{
    "info": {
        "nct_id": "NCT04191460",
        "official_title": "Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging",
        "inclusion_criteria": "1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;\n2. ≥ 18 years of age;\n3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;\n4. Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Previous surgery, chemotherapy or radiotherapy to the oral cavity;\n2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.\n3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;\n4. Patients with renal insufficiency (eGFR<60);\n5. Patients with a previous kidney transplantation in the medical history;\n6. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;\n7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;",
                "criterions": [
                    {
                        "exact_snippets": "biopsy-proven squamous cell carcinoma of the oral cavity",
                        "criterion": "squamous cell carcinoma of the oral cavity",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy-proven"
                        }
                    },
                    {
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                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    }
                ]
            },
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                            "expected_value": "biopsy-proven"
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                    },
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                    }
                ]
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        },
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                                "value": 18,
                                "unit": "years"
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                                "value": 18,
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        },
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                        }
                    },
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                        "criterion": "compliance with regulations",
                        "requirement": {
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                                "national/local regulations"
                            ]
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                "line": "4. Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.",
                "criterions": [
                    {
                        "exact_snippets": "Screening ECG ... within normal limits",
                        "criterion": "ECG results",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within normal limits"
                        }
                    },
                    {
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                        "criterion": "clinical laboratory test results",
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                            "requirement_type": "range",
                            "expected_value": "within normal limits"
                        }
                    },
                    {
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                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": "clinically insignificant"
                        }
                    }
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                                    "criterion": "clinical laboratory test results",
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                                    }
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                "then_criteria": null,
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                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
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                        "exact_snippets": "minimum age of 18 Years",
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        }
    ],
    "exclusion_lines": [
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                    {
                        "exact_snippets": "Previous surgery ... to the oral cavity",
                        "criterion": "previous surgery to the oral cavity",
                        "requirement": {
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                            "expected_value": true
                        }
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                        "criterion": "previous chemotherapy to the oral cavity",
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                        }
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                        "criterion": "previous radiotherapy to the oral cavity",
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                        }
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                        "exact_snippets": "Previous surgery ... to the oral cavity",
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                    },
                    {
                        "exact_snippets": "Previous ... chemotherapy ... to the oral cavity",
                        "criterion": "previous chemotherapy to the oral cavity",
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                            "expected_value": true
                        }
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                        "exact_snippets": "Previous ... radiotherapy to the oral cavity",
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            "identified_line": {
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                            "expected_value": true
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                                "criterion": "allergy or anaphylactic reactions to components of the agent",
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                            {
                                "exact_snippets": "allergy or anaphylactic reactions to any of the components of the agent",
                                "criterion": "allergy or anaphylactic reactions to components of the agent",
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                                }
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                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
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                            "expected_value": false
                        }
                    },
                    {
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                        }
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                    {
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                            "expected_value": true
                        }
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                                "exact_snippets": "Patients pregnant",
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                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "male or female patients with reproductive potential",
                                "criterion": "reproductive potential",
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                                }
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                                }
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                            {
                                "exact_snippets": "male or female patients with reproductive potential",
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                                }
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                        "exact_snippets": "renal insufficiency (eGFR<60)",
                        "criterion": "renal insufficiency",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "eGFR"
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        {
            "identified_line": {
                "line": "5. Patients with a previous kidney transplantation in the medical history;",
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                        "criterion": "kidney transplantation",
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                            "expected_value": true
                        }
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        {
            "identified_line": {
                "line": "7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.",
                "criterions": [
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                        "exact_snippets": "Any condition that the investigator considers to be potentially jeopardizing the patient's well-being",
                        "criterion": "condition jeopardizing patient's well-being",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
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                        "exact_snippets": "Any condition that the investigator considers to be potentially jeopardizing ... the study objectives",
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                        }
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                        "exact_snippets": "Any condition that the investigator considers to be potentially jeopardizing the patient's well-being",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
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        {
            "identified_line": {
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                    {
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                            "expected_value": false
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                            "requirement_type": "status",
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                                            "expected_value": false
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    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}