{
    "info": {
        "nct_id": "NCT05888701",
        "official_title": "\"Don't Eat me\" Signal in Hematological Malignancies: CD24 as New Target to Improve Anti-cancer Immunity.",
        "inclusion_criteria": "Patient inclusion criteria:\n\n* Signed and dated EC-approved informed consent\n* Diagnosis of Mantle-cell Lymphoma (MCL) or B-cell Chronic Lymphocytic Leukemia (CLL) defined according to World Health Organization (WHO) criteria.\n* Female or male, 18 years of age or older.\n* ECOG performance status 0-3.\n* Willingness and ability to comply with routine clinical practice and study procedures.\n\nDonors inclusion criteria:\n\n* Signed and dated EC-approved informed consent.\n* Healthy volunteers agreed to undergo plateletpheresis.\n* Female or male, 18 years of age or older.\n* Willingness and ability to comply with Transfusion Medicine clinical practice and study procedures.\n\nExclusion Criteria\n\nPatient exclusion criteria:\n\n* Other hematological diseases defined by WHO criteria different from MCL and CLL.\n* Previous treatment regimens that included allogeneic stem cell transplantation (ASCT).\n\nDonors exclusion criteria:\n\n-Healthy volunteers agreed to perform any kind of donations with the exception of plateletpheresis.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Signed and dated EC-approved informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed and dated EC-approved informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dated",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "EC-approved",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of Mantle-cell Lymphoma (MCL) or B-cell Chronic Lymphocytic Leukemia (CLL) defined according to World Health Organization (WHO) criteria.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of Mantle-cell Lymphoma (MCL)",
                    "criterion": "Mantle-cell Lymphoma (MCL)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... B-cell Chronic Lymphocytic Leukemia (CLL)",
                    "criterion": "B-cell Chronic Lymphocytic Leukemia (CLL)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female or male, 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "Female or male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "female",
                                "male"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-3.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-3",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willingness and ability to comply with routine clinical practice and study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Willingness and ability to comply with routine clinical practice and study procedures.",
                    "criterion": "compliance with routine clinical practice and study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed and dated EC-approved informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed and dated EC-approved informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed and dated"
                        },
                        {
                            "requirement_type": "approval",
                            "expected_value": "EC-approved"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Healthy volunteers agreed to undergo plateletpheresis.",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "health status",
                            "expected_value": "healthy"
                        }
                    ]
                },
                {
                    "exact_snippets": "agreed to undergo plateletpheresis",
                    "criterion": "consent to plateletpheresis",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female or male, 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "Female or male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "female",
                                "male"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willingness and ability to comply with Transfusion Medicine clinical practice and study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Willingness ... to comply with Transfusion Medicine clinical practice and study procedures.",
                    "criterion": "willingness to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to comply with Transfusion Medicine clinical practice and study procedures.",
                    "criterion": "ability to comply",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other hematological diseases defined by WHO criteria different from MCL and CLL.",
            "criterions": [
                {
                    "exact_snippets": "Other hematological diseases defined by WHO criteria",
                    "criterion": "hematological diseases",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "WHO criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "different from MCL and CLL",
                    "criterion": "hematological diseases",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "MCL",
                                "CLL"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous treatment regimens that included allogeneic stem cell transplantation (ASCT).",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment regimens that included allogeneic stem cell transplantation (ASCT)",
                    "criterion": "previous treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "allogeneic stem cell transplantation (ASCT)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "-Healthy volunteers agreed to perform any kind of donations with the exception of plateletpheresis.",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "health status",
                            "expected_value": "healthy"
                        }
                    ]
                },
                {
                    "exact_snippets": "agreed to perform any kind of donations",
                    "criterion": "willingness to donate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of plateletpheresis",
                    "criterion": "type of donation",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "plateletpheresis"
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Patient inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Donors inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        },
        {
            "line": "Patient exclusion criteria:",
            "criterions": []
        },
        {
            "line": "Donors exclusion criteria:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}