a second opinion",
"criterion": "visit purpose",
"requirement": {
"requirement_type": "purpose",
"expected_value": "second opinion"
}
},
{
"exact_snippets": "do not wish to be treated in this clinic",
"criterion": "treatment preference",
"requirement": {
"requirement_type": "preference",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who are visiting the oncology clinic for a second opinion",
"criterion": "visit purpose",
"requirement": {
"requirement_type": "purpose",
"expected_value": "second opinion"
}
},
{
"exact_snippets": "do not wish to be treated in this clinic",
"criterion": "treatment preference",
"requirement": {
"requirement_type": "preference",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Patients presenting with clinically diagnosed Ménière's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss",
"criterions": [
{
"exact_snippets": "clinically diagnosed Ménière's disease",
"criterion": "Ménière's disease",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "clinically diagnosed"
}
},
{
"exact_snippets": "retrocochlear hearing loss",
"criterion": "retrocochlear hearing loss",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "autoimmune inner ear disease",
"criterion": "autoimmune inner ear disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "fluctuating hearing loss",
"criterion": "fluctuating hearing loss",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of sudden sensory neural hearing loss",
"criterion": "sudden sensory neural hearing loss",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "clinically diagnosed Ménière's disease",
"criterion": "Ménière's disease",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "clinically diagnosed"
}
},
{
"exact_snippets": "retrocochlear hearing loss",
"criterion": "retrocochlear hearing loss",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "autoimmune inner ear disease",
"criterion": "autoimmune inner ear disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "fluctuating hearing loss",
"criterion": "fluctuating hearing loss",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of sudden sensory neural hearing loss",
"criterion": "sudden sensory neural hearing loss",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who already have a hearing aid or a previously diagnosed hearing loss",
"criterions": [
{
"exact_snippets": "Patients who already have a hearing aid",
"criterion": "hearing aid",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "previously diagnosed hearing loss",
"criterion": "hearing loss",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Patients who already have a hearing aid",
"criterion": "hearing aid",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "previously diagnosed hearing loss",
"criterion": "hearing loss",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}