ID

29104

Description

New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I; ODM derived from: https://clinicaltrials.gov/show/NCT00566189

Link

https://clinicaltrials.gov/show/NCT00566189

Keywords

  1. 2/25/18 2/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 25, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes Mellitus, Type 2 NCT00566189

Eligibility Diabetes Mellitus, Type 2 NCT00566189

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
obesity grade i (bmi 30-34,9)
Description

Obesity CTCAE Grades | Body mass index

Data type

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C1305855
weight variance less than 5% in the last 3 months.
Description

Body Weight Variability Percent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C2827666
UMLS CUI [1,3]
C0439165
previous diagnosis of diabetes type 2.
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
insulin requirement, alone or along with oral agents
Description

Insulin Requirement | Insulin Associated with Pharmaceutical Preparations Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C1527415
capacity to understand the procedures of the study.
Description

Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
to agree voluntarily to participate of the study, signing an informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive anti-gad antibodies
Description

Anti-GAD antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C1167896
laboratorial signal of probable failure of insulin production, i. e., seric peptide c lesser than 1 ng/ml.
Description

Insulin Production Failure Probable | Insulin C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0033268
UMLS CUI [1,3]
C0231174
UMLS CUI [1,4]
C0033204
UMLS CUI [2]
C0202100
history of hepatic disease like cirrhosis or chronic active hepatitis.
Description

Liver diseases | Liver Cirrhosis | Hepatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0019189
kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
Description

Renal dysfunction | Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.
Description

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
recent history of neoplasia (< 5 years).
Description

Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0027651
use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
Description

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0086466

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00566189

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Obesity CTCAE Grades | Body mass index
Item
obesity grade i (bmi 30-34,9)
boolean
C0028754 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
Body Weight Variability Percent
Item
weight variance less than 5% in the last 3 months.
boolean
C0005910 (UMLS CUI [1,1])
C2827666 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent
Item
previous diagnosis of diabetes type 2.
boolean
C0011860 (UMLS CUI [1])
Insulin Requirement | Insulin Associated with Pharmaceutical Preparations Oral
Item
insulin requirement, alone or along with oral agents
boolean
C0021641 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
Comprehension Study Protocol
Item
capacity to understand the procedures of the study.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed Consent
Item
to agree voluntarily to participate of the study, signing an informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Anti-GAD antibody positive
Item
positive anti-gad antibodies
boolean
C1167896 (UMLS CUI [1])
Insulin Production Failure Probable | Insulin C-peptide measurement
Item
laboratorial signal of probable failure of insulin production, i. e., seric peptide c lesser than 1 ng/ml.
boolean
C0021641 (UMLS CUI [1,1])
C0033268 (UMLS CUI [1,2])
C0231174 (UMLS CUI [1,3])
C0033204 (UMLS CUI [1,4])
C0202100 (UMLS CUI [2])
Liver diseases | Liver Cirrhosis | Hepatitis, Chronic
Item
history of hepatic disease like cirrhosis or chronic active hepatitis.
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
Renal dysfunction | Creatinine measurement, serum | Gender
Item
kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Neoplasms
Item
recent history of neoplasia (< 5 years).
boolean
C0027651 (UMLS CUI [1])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable
Item
use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial