{
    "info": {
        "nct_id": "NCT00664482",
        "official_title": "A Single-Patient Study Using AGS 006 as an Immunotherapeutic in a Subject With Newly Diagnosed Resectable Pancreatic Cancer",
        "inclusion_criteria": "* A male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply:\n\n  1. Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.\n  2. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.\n  3. Voluntary informed consent given to participate in the study.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.\n2. Active autoimmune disease including, but not limited to:\n3. Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis.\n4. Known hypersensitivity to dimethyl sulfoxide (DMSO).\n5. Body weight less than 30 kg.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* A male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply:",
            "criterions": [
                {
                    "exact_snippets": "male subject",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "newly diagnosed resectable pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.",
            "criterions": [
                {
                    "exact_snippets": "Able to abstain from taking prohibited prescription ... drugs.",
                    "criterion": "abstinence from prohibited prescription drugs",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to abstain from taking ... prohibited non-prescription drugs.",
                    "criterion": "abstinence from prohibited non-prescription drugs",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.",
            "criterions": [
                {
                    "exact_snippets": "Ability to communicate effectively with study personnel",
                    "criterion": "communication ability",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered reliable",
                    "criterion": "reliability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing",
                    "criterion": "willingness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cooperative in terms of compliance with the Protocol requirements",
                    "criterion": "cooperativeness",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Voluntary informed consent given to participate in the study.",
            "criterions": [
                {
                    "exact_snippets": "Voluntary informed consent given",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "MALE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.",
            "criterions": [
                {
                    "exact_snippets": "serious medical condition such as cardiopulmonary disease",
                    "criterion": "cardiopulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious medical condition such as ... circulatory compromise",
                    "criterion": "circulatory compromise",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious medical condition such as ... hepatic ... dysfunction",
                    "criterion": "hepatic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious medical condition such as ... renal dysfunction",
                    "criterion": "renal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious medical condition such as ... other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment",
                    "criterion": "other illness",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "unwarranted high risk for investigational treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Active autoimmune disease including, but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis.",
            "criterions": [
                {
                    "exact_snippets": "Active, acute, or chronic clinically significant infections",
                    "criterion": "clinically significant infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "viral hepatitis",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Known hypersensitivity to dimethyl sulfoxide (DMSO).",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to dimethyl sulfoxide (DMSO).",
                    "criterion": "hypersensitivity to dimethyl sulfoxide (DMSO)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Body weight less than 30 kg.",
            "criterions": [
                {
                    "exact_snippets": "Body weight less than 30 kg.",
                    "criterion": "body weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}