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NCT ID: NCT02230969 Completed - Clinical trials for Relapsing Forms of Multiple Sclerosis

Plegridy Observational Program

POP
Start date: November 12, 2014
Phase:
Study type: Observational

The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

NCT ID: NCT02230800 Completed - Clinical trials for Long-term Adverse Effects of Radiotherapy for Pelvic Cancer

PPALM-Palm Oil and Pentoxifylline Against Late Morbidity

PPALM
Start date: November 25, 2014
Phase: Phase 2
Study type: Interventional

Side effects are common after treatment with radiotherapy for tumours in the pelvis and can affect the way the bowel and urinary system work as well as causing sexual difficulties, skin damage and bone problems. Problems in the bowel, bladder, sexual organs and skin mostly result from thickening of the tissues in response to radiotherapy, a process called "fibrosis". Fibrosis often worsens over time. There has been progress in treating bowel symptoms which usually are the worst problem after radiotherapy. However, even after receiving the best possible treatments, while many patients are better, they are often not cured of all their difficult problems. For some years, it has been hypothesised that if fibrosis could be treated then symptoms would improve. Recent research in laboratory animals has suggested that an effective treatment for radiation-induced fibrosis is combination therapy with a drug called Pentoxifylline together with a nutritional supplement containing gamma-tocotrienol (Tocovid SupraBio), a substance derived from palm oil. Both of these agents are simple to take and side effects are rare. This study will recruit volunteers who continue to have difficult side effects after previous radiotherapy to the pelvis despite receiving the best treatments available from a unique clinic at The Royal Marsden which has pioneered treatment for bowel problems after radiotherapy. Two out of every three volunteers who take part, will be randomly assigned to treatment with Pentoxifylline and Tocovid SupraBio, while one out of three will receive dummy pills. Neither the patients nor the staff assessing them will know which treatment they have been given. Volunteers take the active treatments or dummy tablets for a year and will be assessed regularly while on treatment and for a year afterwards. This study will show whether active treatment is more effective than dummy pills in improving the symptoms caused by radiation-induced fibrosis.

NCT ID: NCT02230774 Completed - Dehydration Clinical Trials

Hydration Amongst Nurses and Doctors Oncall

HANDsOn
Start date: March 2013
Phase: N/A
Study type: Observational

The main purpose of this study is to assess and compare the hydration status of medical and nursing staff and to investigate the relationship between the hydration status, cognitive function and serum cortisol (marker of stress). We hypothesise that a significant proportion of doctors and nurses will be dehydrated at the end of their working day. Some, as in other occupations, may be dehydrated at the start of their working day. This is likely to be associated with impairment in cognitive performance at the end of the working day compared to the beginning and expected to be more pronounced after a night shift. There may be less noticeable difference amongst nursing staff given the protected break time. Dehydration and associated impairment in cognition is of important clinical value as it can impact patient care. participants will be involved in the study for two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as 15 medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15 day and 15 night shifts from each group). Those that do not work both day and night shifts will participate for only one shift and a new participant will be recruited until target number of shifts is achieved.

NCT ID: NCT02230644 Completed - Surgery Clinical Trials

RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation

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

Over 4.6 million operations are undertaken each year in England alone. Of these, many patients experience psychological distress, which has negative implications for patient recovery. Indeed, psychological stress, in particular both trait and state anxiety, anger and distress, has been linked with slower wound healing (Broadbent et al., 2003) and more complicated post-operative recovery (Johnston and Wallace, 1990). However, pre-operative psychological interventions can have significant positive effects on components of of post-operative recovery (Navros et al., 2011; Weinman and Johnston, 1988). In particular, music has been studied in a series of randomised control trials as a way of reducing pre-surgical stress. Studies have shown the effects of music in reducing levels of stress hormones such as cortisol (Leardi et al., 2007) and reducing both heart rate and blood pressure, and have also found music to be more effective than benzodiazepine at reducing pre-surgical anxiety (Bringman et al., 2009). Chelsea and Westminster Hospital NHS Foundation Trust is a major surgical hospital, performing over 15,000 adult operations annually. Consequently, strategies to reduce patient anxiety and improve experience are amongst the hospital's priorities. A renovation of the Surgical Admissions Lounge is currently underway with plans to incorporate visual arts and music in waiting booths to relax and distract patients. When asked how relaxing they found the space, patients at Chelsea and Westminster Hospital involved in a public consultation rated the current unenhanced waiting area as 5.8/10, but 93% of patients said that relaxing music would help them feel less anxious. This project will test whether music and art in the SAL actively reduce adult patient stress compared to normal unenhanced waiting spaces, with a view to extending the arts interventions to other surgical waiting areas such as the day treatment centre if there are significant positive findings.

NCT ID: NCT02229851 Completed - Clinical trials for Adult Growth Hormone Deficiency

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

REAL 1
Start date: October 31, 2014
Phase: Phase 3
Study type: Interventional

This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

NCT ID: NCT02229500 Completed - Clinical trials for Optimum Propionate Delivery to the Large Intestine

Investigating Optimal Propionate Delivery to the Colon Using Stable Isotope Labeling

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

Obesity, with its associated co-morbidities, is a major public health challenge. It is estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is associated with increased risk of developing diabetes, cardiovascular disease, and certain cancers. The increasing epidemic of obesity has necessitated the study of the complex mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been shown to play an important role in regulating short-term food intake. Peripheral administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man. PYY, GLP-1 along with a host of other hormones are produced by the gut in response to nutrient availability in different regions of the gut and provide an exquisite mechanism of nutrient sensing in response to dietary intake. These hormones therefore represent potential targets in the development of novel anti-obesity treatments. A novel and attractive strategy to induce appetite regulation is the enrichment of foods with components that stimulate the release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free fatty acid receptors (FFAR) on colonic L cells. Of the SCFAs produced by colonic fermentation of dietary fibre, propionate has the highest affinity for FFAR 2. Furthermore, propionate is an end product of bacterial metabolism, and thus, unlike acetate, does not undergo conversion to other SCFAs. Increasing colonic propionate is therefore an attractive target for appetite modulation. We have developed a novel delivery system for delivering propionate to the right site in the colon and we now wish to optimise the delivery of propionate to the colon in man using stable isotope labelling methods.

NCT ID: NCT02229227 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus

Start date: November 21, 2014
Phase: Phase 3
Study type: Interventional

This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.

NCT ID: NCT02229019 Completed - Clinical trials for Volunteer Mealtime Assistants

The Southampton Mealtime Assistance Roll-out Trial

SMART
Start date: August 2014
Phase: N/A
Study type: Interventional

The Southampton Mealtime Assistance Study aims to determine whether it is feasible and acceptable to introduce trained volunteers as mealtime assistants in five different departments of one large hospital.

NCT ID: NCT02229006 Completed - Clinical trials for Abdominal Aortic Aneurysm

Sodium Fluoride Imaging of Abdominal Aortic Aneurysms

SoFIA3
Start date: September 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of abdominal aortic aneurysm expansion.

NCT ID: NCT02228460 Completed - Fabry Disease Clinical Trials

Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease

Start date: November 2014
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.