{
    "info": {
        "nct_id": "NCT02443831",
        "official_title": "Immunotherapy With CD19/22 CAR Redirected T-cells for High Risk, Relapsed Paediatric CD19+ and/or CD22+ Acute Lymphoblastic Leukaemia and Other Haematological Malignancies",
        "inclusion_criteria": "1. Children and young adults (age 24 years or younger) with high risk/relapsed CD19+ and / or CD22+ haematological malignancy:\n\n   A) Resistant disease (>5% blasts) at end of UKALL 2019 guidelines or equivalent induction B) ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD >10-4 at week 14 UKALL2019 guidelines or equivalent).\n\n   C) High risk infant ALL (age < 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count > 300 x 109/L or poor steroid early response (i.e. circulating blast count >1x109/L following 7 day steroid pre-phase of induction as per national guidelines or equivalent) D) Intermediate risk infant ALL with MRD > 10-3 at end of induction following national guidelines or equivalent) E) High risk 1st relapse (as defined by updated IntreALL 2019 classification: bone marrow or combined relapse within 30 months of diagnosis OR any relapse within 18 months of diagnosis) F) Standard risk relapse in patients with high risk cytogenetics (defined as BCR-ABL, KMT2A rearrangement, near-haploidy (<30 chromosomes) and low hypodiploidy (30-39 chromosomes), iAMP21 and TCF3-HLF translocations).\n\n   G) Standard risk relapse with bone marrow minimal residual disease (MRD) > 10-3 at end of re-induction H) Any on therapy relapse in patients age 16-24 I) Any relapse of infant ALL J) ALL post ≥ 2nd relapse K) Any refractory relapse of ALL (defined as > 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy) L) ALL with MRD >10-4 prior to planned stem cell transplant M) Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant N) Any relapse of ALL after stem cell transplant O) Any relapse of Burkitt's or other CD19+ and/or CD22+lymphoma Note patients with isolated CNS relapse meeting one or more of the criteria above are eligible for the study\n2. Agreement to have a pregnancy test, use adequate contraception (if applicable)\n3. Written informed consent\nHealthy volunteers allowed\nMust have maximum age of 24 Years",
        "exclusion_criteria": "* Exclusion Criteria for registration:\n\n  1. Active Hepatitis B, C or HIV infection\n  2. Oxygen saturation ≤ 90% on air\n  3. Bilirubin > 3 x upper limit of normal\n  4. Creatinine > 3 x upper limit of normal\n  5. Women who are pregnant or breastfeeding\n  6. Stem Cell Transplant patients only: active significant (overall Grade ≥ II, Seattle criteria) acute GVHD or moderate/ severe chronic GVHD (NIH consensus criteria) requiring systemic steroids.\n  7. Inability to tolerate leucapheresis\n  8. Karnofsky (age ≥ 10 years) or Lansky (age < 10) score ≤ 50%\n  9. Pre-existing significant neurological disorder (other than CNS involvement of underlying haematological malignancy)\n\nExclusion criteria for CD19/22CAR T-cell infusion:\n\n1. Severe intercurrent infection at the time of scheduled CD19/22 CAR T-cell infusion\n2. Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19/22 CAR T-cell infusion\n3. Allogeneic transplant recipients with active significant acute GVHD overall grade ≥II or moderate/severe chronic GVHD requiring systemic steroids at the time of scheduled CD19/22 CAR T-cell infusion. Note: Such patients will be excluded until the patient is GVHD free and off steroids",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Children and young adults (age 24 years or younger) with high risk/relapsed CD19+ and / or CD22+ haematological malignancy:",
                "criterions": [
                    {
                        "exact_snippets": "Children and young adults (age 24 years or younger)",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "high risk/relapsed CD19+ and / or CD22+ haematological malignancy",
                        "criterion": "haematological malignancy",
                        "requirement": {
                            "requirement_type": "risk status",
                            "expected_value": [
                                "high risk",
                                "relapsed"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "high risk/relapsed CD19+ and / or CD22+ haematological malignancy",
                        "criterion": "haematological malignancy",
                        "requirement": {
                            "requirement_type": "CD19 status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "high risk/relapsed CD19+ and / or CD22+ haematological malignancy",
                        "criterion": "haematological malignancy",
                        "requirement": {
                            "requirement_type": "CD22 status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Children and young adults (age 24 years or younger)",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 24,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "high risk/relapsed CD19+ and / or CD22+ haematological malignancy",
                                        "criterion": "haematological malignancy",
                                        "requirement": {
                                            "requirement_type": "CD19 status",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "high risk/relapsed CD19+ and / or CD22+ haematological malignancy",
                                        "criterion": "haematological malignancy",
                                        "requirement": {
                                            "requirement_type": "CD22 status",
                                            "expected_value": "positive"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "high risk/relapsed CD19+ and / or CD22+ haematological malignancy",
                        "criterion": "haematological malignancy",
                        "requirement": {
                            "requirement_type": "risk status",
                            "expected_value": [
                                "high risk",
                                "relapsed"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "A) Resistant disease (>5% blasts) at end of UKALL 2019 guidelines or equivalent induction B) ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD >10-4 at week 14 UKALL2019 guidelines or equivalent).",
                "criterions": [
                    {
                        "exact_snippets": "Resistant disease (>5% blasts)",
                        "criterion": "resistant disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "% blasts"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALL with persisting high level MRD ... MRD >10-4",
                        "criterion": "MRD level",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.0001,
                                "unit": "MRD"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Resistant disease (>5% blasts)",
                                "criterion": "resistant disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "% blasts"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "end of UKALL 2019 guidelines or equivalent induction",
                                "criterion": "end of induction",
                                "requirement": {
                                    "requirement_type": "guideline",
                                    "expected_value": "UKALL 2019 or equivalent"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "ALL with persisting high level MRD ... MRD >10-4",
                                "criterion": "MRD level",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 0.0001,
                                        "unit": "MRD"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "2nd time point of frontline national protocol (currently MRD >10-4 at week 14 UKALL2019 guidelines or equivalent)",
