ID
18153
Beschrijving
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose
Link
https://clinicaltrials.gov/ct2/show/NCT01303952
Trefwoorden
Versies (10)
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- 02-11-16 02-11-16 -
Geüploaded op
24 oktober 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
Beschrijving
Demografie, Vitalzeichen und Untersuchungen
Alias
- UMLS CUI-1
- C1955348
- UMLS CUI-2
- C0518766
- UMLS CUI-3
- C0582103
Beschrijving
Date of Screening
Datatype
text
Maateenheden
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710477
Beschrijving
Date of Birth
Datatype
text
Maateenheden
- YYYY-MM
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Nationality
Datatype
integer
Alias
- UMLS CUI [1]
- C0027473
Beschrijving
specify nationality
Datatype
text
Alias
- UMLS CUI [1]
- C0027473
Beschrijving
Height
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
LDH
Datatype
float
Maateenheden
- U/l
Alias
- UMLS CUI [1]
- C0202113
Beschrijving
1. Systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
1. Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
2. Systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
2. Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
3. Systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
3. Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Sitting heart rate
Datatype
integer
Maateenheden
- beats per minute
Alias
- UMLS CUI [1]
- C2029904
Beschrijving
Body temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Physical examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Abdominal ultrasound
Datatype
integer
Alias
- UMLS CUI [1]
- C2348813
Beschrijving
12-lead electrocardiogram
Datatype
integer
Alias
- UMLS CUI [1]
- C0430456
Beschrijving
Bone marrow
Datatype
integer
Alias
- UMLS CUI [1]
- C0005957
Beschrijving
Walk distance
Datatype
integer
Maateenheden
- Meter
Alias
- UMLS CUI [1]
- C3854161
Beschrijving
dyspnea
Datatype
integer
Alias
- UMLS CUI [1]
- C0013404
Beschrijving
Kardiovaskuläre Symptome
Alias
- UMLS CUI-1
- C0476270
Beschrijving
Date of first Cold Agglutin Disease
Datatype
date
Maateenheden
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0175816
Beschrijving
Thrombophlebitis/Deep Vein Thrombosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0040046
- UMLS CUI [2]
- C0149871
Beschrijving
Pulmonary Embolus
Datatype
integer
Alias
- UMLS CUI [1]
- C0034065
Beschrijving
Cerebrovascular Accident
Datatype
integer
Alias
- UMLS CUI [1]
- C0038454
Beschrijving
Amputation
Datatype
integer
Alias
- UMLS CUI [1]
- C0002688
Beschrijving
Myocardial Infarction
Datatype
integer
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Transient Ischemic Attack
Datatype
integer
Alias
- UMLS CUI [1]
- C0007787
Beschrijving
Unstable Angina
Datatype
integer
Alias
- UMLS CUI [1]
- C0002965
Beschrijving
Renal Vein Thrombosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0238457
Beschrijving
Mesenteric Vein Thrombosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0267412
Beschrijving
Portal Vein Thrombosis (Budd-Chiari)
Datatype
integer
Alias
- UMLS CUI [1]
- C0155773
Beschrijving
Gangrene
Datatype
integer
Alias
- UMLS CUI [1]
- C0017086
Beschrijving
Acute Peripheral Vascular Occlusion
Datatype
integer
Alias
- UMLS CUI [1]
- C0240728
Beschrijving
Sudden Death
Datatype
integer
Alias
- UMLS CUI [1]
- C0011071
Beschrijving
Patient suffers from other accompanying illnesses?
Datatype
integer
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
Only for Woman (under 50): Is the pregnancy test negativ?
