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NCT ID: NCT02674425 Recruiting - Clinical trials for Photoreceptor Sensitivity Thresholds

Wearable Dark-adaptometer in Normal Adult Healthy Volunteers

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

Conventional dark-adaptometers are unsuitable as a mass screening tool due to their high cost, lack of easy portability, need of trained staff and a totally dark room to be operated, arbitrary testing procedures, associated time waste in clinic and patient burden to mention a few. Consequently, dark adaptometers are not routinely used as clinical tools for retinal diagnosis and monitoring despite the inherent benefits over other visual electrophysiology equipment such as the ERG system, whose cost and features may often be surplus to optometrists' requirements. This trial will assess the dark-adaptometry testing performance of a novel light-emitting system by generating full dark-adaptation threshold functions in normal adult healthy volunteers. The novel system has been proposed to overcome the issues associated with current instrumentation; it is semi-automatic and easy to use without the need of any skilled operator. It is envisaged that this system could spread the practice of dark-adaptometry testing and its adoption by high-street optometrists. This will allow diagnosing a number of retinal pathologies more quickly and more reliably that, faced with an ageing population, represents a major asset to the Health Community and the NHS. This trial will involve 20 healthy volunteers, distributed in equal number in 2 groups of 18-40 and 50-70 years old, respectively. Proven the good health and eye condition of the participants, one of their eyes will be randomly-allocated and undergo dark-adaptometry testing 3 times on separate days within 3 weeks. Testing will clarify whether by using the novel system it is possible to reproduce state-of-the-art threshold measurements as good or better than those produced by commercially-available dark-adaptometers. Threshold measurements in the elderly will be compared with literature data adjusted to exclude aged crystalline lens and pupillary miosis contributions. Data variability and system usability will be also assessed.

NCT ID: NCT02674100 Recruiting - Pancreatic Cancer Clinical Trials

American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) Registry

Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical interventions. The investigators seek a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors and the limitations, concerns and complications that earlier users have.

NCT ID: NCT02672059 Recruiting - Chronic Pain Clinical Trials

Pain In Neuropathy Study

PINS
Start date: February 2011
Phase:
Study type: Observational

In the context of peripheral neuropathy, we will aim to elucidate correlates between sensory symptoms and: - Sensory nerve dysfunction. - Cutaneous small nerve fibre innervation density. - Psychological co-morbidity. - Circadian rhythm disturbance co-morbidity. - Functionality and Quality of life. - Patterns of human brain activity in a subset of patients that consent to participate in the FMRI (functional magnetic resonance imaging) component of PINS. 2. We will also collect blood samples in this phenotyped cohort of patients. These blood samples coupled with detailed phenotype data will investigate potential gene associations only in the development of painful neuropathy. 3. Knowledge gained from the study will be used to aid the further development of pain questionnaires, designed to detect patients with painful neuropathy. 4.Knowledge gained from the study will be invaluable in informing on-going investigations of painful peripheral neuropathy in animal models, both in our laboratory and others.

NCT ID: NCT02668263 Recruiting - Breast Cancer Clinical Trials

Investigating the Use of Drains and (Internal) Quilting Sutures on Seroma Formation Following Mastectomy

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

Seroma formation is a common complication following breast and axillary surgery for breast cancer. The use of drains is commonplace in practice after mastectomy, although there is evidence to suggest that they do not affect the incidence of symptomatic seroma formation. Methods have been adopted in attempts to decrease seroma formation, to varying results, which include the use of deep sutures. The aim of this study is to evaluate the effect of drains and quilting sutures on the incidence of seroma formation. Patients undergoing mastectomy and axillary surgery for breast cancer will be eligible. Patients will be randomized to either receive a drain, no drain or no drain with quilting sutures. The primary outcome measure will be the incidence of symptomatic seroma. Secondary outcome measures will be postoperative length of stay and postoperative pain scores.

NCT ID: NCT02666313 Recruiting - Clinical trials for Ankylosing Spondylitis

WEB-Based Physiotherapy for People With Axial Spondyloarthritis

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

Regular exercise is a core component of the long-term management of people with axial spondyloarthritis (axial SpA). However, delivering long-term exercise programmes is unrealistic and unsustainable using traditional NHS services. Web-based physiotherapy, has been developed, a possible alternative service model to support people with axial SpA to exercise regularly however long-term compliance to the programme (12 months) needs to be established. The aim of this prospective cohort study is to assess the feasibility, sustainability and acceptability of a 12 month individualised web-based physiotherapy programme in people with axial SpA. Fifty people with established axial SpA, will receive 12 months of individualised, remotely monitored, web-based physiotherapy. The primary outcome will be four weekly compliance rates with the programme over the 12 month period. Secondary outcomes (baseline, 6 and 12 months) will include function, disease activity, spinal mobility, quality of life, attitudes and motivations towards exercise, fitness, health status, employment, physical activity. The number of interactions with health care professionals and changes in medication will be documented. A subsample of the cohort will be interviewed at 6 and 12 months to gather participants' views of the web-based physiotherapy programme and factors influencing compliance with the programme.

