@base . @prefix rdf: . @prefix : <> . @prefix dc: . @prefix uo: . @prefix dct: . @prefix obo: . @prefix owl: . @prefix sio: . @prefix xml: . @prefix xsd: . @prefix cito: . @prefix doid: . @prefix foaf: . @prefix ncit: . @prefix pato: . @prefix prov: . @prefix rdfs: . @prefix skos: . @prefix vann: . @prefix chear: . @prefix hasco: . @prefix stato: . @prefix hasco1: . @prefix schema: . @prefix protege: . @prefix oboInOwl: . @prefix provcare: . @prefix fibo-fnd-utl-av: . chear:Anthropometry a owl:Class ; rdfs:subClassOf :SubjectCharacteristic . chear:Demographic dct:source "Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition" ; a owl:Class ; rdfs:subClassOf :SubjectCharacteristic ; skos:definition "the science dealing with populations, including matters of health, disease, births, and mortality"^^xsd:string . chear:MedicalTherapy dct:source "https://en.wikipedia.org/wiki/Therapy" ; a owl:Class ; rdfs:label "medical therapy" ; rdfs:subClassOf provcare:Intervention ; skos:definition "the attempted remediation of a health problem, usually following a diagnosis"^^xsd:string . chear:NonHispanicOrLatino oboInOwl:hasExactSynonym "Non-Hispanic" . chear:UnderweightOrNormal oboInOwl:hasExactSynonym "Normal or Underweight", "Underweight or Normal" . chear:UnknownRace oboInOwl:hasExactSynonym "Other Race" . hasco:ResearchStudy sio:hasAttribute _:genid40 ; a owl:Class, owl:NamedIndividual ; rdfs:label "research study", "study" ; rdfs:subClassOf sio:Study, [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom :CohortDescription ], [ a owl:Restriction ; owl:onProperty sio:hasParticipant ; owl:someValuesFrom sio:StudySubject ] . obo:CARO_0000000 obo:IAO_0000412 ; a owl:Class ; rdfs:label "anatomical entity"^^xsd:string ; rdfs:subClassOf obo:CARO_0030000 . obo:CARO_0000003 obo:IAO_0000412 , ; a owl:Class ; rdfs:label "anatomical structure"@en, "connected anatomical structure"^^xsd:string ; rdfs:subClassOf obo:CARO_0000006 . obo:CARO_0000006 obo:IAO_0000412 , ; a owl:Class ; rdfs:label "material anatomical entity"^^xsd:string, "material anatomical entity"@en ; rdfs:subClassOf obo:CARO_0000000 . obo:CARO_0010000 obo:IAO_0000412 , ; a owl:Class ; rdfs:label "multicellular anatomical structure"^^xsd:string ; rdfs:subClassOf obo:CARO_0000003 . obo:CARO_0030000 obo:IAO_0000412 ; a owl:Class ; rdfs:label "biological entity"^^xsd:string . obo:CL_0000000 obo:IAO_0000412 , ; a owl:Class ; rdfs:label "cell"^^xsd:string, "cell"@en ; rdfs:subClassOf obo:CARO_0000003 . obo:DOID_4 obo:IAO_0000412 ; dct:source "http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf" ; a owl:Class ; rdfs:label "disease or condition" ; rdfs:subClassOf sio:BiologicalQuality ; skos:definition "A disease is a disposition (i) to undergo pathological processes that (ii) exists in an organism because of one or more disorders in that organism" . obo:HP_0001513 obo:IAO_0000115 "Accumulation of substantial excess body fat." ; obo:IAO_0000412 ; oboInOwl:hasDbXref "MSH:D009765"^^xsd:string, "SNOMEDCT_US:414915002"^^xsd:string, "SNOMEDCT_US:414916001"^^xsd:string, "UMLS:C0028754"^^xsd:string ; oboInOwl:hasExactSynonym "Having too much body fat", "Obesity"^^xsd:string ; oboInOwl:hasOBONamespace "human_phenotype"^^xsd:string ; oboInOwl:id "HP:0001513"^^xsd:string ; a owl:Class ; rdfs:label "Obesity"^^xsd:string . obo:HP_0001956 obo:IAO_0000115 "Obesity located preferentially in the trunk of the body as opposed to the extremities."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:hasAlternativeId "HP:0008885"^^xsd:string ; oboInOwl:hasDbXref "MSH:D056128"^^xsd:string, "SNOMEDCT_US:248311001"^^xsd:string, "UMLS:C0311277"^^xsd:string ; oboInOwl:hasExactSynonym "Centripetal obesity"^^xsd:string, "Truncal obesity"^^xsd:string ; oboInOwl:hasOBONamespace "human_phenotype"^^xsd:string ; oboInOwl:id "HP:0001956"^^xsd:string ; a owl:Class ; rdfs:label "Truncal obesity"^^xsd:string ; rdfs:subClassOf obo:HP_0001513 . obo:HP_0004324 obo:IAO_0000115 "Abnormally increased body weight." ; obo:IAO_0000412 ; oboInOwl:created_by "peter"^^xsd:string ; oboInOwl:creation_date "2008-02-27T03:21:00Z"^^xsd:string ; oboInOwl:hasAlternativeId "HP:0045083" ; oboInOwl:hasDbXref "MSH:D015430"^^xsd:string, "SNOMEDCT_US:161831008"^^xsd:string, "SNOMEDCT_US:262286000"^^xsd:string, "SNOMEDCT_US:8943002"^^xsd:string, "UMLS:C0043094"^^xsd:string ; oboInOwl:hasExactSynonym "Increased body weight"^^xsd:string ; oboInOwl:hasOBONamespace "human_phenotype"^^xsd:string ; oboInOwl:hasRelatedSynonym "Weight gain"^^xsd:string ; oboInOwl:id "HP:0004324"^^xsd:string ; a owl:Class ; rdfs:label "Increased body weight"^^xsd:string . obo:HP_0004325 obo:IAO_0000115 "Abnormally low body weight." ; obo:IAO_0000412 ; oboInOwl:created_by "peter"^^xsd:string ; oboInOwl:creation_date "2008-02-27T03:22:00Z"^^xsd:string ; oboInOwl:hasAlternativeId "HP:0001823"^^xsd:string, "HP:0001826"^^xsd:string ; oboInOwl:hasDbXref "MSH:D013851"^^xsd:string, "MSH:D015431"^^xsd:string, "SNOMEDCT_US:161832001"^^xsd:string, "SNOMEDCT_US:248342006"^^xsd:string, "SNOMEDCT_US:262285001"^^xsd:string, "SNOMEDCT_US:89362005"^^xsd:string, "UMLS:C0041667"^^xsd:string, "UMLS:C1262477"^^xsd:string, "UMLS:C1844806"^^xsd:string ; oboInOwl:hasExactSynonym "Decreased body weight"^^xsd:string, "Decreased weight"^^xsd:string, "Low body weight"^^xsd:string, "Low weight"^^xsd:string, "Underweight"^^xsd:string, "Weight less than 3rd percentile"^^xsd:string ; oboInOwl:hasOBONamespace "human_phenotype"^^xsd:string ; oboInOwl:id "HP:0004325"^^xsd:string ; a owl:Class ; rdfs:label "Decreased body weight"^^xsd:string ; rdfs:subClassOf chear:UnderweightOrNormal . obo:HP_0008915 obo:IAO_0000115 "Truncal obesity with onset during childhood, defined as between 2 and 10 years of age."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:hasAlternativeId "HP:0008874"^^xsd:string ; oboInOwl:hasDbXref "UMLS:C1859846"^^xsd:string ; oboInOwl:hasExactSynonym "Truncal obesity apparent in childhood"^^xsd:string ; oboInOwl:hasOBONamespace "human_phenotype"^^xsd:string ; oboInOwl:id "HP:0008915"^^xsd:string ; a owl:Class ; rdfs:label "Childhood-onset truncal obesity"^^xsd:string ; rdfs:subClassOf obo:HP_0001956 . obo:HP_0012743 obo:IAO_0000115 "Excessive fat around the stomach and abdomen."