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NCT ID: NCT02884323 Completed - Venous Leg Ulcer Clinical Trials

A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device

Start date: August 2016
Phase: N/A
Study type: Interventional

This is a single centre open label study measuring lower limb physiology in patients with venous leg ulcers at the University Hospital of South Manchester. Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in microcirculation will be measured at baseline after the gekoTM device is activated. Ambulatory venous pressure and venous transit times will be performed whilst the participant is standing, sitting and supine

NCT ID: NCT02884206 Completed - Clinical trials for Chronic Heart Failure (CHF)

Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

PERSPECTIVE
Start date: November 23, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Cognitive function will be assessed using a comprehensive battery of tests with an evaluation of longitudinal change of cognitive domains including memory, executive function, and attention.

NCT ID: NCT02884167 Completed - Constipation Clinical Trials

Multidimensional Risk Factor Assessment in Constipation

Start date: June 2016
Phase: N/A
Study type: Observational

Constipation is a symptom based disorder with a prevalence of 15% in the adult population and its management remains challenging. Although not life threatening, constipation is associated with impaired quality of life, increased healthcare costs and excess work absenteeism. Constipation represents a heterogeneous disorder with a multifactorial pathogenesis. Several risk factors have been suggested to lead to the condition and are divided in 3 main categories: a) physiological, b) environmental and c) demographic. To date, there is lack of large epidemiological studies on proposed aetiological factors of constipation, especially studies assessing all proposed risk factors of constipation together. The overall aim of this study is to investigate the multidimensional (physiological, environmental and demographic) predictors of constipation with the use of a multivariate analysis statistical model. This is a large single centre case control study comparing constipated adults with healthy individuals matched for age, gender and ethnicity. The duration of the study is 2 weeks in total and includes a screening visit, a 2 week run-in period and a baseline visit at the end of the run-in period. Transit time between constipated and healthy individuals is assessed at baseline visit. Differences in gastrointestinal symptoms, dietary intake as well as differences in stool output (e.g. stool frequency and consistency) between constipated and healthy individuals are assessed over the baseline period (the week before the baseline visit). Differences in female sex hormone levels as well as stool markers and markers of fermentation (e.g. fecal water, stool pH, short chain fatty acids) between constipated and healthy individuals are assessed at baseline visit. Furthermore, differences in environmental measures (physical activity, anxiety, smoking) and differences in demographic measures (age, gender, body mass index) between patients suffering from constipation and healthy individuals are also assessed at baseline visit.

NCT ID: NCT02883907 Completed - Osteoarthritis Clinical Trials

Advanced MR Imaging of Osteoarthritis

AMROA
Start date: April 27, 2017
Phase:
Study type: Observational

The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by: 1. Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult. 2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial. Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential to solve these problems. However, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies. This study aims to help address these issues by: 1. Calculating effect sizes for MR measurements to inform sample size calculations for future studies. 2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint. The investigators will examine a single knee of an initial 15 participants with MR. Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA. Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination. This will allow us to assess both the reliability of our MR measurements and the expected progression in our MR measurements in OA subjects in the absence of any disease-modifying intervention.

NCT ID: NCT02882165 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Clinical And Social Characteristics and Demographics in COPD

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

Chronic Obstructive Pulmonary Disease (COPD) is a condition resulting from environmentally induced lung damage e.g. cigarette smoking and air pollution which, over time, causes individuals to suffer from symptoms including chronic cough and progressive breathlessness. In the UK COPD is predominantly caused by cigarette smoking which may have occurred decades before the symptoms appear and the disease is diagnosed. The aim of this study is to identify those COPD patients who currently have milder disease and to investigate whether a detailed, medical assessment which has time to assess all aspects of their care will improve their lung health and general wellbeing. COPD is a major cause of disability and death in the UK, with around 835,000 people currently diagnosed with the disease and an estimated further two million people who suffer from symptoms but do not yet have a diagnosis(1). Approximately 25,000 people each year die from COPD in England and Wales (2), with the disease accounting for 5.4% of all deaths in England and Wales in 2013 (3). Predominantly in its later, more severe stages, COPD causes an enormous symptom burden to patients, and accounts for up to half of emergency admissions to already overstretched hospital services in England (4). People with COPD, with a past history of smoking, are at higher risk of other medical problems such as heart disease and stroke(5). Being breathless and having multiple physical health problems can also lead to mental health problems such as anxiety and depression(5). This means it can be challenging to provide this group of people enough time to fully assess and treat all their problems, particularly due to current pressure on the length of GP appointment times. Whilst COPD is treatable, it is not curable, and emphasis on early diagnosis and intervention provided a key part of the strategy for COPD published by NHS England in 2012(6). With early diagnosis, the opportunity is provided to intervene with the aim of improving symptoms and exercise tolerance, reducing the risk of exacerbations, slowing deterioration and prolonging quality of life.

