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NCT ID: NCT03737617 Not yet recruiting - Bronchiectasis Clinical Trials

Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis

Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Bronchiectasis is a common chronic lung condition where patients have permanent airways damage leading to daily symptoms of cough, sputum production and recurrent respiratory tract infections. Preliminary studies in our research group have found a severe deficiency of the immune system as a rare cause of bronchiectasis (called immunoglobulin G subclass 2 deficiency) and occurs in about 1 in 20 bronchiectasis patients. The pilot work shows that these patients have more chest infections and their lung function deteriorates more rapidly. There are no trials to date to guide doctors to decide whether we should replace this deficiency from donated blood or not. The aim with treatment is to prevent disease progression and avoid the need for long term antibiotics. This trial will help us understand how this treatment works and its acceptability to patients. This study will help us decide whether investigators should pursue future formalised trials in many centres throughout the UK and how investigators should evaluate such a treatment. We are looking to recruit 20 patients to this study 10 of which will receive weekly replacement therapy and the remaining 10 will receive standard care.

NCT ID: NCT03736902 Not yet recruiting - Multiple Sclerosis Clinical Trials

Views on Physical Activity Following a Relapse in People With Multiple Sclerosis

Start date: November 13, 2018
Phase:
Study type: Observational

Multiple Sclerosis (MS) is the most common cause of neurological disability in young adults. Relapsing Remitting Multiple Sclerosis (RRMS) is the most frequent form of MS at the time of diagnosis characterised by relapses, followed by remission. Relapses can result in a sudden change in physical or cognitive symptoms, often impacting a person's ability to function with family, friends and work. The National Institute for Health and Care Excellence (NICE) Clinical Guidelines for MS recommend encouraging people with MS to exercise regularly but does not provide specific advice on whether exercise should be undertaken during a relapse. Despite the wealth of literature documenting the benefits of exercise for people with MS insufficient evidence exists about exercise during relapse. Research has improved our understanding of what helps people with MS to be physically active and difficulties people encounter but has not provided evidence for how this is affected by a relapse. The aim of this study is to understand the attitudes of people with MS to physical activity following relapse, including factors that help them to be active and barriers to physical activity. The information gathered will be useful to inform future research and guide the advice health professionals may offer. Fifteen adults with RRMS who have had a relapse in the preceding 3-4 months will be recruited if their Expanded Disability Status Scale (EDSS) is <7 (EDSS scale is used to quantify disability in MS and monitor changes in the level of disability over time) and they agree to being audio -recorded at interviews. The recruitment will take place at the weekly MS relapse clinic at a hospital in London, UK. Participants will be asked to complete two questionnaires (Patient Determined Disease Steps and the International Physical Activity Questionnaire), answer demographic questions and spend one hour being interviewed by a researcher. It is anticipated the recruitment and interviews be carried out by March 2019.

NCT ID: NCT03736551 Recruiting - Obesity Clinical Trials

Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study

MIX-UP
Start date: October 25, 2017
Phase: N/A
Study type: Interventional

This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology. Patients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day. The feasibility outcomes are: recruitment rate >50%; intervention retention rate at 6 months >60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint.

NCT ID: NCT03735537 Recruiting - Clinical trials for Osteogenesis Imperfecta

Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid

TOPaZ
Start date: November 1, 2016
Phase: Phase 4
Study type: Interventional

Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Recent evidence suggests that the bone anabolic agent teriparatide (TPTD) increases bone mineral density (BMD) and may have the potential to prevent fractures in OI. The purpose of the TOPaZ Trial is to investigate if a a two-year course of teriparatide (TPTD) followed by antiresorptive therapy with a single infusion of zoledronic acid (ZA) in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care Adult patients with a clinical diagnosis of OI who are willing and able to give informed consent and who do not have contraindications to the study medications will be recruited from participating sites. Participants will be randomised 1:1 to receive either standard care for the duration of the trial or TPTD for 24 months followed by a single infusion of ZA, or another antiresorptive agent in the event that ZA is contraindicated. Participants will attend recruiting centres for a Baseline/Screening visit, at 12 months, 24 months and at the end of the trial for formal study visits with telephone calls every 6 months from a site research nurse. Participants randomised to TPTD will also attend recruiting centre at regular intervals during the 24 month treatment period to collect new supplies of TPTD.

