ID

36701

Beschrijving

The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee; ODM derived from: https://clinicaltrials.gov/show/NCT02333084

Link

https://clinicaltrials.gov/show/NCT02333084

Trefwoorden

Versies (1)
  1. 03-06-19 03-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT02333084

Engels

Eligibility Osteoarthritis NCT02333084

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 and ≤ 90 at the time of informed consent.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subjects with symptomatic moderate arthritis of the knee defined as per
Beschrijving

Arthritis of knee Moderate Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0240111
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0231220
kellgren-lawrence grade ii or iii (appendix b). subjects with bilateral arthritis of the knee will also be recruited, but only one knee will be enrolled into the study.
Beschrijving

Kellgren-Lawrence score | Bilateral arthritis of knees | Enrollment Knee Single

Datatype

boolean

Alias
UMLS CUI [1]
C3177117
UMLS CUI [2]
C3864080
UMLS CUI [3,1]
C1516879
UMLS CUI [3,2]
C0022742
UMLS CUI [3,3]
C0205171
ability to walk 50 feet unassisted.
Beschrijving

Able to walk Unaided Feet Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0439846
UMLS CUI [1,3]
C0347981
UMLS CUI [1,4]
C1265611
lequesne's functional index score greater than 7 points
Beschrijving

Lequesne index

Datatype

boolean

Alias
UMLS CUI [1]
C0451257
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others
Beschrijving

Inflammatory disorder Systemic | Inflammatory Bowel Disease | Psoriasis | Eczema

Datatype

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0033860
UMLS CUI [4]
C0013595
subjects with seropositive or sero-negative inflammatory arthritis of the knee such as rheumatoid arthritis or ankylosing spondylitis.
Beschrijving

Arthritis of knee Seropositive | Arthritis of knee Seronegative | Rheumatoid Arthritis | Ankylosing spondylitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0240111
UMLS CUI [1,2]
C0521143
UMLS CUI [2,1]
C0240111
UMLS CUI [2,2]
C0521144
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0038013
subjects taking hormone replacement therapy
Beschrijving

Hormone replacement therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0282402
intra-articular corticosteroid injections 3 weeks prior to enrollment.
Beschrijving

Intraarticular injection of corticosteroids

Datatype

boolean

Alias
UMLS CUI [1]
C2064783
hypersensitivity to fish oil.
Beschrijving

Fish oils allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0571871
hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver of kidney function tests, history of peptic ulceration and upper gastrointestinal hemorrhage, congestive heart failure, hypertension (bp>140/90), cancer and hyperkalemia.
Beschrijving

Non-steroidal anti-inflammatory drug allergy | Liver function tests abnormal finding | Renal function tests abnormal | Peptic Ulcer | Upper gastrointestinal hemorrhage | Congestive heart failure | Hypertensive disease | Blood pressure determination | Malignant Neoplasms | Hyperkalemia

Datatype

boolean

Alias
UMLS CUI [1]
C0570537
UMLS CUI [2]
C0151766
UMLS CUI [3]
C0236151
UMLS CUI [4]
C0030920
UMLS CUI [5]
C0041909
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0020538
UMLS CUI [8]
C0005824
UMLS CUI [9]
C0006826
UMLS CUI [10]
C0020461
major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders.
Beschrijving

Complete Blood Count Abnormal result Major | Blood Coagulation Disorders | Hematological Disease | Nervous system disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009555
UMLS CUI [1,2]
C0459424
UMLS CUI [1,3]
C0205164
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0027765
high alcohol intake (>2 standard drinks per day). pregnant, breastfeeding or planning to become pregnant during the study
Beschrijving

Heavy alcohol consumption Drinks U/day | Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C2030272
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0032992
subjects awaiting surgery on the affected knee within three months.
Beschrijving

Operative Surgical Procedures Expected | Knee affected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1517001
UMLS CUI [2,1]
C0022742
UMLS CUI [2,2]
C1314939
consumption of any other vitamins/supplements will be allowed, provided the dose is not increased, and same brand is continued with. also, the regimen should not contain the same active compounds tested in the prn joint health formula product.
Beschrijving