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:created_by "peter"^^xsd:string ; oboInOwl:creation_date "2014-03-23T05:00:05Z"^^xsd:string ; oboInOwl:hasDbXref "MSH:D056128"^^xsd:string, "SNOMEDCT_US:248311001"^^xsd:string, "UMLS:C0311277"^^xsd:string ; oboInOwl:hasExactSynonym "Abdominal obesity"^^xsd:string, "Central obesity" ; oboInOwl:hasOBONamespace "human_phenotype"^^xsd:string ; oboInOwl:id "HP:0012743"^^xsd:string ; a owl:Class ; rdfs:label "Abdominal obesity"^^xsd:string ; rdfs:subClassOf obo:HP_0001513 . obo:HP_0025499 obo:IAO_0000115 "Obesity with a body mass index of 30 to 34.9 kg per square meter." ; obo:IAO_0000412 ; dc:creator "HPO:probinson"^^xsd:string ; dc:date "2017-05-14T20:06:40Z"^^xsd:dateTime ; oboInOwl:hasExactSynonym "Class 1 obesity", "Obesity grade 1" ; a owl:Class ; rdfs:label "Class I obesity"@en ; rdfs:subClassOf obo:HP_0001513 . obo:HP_0025500 obo:IAO_0000115 "Obesity with a body mass index of 35 to 39.9 kg per square meter." ; obo:IAO_0000412 ; dc:creator "HPO:probinson"^^xsd:string ; dc:date "2017-05-14T20:08:43Z"^^xsd:dateTime ; oboInOwl:hasExactSynonym "Class 2 obesity", "Obesity grade 2" ; a owl:Class ; rdfs:label "Class II obesity"@en ; rdfs:subClassOf obo:HP_0001513 . obo:HP_0025501 obo:IAO_0000115 "Obesity with a body mass index of 40 kg per square meter or higher." ; obo:IAO_0000412 ; dc:creator "HPO:probinson"^^xsd:string ; dc:date "2017-05-14T20:09:17Z"^^xsd:dateTime ; oboInOwl:hasExactSynonym "Class 3 obesity", "Obesity grade 3" ; a owl:Class ; rdfs:label "Class III obesity"@en ; rdfs:subClassOf obo:HP_0001513 . obo:HP_0025502 obo:IAO_0000115 "Increased body weight with a body mass index of 25-29.9 kg per square meter." ; obo:IAO_0000412 ; dc:creator "HPO:probinson"^^xsd:string ; dc:date "2017-05-14T20:12:36Z"^^xsd:dateTime ; a owl:Class ; rdfs:label "Overweight"@en . obo:HP_0045082 obo:IAO_0000115 "Abnormally decreased weight-to-height squared ratio, calculated by dividing the individual's weight in kilograms by the square of the individual's height in meters and used as an indicator of underweight compared to averages." ; obo:IAO_0000412 ; oboInOwl:hasExactSynonym "Decreased BMI" ; a owl:Class ; rdfs:label "Decreased body mass index" . obo:IAO_0000112 a owl:AnnotationProperty . obo:IAO_0000114 a owl:AnnotationProperty . obo:IAO_0000115 a owl:AnnotationProperty . obo:IAO_0000116 a owl:AnnotationProperty . obo:IAO_0000117 a owl:AnnotationProperty . obo:IAO_0000119 a owl:AnnotationProperty . obo:IAO_0000412 a owl:AnnotationProperty . obo:IAO_0000589 a owl:AnnotationProperty . obo:NCIT_C142488 obo:IAO_0000115 "Review of clinical information to determine veracity, thoroughness, and dependability." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142488" ; obo:NCIT_P106 "Activity" ; obo:NCIT_P108 "Data Monitoring" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "Process by which clinical data are examined for completeness, consistency, and accuracy." ; oboInOwl:hasExactSynonym "Data Monitoring", "data monitoring" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "data monitoring" ; rdfs:subClassOf obo:NCIT_C61256 . obo:NCIT_C142526 obo:IAO_0000115 "A clinical trial in which computerized systems are used to plan, collect, access, exchange, and archive data." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142526" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Electronic Clinical Trial" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [DRAFT Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. Synonyms: eClinical study, eClinical investigation." ; oboInOwl:hasExactSynonym "Electronic Clinical Trial", "eClinical Trial", "eclinical trial" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "electronic clinical trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C142539 obo:IAO_0000115 "A clinical trial with the objective of demonstrating clinical insignificance between the responses to two or more treatments." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142539" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Equivalence Trial" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically unimportant. NOTE: This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences." ; oboInOwl:hasExactSynonym "Equivalence Trial", "equivalence trial" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "equivalence trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C142547 obo:IAO_0000115 "A type of clinical trial that involves low dosage and short duration of drug exposure for a limited number of study participants with the intent of gathering preliminary data on the mechanism of action, pharmacodynamics, pharmacokinetics, or bioavailability of promising therapeutic candidate agents in human subjects." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142547" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Exploratory Investigational New Drug Study" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "A clinical study that is conducted early in Phase 1; involves very limited human exposure and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [FDA Guidance for industry, investigators, and Reviewers: exploratory IND studies, January 2006] See also Phase 0." ; oboInOwl:hasExactSynonym "Exploratory IND Study", "Exploratory Investigational New Drug Study", "exploratory IND study" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "exploratory investigational new drug study" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C142601 obo:IAO_0000115 "A clinical trial that is non-interventional by design but includes diagnostic or monitoring procedures that carry minimal risk or impact on patients." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142601" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Low-interventional Clinical Trial" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "A clinical trial which fulfills all of the following conditions: (a) the investigational medicinal products, excluding placebos, are authorized; (b) according to the protocol of the clinical trial, (i) the investigational medicinal products are used in accordance with the terms of the marketing authorization; or (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and (c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned. [REGULATION (EU) No 536/2014 Article 2.2.(3)]" ; oboInOwl:hasExactSynonym "Low-interventional Clinical Trial", "low-interventional clinical trial" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "low-interventional clinical trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C142603 obo:IAO_0000115 "A type of clinical trial in which the therapeutic benefits of a marketed product are either clarified or preferentially compared to another marketed product." