{
    "info": {
        "nct_id": "NCT05269160",
        "official_title": "A Phase I/II Study of Dermaprazole for Radiation Dermatitis in Post-Mastectomy Breast Cancer Patients.",
        "inclusion_criteria": "1. Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy\n2. Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)\n3. Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)\n4. Age 18 years or older\n5. Women of childbearing potential (any woman with menses in the last 12 months) must agree to pregnancy testing and contraceptive use throughout the study period. Testing consists of human chorionic gonadotropin (HCG) urine testing, which if suspected to be falsely positive may be confirmed by ultrasound. If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study. In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable. If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n7. Written Informed Consent\n8. History and Physical within 12 weeks of enrollment\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "1. Prior chest wall radiotherapy\n2. Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment\n3. Concurrent chemotherapy\n4. Biopsy-proven epidermal involvement or positive margins\n5. Open wound at time of consultation, or delayed surgical wound healing as defined as open wound >8 weeks post-op\n6. Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis.\n7. Allergy or sensitivity to proton pump inhibitors\n8. Pregnancy or breast feeding\n9. Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy",
                "criterions": [
                    {
                        "exact_snippets": "Women with breast cancer",
                        "criterion": "gender and condition",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Women with breast cancer",
                        "criterion": "gender and condition",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "breast cancer"
                        }
                    },
                    {
                        "exact_snippets": "treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "surgical procedure",
                            "expected_value": [
                                "Simple (total) mastectomy",
                                "Modified radical mastectomy",
                                "Radical mastectomy",
                                "Segmental mastectomy",
                                "Skin sparing/nipple sparing mastectomy"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)",
                "criterions": [
                    {
                        "exact_snippets": "Histological diagnosis of invasive ductal or lobular carcinoma",
                        "criterion": "histological diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "invasive ductal or lobular carcinoma"
                        }
                    },
                    {
                        "exact_snippets": "diagnosed within 2 years of enrollment",
                        "criterion": "diagnosis timing",
                        "requirement": {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)",
                "criterions": [
                    {
                        "exact_snippets": "Planned to receive adjuvant chest wall radiation",
                        "criterion": "adjuvant chest wall radiation",
                        "requirement": {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least 40Gy or higher biologically equivalent dose (BED)",
                        "criterion": "radiation dose",
                        "requirement": {
                            "requirement_type": "minimum dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "Gy"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Age 18 years or older",
                "criterions": [
                    {
                        "exact_snippets": "Age 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Women of childbearing potential (any woman with menses in the last 12 months) must agree to pregnancy testing and contraceptive use throughout the study period. Testing consists of human chorionic gonadotropin (HCG) urine testing, which if suspected to be falsely positive may be confirmed by ultrasound. If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study. In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable. If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period.",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing potential (any woman with menses in the last 12 months)",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "any woman with menses in the last 12 months"
                        }
                    },
                    {
                        "exact_snippets": "must agree to pregnancy testing",
                        "criterion": "agreement to pregnancy testing",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to ... contraceptive use throughout the study period",
                        "criterion": "agreement to contraceptive use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Testing consists of human chorionic gonadotropin (HCG) urine testing",
                        "criterion": "HCG urine testing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "which if suspected to be falsely positive may be confirmed by ultrasound",
                        "criterion": "ultrasound confirmation",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "if HCG urine test is suspected to be falsely positive"
                        }
                    },
                    {
                        "exact_snippets": "If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study",
                        "criterion": "ultrasound result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable",
                        "criterion": "acceptable contraception methods",
                        "requirement": {
                            "requirement_type": "methods",
                            "expected_value": [
                                "barrier devices",
                                "hormonal methods",
                                "intrauterine devices",
                                "heterosexual celibacy",
                                "surgical sterility",
                                "partner with history of vasectomy"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period",
                        "criterion": "contraception use upon change in sexual activity",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "if celibate patient becomes sexually active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Written Informed Consent",
                "criterions": [
                    {
                        "exact_snippets": "Written Informed Consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. History and Physical within 12 weeks of enrollment",
                "criterions": [
                    {
                        "exact_snippets": "History and Physical within 12 weeks of enrollment",
                        "criterion": "history and physical examination",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 100 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 100 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Prior chest wall radiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Prior chest wall radiotherapy",
                        "criterion": "chest wall radiotherapy",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment",
                "criterions": [
                    {
                        "exact_snippets": "serious medical condition or illness that would preclude the safe administration of the study drug",
                        "criterion": "serious medical condition or illness",
                        "requirement": {
                            "requirement_type": "impact on study drug administration",
                            "expected_value": "preclude safe administration"
                        }
                    },
                    {
                        "exact_snippets": "active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic heart failure",
                        "criterion": "symptomatic heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "psychiatric illness",
                        "criterion": "psychiatric illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "social situations that would limit compliance with treatment",
                        "criterion": "social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Concurrent chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Biopsy-proven epidermal involvement or positive margins",
                "criterions": [
                    {
                        "exact_snippets": "Biopsy-proven epidermal involvement",
                        "criterion": "epidermal involvement",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "biopsy-proven"
                        }
                    },
                    {
                        "exact_snippets": "positive margins",
                        "criterion": "margins",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Open wound at time of consultation, or delayed surgical wound healing as defined as open wound >8 weeks post-op",
                "criterions": [
                    {
                        "exact_snippets": "Open wound at time of consultation",
                        "criterion": "open wound",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "delayed surgical wound healing ... open wound >8 weeks post-op",
                        "criterion": "delayed surgical wound healing",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis.",
                "criterions": [
                    {
                        "exact_snippets": "Known active collagen vascular disease",
                        "criterion": "collagen vascular disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Known active collagen vascular disease",
                        "criterion": "collagen vascular disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic lupus erythematous",
                        "criterion": "systemic lupus erythematous",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scleroderma",
                        "criterion": "scleroderma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "dermatomyositis",
                        "criterion": "dermatomyositis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Allergy or sensitivity to proton pump inhibitors",
                "criterions": [
                    {
                        "exact_snippets": "Allergy or sensitivity to proton pump inhibitors",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Allergy or sensitivity to proton pump inhibitors",
                        "criterion": "sensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Pregnancy or breast feeding",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breast feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate",
                "criterions": [
                    {
                        "exact_snippets": "Use of clopidrogrel",
                        "criterion": "clopidrogrel use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Use of ... St. Johns Wort",
                        "criterion": "St. Johns Wort use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Use of ... rifampin",
                        "criterion": "rifampin use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Use of ... methotrexate",
                        "criterion": "methotrexate use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}