{
    "info": {
        "nct_id": "NCT06770582",
        "official_title": "Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)",
        "inclusion_criteria": "* Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography/computed tomography (PET/CT) scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.\n\n  * NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible\n* High grade T1 disease history that must meet at least ONE of the three criteria below:\n\n  * Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ [CIS]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.\n  * T1 with pathologic high-risk features (lymphovascular invasion [LVI] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)\n  * Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)\n* Restaging TURBT must be performed and must meet ALL of the following criteria below:\n\n  * If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.\n  * All grossly visible papillary tumors must be removed\n\n    * Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial\n* No pure squamous cell carcinoma or adenocarcinoma of the bladder\n* No neuroendocrine (small or large cell) features\n* No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)\n* No prostatic urethral involvement\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3\n* Platelets ≥ 100,000 cells/mm^3\n* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 9 g/dl is acceptable)\n* Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels > 1.5 × institutional ULN\n* Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN\n* All adverse events of their most recent therapy/intervention must have resolved to < grade 3 or returned to baseline prior to registration\n* No history of pelvic radiation therapy\n* No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed\n* No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation\n* No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease [COVID] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible\n* Patients must have recovered from acute cardiac illness\n* New York Heart Association Functional Classification II or better (New York Heart Association [NYHA] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection requiring IV antibiotics\n* No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis\n* No history of allogeneic bone marrow transplant or prior solid organ transplant\n* No active tuberculosis\n* No evidence of hydronephrosis\n* No history of upper tract urothelial carcinoma within 24 months of registration\n* No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography/computed tomography (PET/CT) scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.",
                "criterions": [
                    {
                        "exact_snippets": "Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder",
                        "criterion": "urothelial carcinoma of the bladder",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "T1 high-grade non-muscle invasive"
                        }
                    },
                    {
                        "exact_snippets": "without radiographic evidence of regional nodal disease",
                        "criterion": "regional nodal disease",
                        "requirement": {
                            "requirement_type": "radiographic evidence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "without ... metastatic disease (N0, M0)",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "on computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography/computed tomography (PET/CT) scan",
                        "criterion": "imaging modality",
                        "requirement": {
                            "requirement_type": "types",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "PET/CT"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "who would otherwise be treated with cystectomy off-trial",
                        "criterion": "cystectomy recommendation",
                        "requirement": {
                            "requirement_type": "recommendation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial",
                        "criterion": "medical operability for cystectomy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder",
                                                                "criterion": "urothelial carcinoma of the bladder",
                                                                "requirement": {
                                                                    "requirement_type": "diagnosis",
                                                                    "expected_value": "T1 high-grade non-muscle invasive"
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "without radiographic evidence of regional nodal disease",
                                                                "criterion": "regional nodal disease",
                                                                "requirement": {
                                                                    "requirement_type": "radiographic evidence",
                                                                    "expected_value": false
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "without ... metastatic disease (N0, M0)",
                                                        "criterion": "metastatic disease",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "on computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography/computed tomography (PET/CT) scan",
                                                "criterion": "imaging modality",
                                                "requirement": {
                                                    "requirement_type": "types",
                                                    "expected_value": [
                                                        "CT",
                                                        "MRI",
                                                        "PET/CT"
                                                    ]
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "who would otherwise be treated with cystectomy off-trial",
                                        "criterion": "cystectomy recommendation",
                                        "requirement": {
                                            "requirement_type": "recommendation",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial",
                                "criterion": "medical operability for cystectomy",
                                "requirement": {
                                    "requirement_type": "necessity",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* High grade T1 disease history that must meet at least ONE of the three criteria below:",
                "criterions": [
                    {
                        "exact_snippets": "High grade T1 disease history",
                        "criterion": "high grade T1 disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "High grade T1 disease history",
                                "criterion": "high grade T1 disease",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Criterion 1",
                                        "criterion": "criterion 1",
                                        "requirement": {
