ID

16653

Description

An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00198029

Link

https://clinicaltrials.gov/show/NCT00198029

Keywords

Versions (1)
  1. 7/29/16 7/29/16 -
Uploaded on

July 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Carpometacarpal Osteoarthritis NCT00198029

English

Eligibility Carpometacarpal Osteoarthritis NCT00198029

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
radiographic evidence of at least moderate narrowing (joint space < 1mm) or the presence of osteophytes or sclerosis at the carpometacarpal joint
Description

Evidence roentgenographic | Narrowing Moderate carpometacarpal joint | Narrowing Severe carpometacarpal joint | Articular space | Osteophyte carpometacarpal joint | Sclerosis carpometacarpal joint

Data type

boolean

Alias
UMLS CUI [1,1]
C3887511
UMLS CUI [1,2]
C0034571
UMLS CUI [2,1]
C3854333
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C1321524
UMLS CUI [3,1]
C3854333
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C1321524
UMLS CUI [4]
C0224497
UMLS CUI [5,1]
C1956089
UMLS CUI [5,2]
C1321524
UMLS CUI [6,1]
C0036429
UMLS CUI [6,2]
C1321524
patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of nsaids
Description

Pain Unacceptable | Physical activity modified | Splinting | Non-Steroidal Anti-Inflammatory Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1883420
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0392747
UMLS CUI [3]
C0204861
UMLS CUI [4]
C0003211
if bilateral disease, only the most severely involved hand, (as defined by vas for pain), will be entered in the study.
Description

Bilateral Disease | Hand Involved Severe

Data type

boolean

Alias
UMLS CUI [1]
C1511113
UMLS CUI [2,1]
C0018563
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0205082
proficiency in english.
Description

Proficiency English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0678997
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous bad injury to the thumb
Description

Thumb injury Bad

Data type

boolean

Alias
UMLS CUI [1,1]
C0262649
UMLS CUI [1,2]
C0205169
previous hand surgery on the study thumb
Description

Operative procedure on hand thumb study

Data type

boolean

Alias
UMLS CUI [1,1]
C0187067
UMLS CUI [1,2]
C1269613
UMLS CUI [1,3]
C0008976
known hand comorbidities (i.e. carpal tunnel syndrome, de quervains tenosynovitis etc)
Description

Comorbidity Hand | Carpal Tunnel Syndrome | De Quervain Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0018563
UMLS CUI [2]
C0007286
UMLS CUI [3]
C0149870
rheumatoid arthritis or lupus
Description

Rheumatoid Arthritis | Lupus Erythematosus

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0409974
bleeding problems
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
being on blood thinners (except aspirin)
Description

Anticoagulants | Aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0004057
known allergies to any of the medications being used
Description

Hypersensitivity Pharmaceutical Preparations Used

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1273517
allergies to chicken products
Description

Hypersensitivity Chicken product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008051
UMLS CUI [1,3]
C1514468
current use of oral steroids
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
cancer that is not cured or in remission
Description

Malignant Neoplasms | Cancer in remission

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0687702
severe diabetes
Description

Diabetes Mellitus Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205082
a serious infection somewhere else in the subject's body
Description

Communicable Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
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Similar models

Eligibility Carpometacarpal Osteoarthritis NCT00198029

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Evidence roentgenographic | Narrowing Moderate carpometacarpal joint | Narrowing Severe carpometacarpal joint | Articular space | Osteophyte carpometacarpal joint | Sclerosis carpometacarpal joint
Item
radiographic evidence of at least moderate narrowing (joint space < 1mm) or the presence of osteophytes or sclerosis at the carpometacarpal joint
boolean
C3887511 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C3854333 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1321524 (UMLS CUI [2,3])
C3854333 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1321524 (UMLS CUI [3,3])
C0224497 (UMLS CUI [4])
C1956089 (UMLS CUI [5,1])
C1321524 (UMLS CUI [5,2])
C0036429 (UMLS CUI [6,1])
C1321524 (UMLS CUI [6,2])
Pain Unacceptable | Physical activity modified | Splinting | Non-Steroidal Anti-Inflammatory Agents
Item
patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of nsaids
boolean
C0030193 (UMLS CUI [1,1])
C1883420 (UMLS CUI [1,2])
C0026606 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0204861 (UMLS CUI [3])
C0003211 (UMLS CUI [4])
Bilateral Disease | Hand Involved Severe
Item
if bilateral disease, only the most severely involved hand, (as defined by vas for pain), will be entered in the study.
boolean
C1511113 (UMLS CUI [1])
C0018563 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Proficiency English Language
Item
proficiency in english.
boolean
C0678997 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Thumb injury Bad
Item
previous bad injury to the thumb
boolean
C0262649 (UMLS CUI [1,1])
C0205169 (UMLS CUI [1,2])
Operative procedure on hand thumb study
Item
previous hand surgery on the study thumb
boolean
C0187067 (UMLS CUI [1,1])
C1269613 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Comorbidity Hand | Carpal Tunnel Syndrome | De Quervain Disease
Item
known hand comorbidities (i.e. carpal tunnel syndrome, de quervains tenosynovitis etc)
boolean
C0009488 (UMLS CUI [1,1])
C0018563 (UMLS CUI [1,2])
C0007286 (UMLS CUI [2])
C0149870 (UMLS CUI [3])
Rheumatoid Arthritis | Lupus Erythematosus
Item
rheumatoid arthritis or lupus
boolean
C0003873 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
Hemorrhage
Item
bleeding problems
boolean
C0019080 (UMLS CUI [1])
Anticoagulants | Aspirin
Item
being on blood thinners (except aspirin)
boolean
C0003280 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
Hypersensitivity Pharmaceutical Preparations Used
Item
known allergies to any of the medications being used
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1273517 (UMLS CUI [1,3])
Hypersensitivity Chicken product
Item
allergies to chicken products
boolean
C0020517 (UMLS CUI [1,1])
C0008051 (UMLS CUI [1,2])
C1514468 (UMLS CUI [1,3])
Adrenal Cortex Hormones
Item
current use of oral steroids
boolean
C0001617 (UMLS CUI [1])
Malignant Neoplasms | Cancer in remission
Item
cancer that is not cured or in remission
boolean
C0006826 (UMLS CUI [1])
C0687702 (UMLS CUI [2])
Diabetes Mellitus Severe
Item
severe diabetes
boolean
C0011849 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Communicable Disease Severe
Item
a serious infection somewhere else in the subject's body
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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