{
    "info": {
        "nct_id": "NCT00894712",
        "official_title": "Effect of Topical Application of Sulforaphane- Containing Broccoli Sprout Extracts on Radiation Dermatitis During External-beam Radiation Therapy for Breast Cancer",
        "inclusion_criteria": "* Must have pathologically confirmed invasive adenocarcinoma or ductal carcinoma in situ of the breast.\n* Patients must have undergone segmental mastectomy (i.e., lumpectomy).\n* Patients must not have received prior radiation therapy to the breast.\n* Patients must not have active local-regional disease prior to registration.\n* Patients must not be pregnant because of the potential for fetal harm as a result of radiation treatment. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. They will also be counseled on the importance of avoiding pregnancy and hormonal contraception while undergoing radiation therapy.\n* Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.\n* All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Visible skin pathology, excessive freckles, or skin blemishes in the test area.\n* History of skin disease or hypersensitivity and repeated contact allergies.\n* Sarcoma or squamous cell histology.\n* Metastatic disease to the breast.\n* Current tobacco use.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Must have pathologically confirmed invasive adenocarcinoma or ductal carcinoma in situ of the breast.",
            "criterions": [
                {
                    "exact_snippets": [
                        "pathologically confirmed invasive adenocarcinoma"
                    ],
                    "criterion": "invasive adenocarcinoma",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "pathologically confirmed",
                        "ductal carcinoma in situ of the breast"
                    ],
                    "criterion": "ductal carcinoma in situ",
                    "requirement_type": "confirmation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients must have undergone segmental mastectomy (i.e., lumpectomy).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must have undergone segmental mastectomy (i.e., lumpectomy)"
                    ],
                    "criterion": "segmental mastectomy",
                    "requirement_type": "procedure history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients must not have received prior radiation therapy to the breast.",
            "criterions": [
                {
                    "exact_snippets": [
                        "must not have received prior radiation therapy to the breast"
                    ],
                    "criterion": "radiation therapy to the breast",
                    "requirement_type": "history",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients must not have active local-regional disease prior to registration.",
            "criterions": [
                {
                    "exact_snippets": [
                        "active local-regional disease"
                    ],
                    "criterion": "local-regional disease",
                    "requirement_type": "activity",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients must not be pregnant because of the potential for fetal harm as a result of radiation treatment. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. They will also be counseled on the importance of avoiding pregnancy and hormonal contraception while undergoing radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must not be pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Women of child-bearing age"
                    ],
                    "criterion": "child-bearing age",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "serum pregnancy test prior to study entry"
                    ],
                    "criterion": "serum pregnancy test",
                    "requirement_type": "requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "counseled on the importance of avoiding pregnancy"
                    ],
                    "criterion": "pregnancy avoidance counseling",
                    "requirement_type": "requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "avoiding",
                        "hormonal contraception while undergoing radiation therapy"
                    ],
                    "criterion": "hormonal contraception",
                    "requirement_type": "avoidance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "serious medical or psychiatric illness"
                    ],
                    "criterion": "serious medical or psychiatric illness",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "prevents informed consent"
                    ],
                    "criterion": "ability to provide informed consent",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "compliance with treatment"
                    ],
                    "criterion": "compliance with treatment",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.",
            "criterions": [
                {
                    "exact_snippets": [
                        "All patients must be informed of the investigational nature of this study"
                    ],
                    "criterion": "investigational nature of study",
                    "requirement_type": "awareness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "give written informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be FEMALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Visible skin pathology, excessive freckles, or skin blemishes in the test area.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Visible skin pathology"
                    ],
                    "criterion": "skin pathology",
                    "requirement_type": "visibility",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "excessive freckles"
                    ],
                    "criterion": "freckles",
                    "requirement_type": "quantity",
                    "expected_value": "excessive"
                },
                {
                    "exact_snippets": [
                        "skin blemishes in the test area"
                    ],
                    "criterion": "skin blemishes",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of skin disease or hypersensitivity and repeated contact allergies.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of skin disease"
                    ],
                    "criterion": "skin disease",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "hypersensitivity"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "repeated contact allergies"
                    ],
                    "criterion": "contact allergies",
                    "requirement_type": "frequency",
                    "expected_value": "repeated"
                }
            ]
        },
        {
            "line": "* Sarcoma or squamous cell histology.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Sarcoma"
                    ],
                    "criterion": "sarcoma",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "squamous cell histology"
                    ],
                    "criterion": "squamous cell histology",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Metastatic disease to the breast.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Metastatic disease to the breast"
                    ],
                    "criterion": "metastatic disease",
                    "requirement_type": "location",
                    "expected_value": "breast"
                }
            ]
        },
        {
            "line": "* Current tobacco use.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current tobacco use"
                    ],
                    "criterion": "tobacco use",
                    "requirement_type": "current status",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}