{
    "info": {
        "nct_id": "NCT01631331",
        "official_title": "A Pilot Study to Investigate the Off Label Use of Vismodegib as an Adjuvant to Surgery for Basal Cell Carcinoma Tumors (BCCs)",
        "inclusion_criteria": "* Study patients must have at least one BCC, > 5 mm, eligible for Mohs surgical removal; patients with BCCs that have been treated before (recurrent BCCs, BCCs that failed other chemotherapy) are eligible for this trial, if they meet size criteria\n* No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will be employed\n* Normal hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x the upper limit of normal (ULN)\n* Normal renal function : normal serum creatinine defined as <= 2.5 mg/dL\n* Clinically acceptable complete blood count (CBC)\n* Ability to understand and the willingness to sign a written informed consent document\n* The patient is willing to forego surgical treatment of BCCs by up to 6 months, except when the principal investigator (PI) believes that delay in treatment potentially might compromise the health of the subject\n* Documented negative serum pregnancy test for women of childbearing potential, with agreement to the use of two acceptable methods of contraception during the study and for 7 months after discontinuation of vismodegib\n* For men with female partners of childbearing potential, agreement to use a latex, non-latex, or any other male condom and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug\n* Be willing to not donate blood or semen for three months following discontinuation of study medications\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The patient has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) stage 0\n* The subject has uncontrolled systemic disease, including known human immunodeficiency virus (HIV) positive patients:\n\n  * The patient has history of congestive heart failure\n  * The patient has clinically important history of liver disease, including viral or hepatitis, current alcohol abuse, or cirrhosis\n  * The patient has any condition or situation which in the investigator's opinion may put the patient at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study; this includes history of other skin conditions or disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications\n* The patient has a history of hypersensitivity to any of the ingredients in the study medication formulations\n* The patient is willing to abstain from application of non-study topical medications to the skin for the duration of the study, including prescription and over the counter preparations; for example, topical preparations containing corticosteroids or vitamin A derivatives are not allowed\n* Pregnant or nursing patients will be excluded from the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Study patients must have at least one BCC, > 5 mm, eligible for Mohs surgical removal; patients with BCCs that have been treated before (recurrent BCCs, BCCs that failed other chemotherapy) are eligible for this trial, if they meet size criteria",
            "criterions": [
                {
                    "exact_snippets": "at least one BCC",
                    "criterion": "basal cell carcinoma (BCC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "BCC, > 5 mm",
                    "criterion": "basal cell carcinoma (BCC) size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for Mohs surgical removal",
                    "criterion": "eligibility for Mohs surgical removal",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with BCCs that have been treated before (recurrent BCCs, BCCs that failed other chemotherapy)",
                    "criterion": "previously treated basal cell carcinoma (BCC)",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": [
                                "recurrent",
                                "failed other chemotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "if they meet size criteria",
                    "criterion": "size criteria for previously treated BCC",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will be employed",
            "criterions": [
                {
                    "exact_snippets": "No Eastern Cooperative Oncology Group (ECOG) ... performance status will be employed",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... Karnofsky performance status will be employed",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x the upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "aspartate aminotransferase (AST) ... =< 2 x the upper limit of normal (ULN)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... =< 2 x the upper limit of normal (ULN)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal renal function : normal serum creatinine defined as <= 2.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Normal renal function : normal serum creatinine defined as <= 2.5 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically acceptable complete blood count (CBC)",
            "criterions": [
                {
                    "exact_snippets": "Clinically acceptable complete blood count (CBC)",
                    "criterion": "complete blood count (CBC)",
                    "requirements": [
                        {
                            "requirement_type": "clinical acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is willing to forego surgical treatment of BCCs by up to 6 months, except when the principal investigator (PI) believes that delay in treatment potentially might compromise the health of the subject",
            "criterions": [
                {
                    "exact_snippets": "The patient is willing to forego surgical treatment of BCCs by up to 6 months",
                    "criterion": "willingness to forego surgical treatment of BCCs",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented negative serum pregnancy test for women of childbearing potential, with agreement to the use of two acceptable methods of contraception during the study and for 7 months after discontinuation of vismodegib",
            "criterions": [
                {
                    "exact_snippets": "Documented negative serum pregnancy test for women of childbearing potential",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "women of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "agreement to the use of two acceptable methods of contraception during the study and for 7 months after discontinuation of vismodegib",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 7 months after discontinuation of vismodegib"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For men with female partners of childbearing potential, agreement to use a latex, non-latex, or any other male condom and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug",
            "criterions": [
                {
                    "exact_snippets": "men with female partners of childbearing potential",
                    "criterion": "female partner's childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agreement to use a latex, non-latex, or any other male condom",
                    "criterion": "use of male condom",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advise their female partners to use an additional acceptable method of birth control",
                    "criterion": "female partner's use of additional birth control",
                    "requirements": [
                        {