                                            "requirement_type": "N/A",
                                            "expected_value": "met"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Criterion 2",
                                        "criterion": "criterion 2",
                                        "requirement": {
                                            "requirement_type": "N/A",
                                            "expected_value": "met"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Criterion 3",
                                        "criterion": "criterion 3",
                                        "requirement": {
                                            "requirement_type": "N/A",
                                            "expected_value": "met"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ [CIS]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed recurrence",
                        "criterion": "recurrence",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "high-grade T1 urothelial carcinoma",
                        "criterion": "urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "high-grade"
                        }
                    },
                    {
                        "exact_snippets": "high-grade T1 urothelial carcinoma",
                        "criterion": "urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "T1"
                        }
                    },
                    {
                        "exact_snippets": "(+/- focal carcinoma in situ [CIS])",
                        "criterion": "carcinoma in situ",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "focal"
                        }
                    },
                    {
                        "exact_snippets": "following initial transurethral resection of bladder tumor (TURBT)",
                        "criterion": "transurethral resection of bladder tumor (TURBT)",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least one induction course of intravesical therapy",
                        "criterion": "induction course of intravesical therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "course"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG)",
                        "criterion": "intravesical Bacillus Calmette-Guerin (BCG)",
                        "requirement": {
                            "requirement_type": "doses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "doses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "or intravesical chemotherapy when BCG is not available",
                        "criterion": "intravesical chemotherapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": "when BCG is not available"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "exact_snippets": "Histologically confirmed recurrence",
                                                                        "criterion": "recurrence",
                                                                        "requirement": {
                                                                            "requirement_type": "confirmation",
                                                                            "expected_value": "histologically confirmed"
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "high-grade T1 urothelial carcinoma",
                                                                        "criterion": "urothelial carcinoma",
                                                                        "requirement": {
                                                                            "requirement_type": "grade",
                                                                            "expected_value": "high-grade"
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "high-grade T1 urothelial carcinoma",
                                                                "criterion": "urothelial carcinoma",
                                                                "requirement": {
                                                                    "requirement_type": "stage",
                                                                    "expected_value": "T1"
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "(+/- focal carcinoma in situ [CIS])",
                                                        "criterion": "carcinoma in situ",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": "focal"
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "following initial transurethral resection of bladder tumor (TURBT)",
                                                "criterion": "transurethral resection of bladder tumor (TURBT)",
                                                "requirement": {
                                                    "requirement_type": "completion",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "at least one induction course of intravesical therapy",
                                        "criterion": "induction course of intravesical therapy",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "course"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG)",
                                        "criterion": "intravesical Bacillus Calmette-Guerin (BCG)",
                                        "requirement": {
                                            "requirement_type": "doses",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 5,
                                                "unit": "doses"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "or intravesical chemotherapy when BCG is not available",
                                        "criterion": "intravesical chemotherapy",
                                        "requirement": {
                                            "requirement_type": "availability",
                                            "expected_value": "when BCG is not available"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)",
                "criterions": [
                    {
                        "exact_snippets": "Persistent high-grade T1 urothelial carcinoma",
                        "criterion": "high-grade T1 urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "persistence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "repeat TURBT",
                        "criterion": "repeat TURBT",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "focal CIS",
                        "criterion": "focal CIS",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "optional"
                        }
                    },
                    {
                        "exact_snippets": "in the bladder",
                        "criterion": "location of carcinoma",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "bladder"
                        }
                    },
                    {
                        "exact_snippets": "No prior intravesical therapy required",
                        "criterion": "prior intravesical therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Persistent high-grade T1 urothelial carcinoma",
                                                "criterion": "high-grade T1 urothelial carcinoma",
                                                "requirement": {
                                                    "requirement_type": "persistence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "repeat TURBT",
