</attachment> </content> <context> <related> <reference value="ResearchStudy/mii-exa-studie-cohort"/> </related> </context> </DocumentReference> </resource> <request> <method value="POST"/> <url value="MII_PR_Studie_Dokument"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_EinAuschlussKriterium/mii-exa-studie-ein-auschluss-kriterium"/> <resource> <EvidenceVariable> <id value="mii-exa-studie-ein-auschluss-kriterium"/> <meta> <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-ein-auschluss-kriterium"/> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="extensions"/> </text> <status value="active"/> <characteristic> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionReference"> <valueReference> <reference value="EvidenceVariable/mii-exa-studie-evidence-variable-age-restriction"/> </valueReference> </extension> <description value="Altersbeschränkung"/> <definitionCodeableConcept> <text value="Altersbeschränkung"/> </definitionCodeableConcept> </characteristic> <characteristic> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionCanonical"> <valueCanonical value="https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender"/> </extension> <description value="Geschlecht"/> <definitionCodeableConcept> <text value="Alle"/> </definitionCodeableConcept> <exclude value="false"/> </characteristic> <characteristic> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId"> <valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/> </extension> <description value="Kognitive Fatigue (WeiMUS kognitive Skala >= 17)"/> <definitionCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/> <code value="unknown"/> </coding> </definitionCodeableConcept> <exclude value="false"/> </characteristic> <characteristic> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId"> <valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/> </extension> <description value="Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt"/> <definitionCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/> <code value="unknown"/> </coding> </definitionCodeableConcept> <exclude value="false"/> </characteristic> <characteristic> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByCombination"> <extension url="code"> <valueCode value="any-of"/> </extension> <extension url="characteristic"> <valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/> </extension> <extension url="characteristic"> <valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/> </extension> </extension> <description value="Weitere Einschlusskriterien"/> <definitionCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/> <code value="unknown"/> </coding> </definitionCodeableConcept> <exclude value="false"/> </characteristic> <characteristic> <description value="diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen"/> <definitionCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/> <code value="unknown"/> </coding> </definitionCodeableConcept> <exclude value="true"/> </characteristic> <characteristic> <description value="Einnahme von Antidepressiva, Opioiden, Antikonvulsiva"/> <definitionCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/> <code value="unknown"/> </coding> </definitionCodeableConcept> <exclude value="true"/> </characteristic> <characteristic> <description value="weitere neurologische Erkrankungen"/> <definitionCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/> <code value="unknown"/> </coding> </definitionCodeableConcept> <exclude value="true"/> </characteristic> <characteristic> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByTypeAndValue"> <extension url="type"> <valueCodeableConcept> <coding> <system value="http://snomed.info/sct"/> <code value="424144002"/> <display value="Current chronological age"/> </coding> </valueCodeableConcept> </extension> <extension url="value"> <valueQuantity> <value value="18"/> <comparator value=">="/> <unit value="year"/> <system value="http://unitsofmeasure.org"/> <code value="a"/> </valueQuantity> </extension> </extension> <description value="Alter mindestens 18 Jahre"/> <definitionCodeableConcept> <text value="Mindestalter"/> </definitionCodeableConcept> <exclude value="false"/> </characteristic> </EvidenceVariable> </resource> <request> <method value="POST"/> <url