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32700

Descrizione

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Keywords

  1. 13/11/18 13/11/18 -
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GlaxoSmithKline

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13 novembre 2018

DOI

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Creative Commons BY-NC 3.0

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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    Liver Imaging

    1. StudyEvent: ODM
      1. Liver Imaging
    Liver Imaging
    Descrizione

    Liver Imaging

    Alias
    UMLS CUI-1
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    Date of hepatic or liver imaging test
    Descrizione

    Imaging of liver, Date in time

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    What method was used for this imaging test?
    Descrizione

    Imaging of liver, Imaging modality

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C1275506 (Imaging modality)
    SNOMED
    360037004
    Are images technically adequate?
    Descrizione

    Imaging of liver, Image quality

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0806487 (Image Quality)
    Indicate the liver size
    Descrizione

    Imaging of liver, Liver size

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0426688 (Liver size (observable entity))
    SNOMED
    249566006
    Indicate the liver texture
    Descrizione

    Imaging of liver, Texture perception

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0679033 (Texture Perception)
    Grade the diffuse and/or geographic fatty infiltrate of the liver
    Descrizione

    Imaging of liver, Fatty liver

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0015695 (Fatty Liver)
    SNOMED
    197321007
    Ascites present
    Descrizione

    Imaging of liver, Ascites

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0003962 (Ascites)
    SNOMED
    389026000
    LOINC
    LA17637-2
    Are Focal Hepatic Lesions characterisable?
    Descrizione

    Imaging of liver, Lesion of liver, Focal

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0577053 (Lesion of liver)
    SNOMED
    300331000
    UMLS CUI [1,3]
    C0205234 (Focal)
    SNOMED
    87017008
    LOINC
    LA26555-5
    Gallstones or gallbladder lesions?
    Descrizione

    Imaging of liver, Gallstones, Gallbladder problems, Lesion

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C3842395 (Gallstones/gallbladder problems)
    LOINC
    LA16826-2
    UMLS CUI [1,3]
    C0221198 (Lesion)
    SNOMED
    52988006
    Biliary ductal lesions?
    Descrizione

    Imaging of liver, Biliary tract structure, Lesion

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0005423 (Biliary tract structure)
    SNOMED
    34707002
    UMLS CUI [1,3]
    C0221198 (Lesion)
    SNOMED
    52988006
    Portal/Hepatic vein abnormalities?
    Descrizione

    Imaging of liver, Structure of Hepatic vein, Abnormality; Imaging of liver, Portal vein structure, Abnormality

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [1,2]
    C0019155 (Structure of hepatic vein)
    SNOMED
    8993003
    UMLS CUI [1,3]
    C1704258 (Abnormality)
    UMLS CUI [2,1]
    C2711860 (Imaging of liver)
    SNOMED
    441802002
    UMLS CUI [2,2]
    C0032718 (Portal vein structure)
    SNOMED
    32764006
    UMLS CUI [2,3]
    C1704258 (Abnormality)