                                                "criterion": "repeat TURBT",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "in the bladder",
                                        "criterion": "location of carcinoma",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": "bladder"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "No prior intravesical therapy required",
                                "criterion": "prior intravesical therapy",
                                "requirement": {
                                    "requirement_type": "requirement",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "focal CIS",
                                "criterion": "focal CIS",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "optional"
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "focal CIS",
                                    "criterion": "focal CIS",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": "optional"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Restaging TURBT must be performed and must meet ALL of the following criteria below:",
                "criterions": [
                    {
                        "exact_snippets": "Restaging TURBT must be performed",
                        "criterion": "restaging TURBT",
                        "requirement": {
                            "requirement_type": "performance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Restaging TURBT must be performed",
                        "criterion": "restaging TURBT",
                        "requirement": {
                            "requirement_type": "performance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.",
                "criterions": [
                    {
                        "exact_snippets": "absence of muscularis propria in the initial TURBT",
                        "criterion": "muscularis propria in initial TURBT",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uninvolved muscularis propria in the restaging TURBT",
                        "criterion": "muscularis propria in restaging TURBT",
                        "requirement": {
                            "requirement_type": "involvement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "absence of muscularis propria in the initial TURBT",
                    "criterion": "muscularis propria in initial TURBT",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "uninvolved muscularis propria in the restaging TURBT",
                    "criterion": "muscularis propria in restaging TURBT",
                    "requirement": {
                        "requirement_type": "involvement",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* All grossly visible papillary tumors must be removed",
                "criterions": [
                    {
                        "exact_snippets": "All grossly visible papillary tumors must be removed",
                        "criterion": "grossly visible papillary tumors",
                        "requirement": {
                            "requirement_type": "removal",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "All grossly visible papillary tumors must be removed",
                        "criterion": "grossly visible papillary tumors",
                        "requirement": {
                            "requirement_type": "removal",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial",
                "criterions": [
                    {
                        "exact_snippets": "restaging TURBT is performed outside of the enrolling institution",
                        "criterion": "restaging TURBT location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "outside of the enrolling institution"
                        }
                    },
                    {
                        "exact_snippets": "office cystoscopy should be performed",
                        "criterion": "office cystoscopy",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "performed by a Urologist",
                        "criterion": "Urologist",
                        "requirement": {
                            "requirement_type": "performer",
                            "expected_value": "Urologist"
                        }
                    },
                    {
                        "exact_snippets": "Urologist who will be following the patient",
                        "criterion": "Urologist follow-up",
                        "requirement": {
                            "requirement_type": "follow-up",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "restaging TURBT is performed outside of the enrolling institution",
                    "criterion": "restaging TURBT location",
                    "requirement": {
                        "requirement_type": "location",
                        "expected_value": "outside of the enrolling institution"
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "office cystoscopy should be performed",
                            "criterion": "office cystoscopy",
                            "requirement": {
                                "requirement_type": "procedure",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "performed by a Urologist",
                            "criterion": "Urologist",
                            "requirement": {
                                "requirement_type": "performer",
                                "expected_value": "Urologist"
                            }
                        },
                        {
                            "exact_snippets": "Urologist who will be following the patient",
                            "criterion": "Urologist follow-up",
                            "requirement": {
                                "requirement_type": "follow-up",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No pure squamous cell carcinoma or adenocarcinoma of the bladder",
                "criterions": [
                    {
                        "exact_snippets": "No pure squamous cell carcinoma",
                        "criterion": "pure squamous cell carcinoma of the bladder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No pure ... adenocarcinoma of the bladder",
                        "criterion": "pure adenocarcinoma of the bladder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No pure squamous cell carcinoma",
                        "criterion": "pure squamous cell carcinoma of the bladder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No pure ... adenocarcinoma of the bladder",
                        "criterion": "pure adenocarcinoma of the bladder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No neuroendocrine (small or large cell) features",
                "criterions": [
                    {
                        "exact_snippets": "No neuroendocrine (small or large cell) features",
                        "criterion": "neuroendocrine features",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No neuroendocrine (small or large cell) features",
                        "criterion": "neuroendocrine features",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)",
                "criterions": [
                    {
                        "exact_snippets": "No diffuse carcinoma in situ determined on cystoscopy and biopsy",
