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NCT ID: NCT02505919 Completed - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)

WATER
Start date: October 30, 2015
Phase: N/A
Study type: Interventional

A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.

NCT ID: NCT02505542 Completed - Clinical trials for Ankylosing Spondylitis

Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

C-OPTIMISE
Start date: July 2015
Phase: Phase 3
Study type: Interventional

Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.

NCT ID: NCT02505503 Completed - Clinical trials for Peripheral Arterial Disease

York Study of Unloading Shoes for Vascular Intermittent Claudication

YORVIC
Start date: July 2015
Phase: N/A
Study type: Interventional

Some people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication (IC) and it is a common symptom of peripheral arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of life. The intensity of IC pain experienced during walking depends on several factors, including the type of footwear worn. For example, non-supportive shoes may make the calf muscles work harder during walking, leading to earlier and more-severe symptoms of IC. A member of the research team has developed a shoe that reduces the work done by the lower-leg muscles during walking. Preliminary data indicate that, when wearing these "unloading shoes", people with IC were able to walk further without pain as compared with when wearing a normal pair of shoes. The current project aims to provide further information on the usefulness and acceptability of these shoes. Forty people with IC will complete a set of three walking tests on two separate occasions; once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The participants will then be given a pair of unloading or normal shoes to wear for two weeks, after which we will collect information on how acceptable the shoes were to wear via a survey of all participants and one-to-one interviews with a subset of participants.

NCT ID: NCT02505321 Completed - Diabetes Mellitus Clinical Trials

for Adipose Tissue DIabetes VAriants (fATDIVA)

fATDIVA
Start date: May 29, 2015
Phase: N/A
Study type: Interventional

The adipose (fat) cells under the skin are where individuals store excess fat. The more excess fat they have, the more "strain" they put on these cells which then get bigger and don't work as well as they should. Having some fat under the skin is important. People who have a genetic defect which results in them having almost no fat under their skin have a very high risk of a condition called insulin resistance (where the body does not respond as well to insulin and blood sugar levels rise). This can lead to diabetes and heart disease despite them not being overweight. Scientists have only recently started to understand the importance of fat in insulin resistance and how people unable to store fat very well can have insulin resistance despite not being obese. The investigators have also recently discovered that small changes in a person's genetic code (their body's instruction manual) may also affect their ability to store fat and would like to explore this in more detail. To do this, they will recruit volunteers from the Exeter 10,000 study who gave permission to contact them about further research. The investigators will collect detailed body size measures and blood samples taken before and after a special drink that is high in fat (similar to a thick milk shake), then compare the results between people with and without the particular genetic changes of interest. Knowing more about these genetic changes and how fat cells work could help to improve understanding about why some people develop diabetes and heart disease despite a relatively normal BMI.

NCT ID: NCT02505308 Completed - Diabetes Mellitus Clinical Trials

Defining the Molecular and Physiological Mechanisms of Pancreatic Islet Cell Dysfunction Which Lead to Type 2 Diabetes

DIVA-Exeter
Start date: March 4, 2015
Phase: N/A
Study type: Interventional

Defects in insulin secretion are central to the pathogenesis of type 2 diabetes (T2D) but the molecular basis and physiological consequences of those defects are poorly understood, impeding efforts to develop novel therapeutic approaches. Key questions remain unanswered, such as the extent to which T2D-associated islet dysfunction reflects endogenous defects in beta-cell mass or function, as opposed to disruption of external factors impinging on the beta-cells, such as incretins. Recently the investigators have identified several genetic variations (DNA changes) associated with the production and processing of insulin in non-diabetic individuals and now aim to explore in more detail the role of these genetic variations. Utilising a "recruit by genotype" approach, they will identify individuals with and without genetic variants of interest from existing databases of research volunteers. The investigators will collect detailed medical history and measurements, fasted and stimulated blood samples for the profiling of insulin-related hormones and metabolites. The resulting genetic and non-genetic data will be used to improve understanding of the role of genetic variation on insulin secretion and sensitivity defects that lead to the development of T2D.

