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NCT ID: NCT02942576 Completed - Atrial Fibrillation Clinical Trials

Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

ELIMINATE-AF
Start date: March 21, 2017
Phase: Phase 3
Study type: Interventional

There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

NCT ID: NCT02941991 Completed - Clinical trials for Stargardt's Macular Dystrophy

A Follow up Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt's Macular Dystrophy (SMD)

Start date: January 16, 2013
Phase:
Study type: Observational

The purpose of this study is to evaluate the long term safety and tolerability of hESC-RPE cellular therapy in patients with advanced SMD from 1 to 5 years following the surgical procedure to implant the hESC-RPE cells.

NCT ID: NCT02941926 Completed - Breast Cancer Clinical Trials

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

COMPLEEMENT-1
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

NCT ID: NCT02941822 Completed - Parkinson Disease Clinical Trials

Ambroxol in Disease Modification in Parkinson Disease

AiM-PD
Start date: December 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability and pharmacodynamics of ambroxol in participants with Parkinson Disease. Participants will administer ambroxol at five dose levels and will undergo clinical assessments, lumbar punctures, venepuncture, biomarker blood analysis and cognitive assessment throughout the course of the study.

NCT ID: NCT02941549 Completed - Clinical trials for Non Alcoholic Fatty Liver Disease

Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD

Start date: December 20, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered Epeleuton capsules versus placebo in the treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT02941237 Completed - Clinical trials for Pneumonia in Children

Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries

Start date: May 2, 2017
Phase: N/A
Study type: Interventional

This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.

NCT ID: NCT02940873 Completed - Clinical trials for Type 1 Diabetes Mellitus

Hypoglycaemia Awareness Restoration Programme

HARPdoc
Start date: March 9, 2017
Phase: N/A
Study type: Interventional

Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH), increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe hypoglycaemia reduced when people are taught how to adjust their insulin around their life-styles through structured education but problematic hypoglycaemia may persist. Many people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts about hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot benefit from conventional treatments to reduce hypoglycaemia. The investigators developed the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that combines revision of knowledge about hypoglycaemia avoidance with psychological therapies that directly address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over six weeks, by diabetes educators to groups of 6 people. In a pilot study, severe hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and recurrent severe hypoglycaemia. The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an established educational intervention (Blood Glucose Awareness Training, BGAT) which has also been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic hypoglycaemia persisting despite otherwise optimised insulin self-management will be recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4 centres. The investigators will measure severe hypoglycaemia over two years following courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.

NCT ID: NCT02940327 Completed - Clinical trials for Persistent Pulmonary Hypertension of the Newborn

Markers of Inflammation and Lung Recovery in ECMO Patients for PPHN

Mi-ECMO
Start date: February 19, 2016
Phase:
Study type: Observational

Respiratory failure in newborns is common and has high rates of death. Where conventional intensive care strategies have failed, newborn children are referred to treatment with Extra- Corporeal Membrane Oxygenation (ECMO). This involves connecting children via large bore cannulas placed in their heart and major blood vessels to an artificial lung that adds oxygen to their blood and removes waste gases (carbon dioxide). Although this treatment saves lives, it still has some limitations. In particular, severe complications like bleeding, or damage to the kidneys can occur. These complications can lead to death in some cases and long-term disability in others. Based on ongoing research in adults and children undergoing cardiac surgery the investigators have identified a new process that may underlie some of the complications observed in ECMO. The investigators have noted that when transfused blood is infused in an ECMO circuit, this results in the accelerated release of substances from the donor cells that cause organ damage; at least in adults. There are treatments that can reverse this process. Before the investigators explore whether these treatments should be used in newborn children on ECMO, the investigators must first demonstrate that they can measure the complex inflammatory processes that occur in these critically ill children. The investigators therefore propose to conduct a feasibility study to identify the practical issues and challenges that would need to be overcome in order to perform a successful trial in this high-risk population.

NCT ID: NCT02940249 Completed - Clinical trials for Prevention of Hyperglycaemia

Effects of an Apple Extract on Glycaemia: The GLU-Pomme Study

GLU-Pomme
Start date: January 2017
Phase: N/A
Study type: Interventional

Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Previous research by this group has shown that an apple polyphenol extract reduced hyperglycaemia following a high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.

NCT ID: NCT02940067 Completed - Pancreatic Cancer Clinical Trials

Enhancing Fitness Before Pancreatic Surgery

MedEx
Start date: March 28, 2017
Phase: N/A
Study type: Interventional

This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.