{
    "info": {
        "nct_id": "NCT00615420",
        "official_title": "A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer",
        "inclusion_criteria": "* Patients commencing radiation therapy of 50 Gy or higher with the dosage field affecting the oral mucosa unilaterally or bilaterally (minimum 3 observable sites affected).\n* Patients willing and able to attend weekly assessments throughout their treatment, plus one week after completion of treatment.\nHealthy volunteers allowed",
        "exclusion_criteria": "* Patients unable to understand the consent process (translators will be used if necessary so being English-speaking is not required).\n* Patients unable to attend the follow-up visits\n* Patients participating in other clinical trials which might affect the severity of mucositis\n* Patients allergic to honey, multiple pollens, or to celery",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients commencing radiation therapy of 50 Gy or higher with the dosage field affecting the oral mucosa unilaterally or bilaterally (minimum 3 observable sites affected).",
            "criterions": [
                {
                    "exact_snippets": "commencing radiation therapy of 50 Gy or higher",
                    "criterion": "radiation therapy dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Gy"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "dosage field affecting the oral mucosa unilaterally or bilaterally",
                    "criterion": "oral mucosa affected by radiation",
                    "requirements": [
                        {
                            "requirement_type": "affected sides",
                            "expected_value": [
                                "unilaterally",
                                "bilaterally"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "minimum 3 observable sites affected",
                    "criterion": "observable sites affected",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "sites"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients willing and able to attend weekly assessments throughout their treatment, plus one week after completion of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients willing and able to attend weekly assessments",
                    "criterion": "attendance at weekly assessments",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one week after completion of treatment",
                    "criterion": "attendance at post-treatment assessment",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients unable to understand the consent process (translators will be used if necessary so being English-speaking is not required).",
            "criterions": [
                {
                    "exact_snippets": "Patients unable to understand the consent process",
                    "criterion": "understanding of the consent process",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to attend the follow-up visits",
            "criterions": [
                {
                    "exact_snippets": "unable to attend the follow-up visits",
                    "criterion": "ability to attend follow-up visits",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients participating in other clinical trials which might affect the severity of mucositis",
            "criterions": [
                {
                    "exact_snippets": "Patients participating in other clinical trials",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "affect the severity of mucositis",
                    "criterion": "severity of mucositis",
                    "requirements": [
                        {
                            "requirement_type": "influence",
                            "expected_value": "affected by other clinical trials"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients allergic to honey, multiple pollens, or to celery",
            "criterions": [
                {
                    "exact_snippets": "Patients allergic to honey",
                    "criterion": "allergy to honey",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... multiple pollens",
                    "criterion": "allergy to multiple pollens",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... celery",
                    "criterion": "allergy to celery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}