0 Evaluaciones
ID

42618

Descripción

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.

Palabras clave

Versiones (2)
  1. 10/11/15 10/11/15 -
  2. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Riliva_CRF_EudraCT - Nr. 2012-000108-13- Screening DRKS00004652

    Alemán ( localization.languageCode.DE ) Inglés

    Screening I

    2 formularios  
    Basic data
    Descripción

    Basic data

    Alias
    UMLS CUI-1
    C0178499
    UMLS CUI-2
    C1511726
    Centre number:
    Descripción

    Centre number

    Tipo de datos

    integer

    Date of birth:
    Descripción

    Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender:
    Descripción

    Gender

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Date informed consent signed:
    Descripción

    Informed consent date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985782
    Assessment date:
    Descripción

    Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    1) Secured livedo vasculopathy
    Descripción

    Livedoid vasculitis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0343081
    2) Age ≥ 18 years and ≤ 80 years
    Descripción

    age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3) 40 points on the pain VAS at least one day within the last 7 days before beginning therapy
    Descripción

    Visual Analog Pain Scale

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0042815
    4) In women: secured contraception (Requirement: Pearl Index <1) (in case of men please choose "No")
    Descripción

    contraception

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    5) Adequate communication skills in the German language
    Descripción

    communication skills

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0870313
    6) Patient must be able to recognize the nature, significance and scope of the clinical trial and to align his will hereafter
    Descripción

    informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    1) Participation in another intervention study within the last 30 days before beginning therapy
    Descripción

    intervention study

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1096775
    2) Known allergy to the study medication
    Descripción

    Drug Allergy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013182
    3) Known problems of galactose intolerance, deficit of lactase or glucose-galactose malabsorption
    Descripción

    Intolerance or malabsorption of glucose-galactose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0865194
    4) Pregnancy
    Descripción

    pregnancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    5) Lactation
    Descripción

    Lactation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    6) Known renal impairment (creatinine clearance <30ml/min)
    Descripción

    creatinine clearance

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0812399
    7) Known liver disease (Child-Pugh score B and C)
    Descripción

    Child-Pugh score

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3854424
    8) Known ulcerative gastrointestinal disorders within the last 30 days prior to initiation of therapy or during
    Descripción

    Gastrointestinal ulcer

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0237938
    9) Uncontrolled, severe arterial hypertension
    Descripción

    arterial hypertension severe

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020538
    UMLS CUI [1,2]
    C0205082
    10) Artificial heart valves
    Descripción

    Heart Valve Prosthesis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018825
    11) Acute pulmonary embolism
    Descripción

    Acute pulmonary embolism

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2882221
    12) Known bronchiectasis or pulmonary bleeding
    Descripción

    bronchiectasis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006267
    13) Known vascular retinopathy
    Descripción

    retinopathy vascular

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0035309
    UMLS CUI [1,2]
    C1801960
    14) Intracranial or intracerebral haemorrhage within the last 30 days before beginning of therapy or during therapy
    Descripción

    Cerebral Hemorrhage

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2937358
    15) Brain, spinal cord or eye surgery within the last 30 days before beginning of therapy or during therapy
    Descripción

    neurological surgery; eye surgery

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0524850
    UMLS CUI [2]
    C0038901
    16) Spinal or epidural anaesthesia or puncture within the last 2 weeks before beginning of therapy or during therapy
    Descripción

    epidural anaesthesia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0002913
    17) Application of systemic heparin within 1 day before beginning of therapy
    Descripción

    Heparin therapy systemic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0522794
    UMLS CUI [2]
    C0205373
    18) Intake of NSARs or thrombocyte aggregation inhibitors within 1 day before beginning of therapy or during therapy
    Descripción

    Nonsteroidal anti-inflammatory drug

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0003211
    19) Intake of vitamin-K-antagonists (marcumar, warfarin) and/or thrombin inhibitor (dabigatran) within 7 days before beginning of therapy or during therapy
    Descripción

    vitamin-K-antagonist therapy; dabigatran

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1096489
    UMLS CUI [2]
    C2348066
    20) Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort)
    Descripción

    CYP3A4 inducers

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3850041
    21) Concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole)
    Descripción

    ketoconazole; itraconazole

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0022625
    UMLS CUI [2]
    C0064113
    22) Concomitant systemic treatment with HIV-protease inhibitors (e.g. ritonavir)
    Descripción

    HIV-protease inhibitors

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0162714
    23) Concomitant systemic treatment with dronedarone
    Descripción

    dronedarone

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0766326
    24) Presence of malignant neoplasms at high risk of bleeding
    Descripción

    malignant neoplasms; Bleeding Risk

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C3251812
    25) Recent brain or spinal injury
    Descripción

    brain or spinal injury

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1402439
    26) Known or suspected oesophageal varices
    Descripción

    Esophageal Varices

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0014867
    27) Known arteriovenous malformations
    Descripción

    arteriovenous malformation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0450109
    UMLS CUI [1,2]
    C0302142
    28) Known vascular aneurysms
    Descripción

    Aneurysm vascular

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0002940
    UMLS CUI [1,2]
    C1801960
    29) Known major intraspinal or intracerebral vascular abnormalities
    Descripción

    Abnormality Intraspinal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C1283188
    Urine pregnancy test
    Descripción

    Urine pregnancy test

    Alias
    UMLS CUI-1
    C0430056
    Date of urine pregnancy test:
    Descripción

    date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008
    Result of urine pregnancy test:
    Descripción

    result

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826772
    Please mention details when other:
    Descripción

    Other

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0205394
    Patient meets all the inclusion criteria and none of the exclusion criteria is present:
    Descripción

    inclusion criteria; exclusion criteria

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1512693
    UMLS CUI [2]
    C0680251
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    Similar models

    Screening I

    2 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Basic data
    C0178499 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Centre number
    Item
    Centre number:
    integer
    Date of birth
    Item
    Date of birth:
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender:
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender:
    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])
    Item Group
    Inclusion Criteria
    C1512693 (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])
    Item Group
    Exclusion Criteria
    C0680251 (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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    Aneurysm vascular
    Item
    28) Known vascular aneurysms
    boolean
    C0002940 (UMLS CUI [1,1])
    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])
    Item Group
    Urine pregnancy test
    C0430056 (UMLS CUI-1)
    date
    Item
    Date of urine pregnancy test:
    date
    C0011008 (UMLS CUI [1])
    Item
    Result of urine pregnancy test:
    text
    C2826772 (UMLS CUI [1])
    result
    Code List
    Result of urine pregnancy test:
    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])
    inclusion criteria; exclusion criteria
    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)
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