{
    "info": {
        "nct_id": "NCT01732120",
        "official_title": "Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors",
        "inclusion_criteria": "* Patients 18 and older.\n* Patients willing and able to sign consent.\n* Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).\n* Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients under 18.\n* Patients with Karnofsky Performance Status (KPS) less than 40.\n* Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).\n* Patients with bilateral synchronous renal masses.\n* Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.\n* Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients 18 and older.",
                "criterions": [
                    {
                        "exact_snippets": "Patients 18 and older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients 18 and older",
                        "criterion": "age",
                        "requirement": {
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                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients willing and able to sign consent.",
                "criterions": [
                    {
                        "exact_snippets": "Patients willing ... to sign consent.",
                        "criterion": "willingness to sign consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients ... able to sign consent.",
                        "criterion": "ability to sign consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients willing ... to sign consent.",
                        "criterion": "willingness to sign consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients ... able to sign consent.",
                        "criterion": "ability to sign consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).",
                "criterions": [
                    {
                        "exact_snippets": "non-organ confined renal masses (invading renal vein",
                        "criterion": "renal mass invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "renal vein"
                        }
                    },
                    {
                        "exact_snippets": "non-organ confined renal masses (invading ... inferior vena cava",
                        "criterion": "renal mass invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "inferior vena cava"
                        }
                    },
                    {
                        "exact_snippets": "non-organ confined renal masses (invading ... peri-renal tissue",
                        "criterion": "renal mass invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "peri-renal tissue"
                        }
                    },
                    {
                        "exact_snippets": "non-organ confined renal masses (invading ... ipsilateral adrenal gland",
                        "criterion": "renal mass invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "ipsilateral adrenal gland"
                        }
                    },
                    {
                        "exact_snippets": "non-organ confined renal masses (invading ... metastasis",
                        "criterion": "renal mass invasion",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "metastasis"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "non-organ confined renal masses (invading renal vein",
                                "criterion": "renal mass invasion",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "renal vein"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "non-organ confined renal masses (invading ... inferior vena cava",
                                "criterion": "renal mass invasion",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "inferior vena cava"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "non-organ confined renal masses (invading ... peri-renal tissue",
                                "criterion": "renal mass invasion",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "peri-renal tissue"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "non-organ confined renal masses (invading ... ipsilateral adrenal gland",
                                "criterion": "renal mass invasion",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "ipsilateral adrenal gland"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "non-organ confined renal masses (invading ... metastasis",
                                "criterion": "renal mass invasion",
                                "requirement": {
                                    "requirement_type": "condition",
                                    "expected_value": "metastasis"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with bilateral synchronous renal masses.",
                "criterions": [
                    {
                        "exact_snippets": "bilateral synchronous renal masses",
                        "criterion": "renal masses",
                        "requirement": {
                            "requirement_type": "laterality",
                            "expected_value": "bilateral"
                        }
                    },
                    {
                        "exact_snippets": "bilateral synchronous renal masses",
                        "criterion": "renal masses",
                        "requirement": {
                            "requirement_type": "synchrony",
                            "expected_value": "synchronous"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "bilateral synchronous renal masses",
                        "criterion": "renal masses",
                        "requirement": {
                            "requirement_type": "laterality",
                            "expected_value": "bilateral"
                        }
                    },
                    {
                        "exact_snippets": "bilateral synchronous renal masses",
                        "criterion": "renal masses",
                        "requirement": {
                            "requirement_type": "synchrony",
                            "expected_value": "synchronous"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.",
                "criterions": [
                    {
                        "exact_snippets": "can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications",
                        "criterion": "ability to discontinue anti-platelet or anti-coagulant medications",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications",
                        "criterion": "ability to discontinue anti-platelet or anti-coagulant medications",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)",
                "criterions": [
                    {
                        "exact_snippets": "renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon",
                        "criterion": "renal lesions complexity",
                        "requirement": {
                            "requirement_type": "complexity",
                            "expected_value": "too complex to perform a RAPN without clamp"
                        }
                    },
                    {
                        "exact_snippets": "The renal mass may be deemed too difficult based on pre-operatively radiological findings",
                        "criterion": "renal mass difficulty",
                        "requirement": {
                            "requirement_type": "difficulty",
                            "expected_value": "too difficult based on pre-operatively radiological findings"
                        }
                    },
                    {
                        "exact_snippets": "The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication",
                        "criterion": "surgeon's decision to exclude mass",
                        "requirement": {
                            "requirement_type": "risk assessment",
                            "expected_value": "higher risk of positive margin or complication"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon",
                                "criterion": "renal lesions complexity",
                                "requirement": {
                                    "requirement_type": "complexity",
                                    "expected_value": "too complex to perform a RAPN without clamp"
                                }
                            },
                            {
                                "exact_snippets": "The renal mass may be deemed too difficult based on pre-operatively radiological findings",
                                "criterion": "renal mass difficulty",
                                "requirement": {
                                    "requirement_type": "difficulty",
                                    "expected_value": "too difficult based on pre-operatively radiological findings"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication",
                        "criterion": "surgeon's decision to exclude mass",
                        "requirement": {
                            "requirement_type": "risk assessment",
                            "expected_value": "higher risk of positive margin or complication"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).",
                "criterions": [
                    {
                        "exact_snippets": "organ confined renal mass",
                        "criterion": "renal mass",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "organ confined"
                        }
                    },
                    {
                        "exact_snippets": "planning to undergo a robotic assisted partial nephrectomy (RAPN)",
                        "criterion": "surgical procedure",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "robotic assisted partial nephrectomy (RAPN)"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
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                }
            }
        },
        {
            "identified_line": {
                "line": "* Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.",
                "criterions": [
                    {
                        "exact_snippets": "Karnofsky Performance Status (KPS) equal to or greater than 40",
                        "criterion": "Karnofsky Performance Status (KPS)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "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 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
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                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Patients under 18.",
                "criterions": [
                    {
                        "exact_snippets": "Patients under 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
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                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with Karnofsky Performance Status (KPS) less than 40.",
                "criterions": [
                    {
                        "exact_snippets": "Karnofsky Performance Status (KPS) less than 40",
                        "criterion": "Karnofsky Performance Status (KPS)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
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                                "value": 40,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
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                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}