Datatype
integer
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Signature date
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
Beschrijving
Investigators signature
Datatype
integer
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Einjahres Transfusionsgeschichte
Alias
- UMLS CUI-1
- C1519604
Beschrijving
Date of blood transfusion
Datatype
date
Maateenheden
- YYYY-MM-DD
Alias
- UMLS CUI [1]
- C1264703
Beschrijving
Number of units
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449961
Beschrijving
Hemoglobin before transfusion
Datatype
float
Maateenheden
- ulHGB
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Hemoglobin before transfusion2
Datatype
integer
Maateenheden
- ulHGB
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Any special events circumstances transfusion?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Beschrijving
if yes, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Beschrijving
Signature date
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
Beschrijving
Investigators signature
Datatype
integer
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Vor- und Begleiterkrankungen
Alias
- UMLS CUI-1
- C0243087
Beschrijving
Concomitant disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0243087
Beschrijving
Signature date
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
Beschrijving
Investigators signature
Datatype
integer
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Preexisting and concomitant
Alias
- UMLS CUI-1
- C0243087
Beschrijving
Visite 0 - FACIT
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3476791
Beschrijving
lack of vitality
Datatype
integer
Alias
- UMLS CUI [1]
- C1337102
Beschrijving
nausea
Datatype
integer
Alias
- UMLS CUI [1]
- C0027497
Beschrijving
General health deterioration
Datatype
integer
Alias
- UMLS CUI [1]
- C0563273
Beschrijving
pain
Datatype
integer
Alias
- UMLS CUI [1]
- C0030193
Beschrijving
treatment side-effects
Datatype
integer
Alias
- UMLS CUI [1]
- C0879626
Beschrijving
feeling of illness
Datatype
integer
Alias
- UMLS CUI [1]
- C0231218
Beschrijving
bedrest
Datatype
integer
Alias
- UMLS CUI [1]
- C0004910
Beschrijving
interacts with close friends
Datatype
integer
Alias
- UMLS CUI [1]
- C0518615
Beschrijving
family support
Datatype
integer
Alias
- UMLS CUI [1]
- C0150232
Beschrijving
receives support from friends
Datatype
integer
Alias
- UMLS CUI [1]
- C2984072
Beschrijving
accepts disease
Datatype
integer
Beschrijving
satisfied with talking about disease
Datatype
integer
Beschrijving
feel close to other people
Datatype
integer
Alias
- UMLS CUI [1]
- C2984048
- UMLS CUI [2]
- C2984059
Beschrijving
satisfied with sex life
Datatype
integer
Alias
- UMLS CUI [1]
- C2984060
Beschrijving
sadness
Datatype
integer
Alias
- UMLS CUI [1]
- C3827348
Beschrijving
satisfied with fighting against the illness
Datatype
integer
Beschrijving
losing hope
Datatype
integer
Alias
- UMLS CUI [1]
- C2984056
Beschrijving
nervousness
Datatype
integer
Alias
- UMLS CUI [1]
- C0027769
Beschrijving
worries about death
Datatype
integer
Alias
- UMLS CUI [1]
- C2984076
Beschrijving
worries about condition
Datatype
integer
Alias
- UMLS CUI [1]
- C2984075
Beschrijving
able to work
Datatype
integer
Alias
- UMLS CUI [1]
- C2984044
Beschrijving
satisfied with work
Datatype
integer
Alias
- UMLS CUI [1]
- C0578800
Beschrijving
able to enjoy life
Datatype
integer
Alias
- UMLS CUI [1]
- C2984051
Beschrijving
cope with disease
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0009967
- UMLS CUI [1,2]
- C0012634
Beschrijving
sleeping
Datatype
integer
Alias
- UMLS CUI [1]
- C0474396
Beschrijving
able to enjoy leisure
Datatype
integer
Alias
- UMLS CUI [1]
- C2984052
Beschrijving
currently satisfied with life
Datatype
integer
Alias
- UMLS CUI [1]
- C1954023
Beschrijving
fatigue
Datatype
integer
Alias
- UMLS CUI [1]
- C0015672
Beschrijving
weak
Datatype
integer
Alias
- UMLS CUI [1]
- C3714552
Beschrijving
listless
Datatype
integer
Alias
- UMLS CUI [1]
- C0023380
Beschrijving
tired
Datatype
integer
Alias
- UMLS CUI [1]
- C0848717
Beschrijving
tiredness limiting starting things
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0439659
Beschrijving
tiredness limits finishing things
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3259534
Beschrijving
having energy
Datatype
integer
Alias
- UMLS CUI [1]
- C0542479
Beschrijving
able to do usual activities
Datatype
integer
Alias
- UMLS CUI [1]
- C0441655
Beschrijving
sleep during daytime
Datatype
integer
Alias
- UMLS CUI [1]
- C4075948
Beschrijving
too tired to eat
Datatype
integer
Alias
- UMLS CUI [1]
- C3897355
Beschrijving
need help with usual activities
Datatype
integer
Alias
- UMLS CUI [1]
