{
    "info": {
        "nct_id": "NCT02311101",
        "official_title": "Sequential Intravesical Mitomycin Plus Bacillus Calmette-Guérin for Non-Muscle Invasive Urothelial Bladder Carcinoma: Translational and Phase I Clinical Trial",
        "inclusion_criteria": "1. Newly diagnosed or recurrent multi-focal Ta, large Ta, high-grade Ta, CIS, or T1 bladder cancer\n2. In urologist's opinion a good candidate for BCG induction therapy\n3. Be able to give informed consent\n4. Be age 18 or older.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3 and platelets less than 150,000 cells/mm3)\n2. Immunosuppressed state (e.g. HIV, use of chronic steroids)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Newly diagnosed or recurrent multi-focal Ta, large Ta, high-grade Ta, CIS, or T1 bladder cancer",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed or recurrent multi-focal Ta",
                    "criterion": "multi-focal Ta bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": [
                                "newly diagnosed",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "large Ta",
                    "criterion": "large Ta bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": "large"
                        }
                    ]
                },
                {
                    "exact_snippets": "high-grade Ta",
                    "criterion": "high-grade Ta bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "high-grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "CIS",
                    "criterion": "CIS bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "T1 bladder cancer",
                    "criterion": "T1 bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. In urologist's opinion a good candidate for BCG induction therapy",
            "criterions": [
                {
                    "exact_snippets": "In urologist's opinion a good candidate for BCG induction therapy",
                    "criterion": "BCG induction therapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "urologist's opinion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Be able to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Be able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Be age 18 or older.",
            "criterions": [
                {
                    "exact_snippets": "age 18 or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3 and platelets less than 150,000 cells/mm3)",
            "criterions": [
                {
                    "exact_snippets": "Inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3",
                    "criterion": "granulocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1500,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate marrow function ... platelets less than 150,000 cells/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 150000,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Immunosuppressed state (e.g. HIV, use of chronic steroids)",
            "criterions": [
                {
                    "exact_snippets": "Immunosuppressed state",
                    "criterion": "immunosuppressed state",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of chronic steroids",
                    "criterion": "use of chronic steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}