{
    "info": {
        "nct_id": "NCT04164082",
        "official_title": "Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer",
        "inclusion_criteria": "* High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint\n* Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG\n* Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above.\n\n  * Registration must be within 12 months of last BCG instillation\n* High grade T1 after completing therapy with at least induction BCG (>= 5 doses) or after completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG\n\n  * Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above\n  * Registration must be within 12 months of last BCG instillation\n* Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible\n* Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible\n\n  * The recurrence must be within 6 months of the last BCG dose.\n  * Registration must be within 12 months of last maintenance BCG instillation\n* Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy\n* All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration\n* All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted)\n\n  * All patients must have had a cystoscopy (or TURBT with complete resection) without papillary tumor and negative urinary cytology within 28 days of registration (positive cytology is allowed in patients with CIS)\n* All patients with T1 tumors must undergo a re-staging transurethral resection of bladder tumor (TURBT) within 60 days of registration\n\n  * There must be uninvolved muscularis propria present in the re-staging TURBT. The initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration\n* Patients must have had imaging with CT or MRI abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis\n* Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration\n* Patients must not be currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to study registration\n\n  * Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been more than 4 weeks after the last dose of the previous investigational agent at time of registration\n* Patients must not have prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)\n* Patients must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years prior to registration. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease [GVHD])\n* Patients must not have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment\n\n  * Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible\n  * Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment\n* Patients must not have received prior radiotherapy within 2 weeks of study registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis\n* Patients must not have received radiation therapy to the lung that is > 30 Gy within 6 months prior to trial registration\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  * Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)\n  * A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n  * Patients must not be pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with registration through the last dose of treatment\n* Age >= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) >= 1,500/mm^3\n* Platelet count >= 100,000/mm^3\n* Hemoglobin >= 9.0 g/dL\n* Creatinine =< 1.5 x upper limit of normal (ULN)\n\n  * In patients with creatinine > 1.5 x ULN, if measured or calculated creatinine clearance > 30 mL/min, then patient is eligible\n* Total bilirubin =< 1.5 x ULN\n\n  * In patients with a total bilirubin > 1.5 x ULN, if direct bilirubin < 1.0 X ULN, then patient is eligible\n* Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2.5 x ULN\n* Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration. Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\n* Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration\n\n  * Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Patients must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study\n* Patients must not have active tuberculosis\n* Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted. Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1)\n* Patients must not have a history of idiopathic pulmonary fibrosis or organizing pneumonia\n* Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis\n* Patients with human immunodeficiency virus (HIV) are eligible with the following:\n\n  * On effective anti-retroviral therapy with undetectable viral load within 6 months of registration\n* HIV-infected participants must not have a history of Kaposi sarcoma and/or multicentric Castleman disease\n* Patients must not have a known additional malignancy that has had progression or has required active treatment in the last three years. Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent is allowed, provided that the prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy\n* Patients must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment\n* Patients must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients\n* Patients must not have an active infection requiring systemic therapy\n* Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection\n\n  * Note: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority\n* Patients must not have received live vaccines within 30 days of study drug administration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG",
                "criterions": [
                    {
                        "exact_snippets": "Persistent disease (defined as not achieving disease free status)",
                        "criterion": "persistent disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses)",
                        "criterion": "induction BCG therapy",
                        "requirement": {
                            "requirement_type": "doses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "doses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "first round of maintenance or second induction course (>= 2 doses)",
                        "criterion": "maintenance or second induction course",
                        "requirement": {
                            "requirement_type": "doses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "doses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG",
                        "criterion": "subsequent round of BCG",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 6 months of initial induction BCG"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Persistent disease (defined as not achieving disease free status)",
                                "criterion": "persistent disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses)",
                                "criterion": "induction BCG therapy",
                                "requirement": {
                                    "requirement_type": "doses",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "doses"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "first round of maintenance or second induction course (>= 2 doses)",
                                "criterion": "maintenance or second induction course",
                                "requirement": {
                                    "requirement_type": "doses",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "doses"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG",
                        "criterion": "subsequent round of BCG",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 6 months of initial induction BCG"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above.",
                "criterions": [
                    {
                        "exact_snippets": "Persistent high risk NMIBC (T1, high grade Ta and/or CIS)",
                        "criterion": "persistent high risk NMIBC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must be within 9 months of the last BCG instillation",
                        "criterion": "time since last BCG instillation",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 9,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "despite having received adequate BCG as defined above",
                        "criterion": "adequate BCG",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Persistent high risk NMIBC (T1, high grade Ta and/or CIS)",
                                        "criterion": "persistent high risk NMIBC",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "must be within 9 months of the last BCG instillation",
                                        "criterion": "time since last BCG instillation",
                                        "requirement": {
                                            "requirement_type": "time since",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 9,
                                                        "unit": "months"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "despite having received adequate BCG as defined above",
                                "criterion": "adequate BCG",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Registration must be within 12 months of last BCG instillation",
                "criterions": [
                    {
                        "exact_snippets": "Registration must be within 12 months of last BCG instillation",
                        "criterion": "registration timing",
                        "requirement": {
                            "requirement_type": "time since last BCG instillation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Registration must be within 12 months of last BCG instillation",
                        "criterion": "registration timing",
                        "requirement": {
                            "requirement_type": "time since last BCG instillation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above",
                "criterions": [
                    {
                        "exact_snippets": "Disease recurrence (T1)",
                        "criterion": "disease recurrence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 9 months of the last BCG instillation",
                        "criterion": "time since last BCG instillation",
                        "requirement": {
                            "requirement_type": "time since last BCG instillation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 9,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "despite having received adequate BCG as defined above",
                        "criterion": "adequate BCG treatment",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Disease recurrence (T1)",
                        "criterion": "disease recurrence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 9 months of the last BCG instillation",
                        "criterion": "time since last BCG instillation",