                        "criterion": "diffuse carcinoma in situ",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator",
                        "criterion": "extensive carcinoma in situ",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": "not tumor-associated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No diffuse carcinoma in situ determined on cystoscopy and biopsy",
                                "criterion": "diffuse carcinoma in situ",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator",
                                "criterion": "extensive carcinoma in situ",
                                "requirement": {
                                    "requirement_type": "association",
                                    "expected_value": "not tumor-associated"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prostatic urethral involvement",
                "criterions": [
                    {
                        "exact_snippets": "No prostatic urethral involvement",
                        "criterion": "prostatic urethral involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No prostatic urethral involvement",
                        "criterion": "prostatic urethral involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥ 18",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                        "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal",
                "criterions": [
                    {
                        "exact_snippets": "Negative urine or serum pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "(in persons of childbearing potential)",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 14 days prior to registration",
                        "criterion": "pregnancy test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Childbearing potential is defined as any person who has experienced menarche",
                        "criterion": "menarche",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation",
                        "criterion": "surgical sterilization",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "who is not postmenopausal",
                        "criterion": "postmenopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "and_criteria": [
                                                {
                                                    "and_criteria": [
                                                        {
                                                            "and_criteria": [
                                                                {
                                                                    "exact_snippets": "Childbearing potential is defined as any person who has experienced menarche",
                                                                    "criterion": "menarche",
                                                                    "requirement": {
                                                                        "requirement_type": "status",
                                                                        "expected_value": true
                                                                    }
                                                                },
                                                                {
                                                                    "exact_snippets": "who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation",
                                                                    "criterion": "surgical sterilization",
                                                                    "requirement": {
                                                                        "requirement_type": "status",
                                                                        "expected_value": false
                                                                    }
                                                                }
                                                            ]
                                                        },
                                                        {
                                                            "exact_snippets": "who is not postmenopausal",
                                                            "criterion": "postmenopausal status",
                                                            "requirement": {
                                                                "requirement_type": "status",
                                                                "expected_value": false
                                                            }
                                                        }
                                                    ]
                                                },
                                                {
                                                    "exact_snippets": "(in persons of childbearing potential)",
                                                    "criterion": "childbearing potential",
                                                    "requirement": {
                                                        "requirement_type": "status",
                                                        "expected_value": true
                                                    }
                                                }
                                            ]
                                        },
                                        {
                                            "exact_snippets": "Negative urine or serum pregnancy test",
                                            "criterion": "pregnancy test",
                                            "requirement": {
                                                "requirement_type": "result",
                                                "expected_value": "negative"
                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "within 14 days prior to registration",
                                    "criterion": "pregnancy test timing",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 14,
                                            "unit": "days"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelets ≥ 100,000 cells/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥ 100,000 cells/mm^3",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "cells/mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets ≥ 100,000 cells/mm^3",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "cells/mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) ... ≤ 3 x institutional ULN",
                        "criterion": "Aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x institutional ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) ... ≤ 3 x institutional ULN",
                        "criterion": "Aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x institutional ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All adverse events of their most recent therapy/intervention must have resolved to < grade 3 or returned to baseline prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "All adverse events of their most recent therapy/intervention must have resolved to < grade 3",
