ID

39451

Description

Effects of a High Protein Diet on Clinical Outcomes in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01423266

Link

https://clinicaltrials.gov/show/NCT01423266

Keywords

Versions (1)
  1. 1/11/20 1/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01423266

English

Eligibility Heart Failure NCT01423266

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
obese (bmi > 27 kg/m2);
Description

Obesity | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
history of type 2 dm or documented impaired fasting glucose (ifg) according to fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or metabolic syndrome ( as defined by the international diabetes federation 2011
Description

Diabetes Mellitus, Non-Insulin-Dependent | Impaired fasting glycaemia | Plasma fasting glucose measurement | Criteria Quantity Fulfill | Metabolic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C1272092
UMLS CUI [3]
C0583513
UMLS CUI [4,1]
C0243161
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1550543
UMLS CUI [5]
C0524620
evaluation of hf and optimization of medical therapy; and
Description

Evaluation Heart failure | Optimization Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C2698650
UMLS CUI [2,2]
C0087111
ischemic or idiopathic hf etiology.
Description

Heart failure Ischemic Etiology | Heart failure idiopathic Etiology

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C0015127
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0332240
UMLS CUI [2,3]
C0015127
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age ≤18 years old;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
history of clinically significant illness including acute myocardial infarction or sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory, and/or gastrointestinal disease and malignancy;
Description

Illness Clinical Significance | Myocardial Infarction | Ventricular arrhythmia Sustained | Liver diseases | Respiration Disorders | Gastrointestinal Diseases | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0085612
UMLS CUI [3,2]
C0443318
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0006826
pregnancy or lactation;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serum creatinine level > 1.5 mg/dl;*
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
currently participating in a supervised weight loss program;
Description

Participation Weight Reduction Program

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
physician refusal to permit patient participation in the study; and
Description

Study Subject Participation Status | Refusal to Participate Physician Mediated

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1136454
UMLS CUI [2,2]
C0031831
UMLS CUI [2,3]
C0086597
weight loss of >6% in the last 6 months
Description

Weight loss Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
gout or history of gout
Description

Gout | History of gout

Data type

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0455492
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Similar models

Eligibility Heart Failure NCT01423266

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Obesity | Body mass index
Item
obese (bmi > 27 kg/m2);
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Impaired fasting glycaemia | Plasma fasting glucose measurement | Criteria Quantity Fulfill | Metabolic Syndrome
Item
history of type 2 dm or documented impaired fasting glucose (ifg) according to fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or metabolic syndrome ( as defined by the international diabetes federation 2011
boolean
C0011860 (UMLS CUI [1])
C1272092 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
C0243161 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1550543 (UMLS CUI [4,3])
C0524620 (UMLS CUI [5])
Evaluation Heart failure | Optimization Therapy
Item
evaluation of hf and optimization of medical therapy; and
boolean
C1261322 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C2698650 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Heart failure Ischemic Etiology | Heart failure idiopathic Etiology
Item
ischemic or idiopathic hf etiology.
boolean
C0018801 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0332240 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
age ≤18 years old;
boolean
C0001779 (UMLS CUI [1])
Illness Clinical Significance | Myocardial Infarction | Ventricular arrhythmia Sustained | Liver diseases | Respiration Disorders | Gastrointestinal Diseases | Malignant Neoplasms
Item
history of clinically significant illness including acute myocardial infarction or sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory, and/or gastrointestinal disease and malignancy;
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0085612 (UMLS CUI [3,1])
C0443318 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
pregnancy or lactation;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine level > 1.5 mg/dl;*
boolean
C0201976 (UMLS CUI [1])
Participation Weight Reduction Program
Item
currently participating in a supervised weight loss program;
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
Study Subject Participation Status | Refusal to Participate Physician Mediated
Item
physician refusal to permit patient participation in the study; and
boolean
C2348568 (UMLS CUI [1])
C1136454 (UMLS CUI [2,1])
C0031831 (UMLS CUI [2,2])
C0086597 (UMLS CUI [2,3])
Weight loss Percentage Timespan
Item
weight loss of >6% in the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Gout | History of gout
Item
gout or history of gout
boolean
C0018099 (UMLS CUI [1])
C0455492 (UMLS CUI [2])
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