ID
18153
Description
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
Lien
https://clinicaltrials.gov/ct2/show/NCT01303952
Mots-clés
Versions (10)
- 07/10/2016 07/10/2016 -
- 10/10/2016 10/10/2016 -
- 11/10/2016 11/10/2016 -
- 17/10/2016 17/10/2016 -
- 18/10/2016 18/10/2016 -
- 21/10/2016 21/10/2016 -
- 23/10/2016 23/10/2016 -
- 24/10/2016 24/10/2016 -
- 27/10/2016 27/10/2016 -
- 02/11/2016 02/11/2016 -
Téléchargé le
24 octobre 2016
DOI
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Licence
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
Description
Demografie, Vitalzeichen und Untersuchungen
Alias
- UMLS CUI-1
- C1955348
- UMLS CUI-2
- C0518766
- UMLS CUI-3
- C0582103
Description
Date of Screening
Type de données
text
Unités de mesure
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710477
Description
Date of Birth
Type de données
text
Unités de mesure
- YYYY-MM
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Nationality
Type de données
integer
Alias
- UMLS CUI [1]
- C0027473
Description
specify nationality
Type de données
text
Alias
- UMLS CUI [1]
- C0027473
Description
Height
Type de données
float
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
LDH
Type de données
float
Unités de mesure
- U/l
Alias
- UMLS CUI [1]
- C0202113
Description
1. Systolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
1. Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
2. Systolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
2. Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
3. Systolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
3. Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Sitting heart rate
Type de données
integer
Unités de mesure
- beats per minute
Alias
- UMLS CUI [1]
- C2029904
Description
Body temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Physical examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0031809
Description
Abdominal ultrasound
Type de données
integer
Alias
- UMLS CUI [1]
- C2348813
Description
12-lead electrocardiogram
Type de données
integer
Alias
- UMLS CUI [1]
- C0430456
Description
Bone marrow
Type de données
integer
Alias
- UMLS CUI [1]
- C0005957
Description
Walk distance
Type de données
integer
Unités de mesure
- Meter
Alias
- UMLS CUI [1]
- C3854161
Description
dyspnea
Type de données
integer
Alias
- UMLS CUI [1]
- C0013404
Description
Kardiovaskuläre Symptome
Alias
- UMLS CUI-1
- C0476270
Description
Date of first Cold Agglutin Disease
Type de données
date
Unités de mesure
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0175816
Description
Thrombophlebitis/Deep Vein Thrombosis
Type de données
integer
Alias
- UMLS CUI [1]
- C0040046
- UMLS CUI [2]
- C0149871
Description
Pulmonary Embolus
Type de données
integer
Alias
- UMLS CUI [1]
- C0034065
Description
Cerebrovascular Accident
Type de données
integer
Alias
- UMLS CUI [1]
- C0038454
Description
Amputation
Type de données
integer
Alias
- UMLS CUI [1]
- C0002688
Description
Myocardial Infarction
Type de données
integer
Alias
- UMLS CUI [1]
- C0027051
Description
Transient Ischemic Attack
Type de données
integer
Alias
- UMLS CUI [1]
- C0007787
Description
Unstable Angina
Type de données
integer
Alias
- UMLS CUI [1]
- C0002965
Description
Renal Vein Thrombosis
Type de données
integer
Alias
- UMLS CUI [1]
- C0238457
Description
Mesenteric Vein Thrombosis
Type de données
integer
Alias
- UMLS CUI [1]
- C0267412
Description
Portal Vein Thrombosis (Budd-Chiari)
Type de données
integer
Alias
- UMLS CUI [1]
- C0155773
Description
Gangrene
Type de données
integer
Alias
- UMLS CUI [1]
- C0017086
Description
Acute Peripheral Vascular Occlusion
Type de données
integer
Alias
- UMLS CUI [1]
- C0240728
Description
Sudden Death
Type de données
integer
Alias
- UMLS CUI [1]
- C0011071
Description
Patient suffers from other accompanying illnesses?
Type de données
integer
Alias
- UMLS CUI [1]
- C0009488
Description
Only for Woman (under 50): Is the pregnancy test negativ?
Type de données
integer
Alias
- UMLS CUI [1]
- C0032976
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Signature date
Type de données
date
Alias
- UMLS CUI [1]
- C0807937
Description
Investigators signature
Type de données
integer
Alias
- UMLS CUI [1]
- C2346576
Description
Einjahres Transfusionsgeschichte
Alias
- UMLS CUI-1
- C1519604
Description
Date of blood transfusion
Type de données
date
Unités de mesure
- YYYY-MM-DD
Alias
- UMLS CUI [1]
- C1264703
Description
Number of units
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449961
Description
Hemoglobin before transfusion
Type de données
float
Unités de mesure
- ulHGB
Alias
- UMLS CUI [1]
- C0518015
Description
Hemoglobin before transfusion2
Type de données
integer
Unités de mesure
- ulHGB
Alias
- UMLS CUI [1]
- C0518015
Description
Any special events circumstances transfusion?
