{
    "info": {
        "nct_id": "NCT01666782",
        "official_title": "A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy",
        "inclusion_criteria": "1. 18 years old to less than 65 years old\n2. Subjects with malignancy must be receiving chemotherapy\n3. Medically stable\n4. Able to understand and willingness to sign a written informed consent\n5. Able to comply with study procedures\n6. Life expectancy of more than 3 months\n7. Adequate organ function:\n\n   * ANC >1000/mm3\n   * Platelet >100,000/uL\n   * Creatinine <2 mg/dL\n   * AST and ALT <3 times the ULN\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 64 Years",
        "exclusion_criteria": "1. Allergy to eggs\n2. Prior allergy to Influenza Vaccine\n3. History of Guillain-Barre Syndrome\n4. Current febrile illness\n5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)\n6. Autologous or Allogenic Stem Cell Transplant with in a year\n7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. 18 years old to less than 65 years old",
            "criterions": [
                {
                    "exact_snippets": "18 years old to less than 65 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subjects with malignancy must be receiving chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Subjects with malignancy must be receiving chemotherapy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Medically stable",
            "criterions": [
                {
                    "exact_snippets": "Medically stable",
                    "criterion": "medical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Able to understand and willingness to sign a written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent",
                    "criterion": "consent willingness",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Able to comply with study procedures",
            "criterions": [
                {
                    "exact_snippets": "Able to comply with study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Life expectancy of more than 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of more than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate organ function:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC >1000/mm3",
            "criterions": [
                {
                    "exact_snippets": "ANC >1000/mm3",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet >100,000/uL",
            "criterions": [
                {
                    "exact_snippets": "Platelet >100,000/uL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "uL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine <2 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine <2 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT <3 times the ULN",
            "criterions": [
                {
                    "exact_snippets": "AST ... <3 times the ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times the ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT <3 times the ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times the ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 64 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 64 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 64,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Allergy to eggs",
            "criterions": [
                {
                    "exact_snippets": "Allergy to eggs",
                    "criterion": "egg allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior allergy to Influenza Vaccine",
            "criterions": [
                {
                    "exact_snippets": "Prior allergy to Influenza Vaccine",
                    "criterion": "allergy to Influenza Vaccine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. History of Guillain-Barre Syndrome",
            "criterions": [
                {
                    "exact_snippets": "History of Guillain-Barre Syndrome",
                    "criterion": "Guillain-Barre Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Current febrile illness",
            "criterions": [
                {
                    "exact_snippets": "Current febrile illness",
                    "criterion": "febrile illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)",
            "criterions": [
                {
                    "exact_snippets": "Other immunosuppressive disease",
                    "criterion": "immunosuppressive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recipients of solid organ transplant",
                    "criterion": "solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "recipient status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Autologous or Allogenic Stem Cell Transplant with in a year",
            "criterions": [
                {
                    "exact_snippets": "Autologous or Allogenic Stem Cell Transplant with in a year",
                    "criterion": "stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "autologous",
                                "allogenic"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within a year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)",
            "criterions": [
                {
                    "exact_snippets": "Current immunotherapy or immunochemotherapy",
                    "criterion": "immunotherapy or immunochemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "in the last 6 months",
                    "criterion": "immunotherapy or immunochemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(rituximab or ofatumumab)",
                    "criterion": "specific drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "rituximab",
                                "ofatumumab"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}