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NCT ID: NCT02416843 Completed - Inflammation Clinical Trials

Metabolic and Immune System Responses to a Mixed Meal

Start date: September 2011
Phase: N/A
Study type: Interventional

Overweight and obesity are major problems and their complications such as cardiovascular disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is accumulating evidence to support obesity being a chronic inflammatory disorder mediated in part by the expansion of adipose (fat) tissue. Knowledge of the role of adipose tissue itself has changed dramatically and it has emerged that in addition to storing energy as fats; adipose tissue secretes and responds to various chemical messengers in the body that are related to metabolism and inflammation. After a meal has been consumed, changes in metabolic (and some inflammatory) markers are seen in the blood, which may be influenced by metabolic and inflammatory changes occuring in the adipose tissue itself. The investigators therefore plan to investigate these changes in adipose tissue before and after a meal and compare them to changes occurring in the blood. They also plan to investigate whether these responses are different in people who are overweight compared to 'normal' weight. Participants will include males aged between 35-55 years who fit the criteria for inclusion. After taking some preliminary measurements and monitoring of normal daily activities, participants will attend one day of Laboratory testing in the Physiology Laboratories at the University of Bath. By investigating differences in metabolism and inflammation in adipose tissue and the circulation it is hoped that more will be learnt about the development of diseases associated with being overweight and ultimately help to develop more effective methods for prevention and treatment.

NCT ID: NCT02416453 Completed - Ebola Viral Disease Clinical Trials

A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults

Start date: June 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.

NCT ID: NCT02416375 Completed - Cystic Fibrosis Clinical Trials

Home Monitoring to Predict Exacerbation in Cystic Fibrosis

SmartCare
Start date: May 2015
Phase:
Study type: Observational

The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures.

NCT ID: NCT02415907 Completed - Healthy Clinical Trials

Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine

Start date: April 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.

NCT ID: NCT02415686 Completed - Epilepsy Clinical Trials

Cardiac Arrhythmias in Dravet Syndrome

Start date: June 2015
Phase:
Study type: Observational

SUMMARY Rationale: People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium channel mutation (SCN1A) not only alters cortical excitability but also increases the propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced arrhythmias in human DS subjects. Objective: To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of cardiac arrhythmias between DS subjects and subjects with other types of epilepsy. Study design: Observational study. Study population: Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥ 1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the EEG databases of the participating centres. Only those controls with two or more recorded seizures will be matched to the cases. Intervention: Main study parameters/endpoints: Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising discomfort. If this nevertheless may occur, the study can be terminated. This study provides specific tools to investigate the seizure-related heart rate response. Subjects may thus benefit from participation by identification of otherwise unknown arrhythmias. The rationale of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of sudden death) specifically applies to DS, a rare epileptic syndrome including minors and incapacitated persons. The investigators believe that the lack of risks, the potential diagnostic benefit, the minimal intervention with novel and wearable sensors and the possibility to terminate the study in case of discomfort, justifies the study in this patient group.

NCT ID: NCT02415400 Completed - Clinical trials for Acute Coronary Syndromes

A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

Start date: June 4, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

NCT ID: NCT02414958 Completed - Clinical trials for Diabetes Mellitus, Type 1

Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

Start date: June 30, 2015
Phase: Phase 3
Study type: Interventional

Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.

NCT ID: NCT02414854 Completed - Asthma Clinical Trials

Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

Start date: April 27, 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: - To evaluate the safety and tolerability of dupilumab. - To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. - To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

NCT ID: NCT02414139 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

Start date: June 11, 2015
Phase: Phase 2
Study type: Interventional

Study to evaluate the efficacy and safety of capmatinib as a single-agent treatment for subjects with advanced/metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC) who had wild-type epidermal growth factor receptor (EGFR wt) (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK)-negative rearrangement, and mesenchymal epithelial transition (MET) mutations leading to exon 14 deletion (referred to as MET mutation hereafter) and/or MET amplification.

NCT ID: NCT02414061 Completed - Healthy Clinical Trials

Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast

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

The purpose of this study is to investigate whether the addition of whey protein to a breakfast high in carbohydrate content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.