Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Baseline - Consent; Central Laboratory; Diary; ECG

- 09.01.20 - 1 Formular, 11 Itemgruppen, 56 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Randomisation, Electronically Transferred Lab Data, Possible Liver Events, Diary - Target Day 1, Diary - Target Day 2, Diary Day 2, Target Day 3, Diary Day 3, 12 Lead Electrocardiogram , ECG Information

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - Use of Human Samples

- 03.09.19 - 1 Formular, 3 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Use of human samples by Sponsor, 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 ClinicalStudyDataRequest.com Clinicaltrials.gov 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. In addition to the use of samples for the tests described in the protocol, the sponsor might use samples for additional research; therefore, this form records what is also covered by the subject Informed Consent form of each center.

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Visit 1: Consent Form

- 06.06.19 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Informed Consent

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This document is to be completed at Visit 1 (if consent is given).

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Pharmacogenetics

- 13.03.19 - 1 Formular, 4 Itemgruppen, 15 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Pharmacogenetic (PGx) Research Consent, PGx-Pharmacogenetic Research Consent Withdrawal, Investigator's Signature

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Concomitant Medication, Non-Serious Adverse Events, Study Conclusion

- 11.03.19 - 1 Formular, 14 Itemgruppen, 53 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, CONCOMITANT VACCINATION, Vaccination details, CONCOMITANT MEDICATION, Medication details, NON-SERIOUS ADVERSE EVENTS, Adverse Events, STUDY CONCLUSION, PREGNANCY INFORMATION, ELIMINATION CRITERIA, SUBJECT WITHDRAWAL, INVESTIGATOR'S SIGNATURE, USE OF HUMAN SAMPLES BY GSK, INVESTIGATOR'S SIGNATURE

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 - Lab Reference Ranges, Consent Form

- 07.03.19 - 1 Formular, 6 Itemgruppen, 89 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, LABORATORY REFERENCE RANGES, Hematology, Blood Chemistry, USE OF HUMAN SAMPLES BY GSK, INVESTIGATOR'S SIGNATURE

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