NCT ID: NCT03735186 Completed - Inflammation Clinical Trials

Exercise and Coronary Heart Disease Risk Markers in Male Smokers and Non-Smokers

Start date: August 4, 2017
Phase: N/A
Study type: Interventional

The present study will investigate the effect of acute exercise on fasting and postprandial risk markers for coronary heart disease (CHD) in healthy male cigarette smokers and non-smokers. Participants will complete two, 2-day trials in a random crossover design separated by an interval of at least 1 week. On day 1, participants will rest (control) or complete 60 minute of treadmill exercise at 60% of maximum oxygen uptake (exercise). On day 2, participants will rest and consume two high fat meals (breakfast and lunch) over an 8-h period during which 13 venous blood samples and nine blood pressure measurements will be taken at pre-determined intervals. It is hypothesised that men who smoke cigarettes will exhibit impaired fasting and postprandial metabolic risk markers compared to non-smokers, but a single bout of exercise will be equally, if not more, efficacious for improving the CHD risk factor profile in smokers than non-smokers.

NCT ID: NCT03735147 Recruiting - Influenza Vaccines Clinical Trials

Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children

FluSHED-2
Start date: October 23, 2018
Phase: Phase 4
Study type: Interventional

LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness (VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children will be dependent on virological and host factors. The virus factors include replicative fitness of individual strains and the susceptibility to inhibition by other replicating strains (ability to compete). Host factors which may influence this include pre-existing specific immunity as a result of prior infection or previous vaccination (with either LAIV or IIV), and innate immune factors including mucosal immunity. There is significant variability in shedding across viral subtypes in studies done to date, so there is a need to obtain local data in a small pilot observational study which will look in detail at virus shedding by sequential daily virus samples, something not possible on a larger scale. The data generated will inform future LAIV studies in the UK in terms of optimum time of sample collection for viral shedding studies, which are likely to be required on a regular basis, to supplement field studies of vaccine effectiveness. This study will enrol up to 30 children that will allow these factors to be assessed. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. All participants will have a baseline assessment of pre--existing influenza immunity (blood test, oral fluid collection and nasal swabs), followed by a single dose of LAIV. Parents will then be asked to take nasal swabs at home on days 1, 2, 3, 4, 5, 6, 7, 8, with further nasal swab, blood test and oral fluid collection in hospital 4 weeks later, in order to assess for immune responses to LAIV.

NCT ID: NCT03735056 Recruiting - Multiple Sclerosis Clinical Trials

The PrEliMS Feasibility Trial

PrEliMS
Start date: November 2018
Phase: N/A
Study type: Interventional

The PrEliMS study is a mixed-methods feasibility randomised controlled trial of a point of diagnosis intervention programme which aims to provide emotional support for newly diagnosed people with Multiple Sclerosis (MS). This feasibility study will enable us to plan for a definitive trial to evaluate the clinical and cost-effectiveness of this point of diagnosis intervention programme. The aim is to assess the feasibility of the trial procedures and intervention, and to evaluate the key feasibility parameters before proceeding to a definitive trial. Participants (N=60) will be randomised into three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support).

NCT ID: NCT03733899 Not yet recruiting - Visual Acuity Clinical Trials

An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort

Start date: October 31, 2018
Phase: N/A
Study type: Interventional

This is a controlled, randomized, subject-masked, 3x3 crossover, non-dispensing, contralateral study. Twenty subjects will be recruited based on their scores (with their habitual lenses) from the Contact Lens Dry Eye Questionnaire-8 and examined on four occasions.

NCT ID: NCT03733795 Recruiting - Clinical trials for Cerebral Blood Flow and Neonates During Acute Respiratory Failure

Cerebral Perfusion and Acute Respiratory Failure

Start date: November 2018
Phase:
Study type: Observational

The most common reason for admitting babies and infants to an intensive care unit is due to respiratory distress (breathing difficulties). At present there are a number of different treatments for respiratory distress. These include drug treatments; non-invasive ventilation, where oxygen is given at high pressure to push it through the baby's lungs: ventilation where the baby is put on a breathing machine; or Extracorporeal Membrane Oxygenation (ECMO). This works by taking the blood from the body via a tube (usually) in the baby's neck, redirecting through a machine that oxygenates the blood, then returning it to the baby through another tube. Currently we know little about how different treatments have a different impact on brain perfusion (how much oxygen the brain gets). Using specialist, noninvasive ultrasound and doppler techniques, we are proposing to monitor the effect of these treatments on the brain.

NCT ID: NCT03733665 Active, not recruiting - Heart Failure Clinical Trials

HES and NICOR Data Linkage for Cardiac Failure Population Analysis

Start date: November 6, 2018
Phase:
Study type: Observational [Patient Registry]

This study is a population-based, patient-level analysis of heart failure in England over a 5-year period using a dataset created by linking HES and NICOR databases. Our analyses will look into the re-occurrence of hospitalisation after the initial diagnosis of heart failure, the influence of population factors on risk of re-hospitalisation, and the resultant cost implications in an NHS environment.