ID

42629

Beschrijving

Testosterone Replacement in Diabetes With Vascular Disease (Version 2); ODM derived from: https://clinicaltrials.gov/show/NCT00355537

Link

https://clinicaltrials.gov/show/NCT00355537

Trefwoorden

Versies (2)
  1. 04-03-17 04-03-17 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00355537

Engels

Eligibility Diabetes Mellitus NCT00355537

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male patients greater than 18 years of age
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
type 2 diabetes mellitus
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
serum testosterone less than 11 nmol/l on two consecutive samples taken on different days
Beschrijving

Serum testosterone measurement CONSECUTIVE SAMPLE Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428413
UMLS CUI [1,2]
C0150094
UMLS CUI [1,3]
C1265611
peripheral vascular disease as defined by abpi less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene
Beschrijving

Peripheral Vascular Disease Ankle brachial pressure index | Pain in lower limb Ischemic | Claudication | Rest pain | Complication Distal | FOOT ULCER UNHEALED Arterial | Gangrene Non-healed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
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 [7,1]
C0017086
UMLS CUI [7,2]
C0205301
agreement to maintain antihypertensive and anti-lipid treatments at prior doses during 3 months of study
Beschrijving

Antihypertensive therapy Dosage Maintenance | Antilipidemic Agent Dosage Maintenance

Datatype

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
ability to give written informed consent after verbal and written explanation in the english language
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ability to comply with all study requirements
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or previous breast cancer
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
current or previous prostate cancer
Beschrijving

Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
raised prostate specific antigen or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion
Beschrijving

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

Datatype

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
severe symptoms of benign prostatic hypertrophy ('prostatism')
Beschrijving

Benign prostatic hypertrophy Symptom severe

Datatype

boolean

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

Testosterone

Datatype

boolean

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

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Diabetes Mellitus NCT00355537

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
male patients greater than 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Serum testosterone measurement CONSECUTIVE SAMPLE Quantity
Item
serum testosterone less than 11 nmol/l on two consecutive samples taken on different days
boolean
C0428413 (UMLS CUI [1,1])
C0150094 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Peripheral Vascular Disease Ankle brachial pressure index | Pain in lower limb Ischemic | Claudication | Rest pain | Complication Distal | FOOT ULCER UNHEALED Arterial | Gangrene Non-healed
Item
peripheral vascular disease as defined by abpi less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene
boolean
C0085096 (UMLS CUI [1,1])
C1276055 (UMLS CUI [1,2])
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 [7,1])
C0205301 (UMLS CUI [7,2])
Antihypertensive therapy Dosage Maintenance | Antilipidemic Agent Dosage Maintenance
Item
agreement to maintain antihypertensive and anti-lipid treatments at prior doses during 3 months 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
Item
ability to give written informed consent after verbal and written explanation in the english language
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
ability to comply with all study requirements
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma
Item
current or previous breast cancer
boolean
C0678222 (UMLS CUI [1])
Prostate carcinoma
Item
current or previous prostate cancer
boolean
C0600139 (UMLS CUI [1])
Raised prostate specific antigen | Prostate specific antigen abnormal Rectal examination | Prostate carcinoma Exclusion
Item
raised prostate specific antigen 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 Symptom severe
Item
severe symptoms of benign prostatic hypertrophy ('prostatism')
boolean
C1704272 (UMLS CUI [1,1])
C0436345 (UMLS CUI [1,2])
Testosterone
Item
treatment with testosterone in the 3 months prior to the trial
boolean
C0039601 (UMLS CUI [1])
Investigational New Drugs
Item
investigational drug treatment in the 3 months prior to the trial
boolean
C0013230 (UMLS CUI [1])
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