{
"info": {
"nct_id": "NCT05648682",
"official_title": "Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis Management in Head and Neck Cancer Patients: A Randomized Controlled Study",
"inclusion_criteria": "* Primary diagnosis is head and neck cancer\n* To be receiving radiotherapy at a dose of 50-60 Gy in the oral cavity\n* Not be metastatic\n* OM grade 1 (according to NCI-CTCAE v4.03)\n* Be 18 years or older\n* Volunteer to participate in the study\n* Speak Turkish\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Have an autoimmune disease\n* Have dental disease\n* Using dentures\n* Being allergic to thyme honey\n* Refusing to participate in the research\n* To have received radiotherapy treatment in the 6-month period before the start of the study\n\nCriteria for terminating the study\n\n* The patient's desire to leave the study\n* Continuing the treatment in another city\n* Interruption or termination of radiotherapy treatment\n* Patient's death",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Primary diagnosis is head and neck cancer",
"criterions": [
{
"exact_snippets": "Primary diagnosis is head and neck cancer",
"criterion": "primary diagnosis",
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"expected_value": "head and neck cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Primary diagnosis is head and neck cancer",
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}
}
]
}
},
{
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{
"exact_snippets": "receiving radiotherapy",
"criterion": "radiotherapy",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "dose of 50-60 Gy",
"criterion": "radiotherapy dose",
"requirement": {
"requirement_type": "range",
"expected_value": {
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{
"operator": ">=",
"value": 50,
"unit": "Gy"
},
{
"operator": "<=",
"value": 60,
"unit": "Gy"
}
]
}
}
},
{
"exact_snippets": "in the oral cavity",
"criterion": "radiotherapy location",
"requirement": {
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}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": true
}
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{
"exact_snippets": "dose of 50-60 Gy",
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"requirement": {
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"expected_value": {
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{
"operator": ">=",
"value": 50,
"unit": "Gy"
},
{
"operator": "<=",
"value": 60,
"unit": "Gy"
}
]
}
}
},
{
"exact_snippets": "in the oral cavity",
"criterion": "radiotherapy location",
"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "* Not be metastatic",
"criterions": [
{
"exact_snippets": "Not be metastatic",
"criterion": "metastatic status",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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"criterion": "metastatic status",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* OM grade 1 (according to NCI-CTCAE v4.03)",
"criterions": [
{
"exact_snippets": "OM grade 1 (according to NCI-CTCAE v4.03)",
"criterion": "OM grade",
"requirement": {
"requirement_type": "severity",
"expected_value": "1"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "OM grade 1 (according to NCI-CTCAE v4.03)",
"criterion": "OM grade",
"requirement": {
"requirement_type": "severity",
"expected_value": "1"
}
}
]
}
},
{
"identified_line": {
"line": "* Be 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": {
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"exact_snippets": "18 years or older",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Volunteer to participate in the study",
"criterions": [
{
"exact_snippets": "Volunteer to participate in the study",
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"requirement": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "Volunteer to participate in the study",
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"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Speak Turkish",
"criterions": [
{
"exact_snippets": "Speak Turkish",
"criterion": "language proficiency",
"requirement": {
"requirement_type": "language",
"expected_value": "Turkish"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Speak Turkish",
"criterion": "language proficiency",
"requirement": {
"requirement_type": "language",
"expected_value": "Turkish"
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
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},
"logical_structure": {
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"exact_snippets": "Healthy volunteers allowed",
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}
},
{
"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": [
{
"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": "* Have an autoimmune disease",
"criterions": [
{
"exact_snippets": "Have an autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "autoimmune disease",
"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Have dental disease",
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{
"exact_snippets": "Have dental disease",
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"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Using dentures",
"criterions": [
{
"exact_snippets": "Using dentures",
"criterion": "dentures",
"requirement": {
"requirement_type": "usage",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Using dentures",
"criterion": "dentures",
"requirement": {
"requirement_type": "usage",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Being allergic to thyme honey",
"criterions": [
{
"exact_snippets": "allergic to thyme honey",
"criterion": "allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": "thyme honey"
}
}
]
},
"logical_structure": {
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"exact_snippets": "allergic to thyme honey",
"criterion": "allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": "thyme honey"
}
}
}
},
{
"identified_line": {
"line": "* Refusing to participate in the research",
"criterions": [
{
"exact_snippets": "Refusing to participate in the research",
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}
}
]
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}
}
}
},
{
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{
"exact_snippets": "received radiotherapy treatment",
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"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "in the 6-month period before the start of the study",
"criterion": "time since radiotherapy treatment",
"requirement": {
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"expected_value": {
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{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
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"expected_value": true
}
},
{
"exact_snippets": "in the 6-month period before the start of the study",
"criterion": "time since radiotherapy treatment",
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"operator": "<=",
"value": 6,
"unit": "months"
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}
}
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{
"identified_line": {
"line": "Criteria for terminating the study",
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{
"exact_snippets": "Criteria for terminating the study",
"criterion": "study termination",
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"expected_value": "criteria"
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}
]
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"exact_snippets": "Criteria for terminating the study",
"criterion": "study termination",
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}
}
}
},
{
"identified_line": {
"line": "* The patient's desire to leave the study",
"criterions": [
{
"exact_snippets": "The patient's desire to leave the study",
"criterion": "desire to leave the study",
"requirement": {
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}
}
]
},
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}
}
}
},
{
"identified_line": {
"line": "* Continuing the treatment in another city",
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"exact_snippets": "Continuing the treatment in another city",
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}
}
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{
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}
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{
"exact_snippets": "Patient's death",
"criterion": "death",
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"expected_value": true
}
}
]
},
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}
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}