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  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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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.

Baseline Signs and Symptoms CRFs Multiple Sclerosis Tysabri NCT00027300

- 30/01/17 - 1 modulo, 1 ItemGroup, 6 elementi, 1 linguaggio
ItemGroup: Baseline Signs and Symptoms
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form is to be obtained in week 0.

Relapse Evaluation Visit No. 1: Recent Symptoms Multiple Sclerosis ALAIN01 NCT02419378

- 06/06/16 - 1 modulo, 2 itemgroups, 5 elementi, 1 linguaggio
Itemgroups: Symptoms, Relapse: Recent symptoms RQG
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Relapse Evaluation Visit No. 1

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Stroke Events

- 11/10/19 - 1 modulo, 2 itemgroups, 25 elementi, 1 linguaggio
Itemgroups: Administrative Data, Events Common To Stroke Patients
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Stroke Events Form. It has to be filled in for Week 1, Week 4, Week 8, Week 12, Week 16 and in case of early withdrawal.

NINDS CDE Diagnosis Criteria Summary Amyotrophic Lateral Sclerosis - Diagnosis Criteria Summary

- 19/02/16 - 1 modulo, 1 ItemGroup, 20 elementi, 1 linguaggio
ItemGroup: Symptom/Sign/Diagnosis Criteria Summary Information
NINDS Common Data Elements (Diagnosis Criteria Summary Amyotrophic Lateral Sclerosis) 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.

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

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

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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Adjudication Events - Acute Myocardial Infraction/Hospitalized Angina or Chest Pain

- 07/01/19 - 1 modulo, 12 itemgroups, 108 elementi, 1 linguaggio
Itemgroups: Administrative data, Acute Myocardial Infraction/Hospitalized Angina or Chest Pain, Clinical Presentation, Electrocardiographic Details, Cardiac Enzymes/Markers, CK-MB, Troponin I, Troponin T, Treatment Given for Acute MI/Hospitalized Angina/Chest Pain Event, Other Investigations Undertaken in View of this Event, Final Clinical Diagnosis, Narrative
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 15/10/17 - 1 modulo, 8 itemgroups, 35 elementi, 1 linguaggio
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 6 Booster Dose Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 15/10/17 - 1 modulo, 8 itemgroups, 35 elementi, 1 linguaggio
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 6 Booster Dose Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Visit 4 Dose 2 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 15/10/17 - 1 modulo, 8 itemgroups, 35 elementi, 1 linguaggio
Itemgroups: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms
Visit 4 Dose 2 Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

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