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NCT ID: NCT02058589 Completed - Herpes Zoster Clinical Trials

Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant

Start date: March 20, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.

NCT ID: NCT02057484 Completed - Kidney Transplant Clinical Trials

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

ADDRESS
Start date: March 3, 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

NCT ID: NCT02054481 Completed - Psoriasis Clinical Trials

BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

Start date: February 2014
Phase: Phase 2
Study type: Interventional

The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.

NCT ID: NCT02051608 Completed - Alzheimer's Disease Clinical Trials

A Study of Gantenerumab in Participants With Mild Alzheimer Disease

Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

NCT ID: NCT02050464 Completed - Alzheimer Disease Clinical Trials

Computational Tools for Early Diagnosis of Memory Disorders

ProsKuopio
Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a four-year IT-project funded through the European Union (EU). The project consortium involves a total of 21 universities and industrial partners from 10 European countries. The project delivers the first patient-specific predictive models for early differential diagnosis of dementia and their evolution. An integrated clinical decision support platform will be validated / tested by access to a dozen databases of international cross-sectional and longitudinal studies. As a part of the VPH-DARE@IT project, a new prospective cohort will be collected in Kuopio. This prospective cohort will be used to test further the modeling approaches and tools developed by using the retrospective databases.

NCT ID: NCT02049372 Completed - Clinical trials for Tonsillar Surgery Complications

Complication Registry for Tonsil Surgery

Start date: September 2011
Phase: N/A
Study type: Observational [Patient Registry]

Our aim was to establish a feasible method to prospectively register all tonsil surgery-related complications and to find their possible predictive factors. Our long-term objective is to create a surgical complication registration database, which would provide valuable information for quality assurance and give us a benchmarking tool to improve the results of this surgery in our department.

NCT ID: NCT02048839 Completed - Obesity Clinical Trials

Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors

Start date: January 2014
Phase:
Study type: Observational

SUBJECTS: All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires OVERALL OBJECTIVES: 1. To determine the long-term effectiveness of a lifestyle intervention in high risk women and their offspring a in reducing the incidence of T2DM and cardiovascular disease and their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics markers . 2. To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years. 3. To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years. 4. To study the association between maternal a) glucose-insulin metabolism b) lipid metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later health outcomes in the mothers and their offspring. 5. To study the association between gut microbiota and markers of offspring health 6. To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk 7. To study the cost effectiveness of the intervention. METHODS: Maternal measurements 1. Height, weight, waist and hip circumference 2. Blood pressure, pulse 3. Body fat percentage 4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers 5. Fecal and hair samples 6. Diurnal salivary cortisol assessment 7. Background questionnaire: socioeconomic and health-related background 8. Health-related quality of life (15-D). 9. 3-day food diary and exercise diary 10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days 11. Psychological questionnaires 12. Pulse wave velocity (PWV) will be assessed 13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed 14. Dental and oral health 15. Bone health 16. VHRU of arterial structure Paternal measurements 1. Background questionnaire (incl. height, weight, age) 2. DNA-sample (buccal) 3. 3-day food diary 4. Psychological questionnaires 5. Physical activity questionnaire (12 months) Measurements of children 1. Body weight, height, blood pressure, pulse 2. Body fat percentage 3. Psychological questionnaires 4. Food and physical activities diaries 5. ActiGraph, assessment of physical activity and sleep for 7 days 6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers 7. Fecal, urine and hair samples 8. A copy of child welfare center card (e.g. data on growth, immunizations, health) 9. Endothelial function and pulse wave velocity (PWV) 10. Bone health with peripheral CT 11. Heart structure and function 12. VHRU of arterial structure TIMETABLE Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017 and results will be reported from 2018 onwards in international peer-reviewed journals.

NCT ID: NCT02046616 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Start date: May 28, 2014
Phase: Phase 3
Study type: Interventional

This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.

NCT ID: NCT02045862 Completed - Overactive Bladder Clinical Trials

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

SYNERGY II
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

NCT ID: NCT02045810 Completed - Anesthesia Clinical Trials

Surgical Pleth Index- Relevance in Small Children

SPIinChildren
Start date: January 2014
Phase: N/A
Study type: Interventional

Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption. It has not been tested on small children. The aim of this study is to measure, whether there is a difference in nosiception measured by SPI in a group receiving local anesthetics prior to operation compared to group receiving plasebo.