{
    "info": {
        "nct_id": "NCT00942682",
        "official_title": "Phase I Study of Sorafenib in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors",
        "inclusion_criteria": "* Locally unresectable or metastatic neuroendocrine tumor (carcinoid tumor or pancreatic neuroendocrine tumor). Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, and small cell carcinoma are not eligible.\n* 18 years of age or older\n* Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. Bevacizumab should not have been received within the prior 6 weeks.\n* Prior treatment with chemotherapy is allowed. Patients may not have received prior therapy with RAD001 or sorafenib. There is no limit to the number of prior chemotherapy regimens a patient may have received. Patients may receive concomitant therapy with somatostatin analogs.\n* ECOG performance status 0 or 1\n* Life expectancy 12 weeks or more\n* Adequate bone marrow, liver and renal function as outlined in the protocol\n* Fasting serum glycerides and fasting triglycerides as outlined in the protocol\n* INR < 1.5 or PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.\n* Women of child bearing potential must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with cytotoxic chemotherapy, radiation, immunotherapy, or any investigational drug within the preceding 4 weeks. Bevacizumab should not have been received within the prior 6 weeks.\n* Prior treatment with RAD001 or sorafenib\n* Patients who have undergone major surgery within 4 weeks prior to study enrollment.\n* Chronic treatment with systemic steroids or another immunosuppressive agent\n* Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.\n* Known brain metastases\n* Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.\n* Patients with uncontrolled diabetes mellitis or a fasting plasma glucose > 1.5 ULN\n* Patients who have congestive heart failure (NHYA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment. No new onset angina within 3 months preceding enrollment. No cardiac ventricular arrhythmia requiring antiarrhythmic therapy.\n* Uncontrolled hypertension\n* Active clinically serious infection\n* Serious non-healing wound, ulcer, or bone fracture\n* Evidence of history of bleeding diathesis or coagulopathy\n* Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result\n* Patients who have any severe and/or uncontrolled medical conditions or other conditions what could affect their participation in the study\n* Use of St. John's Wort or rifampin (rifampicin)\n* Patients with a known or suspected hypersensitivity to sorafenib, RAD001 or other rapamycins or to its excipients",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Locally unresectable or metastatic neuroendocrine tumor (carcinoid tumor or pancreatic neuroendocrine tumor). Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, and small cell carcinoma are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Locally unresectable or metastatic neuroendocrine tumor",
                    "criterion": "neuroendocrine tumor",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "locally unresectable"
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoid tumor or pancreatic neuroendocrine tumor",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "carcinoid tumor",
                                "pancreatic neuroendocrine tumor"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed low-grade or intermediate-grade neuroendocrine carcinoma",
                    "criterion": "neuroendocrine carcinoma grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "low-grade",
                                "intermediate-grade"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, and small cell carcinoma are not eligible",
                    "criterion": "tumor type exclusion",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "poorly differentiated neuroendocrine carcinoma",
                                "high-grade neuroendocrine carcinoma",
                                "adenocarcinoid",
                                "goblet cell carcinoid",
                                "small cell carcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. Bevacizumab should not have been received within the prior 6 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Minimum of four weeks since any major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Minimum of four weeks since ... completion of radiation",
                    "criterion": "time since completion of radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Minimum of four weeks since ... completion of all prior systemic anticancer therapy",
                    "criterion": "time since completion of prior systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bevacizumab should not have been received within the prior 6 weeks",
                    "criterion": "time since Bevacizumab received",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with chemotherapy is allowed. Patients may not have received prior therapy with RAD001 or sorafenib. There is no limit to the number of prior chemotherapy regimens a patient may have received. Patients may receive concomitant therapy with somatostatin analogs.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with chemotherapy is allowed.",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may not have received prior therapy with RAD001 or sorafenib.",
                    "criterion": "prior therapy with RAD001",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may not have received prior therapy with RAD001 or sorafenib.",
                    "criterion": "prior therapy with sorafenib",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "There is no limit to the number of prior chemotherapy regimens a patient may have received.",
                    "criterion": "number of prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": "no limit"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may receive concomitant therapy with somatostatin analogs.",
                    "criterion": "concomitant therapy with somatostatin analogs",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy 12 weeks or more",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy 12 weeks or more",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fasting serum glycerides and fasting triglycerides as outlined in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Fasting serum glycerides",
                    "criterion": "fasting serum glycerides",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting triglycerides",
                    "criterion": "fasting triglycerides",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INR < 1.5 or PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.",
            "criterions": [
                {
                    "exact_snippets": "INR < 1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PT/PTT within normal limits",
                    "criterion": "PT/PTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin",
                    "criterion": "anti-coagulation treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child bearing potential must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating.",
            "criterions": [
                {
                    "exact_snippets": "Women of child bearing potential",
                    "criterion": "child bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test within 14 days of the administration of the first study treatment",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days of the administration of the first study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women must not be lactating",
                    "criterion": "lactation",
                    "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": "* Prior treatment with cytotoxic chemotherapy, radiation, immunotherapy, or any investigational drug within the preceding 4 weeks. Bevacizumab should not have been received within the prior 6 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with cytotoxic chemotherapy ... within the preceding 4 weeks.",
