ID

36257

Beschreibung

Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02484508

Link

https://clinicaltrials.gov/show/NCT02484508

Stichworte

Versionen (1)
  1. 25.04.19 25.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. April 2019

DOI

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Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02484508

Englisch

Eligibility Knee Osteoarthritis NCT02484508

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages between 40 and 70 years, both gender
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
kellgren and lawrence grades of i to iii;
Beschreibung

Kellgren-Lawrence score

Datentyp

boolean

Alias
UMLS CUI [1]
C3177117
the subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
Beschreibung

Protocol Compliance | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
meet the following clinical and radiological criteria for diagnosis:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
clinical criteria:
Beschreibung

Criteria Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205210
1. most of the time have knee pain nearly a month
Beschreibung

Knee pain Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0449238
2. bone fricative
Beschreibung

Bone Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C3846158
3. morning stiffness is less than or equal to 30 min
Beschreibung

Morning stiffness Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0457086
UMLS CUI [1,2]
C0449238
4. age is more than or equal to 38 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. bony enlargement. who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
Beschreibung

Bony joint enlargement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221610
radiological criteria:
Beschreibung

Criteria Radiologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205483
1. most of the time have knee pain nearly a month
Beschreibung

Knee pain Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0449238
2. the x-ray showed osteophyte formation
Beschreibung

Osteophyte Formation X-ray

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956089
UMLS CUI [1,2]
C1522492
UMLS CUI [1,3]
C0034571
3. joint fluid examination confirmed with osteoarthritis
Beschreibung

Joint Fluid Examination | Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039097
UMLS CUI [1,2]
C4321457
UMLS CUI [2]
C0029408
4. age is more than or equal to 40 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. morning stiffness is less than or equal to 30 min
Beschreibung

Morning stiffness Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0457086
UMLS CUI [1,2]
C0449238
6. bone fricative. meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) +
Beschreibung

Bone Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C3846158
(6).
Beschreibung

ID.18

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with a history of allergy to similar constituents or chemical components of the drug;
Beschreibung

Hypersensitivity Investigational New Drug Constituents | Hypersensitivity Investigational New Drug Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0729650
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1705248
patients with limited liver and kidney function;
Beschreibung

Liver Dysfunction | Impaired kidney function

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0184571
patients with hematopoietic system disease;
Beschreibung

Hematopoietic system disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018939
patients with diabetes, cushing's syndrome and other endocrine disorders;
Beschreibung

Diabetes Mellitus | Cushing Syndrome | Endocrine System Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0010481
UMLS CUI [3]
C0014130
patients with severe heart and brain disease;
Beschreibung

Heart Disease Severe | Brain Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0006111
UMLS CUI [2,2]
C0205082
patients with low immunity;
Beschreibung

Deficient immunity

Datentyp

boolean

Alias
UMLS CUI [1]
C4062960
patients directly involved with the staff in the study;
Beschreibung

Patients Involvement with Research Personnel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0035173
women during pregnancy or lactation;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participating in other clinical studies or participated in 3 months;
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
the investigators judged who be unfit for the study.
Beschreibung

Study Subject Participation Status Medically unfit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3841806
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Ähnliche Modelle

Eligibility Knee Osteoarthritis NCT02484508

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages between 40 and 70 years, both gender
boolean
C0001779 (UMLS CUI [1])
Kellgren-Lawrence score
Item
kellgren and lawrence grades of i to iii;
boolean
C3177117 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
the subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Criteria Fulfill
Item
meet the following clinical and radiological criteria for diagnosis:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Criteria Clinical
Item
clinical criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Knee pain Duration
Item
1. most of the time have knee pain nearly a month
boolean
C0231749 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Bone Other Coding
Item
2. bone fricative
boolean
C0262950 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
Morning stiffness Duration
Item
3. morning stiffness is less than or equal to 30 min
boolean
C0457086 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Age
Item
4. age is more than or equal to 38 years
boolean
C0001779 (UMLS CUI [1])
Bony joint enlargement
Item
5. bony enlargement. who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
boolean
C0221610 (UMLS CUI [1])
Criteria Radiologic
Item
radiological criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0205483 (UMLS CUI [1,2])
Knee pain Duration
Item
1. most of the time have knee pain nearly a month
boolean
C0231749 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Osteophyte Formation X-ray
Item
2. the x-ray showed osteophyte formation
boolean
C1956089 (UMLS CUI [1,1])
C1522492 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Joint Fluid Examination | Osteoarthritis
Item
3. joint fluid examination confirmed with osteoarthritis
boolean
C0039097 (UMLS CUI [1,1])
C4321457 (UMLS CUI [1,2])
C0029408 (UMLS CUI [2])
Age
Item
4. age is more than or equal to 40 years
boolean
C0001779 (UMLS CUI [1])
Morning stiffness Duration
Item
5. morning stiffness is less than or equal to 30 min
boolean
C0457086 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Bone Other Coding
Item
6. bone fricative. meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) +
boolean
C0262950 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
ID.18
Item
(6).
boolean
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drug Constituents | Hypersensitivity Investigational New Drug Component
Item
patient with a history of allergy to similar constituents or chemical components of the drug;
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0729650 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Liver Dysfunction | Impaired kidney function
Item
patients with limited liver and kidney function;
boolean
C0086565 (UMLS CUI [1])
C0184571 (UMLS CUI [2])
Hematopoietic system disease
Item
patients with hematopoietic system disease;
boolean
C0018939 (UMLS CUI [1])
Diabetes Mellitus | Cushing Syndrome | Endocrine System Diseases
Item
patients with diabetes, cushing's syndrome and other endocrine disorders;
boolean
C0011849 (UMLS CUI [1])
C0010481 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
Heart Disease Severe | Brain Disease Severe
Item
patients with severe heart and brain disease;
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006111 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Deficient immunity
Item
patients with low immunity;
boolean
C4062960 (UMLS CUI [1])
Patients Involvement with Research Personnel
Item
patients directly involved with the staff in the study;
boolean
C0030705 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
women during pregnancy or lactation;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
participating in other clinical studies or participated in 3 months;
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Medically unfit
Item
the investigators judged who be unfit for the study.
boolean
C2348568 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
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