                        "criterion": "adverse events of most recent therapy/intervention",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "adverse events ... returned to baseline prior to registration",
                        "criterion": "adverse events of most recent therapy/intervention",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "returned to baseline"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "All adverse events of their most recent therapy/intervention must have resolved to < grade 3",
                                "criterion": "adverse events of most recent therapy/intervention",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "adverse events ... returned to baseline prior to registration",
                                "criterion": "adverse events of most recent therapy/intervention",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "returned to baseline"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No history of pelvic radiation therapy",
                "criterions": [
                    {
                        "exact_snippets": "No history of pelvic radiation therapy",
                        "criterion": "pelvic radiation therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No history of pelvic radiation therapy",
                        "criterion": "pelvic radiation therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed",
                "criterions": [
                    {
                        "exact_snippets": "No prior systemic chemotherapy ... for urothelial carcinoma.",
                        "criterion": "prior systemic chemotherapy for urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior ... immunotherapy for urothelial carcinoma.",
                        "criterion": "prior immunotherapy for urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed",
                        "criterion": "prior local intravesical therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No prior systemic chemotherapy ... for urothelial carcinoma.",
                                "criterion": "prior systemic chemotherapy for urothelial carcinoma",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No prior ... immunotherapy for urothelial carcinoma.",
                                "criterion": "prior immunotherapy for urothelial carcinoma",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed",
                        "criterion": "prior local intravesical therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation",
                "criterions": [
                    {
                        "exact_snippets": "No prior treatment with anti-PD-1",
                        "criterion": "prior treatment with anti-PD-1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior treatment with ... anti PD-L1",
                        "criterion": "prior treatment with anti PD-L1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior treatment with ... anti PD-L2",
                        "criterion": "prior treatment with anti PD-L2",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior treatment with ... anti-CTLA4 antibody",
                        "criterion": "prior treatment with anti-CTLA4 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior treatment with ... any other antibody or drug targeting T-cell co-stimulation",
                        "criterion": "prior treatment with any other antibody or drug targeting T-cell co-stimulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "No prior treatment with anti-PD-1",
                                                "criterion": "prior treatment with anti-PD-1",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "No prior treatment with ... anti PD-L1",
                                                "criterion": "prior treatment with anti PD-L1",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "No prior treatment with ... anti PD-L2",
                                        "criterion": "prior treatment with anti PD-L2",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "No prior treatment with ... anti-CTLA4 antibody",
                                "criterion": "prior treatment with anti-CTLA4 antibody",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "No prior treatment with ... any other antibody or drug targeting T-cell co-stimulation",
                        "criterion": "prior treatment with any other antibody or drug targeting T-cell co-stimulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease [COVID] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible",
                "criterions": [
                    {
                        "exact_snippets": "No live vaccine administered within 30 days of registration",
                        "criterion": "live vaccine administration",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "All non live vaccines (including the coronavirus disease [COVID] vaccine) are allowed at any time during the study",
                        "criterion": "non live vaccine administration",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "allowed at any time during the study"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "No live vaccine administered within 30 days of registration",
                            "criterion": "live vaccine administration",
                            "requirement": {
                                "requirement_type": "timing",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 30,
                                    "unit": "days"
                                }
                            }
                        }
                    },
                    {
                        "exact_snippets": "All non live vaccines (including the coronavirus disease [COVID] vaccine) are allowed at any time during the study",
                        "criterion": "non live vaccine administration",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "allowed at any time during the study"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have recovered from acute cardiac illness",
                "criterions": [
                    {
                        "exact_snippets": "recovered from acute cardiac illness",
                        "criterion": "acute cardiac illness",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "recovered from acute cardiac illness",
                        "criterion": "acute cardiac illness",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* New York Heart Association Functional Classification II or better (New York Heart Association [NYHA] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)",
                "criterions": [
                    {
                        "exact_snippets": "New York Heart Association Functional Classification II or better",
                        "criterion": "New York Heart Association Functional Classification",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "known history or current symptoms of cardiac disease",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "history or symptoms",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of treatment with cardiotoxic agents",
                        "criterion": "treatment with cardiotoxic agents",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "known history or current symptoms of cardiac disease",
