ID

31834

Beschrijving

The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00372177

Link

https://clinicaltrials.gov/show/NCT00372177

Trefwoorden

  1. 01-10-18 01-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 oktober 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00372177

Eligibility Rheumatoid Arthritis NCT00372177

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects above 50 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
suffering from joint pain which is due to active rheumatoid arthritis
Beschrijving

Arthralgia Due to Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0003873
obvious signs of inflammation in at least one joint (e.g. swelling, erythema, or local elevated temperature)
Beschrijving

Signs Inflammation Joints Quantity | Swelling | Erythema | Temperature elevated Local

Datatype

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0021368
UMLS CUI [1,3]
C0022417
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0038999
UMLS CUI [3]
C0041834
UMLS CUI [4,1]
C0437737
UMLS CUI [4,2]
C0205276
otherwise healthy
Beschrijving

General status Healthy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0947124
UMLS CUI [1,2]
C3898900
informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients 80 years and older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
clinically significant disease of the cardiovascular system, respiratory system, hepato-biliary system or central nervous system (cns)
Beschrijving

Cardiovascular Disease | Respiration Disorder | Hepatobiliary disease | CNS disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0267792
UMLS CUI [4]
C0007682
excretory hepatic or renal insufficiency
Beschrijving

Hepatic Insufficiency Excretory | Renal Insufficiency Excretory

Datatype

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0221102
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0221102
regular intake of any drug, except for hormone replacement therapy in females
Beschrijving

Drug use Regular | Exception Hormone replacement therapy Gender

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242510
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0282402
UMLS CUI [2,3]
C0079399
previous administration of xenogenous proteins
Beschrijving

Proteins Heterogenous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C1512426
history of anaphylactic reaction to any drug administered by a parenteral pathway
Beschrijving

Anaphylaxis Drug Parenteral Administration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1518896
previous participation in a radiopharmaceutical drug trial (unless the effective dose acquired by participation in the current trial will remain below 10 msv)
Beschrijving

Study Subject Participation Status | Radiopharmaceuticals

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0182638
participation in any clinical drug trial within 3 months prior to enrolment
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
women of child-bearing potential (child-bearing potential to be ruled out by one of the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)
Beschrijving

Childbearing Potential | Factor out ruling Childbearing Potential | Postmenopausal state | Hysterectomy | Bilateral oophorectomy | Bilateral tubal ligation

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C3831118
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0278321
UMLS CUI [6]
C0589114
long term medication with strong antiphlogistic agents/pain killers such as methotrexate, corticoids, or immunosuppressants prior to enrolment
Beschrijving

Pharmaceutical Preparations Long-term | Antiphlogistic agent Strong | Analgesics Strong | Methotrexate | Adrenal Cortex Hormones | Immunosuppressive Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0443252
UMLS CUI [2,1]
C0304344
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C0002771
UMLS CUI [3,2]
C0442821
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0001617
UMLS CUI [6]
C0021081

Similar models

Eligibility Rheumatoid Arthritis NCT00372177

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects above 50 years of age
boolean
C0001779 (UMLS CUI [1])
Arthralgia Due to Rheumatoid Arthritis
Item
suffering from joint pain which is due to active rheumatoid arthritis
boolean
C0003862 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
Signs Inflammation Joints Quantity | Swelling | Erythema | Temperature elevated Local
Item
obvious signs of inflammation in at least one joint (e.g. swelling, erythema, or local elevated temperature)
boolean
C0311392 (UMLS CUI [1,1])
C0021368 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0038999 (UMLS CUI [2])
C0041834 (UMLS CUI [3])
C0437737 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
General status Healthy
Item
otherwise healthy
boolean
C0947124 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients 80 years and older
boolean
C0001779 (UMLS CUI [1])
Cardiovascular Disease | Respiration Disorder | Hepatobiliary disease | CNS disorder
Item
clinically significant disease of the cardiovascular system, respiratory system, hepato-biliary system or central nervous system (cns)
boolean
C0007222 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0267792 (UMLS CUI [3])
C0007682 (UMLS CUI [4])
Hepatic Insufficiency Excretory | Renal Insufficiency Excretory
Item
excretory hepatic or renal insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C0221102 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0221102 (UMLS CUI [2,2])
Drug use Regular | Exception Hormone replacement therapy Gender
Item
regular intake of any drug, except for hormone replacement therapy in females
boolean
C0242510 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0282402 (UMLS CUI [2,2])
C0079399 (UMLS CUI [2,3])
Proteins Heterogenous
Item
previous administration of xenogenous proteins
boolean
C0033684 (UMLS CUI [1,1])
C1512426 (UMLS CUI [1,2])
Anaphylaxis Drug Parenteral Administration
Item
history of anaphylactic reaction to any drug administered by a parenteral pathway
boolean
C0002792 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1518896 (UMLS CUI [1,3])
Study Subject Participation Status | Radiopharmaceuticals
Item
previous participation in a radiopharmaceutical drug trial (unless the effective dose acquired by participation in the current trial will remain below 10 msv)
boolean
C2348568 (UMLS CUI [1])
C0182638 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any clinical drug trial within 3 months prior to enrolment
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Childbearing Potential | Factor out ruling Childbearing Potential | Postmenopausal state | Hysterectomy | Bilateral oophorectomy | Bilateral tubal ligation
Item
women of child-bearing potential (child-bearing potential to be ruled out by one of the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)
boolean
C3831118 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0232970 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
C0589114 (UMLS CUI [6])
Pharmaceutical Preparations Long-term | Antiphlogistic agent Strong | Analgesics Strong | Methotrexate | Adrenal Cortex Hormones | Immunosuppressive Agents
Item
long term medication with strong antiphlogistic agents/pain killers such as methotrexate, corticoids, or immunosuppressants prior to enrolment
boolean
C0013227 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0304344 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0002771 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C0025677 (UMLS CUI [4])
C0001617 (UMLS CUI [5])
C0021081 (UMLS CUI [6])

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