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17 Zoekresultaten.
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - Medical Conditions; Alcohol Intake; Drug and Alcohol Screen; Serology (HIV Screen); Electronically Transferred Lab Data

- 11/11/2019 - 1 Formulier, 5 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: Medical Conditions, Alcohol Intake, Drug and Alcohol Sreen, Serology - HIV Screen, Electronically Transferred Laboratory Data
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

AMC-047 AIDS and Cancer Specimen Resource (ACSR) Procurement Form (F37)

- 29/08/2017 - 1 Formulier, 4 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Header - AIDS and Cancer Specimen Resource (ACSR) Procurement Form, Specimen Procurement, Contact Information, Comments
AMC-047 AIDS and Cancer Specimen Resource (ACSR) Procurement Form (F37) Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=21FA0742-63E9-07A9-E044-0003BA3F9857

AMC-048 AIDS and Cancer Specimen Resource (ACSR) Procurement Form (F37)

- 28/08/2017 - 1 Formulier, 4 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Header - AIDS and Cancer Specimen Resource (ACSR) Procurement Form, Specimen Procurement, Contact Information, Comments
AMC-048 AIDS and Cancer Specimen Resource (ACSR) Procurement Form (F37) Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32E18FA2-31A3-4AF2-E044-0003BA3F9857

AMC-052 Histology Result Form 2676563v1.0

- 03/06/2015 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Header module, Anal histology results
AMC-052 Histology Result Form 2676563v1.0 Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3950D614-2D53-3AAB-E044-0003BA3F9857

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - Lab Tests (Blood Sample)

- 27/08/2019 - 1 Formulier, 3 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Laboratory Tests - Antibody Determination, Laboratory Tests - HIV
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. This form contains information on antibody determination and other HIV-related laboratory investigations. For all cohorts, antibody determination is to be performed at Visits 1, 4, 5, 6, 8, 9 and 10, whereas timepoints of HIV-related testing are dependent on Cohort: For Cohort 1 (HIV-pos.), HIV-related testing is to be performed at Visits 1, 5, 8 and 10. For Cohort 2 (HIV-neg., exposed), HIV-related testing is to be performed at Visit 10 (and additionally 2 months post-cessation of breast feeding). For Cohort 3, 4, and 5 (HIV-neg., unexposed infants), HIV-related testing is to be performed at Visits 1 and 10. If clinically indicated, HIV-related testing can also be performed at any other Visit.

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