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NCT ID: NCT02714309 Completed - Obesity, Abdominal Clinical Trials

Metabolic and Appetite Responses to a Whey Protein Preload Following Prior Exercise in Overweight Males

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

Consuming whey protein may have beneficial effects on health, principally by having an impact on blood glucose metabolism, but also by affecting appetite. The purpose of this project is to investigate the effect of consuming whey protein preload prior to breakfast, following a bout of low/moderate intensity exercise (brisk walking), on glucose and lipids in the blood as well as on appetite. It is hypothesised that the consumption of whey protein before a meal after prior low/moderate intensity exercise may positively affect postprandial handling as well as appetite sensations and consequently reduce intake at a subsequent meal.

NCT ID: NCT02714218 Completed - Melanoma Clinical Trials

A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Start date: April 4, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

NCT ID: NCT02714088 Completed - Clinical trials for High-intensity Interval Training

The Effect of Novel High-intensity Interval Training on Physical Fitness in Older Adults

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

High-intensity interval training (HIT) has been demonstrated to be an effective strategy to improve markers of health and fitness across a wide range of healthy and clinical populations. Currently however, there is only limited evidence which has examined the effectiveness of HIT in older adults (>50 years). HIT is an appealing strategy in this group as it has the potential to impact both cardiorespiratory and muscular fitness, which both play an important role in maintaining functional fitness and quality of life in a time-efficient manner. Developing an understanding of novel strategies for delivering this type of exercise training may ultimately provide a viable alternative to traditional modes of exercise training for a broader range of participants. As such, the purpose of this study is to evaluate the effects of a novel, high-intensity interval training exercise protocol to improve physical fitness in adults aged over 50 years. This research also aims to evaluate if this type of training intervention is feasible in this population, through analysis of adherence and intervention fidelity.

NCT ID: NCT02713282 Completed - Schizophrenia Clinical Trials

A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

Start date: April 28, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

NCT ID: NCT02713243 Completed - Clinical trials for Primary Bile Acid Diarrhea

To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.

Start date: January 16, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid diarrhea and to assess its safety and tolerability profile in patients with primary bile acid diarrhea (pBAD) to guide decision-making regarding further clinical development in this indication.

NCT ID: NCT02713152 Completed - Open Angle Glaucoma Clinical Trials

Prevalence of Obstructive Sleep Apnoea in Glaucoma

POSAG
Start date: March 2016
Phase: N/A
Study type: Observational

This study aims to investigate a potential link between Obstructive Sleep Apnoea (OSA) and Open Angle Glaucoma (OAG); initially by determining whether the prevalence of OSA is higher in patients with OAG in comparison to people without glaucoma and if OSA is an independent risk factor for OAG. It will comprehensively phenotype glaucoma patients for variables that may be associated with both OSA and OAG.

NCT ID: NCT02713009 Completed - Obesity Clinical Trials

Impact of Maternal Body Weight on Vitamin D Status During Pregnancy

MO-VITD
Start date: November 2015
Phase: N/A
Study type: Interventional

Research shows high levels of vitamin D deficiency in pregnant women in Northern Ireland. Body composition is a determinant of vitamin D status. Vitamin D is a fat soluble vitamin and therefore may be hidden within the adipose/fat tissue in overweight/obese individuals. All pregnant and breastfeeding women are advised to take a daily supplement containing 10μg vitamin D. The investigators hypothesise that overweight/ obese pregnant women have a lower vitamin D status than their leaner counterparts at the start of pregnancy and may need a higher daily supplementation to achieve a sufficient status. The investigators propose a randomised supplementation study where pregnant women (n 240) from the Western Health and Social Care Trust Area will be invited to take part. Inclusion criteria: pregnant women first trimester, without current pregnancy related complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) > 18.5kg /m². Participants will be randomised to receive either 0μg (placebo) plus a multivitamin or 10μg vitamin D plus a multivitamin from 12 weeks gestation until delivery. The multivitamin already contains 10μg vitamin D; Therefore participants will be randomised to receive a total of 10μg or 20μg vitamin D. Blood samples (20mls) will be taken at 12, 28 and 36 weeks gestation. A sample of blood will be taken from the cord after delivery. Vitamin D status is the main outcome measurement. All blood samples will be analysed for vitamin D and other associated metabolites. Data will be collected on health and lifestyle, supplementation use and food intake. Body composition measurements will be recorded at each appointment and infant anthropometric measurements will be taken from the maternal notes after delivery. Findings from this research will be used to inform nutrition policy on appropriate vitamin D supplementation levels in pregnancy which may be dependent upon pre pregnancy BMI.

