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ID
42618
Beschrijving
Study documentation part: Screening. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.
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- 10-11-15 10-11-15 -
- 17-09-21 17-09-21 -
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17 september 2021
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Creative Commons BY-NC 3.0
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Riliva_CRF_EudraCT - Nr. 2012-000108-13- Screening DRKS00004652
Screening I
- StudyEvent: ODM
Similar models
Screening I
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Centre number
Item
Centre number:
integer
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
Informed consent date
Item
Date informed consent signed:
date
C2985782 (UMLS CUI [1])
Assessment Date
Item
Assessment date:
date
C2985720 (UMLS CUI [1])
Livedoid vasculitis
Item
1) Secured livedo vasculopathy
boolean
C0343081 (UMLS CUI [1])
age
Item
2) Age ≥ 18 years and ≤ 80 years
boolean
C0001779 (UMLS CUI [1])
Visual Analog Pain Scale
Item
3) 40 points on the pain VAS at least one day within the last 7 days before beginning therapy
boolean
C0042815 (UMLS CUI [1])
contraception
Item
4) In women: secured contraception (Requirement: Pearl Index <1) (in case of men please choose "No")
boolean
C0700589 (UMLS CUI [1])
communication skills
Item
5) Adequate communication skills in the German language
boolean
C0870313 (UMLS CUI [1])
informed consent
Item
6) Patient must be able to recognize the nature, significance and scope of the clinical trial and to align his will hereafter
boolean
C0021430 (UMLS CUI [1])
intervention study
Item
1) Participation in another intervention study within the last 30 days before beginning therapy
boolean
C1096775 (UMLS CUI [1])
Drug Allergy
Item
2) Known allergy to the study medication
boolean
C0013182 (UMLS CUI [1])
Intolerance or malabsorption of glucose-galactose
Item
3) Known problems of galactose intolerance, deficit of lactase or glucose-galactose malabsorption
boolean
C0865194 (UMLS CUI [1])
pregnancy
Item
4) Pregnancy
boolean
C0549206 (UMLS CUI [1])
Lactation
Item
5) Lactation
boolean
C0006147 (UMLS CUI [1])
creatinine clearance
Item
6) Known renal impairment (creatinine clearance <30ml/min)
boolean
C0812399 (UMLS CUI [1])
Child-Pugh score
Item
7) Known liver disease (Child-Pugh score B and C)
boolean
C3854424 (UMLS CUI [1])
Gastrointestinal ulcer
Item
8) Known ulcerative gastrointestinal disorders within the last 30 days prior to initiation of therapy or during
boolean
C0237938 (UMLS CUI [1])
arterial hypertension severe
Item
9) Uncontrolled, severe arterial hypertension
boolean
C0020538 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Heart Valve Prosthesis
Item
10) Artificial heart valves
boolean
C0018825 (UMLS CUI [1])
Acute pulmonary embolism
Item
11) Acute pulmonary embolism
boolean
C2882221 (UMLS CUI [1])
bronchiectasis
Item
12) Known bronchiectasis or pulmonary bleeding
boolean
C0006267 (UMLS CUI [1])
retinopathy vascular
Item
13) Known vascular retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
C1801960 (UMLS CUI [1,2])
Cerebral Hemorrhage
Item
14) Intracranial or intracerebral haemorrhage within the last 30 days before beginning of therapy or during therapy
boolean
C2937358 (UMLS CUI [1])
neurological surgery; eye surgery
Item
15) Brain, spinal cord or eye surgery within the last 30 days before beginning of therapy or during therapy
boolean
C0524850 (UMLS CUI [1])
C0038901 (UMLS CUI [2])
C0038901 (UMLS CUI [2])
epidural anaesthesia
Item
16) Spinal or epidural anaesthesia or puncture within the last 2 weeks before beginning of therapy or during therapy
boolean
C0002913 (UMLS CUI [1])
Heparin therapy systemic
Item
17) Application of systemic heparin within 1 day before beginning of therapy
boolean
C0522794 (UMLS CUI [1])
C0205373 (UMLS CUI [2])
C0205373 (UMLS CUI [2])
Nonsteroidal anti-inflammatory drug
Item
18) Intake of NSARs or thrombocyte aggregation inhibitors within 1 day before beginning of therapy or during therapy
boolean
C0003211 (UMLS CUI [1])
vitamin-K-antagonist therapy; dabigatran
Item
19) Intake of vitamin-K-antagonists (marcumar, warfarin) and/or thrombin inhibitor (dabigatran) within 7 days before beginning of therapy or during therapy
boolean
C1096489 (UMLS CUI [1])
C2348066 (UMLS CUI [2])
C2348066 (UMLS CUI [2])
CYP3A4 inducers
Item
20) Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort)
boolean
C3850041 (UMLS CUI [1])
ketoconazole; itraconazole
Item
21) Concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole)
boolean
C0022625 (UMLS CUI [1])
C0064113 (UMLS CUI [2])
C0064113 (UMLS CUI [2])
HIV-protease inhibitors
Item
22) Concomitant systemic treatment with HIV-protease inhibitors (e.g. ritonavir)
boolean
C0162714 (UMLS CUI [1])
dronedarone
Item
23) Concomitant systemic treatment with dronedarone
boolean
C0766326 (UMLS CUI [1])
malignant neoplasms; Bleeding Risk
Item
24) Presence of malignant neoplasms at high risk of bleeding
boolean
C0006826 (UMLS CUI [1])
C3251812 (UMLS CUI [2])
C3251812 (UMLS CUI [2])
brain or spinal injury
Item
25) Recent brain or spinal injury
boolean
C1402439 (UMLS CUI [1])
Esophageal Varices
Item
26) Known or suspected oesophageal varices
boolean
C0014867 (UMLS CUI [1])
arteriovenous malformation
Item
27) Known arteriovenous malformations
boolean
C0450109 (UMLS CUI [1,1])
C0302142 (UMLS CUI [1,2])
C0302142 (UMLS CUI [1,2])
Aneurysm vascular
Item
28) Known vascular aneurysms
boolean
C0002940 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
C1801960 (UMLS CUI [1,2])
Abnormality Intraspinal
Item
29) Known major intraspinal or intracerebral vascular abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C1283188 (UMLS CUI [1,2])
C1283188 (UMLS CUI [1,2])
date
Item
Date of urine pregnancy test:
date
C0011008 (UMLS CUI [1])
CL Item
positive (1)
CL Item
negative (2)
CL Item
not performed as the subject is male (3)
CL Item
other (4)
Other
Item
Please mention details when other:
text
C0205394 (UMLS CUI [1])
Item
Patient meets all the inclusion criteria and none of the exclusion criteria is present:
text
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
Code List
Patient meets all the inclusion criteria and none of the exclusion criteria is present:
CL Item
Yes, approval for treatment with study medication according to the study protocol (1)
CL Item
No, unapproved for the treatment with study medication according to the study protocol (2)
CL Item
No, the inclusion or the exclusion criteria can not be met in future, so end of the study (screening failure) (3)