@prefix fhir: <http://hl7.org/fhir/> .
@prefix mesh: <http://id.nlm.nih.gov/mesh/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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

<http://hl7.org/fhir/uv/vulcan-schedule/ResearchStudy/H2Q-MC-LZZT-ResearchStudy> a fhir:ResearchStudy ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "H2Q-MC-LZZT-ResearchStudy"] ; # 
  fhir:meta [
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa>
     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
     fhir:status [ fhir:v "generated" ] ;
     fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy H2Q-MC-LZZT-ResearchStudy</b></p><a name=\"H2Q-MC-LZZT-ResearchStudy\"> </a><a name=\"hcH2Q-MC-LZZT-ResearchStudy\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ResearchStudySoa.html\">ResearchStudySoa</a></p></div><p><b>identifier</b>: H2Q-MC-LZZT (use: usual, ), <code>https://clinicaltrials.gov/show/</code>/NCTA12313212 (use: official, ), 60809</p><p><b>title</b>: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>protocol</b>: <a href=\"PlanDefinition-H2Q-MC-LZZT-ProtocolDesign.html\">H2Q-MC-LZZT Protocol Schedule of Activities</a></p><p><b>status</b>: Retired</p><p><b>primaryPurposeType</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type treatment}\">Treatment</span></p><p><b>phase</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-phase phase-3}\">Phase 3</span></p><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 26929004}\">Alzheimer's Disease (Disorder)</span></p><p><b>keyword</b>: <span title=\"Codes:{https://www.nlm.nih.gov/mesh D018721}\">Selective M1 muscarinic agonists</span>, <span title=\"Codes:{https://www.nlm.nih.gov/mesh D000544}\">Alzheimer Disease</span>, <span title=\"Codes:{https://www.nlm.nih.gov/mesh D018721}\">Selective M1 muscarinic agonists</span></p><p><b>description</b>: </p><div><h2>Xanomeline (LY246708)</h2>\n<h3>Protocol H2Q-MC-LZZT(c)</h3>\n<p>Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p>\n</div><blockquote><p><b>objective</b></p><p><b>name</b>: To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}\">Primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To document the safety profile of the xanomeline TTS.</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}\">Primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}\">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}\">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}\">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the treatment response as a function of Apo E genotype.</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}\">Secondary</span></p></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
     fhir:use [ fhir:v "usual" ] ;
     fhir:value [ fhir:v "H2Q-MC-LZZT" ]
  ] [
     fhir:use [ fhir:v "official" ] ;
     fhir:system [
       fhir:v "https://clinicaltrials.gov/show/"^^xsd:anyURI ;
       fhir:l <https://clinicaltrials.gov/show/>
     ] ;
     fhir:value [ fhir:v "NCTA12313212" ]
  ] [
     fhir:value [ fhir:v "60809" ]
  ] ) ; # 
  fhir:title [ fhir:v "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"] ; # 
  fhir:protocol ( [
     fhir:l <http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-ProtocolDesign> ;
     fhir:reference [ fhir:v "PlanDefinition/H2Q-MC-LZZT-ProtocolDesign" ]
  ] ) ; # 
  fhir:status [ fhir:v "retired"] ; # 
  fhir:primaryPurposeType [
     fhir:coding ( [
       fhir:system [
         fhir:v "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"^^xsd:anyURI ;
         fhir:l <http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type>
       ] ;
       fhir:code [ fhir:v "treatment" ]
     ] )
  ] ; # 
  fhir:phase [
     fhir:coding ( [
       fhir:system [
         fhir:v "http://terminology.hl7.org/CodeSystem/research-study-phase"^^xsd:anyURI ;
         fhir:l <http://terminology.hl7.org/CodeSystem/research-study-phase>
       ] ;
       fhir:code [ fhir:v "phase-3" ]
     ] )
  ] ; # 
  fhir:condition ( [
     fhir:coding ( [
       a sct:26929004 ;
       fhir:system [
         fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
         fhir:l <http://snomed.info/sct>
       ] ;
       fhir:code [ fhir:v "26929004" ] ;
       fhir:display [ fhir:v "Alzheimer's Disease (Disorder)" ]
     ] )
  ] ) ; # 
  fhir:keyword ( [
     fhir:coding ( [
       a mesh:D018721 ;
       fhir:system [
         fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ;
         fhir:l <https://www.nlm.nih.gov/mesh>
       ] ;
       fhir:code [ fhir:v "D018721" ]
     ] ) ;
     fhir:text [ fhir:v "Selective M1 muscarinic agonists" ]
  ] [
     fhir:coding ( [
       a mesh:D000544 ;
       fhir:system [
         fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ;
         fhir:l <https://www.nlm.nih.gov/mesh>
       ] ;
       fhir:code [ fhir:v "D000544" ]
     ] ) ;
     fhir:text [ fhir:v "Alzheimer Disease" ]
  ] [
     fhir:coding ( [
       a mesh:D018721 ;
       fhir:system [
         fhir:v "https://www.nlm.nih.gov/mesh"^^xsd:anyURI ;
         fhir:l <https://www.nlm.nih.gov/mesh>
       ] ;
       fhir:code [ fhir:v "D018721" ]
     ] ) ;
     fhir:text [ fhir:v "Selective M1 muscarinic agonists" ]
  ] ) ; # 
  fhir:description [ fhir:v "## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"] ; # 
  fhir:objective ( [
     fhir:name [ fhir:v "To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg])." ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/research-study-objective-type>
         ] ;
         fhir:code [ fhir:v "primary" ]
       ] )
     ]
  ] [
     fhir:name [ fhir:v "To document the safety profile of the xanomeline TTS." ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/research-study-objective-type>
         ] ;
         fhir:code [ fhir:v "primary" ]
       ] )
     ]
  ] [
     fhir:name [ fhir:v "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas." ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/research-study-objective-type>
         ] ;
         fhir:code [ fhir:v "secondary" ]
       ] )
     ]
  ] [
     fhir:name [ fhir:v "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas." ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/research-study-objective-type>
         ] ;
         fhir:code [ fhir:v "secondary" ]
       ] )
     ]
  ] [
     fhir:name [ fhir:v "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment." ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/research-study-objective-type>
         ] ;
         fhir:code [ fhir:v "secondary" ]
       ] )
     ]
  ] [
     fhir:name [ fhir:v "To assess the treatment response as a function of Apo E genotype." ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/research-study-objective-type>
         ] ;
         fhir:code [ fhir:v "secondary" ]
       ] )
     ]
  ] ) . # 

<http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-ProtocolDesign> a fhir:Uv .

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