0 Ratings
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

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License

Creative Commons BY 4.0
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    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
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    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])
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