{
    "info": {
        "nct_id": "NCT00542048",
        "official_title": "An Open-label, Uncontrolled, Phase II Trial Evaluating the Single-dose and Steady-state Pharmacokinetics of EndoTAG®-1 and Its Effect on the Blood Supply and the Angiogenesis of Hepatic Metastases in Patients With a Carcinomatous Primary Tumor Other Than Hepatocellular (HCC), Biliary or Bile Duct Carcinoma",
        "inclusion_criteria": "* Unresectable hepatic metastases of a carcinomatous origin with exception of HCC, biliary or bile duct carcinoma\n* At least one measurable hepatic metastases > 20 mm in diameter (measured in MRI)\n* Last application of palliative chemotherapy (drug dependent on the primary tumor) at least 7 days ago\n* Gender: male and female (at least 6 individuals of each gender)\n* Age >= 18 years\n* Negative pregnancy test (females of childbearing potential)\n* Willingness to perform double-barrier-contraception during the study and for 6 month post study medication\n* ECOG performance status 0,1 or 2\n* Assumed life expectancy of > 3 month\n* Signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of significant liver pathology (other than metastases, e.g. cirrhosis of the liver, PSC, PBC) or liver transplantation\n* Laboratory tests (hematology, chemistry) outside specific limits:\n* ANC <= 1.0 x 10^9/L\n* Platelets <= 100 x 10^9/L\n* Hb <= 9.0 g/dL (<= 5.6 mmol/L)\n* Total Bilirubin > 2.0 mg/dL\n* Serum Creatinine > 1.5 mg/dL\n* Renal insufficiency with a GFR < 60 mL/min\n* Currently ongoing taxane-containing palliative chemotherapy regimen or history of taxane administration within 4 weeks prior to study entry\n* Pregnancy or nursing status\n* Positive HIV, HBV or HCV testing\n* The patient has a contraindication for MRI or CEUS according to accepted clinical guidelines\n* Known hypersensitivity to any component of the EndoTAG®-1 formulation, gadolinium-based MR-contrast media or sulphur hexafluoride\n* Claustrophobia or history of active or significant neurological disorder and/or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of the patient during the trial\n* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Unresectable hepatic metastases of a carcinomatous origin with exception of HCC, biliary or bile duct carcinoma",
                "criterions": [
                    {
                        "exact_snippets": "Unresectable hepatic metastases",
                        "criterion": "hepatic metastases",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "carcinomatous origin",
                        "criterion": "origin of metastases",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "carcinomatous"
                        }
                    },
                    {
                        "exact_snippets": "exception of HCC, biliary or bile duct carcinoma",
                        "criterion": "origin of metastases",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "HCC",
                                "biliary carcinoma",
                                "bile duct carcinoma"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Unresectable hepatic metastases",
                                "criterion": "hepatic metastases",
                                "requirement": {
                                    "requirement_type": "resectability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "carcinomatous origin",
                                "criterion": "origin of metastases",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "carcinomatous"
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "exception of HCC, biliary or bile duct carcinoma",
                            "criterion": "origin of metastases",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": [
                                    "HCC",
                                    "biliary carcinoma",
                                    "bile duct carcinoma"
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least one measurable hepatic metastases > 20 mm in diameter (measured in MRI)",
                "criterions": [
                    {
                        "exact_snippets": "measurable hepatic metastases > 20 mm in diameter (measured in MRI)",
                        "criterion": "hepatic metastases",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "measurable hepatic metastases > 20 mm in diameter (measured in MRI)",
                        "criterion": "hepatic metastases",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "measurable hepatic metastases > 20 mm in diameter (measured in MRI)",
                        "criterion": "hepatic metastases",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "measurable hepatic metastases > 20 mm in diameter (measured in MRI)",
                        "criterion": "hepatic metastases",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Last application of palliative chemotherapy (drug dependent on the primary tumor) at least 7 days ago",
                "criterions": [
                    {
                        "exact_snippets": "Last application of palliative chemotherapy ... at least 7 days ago",
                        "criterion": "palliative chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last application",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Last application of palliative chemotherapy ... at least 7 days ago",
                        "criterion": "palliative chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last application",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Gender: male and female (at least 6 individuals of each gender)",
                "criterions": [
                    {
                        "exact_snippets": "Gender: male and female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "at least 6 individuals of each gender",
                        "criterion": "gender representation",
                        "requirement": {
                            "requirement_type": "minimum count per gender",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "individuals"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Gender: male and female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "at least 6 individuals of each gender",
                        "criterion": "gender representation",
                        "requirement": {
                            "requirement_type": "minimum count per gender",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "individuals"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age >= 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age >= 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age >= 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Negative pregnancy test (females of childbearing potential)",
                "criterions": [
                    {
                        "exact_snippets": "Negative pregnancy test (females of childbearing potential)",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test (females of childbearing potential)",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "applicability",
                            "expected_value": "females"
