ID

43854

Description

Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00368017

Link

https://clinicaltrials.gov/show/NCT00368017

Keywords

Versions (2)
  1. 2/5/17 2/5/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00368017

English

Eligibility Chronic Kidney Disease NCT00368017

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with stage 3 or 4 chronic kidney disease as measured by a modification in diet in renal disease study (mdrd) estimate of between 15 ml/min and 59 ml/min.
Description

Chronic Kidney Diseases TNM Kidney tumor staging Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C0474937
UMLS CUI [1,3]
C2170215
2. age between 18 and 75 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. patients without hospitalization for cardiac or infection related morbidity over the previous four weeks (due to the potential confounding effects on baseline study variables).
Description

Morbidity Heart Without Hospitalization | Morbidity Infection Without Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0220880
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0019993
UMLS CUI [2,1]
C0220880
UMLS CUI [2,2]
C0009450
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C0019993
4. patients who are able to provide consent to participate in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with prior documented diagnosis of diabetes mellitus.
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
2. patients with fasting blood glucose > 110mg/dl.
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
3. prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
Description

Prisoners | Mental disorder Significant | Pregnancy | Vulnerable Populations

Data type

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0949366
4. patients with active hepatic disease and/or alt > 2.5 times upper limit of normal.
Description

Liver diseases | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
5. patients with history of congestive heart failure and nyha class iii-iv symptoms at any time.
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
6. patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
Description

Kidney Transplantation Living Donors Scheduled | Kidney Transplantation Living Donors Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0348050
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C0348050
UMLS CUI [2,3]
C0220825
7. patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, hiv infection with aids).
Description

Comorbidity Severe | Liver Cirrhosis Symptomatic | Neoplasm Metastasis | hiv-infection/aids

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0027627
UMLS CUI [4]
C0001175
8. patient with active inflammatory process (eg., sle, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
Description

Biological Response Modifiers Inflammatory disorder | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Gout

Data type

boolean

Alias
UMLS CUI [1,1]
C0005525
UMLS CUI [1,2]
C1290884
UMLS CUI [2]
C0024141
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0018099
9. patients who are on corticosteroid therapy.
Description

Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
10. patients who do not consent to participate in the study.
Description

Clinical Trial Refusal to Participate

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1136454
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Similar models

Eligibility Chronic Kidney Disease NCT00368017

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Kidney Diseases TNM Kidney tumor staging Renal function GFR estimation by MDRD
Item
1. patients with stage 3 or 4 chronic kidney disease as measured by a modification in diet in renal disease study (mdrd) estimate of between 15 ml/min and 59 ml/min.
boolean
C1561643 (UMLS CUI [1,1])
C0474937 (UMLS CUI [1,2])
C2170215 (UMLS CUI [1,3])
Age
Item
2. age between 18 and 75 years old.
boolean
C0001779 (UMLS CUI [1])
Morbidity Heart Without Hospitalization | Morbidity Infection Without Hospitalization
Item
3. patients without hospitalization for cardiac or infection related morbidity over the previous four weeks (due to the potential confounding effects on baseline study variables).
boolean
C0220880 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,4])
C0220880 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0019993 (UMLS CUI [2,4])
Informed Consent
Item
4. patients who are able to provide consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
1. patients with prior documented diagnosis of diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
Fasting blood glucose measurement
Item
2. patients with fasting blood glucose > 110mg/dl.
boolean
C0428568 (UMLS CUI [1])
Prisoners | Mental disorder Significant | Pregnancy | Vulnerable Populations
Item
3. prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
boolean
C0033167 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3])
C0949366 (UMLS CUI [4])
Liver diseases | Alanine aminotransferase increased
Item
4. patients with active hepatic disease and/or alt > 2.5 times upper limit of normal.
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
5. patients with history of congestive heart failure and nyha class iii-iv symptoms at any time.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Kidney Transplantation Living Donors Scheduled | Kidney Transplantation Living Donors Evaluation
Item
6. patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
boolean
C0022671 (UMLS CUI [1,1])
C0348050 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0022671 (UMLS CUI [2,1])
C0348050 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
Comorbidity Severe | Liver Cirrhosis Symptomatic | Neoplasm Metastasis | hiv-infection/aids
Item
7. patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, hiv infection with aids).
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
C0001175 (UMLS CUI [4])
Biological Response Modifiers Inflammatory disorder | Lupus Erythematosus, Systemic | Rheumatoid Arthritis | Gout
Item
8. patient with active inflammatory process (eg., sle, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
boolean
C0005525 (UMLS CUI [1,1])
C1290884 (UMLS CUI [1,2])
C0024141 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0018099 (UMLS CUI [4])
Steroid therapy
Item
9. patients who are on corticosteroid therapy.
boolean
C0149783 (UMLS CUI [1])
Clinical Trial Refusal to Participate
Item
10. patients who do not consent to participate in the study.
boolean
C0008976 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
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