{
    "info": {
        "nct_id": "NCT00001582",
        "official_title": "Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Pregnant women will not be eligible for any aspect of this protocol.\n\nExclusion Criteria for Apheresis Alone:\n\nAny diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the participant should not have any of the following:\n\n1. Congestive Heart Failure\n2. History of angina\n3. Severe hypotension (at the discretion of the participant's physician, the apheresis staff and the attending physician from the Department of Transfusion Medicine (DTM) per DTM Standard Operating Policies.)\n4. Poorly controlled hypertension (average baseline blood pressure greater than 160/90)\n5. History of a coagulation protein disorder.\n\nPediatric patients (less than 18 years) will not undergo apheresis.",
        "miscellaneous_criteria": "* INCLUSION CRITERIA:\n\nParticipants must meet at least one of these criteria:\n\nHave suspected or known disorder of the immune system or cancer\n\nBe a known or potential carrier of autoimmune disorder or immunodeficiency disease. Specific disorders may include but are not limited to:\n\n* X-linked (severe combined immunodeficiency)\n* Autosomal recessive SCID\n* X-linked CD40 ligand deficiency\n* Common variable immunodeficiency\n* Ataxia-telangiectasia\n* Wiskott Aldrich syndrome\n* DiGeorge syndrome\n* Infection with HTLV-1\n\nAge greater than or equal to 18 years.\n\nParticipant must be able to understand and sign informed consent.\n\nParticipants who will undergo apheresis must have hematocrit greater than 28%, and platelet count greater than 50,000.\n\nSubjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a Department of Transfusion Medicine consult physician.\n\nWeight greater than 25 kg is necessary for apheresis.\n\nEXCLUSION CRITERIA:\n\nOverall"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "Pregnant women will not be eligible for any aspect of this protocol.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women will not be eligible",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the participant should not have any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Any diagnosed medical condition which may be worsened by the apheresis procedure.",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "worsened by apheresis",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Congestive Heart Failure",
            "criterions": [
                {
                    "exact_snippets": "Congestive Heart Failure",
                    "criterion": "Congestive Heart Failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of angina",
            "criterions": [
                {
                    "exact_snippets": "History of angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Severe hypotension (at the discretion of the participant's physician, the apheresis staff and the attending physician from the Department of Transfusion Medicine (DTM) per DTM Standard Operating Policies.)",
            "criterions": [
                {
                    "exact_snippets": "Severe hypotension",
                    "criterion": "hypotension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Poorly controlled hypertension (average baseline blood pressure greater than 160/90)",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "average baseline blood pressure greater than 160/90",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "average baseline",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 160,
                                        "unit": "mmHg"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 90,
                                        "unit": "mmHg"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of a coagulation protein disorder.",
            "criterions": [
                {
                    "exact_snippets": "History of a coagulation protein disorder",
                    "criterion": "coagulation protein disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pediatric patients (less than 18 years) will not undergo apheresis.",
            "criterions": [
                {
                    "exact_snippets": "Pediatric patients (less than 18 years)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "will not undergo apheresis",
                    "criterion": "apheresis",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Have suspected or known disorder of the immune system or cancer",
            "criterions": [
                {
                    "exact_snippets": "suspected or known disorder of the immune system",
                    "criterion": "disorder of the immune system",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suspected or known ... cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Be a known or potential carrier of autoimmune disorder or immunodeficiency disease. Specific disorders may include but are not limited to:",
            "criterions": [
                {
                    "exact_snippets": "Be a known or potential carrier of autoimmune disorder",
                    "criterion": "autoimmune disorder",
                    "requirements": [
                        {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Be a known or potential carrier of ... immunodeficiency disease",
                    "criterion": "immunodeficiency disease",
                    "requirements": [
                        {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* X-linked (severe combined immunodeficiency)",
            "criterions": [
                {
                    "exact_snippets": "X-linked (severe combined immunodeficiency)",
                    "criterion": "X-linked severe combined immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Autosomal recessive SCID",
            "criterions": [
                {
                    "exact_snippets": "Autosomal recessive SCID",
                    "criterion": "SCID",
                    "requirements": [
                        {
                            "requirement_type": "inheritance pattern",
                            "expected_value": "autosomal recessive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* X-linked CD40 ligand deficiency",
            "criterions": [
                {
                    "exact_snippets": "X-linked CD40 ligand deficiency",
                    "criterion": "X-linked CD40 ligand deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Common variable immunodeficiency",
            "criterions": [
                {
                    "exact_snippets": "Common variable immunodeficiency",
                    "criterion": "common variable immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ataxia-telangiectasia",
            "criterions": [
                {
                    "exact_snippets": "Ataxia-telangiectasia",
                    "criterion": "Ataxia-telangiectasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Wiskott Aldrich syndrome",
            "criterions": [
                {
                    "exact_snippets": "Wiskott Aldrich syndrome",
                    "criterion": "Wiskott Aldrich syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DiGeorge syndrome",
            "criterions": [
                {
                    "exact_snippets": "DiGeorge syndrome",
                    "criterion": "DiGeorge syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Infection with HTLV-1",
            "criterions": [
                {
                    "exact_snippets": "Infection with HTLV-1",
                    "criterion": "HTLV-1 infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age greater than or equal to 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age greater than or equal to 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Participant must be able to understand and sign informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Participant must be able to understand",
                    "criterion": "understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign informed consent",
                    "criterion": "informed consent signing",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Participants who will undergo apheresis must have hematocrit greater than 28%, and platelet count greater than 50,000.",
            "criterions": [
                {
                    "exact_snippets": "hematocrit greater than 28%",
                    "criterion": "hematocrit",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count greater than 50,000",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50000,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a Department of Transfusion Medicine consult physician.",
            "criterions": [
                {
                    "exact_snippets": "apheresis is desired",
                    "criterion": "apheresis",
                    "requirements": [
                        {
                            "requirement_type": "desire",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "counts are lower than those above",
                    "criterion": "counts",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "lower than those above"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Weight greater than 25 kg is necessary for apheresis.",
            "criterions": [
                {
                    "exact_snippets": "Weight greater than 25 kg",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "kg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "apheresis",
                    "criterion": "apheresis",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Overall",
            "criterions": [
                {
                    "exact_snippets": "Overall",
                    "criterion": "overall health",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Exclusion Criteria for Apheresis Alone:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "Participants must meet at least one of these criteria:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}