ID

23449

Description

Pioglitazone and Metformin in Diabetic Children; ODM derived from: https://clinicaltrials.gov/show/NCT01396564

Link

https://clinicaltrials.gov/show/NCT01396564

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
Uploaded on

July 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01396564

English

Eligibility Type 2 Diabetes NCT01396564

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pediatric patients with type 2 diabetes according to ada.
Description

Patients Pediatric | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1521725
UMLS CUI [2]
C0011860
patients who have not previously received anti-diabetic treatment or have been treated solely with diet and exercise or have received only one anti-diabetic agent, and who have not applied insulin within 1 month of study start.
Description

Antidiabetics Previous Absent | Diet therapy | Exercise | Antidiabetic Single | Insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C0205171
UMLS CUI [5,1]
C0021641
UMLS CUI [5,2]
C0332197
hba1c between >6.5% and <10%.
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
stable body weight at least 3 months before study start.
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
no intense exercise.
Description

Exercise intense Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C0332197
free of other infectious, chronic, or acute inflammatory processes in the 3 months prior to study.
Description

Infectious process Free of | Chronic disease Free of | Inflammatory disorder Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0745283
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C1290884
UMLS CUI [3,2]
C0332296
previous informed consent signed (both children and parents or guardians).
Description

Informed Consent Child Parent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0008059
UMLS CUI [1,3]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
either sex
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
8-17 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
personal history of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
chronic renal failure or serum creatinine over 1.0 mg/dl.
Description

Kidney Failure, Chronic | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0201976
active hepatic disease (alt and ast 3 times normal)
Description

Liver diseases | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
heart conditions
Description

Heart condition

Data type

boolean

Alias
UMLS CUI [1]
C3842523
acute or chronic metabolic acidosis
Description

Metabolic acidosis | Chronic metabolic acidosis

Data type

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
receiving steroids or insulin
Description

Steroids | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021641
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Similar models

Eligibility Type 2 Diabetes NCT01396564

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Pediatric | Diabetes Mellitus, Non-Insulin-Dependent
Item
pediatric patients with type 2 diabetes according to ada.
boolean
C0030705 (UMLS CUI [1,1])
C1521725 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
Antidiabetics Previous Absent | Diet therapy | Exercise | Antidiabetic Single | Insulin Absent
Item
patients who have not previously received anti-diabetic treatment or have been treated solely with diet and exercise or have received only one anti-diabetic agent, and who have not applied insulin within 1 month of study start.
boolean
C0935929 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Glycosylated hemoglobin A
Item
hba1c between >6.5% and <10%.
boolean
C0019018 (UMLS CUI [1])
Stable body weight
Item
stable body weight at least 3 months before study start.
boolean
C0517386 (UMLS CUI [1])
Exercise intense Absent
Item
no intense exercise.
boolean
C0015259 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Infectious process Free of | Chronic disease Free of | Inflammatory disorder Free of
Item
free of other infectious, chronic, or acute inflammatory processes in the 3 months prior to study.
boolean
C0745283 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C1290884 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
Informed Consent Child Parent | Informed Consent Guardian
Item
previous informed consent signed (both children and parents or guardians).
boolean
C0021430 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Gender
Item
either sex
boolean
C0079399 (UMLS CUI [1])
Age
Item
8-17 years old.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
personal history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Kidney Failure, Chronic | Creatinine measurement, serum
Item
chronic renal failure or serum creatinine over 1.0 mg/dl.
boolean
C0022661 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver diseases | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
active hepatic disease (alt and ast 3 times normal)
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Heart condition
Item
heart conditions
boolean
C3842523 (UMLS CUI [1])
Metabolic acidosis | Chronic metabolic acidosis
Item
acute or chronic metabolic acidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
Steroids | Insulin
Item
receiving steroids or insulin
boolean
C0038317 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
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