ID

40784

Description

A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02167516

Link

https://clinicaltrials.gov/show/NCT02167516

Keywords

Versions (1)
  1. 5/12/20 5/12/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 12, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02167516

English

Eligibility Knee Osteoarthritis NCT02167516

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must meet the american college of rheumatology (acr) 1995 revised criteria for koa.
Description

Criteria Fulfill Knee Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0409959
participants must be aged between 40 and 75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
participants shall not take non-steroidal anti-inflammatory drugs (nsaids) or corticosteroids during the 7 days prior to screening.
Description

NSAIDs Absent | Adrenal Cortex Hormones Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0332197
participants shall not take chinese medicine for the treatment of koa during the 7 days prior to screening.
Description

Chinese Medicine Absent | Therapy Knee Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C4331423
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0409959
joint function in the i-iii, x-ray stage in the i-iii.
Description

Joint function Stage X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C1535551
UMLS CUI [1,2]
C1306673
UMLS CUI [1,3]
C0040405
all participants shall agree to participate in the study and sign an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity.
Description

Narrowed joint space | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C1859695
UMLS CUI [2]
C3846158
patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures.
Description

Malignant Neoplasm Knee | Rheumatoid Arthritis | Tuberculosis | Fracture Purulent | Intra-Articular Fractures

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0022742
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0041296
UMLS CUI [4,1]
C0016658
UMLS CUI [4,2]
C0439665
UMLS CUI [5]
C0332715
persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury .
Description

Varus deformity | Injury of nerve of lower extremity Vascular

Data type

boolean

Alias
UMLS CUI [1]
C0544755
UMLS CUI [2,1]
C1264419
UMLS CUI [2,2]
C1801960
patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases.
Description

Cardiovascular Diseases Severe | Brain Diseases Severe | Lung diseases Severe | Liver diseases Severe | Kidney Diseases Severe | Hematological Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0006111
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0018939
UMLS CUI [6,2]
C0205082
pregnant women or breastfeeding mothers or individuals with known psychiatric disorders.
Description

Pregnancy | Breast Feeding | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0004936
patients who are hypersensitive to the trial medication.
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Knee Osteoarthritis NCT02167516

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill Knee Osteoarthritis
Item
participants must meet the american college of rheumatology (acr) 1995 revised criteria for koa.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
Age
Item
participants must be aged between 40 and 75 years.
boolean
C0001779 (UMLS CUI [1])
NSAIDs Absent | Adrenal Cortex Hormones Absent
Item
participants shall not take non-steroidal anti-inflammatory drugs (nsaids) or corticosteroids during the 7 days prior to screening.
boolean
C0003211 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Chinese Medicine Absent | Therapy Knee Osteoarthritis
Item
participants shall not take chinese medicine for the treatment of koa during the 7 days prior to screening.
boolean
C4331423 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0409959 (UMLS CUI [2,2])
Joint function Stage X-Ray Computed Tomography
Item
joint function in the i-iii, x-ray stage in the i-iii.
boolean
C1535551 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Informed Consent
Item
all participants shall agree to participate in the study and sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Narrowed joint space | Other Coding
Item
patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity.
boolean
C1859695 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Malignant Neoplasm Knee | Rheumatoid Arthritis | Tuberculosis | Fracture Purulent | Intra-Articular Fractures
Item
patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures.
boolean
C0006826 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
C0016658 (UMLS CUI [4,1])
C0439665 (UMLS CUI [4,2])
C0332715 (UMLS CUI [5])
Varus deformity | Injury of nerve of lower extremity Vascular
Item
persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury .
boolean
C0544755 (UMLS CUI [1])
C1264419 (UMLS CUI [2,1])
C1801960 (UMLS CUI [2,2])
Cardiovascular Diseases Severe | Brain Diseases Severe | Lung diseases Severe | Liver diseases Severe | Kidney Diseases Severe | Hematological Disease Severe
Item
patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases.
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006111 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0018939 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Pregnancy | Breast Feeding | Mental disorders
Item
pregnant women or breastfeeding mothers or individuals with known psychiatric disorders.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs
Item
patients who are hypersensitive to the trial medication.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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