ID

42983

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00504712

Stichworte

Versionen (2)
  1. 11.04.17 11.04.17 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypogonadism NCT00504712

Englisch

Eligibility Hypogonadism NCT00504712

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

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.
Beschreibung

Serum testosterone measurement Specimen Quantity | Symptoms Compatible with Hypogonadism

Datentyp

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
Beschreibung

Peripheral Vascular Disease

Datentyp

boolean

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

Diagnosis Vascular surgeon

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Antihypertensive therapy Dosage Maintenance | Antilipidemic Agent Dosage Maintenance

Datentyp

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.
Beschreibung

Informed Consent Explanation English Language

Datentyp

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.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Breast Carcinoma

Datentyp

boolean

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

Prostate carcinoma

Datentyp

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.
Beschreibung

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

Datentyp

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’)
Beschreibung

Benign prostatic hypertrophy Severe symptoms | Prostatism

Datentyp

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.
Beschreibung

Testosterone

Datentyp

boolean

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

Investigational New Drug

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Hypogonadism NCT00504712

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