{
    "info": {
        "nct_id": "NCT01221857",
        "official_title": "Allogeneic Stem Cell Transplantation of NiCord®, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Combination With a Second, Unmanipulated Cord Blood Unit in Patients With Hematological Malignancies",
        "inclusion_criteria": "* Applicable disease and eligible for myeloablative SCT\n* Patients must have two partially HLA-matched CBUs\n* Back-up stem cell source\n* Adequate Karnofsky Performance score or Lansky Play-Performance scale\n* Sufficient physiological reserves\n* Signed written informed consent\nHealthy volunteers allowed\nMust have minimum age of 8 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* HLA-matched related donor able to donate\n* Prior allogeneic HSCT\n* Lymphoma patients with progressive disease\n* Other active malignancy\n* Human immunodeficiency virus (HIV) infection\n* Active or uncontrolled infection\n* Active/symptoms of central nervous system (CNS) disease\n* Pregnancy or lactation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Applicable disease and eligible for myeloablative SCT",
            "criterions": [
                {
                    "exact_snippets": "Applicable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "applicability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for myeloablative SCT",
                    "criterion": "myeloablative SCT eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have two partially HLA-matched CBUs",
            "criterions": [
                {
                    "exact_snippets": "two partially HLA-matched CBUs",
                    "criterion": "HLA-matched CBUs",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "CBUs"
                            }
                        },
                        {
                            "requirement_type": "matching",
                            "expected_value": "partially"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Back-up stem cell source",
            "criterions": [
                {
                    "exact_snippets": "Back-up stem cell source",
                    "criterion": "stem cell source",
                    "requirements": [
                        {
                            "requirement_type": "backup",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate Karnofsky Performance score or Lansky Play-Performance scale",
            "criterions": [
                {
                    "exact_snippets": "Adequate Karnofsky Performance score",
                    "criterion": "Karnofsky Performance score",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... Lansky Play-Performance scale",
                    "criterion": "Lansky Play-Performance scale",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sufficient physiological reserves",
            "criterions": [
                {
                    "exact_snippets": "Sufficient physiological reserves",
                    "criterion": "physiological reserves",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "format",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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 8 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 8 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* HLA-matched related donor able to donate",
            "criterions": [
                {
                    "exact_snippets": "HLA-matched related donor",
                    "criterion": "HLA-matched related donor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to donate",
                    "criterion": "donor ability to donate",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allogeneic HSCT",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic HSCT",
                    "criterion": "allogeneic HSCT",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lymphoma patients with progressive disease",
            "criterions": [
                {
                    "exact_snippets": "Lymphoma patients",
                    "criterion": "lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive disease",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "progressive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other active malignancy",
            "criterions": [
                {
                    "exact_snippets": "Other active malignancy",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV) infection",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "Active or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "uncontrolled"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active/symptoms of central nervous system (CNS) disease",
            "criterions": [
                {
                    "exact_snippets": "Active/symptoms of central nervous system (CNS) disease",
                    "criterion": "central nervous system (CNS) disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or lactation",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}