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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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - X Ray Pneumonia Confirmation (X-ray)

- 1/8/19 - 1 form, 2 itemgroups, 3 items, 1 language
Itemgroups: Administrative data, X Ray Pneumonia Confirmation (X-ray)
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the X Ray Pneumonia Confirmation (X-ray) form. It has to be filled in for each x-ray for pneumonia confirmation performed during trial, if necessary.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Chest X-Ray Data

- 12/4/18 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Chest X-Ray
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Log Status Form

- 11/30/18 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Log Status
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Concomitant Medications, Asthma Exacerbations, IP Device Malfunction, Chest X-Ray, Pharmacogenetic Research Consent/ Sample Collection, Investigational Product Compliance and Unsceduled Asthma related Healthcare Resource Utilisation - Subject Logs

- 11/17/18 - 1 form, 9 itemgroups, 81 items, 1 language
Itemgroups: Concomitant Medication, Asthma Exacerbations, Contact Method/ Treatment site for ExacerbationsMethod, Exacerbation Medications, IP Device Malfunction, Chest X-Ray, Pharmacogenetic (PGx) Research Consent/ Sample Collection, Investigational Product Compliance, Unscheduled Asthma related Healthcare Resource Utilisation
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Medical Conditions Form

- 11/28/18 - 1 form, 6 itemgroups, 14 items, 1 language
Itemgroups: Cardiac Disorders, Endocrine Disorders, Eye Disorders, Vascular Disorders, Metabolism and Nutrition Disorders, Infections and Infestations
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Magnesium Sulfate in Bronchial Asthma NCT02455687 - Eligibility Criteria

- 6/15/19 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.; ODM derived from: https://clinicaltrials.gov/show/NCT02455687 Many studies have worked on the efficacy and safety of Intravenous magnesium sulfate and inhaled steroids beside the standard treatment for patients with severe asthma attacks. Investigators hypothesize that, two doses if intravenous magnesium sulfate with or without inhaled budesonide, would make the stay at the Pediatric emergency center (PEC) lesser,and decrease the need of being admitted to Pediatric Intensive Care Unit (PICU) for children with severe asthma attacks,compared to single dose of magnesium sulfate with or without inhaled budesonide.

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Medical Conditions, Family History, Disease Duration, Vital Signs, Candidiasis Examination, Electronically Transferred Lab Data - Screening

- 11/21/18 - 1 form, 11 itemgroups, 34 items, 1 language
Itemgroups: Medical Conditions - Cardiac Disorders, Medical Conditions - Endocrine Disorders, Medical Conditions - Eye Disorders, Medical Conditions - Vascular Disorders, Medical Conditions - Metabolism and Nutrition Disorders, Medical Conditions - Infections and Infestations, Family History, Disease Duration, Vital Signs, Candidiasis Examination, Electronically transferred lab data
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Eligibility Asthma NCT00140439

- 4/4/16 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Improving Asthma Outcomes in an Urban Pediatric Population; ODM derived from: https://clinicaltrials.gov/show/NCT00140439

Eligibility Asthma NCT00392288

- 4/11/16 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT00392288

Eligibility Asthma NCT00583986

- 4/13/16 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD; ODM derived from: https://clinicaltrials.gov/show/NCT00583986

Eligibility Severe Asthma NCT00621946

- 10/27/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00621946

Eligibility Asthma NCT00634517

- 4/18/16 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00634517

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