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  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
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- 9/3/19 - 1 form, 3 itemgroups, 21 items, 1 language
Itemgroups: Administrative documentation, Study Conclusion, Investigator's Signature
Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the Study Conclusion and is to be used twice - at the interim analysis at/after Visit 6 and at the final analysis at the end of the study (or if the subject has been withdrawn).
- 8/28/19 - 1 form, 4 itemgroups, 25 items, 1 language
Itemgroups: Administrative Data, Patient Demographic Factors, Clinical Status, Degree of Health
ICHOM Paediatric Facial Palsy data collection Version 1.0.0 Revised: August 31st, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: For Paediatric Facial Palsy, the following conditions and treatment approaches (or interventions) are covered by ICHOM‘s Standard Set. Conditions: Congenital/Syndromic | Acquired Unilateral (single- and multi-territory) | Bilateral (single- and multi-territory) Treatment approaches: Medical treatment | Surgery | Eye care Physiotherapy/Occupational therapy | Botulinum toxin | Psychological support This document contains the End of pediatric or planned care - Clinical Form. It should be completed at the end of paediatric care (16y to 18y) or when no further treatments are planned, and allow for >1 year follow-up. Collecting Patient-Reported Outcome Measure: eFACE – Clinician. For more information see: Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA. Clinician-Graded Electronic Facial Paralysis Assessment: The eFACE, August 2015. doi: 10.1097/PRS.0000000000001447 FACE-Q Kids. As there is a license for use of this questionnaire, the questions will not be included in this version of the standard set, only subscores. Snellen Chart – Clinician. PROMIS Paediatric Global Health 7 and PROMIS Pediatric Peer Relationships SF 8a. As there is an official distribution site, only the total score of these questionnaires will be included in this version of the standard set. For more information see: http://www. obtain-administer-measures Reference: Butler DP, De la Torre A, Borschel GH, et al. An International Collaborative Standardizing Patient-Centered Outcome Measures in Pediatric Facial Palsy. JAMA Facial Plast Surg. Published online May 09, 2019. doi:10.1001/jamafacial.2019.0224 The Standard set of ICHOM was supported by the royal free charity and the Dianne and Michael Bienes Charitable Foundation Inc.
- 7/20/19 - 1 form, 6 itemgroups, 19 items, 1 language
Itemgroups: Administrative Data, Study Conclusion, Treatment Blind, Pregnancy Information (female), Pregnancy Information (male), Electronic Signature
- 7/20/19 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data, Adverse Event/Concomitant Medication/Repeat Assessment, Liver Event
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 Identifier: NCT00996840 See 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 is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.