{
    "info": {
        "nct_id": "NCT04211727",
        "official_title": "Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System",
        "inclusion_criteria": "* Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle\n* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care\n* Can provide written informed consent\n* Cohort 2 only- Able to independently complete participant questionnaires\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Receiving systemic anti-cancer therapy for a haematological malignancy\n* Known parasitic infection\n* Known inherited or acquired bleeding disorder\n* History of haematological malignancy\n* Known poorly controlled anti-coagulation\n* Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle",
                "criterions": [
                    {
                        "exact_snippets": "Age >18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Currently receiving standard of care systemic anti-cancer therapy",
                        "criterion": "systemic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "currently receiving"
                        }
                    },
                    {
                        "exact_snippets": "solid organ malignancy",
                        "criterion": "solid organ malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has received at least one cycle",
                        "criterion": "anti-cancer therapy cycle",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cycle"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age >18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Currently receiving standard of care systemic anti-cancer therapy",
                        "criterion": "systemic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "currently receiving"
                        }
                    },
                    {
                        "exact_snippets": "solid organ malignancy",
                        "criterion": "solid organ malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has received at least one cycle",
                        "criterion": "anti-cancer therapy cycle",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cycle"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care",
                "criterions": [
                    {
                        "exact_snippets": "Scheduled to be undergoing routine venous laboratory blood tests",
                        "criterion": "venous laboratory blood tests",
                        "requirement": {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Scheduled to be undergoing routine venous laboratory blood tests",
                        "criterion": "venous laboratory blood tests",
                        "requirement": {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Can provide written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Can provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Can provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Cohort 2 only- Able to independently complete participant questionnaires",
                "criterions": [
                    {
                        "exact_snippets": "Able to independently complete participant questionnaires",
                        "criterion": "ability to complete participant questionnaires",
                        "requirement": {
                            "requirement_type": "independence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Cohort 2 only",
                    "criterion": "cohort",
                    "requirement": {
                        "requirement_type": "membership",
                        "expected_value": "Cohort 2"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Able to independently complete participant questionnaires",
                    "criterion": "ability to complete participant questionnaires",
                    "requirement": {
                        "requirement_type": "independence",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Receiving systemic anti-cancer therapy for a haematological malignancy",
                "criterions": [
                    {
                        "exact_snippets": "Receiving systemic anti-cancer therapy",
                        "criterion": "systemic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "haematological malignancy",
                        "criterion": "haematological malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Receiving systemic anti-cancer therapy",
                        "criterion": "systemic anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "haematological malignancy",
                        "criterion": "haematological malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known parasitic infection",
                "criterions": [
                    {
                        "exact_snippets": "Known parasitic infection",
                        "criterion": "parasitic infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known parasitic infection",
                    "criterion": "parasitic infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known inherited or acquired bleeding disorder",
                "criterions": [
                    {
                        "exact_snippets": "Known inherited or acquired bleeding disorder",
                        "criterion": "bleeding disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known inherited or acquired bleeding disorder",
                        "criterion": "bleeding disorder",
                        "requirement": {
                            "requirement_type": "inheritance",
                            "expected_value": [
                                "inherited",
                                "acquired"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known inherited or acquired bleeding disorder",
                        "criterion": "bleeding disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known inherited or acquired bleeding disorder",
                        "criterion": "bleeding disorder",
                        "requirement": {
                            "requirement_type": "inheritance",
                            "expected_value": [
                                "inherited",
                                "acquired"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of haematological malignancy",
                "criterions": [
                    {
                        "exact_snippets": "History of haematological malignancy",
                        "criterion": "haematological malignancy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of haematological malignancy",
                    "criterion": "haematological malignancy",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known poorly controlled anti-coagulation",
                "criterions": [
                    {
                        "exact_snippets": "Known poorly controlled anti-coagulation",
                        "criterion": "anti-coagulation",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known poorly controlled anti-coagulation",
                    "criterion": "anti-coagulation",
                    "requirement": {
                        "requirement_type": "control",
                        "expected_value": "poorly controlled"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result",
                "criterions": [
                    {
                        "exact_snippets": "Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result",
                        "criterion": "ability to perform fine manipulation",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Cohort 2 only",
                    "criterion": "cohort",
                    "requirement": {
                        "requirement_type": "group",
                        "expected_value": "2"
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result",
                        "criterion": "ability to perform fine manipulation",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                },
                "else_criteria": null
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}