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NCT ID: NCT02984280 Completed - Clinical trials for Cardiovascular Diseases

Specific Respiratory Infections as Triggers of Acute Medical Events

Start date: September 2016
Phase: N/A
Study type: Observational

This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics.

NCT ID: NCT02984072 Completed - Actinic Keratosis Clinical Trials

Menthol for PDT Pain Relief

MentholPDT
Start date: October 23, 2018
Phase: Phase 4
Study type: Interventional

Topical photodynamic therapy (PDT) is widely used to treat superficial non-melanoma skin cancer (NMSC) and dysplasia, notably actinic keratosis and may also be effective in a range of other dermatological conditions. A major limitation of PDT is pain during irradiation. A lack of knowledge of the mechanism of PDT-induced pain has limited the development of effective approaches for prevention or relief of this adverse effect. The investigators have investigated the possible efficacy of menthol for PDT pain ex vivo and will now study this in a clinical trial. This proposal describes the prospective randomised double blind, placebo controlled clinical trial that will be undertaken to investigate the use of topical menthol for PDT-induced pain relief in patients with actinic keratosis of the face and scalp who will be attending general dermatology and PDT outpatient clinics at Ninewells Hospital, Dundee.

NCT ID: NCT02983565 Completed - Respiration Failure Clinical Trials

Intelligent Oxygen Therapy During Sleep

Start date: October 2016
Phase: N/A
Study type: Interventional

Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia) especially during sleep which may be harmful. In order to overcome this, the investigators have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent intermittent hypoxia during sleep in patients already on long-term oxygen.

NCT ID: NCT02983045 Completed - Gastric Cancer Clinical Trials

A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors

PIVOT-02
Start date: December 19, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.

NCT ID: NCT02982525 Completed - Clinical trials for Cardiovascular Disease

Mussel Intake and Vitamin D Status in Humans

Mussel
Start date: November 28, 2016
Phase: N/A
Study type: Interventional

A significant proportion of the United Kingdom population have inadequate levels of vitamin D in their blood. Vitamin D is a fat-soluble vitamin that is essential for the growth and maintenance of healthy bones through increasing dietary calcium absorption within the body. A low vitamin D status has also been associated with other diseases such as osteoporosis, cancer (especially colorectal cancer), cardiovascular disease and type 1 diabetes. Our skin is able to synthesise vitamin D upon exposure to sunlight in summer. If exposure to sunlight is limited, then a dietary supply of vitamin D becomes essential. However, very few foods contain vitamin D. Among the best dietary sources of vitamin D are oily fish (including salmon, mackerel, herring and trout) and fish oils. Recently, the investigators found that certain shellfish, especially mussels, contain significant amounts of a metabolite of vitamin D, 25(OH)D3. Consumption of this metabolite, as a supplement, has already been shown to improve vitamin D status in humans. Whether consumption of mussels improves vitamin D status is unknown. In this study the investigators will be looking at whether consumption of 1, 2 or 3 portions of mussels per week for 12 weeks increases vitamin D status in healthy people.

NCT ID: NCT02982343 Completed - Clinical trials for Charcot-Marie-Tooth Disease, Type IA

BALTiC Study: A Feasibility Analysis of Home Based BALance Training in People With Charcot-Marie-Tooth Disease

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

Charcot Marie Tooth (CMT) is the most common inherited neuropathy. It affects the nerves of the hands and feet first, slowly progressing towards the centre of the body. It causes varying degrees of weakness and reduced feeling, usually affecting the feet and ankles first. High incidence of falls and knock on effects in quality of life are common. This is a lifelong condition which, though not life limiting, does not have a cure. Research into the effect of balance rehabilitation in people with CMT has been limited to traditional exercises, which do not address the complex nature of balance impairments in this condition. Multi-sensory rehabilitation has proved beneficial in improving balance in people with sensory neuropathy. Research shows that strengthening trunk muscles can improve balance in older people. Trunk and muscles close to it are largely unaffected in people with CMT, therefore these muscles could be strengthened in these patients. This study proposes to assess the feasibility of multi-sensory balance training, strength training with a focus on the trunk and muscles close to the trunk, and falls management education. This comprehensive approach is reflective of a clinical physiotherapy programme. Though a life-long condition, many people with CMT lead full lives. A home based programme is proposed to so that patients can fit it into their lives without having to travel for treatment. Therapists will use self-management principles within treatment. Measurements will be taken prior to and following treatment including physical measures, questionnaires and interviews. The physiotherapy interventions will be taught home and data collection will be at the National Hospital for Neurology and Neurosurgery, University College London Hospitals (UCLH).

NCT ID: NCT02982187 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Start date: December 30, 2016
Phase: Phase 4
Study type: Interventional

This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2 complete block design in subjects with chronic obstructive pulmonary disease (COPD) to assess the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler (DPI) (closed triple therapy) versus delivering triple therapy using two different types of DPI (open triple therapy). The primary objective of the study is to evaluate the proportion of COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the treatment sequences. At the end Visit 1, subjects will complete the inhaler preference questionnaire (PQ). There is no active treatment and subjects will continue to take their own prescribed COPD medication for the duration of the study. ELLIPTA and DISKUS are registered trademarks of the GSK group of companies; TURBUHALER is a registered trademark of AstraZeneca and HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.

NCT ID: NCT02982122 Completed - Clinical trials for Brain Injuries, Traumatic

CPPopt Guided Therapy: Assessment of Target Effectiveness

COGITATE
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains 25% and only 40% of patients survive without major handicap. Medical/surgical interventions aim to maintain adequate brain perfusion, which is critically dependent on cerebral perfusion pressure (CPP); calculated as the difference between mean arterial pressure (MAP) and intracranial pressure (ICP). Current guidelines aim for a CPP above 50 mmHg, based on population means. However, this 'one size fits all' approach is flawed, because the relation between CPP and brain perfusion varies between individuals. Further, this approach takes no account of autoregulation, a key protective mechanism that maintains cerebral perfusion despite CPP fluctuations. Autoregulation is variably preserved following TBI, and there are large between patient variances in the 'optimal' CPP (CPPopt) at which autoregulation operates best. Individual CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a certain time window. The investigators have shown that maintenance of CPP close to CPPopt is associated with improved outcomes. These data pose the hypothesis that optimisation of management in individuals may be achieved by using the zone of optimal autoregulation as a basis for defining individualised CPP targets. The investigators propose, together with collaborators in the CPPopt study group (Maastricht, Cambridge, Leuven and Aachen) to set up a pilot (multicenter) feasibility study to develop a protocol for a definitive outcome randomized controlled trial (RCT). This study aims to develop protocols for CPPopt guided critical care, and show that they maintain patients closer to their optimum perfusion levels than standard protocols which keep above a population CPP threshold of 60 mmHg. Hence, the main objective is to offer clinicians monitoring and therapy algorithms that achieve individualized optimal CPPopt targets and potentially improve TBI outcome.

NCT ID: NCT02981927 Completed - Clinical trials for Metabolic Responses to Inactivity

Bed Rest, Inactivity and Early Responses

BIER
Start date: January 2015
Phase: N/A
Study type: Interventional

To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet

NCT ID: NCT02981472 Completed - Thrombosis Clinical Trials

A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation

Start date: January 19, 2017
Phase: Phase 2
Study type: Interventional

To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.