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: H2Q-MC-LZZT Exclusion Criteria - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Group;
  fhir:nodeRole fhir:treeRoot;
  fhir:Resource.id [ fhir:value "H2Q-MC-LZZT-ResearchStudy-Exclusion"];
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "generated" ];
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>type</b>: person</p><p><b>actual</b>: false</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Use of any investigational agent or approved Alzheimer’s therapeutic medication within 30 days prior to enrollment into the study.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Serious illness which required hospitalization within 3 months of screening.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Stroke or vascular dementia documented by clinical history and/or radiographic findings interpretable by the investigator as indicative of these disorders</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Seizure disorder other than simple childhood febrile seizures</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Severe head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Parkinson’s disease</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Multiple sclerosis</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Amyotrophic lateral sclerosis</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Myasthenia gravis</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Episode of depression meeting DSM-IV criteria within 3 months of screening.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Schizophrenia.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Bipolar Disease.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Ethanol or psychoactive drug abuse or dependence.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history of syncope within the last 5 years.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Left bundle branch block.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Bradycardia ≤50 beats per minute</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Sinus pauses &gt;2 seconds</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Second or third degree heart block unless treated with a pacemaker</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Wolff-Parkinson-White syndrome</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Sustained supraventricular tachyarrhythmia including SVT≥10 sec, atrial fibrillation, atrial flutter.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">Evidence from ECG recording of Ventricular tachycardia at a rate of ≥120 beats per minute lasting ≥10 seconds.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Clinically significant arrhythmia</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Symptomatic sick sinus syndrome not treated with a pacemaker</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Congestive heart failure refractory to treatment</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Angina except angina controlled with PRN nitroglycerin</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Resting heart rate &lt;50 or &gt;100 beats per minute, on physical exam</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of Uncontrolled hypertension.</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes: \">A history within the last 5 years of a serious gastrointestinal disorder</span></p><p><b>value</b>: true</p><p><b>exclude</b>: true</p></blockquote></div>"
  ];
  fhir:Group.type [ fhir:value "person"];
  fhir:Group.actual [ fhir:value "false"^^xsd:boolean];
  fhir:Group.characteristic [
     fhir:index 0;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 1;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Use of any investigational agent or approved Alzheimer’s therapeutic medication within 30 days prior to enrollment into the study." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 2;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Serious illness which required hospitalization within 3 months of screening." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 3;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Stroke or vascular dementia documented by clinical history and/or radiographic findings interpretable by the investigator as indicative of these disorders" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 4;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Seizure disorder other than simple childhood febrile seizures" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 5;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Severe head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 6;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Parkinson’s disease" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 7;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Multiple sclerosis" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 8;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Amyotrophic lateral sclerosis" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 9;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Myasthenia gravis" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 10;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Episode of depression meeting DSM-IV criteria within 3 months of screening." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 11;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Schizophrenia." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 12;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Bipolar Disease." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 13;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Ethanol or psychoactive drug abuse or dependence." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 14;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history of syncope within the last 5 years." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 15;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Evidence from ECG recording of Left bundle branch block." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 16;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Evidence from ECG recording of Bradycardia ≤50 beats per minute" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 17;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Evidence from ECG recording of Sinus pauses >2 seconds" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 18;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Evidence from ECG recording of Second or third degree heart block unless treated with a pacemaker" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 19;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Evidence from ECG recording of Wolff-Parkinson-White syndrome" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 20;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Evidence from ECG recording of Sustained supraventricular tachyarrhythmia including SVT≥10 sec, atrial fibrillation, atrial flutter." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 21;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "Evidence from ECG recording of Ventricular tachycardia at a rate of ≥120 beats per minute lasting ≥10 seconds." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 22;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Clinically significant arrhythmia" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 23;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Symptomatic sick sinus syndrome not treated with a pacemaker" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 24;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Congestive heart failure refractory to treatment" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 25;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Angina except angina controlled with PRN nitroglycerin" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 26;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Resting heart rate <50 or >100 beats per minute, on physical exam" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 27;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of Uncontrolled hypertension." ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ], [
     fhir:index 28;
     fhir:Group.characteristic.code [
       fhir:CodeableConcept.text [ fhir:value "A history within the last 5 years of a serious gastrointestinal disorder" ]     ];
     fhir:Group.characteristic.valueBoolean [ fhir:value "true"^^xsd:boolean ];
     fhir:Group.characteristic.exclude [ fhir:value "true"^^xsd:boolean ]
  ].

# - ontology header ------------------------------------------------------------

 a owl:Ontology;
  owl:imports fhir:fhir.ttl.