German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
<ResearchStudy xmlns="http://hl7.org/fhir">
<id value="ExampleStudyRAAINBOW"/>
<meta>
<profile
value="https://www.vision-zero-oncology.de/fhir/StructureDefinition/clinical-study"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ResearchStudy</b><a name="ExampleStudyRAAINBOW"> </a></p><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">Resource ResearchStudy "ExampleStudyRAAINBOW" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-clinical-study.html">Profile Clinical Study</a></p></div><p><b>identifier</b>: id: NCT03240627</p><p><b>title</b>: Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.</p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-prim-purp-type.html">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 2/Phase 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-phase.html">ResearchStudyPhase</a>#phase-2-phase-3)</span></p><p><b>category</b>: Interventional Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C98388)</span>, Randomized Controlled Clinical Trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C46079)</span>, Double Blind Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C15228)</span>, Unequal Randomization <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C142743)</span></p><p><b>focus</b>: Pharmacologic Substance <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C1909)</span></p><p><b>condition</b>: Alopecia areata (disorder) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#68225006)</span></p><p><b>location</b>: Germany <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#DE)</span>, France <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#FR)</span></p><p><b>period</b>: 2018-03-01 --> 2022-03-17</p><p><b>principalInvestigator</b>: <a href="https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Practitioner/example">Practitioner/example</a></p><p><b>site</b>: </p><ul><li><a href="https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Charite-dermatology">Organization/Charite-dermatology</a></li><li><a href="https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Sabouraud-Center">Organization/Sabouraud-Center</a></li><li><a href="https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Diagnostic-consulting-center-XXIV-Sofia">Organization/Diagnostic-consulting-center-XXIV-Sofia</a></li><li><a href="https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/SC-Centrul-Medical-Sana-SRL">Organization/SC-Centrul-Medical-Sana-SRL</a></li></ul><blockquote><p><b>arm</b></p><p><b>name</b>: Experimental: LH-8 cutaneous solution</p><p><b>type</b>: Investigational Arm <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C174266)</span></p><p><b>description</b>: LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo Comparator: Placebo cutaneous solution</p><p><b>type</b>: Control Arm <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C174226)</span></p><p><b>description</b>: Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ] Visual assessment and global standardised scalp photographs for SALT evaluation.</p><p><b>type</b>: Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Adverse events [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: General physical examination findings, including irritation of eyes and skin [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation).</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>
</text>
<identifier>
<system value="http://clinicaltrials.gov"/>
<value value="NCT03240627"/>
</identifier>
<title
value="Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata."/>
<status value="completed"/>
<primaryPurposeType>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
<code value="treatment"/>
</coding>
</primaryPurposeType>
<phase>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
<code value="phase-2-phase-3"/>
<display value="Phase 2/Phase 3"/>
</coding>
</phase>
<category>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C98388"/>
<display value="Interventional Study"/>
</coding>
</category>
<category>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C46079"/>
<display value="Randomized Controlled Clinical Trial"/>
</coding>
</category>
<category>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C15228"/>
<display value="Double Blind Study"/>
</coding>
</category>
<category>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C142743"/>
<display value="Unequal Randomization"/>
</coding>
</category>
<focus>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C1909"/>
<display value="Pharmacologic Substance"/>
</coding>
</focus>
<condition>
<coding>
<system value="http://snomed.info/sct"/>
<code value="68225006"/>
<display value="Alopecia areata (disorder)"/>
</coding>
</condition>
<location>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="DE"/>
<display value="Germany"/>
</coding>
</location>
<location>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="FR"/>
<display value="France"/>
</coding>
</location>
<period>
<start value="2018-03-01"/>
<end value="2022-03-17"/>
</period>
<principalInvestigator>
<reference value="Practitioner/example"/>
</principalInvestigator>
<site>
<reference value="Organization/Charite-dermatology"/>
</site>
<site>
<reference value="Organization/Sabouraud-Center"/>
</site>
<site>
<reference value="Organization/Diagnostic-consulting-center-XXIV-Sofia"/>
</site>
<site>
<reference value="Organization/SC-Centrul-Medical-Sana-SRL"/>
</site>
<arm>
<name value="Experimental: LH-8 cutaneous solution"/>
<type>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C174266"/>
<display value="Investigational Arm"/>
</coding>
</type>
<description
value="LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp"/>
</arm>
<arm>
<name value="Placebo Comparator: Placebo cutaneous solution"/>
<type>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C174226"/>
<display value="Control Arm"/>
</coding>
</type>
<description
value="Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp"/>
</arm>
<objective>
<name
value="Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ] Visual assessment and global standardised scalp photographs for SALT evaluation."/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="primary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name value="Adverse events [ Time Frame: 48 weeks ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="General physical examination findings, including irritation of eyes and skin [ Time Frame: 24 weeks treatment ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation)."/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores. [ Time Frame: 48 weeks ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. [ Time Frame: 48 weeks ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
</type>
</objective>
</ResearchStudy>
IG © 2021+ Berlin Institute of Health at Charité (BIH). Package gold#0.1.0 based on FHIR 4.0.1. Generated 2023-12-13
Links: Table of Contents |
QA Report