    Similar models

    Liver Imaging

    1. StudyEvent: ODM
      1. Liver Imaging
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Liver Imaging
    C2711860 (UMLS CUI-1)
    Imaging of liver, Date in time
    Item
    Date of hepatic or liver imaging test
    date
    C2711860 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    What method was used for this imaging test?
    text
    C2711860 (UMLS CUI [1,1])
    C1275506 (UMLS CUI [1,2])
    Code List
    What method was used for this imaging test?
    CL Item
    Ultrasound - transabdominal (1)
    CL Item
    Ultrasound - endoscopic (2)
    CL Item
    Magnetic Resonance Imaging (MRI) (3)
    CL Item
    Computerised Tomography (CT) (4)
    CL Item
    Endoscopic Retrograde Cholangiopancreatography (ERCP)  (5)
    CL Item
    Positron Emission Tomography (PET) (6)
    CL Item
    Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
    CL Item
    Other (8)
    Item
    Are images technically adequate?
    text
    C2711860 (UMLS CUI [1,1])
    C0806487 (UMLS CUI [1,2])
    Code List
    Are images technically adequate?
    CL Item
    Optimal (1)
    CL Item
    Readable, but not optimal  (2)
    CL Item
    Not readable (3)
    CL Item
    Other (4)
    Item
    Indicate the liver size
    text
    C2711860 (UMLS CUI [1,1])
    C0426688 (UMLS CUI [1,2])
    Code List
    Indicate the liver size
    CL Item
    Normal size (1)
    CL Item
    Hypertrophy (or enlarged)  (2)
    CL Item
    Atrophy (or smaller than normal)  (3)
    CL Item
    Segmental hypertrophy (4)
    CL Item
    Other (5)
    Item
    Indicate the liver texture
    text
    C2711860 (UMLS CUI [1,1])
    C0679033 (UMLS CUI [1,2])
    Code List
    Indicate the liver texture
    CL Item
    Normal (1)
    CL Item
    Heterogenous (2)
    CL Item
    Suggestive of fibrosis (3)
    CL Item
    Nodular or suggestive of cirrhosis (4)
    CL Item
    Other (5)
    Item
    Grade the diffuse and/or geographic fatty infiltrate of the liver
    text
    C2711860 (UMLS CUI [1,1])
    C0015695 (UMLS CUI [1,2])
    Code List
    Grade the diffuse and/or geographic fatty infiltrate of the liver
    CL Item
    Not applicable - no fatty infiltration  (1)
    CL Item
    Mild (<=25%) (2)
    CL Item
    Moderate (>25% to <75%) (3)
    CL Item
    Severe (>=75%) (4)
    CL Item
    Other (5)
    Item
    Ascites present
    text
    C2711860 (UMLS CUI [1,1])
    C0003962 (UMLS CUI [1,2])
    Code List
    Ascites present
    CL Item
    None present (1)
    CL Item
    Yes - small amount (2)
    CL Item
    Yes - moderate or severe amount (3)
    CL Item
    Other (4)
    Item
    Are Focal Hepatic Lesions characterisable?
    text
    C2711860 (UMLS CUI [1,1])
    C0577053 (UMLS CUI [1,2])
    C0205234 (UMLS CUI [1,3])
    Code List
    Are Focal Hepatic Lesions characterisable?
    CL Item
    Not applicable - no hepatic lesions  (1)
    CL Item
    Solid (2)
    CL Item
    Cystic (3)
    CL Item
    Hemangioma (4)
    CL Item
    Focal Nodular Hyperplasia (5)
    CL Item
    Other (6)
    Item
    Gallstones or gallbladder lesions?
    text
    C2711860 (UMLS CUI [1,1])
    C3842395 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [1,3])
    Code List
    Gallstones or gallbladder lesions?
    CL Item
    None (1)
    CL Item
    Gallstones (2)
    CL Item
    Gallbladder polyp(s) (3)
    CL Item
    Sludge (4)
    CL Item
    Gallbladder wall thickening/oedema  (5)
    CL Item
    Gallbladder wall gas (6)
    CL Item
    Cholecystitis (7)
    CL Item
    Gallbladder wall calcification  (8)
    CL Item
    Gallbladder mass (9)
    CL Item
    Other (10)
    Item
    Biliary ductal lesions?
    text
    C2711860 (UMLS CUI [1,1])
    C0005423 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [1,3])
    Code List
    Biliary ductal lesions?
    CL Item
    None (1)
    CL Item
    Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
    CL Item
    Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
    CL Item
    Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
    CL Item
    Extrahepatic ductal dilation (5)
    CL Item
    Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
    CL Item
    Acute Cholangitis (7)
    CL Item
    Primary sclerosing cholangitis  (8)
    CL Item
    Choledocholithiasis (gallstone in duct)  (9)
    CL Item
    Ductal filling defect(s), other than gallstone  (10)
    CL Item
    Ductal wall thickening or oedema  (11)
    CL Item
    Choledochal cyst (12)
    CL Item
    Ductal mass (13)
    CL Item
    Extrinsic mass compressing bile duct(s) (14)
    CL Item
    Other (15)
    Item
    Portal/Hepatic vein abnormalities?
    text
    C2711860 (UMLS CUI [1,1])
    C0019155 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C2711860 (UMLS CUI [2,1])
    C0032718 (UMLS CUI [2,2])
    C1704258 (UMLS CUI [2,3])
    Code List
    Portal/Hepatic vein abnormalities?
    CL Item
    None (1)
    CL Item
    Portal vein enlargement (2)
    CL Item
    Hepatic vein enlargement (3)
    CL Item
    Nonocclusive portal vein thrombosis  (4)
    CL Item
    Occlusive portal vein thrombosis - bland  (5)
    CL Item
    Hepatic vein thrombosis - bland (6)
    CL Item
    Occlusive portal vein thrombosis - malignant  (7)
    CL Item
    Hepatic vein thrombosis - malignant  (8)
    CL Item
    Involvement of the main portal vein  (9)
    CL Item
    Involvement of the right portal vein  (10)
    CL Item
    Involvement of the left portal vein  (11)
    CL Item
    Budd-Chiari syndrome (12)
    CL Item
    Other (13)

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