{
    "info": {
        "nct_id": "NCT05615376",
        "official_title": "Beat to Beat A Prospective Study in Paediatric, Adolescent and Young Adult Patients Aged 7 to 18 Years of Age Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG",
        "inclusion_criteria": "* Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days at the time of consent.\n* Patient age ≥ 7 years at time of eligibility screening\n* If age < 18 years, parent or guardian able to provide consent\n* Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:\n\n  1. iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility.\n  2. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.\n  3. Valid phone number associated with iPhone, ascertained from self-report.\n  4. Valid email address, ascertained from self-report.\n  5. Participants or parents need to be able to press down on the wearable device crown for 30 seconds\nHealthy volunteers allowed\nMust have minimum age of 7 Years\nMust have maximum age of 18 Years",
        "exclusion_criteria": "* Unable to wear the wearable device.\n* < 18 years of age without guardian or parent to provide consent.\n* Interpreter required for consent purposes.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days at the time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Paediatric or adolescent diagnosis of cancer",
                    "criterion": "diagnosis of cancer",
                    "requirements": [
                        {
                            "requirement_type": "age group",
                            "expected_value": [
                                "paediatric",
                                "adolescent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "inpatient of The Royal Children's Hospital, Melbourne",
                    "criterion": "inpatient status",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "The Royal Children's Hospital, Melbourne"
                        }
                    ]
                },
                {
                    "exact_snippets": "inpatient of The Royal Children's Hospital, Melbourne for at least 5 days",
                    "criterion": "inpatient duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient age ≥ 7 years at time of eligibility screening",
            "criterions": [
                {
                    "exact_snippets": "Patient age ≥ 7 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If age < 18 years, parent or guardian able to provide consent",
            "criterions": [
                {
                    "exact_snippets": "age < 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "parent or guardian able to provide consent",
                    "criterion": "parent or guardian consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:",
            "criterions": [
                {
                    "exact_snippets": "Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening",
                    "criterion": "participant age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ascertained from automatic hardware/software/device pairing check",
                    "criterion": "hardware/software/device pairing check",
                    "requirements": [
                        {
                            "requirement_type": "ascertainment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility.",
            "criterions": [
                {
                    "exact_snippets": "iPhone (6s or later)",
                    "criterion": "iPhone model",
                    "requirements": [
                        {
                            "requirement_type": "model",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6.0,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "iOS version 15.0 or later",
                    "criterion": "iOS version",
                    "requirements": [
                        {
                            "requirement_type": "version",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.",
            "criterions": [
                {
                    "exact_snippets": "Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English",
                    "criterion": "English proficiency",
                    "requirements": [
                        {
                            "requirement_type": "self-report",
                            "expected_value": "comfort reading, writing, and speaking English"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Valid phone number associated with iPhone, ascertained from self-report.",
            "criterions": [
                {
                    "exact_snippets": "Valid phone number",
                    "criterion": "phone number",
                    "requirements": [
                        {
                            "requirement_type": "validity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "associated with iPhone",
                    "criterion": "phone number association",
                    "requirements": [
                        {
                            "requirement_type": "device",
                            "expected_value": "iPhone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Valid email address, ascertained from self-report.",
            "criterions": [
                {
                    "exact_snippets": "Valid email address",
                    "criterion": "email address",
                    "requirements": [
                        {
                            "requirement_type": "validity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Participants or parents need to be able to press down on the wearable device crown for 30 seconds",
            "criterions": [
                {
                    "exact_snippets": "Participants or parents need to be able to press down on the wearable device crown for 30 seconds",
                    "criterion": "ability to press down on the wearable device crown",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 30,
                                "unit": "seconds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 7 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 7 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Unable to wear the wearable device.",
            "criterions": [
                {
                    "exact_snippets": "Unable to wear the wearable device",
                    "criterion": "wearable device",
                    "requirements": [
                        {
                            "requirement_type": "ability to wear",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 18 years of age without guardian or parent to provide consent.",
            "criterions": [
                {
                    "exact_snippets": "< 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without guardian or parent to provide consent",
                    "criterion": "guardian or parent consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interpreter required for consent purposes.",
            "criterions": [
                {
                    "exact_snippets": "Interpreter required for consent purposes.",
                    "criterion": "interpreter",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}