value="MII_PR_Studie_EinAuschlussKriterium"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Studie/mii-exa-studie-studie"/> <resource> <ResearchStudy> <id value="mii-exa-studie-studie"/> <meta> <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie"/> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="extensions"/> </text> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label"> <extension url="value"> <valueString value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/> </extension> <extension url="type"> <valueCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/title-type"/> <code value="scientific"/> </coding> </valueCodeableConcept> </extension> </extension> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label"> <extension url="value"> <valueString value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/> </extension> <extension url="type"> <valueCodeableConcept> <text value="Öffentlicher Titel"/> </valueCodeableConcept> </extension> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym"> <valueString value="tDCS"/> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung"> <extension url="rekrutierungsstart"> <valueDate value="2023-01-12"/> </extension> <extension url="rekrutierungsziel"> <valueInteger value="40"/> </extension> <extension url="rekrutierungsstand"> <valueInteger value="35"/> </extension> <extension url="rekrutierungsstand-genauigkeit"> <valueString value="good"/> </extension> <extension url="rekrutierungsstand-datum"> <valueDate value="2023-02-17"/> </extension> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung"> <valueString value="Öffentliche Förderinstitutionen, aus Steuermitteln getragene Institutionen (DFG, BMBF u. a.)"/> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum"> <extension url="status"> <valueString value="Zustimmende Bewertung"/> </extension> <extension url="kommission"> <valueString value="Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R."/> </extension> <extension url="ethiknummer"> <valueString value="Az.: 83/18"/> </extension> </extension> <identifier> <system value="https://example.com/fhir/sid/drks"/> <value value="DRKS00031294"/> </identifier> <title value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/> <status value="active"/> <category> <coding> <code value="interventional"/> </coding> </category> <category> <text value="Zufallszuteilung"/> </category> <description value="Diese Studie untersucht den Einfluss repetitiver anodaler Gleichstromstimulation des linken dorsolateralen präfrontalen Kortex (dlPFC ) auf subjektive und objektive Kennwerte und assoziierte EEG-Parameter der Fatigue bei Long-COVID Patient*innen. Die Studie ist sham-kontrolliert und doppelt-verblindet."/> <arm> <name value="frontale anodale tDCS (verum condition)"/> <description value="vier Stimulationen, jeweils 30 Minuten, 1.5mA über dem linken dlPFC"/> </arm> <arm> <name value="frontale sham tDCS"/> <description value="vier Stimulationen, jeweils 30 Minuten"/> </arm> </ResearchStudy> </resource> <request> <method value="POST"/> <url value="MII_PR_Studie_Studie"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Cohort/mii-exa-studie-cohort"/> <resource> <ResearchStudy> <id value="mii-exa-studie-cohort"/> <meta> <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie"/> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="extensions"/> </text> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label"> <extension url="value"> <valueString value="MII Modul Studie"/> </extension> </extension> <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty"> <extension url="role"> <valueCodeableConcept> <coding> <system value="http://example.org/fhir/CodeSystem/associated-party-role"/> <code value="sponsor"/> </coding> </valueCodeableConcept> </extension> <extension url="party"> <valueReference> <reference value="Organization/mii-exa-studie-author"/> </valueReference> </extension> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum"> <extension url="status"> <valueString value="genehmigt"/> </extension> <extension url="kommission"> <valueString value="Ethik-Kommission der Medizinischen Fakultät der Universität Leipzig"/> </extension> <extension url="ethiknummer"> <valueString value="159-12-21052012"/> </extension> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister"> <valueReference> <reference