ID

29104

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.02.18 25.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Februar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00566189

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00566189

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Obesity CTCAE Grades | Body mass index

Datentyp

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.
Beschreibung

Body Weight Variability Percent

Datentyp

boolean

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

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

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

Insulin Requirement | Insulin Associated with Pharmaceutical Preparations Oral

Datentyp

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.
Beschreibung

Comprehension Study Protocol

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive anti-gad antibodies
Beschreibung

Anti-GAD antibody positive

Datentyp

boolean

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

Insulin Production Failure Probable | Insulin C-peptide measurement

Datentyp

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.
Beschreibung

Liver diseases | Liver Cirrhosis | Hepatitis, Chronic

Datentyp

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).
Beschreibung

Renal dysfunction | Creatinine measurement, serum | Gender

Datentyp

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.
Beschreibung

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

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

Neoplasms

Datentyp

boolean

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

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable

Datentyp

boolean

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

Eligibility Diabetes Mellitus, Type 2 NCT00566189

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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