ID

37089

Descripción

Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02264301

Link

https://clinicaltrials.gov/show/NCT02264301

Palabras clave

Versiones (1)
  1. 2/7/19 2/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02264301

Inglés

Eligibility Rheumatoid Arthritis NCT02264301

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
with active ra
Descripción

Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
without taking any other medication for the treatment of active ra in at least 4 last weeks
Descripción

Pharmaceutical Preparations Other Absent | Therapeutic procedure Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0003873
aged from 18 to 75 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
without conflict to the written, informed consent signed prior to the enrollment.
Descripción

Informed Consent | Conflict Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0009671
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
being included in other clinical trial within the last 4 weeks
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
with abnormal liver or kidney function (more than 1 time above the high normal)
Descripción

Increased liver function | Increased renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232743
UMLS CUI [2]
C0232806
with serious cardiovascular disease
Descripción

Cardiovascular Disease Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205404
with hematologic disease
Descripción

Hematological Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018939
being in pregnancy, lactation period or under a pregnancy plan
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
with severe gastrointestinal disease
Descripción

Gastrointestinal Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205082
with contraindication or being allergic to the test drugs
Descripción

Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs
Descripción

Pharmacotherapy Affecting Research results | Anti-Inflammatory Agents, Non-Steroidal | Steroidal anti-inflammatory drugs | Immunosuppressive Agents | Anti-Ulcer Agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0003212
UMLS CUI [4]
C0021081
UMLS CUI [5]
C0003216
being not compatible for the trial medication, or other circumstances at the discretion of investigators
Descripción

Incompatibility Investigational New Drugs | Life circumstances Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679426
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0680082
UMLS CUI [2,2]
C0205394
without legal capacity or only with limited legal capacity.
Descripción

Legal capacity Absent | Legal capacity Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
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Similar models

Eligibility Rheumatoid Arthritis NCT02264301

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
with active ra
boolean
C0003873 (UMLS CUI [1])
Pharmaceutical Preparations Other Absent | Therapeutic procedure Rheumatoid Arthritis
Item
without taking any other medication for the treatment of active ra in at least 4 last weeks
boolean
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Age
Item
aged from 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Conflict Absent
Item
without conflict to the written, informed consent signed prior to the enrollment.
boolean
C0021430 (UMLS CUI [1])
C0009671 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
being included in other clinical trial within the last 4 weeks
boolean
C2348568 (UMLS CUI [1])
Increased liver function | Increased renal function
Item
with abnormal liver or kidney function (more than 1 time above the high normal)
boolean
C0232743 (UMLS CUI [1])
C0232806 (UMLS CUI [2])
Cardiovascular Disease Serious
Item
with serious cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Hematological Disease
Item
with hematologic disease
boolean
C0018939 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
being in pregnancy, lactation period or under a pregnancy plan
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Gastrointestinal Disease Severe
Item
with severe gastrointestinal disease
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs
Item
with contraindication or being allergic to the test drugs
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Pharmacotherapy Affecting Research results | Anti-Inflammatory Agents, Non-Steroidal | Steroidal anti-inflammatory drugs | Immunosuppressive Agents | Anti-Ulcer Agent
Item
being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs
boolean
C0013216 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2])
C0003212 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0003216 (UMLS CUI [5])
Incompatibility Investigational New Drugs | Life circumstances Other
Item
being not compatible for the trial medication, or other circumstances at the discretion of investigators
boolean
C0679426 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0680082 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Legal capacity Absent | Legal capacity Limited
Item
without legal capacity or only with limited legal capacity.
boolean
C0683673 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
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