value="Library/mii-exa-studie-register"/> </valueReference> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility"> <valueReference> <reference value="EvidenceVariable/mii-exa-studie-ein-auschluss-kriterium"/> </valueReference> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym"> <valueString value="LIFE ADULT"/> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung"> <extension url="rekrutierungsstart"> <valueDate value="2009-01-01"/> </extension> <extension url="rekrutierungsziel"> <valueInteger value="10000"/> </extension> <extension url="rekrutierungsstand"> <valueInteger value="10000"/> </extension> <extension url="rekrutierungsstand-genauigkeit"> <valueString value="good"/> </extension> <extension url="rekrutierungsstand-datum"> <valueDate value="2022-05-28"/> </extension> </extension> <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung"> <valueString value="Deutsches Bundesministerium für Bildung und Forschung (BMBF)"/> </extension> <identifier> <system value="https://example.com/fhir/sid/lha"/> <value value="7Q6PJD8NV3-2"/> </identifier> <title value="LIFE-Adult-Study"/> <partOf> <reference value="ResearchStudy/mii-exa-studie-reference-study"/> </partOf> <status value="active"/> <category> <coding> <system value="http://example.org/fhir/CodeSystem/research-study-category"/> <code value="observational"/> </coding> </category> <focus> <text value="Erwachsene der Stadt Leipzig"/> </focus> <keyword> <text value="Bevölkerung, Leipzig, Erwachsene"/> </keyword> <description value="Die LIFE Adult-Studie ist eine langfristig angelegte, bevölkerungsbezogene Kohortenstudie. Stichproben aus der Leipziger Erwachsenenbevölkerung werden hinsichtlich vielfältiger Merkmale und Krankheitsrisiken umfassend untersucht. Insbesondere die Häufigkeit von Volkskrankheiten steht im Mittelpunkt der Forschungsarbeiten. Der Einfluss von Lebensstil- und Umweltfaktoren auf diese Erkrankungen wird charakterisiert. Bisher unbekannte Risikofaktoren für die Entstehung von Volkskrankheiten sollen aufgespürt und neue Möglichkeiten der Früherkennung entwickelt werden."/> <arm> <name value="LIFE-Adult-Kohorte"/> </arm> </ResearchStudy> </resource> <request> <method value="POST"/> <url value="MII_PR_Studie_Cohort"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Proband/mii-exa-studie-proband"/> <resource> <ResearchSubject> <id value="mii-exa-studie-proband"/> <meta> <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband"/> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <identifier> <type> <coding> <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/> <code value="ANON"/> </coding> </type> <system value="https://www.medizininformatik-initiative.de/fhir/sid/patienten"/> <value value="321123456"/> </identifier> <status value="candidate"/> <period> <start value="2023-01-01"/> <end value="2023-12-31"/> </period> <study> <reference value="ResearchStudy/mii-exa-studie-cohort"/> </study> <individual> <reference value="Patient/mii-exa-studie-patient"/> </individual> <consent> <reference value="Consent/mii-exa-studie-consent"/> </consent> </ResearchSubject> </resource> <request> <method value="POST"/> <url value="MII_PR_Studie_Proband"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Beteiligte_Person/mii-exa-studie-beteiligte-person"/> <resource> <PractitionerRole> <id value="mii-exa-studie-beteiligte-person"/> <meta> <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-beteiligte-person"/> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <practitioner> <reference value="Practitioner/mii-exa-studie-practitioner"/> </practitioner> <organization> <reference value="Organization/mii-exa-studie-practitioner-organization"/> </organization> <code> <coding> <system value="http://terminology.hl7.org/CodeSystem/practitioner-role"/> <code value="doctor"/> </coding> </code> <telecom> <system value="phone"/> <value value="0123456789"/> </telecom> </PractitionerRole> </resource> <request> <method value="POST"/> <url value="MII_PR_Studie_Beteiligte_Person"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Register/mii-exa-studie-register"/> <resource> <Library> <id value="mii-exa-studie-register"/> <meta> <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-register"/> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="extensions"/><div