{
    "info": {
        "nct_id": "NCT05453682",
        "official_title": "Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Musc Le-invasive Bladder Cancer:",
        "inclusion_criteria": "1. Patients diagnosed with bladder cancer histologically\n2. Patients with muscle layer involvement in transurethral resection (pT2 or higher)\n3. Patients without pelvic lymph node metastasis by computed tomography (CT) or magnetic resonance images (MRI) of the pelvis.\n4. Patients who want bladder conservation treatment\n5. Patients over 20 years old\n6. Patients with Zubrod (ECOG) performance status 0-1 within 1 week prior to participation in the study\n7. Patients who have signed the consent form with sufficient information by the patient or guardian\n8. Patients with hematologic findings capable of concurrent chemoradiotherapy\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "1. Patients with previous pelvic radiotherapy history\n2. Pregnant or lactating patients\n3. Patients with distant metastasis\n4. Patients judged to be difficult to conserve bladder due to extensive non-invasive/invasive bladder cancer\n5. Patients who have not been disease-free for more than 5 years after diagnosis of cancer (excluding thyroid cancer, non-melanoma skin cancer, T1a prostate cancer, and intraepithelial cancer of the cervix)\n6. Patients with untreated severe acute disease\n7. Patients predicted to have a high probability of radiation complications due to connective tissue disease (lupus, scleroderma, etc.)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients diagnosed with bladder cancer histologically",
            "criterions": [
                {
                    "exact_snippets": "Patients diagnosed with bladder cancer histologically",
                    "criterion": "bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with muscle layer involvement in transurethral resection (pT2 or higher)",
            "criterions": [
                {
                    "exact_snippets": "muscle layer involvement in transurethral resection (pT2 or higher)",
                    "criterion": "muscle layer involvement",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "pT2 or higher"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients without pelvic lymph node metastasis by computed tomography (CT) or magnetic resonance images (MRI) of the pelvis.",
            "criterions": [
                {
                    "exact_snippets": "pelvic lymph node metastasis",
                    "criterion": "pelvic lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "computed tomography (CT) or magnetic resonance images (MRI) of the pelvis",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "computed tomography (CT)",
                                "magnetic resonance images (MRI)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who want bladder conservation treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients who want bladder conservation treatment",
                    "criterion": "bladder conservation treatment",
                    "requirements": [
                        {
                            "requirement_type": "desire",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients over 20 years old",
            "criterions": [
                {
                    "exact_snippets": "Patients over 20 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with Zubrod (ECOG) performance status 0-1 within 1 week prior to participation in the study",
            "criterions": [
                {
                    "exact_snippets": "Zubrod (ECOG) performance status 0-1",
                    "criterion": "Zubrod (ECOG) performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 1 week prior to participation in the study",
                    "criterion": "timeframe for performance status assessment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 week prior to participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients who have signed the consent form with sufficient information by the patient or guardian",
            "criterions": [
                {
                    "exact_snippets": "signed the consent form",
                    "criterion": "consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient information by the patient or guardian",
                    "criterion": "information provided",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "provider",
                            "expected_value": [
                                "patient",
                                "guardian"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with hematologic findings capable of concurrent chemoradiotherapy",
            "criterions": [
                {
                    "exact_snippets": "hematologic findings capable of concurrent chemoradiotherapy",
                    "criterion": "hematologic findings",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "concurrent chemoradiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with previous pelvic radiotherapy history",
            "criterions": [
                {
                    "exact_snippets": "previous pelvic radiotherapy history",
                    "criterion": "pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pregnant or lactating patients",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with distant metastasis",
            "criterions": [
                {
                    "exact_snippets": "Patients with distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients judged to be difficult to conserve bladder due to extensive non-invasive/invasive bladder cancer",
            "criterions": [
                {
                    "exact_snippets": "difficult to conserve bladder due to extensive non-invasive/invasive bladder cancer",
                    "criterion": "bladder conservation difficulty",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": [
                                "extensive non-invasive bladder cancer",
                                "extensive invasive bladder cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients who have not been disease-free for more than 5 years after diagnosis of cancer (excluding thyroid cancer, non-melanoma skin cancer, T1a prostate cancer, and intraepithelial cancer of the cervix)",
            "criterions": [
                {
                    "exact_snippets": "disease-free for more than 5 years after diagnosis of cancer",
                    "criterion": "disease-free status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding thyroid cancer, non-melanoma skin cancer, T1a prostate cancer, and intraepithelial cancer of the cervix",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "thyroid cancer",
                                "non-melanoma skin cancer",
                                "T1a prostate cancer",
                                "intraepithelial cancer of the cervix"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with untreated severe acute disease",
            "criterions": [
                {
                    "exact_snippets": "untreated severe acute disease",
                    "criterion": "severe acute disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients predicted to have a high probability of radiation complications due to connective tissue disease (lupus, scleroderma, etc.)",
            "criterions": [
                {
                    "exact_snippets": "high probability of radiation complications",
                    "criterion": "probability of radiation complications",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "connective tissue disease (lupus, scleroderma, etc.)",
                    "criterion": "connective tissue disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}