ID

19176

Beschreibung

Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00072657

Link

https://clinicaltrials.gov/show/NCT00072657

Stichworte

Versionen (1)
  1. 10.12.16 10.12.16 -
Hochgeladen am

10. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00072657

Englisch

Eligibility Rheumatoid Arthritis NCT00072657

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of ra as defined by the american college of rheumatology (acr) and consistent with revised criteria for ra
Beschreibung

Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
stable disease-modifying drug regimen for 3 months prior to study entry, with no change in drug dosage for at least 3 months prior to study entry
Beschreibung

Disease-Modifying Antirheumatic Drugs Stable Duration | Medication dose changed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C1608430
relatively stable disease course for 3 months prior to study entry
Beschreibung

Clinical course of disease Stable Relative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449259
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0205345
if treated with corticosteroids, must be on a stable dosage for 3 months prior to study entry
Beschreibung

Adrenal Cortex Hormones Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
if taking prednisone, must be on a dosage less than or equal to 10 mg/day or equivalent
Beschreibung

Prednisone Dose U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
resides in greater los angeles area
Beschreibung

Reside Los Angeles County, CA

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2982691
UMLS CUI [1,2]
C3829255
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
inactive ra conditions defined as "in remission"
Beschreibung

Rheumatoid Arthritis remission

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0544452
experiencing frequent, severe disease flares that require changes in primary disease-modifying regimen
Beschreibung

Flare Severe Frequent | Disease-Modifying Antirheumatic Drugs Therapy change Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517205
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332183
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C3665894
UMLS CUI [2,3]
C0686904
serious medical conditions, including: diabetes, congestive heart failure, renal failure requiring specific treatment, cancer (unless cured for period of 5 years or more), unregulated endocrine disorders (including thyroid disorders), chronic uncontrolled infection, or any uncontrolled medical condition that may interfere with the study
Beschreibung

Medical condition Serious | Diabetes Mellitus | Congestive heart failure | Kidney Failure Requirement Therapeutic procedure Specific | Malignant Neoplasms Cure of disease | Endocrine System Diseases Uncontrolled | Thyroid Diseases | Chronic infectious disease Uncontrolled | Medical condition Uncontrolled Interferes with Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0035078
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0205369
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0679252
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0205318
UMLS CUI [7]
C0040128
UMLS CUI [8,1]
C0151317
UMLS CUI [8,2]
C0205318
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0205318
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C0008976
use of analgesics (e.g., opioids) other than acetaminophen or non-steroidal anti-inflammatory agents prescribed for ra treatment, tramadol (ultram) or tylenol with codeine on an as-needed basis, or propoxyphen (darvocet, wygesic)
Beschreibung

Therapeutic procedure Rheumatoid Arthritis | Analgesics | Opioids | Acetaminophen | Anti-Inflammatory Agents, Non-Steroidal | Tramadol | Ultram | Tylenol with Codeine | Propoxyphene | Darvocet | Wygesic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C0002771
UMLS CUI [3]
C0242402
UMLS CUI [4]
C0000970
UMLS CUI [5]
C0003211
UMLS CUI [6]
C0040610
UMLS CUI [7]
C0724054
UMLS CUI [8]
C0724034
UMLS CUI [9]
C0033493
UMLS CUI [10]
C1514497
UMLS CUI [11]
C0724411
use of oxycodone (percocet), hydrocodone (vicodin), morphine, or hydromorphone (dilaudid)
Beschreibung

Oxycodone | Percocet | Hydrocodone | Vicodin | Morphine | Hydromorphone | Dilaudid

Datentyp

boolean

Alias
UMLS CUI [1]
C0030049
UMLS CUI [2]
C0086787
UMLS CUI [3]
C0020264
UMLS CUI [4]
C0483514
UMLS CUI [5]
C0026549
UMLS CUI [6]
C0012306
UMLS CUI [7]
C0728755
use of high levels of methotrexate (greater than 7.5 mg)
Beschreibung

Methotrexate High dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0444956
use of nitrogen mustard, cyclosporine, monoclonal antibodies, or cyclophosphamide within the 6 months prior to study entry
Beschreibung

Mechlorethamine | Cyclosporine | Monoclonal antibodies, antineoplastic | Cyclophosphamide

Datentyp

boolean

Alias
UMLS CUI [1]
C0025033
UMLS CUI [2]
C0010592
UMLS CUI [3]
C3542957
UMLS CUI [4]
C0010583
serious psychiatric conditions, such as bipolar disorder, psychotic disorders, or organic brain syndromes
Beschreibung

Mental disorders Serious | Bipolar Disorder | Psychotic Disorders | Organic brain syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0029221
at risk for suicide
Beschreibung

At risk for suicide

Datentyp

boolean

Alias
UMLS CUI [1]
C0563664
dependent on canes, walkers, or other assistive devices
Beschreibung

Cane user | Dependence on walking stick | Self-Help Devices Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0920240
UMLS CUI [2]
C0524378
UMLS CUI [3,1]
C0036605
UMLS CUI [3,2]
C0851827
unable to commit to study schedule/itinerary or unwilling to be assigned to any of the 3 treatment groups
Beschreibung