xml:lang="de" lang="de"><hr/><p><b>German</b></p><hr/><a name="Library_mii-exa-studie-register"> </a><p><b style="color: maroon">Exception parsing generated Narrative (see /tmp/liquid-6c94488b-80ba-46b1-8051-8241f830a9bd.html): unexpected non-end of element null::a at line 105 column 50</b></p></div> </text> <identifier> <system value="https://example.com/fhir/sid/drks"/> <value value="DRKS"/> </identifier> <name value="DRKS - Deutsches Register Klinischer Studien"/> <status value="active"/> <type> <coding> <system value="http://terminology.hl7.org/CodeSystem/library-type"/> <code value="asset-collection"/> </coding> </type> <relatedArtifact> <type value="documentation"/> <url value="https://drks.de/"/> <document> <url value="https://drks.de/"/> </document> </relatedArtifact> </Library> </resource> <request> <method value="POST"/> <url value="MII_PR_Studie_Register"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-author"/> <resource> <Organization> <id value="mii-exa-studie-author"/> <meta> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <name value="Example Organization for Author"/> </Organization> </resource> <request> <method value="POST"/> <url value="Organization"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-custodian"/> <resource> <Organization> <id value="mii-exa-studie-custodian"/> <meta> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <name value="Example Organization for Custodian"/> </Organization> </resource> <request> <method value="POST"/> <url value="Organization"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-practitioner-organization"/> <resource> <Organization> <id value="mii-exa-studie-practitioner-organization"/> <meta> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <name value="Example Organization for Practitioner"/> </Organization> </resource> <request> <method value="POST"/> <url value="Organization"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/Practitioner/mii-exa-studie-practitioner"/> <resource> <Practitioner> <id value="mii-exa-studie-practitioner"/> <meta> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <name> <family value="Mustermann"/> <given value="Max"/> </name> </Practitioner> </resource> <request> <method value="POST"/> <url value="Practitioner"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/ResearchStudy/mii-exa-studie-reference-study"/> <resource> <ResearchStudy> <id value="mii-exa-studie-reference-study"/> <meta> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <title value="Example Reference Study"/> <status value="completed"/> </ResearchStudy> </resource> <request> <method value="POST"/> <url value="ResearchStudy"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/Patient/mii-exa-studie-patient"/> <resource> <Patient> <id value="mii-exa-studie-patient"/> <meta> <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Patient"/> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <identifier> <use value="official"/> <type> <coding> <system value="http://fhir.de/CodeSystem/identifier-type-de-basis"/> <code value="KVZ10"/> </coding> </type> <system value="http://fhir.de/sid/gkv/kvid-10"/> <value value="D92345678"/> </identifier> <name> <family value="Doe"/> <given value="Jane"/> </name> <gender value="female"/> <birthDate value="1980-11-12"/> <deceasedBoolean value="false"/> </Patient> </resource> <request> <method value="POST"/> <url value="Patient"/> </request> </entry> <entry> <fullUrl value="https://www.medizininformatik-initiative.de/Consent/mii-exa-studie-consent"/> <resource> <Consent> <id value="mii-exa-studie-consent"/> <meta> <security> <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/> <code value="HTEST"/> <display value="test health data"/> </security> </meta> <language value="en"/> <text> <status value="generated"/> </text> <status value="active"/> <scope> <coding> <code value="research"/> </coding> </scope> <category> <coding> <system value="http://loinc.org"/> <code value="59284-0"/> </coding> </category> <patient> <reference value="Patient/mii-exa-studie-patient"/> </patient> <policy> <uri value="urn:oid:2.16.840.1.113883.3.1937.777.24.2.1791"/> </policy> </Consent> </resource> <request> <method value="POST"/> <url value="Consent"/> </request> </entry> </Bundle>