                        "requirement": {
                            "requirement_type": "time since last BCG instillation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 9,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "despite having received adequate BCG as defined above",
                        "criterion": "adequate BCG treatment",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Registration must be within 12 months of last BCG instillation",
                "criterions": [
                    {
                        "exact_snippets": "Registration must be within 12 months of last BCG instillation",
                        "criterion": "time since last BCG instillation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Registration must be within 12 months of last BCG instillation",
                        "criterion": "time since last BCG instillation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible",
                "criterions": [
                    {
                        "exact_snippets": "Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible",
                        "criterion": "mixed variant histology",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pure variant histology is ineligible",
                        "criterion": "pure variant histology",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "pure variant histology is ineligible",
                    "criterion": "pure variant histology",
                    "requirement": {
                        "requirement_type": "eligibility",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible",
                    "criterion": "mixed variant histology",
                    "requirement": {
                        "requirement_type": "eligibility",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible",
                "criterions": [
                    {
                        "exact_snippets": "disease free at 6 months after starting BCG",
                        "criterion": "disease status at 6 months after starting BCG",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "disease free"
                        }
                    },
                    {
                        "exact_snippets": "high grade recurrence (T1, Ta, CIS) while on maintenance therapy",
                        "criterion": "recurrence during maintenance therapy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "high grade recurrence (T1, Ta, CIS) while on maintenance therapy",
                        "criterion": "recurrence during maintenance therapy",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "Ta",
                                "CIS"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "disease free at 6 months after starting BCG",
                                "criterion": "disease status at 6 months after starting BCG",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "disease free"
                                }
                            },
                            {
                                "exact_snippets": "high grade recurrence (T1, Ta, CIS) while on maintenance therapy",
                                "criterion": "recurrence during maintenance therapy",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": "high"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "high grade recurrence (T1, Ta, CIS) while on maintenance therapy",
                        "criterion": "recurrence during maintenance therapy",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "Ta",
                                "CIS"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The recurrence must be within 6 months of the last BCG dose.",
                "criterions": [
                    {
                        "exact_snippets": "The recurrence must be within 6 months of the last BCG dose.",
                        "criterion": "recurrence timing",
                        "requirement": {
                            "requirement_type": "time since last BCG dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "The recurrence must be within 6 months of the last BCG dose.",
                        "criterion": "recurrence timing",
                        "requirement": {
                            "requirement_type": "time since last BCG dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Registration must be within 12 months of last maintenance BCG instillation",
                "criterions": [
                    {
                        "exact_snippets": "Registration must be within 12 months of last maintenance BCG instillation",
                        "criterion": "registration timing",
                        "requirement": {
                            "requirement_type": "time since last BCG instillation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Registration must be within 12 months of last maintenance BCG instillation",
                        "criterion": "registration timing",
                        "requirement": {
                            "requirement_type": "time since last BCG instillation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy",
                "criterions": [
                    {
                        "exact_snippets": "deemed unfit for radical cystectomy by the treating physician",
                        "criterion": "fitness for radical cystectomy",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": "unfit"
                        }
                    },
                    {
                        "exact_snippets": "refuse radical cystectomy",
                        "criterion": "willingness to undergo radical cystectomy",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "deemed unfit for radical cystectomy by the treating physician",
                        "criterion": "fitness for radical cystectomy",
                        "requirement": {
                            "requirement_type": "assessment",
                            "expected_value": "unfit"
                        }
                    },
                    {
                        "exact_snippets": "refuse radical cystectomy",
                        "criterion": "willingness to undergo radical cystectomy",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed urothelial cancer of the bladder",
                        "criterion": "urothelial cancer of the bladder",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "within 60 days prior to registration",
                        "criterion": "time since diagnosis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 60,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologically confirmed urothelial cancer of the bladder",
                        "criterion": "urothelial cancer of the bladder",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "within 60 days prior to registration",
                        "criterion": "time since diagnosis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 60,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted)",
                "criterions": [
                    {
                        "exact_snippets": "All visible tumor must be completely resected",
                        "criterion": "visible tumor",
                        "requirement": {
                            "requirement_type": "resection",
                            "expected_value": "completely resected"
                        }
                    },
                    {
                        "exact_snippets": "60 days prior to registration",
                        "criterion": "resection timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "All visible tumor must be completely resected",
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                            "requirement_type": "resection",
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                    },
                    {
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                        "criterion": "resection timing",
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                            "requirement_type": "timing",
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                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All patients must have had a cystoscopy (or TURBT with complete resection) without papillary tumor and negative urinary cytology within 28 days of registration (positive cytology is allowed in patients with CIS)",
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                    {
                        "exact_snippets": "All patients must have had a cystoscopy (or TURBT with complete resection)",
                        "criterion": "cystoscopy or TURBT with complete resection",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
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                        "criterion": "papillary tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
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                    },
                    {
                        "exact_snippets": "negative urinary cytology",
                        "criterion": "urinary cytology",
                        "requirement": {
                            "requirement_type": "result",
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                    },
                    {
                        "exact_snippets": "within 28 days of registration",
                        "criterion": "time since procedure",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
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                "condition": {
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                        {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "and_criteria": [
                                                {
                                                    "exact_snippets": "All patients must have had a cystoscopy (or TURBT with complete resection)",
                                                    "criterion": "cystoscopy or TURBT with complete resection",
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                                                        "requirement_type": "presence",
                                                        "expected_value": true
                                                    }
                                                },
                                                {
                                                    "exact_snippets": "without papillary tumor",
                                                    "criterion": "papillary tumor",
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                                                        "requirement_type": "presence",
