{
    "info": {
        "nct_id": "NCT01771991",
        "official_title": "Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient",
        "inclusion_criteria": "* must have evidence of neck fibrosis\n* previous radiation treatment to the neck for cancer\n* age greater than or equal to 18 years\n* life expectancy of greater than 12 weeks\n* ability to understand the purpose of the study and the willingness to sign a written informed consent document.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.\n* any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* must have evidence of neck fibrosis",
            "criterions": [
                {
                    "exact_snippets": "must have evidence of neck fibrosis",
                    "criterion": "neck fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* previous radiation treatment to the neck for cancer",
            "criterions": [
                {
                    "exact_snippets": "previous radiation treatment to the neck for cancer",
                    "criterion": "radiation treatment to the neck",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age greater than or equal to 18 years",
            "criterions": [
                {
                    "exact_snippets": "age greater than or equal to 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* life expectancy of greater than 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of greater than 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ability to understand the purpose of the study and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "ability to understand the purpose of the study",
                    "criterion": "understanding of study purpose",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to sign consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "attribution",
                            "expected_value": "compounds of similar chemical or biologic composition to SOD or Cetaphil cram"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "psychological ... conditions that do not permit medical follow-up and compliance with the study protocol",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on follow-up and compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "familial ... conditions that do not permit medical follow-up and compliance with the study protocol",
                    "criterion": "familial conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on follow-up and compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "sociological ... conditions that do not permit medical follow-up and compliance with the study protocol",
                    "criterion": "sociological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on follow-up and compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical conditions that do not permit medical follow-up and compliance with the study protocol",
                    "criterion": "geographical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on follow-up and compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}