ID

42524

Beschreibung

Effect of Interventions on the Progression of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02178137

Link

https://clinicaltrials.gov/show/NCT02178137

Stichworte

Versionen (1)
  1. 18.08.21 18.08.21 -
Rechteinhaber

Indus Hospital and Health Network

Hochgeladen am

18. August 2021

DOI

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Creative Commons BY-NC 4.0
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Eligibility Osteo Arthritis of the Knees NCT02178137

Englisch

Eligibility Osteo Arthritis of the Knees NCT02178137

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees.
Beschreibung

Age | Osteoartrhitis mild to moderate

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0409959
UMLS CUI [3,2]
C0205081
patients should have history of knee pain for at least 6 months and on the majority of days during the preceding month
Beschreibung

Knee pain duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0449238
each joint will be scored separately so one patient with bilateral knee osteoarthritis will be counted as 2 knees.
Beschreibung

Each joint will be scored separately

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C0443299
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C0449820
UMLS CUI [1,5]
C1265611
the osteoarthritis will be graded on basis of clinical score as well as seen on appropriately positioned x rays using the kellgren and lawrence grading. (tibio femoral osteophytes of at least 1 mm, kellgren lawrence grading of 2 or 3)
Beschreibung

Osteoarthritis clinical score | Kellgren and Lawrence grading

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0449820
UMLS CUI [2]
C3177117
patients with diabetes are sent to the diabetes clinic and are included once their hba1c level becomes normal.
Beschreibung

Hba1c levels normal in diabetic patients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0241863
patients giving informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with severe end stage tricompartmental osteoarthritis of the knees .
Beschreibung

Severe end stage tricompartmental osteoarthritis of the knees

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205088
UMLS CUI [1,4]
C0447798
UMLS CUI [1,5]
C1265611
presence of uncontrolled systemic disease like chronic liver and renal disease
Beschreibung

Uncontrolled systemic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
patients with diagnosis other than osteoarthritis, such as knee arthritis due to rheumatoid disease, gout, post traumatic arthritis
Beschreibung

Diagnosis other than osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0409959
patients with history of surgery to any knee will have that knee excluded
Beschreibung

History of knee surgery in the site of lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0262926
pregnant or lactating mothers
Beschreibung

Pregnancy | Breast feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with chronic anaemia
Beschreibung

Chronic anaemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0205191
patients who get an injection in their affected knee
Beschreibung

Injection in affected knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1828121
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
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Ähnliche Modelle

Eligibility Osteo Arthritis of the Knees NCT02178137

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Osteoartrhitis mild to moderate
Item
patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees.
boolean
C0001779 (UMLS CUI [1])
C0409959 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0409959 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
Knee pain duration
Item
patients should have history of knee pain for at least 6 months and on the majority of days during the preceding month
boolean
C0231749 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Each joint will be scored separately
Item
each joint will be scored separately so one patient with bilateral knee osteoarthritis will be counted as 2 knees.
boolean
C0022417 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C1265611 (UMLS CUI [1,5])
Osteoarthritis clinical score | Kellgren and Lawrence grading
Item
the osteoarthritis will be graded on basis of clinical score as well as seen on appropriately positioned x rays using the kellgren and lawrence grading. (tibio femoral osteophytes of at least 1 mm, kellgren lawrence grading of 2 or 3)
boolean
C0409959 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C3177117 (UMLS CUI [2])
Hba1c levels normal in diabetic patients
Item
patients with diabetes are sent to the diabetes clinic and are included once their hba1c level becomes normal.
boolean
C0474680 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0241863 (UMLS CUI [1,4])
Informed consent
Item
patients giving informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Severe end stage tricompartmental osteoarthritis of the knees
Item
patients with severe end stage tricompartmental osteoarthritis of the knees .
boolean
C0409959 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205088 (UMLS CUI [1,3])
C0447798 (UMLS CUI [1,4])
C1265611 (UMLS CUI [1,5])
Uncontrolled systemic disease
Item
presence of uncontrolled systemic disease like chronic liver and renal disease
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Diagnosis other than osteoarthritis
Item
patients with diagnosis other than osteoarthritis, such as knee arthritis due to rheumatoid disease, gout, post traumatic arthritis
boolean
C0205394 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0409959 (UMLS CUI [1,4])
History of knee surgery in the site of lesion
Item
patients with history of surgery to any knee will have that knee excluded
boolean
C0543467 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
Pregnancy | Breast feeding
Item
pregnant or lactating mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chronic anaemia
Item
patients with chronic anaemia
boolean
C0002871 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Injection in affected knee
Item
patients who get an injection in their affected knee
boolean
C1828121 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
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