                            "criterion": "cardiac disease",
                            "requirement": {
                                "requirement_type": "history or symptoms",
                                "expected_value": false
                            }
                        },
                        {
                            "exact_snippets": "history of treatment with cardiotoxic agents",
                            "criterion": "treatment with cardiotoxic agents",
                            "requirement": {
                                "requirement_type": "history",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "New York Heart Association Functional Classification II or better",
                    "criterion": "New York Heart Association Functional Classification",
                    "requirement": {
                        "requirement_type": "classification",
                        "expected_value": {
                            "operator": "<=",
                            "value": 2,
                            "unit": "N/A"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No active infection requiring IV antibiotics",
                "criterions": [
                    {
                        "exact_snippets": "No active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "requiring IV antibiotics",
                        "criterion": "IV antibiotics",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "requiring IV antibiotics",
                        "criterion": "IV antibiotics",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
                "criterions": [
                    {
                        "exact_snippets": "No active autoimmune disease",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "required systemic treatment in the past 2 years",
                        "criterion": "systemic treatment for autoimmune disease",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    },
                    {
                        "exact_snippets": "required systemic treatment in the past 2 years",
                        "criterion": "systemic treatment for autoimmune disease",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No active autoimmune disease",
                                "criterion": "active autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "required systemic treatment in the past 2 years",
                                        "criterion": "systemic treatment for autoimmune disease",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": "past 2 years"
                                        }
                                    },
                                    {
                                        "exact_snippets": "required systemic treatment in the past 2 years",
                                        "criterion": "systemic treatment for autoimmune disease",
                                        "requirement": {
                                            "requirement_type": "necessity",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis",
                "criterions": [
                    {
                        "exact_snippets": "No history of idiopathic pulmonary fibrosis",
                        "criterion": "idiopathic pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of ... organizing pneumonia",
                        "criterion": "organizing pneumonia",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of ... (non-infectious) pneumonitis that required steroids",
                        "criterion": "(non-infectious) pneumonitis that required steroids",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of ... current pneumonitis",
                        "criterion": "current pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No history of idiopathic pulmonary fibrosis",
                                "criterion": "idiopathic pulmonary fibrosis",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No history of ... organizing pneumonia",
                                "criterion": "organizing pneumonia",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No history of ... (non-infectious) pneumonitis that required steroids",
                                "criterion": "(non-infectious) pneumonitis that required steroids",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "No history of ... current pneumonitis",
                        "criterion": "current pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No history of allogeneic bone marrow transplant or prior solid organ transplant",
                "criterions": [
                    {
                        "exact_snippets": "No history of allogeneic bone marrow transplant",
                        "criterion": "allogeneic bone marrow transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of ... prior solid organ transplant",
                        "criterion": "solid organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No history of allogeneic bone marrow transplant",
                        "criterion": "allogeneic bone marrow transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of ... prior solid organ transplant",
                        "criterion": "solid organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No active tuberculosis",
                "criterions": [
                    {
                        "exact_snippets": "No active tuberculosis",
                        "criterion": "active tuberculosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No active tuberculosis",
                        "criterion": "active tuberculosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No evidence of hydronephrosis",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of hydronephrosis",
                        "criterion": "hydronephrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No evidence of hydronephrosis",
                        "criterion": "hydronephrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No history of upper tract urothelial carcinoma within 24 months of registration",
                "criterions": [
                    {
                        "exact_snippets": "No history of upper tract urothelial carcinoma within 24 months of registration",
                        "criterion": "upper tract urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of upper tract urothelial carcinoma within 24 months of registration",
                        "criterion": "upper tract urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No history of upper tract urothelial carcinoma within 24 months of registration",
                        "criterion": "upper tract urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of upper tract urothelial carcinoma within 24 months of registration",
                        "criterion": "upper tract urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial",
                "criterions": [
                    {
                        "exact_snippets": "Patients with a prior or concurrent malignancy",
                        "criterion": "prior or concurrent malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen",
                        "criterion": "interference with safety or efficacy assessment",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with a prior or concurrent malignancy",
