ID

20606

Description

Effect of Androgel on Type 2 Diabetic Males With Hypogonadism; ODM derived from: https://clinicaltrials.gov/show/NCT00350701

Link

https://clinicaltrials.gov/show/NCT00350701

Keywords

  1. 3/6/17 3/6/17 -
Uploaded on

March 6, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus Type 2 NCT00350701

Eligibility Diabetes Mellitus Type 2 NCT00350701

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males with age 35-75 years inclusive.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
evidence of hypogonadism: low free testosterone.
Description

Hypogonadism Evidence of | Blood testosterone free decreased

Data type

boolean

Alias
UMLS CUI [1,1]
C0020619
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C1096126
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
people on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
Description

Anticholesteremic Agents Dose Stable | Blood Pressure Pharmaceutical Preparations | Multivitamin preparation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003277
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0013227
UMLS CUI [3]
C0301532
if currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
Description

Testosterone Replacement | Testosterone Maintenance Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0559956
UMLS CUI [2,1]
C0039601
UMLS CUI [2,2]
C0024501
UMLS CUI [2,3]
C0449238
bp under control even if on medication.
Description

Blood Pressure Controlled | Taking medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C2587213
UMLS CUI [2]
C1290952
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
coronary event or procedure in previous past 4 wks.
Description

Event Coronary | Procedures on Coronary Arteries

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1522318
UMLS CUI [2]
C0869781
high psa
Description

Raised prostate specific antigen

Data type

boolean

Alias
UMLS CUI [1]
C0178415
h/o prostate cancer
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
hepatic or renal disease
Description

Liver disease | Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
participation in any other concurrent clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any other life- threatening , non cardiac disease.
Description

Life threatening illness | Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C0018799
uncontrolled bp
Description

Blood Pressure Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
high hemoglobin
Description

Hemoglobin increased

Data type

boolean

Alias
UMLS CUI [1]
C0549448
use of investigational agent or therapeutic regimen within 30 days of study.
Description

Investigational New Drugs | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266

Similar models

Eligibility Diabetes Mellitus Type 2 NCT00350701

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
males with age 35-75 years inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypogonadism Evidence of | Blood testosterone free decreased
Item
evidence of hypogonadism: low free testosterone.
boolean
C0020619 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1096126 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Anticholesteremic Agents Dose Stable | Blood Pressure Pharmaceutical Preparations | Multivitamin preparation
Item
people on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
boolean
C0003277 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0005823 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0301532 (UMLS CUI [3])
Testosterone Replacement | Testosterone Maintenance Duration
Item
if currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
boolean
C0039601 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0039601 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Blood Pressure Controlled | Taking medication
Item
bp under control even if on medication.
boolean
C0005823 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C1290952 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Event Coronary | Procedures on Coronary Arteries
Item
coronary event or procedure in previous past 4 wks.
boolean
C0441471 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0869781 (UMLS CUI [2])
Raised prostate specific antigen
Item
high psa
boolean
C0178415 (UMLS CUI [1])
Prostate carcinoma
Item
h/o prostate cancer
boolean
C0600139 (UMLS CUI [1])
Liver disease | Kidney Disease
Item
hepatic or renal disease
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in any other concurrent clinical trial
boolean
C2348568 (UMLS CUI [1])
Life threatening illness | Heart Disease
Item
any other life- threatening , non cardiac disease.
boolean
C3846017 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Blood Pressure Uncontrolled
Item
uncontrolled bp
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Hemoglobin increased
Item
high hemoglobin
boolean
C0549448 (UMLS CUI [1])
Investigational New Drugs | Therapies, Investigational
Item
use of investigational agent or therapeutic regimen within 30 days of study.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])

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