{
    "info": {
        "nct_id": "NCT05451576",
        "official_title": "The Role of Sodium Selenite Supplementation in Patients With Locally Advanced Head and Neck Cancer Undergoing Concurrent Chemoradiotherapy",
        "inclusion_criteria": "* Histological proven head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, larynx, or metastatic cervical lymphadenopathy of unknown primary origin) who were scheduled for adjuvant or primary concurrent chemoradiotherapy (CCRT).\n* American Joint Committee on Cancer 8th edition stage III, IVA, and IVB patients.\n* Age 20-75 years old.\n* Adequate hematopoietic or organ function (leukocyte count ≥ 3.0 x 109/L, hemoglobin ≥ 10 g/dL, platelet count ≥ 100 x109/L, serum bilirubin level ≤ 1.5 mg/dL, alanine aminotransferase (ALT) and aspartate aminotransferase levels (AST) ≤ 3 x upper limit of normal, and serum creatinine level ≤ 1.6 mg/dL or creatinine clearance ≥ 60 mL/min/1.73m2).\n* ECOG performance status grade≦2.\n* Subjects understand this study, agree to join this study and are able to sign the written inform consent form.\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Nasopharyngeal cancer.\n* History of selenium allergy or intolerance.\n* Received selenium supplementation in recent 1 month.\n* Uncontrolled infection - according to PI diagnosis\n* Heart failure - New York Heart Association class IV\n* Impaired liver function (serum total bilirubin > 2 x upper limit of normal (ULN), ALT and/or AST > 5 x ULN).\n* Impaired renal function: serum creatinine > 1.5 x ULN.\n* Inadequate bone marrow function (white blood cell count < 2,500 / mm3 (<2.5 x 10^9/L), platelets < 100,000 / mm3 (< 100 x 10^9/L) and hemoglobin < 10 g/dL).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histological proven head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, larynx, or metastatic cervical lymphadenopathy of unknown primary origin) who were scheduled for adjuvant or primary concurrent chemoradiotherapy (CCRT).",
                "criterions": [
                    {
                        "exact_snippets": "Histological proven head and neck squamous cell carcinoma",
                        "criterion": "head and neck squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histological proven"
                        }
                    },
                    {
                        "exact_snippets": "oral cavity, oropharynx, hypopharynx, larynx, or metastatic cervical lymphadenopathy of unknown primary origin",
                        "criterion": "cancer location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx",
                                "metastatic cervical lymphadenopathy of unknown primary origin"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "scheduled for adjuvant or primary concurrent chemoradiotherapy (CCRT)",
                        "criterion": "treatment plan",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "adjuvant concurrent chemoradiotherapy",
                                "primary concurrent chemoradiotherapy"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histological proven head and neck squamous cell carcinoma",
                                "criterion": "head and neck squamous cell carcinoma",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "histological proven"
                                }
                            },
                            {
                                "exact_snippets": "oral cavity, oropharynx, hypopharynx, larynx, or metastatic cervical lymphadenopathy of unknown primary origin",
                                "criterion": "cancer location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": [
                                        "oral cavity",
                                        "oropharynx",
                                        "hypopharynx",
                                        "larynx",
                                        "metastatic cervical lymphadenopathy of unknown primary origin"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "scheduled for adjuvant or primary concurrent chemoradiotherapy (CCRT)",
                        "criterion": "treatment plan",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "adjuvant concurrent chemoradiotherapy",
                                "primary concurrent chemoradiotherapy"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* American Joint Committee on Cancer 8th edition stage III, IVA, and IVB patients.",
                "criterions": [
                    {
                        "exact_snippets": "American Joint Committee on Cancer 8th edition stage III, IVA, and IVB patients",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IVA",
                                "IVB"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "American Joint Committee on Cancer 8th edition stage III, IVA, and IVB patients",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IVA",
                                "IVB"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age 20-75 years old.",
                "criterions": [
                    {
                        "exact_snippets": "Age 20-75 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age 20-75 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate hematopoietic or organ function (leukocyte count ≥ 3.0 x 109/L, hemoglobin ≥ 10 g/dL, platelet count ≥ 100 x109/L, serum bilirubin level ≤ 1.5 mg/dL, alanine aminotransferase (ALT) and aspartate aminotransferase levels (AST) ≤ 3 x upper limit of normal, and serum creatinine level ≤ 1.6 mg/dL or creatinine clearance ≥ 60 mL/min/1.73m2).",
                "criterions": [
                    {
                        "exact_snippets": "leukocyte count ≥ 3.0 x 109/L",
                        "criterion": "leukocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "x 109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥ 10 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≥ 100 x109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "serum bilirubin level ≤ 1.5 mg/dL",
                        "criterion": "serum bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ... ≤ 3 x upper limit of normal",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase levels (AST) ≤ 3 x upper limit of normal",
                        "criterion": "aspartate aminotransferase levels (AST)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "serum creatinine level ≤ 1.6 mg/dL",
                        "criterion": "serum creatinine level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.6,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance ≥ 60 mL/min/1.73m2",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min/1.73m2"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "exact_snippets": "leukocyte count ≥ 3.0 x 109/L",
                                                                        "criterion": "leukocyte count",
                                                                        "requirement": {
                                                                            "requirement_type": "quantity",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 3.0,
                                                                                "unit": "x 109/L"
                                                                            }
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "hemoglobin ≥ 10 g/dL",
                                                                        "criterion": "hemoglobin",
