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Sommario
  1. 1. Test clinico
  2. 2. Documentazione di routine
  3. 3. Registro / studio di coorte
  4. 4. Garanzia di qualità
  5. 5. Dati Standard
  6. 6. Risultato segnalato dal paziente
  7. 7. Specialità mediche
    1. 7.1. Anestesiologia
    1. 7.2. Dermatologia
    1. 7.3. orecchio naso gola
    1. 7.4. Geriatria
    1. 7.5. Ginecologia / Ostetricia
    1. 7.6. Medicina Interna
      1. Ematologia
      1. Malattie infettive
      1. Cardiologia / Angiologia
      1. pneumologia
      1. Gastroenterologia
      1. Nefrologia
      1. Endocrinologia / Malattie metaboliche
      1. Reumatologia
    1. 7.7. Neurologia
    1. 7.8. Oftalmologia
    1. 7.9. Cure palliative
    1. 7.10. Patologia / Forense
    1. 7.11. Pediatria
    1. 7.12. Psichiatria / Psicosomatica
    1. 7.13. Radiologia
    1. 7.14. Chirurgia
      1. Chirurgia generale / viscerale
      1. Neurochirurgia
      1. Chirurgia plastica
      1. Chirurgia toracica
      1. Trauma / Ortopedia
      1. Chirurgia vascolare
    1. 7.15. Urologia
    1. 7.16. Medicina odontoiatrica / OMS
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Medical history Nuclear medicine UKM - Medical history

- 20/09/21 - 1 modulo, 5 itemgroups, 69 elementi, 2 lingue
Itemgroups: Patient demographics, Medical history, Eyes, Thyroid gland, Finding
Medical history form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Univ.-Prof. Dr. med. Michael Schäfers

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Diary Cards

- 11/03/19 - 1 modulo, 19 itemgroups, 85 elementi, 1 linguaggio
Itemgroups: Administrative data, LOCAL SYMPTOMS (at injection site), Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, OTHER LOCAL SYMPTOMS (from Day 0 to Day 20), MEDICATION, GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, OTHER GENERAL SYMPTOMS, Reminder
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 0" Vaccination

- 11/03/19 - 1 modulo, 29 itemgroups, 196 elementi, 1 linguaggio
Itemgroups: Administrative data, ELIMINATION CRITERIA, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, TREATMENT ALLOCATION, GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION, HISTORY OF INFLUENZA VACCINATION, LABORATORY TESTS, HCG URINE PREGNANCY TEST, VACCINE ADMINISTRATION, VACCINE NON-ADMINISTRATION, SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, UNSOLICITED ADVERSE EVENTS
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Visit 1 - Day 0 - Dose 1

- 06/03/19 - 1 modulo, 25 itemgroups, 142 elementi, 1 linguaggio
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, RANDOMISATION / TREATMENT ALLOCATION, VACCINE ADMINISTRATION, VACCINE, VACCINE NON-ADMINISTRATION, IMMEDIATE POST-VACCINATION OBSERVATION, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, UNSOLICITED ADVERSE EVENTS
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

NINDS CDE Symptoms, Frequency and Severity - Headache - Symptoms, Frequency and Severity - Baseline

- 15/06/16 - 1 modulo, 2 itemgroups, 27 elementi, 1 linguaggio
Itemgroups: Demographics, Symptoms, Frequency and Severity - Baseline
NINDS Common Data Elements (Symptoms, Frequency and Severity - Baseline; Headache) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

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