  
  
  
  
  
    
    
      
        
        
          
          
            
            
            
          
        
        
        
          
        
        
        
          
        
        
          
        
        
          
            
            
            
            
          </attachment>
        </content>
        <context>
          <related>
            <reference value="ResearchStudy/mii-exa-studie-cohort"/>
          </related>
        </context>
      </DocumentReference>
    </resource>
    <request>
      <method value="POST"/>
      <url value="MII_PR_Studie_Dokument"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_EinAuschlussKriterium/mii-exa-studie-ein-auschluss-kriterium"/>
    <resource>
      <EvidenceVariable>
        <id value="mii-exa-studie-ein-auschluss-kriterium"/>
        <meta>
          <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-ein-auschluss-kriterium"/>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="extensions"/>
        </text>
        <status value="active"/>
        <characteristic>
          <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionReference">
            <valueReference>
              <reference value="EvidenceVariable/mii-exa-studie-evidence-variable-age-restriction"/>
            </valueReference>
          </extension>
          <description value="Altersbeschränkung"/>
          <definitionCodeableConcept>
            <text value="Altersbeschränkung"/>
          </definitionCodeableConcept>
        </characteristic>
        <characteristic>
          <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionCanonical">
            <valueCanonical value="https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender"/>
          </extension>
          <description value="Geschlecht"/>
          <definitionCodeableConcept>
            <text value="Alle"/>
          </definitionCodeableConcept>
          <exclude value="false"/>
        </characteristic>
        <characteristic>
          <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId">
            <valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/>
          </extension>
          <description value="Kognitive Fatigue (WeiMUS kognitive Skala >= 17)"/>
          <definitionCodeableConcept>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
              <code value="unknown"/>
            </coding>
          </definitionCodeableConcept>
          <exclude value="false"/>
        </characteristic>
        <characteristic>
          <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId">
            <valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/>
          </extension>
          <description value="Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt"/>
          <definitionCodeableConcept>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
              <code value="unknown"/>
            </coding>
          </definitionCodeableConcept>
          <exclude value="false"/>
        </characteristic>
        <characteristic>
          <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByCombination">
            <extension url="code">
              <valueCode value="any-of"/>
            </extension>
            <extension url="characteristic">
              <valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/>
            </extension>
            <extension url="characteristic">
              <valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/>
            </extension>
          </extension>
          <description value="Weitere Einschlusskriterien"/>
          <definitionCodeableConcept>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
              <code value="unknown"/>
            </coding>
          </definitionCodeableConcept>
          <exclude value="false"/>
        </characteristic>
        <characteristic>
          <description value="diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen"/>
          <definitionCodeableConcept>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
              <code value="unknown"/>
            </coding>
          </definitionCodeableConcept>
          <exclude value="true"/>
        </characteristic>
        <characteristic>
          <description value="Einnahme von Antidepressiva, Opioiden, Antikonvulsiva"/>
          <definitionCodeableConcept>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
              <code value="unknown"/>
            </coding>
          </definitionCodeableConcept>
          <exclude value="true"/>
        </characteristic>
        <characteristic>
          <description value="weitere neurologische Erkrankungen"/>
          <definitionCodeableConcept>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
              <code value="unknown"/>
            </coding>
          </definitionCodeableConcept>
          <exclude value="true"/>
        </characteristic>
        <characteristic>
          <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByTypeAndValue">
            <extension url="type">
              <valueCodeableConcept>
                <coding>
                  <system value="http://snomed.info/sct"/>
                  <code value="424144002"/>
                  <display value="Current chronological age"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <extension url="value">
              <valueQuantity>
                <value value="18"/>