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test (females of childbearing potential)",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "applicability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Negative pregnancy test (females of childbearing potential)",
                                        "criterion": "gender",
                                        "requirement": {
                                            "requirement_type": "applicability",
                                            "expected_value": "females"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Negative pregnancy test (females of childbearing potential)",
                                        "criterion": "childbearing potential",
                                        "requirement": {
                                            "requirement_type": "applicability",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Negative pregnancy test (females of childbearing potential)",
                                "criterion": "pregnancy test",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "negative"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Willingness to perform double-barrier-contraception during the study and for 6 month post study medication",
                "criterions": [
                    {
                        "exact_snippets": "Willingness to perform double-barrier-contraception during the study and for 6 month post study medication",
                        "criterion": "double-barrier contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness to perform double-barrier-contraception during the study and for 6 month post study medication",
                        "criterion": "double-barrier contraception",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 6 months post study medication"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willingness to perform double-barrier-contraception during the study and for 6 month post study medication",
                        "criterion": "double-barrier contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness to perform double-barrier-contraception during the study and for 6 month post study medication",
                        "criterion": "double-barrier contraception",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 6 months post study medication"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status 0,1 or 2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 0,1 or 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status 0,1 or 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Assumed life expectancy of > 3 month",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy of > 3 month",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy of > 3 month",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "month"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Signed informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Laboratory tests (hematology, chemistry) outside specific limits:",
                "criterions": [
                    {
                        "exact_snippets": "Laboratory tests (hematology, chemistry) outside specific limits",
                        "criterion": "hematology laboratory tests",
                        "requirement": {
                            "requirement_type": "limits",
                            "expected_value": "outside specific limits"
                        }
                    },
                    {
                        "exact_snippets": "Laboratory tests (hematology, chemistry) outside specific limits",
                        "criterion": "chemistry laboratory tests",
                        "requirement": {
                            "requirement_type": "limits",
                            "expected_value": "outside specific limits"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Laboratory tests (hematology, chemistry) outside specific limits",
                        "criterion": "hematology laboratory tests",
                        "requirement": {
                            "requirement_type": "limits",
                            "expected_value": "outside specific limits"
                        }
                    },
                    {
                        "exact_snippets": "Laboratory tests (hematology, chemistry) outside specific limits",
                        "criterion": "chemistry laboratory tests",
                        "requirement": {
                            "requirement_type": "limits",
                            "expected_value": "outside specific limits"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ANC <= 1.0 x 10^9/L",
                "criterions": [
                    {
                        "exact_snippets": "ANC <= 1.0 x 10^9/L",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ANC <= 1.0 x 10^9/L",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelets <= 100 x 10^9/L",
                "criterions": [
                    {
                        "exact_snippets": "Platelets <= 100 x 10^9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets <= 100 x 10^9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hb <= 9.0 g/dL (<= 5.6 mmol/L)",
                "criterions": [
                    {
                        "exact_snippets": "Hb <= 9.0 g/dL (<= 5.6 mmol/L)",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 9.0,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5.6,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hb <= 9.0 g/dL (<= 5.6 mmol/L)",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 9.0,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5.6,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Total Bilirubin > 2.0 mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Total Bilirubin > 2.0 mg/dL",
                        "criterion": "Total Bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Total Bilirubin > 2.0 mg/dL",
                    "criterion": "Total Bilirubin",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": ">",
                            "value": 2.0,
                            "unit": "mg/dL"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Serum Creatinine > 1.5 mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Serum Creatinine > 1.5 mg/dL",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum Creatinine > 1.5 mg/dL",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Renal insufficiency with a GFR < 60 mL/min",
                "criterions": [
                    {
                        "exact_snippets": "Renal insufficiency",
                        "criterion": "renal insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "GFR < 60 mL/min",
                        "criterion": "GFR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Renal insufficiency",
                        "criterion": "renal insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "GFR < 60 mL/min",
                        "criterion": "GFR",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently ongoing taxane-containing palliative chemotherapy regimen or history of taxane administration within 4 weeks prior to study entry",
                "criterions": [
                    {
                        "exact_snippets": "Currently ongoing taxane-containing palliative chemotherapy regimen",
                        "criterion": "taxane-containing palliative chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    },
                    {
                        "exact_snippets": "history of taxane administration within 4 weeks prior to study entry",
                        "criterion": "taxane administration",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Currently ongoing taxane-containing palliative chemotherapy regimen",
                        "criterion": "taxane-containing palliative chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    },
                    {
                        "exact_snippets": "history of taxane administration within 4 weeks prior to study entry",
                        "criterion": "taxane administration",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnancy or nursing status",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nursing status",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nursing status",
                        "criterion": "nursing status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Positive HIV, HBV or HCV testing",
                "criterions": [
                    {
                        "exact_snippets": "Positive HIV",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive ... HBV",
                        "criterion": "HBV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive ... HCV",
                        "criterion": "HCV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Positive HIV",
                        "criterion": "HIV status",
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                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive ... HBV",
                        "criterion": "HBV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive ... HCV",
                        "criterion": "HCV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The patient has a contraindication for MRI or CEUS according to accepted clinical guidelines",
                "criterions": [
                    {
                        "exact_snippets": "contraindication for MRI",
                        "criterion": "MRI",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "contraindication for ... CEUS",
                        "criterion": "CEUS",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "contraindication for MRI",
                        "criterion": "MRI",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "contraindication for ... CEUS",
                        "criterion": "CEUS",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Claustrophobia or history of active or significant neurological disorder and/or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of the patient during the trial",
                "criterions": [
                    {
                        "exact_snippets": "Claustrophobia",
                        "criterion": "claustrophobia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of active or significant neurological disorder",
                        "criterion": "neurological disorder",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation",
                        "criterion": "psychiatric disorder",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "prohibits understanding and giving of informed consent or interferes in evaluation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Claustrophobia",
                        "criterion": "claustrophobia",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of active or significant neurological disorder",
                                "criterion": "neurological disorder",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation",
                                "criterion": "psychiatric disorder",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "prohibits understanding and giving of informed consent or interferes in evaluation"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent treatment with other experimental drugs.",
                        "criterion": "concurrent treatment with experimental drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Participation in another clinical trial with any investigational drug within 30 days prior to study entry",
                        "criterion": "participation in another clinical trial",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Concurrent treatment with other experimental drugs.",
                        "criterion": "concurrent treatment with experimental drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Participation in another clinical trial with any investigational drug within 30 days prior to study entry",
                        "criterion": "participation in another clinical trial",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* History of significant liver pathology (other than metastases, e.g. cirrhosis of the liver, PSC, PBC) or liver transplantation",
                "criterions": [
                    {
                        "exact_snippets": "History of significant liver pathology (other than metastases, e.g. cirrhosis of the liver, PSC, PBC)",
                        "criterion": "significant liver pathology",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "liver transplantation",
                        "criterion": "liver transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of significant liver pathology (other than metastases, e.g. cirrhosis of the liver, PSC, PBC)",
                                "criterion": "significant liver pathology",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "liver transplantation",
                                "criterion": "liver transplantation",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known hypersensitivity to any component of the EndoTAG®-1 formulation, gadolinium-based MR-contrast media or sulphur hexafluoride",
                "criterions": [
                    {
                        "exact_snippets": "Known hypersensitivity to any component of the EndoTAG®-1 formulation",
                        "criterion": "hypersensitivity to EndoTAG®-1 formulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Known hypersensitivity to ... gadolinium-based MR-contrast media",
                        "criterion": "hypersensitivity to gadolinium-based MR-contrast media",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Known hypersensitivity to ... sulphur hexafluoride",
                        "criterion": "hypersensitivity to sulphur hexafluoride",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known hypersensitivity to any component of the EndoTAG®-1 formulation",
                                "criterion": "hypersensitivity to EndoTAG®-1 formulation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known hypersensitivity to ... gadolinium-based MR-contrast media",
                                "criterion": "hypersensitivity to gadolinium-based MR-contrast media",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known hypersensitivity to ... sulphur hexafluoride",
                                "criterion": "hypersensitivity to sulphur hexafluoride",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}