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NCT ID: NCT03301051 Completed - Influenza Clinical Trials

Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults

Start date: August 31, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 participants

NCT ID: NCT03300583 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Toward Self-management in ILD

Start date: June 1, 2018
Phase:
Study type: Observational

Treating and caring for people with long term conditions accounts for a substantial proportion of health care resources. Self-management is advocated as a mechanism that can empower service users with long term conditions to choose healthier options and also transform the relationship between service user and caregivers from one in which the former is a passive recipient of care to one in which they are an active partner in decision-making. Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often express concern about the lack of information on possible rehabilitation programmes and other services that could potentially improve self-management of the disease. In addition, there is a general perception about a lack of co-ordination between health care professionals especially in relation to referral to services for comprehensive management of the disease. Therefore, the needs of patients with ILD and their carers, and possible gaps in service provision need to be explored further. In this study, the investigators propose to explore the needs of ILD patients from all types of ILD and all stages of severity and to also involve carers and clinicians. The investigators will conduct three focus groups for patients and carers and six one-to-one interviews with clinicians to explore perceptions about service gaps and needs in two ILD centres in South and North London, UK. This study will provide valuable information to develop the building blocks of a self-management resource and will enable the investigators to make it specific to the different types of ILD.

NCT ID: NCT03300102 Completed - Cancer Clinical Trials

Acceptability and Feasibility Study of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools

Tumouroids
Start date: January 10, 2018
Phase:
Study type: Observational

In England, more than three hundred thousand people are diagnosed with cancer each year. The diagnostic and treatment pathways for multiple cancers have greatly developed over the past decade. However, novel treatments are expensive and currently discrimination between responders and non-responders is still suboptimal. There is a pressing need to develop tools that allow for better disease characterisation and stratification. Personalised medicine, whereby prevention, diagnosis, and treatment of diseases is aimed at the individual level, is a growing field. Predicting patient-specific treatment response is challenging as response depends not only on the characteristics of cancer cells but also on how these cells interact with their immediate surrounding environment and on how the tumour interacts with the host. A simplistic model is therefore insufficient to predict treatment response. Complex, patient-derived animal models have been used to this effect but are expensive, may take up to 6 months to provide clinically relevant answers, and pose ethical issues. In the past in vitro models lacked complexity as they were based solely on the two-dimensional (2D) growth of cancer cells. Nowadays the use of 3D tumour models has provided an extra level of complexity to in vitro studies. With these models it is possible to recreate tumour characteristics that were lost in 2D, such as cell-cell interaction between cancer cells and between cancer and stromal cells, cell-matrix interaction, or hypoxia. The investigators have developed a 3D complex tumour model - named tumouroid. Using this model, preliminary work has been undertaken which allows the growth of patient-derived tumouroids using primary cancer cells from patients. This personalised platform can be challenged by therapeutics used in clinical practice and response to treatment can be assessed via appropriate assays. The study goals are twofold: To assess patient acceptability to the use of patient derived tumour models for future decision-making, and To assess the feasibility of generating patient derived renal cancer tumouroids and using them as platforms to test drug response.

NCT ID: NCT03299972 Completed - Sarcopenia Clinical Trials

Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men

Start date: October 27, 2017
Phase: N/A
Study type: Interventional

The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on energy metabolism, markers of appetite, inflammation and hormonal response and body composition and strength and functional performance. Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13 per group). Participants will be randomised to either: a) control group, b) whey protein supplement group, c) resistance exercise + control group or d) resistance exercise + whey protein supplementation group.

NCT ID: NCT03298880 Completed - Vagal Bradycardia Clinical Trials

Testing of a Valsalva Assist Device (VAD) in Healthy Volunteers Performing a Valsalva Manoeuvre

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

A prototype for a Valsalva Assist Device (VAD), which provides resistance to exhalation, has been developed and is ready for testing in healthy volunteers. There is a need to ensure the device can deliver the required strain and evaluate the physiological response (lowered heart rate) when used to deliver a Valsalva manoeuvre (VM) with and without postural modification.

NCT ID: NCT03298776 Completed - Endoscopy Clinical Trials

I-Scan a Novel Endoscopic Tool for the Macroscopic Identification of Mucosal Lesions

Start date: September 26, 2013
Phase: N/A
Study type: Interventional

The use of endoscopy for the diagnosis of gastrointestinal diseases has continued to increase in recent years. Endoscopy provides an advantage over other noninvasive or minimally invasive procedures in that it allows both direct visualisation of the mucosa but direct and accurate sampling of abnormalities for histological examination. However standard endoscopy does have some limitations particularly with small lesions and pan mucosal changes. Some lesions may be entirely benign and require no further intervention but as a result of difficulty with accurate endoscopic characterization of lesions in many cases unnecessary biopsies or polypectomies are undertaken. Therefore any technology that can augment the use of standard endoscopy to minimise unnecessary intervention should be encouraged. IScan is a digital enhancement technique available with Pentax endoscopes. There have been other novel endoscopic advances for example, Narrow band imaging but these have not been adopted widely for a number of reasons including technical difficulties or patient tolerability. The aim of this study is to assess whether Pentax IScan technology is a reliable method of improving our recognition of macroscopic mucosal lesions compared to standard white light endoscopy

NCT ID: NCT03298061 Completed - Clinical trials for Churg-Strauss Syndrome

Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

Start date: April 14, 2015
Phase: Phase 3
Study type: Interventional

Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody, therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921 was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8 weeks to study completion at Week 60. This is a LAP to support provision of open-label mepolizumab on an individual basis to eligible subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under this LAP within a 6-month period starting from completion of study MEA115921 (that is, at Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will initiate mepolizumab at the time point that would have been Week 60 if the subject had completed the study. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject meets any of the withdrawal/stopping criteria.

NCT ID: NCT03295630 Completed - Critical Care Clinical Trials

Validity of an Actigraph Accelerometer Following Critical Illness

Start date: September 19, 2016
Phase: N/A
Study type: Interventional

This study will determine whether an Actigraph GT3X accelerometer can identify body position and quantify step count in a ward based population recovering from critical illness.

NCT ID: NCT03295071 Completed - Clinical trials for Leber Hereditary Optic Neuropathy

REALITY LHON Registry

REALITY
Start date: January 3, 2018
Phase:
Study type: Observational [Patient Registry]

This study is a multi-country retrospective and cross-sectional observational study of affected LHON subjects, based on retrospective subjects' medical chart abstractions and cross-sectional administration of patient-reported outcomes (PROs).

NCT ID: NCT03295032 Completed - Stroke Clinical Trials

A Mixed-methods Evaluation of an Adapted Acceptance and Commitment Therapy (ACT) Group for Stroke Survivors

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Stroke is one of the main causes of acquired adult disability in the UK. Many psychological problems can also occur post-stroke; this has a marked impact on health service usage. As such, there is an outstanding need to increase and improve psychological resources within stroke services. The investigators proposed to adapt and evaluate the effectiveness of an acceptance and commitment therapy (ACT) group intervention for adult stroke survivors and their carers. The group will endeavour to promote positive adjustment and reduce levels of depression and anxiety. This study will have two parts.