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Description
if yes, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Description
Signature date
Type de données
date
Alias
- UMLS CUI [1]
- C0807937
Description
Investigators signature
Type de données
integer
Alias
- UMLS CUI [1]
- C2346576
Description
Vor- und Begleiterkrankungen
Alias
- UMLS CUI-1
- C0243087
Description
Concomitant disease
Type de données
integer
Alias
- UMLS CUI [1]
- C0243087
Description
Signature date
Type de données
date
Alias
- UMLS CUI [1]
- C0807937
Description
Investigators signature
Type de données
integer
Alias
- UMLS CUI [1]
- C2346576
Description
Preexisting and concomitant
Alias
- UMLS CUI-1
- C0243087
Description
Visite 0 - FACIT
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3476791
Description
lack of vitality
Type de données
integer
Alias
- UMLS CUI [1]
- C1337102
Description
nausea
Type de données
integer
Alias
- UMLS CUI [1]
- C0027497
Description
General health deterioration
Type de données
integer
Alias
- UMLS CUI [1]
- C0563273
Description
pain
Type de données
integer
Alias
- UMLS CUI [1]
- C0030193
Description
treatment side-effects
Type de données
integer
Alias
- UMLS CUI [1]
- C0879626
Description
feeling of illness
Type de données
integer
Alias
- UMLS CUI [1]
- C0231218
Description
bedrest
Type de données
integer
Alias
- UMLS CUI [1]
- C0004910
Description
interacts with close friends
Type de données
integer
Alias
- UMLS CUI [1]
- C0518615
Description
family support
Type de données
integer
Alias
- UMLS CUI [1]
- C0150232
Description
receives support from friends
Type de données
integer
Alias
- UMLS CUI [1]
- C2984072
Description
accepts disease
Type de données
integer
Description
satisfied with talking about disease
Type de données
integer
Description
feel close to other people
Type de données
integer
Alias
- UMLS CUI [1]
- C2984048
- UMLS CUI [2]
- C2984059
Description
satisfied with sex life
Type de données
integer
Alias
- UMLS CUI [1]
- C2984060
Description
sadness
Type de données
integer
Alias
- UMLS CUI [1]
- C3827348
Description
satisfied with fighting against the illness
Type de données
integer
Description
losing hope
Type de données
integer
Alias
- UMLS CUI [1]
- C2984056
Description
nervousness
Type de données
integer
Alias
- UMLS CUI [1]
- C0027769
Description
worries about death
Type de données
integer
Alias
- UMLS CUI [1]
- C2984076
Description
worries about condition
Type de données
integer
Alias
- UMLS CUI [1]
- C2984075
Description
able to work
Type de données
integer
Alias
- UMLS CUI [1]
- C2984044
Description
satisfied with work
Type de données
integer
Alias
- UMLS CUI [1]
- C0578800
Description
able to enjoy life
Type de données
integer
Alias
- UMLS CUI [1]
- C2984051
Description
cope with disease
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0009967
- UMLS CUI [1,2]
- C0012634
Description
sleeping
Type de données
integer
Alias
- UMLS CUI [1]
- C0474396
Description
able to enjoy leisure
Type de données
integer
Alias
- UMLS CUI [1]
- C2984052
Description
currently satisfied with life
Type de données
integer
Alias
- UMLS CUI [1]
- C1954023
Description
fatigue
Type de données
integer
Alias
- UMLS CUI [1]
- C0015672
Description
weak
Type de données
integer
Alias
- UMLS CUI [1]
- C3714552
Description
listless
Type de données
integer
Alias
- UMLS CUI [1]
- C0023380
Description
tired
Type de données
integer
Alias
- UMLS CUI [1]
- C0848717
Description
tiredness limiting starting things
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0439659
Description
tiredness limits finishing things
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3259534
Description
having energy
Type de données
integer
Alias
- UMLS CUI [1]
- C0542479
Description
able to do usual activities
Type de données
integer
Alias
- UMLS CUI [1]
- C0441655
Description
sleep during daytime
Type de données
integer
Alias
- UMLS CUI [1]
- C4075948
Description
too tired to eat
Type de données
integer
Alias
- UMLS CUI [1]
- C3897355
Description
need help with usual activities
Type de données
integer
Alias
- UMLS CUI [1]
- C3898152
Description
frustrated by fatigue
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0016770
- UMLS CUI [1,2]
- C0015672
Description
fatigue limiting social activity
Type de données