                <comparator value=">="/>
                <unit value="year"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="a"/>
              </valueQuantity>
            </extension>
          </extension>
          <description value="Alter mindestens 18 Jahre"/>
          <definitionCodeableConcept>
            <text value="Mindestalter"/>
          </definitionCodeableConcept>
          <exclude value="false"/>
        </characteristic>
      </EvidenceVariable>
    </resource>
    <request>
      <method value="POST"/>
      <url value="MII_PR_Studie_EinAuschlussKriterium"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Studie/mii-exa-studie-studie"/>
    <resource>
      <ResearchStudy>
        <id value="mii-exa-studie-studie"/>
        <meta>
          <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie"/>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="extensions"/>
        </text>
        <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">
          <extension url="value">
            <valueString value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/>
          </extension>
          <extension url="type">
            <valueCodeableConcept>
              <coding>
                <system value="http://terminology.hl7.org/CodeSystem/title-type"/>
                <code value="scientific"/>
              </coding>
            </valueCodeableConcept>
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">
          <extension url="value">
            <valueString value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/>
          </extension>
          <extension url="type">
            <valueCodeableConcept>
              <text value="Öffentlicher Titel"/>
            </valueCodeableConcept>
          </extension>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym">
          <valueString value="tDCS"/>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung">
          <extension url="rekrutierungsstart">
            <valueDate value="2023-01-12"/>
          </extension>
          <extension url="rekrutierungsziel">
            <valueInteger value="40"/>
          </extension>
          <extension url="rekrutierungsstand">
            <valueInteger value="35"/>
          </extension>
          <extension url="rekrutierungsstand-genauigkeit">
            <valueString value="good"/>
          </extension>
          <extension url="rekrutierungsstand-datum">
            <valueDate value="2023-02-17"/>
          </extension>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung">
          <valueString value="Öffentliche Förderinstitutionen, aus Steuermitteln getragene Institutionen (DFG, BMBF u. a.)"/>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum">
          <extension url="status">
            <valueString value="Zustimmende Bewertung"/>
          </extension>
          <extension url="kommission">
            <valueString value="Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R."/>
          </extension>
          <extension url="ethiknummer">
            <valueString value="Az.: 83/18"/>
          </extension>
        </extension>
        <identifier>
          <system value="https://example.com/fhir/sid/drks"/>
          <value value="DRKS00031294"/>
        </identifier>
        <title value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/>
        <status value="active"/>
        <category>
          <coding>
            <code value="interventional"/>
          </coding>
        </category>
        <category>
          <text value="Zufallszuteilung"/>
        </category>
        <description value="Diese Studie untersucht den Einfluss repetitiver anodaler Gleichstromstimulation des linken dorsolateralen präfrontalen Kortex (dlPFC ) auf subjektive und objektive Kennwerte und assoziierte EEG-Parameter der Fatigue bei Long-COVID Patient*innen. Die Studie ist sham-kontrolliert und doppelt-verblindet."/>
        <arm>
          <name value="frontale anodale tDCS  (verum condition)"/>
          <description value="vier Stimulationen, jeweils 30 Minuten, 1.5mA über dem linken dlPFC"/>
        </arm>
        <arm>
          <name value="frontale sham tDCS"/>
          <description value="vier Stimulationen, jeweils 30 Minuten"/>
        </arm>
      </ResearchStudy>
    </resource>
    <request>
      <method value="POST"/>
      <url value="MII_PR_Studie_Studie"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Cohort/mii-exa-studie-cohort"/>
    <resource>
      <ResearchStudy>
        <id value="mii-exa-studie-cohort"/>
        <meta>
          <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie"/>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="extensions"/>
        </text>
        <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">
          <extension url="value">
            <valueString value="MII Modul Studie"/>
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty">
          <extension url="role">
            <valueCodeableConcept>
              <coding>
                <system value="http://example.org/fhir/CodeSystem/associated-party-role"/>
                <code value="sponsor"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <extension url="party">
            <valueReference>
              <reference value="Organization/mii-exa-studie-author"/>
            </valueReference>
          </extension>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum">
          <extension url="status">
