{
    "info": {
        "nct_id": "NCT02941276",
        "official_title": "Long-term Evaluation of the Effectiveness Of a Novel Intra-oral Electro-stimulator for the Treatment of raDiotherapy-ASsociated Dry Mouth",
        "inclusion_criteria": "1. To be at least 18 years old\n2. To have received more than 40 Gy of external beam RT for cancer in the H&N region at least 4 months before entry into the study\n3. To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema\n4. To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale (0=no dryness; 100\n\n   =maximum dryness).\n5. To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)\n6. To have at least one parotid gland\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V)\n2. To have known allergy to materials similar to those used in the investigational product\n3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids\n4. To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes).\n5. To use of pilocarpine as systemic therapy\n6. To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min)\n7. To have no parotid glands",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. To be at least 18 years old",
            "criterions": [
                {
                    "exact_snippets": "at least 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. To have received more than 40 Gy of external beam RT for cancer in the H&N region at least 4 months before entry into the study",
            "criterions": [
                {
                    "exact_snippets": "received more than 40 Gy of external beam RT for cancer in the H&N region",
                    "criterion": "external beam RT for cancer in the H&N region",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "Gy"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 4 months before entry into the study",
                    "criterion": "time since RT",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema",
            "criterions": [
                {
                    "exact_snippets": "grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema",
                    "criterion": "RTOG/EORTC Late Radiation Morbidity Scoring",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "grade"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 2,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. To have a degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale (0=no dryness; 100",
            "criterions": [
                {
                    "exact_snippets": "degree of minimum degree of dryness of 50mm (≥50mm) on a 100mm VAS scale",
                    "criterion": "degree of dryness",
                    "requirements": [
                        {
                            "requirement_type": "minimum degree",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "=maximum dryness).",
            "criterions": [
                {
                    "exact_snippets": "maximum dryness",
                    "criterion": "dryness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "maximum"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. To have demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)",
            "criterions": [
                {
                    "exact_snippets": "demonstrable residual salivary gland function (increase in salivary flow on appropriate stimulation (e.g. chewing paraffin wax)",
                    "criterion": "residual salivary gland function",
                    "requirements": [
                        {
                            "requirement_type": "demonstrability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "increase in salivary flow",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. To have at least one parotid gland",
            "criterions": [
                {
                    "exact_snippets": "at least one parotid gland",
                    "criterion": "parotid gland",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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. To have severe uncontrolled systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASA IV and ASA V)",
            "criterions": [
                {
                    "exact_snippets": "severe uncontrolled systemic disease ... classification of the American Society of Anesthesiology: ASA IV and ASA V",
                    "criterion": "systemic disease severity",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "ASA IV",
                                "ASA V"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. To have known allergy to materials similar to those used in the investigational product",
            "criterions": [
                {
                    "exact_snippets": "known allergy to materials similar to those used in the investigational product",
                    "criterion": "allergy to materials similar to investigational product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids",
            "criterions": [
                {
                    "exact_snippets": "To wear other active implants such as cardiac pacemaker",
                    "criterion": "cardiac pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "To wear other active implants such as ... defibrillator",
                    "criterion": "defibrillator",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "To wear other active implants such as ... hearing aids",
                    "criterion": "hearing aids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. To have an unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow as measured via sialometry for 15 minutes).",
            "criterions": [
                {
                    "exact_snippets": "unstimulated whole salivary flow of 0ml/15min (complete absence of unstimulated salivary flow ... for 15 minutes)",
                    "criterion": "unstimulated whole salivary flow",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "ml/15min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. To use of pilocarpine as systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "use of pilocarpine as systemic therapy",
                    "criterion": "pilocarpine",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "therapy type",
                            "expected_value": "systemic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min)",
            "criterions": [
                {
                    "exact_snippets": "grade 3 RTOG/EROTC",
                    "criterion": "RTOG/EROTC grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 3"
                        }
                    ]
                },
                {
                    "exact_snippets": "no resting saliva (sialometry = 0mL/1.5 min)",
                    "criterion": "resting saliva",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "mL/1.5 min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. To have no parotid glands",
            "criterions": [
                {
                    "exact_snippets": "no parotid glands",
                    "criterion": "parotid glands",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}