ID

37052

Descrição

Effect of Andosan in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01815411

Link

https://clinicaltrials.gov/show/NCT01815411

Palavras-chave

Versões (1)
  1. 01/07/2019 01/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

1 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01815411

Inglês

Eligibility Rheumatoid Arthritis NCT01815411

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age>18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
able and willing to give written informed consent, and to comply with the requirements of the study protocol.
Descrição

Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
fulfilling the acr 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis.
Descrição

Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
moderate disease activity based on the clinical evaluation including das28-esr (das28 3.2-5.1) [11, 12].
Descrição

Moderate disease activity DAS28

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368567
UMLS CUI [1,2]
C4481729
stable medication by disease modifying drugs (dmards) and systemic glucocorticosteroids for 3 months prior to the inclusion.
Descrição

DMARDs Stable | Systemic Glucocorticoids Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C3540777
UMLS CUI [2,2]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
lack of cooperativity.
Descrição

Cooperative Behavior Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009964
UMLS CUI [1,2]
C0332268
clinically significant chronic infection, including positive serology for hepatitis b or c, history of positive hiv status.
Descrição

Chronic infectious disease | Hepatitis B Seropositive | Hepatitis C Seropositive | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0521143
UMLS CUI [4]
C0019699
acute significant infection during the last 3 weeks before the inclusion. surgery during the last 4 weeks before the inclusion, and during the study period.
Descrição

Communicable Disease | Operative Surgical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0543467
clinically significant malignancy .
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
drug addiction
Descrição

Drug Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1510472
any inflammatory disease of permanence not related to ra.
Descrição

Inflammatory disorder Permanent | Relationship Absent Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0205355
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0003873
use of prednisolone >7,5 mg daily for 1 month prior to the inclusion.
Descrição

Prednisolone U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032950
UMLS CUI [1,2]
C0456683
use of biologic treatment including antibodies to cytokines and their receptors for 6 weeks prior to the inclusion.
Descrição

Biological treatment | Antibodies Cytokine | Antibodies Cytokine Receptors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2,1]
C3495458
UMLS CUI [2,2]
C0079189
UMLS CUI [3,1]
C3495458
UMLS CUI [3,2]
C0206552
use of intramuscular, intra-articular or intravenous injections of corticosteroids during or within 4 weeks prior to inclusion in the trial.
Descrição

Adrenal Cortex Hormones Intramuscular injection | Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intravenous Injection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0021492
UMLS CUI [2]
C2064783
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0021494
vaccination during the trial.
Descrição

Vaccination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042196
pregnancy or breast-feeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Rheumatoid Arthritis NCT01815411

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age>18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
able and willing to give written informed consent, and to comply with the requirements of the study protocol.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Rheumatoid Arthritis
Item
fulfilling the acr 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis.
boolean
C0003873 (UMLS CUI [1])
Moderate disease activity DAS28
Item
moderate disease activity based on the clinical evaluation including das28-esr (das28 3.2-5.1) [11, 12].
boolean
C2368567 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
DMARDs Stable | Systemic Glucocorticoids Stable
Item
stable medication by disease modifying drugs (dmards) and systemic glucocorticosteroids for 3 months prior to the inclusion.
boolean
C0242708 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C3540777 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cooperative Behavior Lacking
Item
lack of cooperativity.
boolean
C0009964 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Chronic infectious disease | Hepatitis B Seropositive | Hepatitis C Seropositive | HIV Seropositivity
Item
clinically significant chronic infection, including positive serology for hepatitis b or c, history of positive hiv status.
boolean
C0151317 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0019699 (UMLS CUI [4])
Communicable Disease | Operative Surgical Procedures
Item
acute significant infection during the last 3 weeks before the inclusion. surgery during the last 4 weeks before the inclusion, and during the study period.
boolean
C0009450 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Malignant Neoplasms
Item
clinically significant malignancy .
boolean
C0006826 (UMLS CUI [1])
Drug Dependence
Item
drug addiction
boolean
C1510472 (UMLS CUI [1])
Inflammatory disorder Permanent | Relationship Absent Rheumatoid Arthritis
Item
any inflammatory disease of permanence not related to ra.
boolean
C1290884 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
Prednisolone U/day
Item
use of prednisolone >7,5 mg daily for 1 month prior to the inclusion.
boolean
C0032950 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Biological treatment | Antibodies Cytokine | Antibodies Cytokine Receptors
Item
use of biologic treatment including antibodies to cytokines and their receptors for 6 weeks prior to the inclusion.
boolean
C1531518 (UMLS CUI [1])
C3495458 (UMLS CUI [2,1])
C0079189 (UMLS CUI [2,2])
C3495458 (UMLS CUI [3,1])
C0206552 (UMLS CUI [3,2])
Adrenal Cortex Hormones Intramuscular injection | Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intravenous Injection
Item
use of intramuscular, intra-articular or intravenous injections of corticosteroids during or within 4 weeks prior to inclusion in the trial.
boolean
C0001617 (UMLS CUI [1,1])
C0021492 (UMLS CUI [1,2])
C2064783 (UMLS CUI [2])
C0001617 (UMLS CUI [3,1])
C0021494 (UMLS CUI [3,2])
Vaccination
Item
vaccination during the trial.
boolean
C0042196 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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