[96a5a0]: / output / allTrials / identified / NCT05367076_identified.json

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{
"info": {
"nct_id": "NCT05367076",
"official_title": "Development of a Web-based Exercise Training Program for Brain Repair and Cognitive Recovery for Paediatric Brain Tumour Survivors in the Community: a Feasibility Study",
"inclusion_criteria": "1. Between 6 years and 17 years and 11 months of age at time of enrollment\n2. Diagnosed with a brain tumour\n3. 1 to 15 years between diagnosis and time of study enrollment\n4. Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist\n5. Either declare English as their native language or have at least two years of schooling in English at the time of their first assessment\n6. Have a parent or legal guardian willing to complete the Health and Quality of Life measures\n7. Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardians\nHealthy volunteers allowed\nMust have minimum age of 6 Years\nMust have maximum age of 18 Years",
"exclusion_criteria": "1. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk\n2. Diagnosed with a neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability prior to initial brain tumour diagnosis that would preclude safe participation\n3. Receiving palliative care\n4. Require sedation for neuroimaging\n5. Have ferrous metal implants (i.e. cochlear implant, braces, etc.)\n6. Have a programmable shunt\n7. Pregnant\n8. Completed any prior cognitive rehabilitation intervention within three months of enrollment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Between 6 years and 17 years and 11 months of age at time of enrollment",
"criterions": [
{
"exact_snippets": "Between 6 years and 17 years and 11 months of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "years"
},
{
"operator": "<=",
"value": 17.9167,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "2. Diagnosed with a brain tumour",
"criterions": [
{
"exact_snippets": "Diagnosed with a brain tumour",
"criterion": "brain tumour",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "3. 1 to 15 years between diagnosis and time of study enrollment",
"criterions": [
{
"exact_snippets": "1 to 15 years between diagnosis and time of study enrollment",
"criterion": "time since diagnosis",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "years"
},
{
"operator": "<=",
"value": 15,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "4. Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist",
"criterions": [
{
"exact_snippets": "Medically stable (i.e. must be in remission)",
"criterion": "medical stability",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "remission"
}
]
},
{
"exact_snippets": "as determined by a permanent SickKids staff Neuro-Oncologist",
"criterion": "determination by Neuro-Oncologist",
"requirements": [
{
"requirement_type": "authority",
"expected_value": "permanent SickKids staff Neuro-Oncologist"
}
]
}
]
},
{
"line": "5. Either declare English as their native language or have at least two years of schooling in English at the time of their first assessment",
"criterions": [
{
"exact_snippets": "declare English as their native language",
"criterion": "native language",
"requirements": [
{
"requirement_type": "language",
"expected_value": "English"
}
]
},
{
"exact_snippets": "at least two years of schooling in English",
"criterion": "schooling in English",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
]
}
]
},
{
"line": "6. Have a parent or legal guardian willing to complete the Health and Quality of Life measures",
"criterions": [
{
"exact_snippets": "Have a parent or legal guardian willing to complete the Health and Quality of Life measures",
"criterion": "parent or legal guardian willingness",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "7. Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardians",
"criterions": [
{
"exact_snippets": "Informed consent (and assent, where applicable) will be obtained",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "assent, where applicable",
"criterion": "assent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"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 6 Years",
"criterions": [
{
"exact_snippets": "minimum age of 6 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 6,
"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": "1. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk",
"criterions": [
{
"exact_snippets": "Any condition or diagnosis, that could ... interfere with the participant's ability to comply with study instructions",
"criterion": "condition or diagnosis",
"requirements": [
{
"requirement_type": "interference with compliance",
"expected_value": true
}
]
},
{
"exact_snippets": "Any condition or diagnosis, that could ... confound the interpretation of the study results",
"criterion": "condition or diagnosis",
"requirements": [
{
"requirement_type": "confounding interpretation",
"expected_value": true
}
]
},
{
"exact_snippets": "Any condition or diagnosis, that could ... put the participant at risk",
"criterion": "condition or diagnosis",
"requirements": [
{
"requirement_type": "risk to participant",
"expected_value": true
}
]
}
]
},
{
"line": "2. Diagnosed with a neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability prior to initial brain tumour diagnosis that would preclude safe participation",
"criterions": [
{
"exact_snippets": "Diagnosed with a neurodevelopmental or neurological disorder",
"criterion": "neurodevelopmental or neurological disorder",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "Diagnosed with ... cerebral palsy",
"criterion": "cerebral palsy",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "Diagnosed with ... developmental delay",
"criterion": "developmental delay",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "Diagnosed with ... learning disability",
"criterion": "learning disability",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "3. Receiving palliative care",
"criterions": [
{
"exact_snippets": "Receiving palliative care",
"criterion": "palliative care",
"requirements": [
{
"requirement_type": "receiving",
"expected_value": true
}
]
}
]
},
{
"line": "4. Require sedation for neuroimaging",
"criterions": [
{
"exact_snippets": "Require sedation for neuroimaging",
"criterion": "sedation for neuroimaging",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "5. Have ferrous metal implants (i.e. cochlear implant, braces, etc.)",
"criterions": [
{
"exact_snippets": "Have ferrous metal implants (i.e. cochlear implant, braces, etc.)",
"criterion": "ferrous metal implants",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "6. Have a programmable shunt",
"criterions": [
{
"exact_snippets": "Have a programmable shunt",
"criterion": "programmable shunt",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "7. Pregnant",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "8. Completed any prior cognitive rehabilitation intervention within three months of enrollment",
"criterions": [
{
"exact_snippets": "Completed any prior cognitive rehabilitation intervention",
"criterion": "prior cognitive rehabilitation intervention",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
},
{
"exact_snippets": "within three months of enrollment",
"criterion": "time since prior cognitive rehabilitation intervention",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}