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NCT ID: NCT02841917 Completed - Aortic Stenosis Clinical Trials

Reactive Oxygen Species Following Aortic Valve Replacement

ROS
Start date: November 29, 2016
Phase:
Study type: Observational

Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with severe AS are deemed inoperable due to comorbidities such as severe respiratory disease, chronic renal disease and peripheral vascular disease. Transcatheter aortic valve replacement (TAVR) has emerged as a novel therapeutic modality for inoperable patients and an effective alternative to SAVR in selected high and intermediate-risk patients. Myocardial ischemia and reperfusion injury (MRI), mediated by reactive oxygen species (ROS), related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. In contrast to SAVR, transcatheter deployment of aortic prostheses requires shorter time of ischemia and hypotension and may be associated with less ROS mediated MRI. Inflammatory responses and reperfusion injury following TAVR have not been previously described nor compared to SAVR. The aim of this study is therefore to compare the oxidative stress response in patients with isolated severe symptomatic AS undergoing SAVR or TAVR and determine whether it correlates with clinical outcomes.

NCT ID: NCT02841527 Completed - Obesity Clinical Trials

Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity

ByBandSleeve
Start date: January 1, 2012
Phase: N/A
Study type: Interventional

Obesity is an increasing health problem in the United Kingdom (UK) and is predicted to worsen. In the UK and worldwide the three most commonly performed operations are laparoscopic adjustable gastric banding ('BAND surgery'), laparoscopic gastric bypass ('BYPASS') and laparoscopic sleeve gastrectomy ('SLEEVE'). All lead to weight loss, but they are associated with different problems. This study (BYBANDSLEEVE) is a randomised trial with a target recruitment of 1341 patients in twelve hospitals and its aim is to compare the effectiveness, cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery.

NCT ID: NCT02841449 Completed - Healthy Clinical Trials

The Effect of Hydration Status on Glycemic Control and Appetite Regulation

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

The aim of this study is to investigate whether hydration status affects blood sugar control and appetite regulation. In order to do this, participants will undergo a monitoring phase whereby their weight, diet and physical activity are monitored, followed by a dehydration protocol involving fluid restriction and sitting in a heat tent. In one arm of the trial, participants will remain dehydrated for the remainder of the day (i.e. after the heat tent) by having their fluid intake restricted, and in the other arm of the trial, participants will be rehydrated by consuming the necessary amount of plain water. All participants will undergo both arms of the trial, the order of which will be chosen randomly. Several measures will be taken throughout the trial. Before participants go into the heat tent, they will provide a urine sample (for baseline hydration status as indicated by urine osmolality), a blood sample (for glucose, insulin, arginine vasopressin,/copeptin, ghrelin and serum osmolality and plasma volume), and have a peripheral quantitative computer tomography scan of their thigh to indicate muscle size. On the day proceeding the heat tent, participants will have these measures repeated, along with metabolic rate before consuming a 75 g glucose drink, followed by 15 minutely blood samples and hourly metabolic rate measures for 120 minutes (i.e. an oral glucose tolerance test; OGTT). Following this, participants will be presented with a large bowl of pasta and sauce and will be instructed to eat until satisfied (maximum 30 min). Blood samples will be taken every 10 minutes for 60 minutes following the meal. Participants also have the option to opt-in to have a muscle biopsy taken. This will be taken before and ~120 minutes after the glucose drink.

NCT ID: NCT02841007 Completed - Clinical trials for Ankle Fracture Requiring Internal Fixation

Midds Ankle Fracture

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

The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to obtain data to support the powering of a larger study to demonstrate the effectiveness of the geko™ device at reducing length of stay for this population of patients. This study will also allow us to assess the acceptability, tolerability and compliance of treatment with the geko device.

NCT ID: NCT02840318 Completed - Dementia Clinical Trials

Compassion Pilot Intervention Study to Enhanced Integrated Care for People With Severe Memory Problems

Start date: February 2014
Phase: N/A
Study type: Interventional

The investigators developed the theory-driven 'Compassion Intervention', an integrated, interdisciplinary approach to address existing gaps in end-of-life care for people with advanced dementia. The Intervention consists of two core components: facilitation of an integrated, multi-disciplinary approach to assessment, treatment and care; and education, training and support for formal and informal carers. The intervention is implemented by an Interdisciplinary Care Leader. The primary aim is to understand how the Intervention operates in two care homes (with nursing support) in two different health and social care economies; one in the Camden Commissioning Group and one in the Barnet Commissioning Group, both in London, UK. The secondary aim is to collect preliminary outcome data and estimate the cost of employing an Interdisciplinary Care Leader to inform further evaluative studies. The final aim is to check that the Intervention causes no harm to residents and their family carers.

NCT ID: NCT02837731 Completed - Sepsis Clinical Trials

Fluid Responsiveness Evaluation in Sepsis-associated Hypotension

FRESH
Start date: October 2016
Phase: N/A
Study type: Interventional

This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.

NCT ID: NCT02837094 Completed - Type 1 Diabetes Clinical Trials

Enhanced Epidermal Antigen Specific Immunotherapy Trial -1

EE-ASI-1
Start date: September 29, 2016
Phase: Phase 1
Study type: Interventional

The study is a two centre, open-label, uncontrolled single group phase 1A study of C19-A3 GNP peptide (10 μg peptide equivalent content) administered via Nanopass microneedles every 28 days for 8 weeks (3 doses), with follow-up for 6 weeks (14 weeks in total from first dose). Treatment will be given into the arm at a volume of 50ul. No blinding or randomisation will be performed. In keeping with standard phase 1 study designs, no placebo or control group is included as the primary aim is to establish whether there are any major unexpected safety issues in the use of this IMP for the first time in man. 8 subjects will be recruited at 2 centres: Cardiff, UK and Linköping, Sweden.

NCT ID: NCT02836496 Completed - Clinical trials for Hypereosinophilic Syndrome

Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)

Start date: March 7, 2017
Phase: Phase 3
Study type: Interventional

Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).

NCT ID: NCT02834780 Completed - Clinical trials for Hepatocellular Carcinoma

Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma

Start date: December 28, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.

NCT ID: NCT02834442 Completed - Healthy Clinical Trials

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects

Start date: July 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.