ID

34018

Beschrijving

A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT01207115

Link

https://clinicaltrials.gov/show/NCT01207115

Trefwoorden

Versies (1)
  1. 11-01-19 11-01-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 januari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT01207115

Engels

Eligibility Osteoarthritis of the Knee NCT01207115

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of oa of the knee joint and meeting american college of rheumatology (acr) clinical and radiographic criteria,
Beschrijving

Osteoarthritis, Knee

Datatype

boolean

Alias
UMLS CUI [1]
C0409959
pain score as required by the protocol at screening and baseline
Beschrijving

Pain score | Study Protocol Requirement

Datatype

boolean

Alias
UMLS CUI [1]
C0582148
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C1514873
willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.
Beschrijving

Analgesics Washout | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1710661
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of sensitivity to histamine medications, acetaminophen (paracetamol), or non-steroidal anti-inflammatory drugs (nsaids)
Beschrijving

Hypersensitivity Histamine | Allergy to acetaminophen | Allergy to nonsteroidal anti-inflammatory agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019588
UMLS CUI [2]
C0570513
UMLS CUI [3]
C0746949
active gastrointestinal (gi) disease, gi bleeding or gi ulceration, or history of gi bleeding or gi ulceration in the last 6 months
Beschrijving

Gastrointestinal Disease | Gastrointestinal Hemorrhage | Gastrointestinal ulceration

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0017181
UMLS CUI [3]
C1963975
history of major psychiatric disorders
Beschrijving

Major psychiatric illness

Datatype

boolean

Alias
UMLS CUI [1]
C4534351
diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint
Beschrijving

Rheumatoid Arthritis | Autoimmune Disease | Arthritis | Exception Osteoarthritis Clinical Trial Joint | Syndrome Painful Interferes with Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0003864
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0029408
UMLS CUI [4,3]
C0008976
UMLS CUI [4,4]
C0022417
UMLS CUI [5,1]
C0039082
UMLS CUI [5,2]
C0030193
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C0008976
any cardiac, respiratory, neurological or other medical condition or illness that is not well controlled with treatment
Beschrijving

Heart Disease Poorly controlled | Respiration Disorder Poorly controlled | Nervous system disorder Poorly controlled | Other medical condition Poorly controlled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C3853134
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Similar models

Eligibility Osteoarthritis of the Knee NCT01207115

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Osteoarthritis, Knee
Item
history of oa of the knee joint and meeting american college of rheumatology (acr) clinical and radiographic criteria,
boolean
C0409959 (UMLS CUI [1])
Pain score | Study Protocol Requirement
Item
pain score as required by the protocol at screening and baseline
boolean
C0582148 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Analgesics Washout | Protocol Compliance
Item
willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.
boolean
C0002771 (UMLS CUI [1,1])
C1710661 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Histamine | Allergy to acetaminophen | Allergy to nonsteroidal anti-inflammatory agents
Item
history of sensitivity to histamine medications, acetaminophen (paracetamol), or non-steroidal anti-inflammatory drugs (nsaids)
boolean
C0020517 (UMLS CUI [1,1])
C0019588 (UMLS CUI [1,2])
C0570513 (UMLS CUI [2])
C0746949 (UMLS CUI [3])
Gastrointestinal Disease | Gastrointestinal Hemorrhage | Gastrointestinal ulceration
Item
active gastrointestinal (gi) disease, gi bleeding or gi ulceration, or history of gi bleeding or gi ulceration in the last 6 months
boolean
C0017178 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C1963975 (UMLS CUI [3])
Major psychiatric illness
Item
history of major psychiatric disorders
boolean
C4534351 (UMLS CUI [1])
Rheumatoid Arthritis | Autoimmune Disease | Arthritis | Exception Osteoarthritis Clinical Trial Joint | Syndrome Painful Interferes with Clinical Trial
Item
diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint
boolean
C0003873 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0003864 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0029408 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0022417 (UMLS CUI [4,4])
C0039082 (UMLS CUI [5,1])
C0030193 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C0008976 (UMLS CUI [5,4])
Heart Disease Poorly controlled | Respiration Disorder Poorly controlled | Nervous system disorder Poorly controlled | Other medical condition Poorly controlled
Item
any cardiac, respiratory, neurological or other medical condition or illness that is not well controlled with treatment
boolean
C0018799 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C3843040 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
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