ID

29456

Description

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

Link

https://clinicaltrials.gov/show/NCT00680706

Keywords

  1. 3/27/18 3/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 27, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT00680706

Eligibility Heart Failure NCT00680706

Inclusion Criteria
Description

Inclusion Criteria

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

Heart failure | Loop Diuretics

Data type

boolean

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

Dyspnea Worsening

Data type

boolean

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

Dyspnea sitting | Supine dyspnoea

Data type

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.
Description

Other Coding

Data type

boolean

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

NT-proBNP Elevated

Data type

boolean

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

Able to communicate English Language | Able to communicate Spanish Language

Data type

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.
Description

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Decompensated cardiac failure Admitting diagnosis Primary

Data type

boolean

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

Exclusion Criteria

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

Renal failure on dialysis

Data type

boolean

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

Valvular disease Severe

Data type

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).
Description

Electrocardiogram: myocardial infarction | ST segment elevation

Data type

boolean

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

Troponin Initial Elevated

Data type

boolean

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

Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation

Data type

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.
Description

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

Data type

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
Description

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

Data type

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.
Description

Fatty Acids Supplement Daily

Data type

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.
Description

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

Data type

boolean

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

Similar models

Eligibility Heart Failure NCT00680706

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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