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                                            ]
                                        },
                                        {
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                                                    "operator": "<=",
                                                    "value": 28,
                                                    "unit": "days"
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                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "negative urinary cytology",
                                    "criterion": "urinary cytology",
                                    "requirement": {
                                        "requirement_type": "result",
                                        "expected_value": "negative"
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                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "All patients must have had a cystoscopy (or TURBT with complete resection)",
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                                                "expected_value": true
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                                        {
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                                            "criterion": "papillary tumor",
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                                            "unit": "days"
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                            ]
                        },
                        {
                            "exact_snippets": "negative urinary cytology",
                            "criterion": "urinary cytology",
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                                "requirement_type": "result",
                                "expected_value": "positive"
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                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* All patients with T1 tumors must undergo a re-staging transurethral resection of bladder tumor (TURBT) within 60 days of registration",
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                    {
                        "exact_snippets": "T1 tumors",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "T1"
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                    },
                    {
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                        "criterion": "re-staging TURBT",
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                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 60 days of registration",
                        "criterion": "timeframe for re-staging TURBT",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "T1 tumors",
                    "criterion": "tumor stage",
                    "requirement": {
                        "requirement_type": "stage",
                        "expected_value": "T1"
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                },
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                    "and_criteria": [
                        {
                            "exact_snippets": "undergo a re-staging transurethral resection of bladder tumor (TURBT)",
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                            "requirement": {
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                                "expected_value": true
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                        },
                        {
                            "exact_snippets": "within 60 days of registration",
                            "criterion": "timeframe for re-staging TURBT",
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                                "requirement_type": "timeframe",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 60,
                                    "unit": "days"
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                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* There must be uninvolved muscularis propria present in the re-staging TURBT. The initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration",
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                    {
                        "exact_snippets": "uninvolved muscularis propria present in the re-staging TURBT",
                        "criterion": "uninvolved muscularis propria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration",
                        "criterion": "initial TURBT timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "uninvolved muscularis propria present in the re-staging TURBT",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration",
                        "criterion": "initial TURBT timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have had imaging with CT or MRI abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis",
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                    {
                        "exact_snippets": "Patients must have had imaging with CT or MRI abdomen/pelvis within 90 days of registration",
                        "criterion": "imaging with CT or MRI abdomen/pelvis",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "demonstrating no evidence of metastasis",
                        "criterion": "evidence of metastasis",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must have had imaging with CT or MRI abdomen/pelvis within 90 days of registration",
                        "criterion": "imaging with CT or MRI abdomen/pelvis",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "demonstrating no evidence of metastasis",
                        "criterion": "evidence of metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "history of urothelial carcinoma in the ureters",
                        "criterion": "urothelial carcinoma in the ureters",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of urothelial carcinoma in the ... prostatic urethra",
                        "criterion": "urothelial carcinoma in the prostatic urethra",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "24 months prior to registration",
                        "criterion": "time since last occurrence of urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of urothelial carcinoma in the ureters",
                                "criterion": "urothelial carcinoma in the ureters",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
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                            },
                            {
                                "exact_snippets": "history of urothelial carcinoma in the ... prostatic urethra",
                                "criterion": "urothelial carcinoma in the prostatic urethra",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
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                            }
                        ]
                    },
                    {
                        "exact_snippets": "24 months prior to registration",
                        "criterion": "time since last occurrence of urothelial carcinoma",
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                            "requirement_type": "duration",
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                                "operator": ">=",
                                "value": 24,
                                "unit": "months"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not be currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to study registration",
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                    {
                        "exact_snippets": "Patients must not be currently participating in ... a study of an investigational agent",
                        "criterion": "participation in a study of an investigational agent",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
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                    },
                    {
                        "exact_snippets": "Patients must not ... have participated in a study of an investigational agent",
                        "criterion": "past participation in a study of an investigational agent",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not ... have used an investigational device within 4 weeks prior to study registration",
                        "criterion": "use of an investigational device",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients must not be currently participating in ... a study of an investigational agent",
                            "criterion": "participation in a study of an investigational agent",
                            "requirement": {
                                "requirement_type": "participation",
                                "expected_value": false
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                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients must not ... have participated in a study of an investigational agent",
                            "criterion": "past participation in a study of an investigational agent",
                            "requirement": {
                                "requirement_type": "participation",
                                "expected_value": false
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                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients must not ... have used an investigational device within 4 weeks prior to study registration",
                            "criterion": "use of an investigational device",
                            "requirement": {
                                "requirement_type": "time since last use",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 4,
                                    "unit": "weeks"
                                }
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been more than 4 weeks after the last dose of the previous investigational agent at time of registration",
                "criterions": [
                    {
                        "exact_snippets": "Participants who have entered the follow-up phase of an investigational study",
                        "criterion": "participation in investigational study follow-up phase",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "more than 4 weeks after the last dose of the previous investigational agent",
                        "criterion": "time since last dose of investigational agent",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                        {