Vitamins Dose Stable allowed | Supplements Dose Stable allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042890
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0683607
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0683607
vitamins/supplements cannot be introduced during a subject's participation in the study.
Beschrijving

Vitamins Introduction | Supplements Introduction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042890
UMLS CUI [1,2]
C1293116
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C1293116
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Similar models

Eligibility Osteoarthritis NCT02333084

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 and ≤ 90 at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Arthritis of knee Moderate Symptomatic
Item
subjects with symptomatic moderate arthritis of the knee defined as per
boolean
C0240111 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Kellgren-Lawrence score | Bilateral arthritis of knees | Enrollment Knee Single
Item
kellgren-lawrence grade ii or iii (appendix b). subjects with bilateral arthritis of the knee will also be recruited, but only one knee will be enrolled into the study.
boolean
C3177117 (UMLS CUI [1])
C3864080 (UMLS CUI [2])
C1516879 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
Able to walk Unaided Feet Quantity
Item
ability to walk 50 feet unassisted.
boolean
C2712089 (UMLS CUI [1,1])
C0439846 (UMLS CUI [1,2])
C0347981 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Lequesne index
Item
lequesne's functional index score greater than 7 points
boolean
C0451257 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inflammatory disorder Systemic | Inflammatory Bowel Disease | Psoriasis | Eczema
Item
subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others
boolean
C1290884 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0021390 (UMLS CUI [2])
C0033860 (UMLS CUI [3])
C0013595 (UMLS CUI [4])
Arthritis of knee Seropositive | Arthritis of knee Seronegative | Rheumatoid Arthritis | Ankylosing spondylitis
Item
subjects with seropositive or sero-negative inflammatory arthritis of the knee such as rheumatoid arthritis or ankylosing spondylitis.
boolean
C0240111 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0240111 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0003873 (UMLS CUI [3])
C0038013 (UMLS CUI [4])
Hormone replacement therapy
Item
subjects taking hormone replacement therapy
boolean
C0282402 (UMLS CUI [1])
Intraarticular injection of corticosteroids
Item
intra-articular corticosteroid injections 3 weeks prior to enrollment.
boolean
C2064783 (UMLS CUI [1])
Fish oils allergy
Item
hypersensitivity to fish oil.
boolean
C0571871 (UMLS CUI [1])
Non-steroidal anti-inflammatory drug allergy | Liver function tests abnormal finding | Renal function tests abnormal | Peptic Ulcer | Upper gastrointestinal hemorrhage | Congestive heart failure | Hypertensive disease | Blood pressure determination | Malignant Neoplasms | Hyperkalemia
Item
hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver of kidney function tests, history of peptic ulceration and upper gastrointestinal hemorrhage, congestive heart failure, hypertension (bp>140/90), cancer and hyperkalemia.
boolean
C0570537 (UMLS CUI [1])
C0151766 (UMLS CUI [2])
C0236151 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
C0041909 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0020538 (UMLS CUI [7])
C0005824 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C0020461 (UMLS CUI [10])
Complete Blood Count Abnormal result Major | Blood Coagulation Disorders | Hematological Disease | Nervous system disorder
Item
major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders.
boolean
C0009555 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0005779 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
Heavy alcohol consumption Drinks U/day | Pregnancy | Breast Feeding | Pregnancy, Planned
Item
high alcohol intake (>2 standard drinks per day). pregnant, breastfeeding or planning to become pregnant during the study
boolean
C2030272 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
Operative Surgical Procedures Expected | Knee affected
Item
subjects awaiting surgery on the affected knee within three months.
boolean
C0543467 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0022742 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Vitamins Dose Stable allowed | Supplements Dose Stable allowed
Item
consumption of any other vitamins/supplements will be allowed, provided the dose is not increased, and same brand is continued with. also, the regimen should not contain the same active compounds tested in the prn joint health formula product.
boolean
C0042890 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0683607 (UMLS CUI [1,4])
C0242295 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
Vitamins Introduction | Supplements Introduction
Item
vitamins/supplements cannot be introduced during a subject's participation in the study.
boolean
C0042890 (UMLS CUI [1,1])
C1293116 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C1293116 (UMLS CUI [2,2])
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