{
    "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": [
        {
            "line": "* Primary diagnosis is head and neck cancer",
            "criterions": [
                {
                    "exact_snippets": "Primary diagnosis is head and neck cancer",
                    "criterion": "primary diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "head and neck cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* To be receiving radiotherapy at a dose of 50-60 Gy in the oral cavity",
            "criterions": [
                {
                    "exact_snippets": "receiving radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dose of 50-60 Gy",
                    "criterion": "radiotherapy dose",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "Gy"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 60,
                                        "unit": "Gy"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "in the oral cavity",
                    "criterion": "radiotherapy location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "oral cavity"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not be metastatic",
            "criterions": [
                {
                    "exact_snippets": "Not be metastatic",
                    "criterion": "metastatic status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Volunteer to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Volunteer to participate in the study",
                    "criterion": "volunteer status",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Speak Turkish",
            "criterions": [
                {
                    "exact_snippets": "Speak Turkish",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": "Turkish"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Have an autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Have an autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have dental disease",
            "criterions": [
                {
                    "exact_snippets": "Have dental disease",
                    "criterion": "dental disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Using dentures",
            "criterions": [
                {
                    "exact_snippets": "Using dentures",
                    "criterion": "dentures",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Being allergic to thyme honey",
            "criterions": [
                {
                    "exact_snippets": "allergic to thyme honey",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "thyme honey"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refusing to participate in the research",
            "criterions": [
                {
                    "exact_snippets": "Refusing to participate in the research",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* To have received radiotherapy treatment in the 6-month period before the start of the study",
            "criterions": [
                {
                    "exact_snippets": "received radiotherapy treatment",
                    "criterion": "radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the 6-month period before the start of the study",
                    "criterion": "time since radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Criteria for terminating the study",
            "criterions": [
                {
                    "exact_snippets": "Criteria for terminating the study",
                    "criterion": "study termination",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "criteria"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Continuing the treatment in another city",
            "criterions": [
                {
                    "exact_snippets": "Continuing the treatment in another city",
                    "criterion": "treatment location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "another city"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interruption or termination of radiotherapy treatment",
            "criterions": [
                {
                    "exact_snippets": "Interruption or termination of radiotherapy treatment",
                    "criterion": "radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "interruption",
                                "termination"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient's death",
            "criterions": [
                {
                    "exact_snippets": "Patient's death",
                    "criterion": "death",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}