                            "exact_snippets": "Participants who have entered the follow-up phase of an investigational study",
                            "criterion": "participation in investigational study follow-up phase",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
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                        },
                        {
                            "exact_snippets": "more than 4 weeks after the last dose of the previous investigational agent",
                            "criterion": "time since last dose of investigational agent",
                            "requirement": {
                                "requirement_type": "time since last dose",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 4,
                                    "unit": "weeks"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
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                            {
                                "exact_snippets": "Participants who have entered the follow-up phase of an investigational study",
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                                "exact_snippets": "more than 4 weeks after the last dose of the previous investigational agent",
                                "criterion": "time since last dose of investigational agent",
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                                    "requirement_type": "time since last dose",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 4,
                                        "unit": "weeks"
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                                }
                            }
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years prior to registration. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease [GVHD])",
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                    {
                        "exact_snippets": "prior allogeneic hematopoietic stem cell transplantation within the last 5 years",
                        "criterion": "prior allogeneic hematopoietic stem cell transplantation",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no symptoms of graft versus host disease [GVHD]",
                        "criterion": "symptoms of graft versus host disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                            {
                                "exact_snippets": "prior allogeneic hematopoietic stem cell transplantation within the last 5 years",
                                "criterion": "prior allogeneic hematopoietic stem cell transplantation",
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                                    "requirement_type": "time since procedure",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "years"
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                                }
                            },
                            {
                                "exact_snippets": "no symptoms of graft versus host disease [GVHD]",
                                "criterion": "symptoms of graft versus host disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
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                            }
                        ]
                    }
                },
                "then_criteria": {
                    "exact_snippets": "no symptoms of graft versus host disease [GVHD]",
                    "criterion": "symptoms of graft versus host disease",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have received prior systemic anti-cancer therapy",
                        "criterion": "prior systemic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "including investigational agents",
                        "criterion": "prior investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to treatment",
                        "criterion": "time since last treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must not have received prior systemic anti-cancer therapy",
                                "criterion": "prior systemic anti-cancer therapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "including investigational agents",
                                "criterion": "prior investigational agents",
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                        ]
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to treatment",
                        "criterion": "time since last treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
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                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible",
                "criterions": [
                    {
                        "exact_snippets": "Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline.",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants with =< grade 2 neuropathy may be eligible",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "grade"
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                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Participants with =< grade 2 neuropathy may be eligible",
                    "criterion": "neuropathy",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 2,
                                    "unit": "grade"
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                            ]
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline.",
                    "criterion": "recovery from adverse events",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
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                                {
                                    "operator": "<=",
                                    "value": 1,
                                    "unit": "grade"
                                }
                            ]
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment",
                "criterions": [
                    {
                        "exact_snippets": "received major surgery",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recovered adequately from the toxicity and/or complications",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "adequate recovery"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "received major surgery",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "recovered adequately from the toxicity and/or complications",
                    "criterion": "recovery from surgery",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "adequate recovery"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have received prior radiotherapy within 2 weeks of study registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have received prior radiotherapy within 2 weeks of study registration",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants must have recovered from all radiation-related toxicities",
                        "criterion": "radiation-related toxicities",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "not require corticosteroids",
                        "criterion": "corticosteroids",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not have had radiation pneumonitis",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must not have received prior radiotherapy within 2 weeks of study registration",
                                "criterion": "prior radiotherapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Participants must have recovered from all radiation-related toxicities",
                                "criterion": "radiation-related toxicities",
                                "requirement": {
                                    "requirement_type": "recovery",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "not require corticosteroids",
                                "criterion": "corticosteroids",
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                                    "requirement_type": "requirement",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "not have had radiation pneumonitis",
                                "criterion": "radiation pneumonitis",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have received radiation therapy to the lung that is > 30 Gy within 6 months prior to trial registration",
                "criterions": [
                    {
                        "exact_snippets": "radiation therapy to the lung",
                        "criterion": "radiation therapy to the lung",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "Gy"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiation therapy to the lung",
                        "criterion": "radiation therapy to the lung",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "radiation therapy to the lung",
                                    "criterion": "radiation therapy to the lung",
                                    "requirement": {
                                        "requirement_type": "dose",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 30,
                                            "unit": "Gy"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "radiation therapy to the lung",
                                    "criterion": "radiation therapy to the lung",
                                    "requirement": {
                                        "requirement_type": "time since last treatment",
                                        "expected_value": {
                                            "operator": "<",
                                            "value": 6,
                                            "unit": "months"
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects",
                "criterions": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not nursing",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not nursing",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)",
                "criterions": [
                    {
                        "exact_snippets": "Women and men of reproductive potential",
                        "criterion": "reproductive potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agree to use an appropriate method of birth control",
                        "criterion": "use of birth control",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "appropriate method of birth control ... abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)",
                        "criterion": "method of birth control",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "abstinence",
                                "oral contraceptives",