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142603" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Marketing Support Trials" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decision-makers the rationale for preferring one therapy over another." ; oboInOwl:hasExactSynonym "Marketing Support Trials", "marketing support trials" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "marketing support trials" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C142609 obo:IAO_0000115 "A type of clinical trial in which 10,000 or more subjects are enrolled." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142609" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Mega-Trial" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "Massive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects." ; oboInOwl:hasExactSynonym "Mega-Trial", "large sample trial", "mega-trials" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "mega-trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C142641 obo:IAO_0000115 "A study designed to test the effectiveness of an intervention in a broad routine clinical practice." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142641" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Pragmatic Trial" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "Term used to describe a clinical study designed to examine the benefits of a product under real world conditions." ; oboInOwl:hasExactSynonym "Pragmatic Trial", "pragmatic trial" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "pragmatic trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C142722 obo:IAO_0000115 "A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). (ICH)" ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C142722" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Superiority Trial" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). [ICH E9]" ; oboInOwl:hasExactSynonym "Superiority Trial", "superiority trial" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "superiority trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C15206 obo:IAO_0000115 "Research conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, study of mechanisms of human diseases, therapy, clinical trials, epidemiologic, behavior, and health services research." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C15206" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Clinical Study" ; obo:NCIT_P207 "C0008972" ; obo:NCIT_P322 "CDISC", "CDISC-GLOSS", "FDA" ; obo:NCIT_P325 "A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial.", "A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial. (CDISC Glossary)" ; obo:NCIT_P366 "Clinical_Study" ; oboInOwl:hasExactSynonym "CLINICAL STUDY", "Clinical Research", "Clinical Studies", "Clinical Study", "Study", "clinical study" ; oboInOwl:inSubset , , , , , ; a owl:Class ; rdfs:label "clinical study" ; rdfs:subClassOf obo:NCIT_C63536 . obo:NCIT_C15362 obo:IAO_0000115 "An uncontrolled observational study containing a detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin)." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C15362" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Case Study" ; obo:NCIT_P207 "C0085973" ; obo:NCIT_P322 "CDISC" ; obo:NCIT_P325 "A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin).", "A study in which the subject with the condition under study (the case) is compared against a theoretical/historical model of distribution that serves as a control." ; obo:NCIT_P366 "Case_Study" ; oboInOwl:hasExactSynonym "CASE ONLY", "Case Report", "Case Study", "case report" ; oboInOwl:inSubset , , , ; a owl:Class ; rdfs:label "case study" ; rdfs:subClassOf hasco:ResearchStudy . obo:NCIT_C15429 obo:IAO_0000115 "Systematic investigation into a subject in order to discover facts, establish or revise a theory, or develop a plan of action based on the facts discovered." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C15429" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Research Activity" ; obo:NCIT_P207 "C0242481" ; obo:NCIT_P325 "A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future." ; obo:NCIT_P366 "Research_Activity" ; oboInOwl:hasExactSynonym "Research", "Research Activity", "research study" ; a owl:Class ; rdfs:label "research activity" ; rdfs:subClassOf obo:NCIT_C16203 . obo:NCIT_C15602 obo:IAO_0000115 "A clinical research protocol designed to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand), to confirm efficacy, to monitor adverse reactions to the new medication or treatment regimen with respect to long-term use and by comparing the intervention to other standard or experimental interventions as well as to a placebo." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C15602" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Phase III Trial" ; obo:NCIT_P207 "C0282461" ; obo:NCIT_P322 "CDISC", "CDISC-GLOSS" ; obo:NCIT_P325 "A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.", "Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)", "Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [after FDA CDER handbook, ICH E8]" ; obo:NCIT_P366 "Phase_III_Trial" ; oboInOwl:hasExactSynonym "3", "Clinical Trials, Phase III", "PHASE III TRIAL", "Phase 3 Study", "Phase III Clinical Trial", "Phase III Protocol", "Phase III Study", "Phase III Trial", "Phase III Trials", "Trial Phase 3", "phase 3", "phase III trial" ; oboInOwl:inSubset , , , , ; a owl:Class ; rdfs:label "phase III trial" ; rdfs:subClassOf obo:NCIT_C70820 . obo:NCIT_C15693 obo:IAO_0000115 "A clinical research protocol designed to study the safety, dosage levels and response to new treatment. Phase I/II trials combine a Phase I and a Phase II trial of the same treatment into a single protocol." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C15693" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Phase I/II Trial" ; obo:NCIT_P207 "C1519043" ; obo:NCIT_P322 "CDISC" ; obo:NCIT_P325 "A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II.", "A trial to study the safety, dosage levels, and response to a new treatment." ; obo:NCIT_P366 "Phase_I_II_Trial" ; oboInOwl:hasExactSynonym "1-2", "PHASE I/II TRIAL", "Phase I/II Trial", "Phase I/II trial", "Trial Phase 1-2", "Trial Phase 1/2" ; oboInOwl:inSubset , , , ; a owl:Class ; rdfs:label "phase I/II trial" ; rdfs:subClassOf obo:NCIT_C70820 . obo:NCIT_C15835 obo:IAO_0000115 "Select candidate vaccines or concepts suitable for Phase I and Phase II trials and conduct these trials." