0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
{
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"id" : "H2Q-MC-LZZT-ResearchStudy-Exclusion",
"text" : {
"status" : "generated",
"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Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline.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 >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 <50 or >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>"
},
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{
"code" : {
"text" : "Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Use of any investigational agent or approved Alzheimer’s therapeutic medication within 30 days prior to enrollment into the study."
},
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"exclude" : true
},
{
"code" : {
"text" : "Serious illness which required hospitalization within 3 months of screening."
},
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"exclude" : true
},
{
"code" : {
"text" : "Stroke or vascular dementia documented by clinical history and/or radiographic findings interpretable by the investigator as indicative of these disorders"
},
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"exclude" : true
},
{
"code" : {
"text" : "Seizure disorder other than simple childhood febrile seizures"
},
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"exclude" : true
},
{
"code" : {
"text" : "Severe head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Parkinson’s disease"
},
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"exclude" : true
},
{
"code" : {
"text" : "Multiple sclerosis"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Amyotrophic lateral sclerosis"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Myasthenia gravis"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Episode of depression meeting DSM-IV criteria within 3 months of screening."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Schizophrenia."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Bipolar Disease."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Ethanol or psychoactive drug abuse or dependence."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history of syncope within the last 5 years."
},
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"exclude" : true
},
{
"code" : {
"text" : "Evidence from ECG recording of Left bundle branch block."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Evidence from ECG recording of Bradycardia ≤50 beats per minute"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Evidence from ECG recording of Sinus pauses >2 seconds"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Evidence from ECG recording of Second or third degree heart block unless treated with a pacemaker"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Evidence from ECG recording of Wolff-Parkinson-White syndrome"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Evidence from ECG recording of Sustained supraventricular tachyarrhythmia including SVT≥10 sec, atrial fibrillation, atrial flutter."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "Evidence from ECG recording of Ventricular tachycardia at a rate of ≥120 beats per minute lasting ≥10 seconds."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Clinically significant arrhythmia"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Symptomatic sick sinus syndrome not treated with a pacemaker"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Congestive heart failure refractory to treatment"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Angina except angina controlled with PRN nitroglycerin"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Resting heart rate <50 or >100 beats per minute, on physical exam"
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of Uncontrolled hypertension."
},
"valueBoolean" : true,
"exclude" : true
},
{
"code" : {
"text" : "A history within the last 5 years of a serious gastrointestinal disorder"
},
"valueBoolean" : true,
"exclude" : true
}
]
}