                                "implantable hormonal contraceptives",
                                "double barrier method (diaphragm plus condom)"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Women and men of reproductive potential",
                                "criterion": "reproductive potential",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "agree to use an appropriate method of birth control",
                                "criterion": "use of birth control",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "appropriate method of birth control ... abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)",
                        "criterion": "method of birth control",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "abstinence",
                                "oral contraceptives",
                                "implantable hormonal contraceptives",
                                "double barrier method (diaphragm plus condom)"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required",
                "criterions": [
                    {
                        "exact_snippets": "A woman of childbearing potential (WOCBP)",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "woman of childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "must not have a positive urine pregnancy test within 7 days prior to registration",
                        "criterion": "urine pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "must not have a positive urine pregnancy test within 7 days prior to registration",
                        "criterion": "urine pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to registration"
                        }
                    },
                    {
                        "exact_snippets": "If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "urine test is positive or cannot be confirmed as negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "A woman of childbearing potential (WOCBP)",
                                    "criterion": "gender and reproductive status",
                                    "requirement": {
                                        "requirement_type": "expected_value",
                                        "expected_value": "woman of childbearing potential"
                                    }
                                },
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "must not have a positive urine pregnancy test within 7 days prior to registration",
                                            "criterion": "urine pregnancy test",
                                            "requirement": {
                                                "requirement_type": "result",
                                                "expected_value": false
                                            }
                                        },
                                        {
                                            "exact_snippets": "must not have a positive urine pregnancy test within 7 days prior to registration",
                                            "criterion": "urine pregnancy test",
                                            "requirement": {
                                                "requirement_type": "timing",
                                                "expected_value": "within 7 days prior to registration"
                                            }
                                        }
                                    ]
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required",
                    "criterion": "serum pregnancy test",
                    "requirement": {
                        "requirement_type": "condition",
                        "expected_value": "urine test is positive or cannot be confirmed as negative"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not be pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with registration through the last dose of treatment",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not be pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not be ... breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not be ... expecting to conceive",
                        "criterion": "expecting to conceive",
                        "requirement": {
                            "requirement_type": "expectation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not be ... expecting to ... father children",
                        "criterion": "expecting to father children",
                        "requirement": {
                            "requirement_type": "expectation",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must not be pregnant",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients must not be ... breastfeeding",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must not be ... expecting to conceive",
                                "criterion": "expecting to conceive",
                                "requirement": {
                                    "requirement_type": "expectation",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients must not be ... expecting to ... father children",
                                "criterion": "expecting to father children",
                                "requirement": {
                                    "requirement_type": "expectation",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age >= 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age >= 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age >= 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 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 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": "* Absolute neutrophil count (ANC) >= 1,500/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/mm^3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/mm^3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count >= 100,000/mm^3",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count >= 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count >= 100,000/mm^3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin >= 9.0 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin >= 9.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin >= 9.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine =< 1.5 x upper limit of normal (ULN)",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine =< 1.5 x upper limit of normal (ULN)",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Creatinine =< 1.5 x upper limit of normal (ULN)",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* In patients with creatinine > 1.5 x ULN, if measured or calculated creatinine clearance > 30 mL/min, then patient is eligible",
                "criterions": [
                    {
                        "exact_snippets": "creatinine > 1.5 x ULN",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance > 30 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "creatinine > 1.5 x ULN",
                            "criterion": "creatinine level",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 1.5,
                                    "unit": "x ULN"
                                }
                            }
                        },
                        {
                            "exact_snippets": "creatinine clearance > 30 mL/min",
                            "criterion": "creatinine clearance",
                            "requirement": {
                                "requirement_type": "clearance",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 30,
                                    "unit": "mL/min"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin =< 1.5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin =< 1.5 x ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin =< 1.5 x ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* In patients with a total bilirubin > 1.5 x ULN, if direct bilirubin < 1.0 X ULN, then patient is eligible",
                "criterions": [
                    {
                        "exact_snippets": "total bilirubin > 1.5 x ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "direct bilirubin < 1.0 X ULN",
                        "criterion": "direct bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "total bilirubin > 1.5 x ULN",
                            "criterion": "total bilirubin",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 1.5,
                                    "unit": "x ULN"
                                }
                            }
                        },
                        {
                            "exact_snippets": "direct bilirubin < 1.0 X ULN",
                            "criterion": "direct bilirubin",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 1.0,
                                    "unit": "x ULN"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2.5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... =< 2.5 x ULN",
                        "criterion": "Aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) =< 2.5 x ULN",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... =< 2.5 x ULN",
                        "criterion": "Aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) =< 2.5 x ULN",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have a diagnosis of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)",
                        "criterion": "chronic systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "dosing",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily of prednisone equivalent"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to registration",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days prior to registration"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients must not have a diagnosis of immunodeficiency",
                            "criterion": "immunodeficiency",
                            "requirement": {
                                "requirement_type": "diagnosis",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "exact_snippets": "is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)",
                        "criterion": "chronic systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "dosing",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily of prednisone equivalent"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to registration",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days prior to registration"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed",
                "criterions": [
                    {
                        "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed",
