ID

31654

Description

Global Performance Evaluation of the AMS CONTINUUM™ Device; ODM derived from: https://clinicaltrials.gov/show/NCT01083199

Link

https://clinicaltrials.gov/show/NCT01083199

Keywords

  1. 9/17/18 9/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT01083199

Eligibility Prostate Cancer NCT01083199

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study
Description

Gender | Age | Indication Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0194810
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
if contraindicated for surgery
Description

Medical contraindication Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0543467
inability to understand the study or a history of non-compliance with medical advice
Description

Comprehension Study Protocol Unable | Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
unwilling or unable to sign an informed consent form (icf)
Description

Informed Consent Unwilling | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
a history of:
Description

Medical History

Data type

boolean

Alias
UMLS CUI [1]
C0262926
1. recurrent urinary tract infections (uti)
Description

Recurrent urinary tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0262655
2. recurrent stricture disease
Description

Stricture Recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C2945760
neurological disease with a history of bladder dysfunction (e.g., parkinson's disease)
Description

Nervous system disorder | Bladder dysfunction | Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0232841
UMLS CUI [3]
C0030567
uncontrolled insulin-dependent diabetes
Description

DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED

Data type

boolean

Alias
UMLS CUI [1]
C0743113
chemotherapy within the past 6 months
Description

Chemotherapy Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
non-topical steroid use within the past 6 months
Description

Steroid use Recently | Exception Topical steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0281991
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2064827
allergy to nitinol, nickel, titanium or silicone
Description

Hypersensitivity Nitinol | Allergy to nickel | Hypersensitivity Titanium | Silicone allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0068790
UMLS CUI [2]
C1690547
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0040302
UMLS CUI [4]
C0571242

Similar models

Eligibility Prostate Cancer NCT01083199

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Indication Radical prostatectomy
Item
all males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0194810 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Operative Surgical Procedures
Item
if contraindicated for surgery
boolean
C1301624 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Comprehension Study Protocol Unable | Compliance behavior Lacking
Item
inability to understand the study or a history of non-compliance with medical advice
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Informed Consent Unwilling | Informed Consent Unable
Item
unwilling or unable to sign an informed consent form (icf)
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medical History
Item
a history of:
boolean
C0262926 (UMLS CUI [1])
Recurrent urinary tract infection
Item
1. recurrent urinary tract infections (uti)
boolean
C0262655 (UMLS CUI [1])
Stricture Recurrent
Item
2. recurrent stricture disease
boolean
C1261287 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
Nervous system disorder | Bladder dysfunction | Parkinson Disease
Item
neurological disease with a history of bladder dysfunction (e.g., parkinson's disease)
boolean
C0027765 (UMLS CUI [1])
C0232841 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED
Item
uncontrolled insulin-dependent diabetes
boolean
C0743113 (UMLS CUI [1])
Chemotherapy Recently
Item
chemotherapy within the past 6 months
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Steroid use Recently | Exception Topical steroids
Item
non-topical steroid use within the past 6 months
boolean
C0281991 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2064827 (UMLS CUI [2,2])
Hypersensitivity Nitinol | Allergy to nickel | Hypersensitivity Titanium | Silicone allergy
Item
allergy to nitinol, nickel, titanium or silicone
boolean
C0020517 (UMLS CUI [1,1])
C0068790 (UMLS CUI [1,2])
C1690547 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0040302 (UMLS CUI [3,2])
C0571242 (UMLS CUI [4])

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