{
    "info": {
        "nct_id": "NCT01931462",
        "official_title": "A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors",
        "inclusion_criteria": "1. Patient must have a solitary, polar, clinical T1 renal mass\n2. Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation.\n3. Women of child-bearing potential must have negative serum or urine pregnancy test\n4. Patient must be able to give written informed consent\n5. Patient must be 18 years or older\n6. No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. T stage greater than clinical T1\n2. Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland\n3. Prior surgery or radiation therapy to the region of interest\n4. Patient has a single functioning kidney\n5. Patient has an uncorrectable coagulopathy\n6. Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient must have a solitary, polar, clinical T1 renal mass",
            "criterions": [
                {
                    "exact_snippets": "solitary",
                    "criterion": "renal mass",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "solitary"
                        }
                    ]
                },
                {
                    "exact_snippets": "polar",
                    "criterion": "renal mass",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "polar"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical T1",
                    "criterion": "renal mass",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "clinical T1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation.",
            "criterions": [
                {
                    "exact_snippets": "adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": "eGFR (estimated glomerular filtration rate)"
                        },
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine performed within 30 days prior to the partial nephrectomy operation",
                    "criterion": "serum creatinine test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 30 days prior to the partial nephrectomy operation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Women of child-bearing potential must have negative serum or urine pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum or urine pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient must be able to give written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient must be able to give written informed consent",
                    "criterion": "ability to give written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient must be 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Patient must be 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery",
            "criterions": [
                {
                    "exact_snippets": "No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery",
                    "criterion": "blood-thinning medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery",
                    "criterion": "anti-inflammatory medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery",
                    "criterion": "herbs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery",
                    "criterion": "supplements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. T stage greater than clinical T1",
            "criterions": [
                {
                    "exact_snippets": "T stage greater than clinical T1",
                    "criterion": "T stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "clinical T"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland",
            "criterions": [
                {
                    "exact_snippets": "Tumor extends beyond kidney into major veins",
                    "criterion": "tumor extension into major veins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor extends beyond kidney into ... perinephric tissues",
                    "criterion": "tumor extension into perinephric tissues",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor extends beyond kidney into ... adrenal gland",
                    "criterion": "tumor extension into adrenal gland",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior surgery or radiation therapy to the region of interest",
            "criterions": [
                {
                    "exact_snippets": "Prior surgery ... to the region of interest",
                    "criterion": "prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "region of interest"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... radiation therapy to the region of interest",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "region of interest"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient has a single functioning kidney",
            "criterions": [
                {
                    "exact_snippets": "Patient has a single functioning kidney",
                    "criterion": "functioning kidney",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient has an uncorrectable coagulopathy",
            "criterions": [
                {
                    "exact_snippets": "uncorrectable coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition",
            "criterions": [
                {
                    "exact_snippets": "underlying cardiac ... condition",
                    "criterion": "cardiac condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "other serious comorbid condition",
                    "criterion": "comorbid condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}