ID

31834

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00372177

Nyckelord

Versioner (1)
  1. 2018-10-01 2018-10-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00372177

Engelsk

Eligibility Rheumatoid Arthritis NCT00372177

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Arthralgia Due to Rheumatoid Arthritis

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

General status Healthy

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients 80 years and older
Beskrivning

Age

Datatyp

boolean

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

Cardiovascular Disease | Respiration Disorder | Hepatobiliary disease | CNS disorder

Datatyp

boolean

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

Hepatic Insufficiency Excretory | Renal Insufficiency Excretory

Datatyp

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
Beskrivning

Drug use Regular | Exception Hormone replacement therapy Gender

Datatyp

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
Beskrivning

Proteins Heterogenous

Datatyp

boolean

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

Anaphylaxis Drug Parenteral Administration

Datatyp

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)
Beskrivning

Study Subject Participation Status | Radiopharmaceuticals

Datatyp

boolean

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

Study Subject Participation Status | Investigational New Drugs

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
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Similar models

Eligibility Rheumatoid Arthritis NCT00372177

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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