Protocol Compliance Unable | Protocol Compliance Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00072657

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
diagnosis of ra as defined by the american college of rheumatology (acr) and consistent with revised criteria for ra
boolean
C0003873 (UMLS CUI [1])
Disease-Modifying Antirheumatic Drugs Stable Duration | Medication dose changed
Item
stable disease-modifying drug regimen for 3 months prior to study entry, with no change in drug dosage for at least 3 months prior to study entry
boolean
C0242708 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1608430 (UMLS CUI [2])
Clinical course of disease Stable Relative
Item
relatively stable disease course for 3 months prior to study entry
boolean
C0449259 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205345 (UMLS CUI [1,3])
Adrenal Cortex Hormones Dose Stable
Item
if treated with corticosteroids, must be on a stable dosage for 3 months prior to study entry
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Prednisone Dose U/day
Item
if taking prednisone, must be on a dosage less than or equal to 10 mg/day or equivalent
boolean
C0032952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Reside Los Angeles County, CA
Item
resides in greater los angeles area
boolean
C2982691 (UMLS CUI [1,1])
C3829255 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Rheumatoid Arthritis remission
Item
inactive ra conditions defined as "in remission"
boolean
C0003873 (UMLS CUI [1,1])
C0544452 (UMLS CUI [1,2])
Flare Severe Frequent | Disease-Modifying Antirheumatic Drugs Therapy change Patient need for
Item
experiencing frequent, severe disease flares that require changes in primary disease-modifying regimen
boolean
C1517205 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332183 (UMLS CUI [1,3])
C0242708 (UMLS CUI [2,1])
C3665894 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Medical condition Serious | Diabetes Mellitus | Congestive heart failure | Kidney Failure Requirement Therapeutic procedure Specific | Malignant Neoplasms Cure of disease | Endocrine System Diseases Uncontrolled | Thyroid Diseases | Chronic infectious disease Uncontrolled | Medical condition Uncontrolled Interferes with Clinical Trial
Item
serious medical conditions, including: diabetes, congestive heart failure, renal failure requiring specific treatment, cancer (unless cured for period of 5 years or more), unregulated endocrine disorders (including thyroid disorders), chronic uncontrolled infection, or any uncontrolled medical condition that may interfere with the study
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0035078 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0205369 (UMLS CUI [4,4])
C0006826 (UMLS CUI [5,1])
C0679252 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0040128 (UMLS CUI [7])
C0151317 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C3843040 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0008976 (UMLS CUI [9,4])
Therapeutic procedure Rheumatoid Arthritis | Analgesics | Opioids | Acetaminophen | Anti-Inflammatory Agents, Non-Steroidal | Tramadol | Ultram | Tylenol with Codeine | Propoxyphene | Darvocet | Wygesic
Item
use of analgesics (e.g., opioids) other than acetaminophen or non-steroidal anti-inflammatory agents prescribed for ra treatment, tramadol (ultram) or tylenol with codeine on an as-needed basis, or propoxyphen (darvocet, wygesic)
boolean
C0087111 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0002771 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
C0000970 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
C0040610 (UMLS CUI [6])
C0724054 (UMLS CUI [7])
C0724034 (UMLS CUI [8])
C0033493 (UMLS CUI [9])
C1514497 (UMLS CUI [10])
C0724411 (UMLS CUI [11])
Oxycodone | Percocet | Hydrocodone | Vicodin | Morphine | Hydromorphone | Dilaudid
Item
use of oxycodone (percocet), hydrocodone (vicodin), morphine, or hydromorphone (dilaudid)
boolean
C0030049 (UMLS CUI [1])
C0086787 (UMLS CUI [2])
C0020264 (UMLS CUI [3])
C0483514 (UMLS CUI [4])
C0026549 (UMLS CUI [5])
C0012306 (UMLS CUI [6])
C0728755 (UMLS CUI [7])
Methotrexate High dose
Item
use of high levels of methotrexate (greater than 7.5 mg)
boolean
C0025677 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Mechlorethamine | Cyclosporine | Monoclonal antibodies, antineoplastic | Cyclophosphamide
Item
use of nitrogen mustard, cyclosporine, monoclonal antibodies, or cyclophosphamide within the 6 months prior to study entry
boolean
C0025033 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C3542957 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
Mental disorders Serious | Bipolar Disorder | Psychotic Disorders | Organic brain syndrome
Item
serious psychiatric conditions, such as bipolar disorder, psychotic disorders, or organic brain syndromes
boolean
C0004936 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0005586 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0029221 (UMLS CUI [4])
At risk for suicide
Item
at risk for suicide
boolean
C0563664 (UMLS CUI [1])
Cane user | Dependence on walking stick | Self-Help Devices Dependent
Item
dependent on canes, walkers, or other assistive devices
boolean
C0920240 (UMLS CUI [1])
C0524378 (UMLS CUI [2])
C0036605 (UMLS CUI [3,1])
C0851827 (UMLS CUI [3,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
unable to commit to study schedule/itinerary or unwilling to be assigned to any of the 3 treatment groups
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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