integer
Alias
- UMLS CUI [1]
- C3898911
Description
Visit 0 - SF36
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3640521
Description
general health condition
Type de données
integer
Alias
- UMLS CUI [1]
- C2964120
Description
current state of health
Type de données
integer
Alias
- UMLS CUI [1]
- C3534559
Description
limited in activities
Type de données
text
Description
Vigorous activities
Type de données
integer
Alias
- UMLS CUI [1]
- C3484322
Description
Moderate activities
Type de données
integer
Alias
- UMLS CUI [1]
- C3484321
Description
Lifting or carrying groceries
Type de données
integer
Alias
- UMLS CUI [1]
- C2963469
Description
Climbing several flights of stairs
Type de données
integer
Alias
- UMLS CUI [1]
- C2963450
Description
Climbing one flight of stairs
Type de données
integer
Alias
- UMLS CUI [1]
- C2963449
Description
Bending, kneeling, or stooping
Type de données
integer
Alias
- UMLS CUI [1]
- C3484318
Description
Walking more than a mile
Type de données
integer
Alias
- UMLS CUI [1]
- C2963455
Description
Walking several blocks
Type de données
integer
Alias
- UMLS CUI [1]
- C3484325
Description
Walking one block
Type de données
integer
Alias
- UMLS CUI [1]
- C3484324
Description
Bathing or dressing yourself
Type de données
integer
Alias
- UMLS CUI [1]
- C2963459
Description
problems in past 4 weeks
Type de données
text
Description
Cut down the amount of time you spent on work or other activities
Type de données
integer
Alias
- UMLS CUI [1]
- C3899484
Description
Accomplished less than you would like
Type de données
integer
Alias
- UMLS CUI [1]
- C3900126
Description
Were limited in the kind of work or other activities
Type de données
integer
Alias
- UMLS CUI [1]
- C3898591
Description
Had difficulty performing the work or other activities (for example, it took extra effort)
Type de données
integer
Alias
- UMLS CUI [1]
- C3898961
Description
emotional problems
Type de données
text
Description
Cut down the amount of time you spent on work or other activities
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3899484
- UMLS CUI [1,2]
- C0677660
Description
Accomplished less than you would like
Type de données
integer
Alias
- UMLS CUI [1]
- C3900126
Description
Didnt do work or other activities as carefully as usual
Type de données
integer
Alias
- UMLS CUI [1]
- C3899381
Description
emotional problems limiting social activities
Type de données
integer
Alias
- UMLS CUI [1]
- C3484328
Description
bodily pain during the past 4 weeks
Type de données
integer
Alias
- UMLS CUI [1]
- C3534550
Description
pain interfere with your normal work
Type de données
integer
Alias
- UMLS CUI [1]
- C3484326
Description
feelings last 4 weeks
Type de données
text
Description
Did you feel full of pep?
Type de données
integer
Alias
- UMLS CUI [1]
- C3484313
Description
Have you been a very nervous person?
Type de données
integer
Alias
- UMLS CUI [1]
- C3475469
Description
Have you felt so down in the dumps that nothing could cheer you up?
Type de données
integer
Alias
- UMLS CUI [1]
- C3475473
Description
Have you felt calm and peaceful?
Type de données
integer
Alias
- UMLS CUI [1]
- C3475471
Description
Did you have a lot of energy?
Type de données
integer
Alias
- UMLS CUI [1]
- C3484316
Description
Have you felt downhearted and blue?
Type de données
integer
Alias
- UMLS CUI [1]
- C3475472
Description
Did you feel worn out?
Type de données
integer
Alias
- UMLS CUI [1]
- C3484315
Description
Have you been a happy person?
Type de données
integer
Alias
- UMLS CUI [1]
- C3475468
Description
Did you feel tired?
Type de données
integer
Alias
- UMLS CUI [1]
- C3484314
Description
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.)?
Type de données
integer
Alias
- UMLS CUI [1]
- C3484327
Description
How TRUE or FALSE is each of the following statements for you.
Type de données
text
Description
I seem to get sick a little easier than other people
Type de données
integer
Alias
- UMLS CUI [1]
- C3899028
Description
I am as healthy as anybody I know
Type de données
integer
Alias
- UMLS CUI [1]
- C3900054
Description
I expect my health to get worse
Type de données
integer
Alias
- UMLS CUI [1]
- C3475697
Description
My health is excellent
Type de données
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])