{
    "info": {
        "nct_id": "NCT02072811",
        "official_title": "Evaluation of the Efficacy of Induction-consolidation Treatment Using a Double Induction in Patients With AML <60 Years Old, Depending on the Percentage of Blasts in the 14 Day, Residual Disease and Leukemic Hematopoietic Cells",
        "inclusion_criteria": "* Adult acute myeloid leukemia\n* Age: ≥18 and ≤ 60\n* Clinical condition of the patient allows to carry out induction therapy: ECOG performance status: ≤ 2 and the Hematopoietic Cell Transplant-Co-morbidity Index (HCT-I): ≤3\n* Informed consent to participate in the study (ICF signed)\n* The second early induction start criteria is in addition to the listed above, the percentage of the blasts on the level >10% on 7th day.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 60 Years",
        "exclusion_criteria": "* No informed consent for participation in the study, mental illness, which don't allow to obtain informed consent and conduct the treatment according to the protocol\n* Pregnancy\n* HIV infection\n* Active cancer\n* Active hepatitis virus infection",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult acute myeloid leukemia",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adult acute myeloid leukemia"
                    ],
                    "criterion": "acute myeloid leukemia",
                    "requirement_type": "age group",
                    "expected_value": "adult"
                }
            ]
        },
        {
            "line": "* Age: ≥18 and ≤ 60",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age: ≥18 and ≤ 60"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            },
                            {
                                "operator": "<=",
                                "value": 60
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Clinical condition of the patient allows to carry out induction therapy: ECOG performance status: ≤ 2 and the Hematopoietic Cell Transplant-Co-morbidity Index (HCT-I): ≤3",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG performance status: ≤ 2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Hematopoietic Cell Transplant-Co-morbidity Index (HCT-I): ≤3"
                    ],
                    "criterion": "Hematopoietic Cell Transplant-Co-morbidity Index",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Informed consent to participate in the study (ICF signed)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Informed consent to participate in the study",
                        "ICF signed"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "signed",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* The second early induction start criteria is in addition to the listed above, the percentage of the blasts on the level >10% on 7th day.",
            "criterions": [
                {
                    "exact_snippets": [
                        "percentage of the blasts",
                        "level >10%",
                        "on 7th day"
                    ],
                    "criterion": "blasts",
                    "requirement_type": "percentage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 10
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 60 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 60 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 60
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* No informed consent for participation in the study, mental illness, which don't allow to obtain informed consent and conduct the treatment according to the protocol",
            "criterions": [
                {
                    "exact_snippets": [
                        "No informed consent for participation in the study"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "mental illness"
                    ],
                    "criterion": "mental illness",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* HIV infection",
            "criterions": [
                {
                    "exact_snippets": [
                        "HIV infection"
                    ],
                    "criterion": "HIV infection",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Active cancer",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active cancer"
                    ],
                    "criterion": "cancer",
                    "requirement_type": "activity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Active hepatitis virus infection",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active hepatitis virus infection"
                    ],
                    "criterion": "hepatitis virus infection",
                    "requirement_type": "activity",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}