{
    "info": {
        "nct_id": "NCT00785694",
        "official_title": "Recurrence of Bladder Cancer After Transurethral Resection With Hexvix",
        "inclusion_criteria": "* The subject is not of childbearing potential and signed informed consent.\n* Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The subject was previously included in this study.\n* The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).\n* The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.\n* The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.\n* The subject has gross haematuria.\n* The subject has a history of porphyria.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The subject is not of childbearing potential and signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "The subject is not of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.",
            "criterions": [
                {
                    "exact_snippets": "1 or more primary bladder tumours",
                    "criterion": "primary bladder tumours",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed on an outpatient cystoscopy",
                    "criterion": "confirmation of bladder tumours",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "outpatient cystoscopy"
                        }
                    ]
                },
                {
                    "exact_snippets": "1 or more recurrent bladder tumours",
                    "criterion": "recurrent bladder tumours",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "appearing within 12 months of removal of a previous bladder tumour",
                    "criterion": "time since previous bladder tumour removal",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed on an outpatient cystoscopy",
                    "criterion": "confirmation of recurrent bladder tumours",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "outpatient cystoscopy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* The subject was previously included in this study.",
            "criterions": [
                {
                    "exact_snippets": "The subject was previously included in this study.",
                    "criterion": "previous inclusion in study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).",
            "criterions": [
                {
                    "exact_snippets": "history/is suspected to have TaG3",
                    "criterion": "TaG3 tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than or equal to T1 tumours",
                    "criterion": "T1 tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ (CIS)",
                    "criterion": "carcinoma in situ (CIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.",
            "criterions": [
                {
                    "exact_snippets": "The subject is suspected to have single primary or single recurrent TaG1 tumours",
                    "criterion": "tumour type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "single primary",
                                "single recurrent TaG1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence occurs more than 1 year after initial diagnosis or previous recurrence",
                    "criterion": "recurrence timing",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has gross haematuria.",
            "criterions": [
                {
                    "exact_snippets": "gross haematuria",
                    "criterion": "gross haematuria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a history of porphyria.",
            "criterions": [
                {
                    "exact_snippets": "history of porphyria",
                    "criterion": "porphyria",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.",
            "criterions": [
                {
                    "exact_snippets": "known tumours in the prostatic urethra",
                    "criterion": "tumours in the prostatic urethra",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known tumours in the distal urethra",
                    "criterion": "tumours in the distal urethra",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known tumours in the upper urinary tract",
                    "criterion": "tumours in the upper urinary tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}