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NCT ID: NCT03047785 Completed - Clinical trials for Myocardial Infarction

Is the Current Threshold for Diagnosis of "Abnormality", Including Non ST Elevation Myocardial Infarction, Using Raised Highly Sensitive Troponin Appropriate for a Hospital Population? The CHARIOT Study

CHARIOT
Start date: June 29, 2017
Phase:
Study type: Observational

Currently when defining the upper limit of normal (ULN) or 99th percentile of a troponin assay manufacturer's use a healthy population traditionally aged 18-40. The 99th percentile value is the recommended value to use when diagnosing patients with an acute myocardial infarction. With the advent of the new highly sensitive troponin assays it has become clear that many patients have a troponin level above the 99th percentile when they have not suffered a myocardial infarction. We believe part of the problem with interpreting the the troponin values for patients is that the 99th percentile value which determines the ULN has been derived from population that is very different to the hospital population of patients. This study aims to demonstrate what the 99th percentile is for the population of people who use the hospital services who are traditionally older and have more comorbidities when compared to the population traditionally used to define the 99th percentile of a troponin assay. An amendment was approved to follow-up patients' clinical outcomes at 1 year using NHS Digital data.

NCT ID: NCT03047382 Completed - Acute Kidney Injury Clinical Trials

Electronic Alerting Tool to Help Prevent Acute Kidney Injury

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

Around a third of patients who develop acute kidney injury (AKI) do so after a hospital admission (hospital-acquired - HA-AKI). The primary aim of the study is to prospectively test whether introducing a complex intervention (a 'care package' - comprising a clinical prediction rule incorporating an electronic alert which generates a checklist for patient management to relevant health professionals) can identify patients on admission to hospital who are at risk of developing HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to be put in place. The investigators will introduce the care package in one acute hospital and evaluate its effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a sister hospital within the same Trust (which will act as a control site). The investigators will extend evaluation for a further ten months to assess sustainability on the first site and introduce the package at the control hospital to assess generalisability. The primary aim is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI, management of patients already with AKI on admission to hospital (whose care may also benefit from the checklist) and a cost-effectiveness analysis.

NCT ID: NCT03046953 Completed - Clinical trials for T-Cell Lymphoma Relapsed

Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma

AVAIL-T
Start date: November 14, 2017
Phase: Phase 2
Study type: Interventional

The AVAIL-T trial is a trial to find out how effective avelumab is at treating patients with primary T-cell lymphoma that is refratory to or has relapsed following initial treatment.

NCT ID: NCT03046589 Completed - Clinical trials for Safety and Tolerability

DP13 SAD & MAD in Healthy Male Subjects

Start date: March 6, 2017
Phase: Phase 1
Study type: Interventional

Primary Objectives: 1. To determine the safety and tolerability of single and multiple oral doses of DP13 in healthy male subjects 2. To assess the pharmacodynamics of single and multiple ascending oral doses as well as dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects Secondary Objectives: 1. To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male subjects 2. To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male subjects

NCT ID: NCT03046069 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

FF/UMEC/VI Inhaler: Qualitative Analysis and Subject Preference Survey

Start date: February 20, 2017
Phase:
Study type: Observational

Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting), long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled corticosteroids (ICS). For subjects at higher risk of exacerbation, treatment with all these three classes of medication is recommended. This study aims to explore the potential utility of a device called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) inhaler containing all three groups of compound. This is a mixed methods study with a qualitative phase and a quantitative Discrete Choice Experiment (DCE) phase and will be conducted in four stages: qualitative concept elicitation, DCE development, DCE piloting and testing, and conduct of the DCE. The study will conducted in the United Kingdom (UK), United States (US) and Germany and approximately 573 subjects with COPD will be included.

NCT ID: NCT03046056 Completed - Clinical trials for Small Bowel Crohn's Disease

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

DIVERGENCE 1
Start date: April 11, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

NCT ID: NCT03045926 Completed - Clinical trials for Chronic Functional Diarrhea of Unknown Origin

Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea

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

The main purpose of this study is to assess the concentration of elemental impurities in blood and urine after chronic administration of Smecta® in subjects with chronic functional diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote composition will be investigated.

NCT ID: NCT03045887 Completed - Asthma Clinical Trials

Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2292767 in Healthy Participants Who Smoke Cigarettes

Start date: February 6, 2017
Phase: Phase 1
Study type: Interventional

This study is the first administration of GSK2292767 to humans. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat inhaled doses of GSK2292767 in healthy smokers. This study is intended to provide sufficient confidence in the safety of the molecule and preliminary information on target engagement to allow progression to further repeat dose and proof of mechanism studies. This is a two part, single site, randomized, double-blind (sponsor open), placebo controlled study. Part A will consist of two 3-period interlocking cohorts to evaluate the safety, tolerability and pharmacokinetics of ascending single doses of GSK2292767 administered as a dry powder inhalation. Part B is planned to follow Part A and progression will be based on an acceptable safety, tolerability and pharmacokinetic profiles. Subjects will receive repeat doses of GSK2292767 once daily for 14 days during Part B.

NCT ID: NCT03045523 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis

Start date: January 2017
Phase: Phase 2
Study type: Interventional

This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR mutation and a second gating (class III) mutation and on stable treatment with ivacaftor. Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.

NCT ID: NCT03044483 Completed - Microcirculation Clinical Trials

Establishing Normal Ranges of Microcirculatory Function as Determined by CytoCam-IDF Imaging

Start date: July 6, 2017
Phase:
Study type: Observational

When infection strikes, the body's immune system reacts by producing chemicals in the bloodstream and changes in white blood cells to attack the infecting organism (bacteria, viruses or other organisms) and prevent it spreading. This is termed the 'inflammatory response'. Though beneficial in fighting infection, this response can sometimes be excessive, causing harmful effects on body organs. This is termed the 'systemic inflammatory response syndrome' and when linked to infection is termed 'sepsis'. Previous research has shown that in patients who have sepsis, the small blood vessels supplying oxygen and nutrients to muscles and other organs (the microcirculation) become abnormal and do not function as they would in health. However, it is difficult to assess the function of microcirculation in clinical practice, and we want to find new, easier ways of doing so. The aim of this study is to test a new method for assessing the function of these small blood vessels, by directly visualising them using a highly sensitive microscope, the size of a pen, placed under the tongue. By understanding the flow of blood in these vessels in healthy individuals, we will gain a better understanding of how these vessels are affected in illness.