NCT ID: NCT02881866 Completed - Dyspnea Clinical Trials

Specificity of Dyspnoea Relief With Inhaled Furosemide

FurosAH
Start date: October 2015
Phase: Phase 1
Study type: Interventional

This study evaluates the effect of inhaled furosemide on different types of breathlessness relief in healthy volunteers. Each volunteer inhaled mists of either furosemide or a control substance on 3 occasions per day on 2 separate days. On one day they performed one breathlessness test which creates an 'urge to breathe' known as air hunger (AH) and the other day they performed a breathlessness test which increases the sense of work/effort (WE) of breathing. The study is double blinded so neither the volunteer or the research knows which mist is being inhaled.

NCT ID: NCT02881632 Completed - Bronchiolitis Clinical Trials

Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis

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

A cohort observational study to characterise baseline Structured Light Plethysmography (SLP) outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM

NCT ID: NCT02881411 Completed - Clinical trials for Fibromyalgia Syndrome

Self Soft Tissue Therapy for Fibromyalgia Syndrome

Start date: July 2016
Phase: N/A
Study type: Interventional

The main aims of this preliminary research are to determine if combined self-soft tissue therapy (SSTT) alongside an established 6 week FMS Coping Skills Programme (FCSP) is a feasible and acceptable treatment approach for FMS. All participants on the six week FCSP will be randomly allocated to a control (FMS Coping Skills Programme) or intervention group (FMS Coping Skills Programme plus SSTT). All participants will be assessed for outcome measurements at the start of the feasibility study, at six weeks and three months after completion. This feasibility study hypothesis is that the SST approach will be acceptable to FMS patients and that the combined 6 week FCSP (hands off) and SSTT (hands on) will be beneficial. This feasibility study will inform a larger randomized controlled trial (RCT) on this combined treatment approach to FMS.

NCT ID: NCT02880930 Completed - Wheezing Clinical Trials

Optimizing Vitamin D Status in Children With Wheeze / Asthma (OPTIVIT)

OPTIVIT
Start date: December 2016
Phase: N/A
Study type: Interventional

Vitamin D deficiency is highly prevalent in the UK. Research shows that vitamin D enhances the immune system and may help protect against chest infections that can cause wheezing illness or worsen asthma symptoms. The Department of Health recommends a dose of 10 micrograms of vitamin D/day to prevent severe vitamin D deficiency in children. However, many studies have reported that this dose is not enough to raise plasma 25(OH)D concentration to the levels most likely to prevent against worsening of asthma symptoms. Such studies suggest that 25 micrograms of vitamin D/day. This dose is safe but its effects on vitamin D blood levels have not yet been specifically tested in children with asthma/wheeze. This study is designed to determine the optimal oral daily vitamin D supplementation dose to treat vitamin D deficiency in children with asthma or preschool wheeze. Over the 6-month course of the study, participants will meet with the study team four times in clinic or in their own home and will be contacted by telephone five times. Children will be asked to give a drop of blood via a fingerprick to test their vitamin D level and a sample of nasal epithelial lining fluid for measurement of inflammatory markers on three separate occasions.

NCT ID: NCT02880449 Completed - Physical Activity Clinical Trials

Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas

Start date: September 2016
Phase: N/A
Study type: Interventional

The aim of the project is pilot an intervention to promote physical activity (PA) among older women. Participants will be women aged ≥50 years attending an identified community centre situated in a socioeconomically deprived area of Belfast. The intervention consists of education, social support and information on local opportunities for physical activity (PA), based on Social Practice Theory. A stepped wedge design shall be used. The intervention was developed using findings from a literature review, systematic review and interviews with stakeholders. Outcome measures are accelerometer data, self-reported PA, a mental health questionnaire and qualitative interviews.