ID

29456

Beschrijving

Thiamine and Acute Decompensated Heart Failure: Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00680706

Link

https://clinicaltrials.gov/show/NCT00680706

Trefwoorden

Versies (1)
  1. 27-03-18 27-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 maart 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00680706

Engels

Eligibility Heart Failure NCT00680706

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. history of heart failure on a loop diuretic.
Beschrijving

Heart failure | Loop Diuretics

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0354100
2. worsening dyspnea over the past 24 hours.
Beschrijving

Dyspnea Worsening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0332271
3. currently dyspneic sitting or supine, on or off oxygen.
Beschrijving

Dyspnea sitting | Supine dyspnoea

Datatype

boolean

Alias
UMLS CUI [1]
C2183404
UMLS CUI [2]
C1168185
4. radiographic cephalization of vessels. this criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.
Beschrijving

Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
5. elevated nt pro-bnp (>450).
Beschrijving

NT-proBNP Elevated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0754710
UMLS CUI [1,2]
C3163633
6. able to communicate in english or spanish.
Beschrijving

Able to communicate English Language | Able to communicate Spanish Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C2364293
UMLS CUI [2,2]
C0037750
7. able and willing to provide informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
8. age > 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
9. a primary admitting diagnosis of acute decompensated heart failure.
Beschrijving

Decompensated cardiac failure Admitting diagnosis Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C0332133
UMLS CUI [1,3]
C0205225
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. renal failure on dialysis.
Beschrijving

Renal failure on dialysis

Datatype

boolean

Alias
UMLS CUI [1]
C3875178
2. severe valvular disease.
Beschrijving

Valvular disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0205082
3. ekg criteria for acute myocardial infarction (st segment elevation > 1mm on two contiguous leads).
Beschrijving

Electrocardiogram: myocardial infarction | ST segment elevation

Datatype

boolean

Alias
UMLS CUI [1]
C0428953
UMLS CUI [2]
C0520886
4. initial troponin elevated.
Beschrijving

Troponin Initial Elevated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0041199
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C3163633
5. ventricular arrhythmia (ventricular tachycardia or fibrillation).
Beschrijving

Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2]
C0042514
UMLS CUI [3]
C0042510
6. supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate >120 beats per minute.
Beschrijving

Supraventricular arrhythmia | Atrial Fibrillation | Atrial Flutter | Ventricular Heart Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0428974
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0004239
UMLS CUI [4]
C1883530
7. taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. fortified foods, such as cereals, are acceptable
Beschrijving

Thiamine Supplementation Daily | Multivitamin preparation | Fortified Food Acceptable | Cereals Acceptable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039840
UMLS CUI [1,2]
C0242297
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0301532
UMLS CUI [3,1]
C0016498
UMLS CUI [3,2]
C1879533
UMLS CUI [4,1]
C0007757
UMLS CUI [4,2]
C1879533
8. taking a daily fatty acid supplement.
Beschrijving

Fatty Acids Supplement Daily

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015684
UMLS CUI [1,2]
C2348609
UMLS CUI [1,3]
C0332173
9. pregnancy as determined by standard serum or urine b-hcg assay.
Beschrijving

Pregnancy Serum pregnancy test | Pregnancy Urine human chorionic gonadotropin pregnancy test

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430064
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C2188702
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Similar models

Eligibility Heart Failure NCT00680706

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure | Loop Diuretics
Item
1. history of heart failure on a loop diuretic.
boolean
C0018801 (UMLS CUI [1])
C0354100 (UMLS CUI [2])
Dyspnea Worsening
Item
2. worsening dyspnea over the past 24 hours.
boolean
C0013404 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
Dyspnea sitting | Supine dyspnoea
Item
3. currently dyspneic sitting or supine, on or off oxygen.
boolean
C2183404 (UMLS CUI [1])
C1168185 (UMLS CUI [2])
Other Coding
Item
4. radiographic cephalization of vessels. this criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.
boolean
C3846158 (UMLS CUI [1])
NT-proBNP Elevated
Item
5. elevated nt pro-bnp (>450).
boolean
C0754710 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
Able to communicate English Language | Able to communicate Spanish Language
Item
6. able to communicate in english or spanish.
boolean
C2364293 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Informed Consent
Item
7. able and willing to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
8. age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Decompensated cardiac failure Admitting diagnosis Primary
Item
9. a primary admitting diagnosis of acute decompensated heart failure.
boolean
C0581377 (UMLS CUI [1,1])
C0332133 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Renal failure on dialysis
Item
1. renal failure on dialysis.
boolean
C3875178 (UMLS CUI [1])
Valvular disease Severe
Item
2. severe valvular disease.
boolean
C3258293 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Electrocardiogram: myocardial infarction | ST segment elevation
Item
3. ekg criteria for acute myocardial infarction (st segment elevation > 1mm on two contiguous leads).
boolean
C0428953 (UMLS CUI [1])
C0520886 (UMLS CUI [2])
Troponin Initial Elevated
Item
4. initial troponin elevated.
boolean
C0041199 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C3163633 (UMLS CUI [1,3])
Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation
Item
5. ventricular arrhythmia (ventricular tachycardia or fibrillation).
boolean
C0085612 (UMLS CUI [1])
C0042514 (UMLS CUI [2])
C0042510 (UMLS CUI [3])
Supraventricular arrhythmia | Atrial Fibrillation | Atrial Flutter | Ventricular Heart Rate
Item
6. supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate >120 beats per minute.
boolean
C0428974 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0004239 (UMLS CUI [3])
C1883530 (UMLS CUI [4])
Thiamine Supplementation Daily | Multivitamin preparation | Fortified Food Acceptable | Cereals Acceptable
Item
7. taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. fortified foods, such as cereals, are acceptable
boolean
C0039840 (UMLS CUI [1,1])
C0242297 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0301532 (UMLS CUI [2])
C0016498 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
C0007757 (UMLS CUI [4,1])
C1879533 (UMLS CUI [4,2])
Fatty Acids Supplement Daily
Item
8. taking a daily fatty acid supplement.
boolean
C0015684 (UMLS CUI [1,1])
C2348609 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Pregnancy Serum pregnancy test | Pregnancy Urine human chorionic gonadotropin pregnancy test
Item
9. pregnancy as determined by standard serum or urine b-hcg assay.
boolean
C0032961 (UMLS CUI [1,1])
C0430064 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C2188702 (UMLS CUI [2,2])
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