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C15835" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Phase I and II Vaccine Trials" ; obo:NCIT_P207 "C1519044" ; obo:NCIT_P366 "Phase_I_and_II_Vaccine_Trials" ; oboInOwl:hasExactSynonym "Phase I and II Vaccine Trials" ; a owl:Class ; rdfs:label "phase I and II Vaccine trial" ; rdfs:subClassOf obo:NCIT_C15693, obo:NCIT_C15864 . obo:NCIT_C15864 obo:IAO_0000412 ; obo:NCIT_NHC0 "C15864" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Vaccine Clinical Trial" ; obo:NCIT_P207 "C1519888" ; obo:NCIT_P366 "Vaccine_Clinical_Trial" ; oboInOwl:hasExactSynonym "Vaccine Clinical Trial" ; a owl:Class ; rdfs:label "vaccine clinical trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C15873 obo:IAO_0000115 "Select suitable vaccine candidates and support efficacy trials when appropriate criteria are met." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C15873" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Phase III Large Scale Vaccine Trial" ; obo:NCIT_P207 "C1519902" ; obo:NCIT_P366 "Vaccine_Trial-Phase_III_Large_Scale" ; oboInOwl:hasExactSynonym "Phase III Large Scale Vaccine Trial", "Vaccine Trial-Phase III Large Scale" ; a owl:Class ; rdfs:label "phase III large scale vaccine trial" ; rdfs:subClassOf obo:NCIT_C15602, obo:NCIT_C15864 . obo:NCIT_C16104 obo:IAO_0000412 ; obo:NCIT_NHC0 "C16104" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Multi-Institutional Clinical Trial" ; obo:NCIT_P207 "C0206012" ; obo:NCIT_P322 "CDISC-GLOSS" ; obo:NCIT_P325 "A clinical trial that is carried out at more than one medical institution.", "Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/ institution." ; obo:NCIT_P366 "Multi-Institutional_Clinical_Trial" ; oboInOwl:hasExactSynonym "Multi-Institutional Clinical Trial", "multicenter study", "multicenter trial" ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "multi-institutional clinical trial" ; rdfs:subClassOf obo:NCIT_C70824, obo:NCIT_C71104 . obo:NCIT_C16123 obo:IAO_0000115 "A clinical trial that is not therapeutic, preventive or diagnostic." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C16123" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Clinical Trial, Other" ; obo:NCIT_P207 "C1516648" ; obo:NCIT_P366 "Clinical_Trials_Other" ; oboInOwl:hasExactSynonym "Clinical Trial, Other", "Clinical Trials, Other", "Other Clinical Trial" ; a owl:Class ; rdfs:label "clinical trial, other" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C16203 obo:IAO_0000115 "Any specific activity undertaken during the course of a clinical study or research protocol." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C16203" ; obo:NCIT_P106 "Activity" ; obo:NCIT_P108 "Clinical or Research Activity" ; obo:NCIT_P207 "C1516654" ; obo:NCIT_P366 "Clinical_or_Research_Activity" ; oboInOwl:hasExactSynonym "Clinical or Research Activity" ; a owl:Class ; rdfs:label "clinical or research activity" ; rdfs:subClassOf obo:NCIT_C43431 . obo:NCIT_C16352 oboInOwl:hasExactSynonym "Black" . obo:NCIT_C17459 oboInOwl:hasExactSynonym "Hispanic", "Hispanic Populations", "Hispanic or Latino", "Hispanics or Latinos", "Latino Population", "Spanish Origins" . obo:NCIT_C18237 obo:IAO_0000115 "Denotes a person having origins in any indigenous people of Alaska and their descendants and who maintains tribal affiliation, or community or cultural attachment. The concept refers to population subgroups such as Eskimos, Aleuts, Inupiat, Yupik, Alutiiq, Egegik,and Pribilovian, Alaskan Athabascan, Tlingit, and Haida. The concept refers also to individuals who classify themselves as such." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C18237" ; obo:NCIT_P106 "Population Group" ; obo:NCIT_P108 "Alaska Native" ; obo:NCIT_P207 "C0682125" ; obo:NCIT_P325 "The native people of Alaska." ; obo:NCIT_P366 "Alaska_Native" ; oboInOwl:hasExactSynonym "ALASKA NATIVE", "Alaska Indian", "Alaska Indians", "Alaska Native", "Alaska Natives", "Alaskan Native" ; a owl:Class ; rdfs:label "Alaska Native" ; rdfs:subClassOf obo:NCIT_C41259 . obo:NCIT_C18707 obo:IAO_0000115 "A clinical trial that uses materials from some other clinical trial." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C18707" ; obo:NCIT_P106 "Governmental or Regulatory Activity" ; obo:NCIT_P108 "Adjunct Clinical Trial" ; obo:NCIT_P207 "C1516638" ; obo:NCIT_P366 "Clinical_Trials_Adjunct" ; oboInOwl:hasExactSynonym "Adjunct Clinical Trial", "Clinical Trial, Adjunct", "Clinical Trials, Adjunct" ; a owl:Class ; rdfs:label "adjunct clinical trial" ; rdfs:subClassOf obo:NCIT_C71104 . obo:NCIT_C25613 obo:IAO_0000115 "A fraction or ratio with 100 understood as the denominator." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C25613" ; obo:NCIT_P106 "Conceptual Entity" ; obo:NCIT_P108 "Percentage" ; obo:NCIT_P207 "C0439165" ; obo:NCIT_P322 "CDISC", "NCPDP" ; obo:NCIT_P325 "One hundred times the quotient of one quantity divided by another, with the same units of measurement." ; obo:NCIT_P366 "Percentage" ; oboInOwl:hasExactSynonym "%", "Percentage" ; oboInOwl:inSubset , , , , , , , , ; a owl:Class ; rdfs:label "percentage" ; rdfs:subClassOf provcare:StatisticalMeasure . obo:NCIT_C41219 oboInOwl:hasExactSynonym "Hawaiiaan", "Hawaiian or Pacific Islander", "Pacific Islander" . obo:NCIT_C41259 oboInOwl:hasExactSynonym "AMERICAN INDIAN OR ALASKA NATIVE", "American Indian or Alaska Native", "First Nations", "Native American", "Native Americans", "american indian or alaska native" . obo:NCIT_C43431 obo:IAO_0000115 "An active process; excludes processes and mechanisms which fulfill biological functions." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C43431" ; obo:NCIT_P106 "Activity" ; obo:NCIT_P108 "Activity" ; obo:NCIT_P207 "C0441655" ; obo:NCIT_P322 "BRIDG" ; obo:NCIT_P325 "Any action that can, in the context of a study or a post-marketing investigation, be defined, planned, scheduled or performed. EXAMPLE(S): surgical procedure, laboratory test, administration of a drug." ; obo:NCIT_P366 "Activity" ; oboInOwl:hasExactSynonym "Activity", "General activity" ; oboInOwl:inSubset ; a owl:Class ; rdfs:label "activity" ; rdfs:subClassOf owl:Thing . obo:NCIT_C43877 obo:IAO_0000115 "Denotes a person having origins in one of the indigenous peoples of North America, who lived on the continent prior to the European colonization. The term includes individuals belonging to a large number of tribes, states, and ethnic groups, many of them still enduring as communities." