Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: NCT03640312 Eligibility Criteria - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@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 xsd: <http://www.w3.org/2001/XMLSchema#> .

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

 a fhir:Group ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "367881"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "26" ] ;
fhir:lastUpdated [ fhir:v "2025-08-18T13:22:42.074Z"^^xsd:dateTime ]
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Group 367881</b></p><a name=\"367881\"> </a><a name=\"hc367881\"> </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\">version: 26; Last updated: 2025-08-18 13:22:42+0000</p></div><p><b>Artifact Author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>CiteAs</b>: </p><div><p>NCT03640312 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367881. Revised 2025-08-18. Available at: https://fevir.net/resources/Group/367881. Computable resource at: https://fevir.net/resources/Group/367881#json.</p>\n</div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"https://fevir.net/resources/Group/367881\">https://fevir.net/resources/Group/367881</a></p><p><b>identifier</b>: FEvIR Object Identifier/367881, FEvIR Linking Identifier/NCT03640312 Eligibility Criteria</p><p><b>name</b>: NCT03640312_Eligibility_Criteria</p><p><b>title</b>: NCT03640312 Eligibility Criteria</p><p><b>status</b>: Active</p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>description</b>: </p><div><p>Inclusion Criteria:</p>\n<ul>\n<li>Adults (≥18 years)</li>\n<li>Spanish or English speaker.</li>\n<li>Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).</li>\n<li>Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.</li>\n<li>Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.</li>\n<li>Research grade blood pressure measurement (baseline mean) SBP&gt;= 115 mmHg and DBP &gt;= 60 mmHg</li>\n</ul>\n<p>Exclusion Criteria:</p>\n<ul>\n<li>Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.</li>\n<li>Previous diagnosis of coronary artery disease, stroke, or heart failure.</li>\n<li>Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or &gt;300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)</li>\n<li>Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR &lt;50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).</li>\n<li>Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).</li>\n<li>Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.</li>\n<li>Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.</li>\n<li>Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.</li>\n<li>Inability or unwillingness to provide written informed consent.</li>\n<li>Unable to complete study procedures.</li>\n</ul>\n</div><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><p><b>membership</b>: Conceptual</p><p><b>combinationMethod</b>: All of</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Eligibility Criteria</span></p><p><b>value</b>: Inclusion Criteria:\n\n* Adults (≥18 years)\n* Spanish or English speaker.\n* Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).\n* Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.\n* Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.\n* Research grade blood pressure measurement (baseline mean) SBP\\&gt;= 115 mmHg and DBP \\&gt;= 60 mmHg\n\nExclusion Criteria:\n\n* Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.\n* Previous diagnosis of coronary artery disease, stroke, or heart failure.\n* Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \\&gt;300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)\n* Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \\&lt;50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).\n* Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).\n* Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.\n* Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n* Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.\n* Inability or unwillingness to provide written informed consent.\n* Unable to complete study procedures.</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Accepts Healthy Volunteers</span></p><p><b>value</b>: false</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Age</span></p><p><b>value</b>: 18-? year</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Age Group</span></p><p><b>value</b>: <span title=\"Codes:\">Adult or Older Adult</span></p><p><b>exclude</b>: false</p></blockquote></div>"^^rdf:XMLLiteral
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fhir:v "NCT03640312 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367881. Revised 2025-08-18. Available at: https://fevir.net/resources/Group/367881. Computable resource at: https://fevir.net/resources/Group/367881#json."     ]
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fhir:display [ fhir:v "Active" ]       ] )     ]
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  fhir:description [ fhir:v "Inclusion Criteria:\n\n* Adults (≥18 years)\n* Spanish or English speaker.\n* Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).\n* Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.\n* Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.\n* Research grade blood pressure measurement (baseline mean) SBP\\>= 115 mmHg and DBP \\>= 60 mmHg\n\nExclusion Criteria:\n\n* Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.\n* Previous diagnosis of coronary artery disease, stroke, or heart failure.\n* Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \\>300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)\n* Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \\<50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).\n* Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).\n* Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.\n* Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n* Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.\n* Inability or unwillingness to provide written informed consent.\n* Unable to complete study procedures."] ; # 
  fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # 
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fhir:display [ fhir:v "Inclusion Criteria:\n\n* Adults (≥18 years)\n* Spanish or English speaker.\n* Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).\n* Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.\n* Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.\n* Research grade blood pressure measurement (baseline mean) SBP\\>= 115 mmHg and DBP \\>= 60 mmHg\n\nExclusion Criteria:\n\n* Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.\n* Previous diagnosis of coronary artery disease, stroke, or heart failure.\n* Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \\>300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)\n* Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \\<50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).\n* Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).\n* Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.\n* Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n* Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.\n* Inability or unwillingness to provide written informed consent.\n* Unable to complete study procedures." ]     ] ;
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