                    "criterion": "prior cytotoxic chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... radiation ... within the preceding 4 weeks.",
                    "criterion": "prior radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... immunotherapy ... within the preceding 4 weeks.",
                    "criterion": "prior immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... any investigational drug within the preceding 4 weeks.",
                    "criterion": "prior investigational drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bevacizumab should not have been received within the prior 6 weeks.",
                    "criterion": "prior Bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with RAD001 or sorafenib",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with RAD001",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "RAD001"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... sorafenib",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "sorafenib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone major surgery within 4 weeks prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "undergone major surgery within 4 weeks prior to study enrollment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic treatment with systemic steroids or another immunosuppressive agent",
            "criterions": [
                {
                    "exact_snippets": "Chronic treatment with systemic steroids",
                    "criterion": "chronic treatment with systemic steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "another immunosuppressive agent",
                    "criterion": "treatment with another immunosuppressive agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Patients should not receive immunization with attenuated live vaccines during study period",
                    "criterion": "immunization with attenuated live vaccines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients should not receive immunization with attenuated live vaccines ... within 1 week of study entry",
                    "criterion": "immunization with attenuated live vaccines",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not within 1 week of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.",
            "criterions": [
                {
                    "exact_snippets": "prior or concurrent malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "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": "other adequately treated in situ cancer",
                    "criterion": "in situ cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "any other cancer from which the patient has been disease free for five years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled diabetes mellitis or a fasting plasma glucose > 1.5 ULN",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled diabetes mellitis",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting plasma glucose > 1.5 ULN",
                    "criterion": "fasting plasma glucose",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have congestive heart failure (NHYA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment. No new onset angina within 3 months preceding enrollment. No cardiac ventricular arrhythmia requiring antiarrhythmic therapy.",
            "criterions": [
                {
                    "exact_snippets": "congestive heart failure (NHYA Class III or IV)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "NHYA Class III",
                                "NHYA Class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sustained ventricular tachycardia",
                    "criterion": "sustained ventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular fibrillation",
                    "criterion": "ventricular fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant bradycardia",
                    "criterion": "clinically significant bradycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced heart block",
                    "criterion": "advanced heart block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of acute myocardial infarction within the six months preceding enrollment",
                    "criterion": "acute myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No new onset angina within 3 months preceding enrollment",
                    "criterion": "new onset angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No cardiac ventricular arrhythmia requiring antiarrhythmic therapy",
                    "criterion": "cardiac ventricular arrhythmia requiring antiarrhythmic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active clinically serious infection",
            "criterions": [
                {
                    "exact_snippets": "Active clinically serious infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically serious"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious non-healing wound, ulcer, or bone fracture",
            "criterions": [
                {
                    "exact_snippets": "Serious non-healing wound",
                    "criterion": "non-healing wound",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious ... ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious ... bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of history of bleeding diathesis or coagulopathy",
            "criterions": [
                {
                    "exact_snippets": "Evidence of history of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of history of ... coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result",
            "criterions": [
                {
                    "exact_snippets": "presence of active or suspected acute or chronic uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of immunocompromise",
                    "criterion": "immunocompromise",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive HIV test result",
                    "criterion": "HIV test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have any severe and/or uncontrolled medical conditions or other conditions what could affect their participation in the study",
            "criterions": [
                {
                    "exact_snippets": "severe and/or uncontrolled medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other conditions what could affect their participation in the study",
                    "criterion": "conditions affecting participation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "affect participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a known or suspected hypersensitivity to sorafenib, RAD001 or other rapamycins or to its excipients",
            "criterions": [
                {
                    "exact_snippets": "known or suspected hypersensitivity to sorafenib",
                    "criterion": "hypersensitivity to sorafenib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known or suspected hypersensitivity to ... RAD001",
                    "criterion": "hypersensitivity to RAD001",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known or suspected hypersensitivity to ... other rapamycins",
                    "criterion": "hypersensitivity to other rapamycins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known or suspected hypersensitivity ... to its excipients",
                    "criterion": "hypersensitivity to excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Adequate bone marrow, liver and renal function as outlined in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as outlined in the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as outlined in the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as outlined in the protocol"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Use of St. John's Wort or rifampin (rifampicin)",
            "criterions": [
                {
                    "exact_snippets": "Use of St. John's Wort",
                    "criterion": "St. John's Wort",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of ... rifampin (rifampicin)",
                    "criterion": "rifampin (rifampicin)",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}