NCT ID: NCT02712983 Completed - Clinical trials for Non-cystic Fibrosis Bronchiectasis

Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

iBEST-1
Start date: February 8, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.

NCT ID: NCT02712632 Completed - Diabetes Clinical Trials

Genetics of Diabetes Audit and Research in Tayside and Scotland

GoDARTS
Start date: June 20, 2016
Phase:
Study type: Observational

The GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet the planned inclusion criteria. The study aims to investigate biomarkers associated with diabetes progression, therapeutic response, diabetes complications and related traits, and specifically to investigate mechanisms of action and response to metformin. The study will specifically target patients who have been diagnosed within the past 2 years and follow up will be by linkage to electronic health record data. Up to 6,000 patients will be recruited into the study over a period of 2-3 years with a primary aim to identify 1000 of these patients who should be suitable to be started on metformin therapy. Most patients will undergo a single screening visit lasting approximately 20 minutes conducted on an outpatient basis. Patients commenced on metformin therapy will need to attend a second clinic visit to be carried out between 4-6 months after initiation of metformin therapy. Up to 9 health boards will be approached regarding participating in the study, and it is estimated that between 4-6 diabetes patients will be recruited into the study each week, at each site. All screened patients will provide consent for data linkage and longitudinal follow up and their samples and data will be used to supplement the SHARE/SDRN bioresource. The collection into the resource will be managed by the co-ordinating centre study team based at the University of Dundee/NHS Tayside. The resource will be hosted by the Tayside Biorepository and access to samples and data will be managed by the Tayside Biorepository on behalf of the whole of Scotland.

NCT ID: NCT02712385 Completed - Clinical trials for Cerebrovascular Disorders

Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE)

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

BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI with TIA survivors often being left with considerable functional impairment. TIA and strokes share common risk factors with cardiovascular disease. Cardiac rehabilitation post-myocardial infarction has shown significant reductions in morbidity and mortality, with home-based programmes producing better adherence and similar outcomes to hospital-and community-based programmes. However, the value of rehabilitation programmes for stroke prevention following a TIA or minor stroke is unclear. AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients can be developed, using MRC guidelines for developing complex health service interventions, from an approved home-based cardiac rehabilitation programme (the 'Heart Manual') and to undertake feasibility and pilot studies of the novel programme. METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first TIA/mild stroke will be invited to participate. The novel home-based programme manual will be developed following systematic reviews of the literature and qualitative exploration with the target population, using focus groups. A feasibility study will initially be undertaken lasting 6 weeks and then developed into a pilot trial of 12 weeks duration. The feasibility will recruit to 3 different treatments: (1) standard care; (2) standard care plus the manual; (3) standard care, manual plus a pedometer. Whilst for the pilot study there will also be 3 arms but this will include: 1) control group; 2) manual and pedometer supported by telephone follow-up with a GP; 3) manual and pedometer supported by telephone follow-up with a stroke nurse. Interviews and focus groups will be employed to assess the interventions' acceptability. The intervention, 'The Healthy Brain Rehabilitation Manual' will be refined and modified at all stages of the research. CONCLUSIONS - The findings will inform the development of a novel secondary prevention programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients and of a trial to test its effectiveness and longer-term potential to improve outcomes for TIA/stroke patients.