            <valueString value="genehmigt"/>
          </extension>
          <extension url="kommission">
            <valueString value="Ethik-Kommission der Medizinischen Fakultät der Universität Leipzig"/>
          </extension>
          <extension url="ethiknummer">
            <valueString value="159-12-21052012"/>
          </extension>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister">
          <valueReference>
            <reference value="Library/mii-exa-studie-register"/>
          </valueReference>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility">
          <valueReference>
            <reference value="EvidenceVariable/mii-exa-studie-ein-auschluss-kriterium"/>
          </valueReference>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym">
          <valueString value="LIFE ADULT"/>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung">
          <extension url="rekrutierungsstart">
            <valueDate value="2009-01-01"/>
          </extension>
          <extension url="rekrutierungsziel">
            <valueInteger value="10000"/>
          </extension>
          <extension url="rekrutierungsstand">
            <valueInteger value="10000"/>
          </extension>
          <extension url="rekrutierungsstand-genauigkeit">
            <valueString value="good"/>
          </extension>
          <extension url="rekrutierungsstand-datum">
            <valueDate value="2022-05-28"/>
          </extension>
        </extension>
        <extension url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung">
          <valueString value="Deutsches Bundesministerium für Bildung und Forschung (BMBF)"/>
        </extension>
        <identifier>
          <system value="https://example.com/fhir/sid/lha"/>
          <value value="7Q6PJD8NV3-2"/>
        </identifier>
        <title value="LIFE-Adult-Study"/>
        <partOf>
          <reference value="ResearchStudy/mii-exa-studie-reference-study"/>
        </partOf>
        <status value="active"/>
        <category>
          <coding>
            <system value="http://example.org/fhir/CodeSystem/research-study-category"/>
            <code value="observational"/>
          </coding>
        </category>
        <focus>
          <text value="Erwachsene der Stadt Leipzig"/>
        </focus>
        <keyword>
          <text value="Bevölkerung, Leipzig, Erwachsene"/>
        </keyword>
        <description value="Die LIFE Adult-Studie ist eine langfristig angelegte, bevölkerungsbezogene Kohortenstudie. Stichproben aus der Leipziger Erwachsenenbevölkerung werden hinsichtlich vielfältiger Merkmale und Krankheitsrisiken umfassend untersucht. Insbesondere die Häufigkeit von Volkskrankheiten steht im Mittelpunkt der Forschungsarbeiten. Der Einfluss von Lebensstil- und Umweltfaktoren auf diese Erkrankungen wird charakterisiert. Bisher unbekannte Risikofaktoren für die Entstehung von Volkskrankheiten sollen aufgespürt und neue Möglichkeiten der Früherkennung entwickelt werden."/>
        <arm>
          <name value="LIFE-Adult-Kohorte"/>
        </arm>
      </ResearchStudy>
    </resource>
    <request>
      <method value="POST"/>
      <url value="MII_PR_Studie_Cohort"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Proband/mii-exa-studie-proband"/>
    <resource>
      <ResearchSubject>
        <id value="mii-exa-studie-proband"/>
        <meta>
          <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband"/>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <identifier>
          <type>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
              <code value="ANON"/>
            </coding>
          </type>
          <system value="https://www.medizininformatik-initiative.de/fhir/sid/patienten"/>
          <value value="321123456"/>
        </identifier>
        <status value="candidate"/>
        <period>
          <start value="2023-01-01"/>
          <end value="2023-12-31"/>
        </period>
        <study>
          <reference value="ResearchStudy/mii-exa-studie-cohort"/>
        </study>
        <individual>
          <reference value="Patient/mii-exa-studie-patient"/>
        </individual>
        <consent>
          <reference value="Consent/mii-exa-studie-consent"/>
        </consent>
      </ResearchSubject>
    </resource>
    <request>
      <method value="POST"/>
      <url value="MII_PR_Studie_Proband"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Beteiligte_Person/mii-exa-studie-beteiligte-person"/>
    <resource>
      <PractitionerRole>
        <id value="mii-exa-studie-beteiligte-person"/>
        <meta>
          <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-beteiligte-person"/>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <practitioner>
          <reference value="Practitioner/mii-exa-studie-practitioner"/>
        </practitioner>
        <organization>
          <reference value="Organization/mii-exa-studie-practitioner-organization"/>
        </organization>
        <code>
          <coding>
            <system value="http://terminology.hl7.org/CodeSystem/practitioner-role"/>
            <code value="doctor"/>
          </coding>
        </code>
        <telecom>
          <system value="phone"/>
          <value value="0123456789"/>
        </telecom>
      </PractitionerRole>
    </resource>
    <request>
      <method value="POST"/>
      <url value="MII_PR_Studie_Beteiligte_Person"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Register/mii-exa-studie-register"/>