                                "criterion": "time point",
                                "requirement": {
                                    "requirement_type": "protocol",
                                    "expected_value": "2nd time point of frontline national protocol"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "C) High risk infant ALL (age < 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count > 300 x 109/L or poor steroid early response (i.e. circulating blast count >1x109/L following 7 day steroid pre-phase of induction as per national guidelines or equivalent) D) Intermediate risk infant ALL with MRD > 10-3 at end of induction following national guidelines or equivalent) E) High risk 1st relapse (as defined by updated IntreALL 2019 classification: bone marrow or combined relapse within 30 months of diagnosis OR any relapse within 18 months of diagnosis) F) Standard risk relapse in patients with high risk cytogenetics (defined as BCR-ABL, KMT2A rearrangement, near-haploidy (<30 chromosomes) and low hypodiploidy (30-39 chromosomes), iAMP21 and TCF3-HLF translocations).",
                "criterions": [
                    {
                        "exact_snippets": "age < 6 months at diagnosis",
                        "criterion": "age at diagnosis",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "MLL gene rearrangement",
                        "criterion": "MLL gene rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "presenting white cell count > 300 x 109/L",
                        "criterion": "white cell count",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 300,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "poor steroid early response ... circulating blast count >1x109/L following 7 day steroid pre-phase of induction",
                        "criterion": "steroid early response",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "poor"
                        }
                    },
                    {
                        "exact_snippets": "circulating blast count >1x109/L following 7 day steroid pre-phase of induction",
                        "criterion": "circulating blast count",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "MRD > 10-3 at end of induction",
                        "criterion": "MRD at end of induction",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.001,
                                "unit": ""
                            }
                        }
                    },
                    {
                        "exact_snippets": "bone marrow or combined relapse within 30 months of diagnosis",
                        "criterion": "bone marrow or combined relapse",
                        "requirement": {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any relapse within 18 months of diagnosis",
                        "criterion": "any relapse",
                        "requirement": {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 18,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "high risk cytogenetics (defined as BCR-ABL, KMT2A rearrangement, near-haploidy (<30 chromosomes) and low hypodiploidy (30-39 chromosomes), iAMP21 and TCF3-HLF translocations)",
                        "criterion": "high risk cytogenetics",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "BCR-ABL",
                                "KMT2A rearrangement",
                                "near-haploidy (<30 chromosomes)",
                                "low hypodiploidy (30-39 chromosomes)",
                                "iAMP21",
                                "TCF3-HLF translocations"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "age < 6 months at diagnosis",
                                                "criterion": "age at diagnosis",
                                                "requirement": {
                                                    "requirement_type": "age",
                                                    "expected_value": {
                                                        "operator": "<",
                                                        "value": 6,
                                                        "unit": "months"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "MLL gene rearrangement",
                                                "criterion": "MLL gene rearrangement",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "presenting white cell count > 300 x 109/L",
                                                "criterion": "white cell count",
                                                "requirement": {
                                                    "requirement_type": "count",
                                                    "expected_value": {
                                                        "operator": ">",
                                                        "value": 300,
                                                        "unit": "x 10^9/L"
                                                    }
                                                }
                                            },
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "poor steroid early response ... circulating blast count >1x109/L following 7 day steroid pre-phase of induction",
                                                        "criterion": "steroid early response",
                                                        "requirement": {
                                                            "requirement_type": "response",
                                                            "expected_value": "poor"
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "circulating blast count >1x109/L following 7 day steroid pre-phase of induction",
                                                        "criterion": "circulating blast count",
                                                        "requirement": {
                                                            "requirement_type": "count",
                                                            "expected_value": {
                                                                "operator": ">",
                                                                "value": 1,
                                                                "unit": "x 10^9/L"
                                                            }
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "MRD > 10-3 at end of induction",
                                "criterion": "MRD at end of induction",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 0.001,
                                        "unit": ""
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "bone marrow or combined relapse within 30 months of diagnosis",
                                        "criterion": "bone marrow or combined relapse",
                                        "requirement": {
                                            "requirement_type": "time since diagnosis",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 30,
                                                "unit": "months"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "any relapse within 18 months of diagnosis",
                                        "criterion": "any relapse",
                                        "requirement": {
                                            "requirement_type": "time since diagnosis",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 18,
                                                "unit": "months"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "high risk cytogenetics (defined as BCR-ABL, KMT2A rearrangement, near-haploidy (<30 chromosomes) and low hypodiploidy (30-39 chromosomes), iAMP21 and TCF3-HLF translocations)",