NCT ID: NCT02666274 Recruiting - Clinical trials for Gram-Negative Bacterial Infections

Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread

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

There are many bacteria that naturally live in our gut and are essential for good health. These bacteria have a variety of helpful functions, such as aiding digestion, synthesizing vitamins, repressing the growth of harmful bacteria and defending against some diseases. The desirable bacteria that live in the gut are collectively known as 'gut flora', or more appropriately, as 'gut microbiota'. The less desirable resistant bacteria, however, can also be carried in a person's gut for prolonged periods of time and be found in the stools without causing illness. Persons that carry the resistant bacteria in the gut are known as "carriers" and they require no treatment. Knowing that a person carries resistant bacteria is helpful, because it will inform the choice of antibiotic if the person were to become unwell or had an intervention such as surgery in the future. There is some evidence that resistant bacteria found in the stools can sometimes be passed from one person to another and eventually make someone ill if they infect (invade) their body. The investigators do not know how often this may happen, or how much carrying resistant bacteria in the stools may facilitate the spread of resistant bacteria in the population. It is important to address these questions and study ways to stop the resistant bacteria from spreading to safeguard the efficacy of antibiotics.

NCT ID: NCT02666079 Recruiting - Breast Cancer Clinical Trials

The LightPath® Breast Cancer Study

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

This study is a prospective, single arm, multi-centre study to evaluate the intra-operative use of the LightPath® Imaging System for the assessment of tumour margin status compared to hospital standard of care histopathology in wide local excision (WLE) for breast cancer The intraoperative 18F-fluorodeoxyglucose (18F-FDG) LightPath® Images will be used to inform the surgeons about detectable residual cancer, in an attempt to achieve better guided cancer surgery and complete tumour excision with clear WLE resection margins. Study sites will use the local criteria considered standard of care to guide decisions to act on positive margins. In the LightPath® arm the resection margin status of the WLE specimen, cavity shavings (if any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the LightPath® Imaging System will be compared with histopathology results.

NCT ID: NCT02662127 Recruiting - Clinical trials for Chronic Venous Insufficiency

Effect of Standing, Lying and Stockings on Blood Bio-markers (v.1)

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

Venous disease effects 25% of the population and most healthy people experience venous symptoms after standing for too long. The prime function of leg veins is drainage. Failure leads to a condition called chronic venous insufficiency (CVI) with leg pain, heaviness, swelling, varicose veins, ankle skin changes, eczema and occasionally venous ulcers. The aim of the study is to identify blood components (biomarkers) that occur during the damaging phase of standing versus the healing phases of lying recovery and with medical compression stockings. This will be achieved by taking a blood sample from the ankle region at 3 separate visits (days) to the vascular laboratory at Ealing Hospital. The first visit will be after supervised standing for 1 hour. The second after supervised lying and the third standing whilst wearing a medical compression stocking. Healthy volunteers will be compared to patients with advanced CVI. The potential importance to patients and the public is threefold. Firstly, biomarker profiles will be obtained in each of the 3 states to increase understanding in the cellular mechanisms of damage and recovery. In this way "bad" and "good" biomarkers can be identified. Secondly, drug treatments may develop from this research to adjust biomarkers towards a favourable profile. Thirdly, the success of treating CVI with surgery, venous intervention or compression can be monitored. Whilst it is known that relief of gravitational stress is the treatment for all forms of CVI, the mechanisms of repair and its discrimination from damage have yet to be identified.

NCT ID: NCT02643732 Recruiting - Fatigue Clinical Trials

Fatigue in Sarcoidosis - Treatment With Methylphenidate

FaST-MP
Start date: November 2016
Phase: N/A
Study type: Interventional

This is a small randomised-controlled trial (RCT) using methylphenidate as a treatment for clinically-significant fatigue in sarcoidosis patients with stable disease. The primary outcomes are feasibility, aimed at determining factors that will influence the design a future, larger RCT, which will be powered to look at clinical efficacy of the intervention.

NCT ID: NCT02639936 Recruiting - Active Tuberculosis Clinical Trials

New Generation IGRA in Immunocompromised Individuals

TBnet#54
Start date: December 2015
Phase: N/A
Study type: Observational

Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients