{
    "info": {
        "nct_id": "NCT01362582",
        "official_title": "Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy",
        "inclusion_criteria": "* Written informed consent\n* Histological confirmed advanced pancreatic adenocarcinoma\n* At least one previous chemotherapy (gemcitabine-based)\n* ≥ 18 years old\n* Body weight ≥ 50 and ≤ 95 kg\n* BMI ≥ 19\n* Negative pregnancy test (females of childbearing potential)\n* Willingness to perform double-barrier contraception during study\n* Expected life expectancy > 3 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Major surgery < 4 weeks prior to enrollment\n* Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days\n* PINI-Index > 10\n* Pregnancy or breastfeeding\n* > 4 weeks of parenteral nutrition within the last 6 months\n* Parenteral nutrition < 4 weeks prior to enrollment\n* Vulnerable populations (e.g. subjects incapable of giving consent personally)\n* Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "criterion": "informed consent",
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                            "expected_value": "written"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histological confirmed advanced pancreatic adenocarcinoma",
                "criterions": [
                    {
                        "exact_snippets": "Histological confirmed advanced pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histological"
                        }
                    },
                    {
                        "exact_snippets": "Histological confirmed advanced pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Histological confirmed advanced pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histological"
                        }
                    },
                    {
                        "exact_snippets": "Histological confirmed advanced pancreatic adenocarcinoma",
                        "criterion": "pancreatic adenocarcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least one previous chemotherapy (gemcitabine-based)",
                "criterions": [
                    {
                        "exact_snippets": "At least one previous chemotherapy (gemcitabine-based)",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "treatment"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one previous chemotherapy (gemcitabine-based)",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "gemcitabine-based"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "At least one previous chemotherapy (gemcitabine-based)",
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                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "treatment"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one previous chemotherapy (gemcitabine-based)",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "gemcitabine-based"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ≥ 18 years old",
                "criterions": [
                    {
                        "exact_snippets": "≥ 18 years old",
                        "criterion": "age",
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                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
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                    {
                        "exact_snippets": "≥ 18 years old",
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                                "value": 18,
                                "unit": "years"
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                        }
                    }
                ]
            }
        },
        {
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                "line": "* Body weight ≥ 50 and ≤ 95 kg",
                "criterions": [
                    {
                        "exact_snippets": "Body weight ≥ 50 and ≤ 95 kg",
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                            "requirement_type": "range",
                            "expected_value": {
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                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "kg"
                                    },
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                                        "unit": "kg"
                                    }
                                ]
                            }
                        }
                    }
                ]
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                    {
                        "exact_snippets": "Body weight ≥ 50 and ≤ 95 kg",
                        "criterion": "body weight",
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                            "expected_value": {
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                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "kg"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 95,
                                        "unit": "kg"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
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                    {
                        "exact_snippets": "BMI ≥ 19",
                        "criterion": "BMI",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "BMI ≥ 19",
                        "criterion": "BMI",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "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"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "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 study",
                "criterions": [
                    {
                        "exact_snippets": "Willingness to perform double-barrier contraception during study",
                        "criterion": "double-barrier contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willingness to perform double-barrier contraception during study",
                        "criterion": "double-barrier contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Expected life expectancy > 3 months",
                "criterions": [
                    {
                        "exact_snippets": "Expected life expectancy > 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Expected life expectancy > 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "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": {
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                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
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                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "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": "* Major surgery < 4 weeks prior to enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery < 4 weeks prior to enrollment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
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                    "criterion": "major surgery",
                    "requirement": {
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                        "expected_value": {
                            "operator": "<",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days",
                "criterions": [
                    {
                        "exact_snippets": "Weight loss > 2% within the last seven days",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Weight loss > 2% within the last seven days",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "time frame",
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                        }
                    },
                    {
                        "exact_snippets": "caloric intake ≤ 500 kcal expected within the next five days",
                        "criterion": "caloric intake",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 500,
                                "unit": "kcal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "caloric intake ≤ 500 kcal expected within the next five days",
                        "criterion": "caloric intake",
                        "requirement": {
                            "requirement_type": "time frame",
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                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Weight loss > 2% within the last seven days",
                                "criterion": "weight loss",
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                                        "value": 2,
                                        "unit": "%"
                                    }
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                            },
                            {
                                "exact_snippets": "Weight loss > 2% within the last seven days",
                                "criterion": "weight loss",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within the last seven days"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "caloric intake ≤ 500 kcal expected within the next five days",
                                "criterion": "caloric intake",
                                "requirement": {
                                    "requirement_type": "quantity",
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                                        "unit": "kcal"
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                            },
                            {
                                "exact_snippets": "caloric intake ≤ 500 kcal expected within the next five days",
                                "criterion": "caloric intake",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "expected within the next five days"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PINI-Index > 10",
                "criterions": [
                    {
                        "exact_snippets": "PINI-Index > 10",
                        "criterion": "PINI-Index",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PINI-Index > 10",
                        "criterion": "PINI-Index",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnancy or breastfeeding",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* > 4 weeks of parenteral nutrition within the last 6 months",
                "criterions": [
                    {
                        "exact_snippets": "parenteral nutrition ... > 4 weeks",
                        "criterion": "parenteral nutrition",
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                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within the last 6 months",
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                        "requirement": {
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                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
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                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within the last 6 months",
                        "criterion": "time frame",
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                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Parenteral nutrition < 4 weeks prior to enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Parenteral nutrition < 4 weeks prior to enrollment",
                        "criterion": "parenteral nutrition",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
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        },
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                        "exact_snippets": "Vulnerable populations (e.g. subjects incapable of giving consent personally)",
                        "criterion": "vulnerable populations",
                        "requirement": {
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                        }
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                            "expected_value": false
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                ]
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            }
        }
    ],
    "failed_miscellaneous": []
}