                                "criterion": "high risk cytogenetics",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "BCR-ABL",
                                        "KMT2A rearrangement",
                                        "near-haploidy (<30 chromosomes)",
                                        "low hypodiploidy (30-39 chromosomes)",
                                        "iAMP21",
                                        "TCF3-HLF translocations"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "G) Standard risk relapse with bone marrow minimal residual disease (MRD) > 10-3 at end of re-induction H) Any on therapy relapse in patients age 16-24 I) Any relapse of infant ALL J) ALL post ≥ 2nd relapse K) Any refractory relapse of ALL (defined as > 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy) L) ALL with MRD >10-4 prior to planned stem cell transplant M) Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant N) Any relapse of ALL after stem cell transplant O) Any relapse of Burkitt's or other CD19+ and/or CD22+lymphoma Note patients with isolated CNS relapse meeting one or more of the criteria above are eligible for the study",
                "criterions": [
                    {
                        "exact_snippets": "Standard risk relapse with bone marrow minimal residual disease (MRD) > 10-3",
                        "criterion": "standard risk relapse with bone marrow MRD",
                        "requirement": {
                            "requirement_type": "MRD level",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.001,
                                "unit": ""
                            }
                        }
                    },
                    {
                        "exact_snippets": "on therapy relapse in patients age 16-24",
                        "criterion": "on therapy relapse",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 16,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "relapse of infant ALL",
                        "criterion": "relapse of infant ALL",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ALL post ≥ 2nd relapse",
                        "criterion": "ALL post relapse",
                        "requirement": {
                            "requirement_type": "number of relapses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": ""
                            }
                        }
                    },
                    {
                        "exact_snippets": "refractory relapse of ALL (defined as > 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy)",
                        "criterion": "refractory relapse of ALL",
                        "requirement": {
                            "requirement_type": "blasts by flow cytometry",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALL with MRD >10-4 prior to planned stem cell transplant",
                        "criterion": "ALL with MRD prior to planned stem cell transplant",
                        "requirement": {
                            "requirement_type": "MRD level",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.0001,
                                "unit": ""
                            }
                        }
                    },
                    {
                        "exact_snippets": "relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant",
                        "criterion": "relapse of ALL eligible for stem cell transplant",
                        "requirement": {
                            "requirement_type": "HLA matched donor availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant",
                        "criterion": "relapse of ALL eligible for stem cell transplant",
                        "requirement": {
                            "requirement_type": "contraindication to transplant",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "relapse of ALL after stem cell transplant",
                        "criterion": "relapse of ALL after stem cell transplant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "relapse of Burkitt's or other CD19+ and/or CD22+lymphoma",
                        "criterion": "relapse of Burkitt's or other CD19+ and/or CD22+ lymphoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant",
                                        "criterion": "relapse of ALL eligible for stem cell transplant",
                                        "requirement": {
                                            "requirement_type": "HLA matched donor availability",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant",
                                        "criterion": "relapse of ALL eligible for stem cell transplant",
                                        "requirement": {
                                            "requirement_type": "contraindication to transplant",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "relapse of ALL after stem cell transplant",
                                "criterion": "relapse of ALL after stem cell transplant",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "relapse of Burkitt's or other CD19+ and/or CD22+lymphoma",
                                "criterion": "relapse of Burkitt's or other CD19+ and/or CD22+ lymphoma",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Standard risk relapse with bone marrow minimal residual disease (MRD) > 10-3",
                        "criterion": "standard risk relapse with bone marrow MRD",
                        "requirement": {
                            "requirement_type": "MRD level",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.001,
                                "unit": ""
                            }
                        }
                    },
                    {
                        "exact_snippets": "on therapy relapse in patients age 16-24",
                        "criterion": "on therapy relapse",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 16,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "relapse of infant ALL",
                        "criterion": "relapse of infant ALL",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ALL post ≥ 2nd relapse",
                        "criterion": "ALL post relapse",
                        "requirement": {
                            "requirement_type": "number of relapses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": ""
                            }
                        }
                    },
                    {
                        "exact_snippets": "refractory relapse of ALL (defined as > 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy)",
                        "criterion": "refractory relapse of ALL",
                        "requirement": {
                            "requirement_type": "blasts by flow cytometry",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALL with MRD >10-4 prior to planned stem cell transplant",
                        "criterion": "ALL with MRD prior to planned stem cell transplant",
                        "requirement": {
                            "requirement_type": "MRD level",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.0001,
                                "unit": ""
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Agreement to have a pregnancy test, use adequate contraception (if applicable)",
                "criterions": [
                    {
                        "exact_snippets": "Agreement to have a pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "use adequate contraception (if applicable)",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
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                "line": "* Exclusion Criteria for registration:",
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}