{
    "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": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for surgical resection of the primary tumor",
                    "criterion": "eligibility for surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ≥ 18 years of age;",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;",
            "criterions": [
                {
                    "exact_snippets": "written informed consent must be given",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "according to ICH/GCP, and national/local regulations",
                    "criterion": "compliance with regulations",
                    "requirements": [
                        {
                            "requirement_type": "standards",
                            "expected_value": [
                                "ICH/GCP",
                                "national/local regulations"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical laboratory test results are within normal limits",
                    "criterion": "clinical laboratory test results",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "if any are outside of normal limits they are considered to be clinically insignificant",
                    "criterion": "ECG and clinical laboratory test results",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": "clinically insignificant"
                        }
                    ]
                }
            ]
        },
        {
            "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 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. Previous surgery, chemotherapy or radiotherapy to the oral cavity;",
            "criterions": [
                {
                    "exact_snippets": "Previous surgery ... to the oral cavity",
                    "criterion": "previous surgery to the oral cavity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous ... chemotherapy ... to the oral cavity",
                    "criterion": "previous chemotherapy to the oral cavity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous ... radiotherapy to the oral cavity",
                    "criterion": "previous radiotherapy to the oral cavity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant allergy",
                    "criterion": "clinically significant allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anaphylactic reactions",
                    "criterion": "anaphylactic reactions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergy or anaphylactic reactions to any of the components of the agent",
                    "criterion": "allergy or anaphylactic reactions to components of the agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;",
            "criterions": [
                {
                    "exact_snippets": "Patients pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of effective contraception",
                    "criterion": "effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female patients with reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with renal insufficiency (eGFR<60);",
            "criterions": [
                {
                    "exact_snippets": "renal insufficiency (eGFR<60)",
                    "criterion": "renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "eGFR"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with a previous kidney transplantation in the medical history;",
            "criterions": [
                {
                    "exact_snippets": "previous kidney transplantation in the medical history",
                    "criterion": "kidney transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.",
            "criterions": [
                {
                    "exact_snippets": "Any condition that the investigator considers to be potentially jeopardizing the patient's well-being",
                    "criterion": "condition jeopardizing patient's well-being",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Any condition that the investigator considers to be potentially jeopardizing ... the study objectives",
                    "criterion": "condition jeopardizing study objectives",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "6. 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;",
            "criterions": [
                {
                    "exact_snippets": "Immuno-compromised patients who do not have the ability to respond normally to an infection",
                    "criterion": "immune system response",
                    "requirements": [
                        {
                            "requirement_type": "ability to respond to infection",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "impaired or weakened immune system",
                    "criterion": "immune system status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "impaired or weakened"
                        }
                    ]
                },
                {
                    "exact_snippets": "caused by either a pre-existing disease",
                    "criterion": "cause of immune system compromise",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "pre-existing disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "caused by ... concomitant medications",
                    "criterion": "cause of immune system compromise",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "concomitant medications"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}