{
    "info": {
        "nct_id": "NCT01936376",
        "official_title": "A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria (Cisplatin Treatment Group):\n\n1. Males and females ≥ 18 years of age\n2. Diagnosis of head & neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:\n\n   * as single agent chemotherapy in conjunction with local radiotherapy course, or\n   * as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)\n3. Willingness and ability to comply with study procedures and study restrictions\n4. Ability to provide written informed consent\n\nInclusion Criteria (Control Group):\n\n1. Males and females ≥ 18 years of age\n2. Diagnosis of head & neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)\n3. Willingness and ability to comply with study procedures and study restrictions\n4. Ability to provide written informed consent\n\nExclusion Criteria (All Subjects):\n\n1. Chronic kidney disease defined by eGFR <60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (>30 mcg/mg creatinine) will be excluded\n2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)\n3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month\n4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine\n5. Use of creatine supplements within 7 days prior to hospitalization\n6. Solid organ transplant recipients\n7. Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)\n8. Significant anemia (Hemoglobin < 10 g/dL)\n9. Pregnancy\n10. Institutionalized individuals"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "Inclusion Criteria (Cisplatin Treatment Group):",
            "criterions": [
                {
                    "exact_snippets": "Cisplatin Treatment Group",
                    "criterion": "treatment group",
                    "requirements": [
                        {
                            "requirement_type": "group",
                            "expected_value": "Cisplatin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Males and females ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Males and females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Diagnosis of head & neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of head & neck cancer",
                    "criterion": "head & neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy",
                    "criterion": "cisplatin chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "cycle number",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 75,
                                        "unit": "mg/m2/cycle"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "mg/m2/cycle"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* as single agent chemotherapy in conjunction with local radiotherapy course, or",
            "criterions": [
                {
                    "exact_snippets": "single agent chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "single agent"
                        }
                    ]
                },
                {
                    "exact_snippets": "local radiotherapy course",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "local"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)",
            "criterions": [
                {
                    "exact_snippets": "TPF combination (docetaxel, cisplatin, and fluorouracil)",
                    "criterion": "TPF combination",
                    "requirements": [
                        {
                            "requirement_type": "components",
                            "expected_value": [
                                "docetaxel",
                                "cisplatin",
                                "fluorouracil"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Willingness and ability to comply with study procedures and study restrictions",
            "criterions": [
                {
                    "exact_snippets": "Willingness ... to comply with study procedures and study restrictions",
                    "criterion": "willingness to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to comply with study procedures and study restrictions",
                    "criterion": "ability to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Ability to provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Males and females ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Males and females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Diagnosis of head & neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of head & neck cancer",
                    "criterion": "head & neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "similar condition such as an upper body, localised malignancy",
                    "criterion": "similar condition",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "These control patients will be scheduled to receive a non-nephrotoxic treatment modality",
                    "criterion": "non-nephrotoxic treatment modality",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Willingness and ability to comply with study procedures and study restrictions",
            "criterions": [
                {
                    "exact_snippets": "Willingness ... to comply with study procedures and study restrictions",
                    "criterion": "willingness to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to comply with study procedures and study restrictions",
                    "criterion": "ability to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Ability to provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Chronic kidney disease defined by eGFR <60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (>30 mcg/mg creatinine) will be excluded",
            "criterions": [
                {
                    "exact_snippets": "Chronic kidney disease defined by eGFR <60 mL/min/1.73m2",
                    "criterion": "chronic kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "eGFR",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "mL/min/1.73m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement",
                    "criterion": "persistent dipstick proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "those with microalbuminuria (>30 mcg/mg creatinine) will be excluded",
                    "criterion": "microalbuminuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "mcg/mg creatinine"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)",
            "criterions": [
                {
                    "exact_snippets": "Patients currently receiving other potentially nephrotoxic agents",
                    "criterion": "use of nephrotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic use of high dose NSAIDs",
                    "criterion": "use of high dose NSAIDs",
                    "requirements": [
                        {
                            "requirement_type": "chronic use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intravenous aminoglycosides",
                    "criterion": "use of intravenous aminoglycosides",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intravenous colistin",
                    "criterion": "use of intravenous colistin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intravenous vancomycin",
                    "criterion": "use of intravenous vancomycin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ACEi",
                    "criterion": "use of ACE inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month",
            "criterions": [
                {
                    "exact_snippets": "Any major surgery ... in the previous month",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "previous month"
                        }
                    ]
                },
                {
                    "exact_snippets": "high risk of acute kidney injury",
                    "criterion": "risk of acute kidney injury",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine",
            "criterions": [
                {
                    "exact_snippets": "Patients currently receiving trimethoprim",
                    "criterion": "trimethoprim",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients currently receiving ... cimetidine",
                    "criterion": "cimetidine",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients currently receiving ... other medications known to alter the tubular secretion of creatinine",
                    "criterion": "medications known to alter the tubular secretion of creatinine",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Use of creatine supplements within 7 days prior to hospitalization",
            "criterions": [
                {
                    "exact_snippets": "Use of creatine supplements within 7 days prior to hospitalization",
                    "criterion": "creatine supplement use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Solid organ transplant recipients",
            "criterions": [
                {
                    "exact_snippets": "Solid organ transplant recipients",
                    "criterion": "solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "recipient status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)",
            "criterions": [
                {
                    "exact_snippets": "Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum ALT ... >2xULN",
                    "criterion": "serum ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "xULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... >2xULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "xULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin >2xULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "xULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Significant anemia (Hemoglobin < 10 g/dL)",
            "criterions": [
                {
                    "exact_snippets": "Significant anemia (Hemoglobin < 10 g/dL)",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin < 10 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Institutionalized individuals",
            "criterions": [
                {
                    "exact_snippets": "Institutionalized individuals",
                    "criterion": "institutionalization status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria (Control Group):",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria (All Subjects):",
            "criterions": []
        }
    ]
}