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: H2Q-MC-LZZT Exclusion Criteria - XML Representation

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<Group xmlns="http://hl7.org/fhir">
  <id value="H2Q-MC-LZZT-ResearchStudy-Exclusion"/>
  <text>
    <status value="generated"/>
    <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Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline.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>
  </text>
  <type value="person"/>
  <actual value="false"/>
  <characteristic>
    <code>
      <text
            value="Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Use of any investigational agent or approved Alzheimer’s therapeutic medication within 30 days prior to enrollment into the study."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Serious illness which required hospitalization within 3 months of screening."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Stroke or vascular dementia documented by clinical history and/or radiographic findings interpretable by the investigator as indicative of these disorders"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Seizure disorder other than simple childhood febrile seizures"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Severe head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Parkinson’s disease"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Multiple sclerosis"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Amyotrophic lateral sclerosis"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Myasthenia gravis"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Episode of depression meeting DSM-IV criteria within 3 months of screening."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="A history within the last 5 years of Schizophrenia."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="A history within the last 5 years of Bipolar Disease."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of Ethanol or psychoactive drug abuse or dependence."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="A history of syncope within the last 5 years."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Evidence from ECG recording of Left bundle branch block."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Evidence from ECG recording of Bradycardia ≤50 beats per minute"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Evidence from ECG recording of Sinus pauses &gt;2 seconds"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Evidence from ECG recording of Second or third degree heart block unless treated with a pacemaker"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Evidence from ECG recording of Wolff-Parkinson-White syndrome"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Evidence from ECG recording of Sustained supraventricular tachyarrhythmia including SVT≥10 sec, atrial fibrillation, atrial flutter."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="Evidence from ECG recording of Ventricular tachycardia at a rate of ≥120 beats per minute lasting ≥10 seconds."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of Clinically significant arrhythmia"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of Symptomatic sick sinus syndrome not treated with a pacemaker"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of Congestive heart failure refractory to treatment"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of Angina except angina controlled with PRN nitroglycerin"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of Resting heart rate &lt;50 or &gt;100 beats per minute, on physical exam"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of Uncontrolled hypertension."/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
  <characteristic>
    <code>
      <text
            value="A history within the last 5 years of a serious gastrointestinal disorder"/>
    </code>
    <valueBoolean value="true"/>
    <exclude value="true"/>
  </characteristic>
</Group>