- C3898152
Beschrijving
frustrated by fatigue
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0016770
- UMLS CUI [1,2]
- C0015672
Beschrijving
fatigue limiting social activity
Datatype
integer
Alias
- UMLS CUI [1]
- C3898911
Beschrijving
Visit 0 - SF36
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3640521
Beschrijving
general health condition
Datatype
integer
Alias
- UMLS CUI [1]
- C2964120
Beschrijving
current state of health
Datatype
integer
Alias
- UMLS CUI [1]
- C3534559
Beschrijving
limited in activities
Datatype
text
Beschrijving
Vigorous activities
Datatype
integer
Alias
- UMLS CUI [1]
- C3484322
Beschrijving
Moderate activities
Datatype
integer
Alias
- UMLS CUI [1]
- C3484321
Beschrijving
Lifting or carrying groceries
Datatype
integer
Alias
- UMLS CUI [1]
- C2963469
Beschrijving
Climbing several flights of stairs
Datatype
integer
Alias
- UMLS CUI [1]
- C2963450
Beschrijving
Climbing one flight of stairs
Datatype
integer
Alias
- UMLS CUI [1]
- C2963449
Beschrijving
Bending, kneeling, or stooping
Datatype
integer
Alias
- UMLS CUI [1]
- C3484318
Beschrijving
Walking more than a mile
Datatype
integer
Alias
- UMLS CUI [1]
- C2963455
Beschrijving
Walking several blocks
Datatype
integer
Alias
- UMLS CUI [1]
- C3484325
Beschrijving
Walking one block
Datatype
integer
Alias
- UMLS CUI [1]
- C3484324
Beschrijving
Bathing or dressing yourself
Datatype
integer
Alias
- UMLS CUI [1]
- C2963459
Beschrijving
problems in past 4 weeks
Datatype
text
Beschrijving
Cut down the amount of time you spent on work or other activities
Datatype
integer
Alias
- UMLS CUI [1]
- C3899484
Beschrijving
Accomplished less than you would like
Datatype
integer
Alias
- UMLS CUI [1]
- C3900126
Beschrijving
Were limited in the kind of work or other activities
Datatype
integer
Alias
- UMLS CUI [1]
- C3898591
Beschrijving
Had difficulty performing the work or other activities (for example, it took extra effort)
Datatype
integer
Alias
- UMLS CUI [1]
- C3898961
Beschrijving
emotional problems
Datatype
text
Beschrijving
Cut down the amount of time you spent on work or other activities
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3899484
- UMLS CUI [1,2]
- C0677660
Beschrijving
Accomplished less than you would like
Datatype
integer
Alias
- UMLS CUI [1]
- C3900126
Beschrijving
Didnt do work or other activities as carefully as usual
Datatype
integer
Alias
- UMLS CUI [1]
- C3899381
Beschrijving
emotional problems limiting social activities
Datatype
integer
Alias
- UMLS CUI [1]
- C3484328
Beschrijving
bodily pain during the past 4 weeks
Datatype
integer
Alias
- UMLS CUI [1]
- C3534550
Beschrijving
pain interfere with your normal work
Datatype
integer
Alias
- UMLS CUI [1]
- C3484326
Beschrijving
feelings last 4 weeks
Datatype
text
Beschrijving
Did you feel full of pep?
Datatype
integer
Alias
- UMLS CUI [1]
- C3484313
Beschrijving
Have you been a very nervous person?
Datatype
integer
Alias
- UMLS CUI [1]
- C3475469
Beschrijving
Have you felt so down in the dumps that nothing could cheer you up?
Datatype
integer
Alias
- UMLS CUI [1]
- C3475473
Beschrijving
Have you felt calm and peaceful?
Datatype
integer
Alias
- UMLS CUI [1]
- C3475471
Beschrijving
Did you have a lot of energy?
Datatype
integer
Alias
- UMLS CUI [1]
- C3484316
Beschrijving
Have you felt downhearted and blue?
Datatype
integer
Alias
- UMLS CUI [1]
- C3475472
Beschrijving
Did you feel worn out?
Datatype
integer
Alias
- UMLS CUI [1]
- C3484315
Beschrijving
Have you been a happy person?
Datatype
integer
Alias
- UMLS CUI [1]
- C3475468
Beschrijving
Did you feel tired?
Datatype
integer
Alias
- UMLS CUI [1]
- C3484314
Beschrijving
During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?
Datatype
integer
Alias
- UMLS CUI [1]
- C3484327
Beschrijving
How TRUE or FALSE is each of the following statements for you.
Datatype
text
Beschrijving
I seem to get sick a little easier than other people
Datatype
integer
Alias
- UMLS CUI [1]
- C3899028
Beschrijving
I am as healthy as anybody I know
Datatype
integer
Alias
- UMLS CUI [1]
- C3900054
Beschrijving
I expect my health to get worse
Datatype
integer
Alias
- UMLS CUI [1]
- C3475697
Beschrijving
My health is excellent
Datatype
integer
Alias
- UMLS CUI [1]
- C3476206
Similar models
Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
C0680251 (UMLS CUI-2)
C0518766 (UMLS CUI-2)
C0582103 (UMLS CUI-3)
C1710477 (UMLS CUI [1,2])
C0175816 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
C0449961 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
C2984059 (UMLS CUI [2])
C0012634 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C3259534 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
C0677660 (UMLS CUI [1,2])