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NCT ID: NCT02736422 Completed - Healthy Volunteers Clinical Trials

Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers

Start date: July 2011
Phase: Phase 1
Study type: Interventional

Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI) provides novel regional functional images of the lungs. Over the past 14 years researchers at Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been developing and evaluating different MRI techniques to investigate different aspects of the lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these new methods in volunteers with healthy and diseased lungs. This proposed study is to further test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance imaging in the lungs and monitoring the transient changes in vital signs during and following the gas inhalation. This includes evaluation of pulse sequences to image xenon in the heart and brain as well as in the lungs of volunteers.

NCT ID: NCT02736396 Completed - Cognition Disorders Clinical Trials

Southend Imaging Study

SIS
Start date: June 2016
Phase:
Study type: Observational

The study objective is to correlate global cognition and episodic memory performance to resting state fMRI functional connectivity. This is a non-treatment, prospective, natural history data collection study in a cross-sectional cohort of patients with cognitive impairment.

NCT ID: NCT02735980 Completed - Clinical trials for Small Cell Lung Cancer

A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

Start date: May 11, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

NCT ID: NCT02735486 Completed - Clinical trials for Cardiovascular Disease

Acute Effects of Ginger Extract Consumption on Risk Markers of Cardiovascular Disease

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

The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.

NCT ID: NCT02735239 Completed - Esophageal Cancer Clinical Trials

Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer

Start date: June 24, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable OC. The immunotherapy will be given for a 4-week period before starting the standard chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2 (Cohorts B, C, C-FLOT, D/D2).

NCT ID: NCT02735044 Completed - Clinical trials for Type 1 Diabetes Mellitus

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

EDITION JUNIOR
Start date: April 14, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: - Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). - To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.

NCT ID: NCT02734849 Completed - Nasal Polyposis Clinical Trials

Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Start date: April 2016
Phase: Phase 2
Study type: Interventional

This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

NCT ID: NCT02733991 Completed - Type 1 Diabetes Clinical Trials

Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

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

A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study. The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.

NCT ID: NCT02733679 Completed - Clinical trials for Ataxia-Telangiectasia

Response of Individuals With Ataxia-Telangiectasia to Metformin and Pioglitazone

RAMP
Start date: September 29, 2016
Phase: Phase 4
Study type: Interventional

This study aims to investigate the link between the Ataxia Telangiectasia Mutated (ATM) gene and metformin response. This link has been identified from large studies of the human genome, and this study aims to confirm this link in a clinical study. The ATM gene is involved in DNA repair - if a person inherits a "faulty" copy of this gene from both their parents, they have a genetic condition called Ataxia-telangiectasia (A-T). A-T is associated with, among other things, a resistance to insulin, which causes fatty liver and diabetes. This study will recruit people who have A-T, but have not developed diabetes, and compare this group to "healthy" controls, i.e. people who do not have A-T or diabetes. The study will compare how the groups respond to two drugs used to treat diabetes (metformin and pioglitazone), with the intention that this will guide the management of diabetes in A-T. This is an, open label unblinded study recruiting 15 people with A-T and 15 age and gender matched controls. Each participant will have three study visits to the Clinical Research Centre at Ninewells hospital in Dundee - one at baseline, a second after 8 weeks of metformin and the final visit after eight weeks of pioglitazone. During each visit we will carry out a number of investigations to study the insulin resistance of A-T and how it responds to metformin and pioglitazone.

NCT ID: NCT02733575 Completed - Psychosis Clinical Trials

Compassion Focused Therapy for Distressing Experiences

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

This study aims to develop and test the feasibility of a new therapy called Compassion Focused Therapy (CFT) for psychosis. This therapy helps people with psychosis manage distressing experiences by building internal feelings of safeness and affiliation, and by providing contexts, practices and insights that facilitate the development of compassion to self and others. The focus is on helping people feel safe in relation to their experiences and their social worlds. CFT is a promising new approach that has been successfully provided for people with a range of mental health difficulties. It is also firmly based in the most up-to-date knowledge and science about how the mind works (both normally and under stress). 9 participants will be recruited from NHS psychological therapies services for people with psychosis in South London and Maudsley (SLAM) NHS Foundation Trust. Following a short baseline period they will receive up to 26 weekly sessions (about 6 months) of CFT with a clinical psychologist, and will provide interview and questionnaire research data at five different points during the study. At these assessment points, data will be gathered on participants' experiences, mood, perceptions of their position in the social world, and heart rate variability. The initial therapy protocol has been developed by psychologists with expertise in CFT, alongside people with lived experience of hearing voices and having distressing beliefs. However, it will continue to be developed and evolve as the study progresses, and as more is learnt (e.g. from the service-user participants) about applying the model in this population. At the end of this study, the aim is to have all the information needed to run a randomised controlled trial of this therapy.