ID

35654

Beskrivning

Omega-3 for Depression and Other Cardiac Risk Factors - 2; ODM derived from: https://clinicaltrials.gov/show/NCT02021669

Länk

https://clinicaltrials.gov/show/NCT02021669

Nyckelord

Versioner (1)
  1. 2019-03-14 2019-03-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT02021669

Engelsk

Eligibility Depression NCT02021669

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02021669
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented coronary heart disease
Beskrivning

Coronary heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0010068
diagnosis of major depression based on structured interview
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
moderate to severe cognitive impairment
Beskrivning

Moderate cognitive impairment | Severe cognitive impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C3839816
UMLS CUI [2]
C3554639
meets dsm-5 criteria for depressive disorder due to a general medical condition or medication
Beskrivning

Depressive disorder Due to Medical condition General | Depressive disorder Due to Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3843040
UMLS CUI [1,4]
C0205246
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0013227
major axis i psychiatric disorder other than unipolar depression or an anxiety disorder, a high risk of suicide, or current substance abuse other than tobacco;
Beskrivning

Axis I diagnosis Major | Exception Unipolar Depression | Anxiety Disorders | High suicide risk | Substance Use Disorders | Exception Tobacco Use Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0041696
UMLS CUI [3]
C0003469
UMLS CUI [4]
C1271074
UMLS CUI [5]
C0038586
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0040336
not expected to survive one year or physically unable to tolerate the study protocol
Beskrivning

Life Expectancy | Intolerance Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0231199
UMLS CUI [2,2]
C2348563
known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish
Beskrivning

Sertraline allergy | Hypersensitivity Omega-3 Fatty Acids | Fish oils allergy | Shellfish allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0570766
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015689
UMLS CUI [3]
C0571871
UMLS CUI [4]
C0577625
taking an antidepressant or an omega-3 supplement at baseline
Beskrivning

Antidepressive Agents | Omega-3 Fatty Acids Supplement

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0015689
UMLS CUI [2,2]
C0242295
exempted by their cardiologist or primary care physician
Beskrivning

Exemption Cardiologist | Exemption Primary Care Physician

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348482
UMLS CUI [1,2]
C0175906
UMLS CUI [2,1]
C2348482
UMLS CUI [2,2]
C0033131
refuses to provide informed consent
Beskrivning

Informed Consent Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
participating in a competing protocol or trial
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Depression NCT02021669

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02021669
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Coronary heart disease
Item
documented coronary heart disease
boolean
C0010068 (UMLS CUI [1])
Major Depressive Disorder
Item
diagnosis of major depression based on structured interview
boolean
C1269683 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Moderate cognitive impairment | Severe cognitive impairment
Item
moderate to severe cognitive impairment
boolean
C3839816 (UMLS CUI [1])
C3554639 (UMLS CUI [2])
Depressive disorder Due to Medical condition General | Depressive disorder Due to Pharmaceutical Preparations
Item
meets dsm-5 criteria for depressive disorder due to a general medical condition or medication
boolean
C0011581 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C0205246 (UMLS CUI [1,4])
C0011581 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Axis I diagnosis Major | Exception Unipolar Depression | Anxiety Disorders | High suicide risk | Substance Use Disorders | Exception Tobacco Use Disorder
Item
major axis i psychiatric disorder other than unipolar depression or an anxiety disorder, a high risk of suicide, or current substance abuse other than tobacco;
boolean
C0270287 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0041696 (UMLS CUI [2,2])
C0003469 (UMLS CUI [3])
C1271074 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0040336 (UMLS CUI [6,2])
Life Expectancy | Intolerance Study Protocol
Item
not expected to survive one year or physically unable to tolerate the study protocol
boolean
C0023671 (UMLS CUI [1])
C0231199 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Sertraline allergy | Hypersensitivity Omega-3 Fatty Acids | Fish oils allergy | Shellfish allergy
Item
known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish
boolean
C0570766 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0015689 (UMLS CUI [2,2])
C0571871 (UMLS CUI [3])
C0577625 (UMLS CUI [4])
Antidepressive Agents | Omega-3 Fatty Acids Supplement
Item
taking an antidepressant or an omega-3 supplement at baseline
boolean
C0003289 (UMLS CUI [1])
C0015689 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
Exemption Cardiologist | Exemption Primary Care Physician
Item
exempted by their cardiologist or primary care physician
boolean
C2348482 (UMLS CUI [1,1])
C0175906 (UMLS CUI [1,2])
C2348482 (UMLS CUI [2,1])
C0033131 (UMLS CUI [2,2])
Informed Consent Refused
Item
refuses to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participating in a competing protocol or trial
boolean
C2348568 (UMLS CUI [1])
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