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C43877" ; obo:NCIT_P106 "Population Group" ; obo:NCIT_P108 "American Indian" ; obo:NCIT_P207 "C0002460" ; obo:NCIT_P325 "The native people of North America." ; obo:NCIT_P366 "American_Indian" ; oboInOwl:hasExactSynonym "AMERICAN INDIAN", "American Indian" ; a owl:Class ; rdfs:label "American Indian" ; rdfs:subClassOf obo:NCIT_C41259 . obo:NCIT_C44256 obo:IAO_0000115 "Quotient of quantities of the same kind for different components within the same system." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C44256" ; obo:NCIT_P106 "Quantitative Concept" ; obo:NCIT_P108 "Ratio" ; obo:NCIT_P207 "C0456603" ; obo:NCIT_P322 "CDISC", "UCUM" ; obo:NCIT_P325 "The quotient of one quantity divided by another, with the same units of measurement." ; obo:NCIT_P366 "Ratio" ; oboInOwl:hasExactSynonym "RATIO", "Ratio", "ratio", "{RATIO}", "{Ratio}" ; oboInOwl:inSubset , , , , , , , ; a owl:Class ; rdfs:label "ratio" ; rdfs:subClassOf provcare:StatisticalMeasure . obo:NCIT_C61256 obo:IAO_0000115 "The act of observing something (and sometimes keeping a record of it)." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C61256" ; obo:NCIT_P106 "Activity" ; obo:NCIT_P108 "Monitoring" ; obo:NCIT_P208 "CL415337" ; obo:NCIT_P325 "In medicine, to regularly watch and check a person or condition to see if there is any change. Also refers to a device that records and/or displays patient data, such as for an electrocardiogram (EKG)." ; obo:NCIT_P366 "Monitoring" ; oboInOwl:hasExactSynonym "Monitoring", "monitor" ; a owl:Class ; rdfs:label "monitoring" . obo:NCIT_C63536 obo:IAO_0000115 "A detailed examination, analysis, or critical inspection of a subject designed to discover facts about it." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C63536" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Study" ; obo:NCIT_P207 "C0947630" ; obo:NCIT_P366 "Study" ; oboInOwl:hasExactSynonym "Study" ; a owl:Class ; rdfs:label "study" ; rdfs:subClassOf obo:NCIT_C15429 . obo:NCIT_C70820 obo:IAO_0000412 ; obo:NCIT_NHC0 "C70820" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Clinical Study by Phase" ; obo:NCIT_P207 "C2347801" ; obo:NCIT_P366 "Clinical_Study_by_Phase" ; oboInOwl:hasExactSynonym "Clinical Study by Phase" ; a owl:Class ; rdfs:label "clinical study by phase" ; rdfs:subClassOf obo:NCIT_C15206 . obo:NCIT_C70824 obo:IAO_0000412 ; obo:NCIT_NHC0 "C70824" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Clinical Study by Organizational Parameters" ; obo:NCIT_P207 "C2347800" ; obo:NCIT_P366 "Clinical_Study_by_Organizational_Parameters" ; oboInOwl:hasExactSynonym "Clinical Study by Organizational Parameters" ; a owl:Class ; rdfs:label "clinical study by organizational parameters" ; rdfs:subClassOf obo:NCIT_C15206 . obo:NCIT_C71104 obo:IAO_0000115 "A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." ; obo:IAO_0000412 ; obo:NCIT_NHC0 "C71104" ; obo:NCIT_P106 "Research Activity" ; obo:NCIT_P108 "Clinical Trial" ; obo:NCIT_P207 "C0008976" ; obo:NCIT_P322 "CDISC", "CDISC-GLOSS" ; obo:NCIT_P325 "1) A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). 2) A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.(1. modified from ICH E6 Glossary, Directive 2001/20/EC. 2. NIH revised definition 2015) (CDISC Glossary)", "A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [after ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation.", "A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease." ; obo:NCIT_P366 "Clinical_Trial_Generic" ; sio:hasAttribute _:genid42, _:genid43 ; oboInOwl:hasExactSynonym "Clinical Trial", "Clinical Trials", "Clinical Trials, Unspecified", "Trial", "clinical trial" ; oboInOwl:inSubset , , , ; a owl:Class, owl:NamedIndividual ; rdfs:label "clinical trial" ; rdfs:subClassOf hasco:ResearchStudy, obo:NCIT_C15206 . obo:NCIT_NHC0 a owl:AnnotationProperty . obo:NCIT_P106 a owl:AnnotationProperty . obo:NCIT_P108 a owl:AnnotationProperty . obo:NCIT_P207 a owl:AnnotationProperty . obo:NCIT_P208 a owl:AnnotationProperty . obo:NCIT_P322 a owl:AnnotationProperty . obo:NCIT_P325 a owl:AnnotationProperty . obo:NCIT_P366 a owl:AnnotationProperty . obo:PATO_0000001 obo:IAO_0000412 ; obo:IAO_0000589 "quality (PATO)" ; a owl:Class ; rdfs:label "quality"^^xsd:string . obo:PATO_0000068 obo:IAO_0000412 ; a owl:Class ; rdfs:label "qualitative"^^xsd:string ; rdfs:subClassOf obo:PATO_0000001 . obo:PATO_0000069 obo:IAO_0000412 ; a owl:Class ; rdfs:label "deviation(from_normal)"^^xsd:string ; rdfs:subClassOf obo:PATO_0000068 . obo:PATO_0000125 obo:IAO_0000412 ; a owl:Class . obo:PATO_0000128 obo:IAO_0000412 , ; a owl:Class ; rdfs:label "weight"^^xsd:string ; rdfs:subClassOf obo:PATO_0001035 . obo:PATO_0000460 obo:IAO_0000412 ; a owl:Class ; rdfs:label "abnormal"^^xsd:string ; rdfs:subClassOf obo:PATO_0000069 . obo:PATO_0000582 obo:IAO_0000412 ; a owl:Class ; rdfs:label "increased weight"^^xsd:string ; rdfs:subClassOf obo:PATO_0000128, obo:PATO_0002245 . obo:PATO_0001018 obo:IAO_0000412 ; a owl:Class ; rdfs:label "physical quality"^^xsd:string ; rdfs:subClassOf obo:PATO_0001241 . obo:PATO_0001035 obo:IAO_0000412 ; a owl:Class ; rdfs:label "force"^^xsd:string ; rdfs:subClassOf obo:PATO_0001018 . obo:PATO_0001241 obo:IAO_0000412 ; a owl:Class ; rdfs:label "physical object quality"^^xsd:string ; rdfs:subClassOf obo:PATO_0000001 . obo:PATO_0001309 obo:IAO_0000115 "A process quality inhering in a bearer by virtue of the bearer's magnitude of the temporal extent between the starting and ending point."