NCT ID: NCT02505282 Completed - Clinical trials for Orthostatic Hypotension

Vitamin K Status and Markers of Vascular Function in Patients With and Without Postural Hypotension

VITKOH
Start date: April 2012
Phase: N/A
Study type: Observational

Postural hypotension is common in older people, leading to falls, decline in function, and dependence. Available treatments have limited efficacy and tolerability; novel approaches to treatment are therefore needed. Decreased vascular health, stiffening of the arteries and consequent decreased vascular reactivity are thought to contribute to postural hypotension and are therefore therapeutic targets. Recent trial evidence has suggested that vitamin K may exert beneficial effects on vascular health particularly in respect to inhibiting calcification. Calcification increases vascular stiffness, decreases compliance and thus decreases the ability of blood vessels to autoregulate blood pressure and flow - which could contribute to postural drops in blood pressure. Worsened vascular health could also impact adversely on baroceptor function, which is needed for blood pressure autoregulation and which is disrupted in patients with orthostatic hypotension. Vitamin K intake is below recommended daily intake in 60% of adults in the UK. In animals, vitamin K supplementation may be able to reverse calcification of arteries, and in humans Vitamin K has been shown to arrest decline in carotid artery elasticity compared to placebo. High levels of circulating vitamin K were also associated with lower levels of CRP in the Framingham cohort, suggesting a possible role in the suppression of chronic inflammation that is known to accompany vascular disease. The recent ECKO study suggested that vitamin K may reduce falls and fractures; an intriguing question that follows on from this is whether this could be due to beneficial effects on vascular health and postural hypotension, leading to less dizziness and reduced falls. This cross-sectional comparative study aims to find whether there is a difference in the vitamin K status of patients with postural hypotension compared to those without postural hypotension and whether differences in vitamin K status are associated with other markers of vascular function in patients with and without postural hypotension. This could potentially lead to new treatments for the condition for which there is currently little of proven benefit.

NCT ID: NCT02504671 Completed - Clinical trials for Arthritis, Rheumatoid

Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

Start date: July 23, 2015
Phase: Phase 2
Study type: Interventional

This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group, placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into the study, following a screening period of up to four weeks. The total treatment period is up to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in combination with MTX (at a weekly dose between 15-25 milligram [mg]), previously received for at least 12 weeks, with a stable and tolerated dose and route of administration for >=4 weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that do not achieve adequate disease improvement.

NCT ID: NCT02504268 Completed - Clinical trials for Rheumatoid Arthritis

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

AVERT-2
Start date: September 3, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

NCT ID: NCT02504216 Completed - Clinical trials for Peripheral Artery Disease

Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities

VOYAGER PAD
Start date: August 18, 2015
Phase: Phase 3
Study type: Interventional

The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

NCT ID: NCT02503969 Completed - Colorectal Cancer Clinical Trials

Exploratory Analysis on the Impact of Morbidities on Colorectal Cancer Screening Uptake

Start date: September 2015
Phase: N/A
Study type: Observational

The primary aim of this project is to examine the association between having a long-term condition (morbidity) and screening uptake for colorectal cancer. Whilst this project will consider all morbidity and co-morbidities, there will be a particular focus on common mental health disorders, such as depression and anxiety. The secondary aim of this project is to examine other factors that may influence uptake rate. Information on a wide array of potential factors is available for this project. These include demographics (age, gender, ethnicity), socio-economic status (deprivation, education status) and lifestyle (smoking status, drinking patterns, degree of exercise). In addition, any potential moderating effect of these factors on the association between morbidity and screening uptake shall be explored. In summary, the following shall be explored: - Uptake rates by type of mental health disorder. - Uptake rates by chronic physical health problems. - Associations between uptake, morbidity (both physical and mental) and broader health determinants such as demographics, socio-economic status and lifestyle.