    <resource>
      <Library>
        <id value="mii-exa-studie-register"/>
        <meta>
          <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-register"/>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="extensions"/><div xml:lang="de" lang="de"><hr/><p><b>German</b></p><hr/><a name="Library_mii-exa-studie-register"> </a><p><b style="color: maroon">Exception parsing generated Narrative (see /tmp/liquid-6c94488b-80ba-46b1-8051-8241f830a9bd.html): unexpected non-end of element null::a  at line 105 column 50</b></p></div>
        </text>
        <identifier>
          <system value="https://example.com/fhir/sid/drks"/>
          <value value="DRKS"/>
        </identifier>
        <name value="DRKS - Deutsches Register Klinischer Studien"/>
        <status value="active"/>
        <type>
          <coding>
            <system value="http://terminology.hl7.org/CodeSystem/library-type"/>
            <code value="asset-collection"/>
          </coding>
        </type>
        <relatedArtifact>
          <type value="documentation"/>
          <url value="https://drks.de/"/>
          <document>
            <url value="https://drks.de/"/>
          </document>
        </relatedArtifact>
      </Library>
    </resource>
    <request>
      <method value="POST"/>
      <url value="MII_PR_Studie_Register"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-author"/>
    <resource>
      <Organization>
        <id value="mii-exa-studie-author"/>
        <meta>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <name value="Example Organization for Author"/>
      </Organization>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Organization"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-custodian"/>
    <resource>
      <Organization>
        <id value="mii-exa-studie-custodian"/>
        <meta>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <name value="Example Organization for Custodian"/>
      </Organization>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Organization"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-practitioner-organization"/>
    <resource>
      <Organization>
        <id value="mii-exa-studie-practitioner-organization"/>
        <meta>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <name value="Example Organization for Practitioner"/>
      </Organization>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Organization"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/Practitioner/mii-exa-studie-practitioner"/>
    <resource>
      <Practitioner>
        <id value="mii-exa-studie-practitioner"/>
        <meta>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <name>
          <family value="Mustermann"/>
          <given value="Max"/>
        </name>
      </Practitioner>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Practitioner"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/ResearchStudy/mii-exa-studie-reference-study"/>
    <resource>
      <ResearchStudy>
        <id value="mii-exa-studie-reference-study"/>
        <meta>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <title value="Example Reference Study"/>
        <status value="completed"/>
      </ResearchStudy>
    </resource>
    <request>
      <method value="POST"/>
      <url value="ResearchStudy"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/Patient/mii-exa-studie-patient"/>
    <resource>
      <Patient>
        <id value="mii-exa-studie-patient"/>
        <meta>
          <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Patient"/>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <identifier>
          <use value="official"/>
          <type>
            <coding>
              <system value="http://fhir.de/CodeSystem/identifier-type-de-basis"/>
              <code value="KVZ10"/>
            </coding>
          </type>
          <system value="http://fhir.de/sid/gkv/kvid-10"/>
          <value value="D92345678"/>
        </identifier>
        <name>
          <family value="Doe"/>
          <given value="Jane"/>
        </name>
        <gender value="female"/>
        <birthDate value="1980-11-12"/>
        <deceasedBoolean value="false"/>
      </Patient>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Patient"/>
    </request>
  </entry>
  <entry>
    <fullUrl value="https://www.medizininformatik-initiative.de/Consent/mii-exa-studie-consent"/>
    <resource>
      <Consent>
        <id value="mii-exa-studie-consent"/>
        <meta>
          <security>
            <system value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
            <code value="HTEST"/>
            <display value="test health data"/>
          </security>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
        </text>
        <status value="active"/>
        <scope>
          <coding>
            <code value="research"/>
          </coding>
        </scope>
        <category>
          <coding>
            <system value="http://loinc.org"/>
            <code value="59284-0"/>
          </coding>
        </category>
        <patient>
          <reference value="Patient/mii-exa-studie-patient"/>
        </patient>
        <policy>
          <uri value="urn:oid:2.16.840.1.113883.3.1937.777.24.2.1791"/>
        </policy>
      </Consent>
    </resource>
    <request>
      <method value="POST"/>
      <url value="Consent"/>
    </request>
  </entry>
</Bundle>