                        "criterion": "replacement therapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed",
                        "criterion": "replacement therapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study",
                "criterions": [
                    {
                        "exact_snippets": "known psychiatric ... disorder",
                        "criterion": "psychiatric disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "substance abuse disorder",
                        "criterion": "substance abuse disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "known psychiatric ... disorder",
                                "criterion": "psychiatric disorder",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "substance abuse disorder",
                                "criterion": "substance abuse disorder",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have active tuberculosis",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have active tuberculosis",
                        "criterion": "active tuberculosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must not have active tuberculosis",
                        "criterion": "active tuberculosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted. Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1)",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration",
                        "criterion": "antibiotic treatment for active infection",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prophylactic antibiotics are permitted",
                        "criterion": "prophylactic antibiotic use",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1)",
                        "criterion": "urinary tract infection (UTI) treatment",
                        "requirement": {
                            "requirement_type": "adequate treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration",
                                    "criterion": "antibiotic treatment for active infection",
                                    "requirement": {
                                        "requirement_type": "time since last treatment",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 14,
                                            "unit": "days"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "Prophylactic antibiotics are permitted",
                                    "criterion": "prophylactic antibiotic use",
                                    "requirement": {
                                        "requirement_type": "permission",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1)",
                        "criterion": "urinary tract infection (UTI) treatment",
                        "requirement": {
                            "requirement_type": "adequate treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have a history of idiopathic pulmonary fibrosis or organizing pneumonia",
                "criterions": [
                    {
                        "exact_snippets": "history of idiopathic pulmonary fibrosis",
                        "criterion": "idiopathic pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of ... organizing pneumonia",
                        "criterion": "organizing pneumonia",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "history of idiopathic pulmonary fibrosis",
                        "criterion": "idiopathic pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of ... organizing pneumonia",
                        "criterion": "organizing pneumonia",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis",
                "criterions": [
                    {
                        "exact_snippets": "history of (non-infectious) pneumonitis that required steroids",
                        "criterion": "history of non-infectious pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        }
                    },
                    {
                        "exact_snippets": "current pneumonitis",
                        "criterion": "current pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "history of (non-infectious) pneumonitis that required steroids",
                                    "criterion": "history of non-infectious pneumonitis",
                                    "requirement": {
                                        "requirement_type": "treatment",
                                        "expected_value": "steroids"
                                    }
                                },
                                {
                                    "exact_snippets": "current pneumonitis",
                                    "criterion": "current pneumonitis",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with human immunodeficiency virus (HIV) are eligible with the following:",
                "criterions": [
                    {
                        "exact_snippets": "Patients with human immunodeficiency virus (HIV)",
                        "criterion": "human immunodeficiency virus (HIV)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with human immunodeficiency virus (HIV)",
                        "criterion": "human immunodeficiency virus (HIV)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* On effective anti-retroviral therapy with undetectable viral load within 6 months of registration",
                "criterions": [
                    {
                        "exact_snippets": "On effective anti-retroviral therapy",
                        "criterion": "anti-retroviral therapy",
                        "requirement": {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "undetectable viral load",
                        "criterion": "viral load",
                        "requirement": {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 6 months of registration",
                        "criterion": "time since registration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "On effective anti-retroviral therapy",
                        "criterion": "anti-retroviral therapy",
                        "requirement": {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "undetectable viral load",
                        "criterion": "viral load",
                        "requirement": {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 6 months of registration",
                        "criterion": "time since registration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* HIV-infected participants must not have a history of Kaposi sarcoma and/or multicentric Castleman disease",
                "criterions": [
                    {
                        "exact_snippets": "HIV-infected participants",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must not have a history of Kaposi sarcoma",
                        "criterion": "history of Kaposi sarcoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "must not have a history of ... multicentric Castleman disease",
                        "criterion": "history of multicentric Castleman disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "HIV-infected participants",
                    "criterion": "HIV infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "or_criteria": [
                        {
                            "exact_snippets": "must not have a history of Kaposi sarcoma",
                            "criterion": "history of Kaposi sarcoma",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        },
                        {
                            "exact_snippets": "must not have a history of ... multicentric Castleman disease",
                            "criterion": "history of multicentric Castleman disease",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have a known additional malignancy that has had progression or has required active treatment in the last three years. Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent is allowed, provided that the prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have a known additional malignancy",
                        "criterion": "additional malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "additional malignancy that has had progression",
                        "criterion": "additional malignancy progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "additional malignancy that ... has required active treatment in the last three years",
                        "criterion": "active treatment for additional malignancy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                        "criterion": "basal or squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "potentially curative therapy"
                        }
                    },
                    {
                        "exact_snippets": "Exceptions include ... in situ cervical cancer",
                        "criterion": "in situ cervical cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "A history of prostate cancer that was treated with definitive intent is allowed",
                        "criterion": "history of prostate cancer",
                        "requirement": {
                            "requirement_type": "treatment intent",
                            "expected_value": "definitive"
                        }
                    },
                    {
                        "exact_snippets": "prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy",
                        "criterion": "prostate-specific antigen (PSA)",
                        "requirement": {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy",
                        "criterion": "prostate-specific antigen (PSA)",
                        "requirement": {
                            "requirement_type": "time undetectable",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients must not have a known additional malignancy",
                                    "criterion": "additional malignancy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "additional malignancy that has had progression",
                                    "criterion": "additional malignancy progression",
                                    "requirement": {
                                        "requirement_type": "progression",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "additional malignancy that ... has required active treatment in the last three years",
                                    "criterion": "active treatment for additional malignancy",
                                    "requirement": {
                                        "requirement_type": "time since last treatment",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": ">=",
                                                    "value": 3,