                                                                        "requirement": {
                                                                            "requirement_type": "quantity",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 10,
                                                                                "unit": "g/dL"
                                                                            }
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "platelet count ≥ 100 x109/L",
                                                                "criterion": "platelet count",
                                                                "requirement": {
                                                                    "requirement_type": "quantity",
                                                                    "expected_value": {
                                                                        "operator": ">=",
                                                                        "value": 100,
                                                                        "unit": "x109/L"
                                                                    }
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "serum bilirubin level ≤ 1.5 mg/dL",
                                                        "criterion": "serum bilirubin level",
                                                        "requirement": {
                                                            "requirement_type": "quantity",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 1.5,
                                                                "unit": "mg/dL"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "alanine aminotransferase (ALT) ... ≤ 3 x upper limit of normal",
                                                "criterion": "alanine aminotransferase (ALT)",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 3,
                                                        "unit": "x upper limit of normal"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "aspartate aminotransferase levels (AST) ≤ 3 x upper limit of normal",
                                        "criterion": "aspartate aminotransferase levels (AST)",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 3,
                                                "unit": "x upper limit of normal"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "serum creatinine level ≤ 1.6 mg/dL",
                                        "criterion": "serum creatinine level",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.6,
                                                "unit": "mg/dL"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "creatinine clearance ≥ 60 mL/min/1.73m2",
                                        "criterion": "creatinine clearance",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 60,
                                                "unit": "mL/min/1.73m2"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "creatinine clearance ≥ 60 mL/min/1.73m2",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min/1.73m2"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status grade≦2.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status grade≦2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status grade≦2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects understand this study, agree to join this study and are able to sign the written inform consent form.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects understand this study",
                        "criterion": "understanding of the study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agree to join this study",
                        "criterion": "agreement to participate",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "able to sign the written inform consent form",
                        "criterion": "ability to sign informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects understand this study",
                        "criterion": "understanding of the study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agree to join this study",
                        "criterion": "agreement to participate",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "able to sign the written inform consent form",
                        "criterion": "ability to sign informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "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": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 20 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Nasopharyngeal cancer.",
                "criterions": [
                    {
                        "exact_snippets": "Nasopharyngeal cancer",
                        "criterion": "nasopharyngeal cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of selenium allergy or intolerance.",
                "criterions": [
                    {
                        "exact_snippets": "History of selenium allergy",
                        "criterion": "selenium allergy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "selenium ... intolerance",
                        "criterion": "selenium intolerance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Received selenium supplementation in recent 1 month.",
                "criterions": [
                    {
                        "exact_snippets": "Received selenium supplementation in recent 1 month.",
                        "criterion": "selenium supplementation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled infection - according to PI diagnosis",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Heart failure - New York Heart Association class IV",
                "criterions": [
                    {
                        "exact_snippets": "Heart failure - New York Heart Association class IV",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "New York Heart Association class IV"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Impaired liver function (serum total bilirubin > 2 x upper limit of normal (ULN), ALT and/or AST > 5 x ULN).",
                "criterions": [
                    {
                        "exact_snippets": "Impaired liver function (serum total bilirubin > 2 x upper limit of normal (ULN)",
                        "criterion": "serum total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Impaired liver function ... ALT and/or AST > 5 x ULN",
                        "criterion": "ALT and/or AST",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Impaired renal function: serum creatinine > 1.5 x ULN.",
                "criterions": [
                    {
                        "exact_snippets": "Impaired renal function: serum creatinine > 1.5 x ULN.",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Inadequate bone marrow function (white blood cell count < 2,500 / mm3 (<2.5 x 10^9/L), platelets < 100,000 / mm3 (< 100 x 10^9/L) and hemoglobin < 10 g/dL).",
                "criterions": [
                    {
                        "exact_snippets": "white blood cell count < 2,500 / mm3 (<2.5 x 10^9/L)",
                        "criterion": "white blood cell count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2500,
                                "unit": "/ mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets < 100,000 / mm3 (< 100 x 10^9/L)",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "/ mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin < 10 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}