                            "requirement_type": "advice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 2 months after discontinuation of study drug",
                    "criterion": "duration of birth control use",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "during the study and for 2 months after discontinuation of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be willing to not donate blood or semen for three months following discontinuation of study medications",
            "criterions": [
                {
                    "exact_snippets": "willing to not donate blood",
                    "criterion": "blood donation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to not donate ... semen",
                    "criterion": "semen donation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* The patient has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) stage 0",
            "criterions": [
                {
                    "exact_snippets": "history of invasive cancer within the past five years",
                    "criterion": "history of invasive cancer",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... stage I cervical cancer",
                    "criterion": "stage I cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... ductal carcinoma in situ of the breast",
                    "criterion": "ductal carcinoma in situ of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... chronic lymphocytic leukemia (CLL) stage 0",
                    "criterion": "chronic lymphocytic leukemia (CLL) stage 0",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has uncontrolled systemic disease, including known human immunodeficiency virus (HIV) positive patients:",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known human immunodeficiency virus (HIV) positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has history of congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "history of congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has clinically important history of liver disease, including viral or hepatitis, current alcohol abuse, or cirrhosis",
            "criterions": [
                {
                    "exact_snippets": "clinically important history of liver disease",
                    "criterion": "history of liver disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically important"
                        }
                    ]
                },
                {
                    "exact_snippets": "viral or hepatitis",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has any condition or situation which in the investigator's opinion may put the patient at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study; this includes history of other skin conditions or disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications",
            "criterions": [
                {
                    "exact_snippets": "any condition or situation which in the investigator's opinion may put the patient at significant risk",
                    "criterion": "condition or situation",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "significant risk"
                        }
                    ]
                },
                {
                    "exact_snippets": "any condition or situation which ... could confound the study results",
                    "criterion": "condition or situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on study results",
                            "expected_value": "could confound"
                        }
                    ]
                },
                {
                    "exact_snippets": "any condition or situation which ... could interfere significantly with the subject's participation in the study",
                    "criterion": "condition or situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on participation",
                            "expected_value": "could interfere significantly"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of other skin conditions or disease",
                    "criterion": "skin conditions or disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metabolic dysfunction",
                    "criterion": "metabolic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination finding",
                    "criterion": "physical examination finding",
                    "requirements": [
                        {
                            "requirement_type": "suspicion of disease or condition",
                            "expected_value": "reasonable suspicion"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical laboratory finding giving reasonable suspicion of a disease or condition",
                    "criterion": "clinical laboratory finding",
                    "requirements": [
                        {
                            "requirement_type": "suspicion of disease or condition",
                            "expected_value": "reasonable suspicion"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease or condition that contraindicates use of an investigational drug",
                    "criterion": "disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": "use of an investigational drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease or condition ... that might affect interpretation of the results of the study",
                    "criterion": "disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on study results",
                            "expected_value": "might affect interpretation"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease or condition ... that might ... render the patient at high risk from treatment complications",
                    "criterion": "disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "high risk from treatment complications"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has a history of hypersensitivity to any of the ingredients in the study medication formulations",
            "criterions": [
                {
                    "exact_snippets": "history of hypersensitivity to any of the ingredients in the study medication formulations",
                    "criterion": "hypersensitivity to study medication ingredients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is willing to abstain from application of non-study topical medications to the skin for the duration of the study, including prescription and over the counter preparations; for example, topical preparations containing corticosteroids or vitamin A derivatives are not allowed",
            "criterions": [
                {
                    "exact_snippets": "willing to abstain from application of non-study topical medications to the skin for the duration of the study",
                    "criterion": "abstinence from non-study topical medications",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "topical preparations containing corticosteroids or vitamin A derivatives are not allowed",
                    "criterion": "use of topical preparations",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": [
                                "corticosteroids",
                                "vitamin A derivatives"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing patients will be excluded from the study",
            "criterions": [
                {
                    "exact_snippets": "Pregnant ... will be excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing ... will be excluded",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}