ID
18382
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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Geüploaded op
2 november 2016
DOI
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Licentie
Creative Commons BY 4.0
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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
Visit 0 - SF36
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3640521
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