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:hasAlternativeId "PATO:0000081"^^xsd:string ; oboInOwl:hasExactSynonym "period"^^xsd:string ; oboInOwl:hasOBONamespace "quality"^^xsd:string ; oboInOwl:hasRelatedSynonym "time"^^xsd:string ; oboInOwl:id "PATO:0001309"^^xsd:string ; oboInOwl:inSubset , ; a owl:Class ; rdfs:label "duration" ; rdfs:subClassOf provcare:StatisticalMeasure . obo:PATO_0001708 obo:IAO_0000412 ; a owl:Class . obo:PATO_0001869 obo:IAO_0000412 ; a owl:Class ; rdfs:label "pathological"^^xsd:string ; rdfs:subClassOf obo:PATO_0000460 . obo:PATO_0002245 obo:IAO_0000412 ; a owl:Class ; rdfs:label "increased force"^^xsd:string ; rdfs:subClassOf obo:PATO_0001035, obo:PATO_0002305 . obo:PATO_0002300 obo:IAO_0000412 ; a owl:Class ; rdfs:label "increased quality"^^xsd:string ; rdfs:subClassOf obo:PATO_0000069 . obo:PATO_0002305 obo:IAO_0000412 ; a owl:Class ; rdfs:label "increased object quality"^^xsd:string ; rdfs:subClassOf obo:PATO_0001241, obo:PATO_0002300 . obo:STATO_0000032 a owl:AnnotationProperty . obo:STATO_0000193 obo:IAO_0000114 obo:IAO_0000122 ; obo:IAO_0000115 "is a population whose individual members realize (may be expressed as) a combination of inclusion rule values specifications or resulting from a sampling process (e.g. recruitment followed by randomization to group) on which a number of measurements will be carried out, which may be used as input to statistical tests and statistical inference." ; obo:IAO_0000117 "Alejandra Gonzalez-Beltran"@en, "Orlaith Burke", "Philippe Rocca-Serra" ; obo:IAO_0000119 "STATO"@en ; obo:IAO_0000412 ; obo:STATO_0000032 "statistical sample"@en ; a owl:Class ; rdfs:label "study group population" . obo:STATO_0000203 obo:IAO_0000112 ""@en ; obo:IAO_0000114 obo:IAO_0000122 ; obo:IAO_0000115 "a cohort is a study group population where the members are human beings which meet inclusion criteria and undergo a longitudinal design"@en ; obo:IAO_0000116 "possibly submit to 'Population and Community Ontology'"@en ; obo:IAO_0000117 "Alejandra Gonzalez-Beltran"@en, "Orlaith Burke", "Philippe Rocca-Serra"@en ; obo:IAO_0000119 "STATO"@en ; obo:IAO_0000412 ; obo:STATO_0000032 ""@en ; sio:hasAttribute _:genid44, _:genid45 ; a owl:Class, owl:NamedIndividual ; rdfs:label "cohort" ; rdfs:subClassOf obo:STATO_0000193, [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom :PopulationSize ] . obo:UBERON_0000061 obo:IAO_0000412 ; a owl:Class ; rdfs:label "anatomical structure"^^xsd:string ; rdfs:subClassOf obo:CARO_0000003 . obo:UBERON_0001062 obo:IAO_0000412 ; a owl:Class ; rdfs:label "anatomical entity"^^xsd:string . obo:UO_0000001 obo:IAO_0000115 "A unit which is a standard measure of the distance between two points."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:created_by "george gkoutos"^^xsd:string ; oboInOwl:hasOBONamespace "unit.ontology"^^xsd:string ; oboInOwl:id "UO:0000001"^^xsd:string ; oboInOwl:inSubset ; a owl:Class ; rdfs:label "length unit"^^xsd:string . obo:UO_0000002 obo:IAO_0000115 "A unit which is a standard measure of the amount of matter/energy of a physical object."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:created_by "george gkoutos"^^xsd:string ; oboInOwl:hasOBONamespace "unit.ontology"^^xsd:string ; oboInOwl:id "UO:0000002"^^xsd:string ; oboInOwl:inSubset ; a owl:Class ; rdfs:label "mass unit"^^xsd:string . obo:UO_0000009 obo:IAO_0000115 "A mass unit which is equal to the mass of the International Prototype Kilogram kept by the BIPM at Svres, France."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:created_by "george gkoutos"^^xsd:string ; oboInOwl:hasExactSynonym "kg"^^xsd:string ; oboInOwl:hasOBONamespace "unit.ontology"^^xsd:string ; oboInOwl:id "UO:0000009"^^xsd:string ; oboInOwl:inSubset ; a owl:Class ; rdfs:label "kilogram"^^xsd:string ; rdfs:subClassOf obo:UO_0000002, obo:UO_0000045, sio:UnitOfMeasurement . obo:UO_0000015 obo:IAO_0000115 "A length unit which is equal to one hundredth of a meter or 10^[-2] m."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:created_by "george gkoutos"^^xsd:string ; oboInOwl:hasExactSynonym "centimetre"^^xsd:string, "cm"^^xsd:string ; oboInOwl:hasOBONamespace "unit.ontology"^^xsd:string ; oboInOwl:id "UO:0000015"^^xsd:string ; oboInOwl:inSubset ; a owl:Class ; rdfs:label "centimeter"^^xsd:string ; rdfs:subClassOf obo:UO_0000001, sio:UnitOfMeasurement . obo:UO_0000045 obo:IAO_0000115 "A unit which is one of a particular measure to which all measures of that type can be related."^^xsd:string ; obo:IAO_0000412 ; oboInOwl:created_by "george gkoutos"^^xsd:string ; oboInOwl:hasOBONamespace "unit.ontology"^^xsd:string ; oboInOwl:id "UO:0000045"^^xsd:string ; oboInOwl:inSubset ; a owl:Class ; rdfs:label "base unit"^^xsd:string . dc:date a owl:AnnotationProperty . dct:abstract a owl:AnnotationProperty . dct:source a owl:AnnotationProperty . oboInOwl:hasExactSynonym "BMI" . sio:Mean dct:source ; a owl:Class ; rdfs:label "mean" ; rdfs:subClassOf provcare:CentralTendencyMeasure ; skos:definition "the central value of a discrete set of numbers: specifically, the sum of the values divided by the number of values"^^xsd:string . sio:Median a owl:Class ; rdfs:subClassOf provcare:CentralTendencyMeasure . sio:MedicalIntervention a owl:Class . sio:Patient dct:source "https://www.tititudorancea.com/z/patient_en.htm" ; a owl:Class ; rdfs:label "patient" ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom :ElectronicHealthRecord ], [ a owl:Restriction ; owl:onProperty sio:hasProperty ; owl:someValuesFrom obo:DOID_4 ] ; skos:definition "a person who receives medical attention, care, or treatment, or who is registered with medical professional or institution with the purpose to receive medical care when necessary"^^xsd:string . sio:Person a owl:Class ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom :SubjectCharacteristic ] . sio:StandardDeviation dct:source ; a owl:Class ; rdfs:label "standard deviation"^^xsd:string ; rdfs:subClassOf provcare:DispersionMeasure ; skos:definition "a measure that is used to quantify the amount of variation or dispersion of a set of data values"^^xsd:string . sio:Study a owl:Class . sio:StudySubject dct:source "https://en.wikipedia.org/wiki/Research_participant" ; a owl:Class ; rdfs:label "study subject" ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty sio:isParticipantIn ; owl:someValuesFrom hasco:ResearchStudy ], [ a owl:Restriction ; owl:onProperty sio:hasProperty ; owl:someValuesFrom obo:DOID_4 ], [ a owl:Restriction ; owl:onProperty sio:hasProperty ; owl:someValuesFrom provcare:Intervention ], [ a owl:Restriction ; owl:onProperty sio:hasProperty ; owl:someValuesFrom :EnrollmentStatus ] ; skos:definition "A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who participates in human subject research by being the target of observation by researchers"^^xsd:string . sio:UnitOfMeasurement a owl:Class ; rdfs:label "unit of measurement" . sio:Year a owl:Class ; rdfs:subClassOf sio:UnitOfMeasurement . sio:hasParticipant a owl:ObjectProperty . sio:hasProperty a owl:ObjectProperty . sio:hasUnit a owl:ObjectProperty . sio:hasValue a owl:DataProperty, owl:NamedIndividual . provcare:CentralTendencyMeasure a owl:Class ; rdfs:comment "Statistical measure describing the distribution of single variable" ; rdfs:subClassOf