                                                    "unit": "years"
                                                }
                                            ]
                                        }
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                                        "criterion": "basal or squamous cell carcinoma of the skin",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": "potentially curative therapy"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Exceptions include ... in situ cervical cancer",
                                        "criterion": "in situ cervical cancer",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "A history of prostate cancer that was treated with definitive intent is allowed",
                                        "criterion": "history of prostate cancer",
                                        "requirement": {
                                            "requirement_type": "treatment intent",
                                            "expected_value": "definitive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy",
                                        "criterion": "prostate-specific antigen (PSA)",
                                        "requirement": {
                                            "requirement_type": "detectability",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy",
                                        "criterion": "prostate-specific antigen (PSA)",
                                        "requirement": {
                                            "requirement_type": "time undetectable",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 1,
                                                        "unit": "year"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have known active CNS metastases",
                        "criterion": "active CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have ... carcinomatous meningitis",
                        "criterion": "carcinomatous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Participants with previously treated brain metastases may participate provided they are radiologically stable",
                        "criterion": "radiological stability of previously treated brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "without evidence of progression for at least 4 weeks by repeat imaging",
                        "criterion": "progression of previously treated brain metastases",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0,
                                "unit": "evidence"
                            }
                        }
                    },
                    {
                        "exact_snippets": "clinically stable",
                        "criterion": "clinical stability of previously treated brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "without requirement of steroid treatment for at least 14 days prior to first dose of study treatment",
                        "criterion": "steroid treatment requirement",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "Patients must not have known active CNS metastases",
                                    "criterion": "active CNS metastases",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "Patients must not have ... carcinomatous meningitis",
                                    "criterion": "carcinomatous meningitis",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Participants with previously treated brain metastases may participate provided they are radiologically stable",
                                        "criterion": "radiological stability of previously treated brain metastases",
                                        "requirement": {
                                            "requirement_type": "stability",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "without evidence of progression for at least 4 weeks by repeat imaging",
                                        "criterion": "progression of previously treated brain metastases",
                                        "requirement": {
                                            "requirement_type": "progression",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 0,
                                                "unit": "evidence"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "clinically stable",
                                        "criterion": "clinical stability of previously treated brain metastases",
                                        "requirement": {
                                            "requirement_type": "stability",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "without requirement of steroid treatment for at least 14 days prior to first dose of study treatment",
                                        "criterion": "steroid treatment requirement",
                                        "requirement": {
                                            "requirement_type": "requirement",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients",
                "criterions": [
                    {
                        "exact_snippets": "severe hypersensitivity (>= grade 3) to pembrolizumab",
                        "criterion": "hypersensitivity to pembrolizumab",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "severe hypersensitivity (>= grade 3) to ... any of its excipients",
                        "criterion": "hypersensitivity to pembrolizumab excipients",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "or_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "severe hypersensitivity (>= grade 3) to pembrolizumab",
                                    "criterion": "hypersensitivity to pembrolizumab",
                                    "requirement": {
                                        "requirement_type": "severity",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 3,
                                            "unit": "grade"
                                        }
                                    }
                                }
                            ]
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "severe hypersensitivity (>= grade 3) to ... any of its excipients",
                                    "criterion": "hypersensitivity to pembrolizumab excipients",
                                    "requirement": {
                                        "requirement_type": "severity",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 3,
                                            "unit": "grade"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have an active infection requiring systemic therapy",
                "criterions": [
                    {
                        "exact_snippets": "active infection requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "active infection requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have received live vaccines within 30 days of study drug administration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have received live vaccines within 30 days of study drug administration",
                        "criterion": "live vaccine administration",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed",
                        "criterion": "seasonal influenza vaccine (injection)",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed",
                        "criterion": "intranasal influenza vaccine",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "COVID-19 vaccinations are permitted",
                        "criterion": "COVID-19 vaccination",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients must not have received live vaccines within 30 days of study drug administration",
                                    "criterion": "live vaccine administration",
                                    "requirement": {
                                        "requirement_type": "time since last administration",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 30,
                                            "unit": "days"
                                        }
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed",
                        "criterion": "seasonal influenza vaccine (injection)",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed",
                        "criterion": "intranasal influenza vaccine",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "COVID-19 vaccinations are permitted",
                        "criterion": "COVID-19 vaccination",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have prior therapy with an anti-PD-1",
                        "criterion": "prior therapy with anti-PD-1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have prior therapy with an anti-PD-L1",
                        "criterion": "prior therapy with anti-PD-L1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have prior therapy with an anti PD L2 agent",
                        "criterion": "prior therapy with anti-PD-L2",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have prior therapy ... with an agent directed to another stimulatory or co-inhibitory T-cell receptor",
                        "criterion": "prior therapy with agent directed to another stimulatory or co-inhibitory T-cell receptor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have prior therapy ... (e.g., CTLA-4",
                        "criterion": "prior therapy with agent directed to CTLA-4",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have prior therapy ... OX 40",
                        "criterion": "prior therapy with agent directed to OX 40",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have prior therapy ... CD137",
                        "criterion": "prior therapy with agent directed to CD137",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients must not have prior therapy with an anti-PD-1",
                                        "criterion": "prior therapy with anti-PD-1",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients must not have prior therapy with an anti-PD-L1",
                                        "criterion": "prior therapy with anti-PD-L1",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients must not have prior therapy with an anti PD L2 agent",
                                        "criterion": "prior therapy with anti-PD-L2",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Patients must not have prior therapy ... with an agent directed to another stimulatory or co-inhibitory T-cell receptor",
                                "criterion": "prior therapy with agent directed to another stimulatory or co-inhibitory T-cell receptor",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Patients must not have prior therapy ... (e.g., CTLA-4",
