{
    "info": {
        "nct_id": "NCT00440973",
        "official_title": "Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma",
        "inclusion_criteria": "* Pathological proof of clear cell carcinoma (or mixed tumors ≥ 75% clear cell component)\n* Evidence of measurable metastatic disease, no progression diseases or the patient's condition will not need radiotherapy in the next 4 weeks.\n* Previous definitive radiotherapy to 1 metastatic site is acceptable\n* At least 4 weeks have elapsed since radiation therapy\n* Patients must be free of serious co-morbidity and have a life expectancy of ≥24 weeks\n* Patients should have adequate physiologic reserves as evidence of adequate performance status, blood parameters, hepatic and kidney function, no evidence of active cardiac diseases and showing an acceptable function and adequate coagulation profile.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of central nervous System metastases\n* Known HIV positive\n* Recent history of brain's vascular disease within 6 months; patients requiring regular antianginal therapy (coronary disease) or insufficient circulation in lower extremities are not eligible\n* Active autoimmune disease\n* Patients who have had steroid therapy in the past three weeks\n* Patients taking concurrent anticancer drugs\n* Biphosphonates (Zometa) are not allowed, unless started 4 weeks prior to participation in the study\n* Female patients pregnant or breast-feeding\n* The patient has an unstable medical condition, such as uncontrolled Diabetes mellitus or Hypertension; active infections requiring systemic antibiotics, antivirals, or antifungal; clinical evidence of cardiac or pulmonary dysfunction including, uncontrolled arrhythmias, unstable coagulation disorders; or recent myocardial infarction (within 6 months)\n* Any condition including abnormal laboratory results, that in the opinion of the investigator places the patient at an unacceptable risk if he/she participate in the study\n* Prior malignancy (within the last 3 years), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been - free for at least 3 years\n* Uncontrolled Blood pressure > 150/100\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study\n* Minor surgery 7 days before day 0\n* Serious, non healing wound, ulcer, or bone fracture; and,inability to accomplish the treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathological proof of clear cell carcinoma (or mixed tumors ≥ 75% clear cell component)",
            "criterions": [
                {
                    "exact_snippets": "Pathological proof of clear cell carcinoma",
                    "criterion": "clear cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mixed tumors ≥ 75% clear cell component",
                    "criterion": "mixed tumors clear cell component",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of measurable metastatic disease, no progression diseases or the patient's condition will not need radiotherapy in the next 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of measurable metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no progression diseases",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient's condition will not need radiotherapy in the next 4 weeks",
                    "criterion": "need for radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "not in the next 4 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous definitive radiotherapy to 1 metastatic site is acceptable",
            "criterions": [
                {
                    "exact_snippets": "Previous definitive radiotherapy to 1 metastatic site is acceptable",
                    "criterion": "previous definitive radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "metastatic site"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks have elapsed since radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks have elapsed since radiation therapy",
                    "criterion": "time since radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "elapsed time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be free of serious co-morbidity and have a life expectancy of ≥24 weeks",
            "criterions": [
                {
                    "exact_snippets": "Patients must be free of serious co-morbidity",
                    "criterion": "serious co-morbidity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of ≥24 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients should have adequate physiologic reserves as evidence of adequate performance status, blood parameters, hepatic and kidney function, no evidence of active cardiac diseases and showing an acceptable function and adequate coagulation profile.",
            "criterions": [
                {
                    "exact_snippets": "adequate physiologic reserves",
                    "criterion": "physiologic reserves",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate performance status",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... blood parameters",
                    "criterion": "blood parameters",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... kidney function",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of active cardiac diseases",
                    "criterion": "active cardiac diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "acceptable function",
                    "criterion": "function",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate coagulation profile",
                    "criterion": "coagulation profile",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* History of central nervous System metastases",
            "criterions": [
                {
                    "exact_snippets": "History of central nervous System metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV positive",
            "criterions": [
                {
                    "exact_snippets": "Known HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent history of brain's vascular disease within 6 months; patients requiring regular antianginal therapy (coronary disease) or insufficient circulation in lower extremities are not eligible",
            "criterions": [
                {
                    "exact_snippets": "Recent history of brain's vascular disease within 6 months",
                    "criterion": "brain's vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients requiring regular antianginal therapy (coronary disease)",
                    "criterion": "coronary disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "regular antianginal therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "insufficient circulation in lower extremities",
                    "criterion": "circulation in lower extremities",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had steroid therapy in the past three weeks",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had steroid therapy in the past three weeks",
                    "criterion": "steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients taking concurrent anticancer drugs",
            "criterions": [
                {
                    "exact_snippets": "Patients taking concurrent anticancer drugs",
                    "criterion": "concurrent anticancer drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biphosphonates (Zometa) are not allowed, unless started 4 weeks prior to participation in the study",
            "criterions": [
                {
                    "exact_snippets": "Biphosphonates (Zometa) are not allowed",
                    "criterion": "biphosphonates (Zometa) usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless started 4 weeks prior to participation in the study",
                    "criterion": "biphosphonates (Zometa) usage",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "started 4 weeks prior to participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients pregnant or breast-feeding",
            "criterions": [
                {
                    "exact_snippets": "Female patients pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients ... breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has an unstable medical condition, such as uncontrolled Diabetes mellitus or Hypertension; active infections requiring systemic antibiotics, antivirals, or antifungal; clinical evidence of cardiac or pulmonary dysfunction including, uncontrolled arrhythmias, unstable coagulation disorders; or recent myocardial infarction (within 6 months)",
            "criterions": [
                {
                    "exact_snippets": "unstable medical condition, such as uncontrolled Diabetes mellitus",
                    "criterion": "Diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable medical condition, such as ... Hypertension",
                    "criterion": "Hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "active infections requiring systemic antibiotics, antivirals, or antifungal",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "systemic antibiotics",
                                "antivirals",
                                "antifungal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical evidence of cardiac or pulmonary dysfunction including, uncontrolled arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical evidence of cardiac or pulmonary dysfunction including, ... unstable coagulation disorders",
                    "criterion": "coagulation disorders",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "recent myocardial infarction (within 6 months)",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition including abnormal laboratory results, that in the opinion of the investigator places the patient at an unacceptable risk if he/she participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Any condition including abnormal laboratory results",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "unacceptable risk in the opinion of the investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior malignancy (within the last 3 years), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been - free for at least 3 years",
            "criterions": [
                {
                    "exact_snippets": "Prior malignancy (within the last 3 years)",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... other cancer for which the patient has been - free for at least 3 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled Blood pressure > 150/100",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled Blood pressure > 150/100",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "systolic",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0",
                    "criterion": "recent major surgical procedure, open biopsy, or significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipation of need for major surgical procedure during the course of the study",
                    "criterion": "anticipated need for major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minor surgery 7 days before day 0",
            "criterions": [
                {
                    "exact_snippets": "Minor surgery 7 days before day 0",
                    "criterion": "minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days before day 0"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious, non healing wound, ulcer, or bone fracture; and,inability to accomplish the treatment",
            "criterions": [
                {
                    "exact_snippets": "Serious, non healing wound, ulcer, or bone fracture",
                    "criterion": "wound, ulcer, or bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "healing status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to accomplish the treatment",
                    "criterion": "ability to accomplish the treatment",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}