provcare:StatisticalMeasure . provcare:ClinicalIntervention a owl:Class ; rdfs:seeAlso "http://purl.bioontology.org/ontology/SNOMEDCT/386053000" ; rdfs:subClassOf provcare:Intervention . provcare:DataAnalysisInstrument a owl:Class . provcare:DispersionMeasure a owl:Class ; rdfs:comment "Statistical measure characterizing the distribution of single variable" ; rdfs:subClassOf provcare:StatisticalMeasure . provcare:Intervention a owl:Class ; rdfs:comment "Capturing the interventions variables in research studies", "The intervention type used in a research study (corresponding to I in the PICO(T) model )" ; rdfs:label "study intervention" ; rdfs:seeAlso "http://purl.bioontology.org/ontology/SNOMEDCT/386053000" ; rdfs:subClassOf provcare:StudyMethod ; rdfs:synonym "Study intervention" . provcare:StatisticalMeasure dct:source ; a owl:Class ; rdfs:label "statistical measure" ; rdfs:subClassOf provcare:DataAnalysisInstrument, [ a owl:Restriction ; owl:allValuesFrom sio:UnitOfMeasurement ; owl:onProperty sio:hasAttribute ], [ a owl:Restriction ; owl:onProperty sio:hasValue ; owl:someValuesFrom xsd:decimal ] ; skos:definition "a standard unit used to express the size, amount, or degree of something"^^xsd:string . provcare:StudyMethod a owl:Class . oboInOwl:created_by a owl:AnnotationProperty . oboInOwl:creation_date a owl:AnnotationProperty . oboInOwl:hasAlternativeId a owl:AnnotationProperty . oboInOwl:hasDbXref a owl:AnnotationProperty . oboInOwl:hasExactSynonym a owl:AnnotationProperty . oboInOwl:hasOBONamespace a owl:AnnotationProperty . oboInOwl:hasRelatedSynonym a owl:AnnotationProperty . oboInOwl:id a owl:AnnotationProperty . oboInOwl:inSubset a owl:AnnotationProperty . fibo-fnd-utl-av:adaptedFrom a owl:AnnotationProperty . rdfs:subClassOf a owl:ObjectProperty . rdfs:synonym a owl:AnnotationProperty . owl:DataProperty a owl:Class . skos:definition a owl:Class . prov:wasAttributedTo a owl:AnnotationProperty . <> dct:abstract "The Study Cohort Ontology (SCO) is developed to model overall structure and patterns of cohort variables and control/intervention groups defined within the structured population descriptions (commonly referred to as Table1's or Cohort Summary Tables)of observational case studies and clinical trials. We maintain only domain agnostic and commonly occuring subject variables and interventions in SCO, and we have a suite of ontologies (Diseases, Medications, LabResults etc) to encode Diabetes related terminology. We have adopted a bottom-up approach to modeling and we have revised the structure of SCO upon investigation of a few research studies (11 to be precise) from the Pharmacological Interventions (Chapter 8) and Cardiovascular Complications (Chapter 9) of the American Diabetes Association (ADA)’s Standards of Medical Care 2018 CPG. We enable deep drive visualizations driven off queries to knowledge graphs modeled on SCO, to help assist physician visualize the similarity of a patient to a study group, at a quick glance. We welcome contributions and suggestions to extend SCO to represent cohort descriptions of publications targeted to other diseases, and we plan to release set of tools to make this process seamless."^^xsd:string ; dct:contributor "Deborah L. McGuinness", "James P. McCusker", "Oshani Seneviratne" ; dct:creator "Shruthi Chari" ; dct:description "The Study Cohort Ontology encodes the vocabulary to represent population desriptions in research studies, and provides the ability to model the aggregative descriptive statistical measures defined on the variables of subjects who are participants in the study population. We make it possible to represent a study component considered for determining the patient alignment to a research study, and we assist physicians in evaluating the fit of their patient population to the study population. In SCO, we are building a world-view inspired by the upper level Ontology SemanticScience Integrated Ontology (SIO) to model the descriptive statistics of characteristics on a set of patients (patient group) administered a medical intervention, and studied for an outcome in a research study. Since we capture the various definitions of patient groups (ie. by interventional measures or by control mechanisms), we provide the basic framework for filtering searches and to define cohort similarity at different granularities. ( cohort level and the study group levels ). For researchers who wish to contribute to the expansion of our ontology, we advise that they refer to our ontology documentation to familiarize themselves with the structure and term annotations ( such as definitions and labels)." ; dct:title "Semantic Modeling of Cohort Descriptions in Research Studies" ; a owl:Ontology ; rdfs:label "Study Cohort Ontology" ; owl:imports <../chearexternal.ttl> ; owl:versionIRI <1.1.0> . :Active dct:title "Clinical Trials Protocol Template - NIH Office of Science Policy" ; fibo-fnd-utl-av:adaptedFrom "https://osp.od.nih.gov/wp-content/uploads/2014/01/Protocol_Template_05Feb2016_508.pdf" ; a owl:Class ; rdfs:label "active" ; rdfs:subClassOf :EnrollmentStatus ; skos:definition "participants following clinical trial protocol"^^xsd:string . :CohortDescription a owl:Class ; rdfs:comment "All typical components that constitute the description of study populations, captured in the first table of a research study, and hence called Table 1s" ; rdfs:label "cohort description" ; rdfs:subClassOf sio:Dataset, [ a owl:Restriction ; owl:onProperty sio:hasDataItem ; owl:someValuesFrom provcare:Intervention ], [ a owl:Restriction ; owl:onProperty sio:hasDataItem ; owl:someValuesFrom provcare:StatisticalMeasure ], [ a owl:Restriction ; owl:onProperty sio:hasDataItem ; owl:someValuesFrom :StudyArm ], [ a owl:Restriction ; owl:onProperty sio:hasDataItem ; owl:someValuesFrom :SubjectCharacteristic ] ; rdfs:synonym "Table 1" . :ControlArm sio:hasAttribute [ sio:hasValue "An arm type that can receive an intervention that is considered effective (the standard), a placebo, or no intervention" ; fibo-fnd-utl-av:adaptedFrom "https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/3392/control-arm" ; a skos:definition ] ; a owl:Class, owl:NamedIndividual ; rdfs:label "control arm" ; rdfs:seeAlso "http://semanticscience.org/resource/SIO_001068.rdf" ; rdfs:subClassOf :StudyArm . :Discontinued dct:title "Clinical Trials Protocol Template - NIH Office of Science Policy" ; fibo-fnd-utl-av:adaptedFrom "https://osp.od.nih.gov/wp-content/uploads/2014/01/Protocol_Template_05Feb2016_508.pdf" ; a owl:Class ; rdfs:label "discontinued" ; rdfs:subClassOf :EnrollmentStatus ; skos:definition "participants no longer, following clinical trial protocol"^^xsd:string . :Duration a owl:Class . :ElectronicHealthRecord dct:source ; a owl:Class ; rdfs:label "electronic health record"^^xsd:string ; rdfs:subClassOf sio:Dataset, [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom chear:Anthropometry ], [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom chear:Demographic ], [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom :OrderedLaboratoryTestResult ], [ a owl:Restriction ; owl:onProperty sio:hasProperty ; owl:someValuesFrom provcare:Intervention ] ; skos:definition "a digital version of a patient’s paper chart"^^xsd:string . :EnrollmentStatus fibo-fnd-utl-av:adaptedFrom "https://research-compliance.umich.edu/sites/default/files/resource-download/enrollmentdefinition_additionalhelp.pdf" ; a owl:Class ; rdfs:label "enrollment status"^^xsd:string ; rdfs:subClassOf sio:StatusDescriptor ; skos:definition "patients are consented and screened, with eligibility verified"^^xsd:string . :IntentionToTreatPopulation dct:source "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159210/" ; a owl:Class ; rdfs:label "intention to treat population"^^xsd:string ; rdfs:subClassOf obo:STATO_0000203 ; skos:definition "every subject who is randomized according to randomized treatment assignment, ignoring noncompliance, protocol deviations, withdrawal, and anything that happens after randomization" . :InterventionArm sio:hasAttribute _:genid42 ; a owl:Class, owl:NamedIndividual ; rdfs:label "intervention arm" ; rdfs:seeAlso "http://semanticscience.org/resource/SIO_001069.rdf" ; rdfs:subClassOf :StudyArm, [ a owl:Restriction ; owl:onProperty rdfs:subClassOf ; owl:someValuesFrom sio:StudySubject ] . :Meta-analysis sio:hasAttribute _:genid43 ; a owl:Class, owl:NamedIndividual ; rdfs:label "meta-analysis" ; rdfs:subClassOf hasco:ResearchStudy . :OrderedLaboratoryTestResult a owl:Class ; rdfs:label "laboratory test result" ; rdfs:subClassOf :SubjectCharacteristic . :PopulationSize fibo-fnd-utl-av:adaptedFrom "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4296634/" ; a owl:Class ; rdfs:label "population size"^^xsd:string ; rdfs:subClassOf provcare:StatisticalMeasure, [ a owl:Restriction ; owl:onProperty sio:hasValue ; owl:someValuesFrom xsd:integer ] ; skos:definition "number of patients to which the study results could be reasonably generalized"^^xsd:string . :RandomizedPopulation sio:hasAttribute _:genid44 ; a owl:Class, owl:NamedIndividual ; rdfs:label "randomized population" ; rdfs:subClassOf obo:STATO_0000203 . :SafetyPopulation sio:hasAttribute _:genid45 ; a owl:Class, owl:NamedIndividual ; rdfs:label "safety population" ; rdfs:subClassOf obo:STATO_0000203 . :StudyArm sio:hasAttribute [ dct:source "https://clinicaltrials.gov/ct2/about-studies/glossary" ; sio:hasValue "A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol." ; a skos:definition ], [ sio:hasValue "An arm in a clinical trial is a group of subjects receiving the same therapeutic intervention (or none)" ; a skos:definition ; prov:wasAttributedTo ] ; a owl:Class, owl:NamedIndividual ; rdfs:label "study arm" ; rdfs:subClassOf obo:STATO_0000203, [ a owl:Class ; owl:intersectionOf ([ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom [ a owl:Class ; owl:unionOf (obo:DOID_4 provcare:Intervention :SubjectCharacteristic ) ] ] [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom provcare:StatisticalMeasure ] ] [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom [ a owl:Restriction ; owl:onProperty sio:hasValue ; owl:someValuesFrom xsd:decimal ] ] ] ) ] . :SubjectCharacteristic dct:source "R. J. Little et al., \"The prevention and treatment of missing data in clinical trials,\" New England J. Medicine, vol. 367, no. 14, pp. 1355{1360, 2012" ; a owl:Class ; rdfs:label "subject characteristic" ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom sio:DimensionalQuantity ], [ a owl:Restriction ; owl:onProperty sio:hasAttribute ; owl:someValuesFrom sio:UnitOfMeasurement ] ; skos:definition "Property that summarizes important attributes of the participants enrolled in a study" . :YearOfFollowUp a owl:Class ; rdfs:subClassOf :Duration . :YearsOfExposure a owl:Class ; rdfs:subClassOf :Duration, [ a owl:Restriction ; owl:onProperty sio:hasUnit ; owl:someValuesFrom sio:Year ] . a owl:NamedIndividual . a owl:NamedIndividual . _:genid40 dct:source ; sio:hasValue "A scientific investigation that involves testing a hypothesi", "A scientific study of nature that sometimes includes processes involved in health and disease" ; a skos:definition ; prov:wasAttributedTo . _:genid42 dct:source "https://clinicaltrials.gov/ct2/about-studies/glossary" ; sio:hasValue "A prospective study designed to evaluate whether one or more interventions are associated with an outcome", "An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial" ; a skos:definition ; prov:wasAttributedTo . _:genid43 dct:source "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3049418/" ; sio:hasValue "A prospective study designed to evaluate whether one or more interventions are associated with an outcome", "A quantitative, formal, epidemiological study design used to systematically assess previous research studies to derive conclusions about that body of research" ; a skos:definition ; prov:wasAttributedTo . _:genid44 sio:hasValue "A cohort is the group of subjects enrolled in a study\"", "set of patients recruited for research studies, who are randomly assigned to different study groups, intending to ensure that all potential confounding factors are divided equally among the groups that will later be compared (structural equivalence)" ; fibo-fnd-utl-av:adaptedFrom "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3196997/" ; a skos:definition ; prov:wasAttributedTo . _:genid45 sio:hasValue "\"Top-level group of subjects participating in a study\"", "set of patients recruited for research studies, who are a part of the experimental treatment population, additionally patients receiving the experimental intervention is analyzed with the experimental group" ; fibo-fnd-utl-av:adaptedFrom "https://www.dummies.com/education/science/biology/how-to-define-analytical-populations-for-a-clinical-study/", "https://www.ncbi.nlm.nih.gov/books/NBK209903/" ; a skos:definition ; prov:wasAttributedTo .