                        "criterion": "prior or concurrent malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen",
                        "criterion": "interference with safety or efficacy assessment",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible",
                "criterions": [
                    {
                        "exact_snippets": "nodal disease ≥ 1 cm on short-axis",
                        "criterion": "nodal disease",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "suspicious nodes that are PET-avid",
                        "criterion": "suspicious nodes",
                        "requirement": {
                            "requirement_type": "PET-avid",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "or_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "nodal disease  1 cm on short-axis",
                                    "criterion": "nodal disease",
                                    "requirement": {
                                        "requirement_type": "size",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 1,
                                            "unit": "cm"
                                        }
                                    }
                                }
                            ]
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "suspicious nodes that are PET-avid",
                                    "criterion": "suspicious nodes",
                                    "requirement": {
                                        "requirement_type": "PET-avid",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* T1 with pathologic high-risk features (lymphovascular invasion [LVI] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)",
                "criterions": [
                    {
                        "exact_snippets": "T1 with pathologic high-risk features (lymphovascular invasion [LVI] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features)",
                        "criterion": "pathologic high-risk features",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "lymphovascular invasion",
                                "variant histology of micropapillary",
                                "variant histology of sarcomatoid",
                                "variant histology of plasmacytoid"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "post initial TURBT",
                        "criterion": "initial TURBT",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No prior intravesical therapy required",
                        "criterion": "prior intravesical therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "T1 with pathologic high-risk features (lymphovascular invasion [LVI] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features)",
                                        "criterion": "pathologic high-risk features",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": "lymphovascular invasion"
                                        }
                                    },
                                    {
                                        "exact_snippets": "T1 with pathologic high-risk features (lymphovascular invasion [LVI] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features)",
                                        "criterion": "pathologic high-risk features",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": "variant histology of micropapillary"
                                        }
                                    },
                                    {
                                        "exact_snippets": "T1 with pathologic high-risk features (lymphovascular invasion [LVI] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features)",
                                        "criterion": "pathologic high-risk features",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": "variant histology of sarcomatoid"
                                        }
                                    },
                                    {
                                        "exact_snippets": "T1 with pathologic high-risk features (lymphovascular invasion [LVI] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features)",
                                        "criterion": "pathologic high-risk features",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": "variant histology of plasmacytoid"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "post initial TURBT",
                                "criterion": "initial TURBT",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "No prior intravesical therapy required",
                        "criterion": "prior intravesical therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 9 g/dl is acceptable)",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 9 g/dl",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Hemoglobin  9 g/dl",
                    "criterion": "hemoglobin level",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": ">=",
                            "value": 9,
                            "unit": "g/dl"
                        }
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels > 1.5 × institutional ULN",
                "criterions": [
                    {
                        "exact_snippets": "Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula",
                        "criterion": "creatinine clearance (CrCL)",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance (CrCL) of ... ≤ 1.5 × upper limit of normal (ULN)",
                        "criterion": "creatinine clearance (CrCL)",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine levels > 1.5 × institutional ULN",
                        "criterion": "creatinine levels",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "× institutional ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤ institutional upper limit of normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Not applicable to patients with known Gilbert's syndrome",
                        "criterion": "Gilbert's syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Gilbert's syndrome",
                    "criterion": "Gilbert's syndrome",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Total bilirubin ≤ institutional upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 1,
                            "unit": "ULN"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)",
                "criterions": [
                    {
                        "exact_snippets": "prior diagnosis of prostate cancer",
                        "criterion": "prior diagnosis of prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "definitive treatment for their prostate cancer",
                        "criterion": "definitive treatment for prostate cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "prior diagnosis of prostate cancer",
                            "criterion": "prior diagnosis of prostate cancer",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "definitive treatment for their prostate cancer",
                            "criterion": "definitive treatment for prostate cancer",
                            "requirement": {
                                "requirement_type": "treatment status",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}