ID

31836

Descripción

A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00455208

Link

https://clinicaltrials.gov/show/NCT00455208

Palabras clave

Versiones (1)
  1. 1/10/18 1/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00455208

Inglés

Eligibility Rheumatoid Arthritis NCT00455208

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage
Descripción

Rheumatoid Arthritis | Osteoarthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0029408
able and willing to comply with study visits and procedures specified in this protocol for at least six months period
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
able to understand and willing to sign and date the written informed consent form prior to admission of the study
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
able and willing to provide adequate information for locator purposes
Descripción

Consent for release of information

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0511175
able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation
Descripción

Self-Evaluation Information | Diagnostic report Arthritis | Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2936633
UMLS CUI [1,2]
C1533716
UMLS CUI [2,1]
C0498033
UMLS CUI [2,2]
C0003864
UMLS CUI [3]
C0220825
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
over-weighted
Descripción

Overweight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497406
hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation
Descripción

Hypertensive disease | Diabetes Mellitus | Cardiovascular Disease | Kidney Disease | Cutaneous hypersensitivity Serious | Comorbidity Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk | Exception Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0022658
UMLS CUI [5,1]
C0585186
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0003864
patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded
Descripción

Biological Response Modifiers | Immunosuppressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005525
UMLS CUI [2]
C0021081
unable to spend 3 hours for treatment at the study center
Descripción

Therapeutic procedure Medical center Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0565990
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Rheumatoid Arthritis NCT00455208

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | Osteoarthritis
Item
having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage
boolean
C0003873 (UMLS CUI [1])
C0029408 (UMLS CUI [2])
Protocol Compliance
Item
able and willing to comply with study visits and procedures specified in this protocol for at least six months period
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
able to understand and willing to sign and date the written informed consent form prior to admission of the study
boolean
C0021430 (UMLS CUI [1])
Consent for release of information
Item
able and willing to provide adequate information for locator purposes
boolean
C0511175 (UMLS CUI [1])
Self-Evaluation Information | Diagnostic report Arthritis | Evaluation
Item
able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation
boolean
C2936633 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0498033 (UMLS CUI [2,1])
C0003864 (UMLS CUI [2,2])
C0220825 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Overweight
Item
over-weighted
boolean
C0497406 (UMLS CUI [1])
Hypertensive disease | Diabetes Mellitus | Cardiovascular Disease | Kidney Disease | Cutaneous hypersensitivity Serious | Comorbidity Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk | Exception Arthritis
Item
hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation
boolean
C0020538 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0585186 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0009488 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0003864 (UMLS CUI [8,2])
Biological Response Modifiers | Immunosuppressive Agents
Item
patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded
boolean
C0005525 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
Therapeutic procedure Medical center Unable
Item
unable to spend 3 hours for treatment at the study center
boolean
C0087111 (UMLS CUI [1,1])
C0565990 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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