Keywords
Clinical Trial, Phase II ×
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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

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- 8/15/19 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data, Pharmacodynamics Results
- 8/15/19 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Pharmacodynamics
- 7/24/19 - 1 form, 6 itemgroups, 63 items, 1 language
Itemgroups: Administrative Data, Liver imaging - General, Focal Hepatic Lesions, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
- 7/24/19 - 1 form, 10 itemgroups, 57 items, 1 language
Itemgroups: Administrative Data, Liver Events Lab, Liver Events Clinical, Investigational Product Liver, Pharmakokinetics Liver, Liver disease medical conditions, Drug related liver disease conditions, Other Liver Disease, Other medical conditions, Alcohol Intake
- 7/24/19 - 1 form, 14 itemgroups, 159 items, 1 language
Itemgroups: Administrative Data, Liver Biopsy, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Hepatocytes, Hepatocyte Inclusions or Vacuoles, Hepatocyte Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Parasites or Ova, Histologic Staining or Additional Studies Obtained
- 7/20/19 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Pharmacokinetics Blood
- 7/20/19 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative documentation, Fluid Intake
- 7/20/19 - 1 form, 7 itemgroups, 91 items, 1 language
Itemgroups: 12-Lead ECG Abnormalities Administrative Data, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation, Other ECG abnormalities
- 7/20/19 - 1 form, 6 itemgroups, 29 items, 1 language
Itemgroups: Administrative Data, Dosing Date/Time, Vital Signs, Oxygen Administration, Pulse Oximeter, ABG
Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains the participant's vital signs including ventilator settings, which are assessed at Screening, on Day 1 at 4 hrs (cohorts 1 and 3 only), Day 2 at 0 hrs, Day 3 at 0 hrs, Day 3 at 24 hrs (i.e. Day 4 at 0 hrs), and Follow-Up (for all cohorts, except for Day 1 at 4 hrs). This form can also be used for any repeat/unscheduled assessment of vital signs.
- 7/20/19 - 1 form, 3 itemgroups, 5 items, 1 language
Itemgroups: Administrative Data, Surgery, Surgery Dates/Times
- 7/20/19 - 1 form, 4 itemgroups, 6 items, 1 language
Itemgroups: Administrative Data, Trauma, Glasgow Coma Scale, Injury Severity Score
- 7/20/19 - 1 form, 4 itemgroups, 34 items, 1 language
Itemgroups: Administrative Data, Eligibility Criteria, Inclusion Criteria, Exclusion Criteria