                                "criterion": "prior therapy with agent directed to CTLA-4",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients must not have prior therapy ... OX 40",
                                "criterion": "prior therapy with agent directed to OX 40",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Patients must not have prior therapy ... CD137",
                                "criterion": "prior therapy with agent directed to CD137",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Note: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority",
                "criterions": [
                    {
                        "exact_snippets": "testing for hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "testing",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "testing for hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "testing",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "mandated by a local health authority",
                    "criterion": "local health authority mandate",
                    "requirement": {
                        "requirement_type": "mandate",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "testing for hepatitis B",
                            "criterion": "hepatitis B",
                            "requirement": {
                                "requirement_type": "testing",
                                "expected_value": false
                            }
                        },
                        {
                            "exact_snippets": "testing for hepatitis C",
                            "criterion": "hepatitis C",
                            "requirement": {
                                "requirement_type": "testing",
                                "expected_value": false
                            }
                        }
                    ]
                }
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint",
                "criterions": [
                    {
                        "exact_snippets": "High grade Ta, T1 or CIS urothelial carcinoma",
                        "criterion": "urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "High grade Ta, T1 or CIS urothelial carcinoma",
                        "criterion": "urothelial carcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Ta",
                                "T1",
                                "CIS"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "High grade Ta, T1 or CIS urothelial carcinoma",
                                "criterion": "urothelial carcinoma",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": "high"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "High grade Ta, T1 or CIS urothelial carcinoma",
                                        "criterion": "urothelial carcinoma",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "Ta"
                                        }
                                    },
                                    {
                                        "exact_snippets": "High grade Ta, T1 or CIS urothelial carcinoma",
                                        "criterion": "urothelial carcinoma",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "T1"
                                        }
                                    },
                                    {
                                        "exact_snippets": "High grade Ta, T1 or CIS urothelial carcinoma",
                                        "criterion": "urothelial carcinoma",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "CIS"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* High grade T1 after completing therapy with at least induction BCG (>= 5 doses) or after completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG",
                "criterions": [
                    {
                        "exact_snippets": "High grade T1",
                        "criterion": "tumor grade",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "high grade T1"
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses)",
                        "criterion": "induction BCG therapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses)",
                        "criterion": "induction BCG therapy",
                        "requirement": {
                            "requirement_type": "dose count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "doses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance",
                        "criterion": "induction BCG therapy with maintenance",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance",
                        "criterion": "induction BCG therapy with maintenance",
                        "requirement": {
                            "requirement_type": "dose count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "doses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance",
                        "criterion": "induction BCG therapy with maintenance",
                        "requirement": {
                            "requirement_type": "maintenance",
                            "expected_value": "first round"
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses) and ... second induction course (>= 2 doses)",
                        "criterion": "induction BCG therapy with second induction",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses) and ... second induction course (>= 2 doses)",
                        "criterion": "induction BCG therapy with second induction",
                        "requirement": {
                            "requirement_type": "dose count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "doses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "completing therapy with at least induction BCG (>= 5 doses) and ... second induction course (>= 2 doses)",
                        "criterion": "induction BCG therapy with second induction",
                        "requirement": {
                            "requirement_type": "second induction course",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "doses"
                            }
                        }
                    },
                    {
                        "exact_snippets": "The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG",
                        "criterion": "subsequent BCG round timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 6 months of initial induction BCG"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration. Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration.",
                        "criterion": "active autoimmune disease requiring systemic treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration.",
                        "criterion": "active autoimmune disease requiring systemic treatment",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis",
                        "criterion": "specific autoimmune diseases",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "lupus erythematosus",
                                "rheumatoid arthritis",
                                "inflammatory bowel disease",
                                "antiphospholipid syndrome",
                                "Wegener's granulomatosis",
                                "Sjogren's syndrome",
                                "Bell's palsy",
                                "Guillain-Barre syndrome",
                                "multiple sclerosis",
                                "autoimmune thyroid disease",
                                "vasculitis",
                                "glomerulonephritis"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration.",
                                            "criterion": "active autoimmune disease requiring systemic treatment",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration.",
                                            "criterion": "active autoimmune disease requiring systemic treatment",
                                            "requirement": {
                                                "requirement_type": "time frame",
                                                "expected_value": {
                                                    "comparisons": [
                                                        {
                                                            "operator": "<=",
                                                            "value": 24,
                                                            "unit": "months"
                                                        }
                                                    ]
                                                }
                                            }
                                        }
                                    ]
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis",
                                    "criterion": "specific autoimmune diseases",
                                    "requirement": {
                                        "requirement_type": "exclusion",
                                        "expected_value": [
                                            "lupus erythematosus",
                                            "rheumatoid arthritis",
                                            "inflammatory bowel disease",
                                            "antiphospholipid syndrome",
                                            "Wegener's granulomatosis",
                                            "Sjogren's syndrome",
                                            "Bell's palsy",
                                            "Guillain-Barre syndrome",
                                            "multiple sclerosis",
                                            "autoimmune thyroid disease",
                                            "vasculitis",
                                            "glomerulonephritis"
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection",
                "criterions": [
                    {
                        "exact_snippets": "known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)",
                        "criterion": "hepatitis B history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)",
                        "criterion": "active hepatitis C virus infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)",
                            "criterion": "hepatitis B history",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)",
                            "criterion": "active hepatitis C virus infection",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}