{
    "info": {
        "nct_id": "NCT05186948",
        "official_title": "Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)",
        "inclusion_criteria": "* For all participants:\n\n  1. Able to provide informed consent.\n  2. Visual acuity sufficient to be able to read the consent form with corrective lenses.\n  3. Over 18 years of age.\n  4. English- or French-speaking.\n* For patients only:\n\n  1. Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy\n  2. First-time cancer diagnosis.\n  3. ECOG performance < 2\n  4. Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* For all participants:\n\n  1. Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.\n  2. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).\n  3. Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.\n  4. Previous history of cancer or chemotherapy\n  5. Distant metastases\n  6. Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.\n  7. Diagnosis of a substance abuse disorder.\n  8. Recreational drug use (e.g., alcohol, marijuana) is a potential exclusion criterion that will be determined on an individual basis as per the discretion of the research team. All recreational drug use will be documented.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Able to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to provide informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Visual acuity sufficient to be able to read the consent form with corrective lenses.",
            "criterions": [
                {
                    "exact_snippets": "Visual acuity sufficient to be able to read the consent form with corrective lenses.",
                    "criterion": "visual acuity",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": "able to read the consent form with corrective lenses"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Over 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Over 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. English- or French-speaking.",
            "criterions": [
                {
                    "exact_snippets": "English- or French-speaking",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": [
                                "English",
                                "French"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For patients only:",
            "criterions": [
                {
                    "exact_snippets": "patients only",
                    "criterion": "patient status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "patient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Initial diagnosis of breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I-IIIA",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "schedule",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. First-time cancer diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "First-time cancer diagnosis",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": "first-time"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance < 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance < 2",
                    "criterion": "ECOG performance",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles",
            "criterions": [
                {
                    "exact_snippets": "Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles",
                    "criterion": "curative intent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "regimen",
                            "expected_value": [
                                "Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles",
                                "Taxotere/Cyclophosphamide for 4 cycles"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "1. Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.",
            "criterions": [
                {
                    "exact_snippets": "Evidence or medical history of neurological/psychiatric issues",
                    "criterion": "neurological/psychiatric issues",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known to affect movements",
                    "criterion": "issues affecting movements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known to affect ... oculomotor control",
                    "criterion": "issues affecting oculomotor control",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).",
            "criterions": [
                {
                    "exact_snippets": "Presence of comorbid neurological conditions",
                    "criterion": "comorbid neurological conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Strabismus",
                    "criterion": "Strabismus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cranial nerve palsy",
                    "criterion": "cranial nerve palsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke-causing hemianopsia",
                    "criterion": "stroke-causing hemianopsia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of macular edema",
                    "criterion": "macular edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments",
                    "criterion": "pre-existing ocular conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on eye movement assessments",
                            "expected_value": "prevent participants from performing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Previous history of cancer or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previous history of cancer",
                    "criterion": "history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous history of ... chemotherapy",
                    "criterion": "history of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Distant metastases",
            "criterions": [
                {
                    "exact_snippets": "Distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.",
            "criterions": [
                {
                    "exact_snippets": "Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function",
                    "criterion": "use of new prescription drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since start/change/irregular use",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "influence on ocular motor visual function",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment",
                    "criterion": "occasional use of benzodiazepines",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing relative to eye movement assessment",
                            "expected_value": "should not occur within a short time period prior to or during"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Diagnosis of a substance abuse disorder.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of a substance abuse disorder",
                    "criterion": "substance abuse disorder",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Recreational drug use (e.g., alcohol, marijuana) is a potential exclusion criterion that will be determined on an individual basis as per the discretion of the research team. All recreational drug use will be documented.",
            "criterions": [
                {
                    "exact_snippets": "Recreational drug use (e.g., alcohol, marijuana) ... potential exclusion criterion",
                    "criterion": "recreational drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "All recreational drug use will be documented.",
                    "criterion": "recreational drug use",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* For all participants:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "* For all participants:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}