ID

42983

Description

Testosterone for Peripheral Vascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00504712

Link

https://clinicaltrials.gov/show/NCT00504712

Keywords

Versions (2)
  1. 4/11/17 4/11/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

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.

Back to model comments
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 Hypogonadism NCT00504712

English

Eligibility Hypogonadism NCT00504712

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes mellitus.
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
2. serum testosterone 12 nmol/l or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
Description

Serum testosterone measurement Specimen Quantity | Symptoms Compatible with Hypogonadism

Data type

boolean

Alias
UMLS CUI [1,1]
C0428413
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1524057
UMLS CUI [2,3]
C0020619
3. peripheral vascular disease as defined by
Description

Peripheral Vascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0085096
previous diagnosis by a specialist vascular surgeon or
Description

Diagnosis Vascular surgeon

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0586909
abpi less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
Description

Ankle brachial pressure index | Pain in lower limb Ischemic | Claudication | Rest pain | Complication Distal | FOOT ULCER UNHEALED Arterial | Gangrene

Data type

boolean

Alias
UMLS CUI [1]
C1276055
UMLS CUI [2,1]
C0023222
UMLS CUI [2,2]
C0475224
UMLS CUI [3]
C1456822
UMLS CUI [4]
C0234253
UMLS CUI [5,1]
C0009566
UMLS CUI [5,2]
C0205108
UMLS CUI [6,1]
C0744185
UMLS CUI [6,2]
C0221464
UMLS CUI [7]
C0017086
4. agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
Description

Antihypertensive therapy Dosage Maintenance | Antilipidemic Agent Dosage Maintenance

Data type

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0024501
UMLS CUI [2,1]
C1516000
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0024501
5. ability to give written informed consent after verbal and written explanation in the english language.
Description

Informed Consent Explanation English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0681841
UMLS CUI [1,3]
C0376245
6. ability to comply with all study requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current or previous breast cancer.
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
2. current or previous prostate cancer.
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
3. raised prostate specific antigen (psa) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
Description

Raised prostate specific antigen | Prostate specific antigen abnormal Rectal examination | Prostate carcinoma Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C0580555
UMLS CUI [2,2]
C0199900
UMLS CUI [3,1]
C0600139
UMLS CUI [3,2]
C2828389
4. severe symptoms of benign prostatic hypertrophy (‘prostatism’)
Description

Benign prostatic hypertrophy Severe symptoms | Prostatism

Data type

boolean

Alias
UMLS CUI [1,1]
C1704272
UMLS CUI [1,2]
C0436345
UMLS CUI [2]
C0242453
5. treatment with testosterone in the 3 months prior to the trial.
Description

Testosterone

Data type

boolean

Alias
UMLS CUI [1]
C0039601
6. investigational drug treatment in the 3 months prior to the trial.
Description

Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
Back to the top of the page

Similar models

Eligibility Hypogonadism NCT00504712

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Serum testosterone measurement Specimen Quantity | Symptoms Compatible with Hypogonadism
Item
2. serum testosterone 12 nmol/l or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
boolean
C0428413 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C1524057 (UMLS CUI [2,2])
C0020619 (UMLS CUI [2,3])
Peripheral Vascular Disease
Item
3. peripheral vascular disease as defined by
boolean
C0085096 (UMLS CUI [1])
Diagnosis Vascular surgeon
Item
previous diagnosis by a specialist vascular surgeon or
boolean
C0011900 (UMLS CUI [1,1])
C0586909 (UMLS CUI [1,2])
Ankle brachial pressure index | Pain in lower limb Ischemic | Claudication | Rest pain | Complication Distal | FOOT ULCER UNHEALED Arterial | Gangrene
Item
abpi less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
boolean
C1276055 (UMLS CUI [1])
C0023222 (UMLS CUI [2,1])
C0475224 (UMLS CUI [2,2])
C1456822 (UMLS CUI [3])
C0234253 (UMLS CUI [4])
C0009566 (UMLS CUI [5,1])
C0205108 (UMLS CUI [5,2])
C0744185 (UMLS CUI [6,1])
C0221464 (UMLS CUI [6,2])
C0017086 (UMLS CUI [7])
Antihypertensive therapy Dosage Maintenance | Antilipidemic Agent Dosage Maintenance
Item
4. agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
boolean
C0585941 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
C1516000 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
Informed Consent Explanation English Language
Item
5. ability to give written informed consent after verbal and written explanation in the english language.
boolean
C0021430 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Protocol Compliance
Item
6. ability to comply with all study requirements.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma
Item
1. current or previous breast cancer.
boolean
C0678222 (UMLS CUI [1])
Prostate carcinoma
Item
2. current or previous prostate cancer.
boolean
C0600139 (UMLS CUI [1])
Raised prostate specific antigen | Prostate specific antigen abnormal Rectal examination | Prostate carcinoma Excluded
Item
3. raised prostate specific antigen (psa) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
boolean
C0178415 (UMLS CUI [1])
C0580555 (UMLS CUI [2,1])
C0199900 (UMLS CUI [2,2])
C0600139 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Benign prostatic hypertrophy Severe symptoms | Prostatism
Item
4. severe symptoms of benign prostatic hypertrophy (‘prostatism’)
boolean
C1704272 (UMLS CUI [1,1])
C0436345 (UMLS CUI [1,2])
C0242453 (UMLS CUI [2])
Testosterone
Item
5. treatment with testosterone in the 3 months prior to the trial.
boolean
C0039601 (UMLS CUI [1])
Investigational New Drug
Item
6. investigational drug treatment in the 3 months prior to the trial.
boolean
C0013230 (UMLS CUI [1])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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