A randomised double-blind, placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment-resistant bipolar depression (the PAX-BD study).

Background: Options for 'treatment-resistant bipolar depression' (TRBD) are limited. Two small, short-term, trials of pramipexole suggest it might be an option.

Aims: To evaluate the clinical effectiveness and safety of pramipexole in the management of TRBD.

Trial of alginates in throat symptoms: protocol for a pragmatic, multicentre, placebo controlled, double blind, parallel, randomised controlled trial of liquid alginate (Gaviscon Advance) for the treatment of persistent throat symptoms.

Introduction: Persistent throat symptoms (PTS) are indicators for over 60 000 new patient referrals to NHS secondary care annually. PTS have been attributed to manifestation of gastro-oesophageal reflux disease (GORD) with the hypothesis that gastric refluxate damages and irritates the mucosa of the upper aerodigestive tract. Symptoms of PTS and GORD are commonly treated with proton pump inhibitors (PPIs) or alginates are often, incorrectly, advocated.

Exploring the Relationships Between Clinical Examination Findings, Subjective Reported Symptoms and Objective Nasal Patency Measures in Nasal Obstruction: A Baseline NAIROS Sub-Study Analysis.

Background: The role of objective nasal airflow measures using peak nasal inspiratory flow (PNIF) and rhinospirometry in supporting clinical examination findings when offering patients septoplasty remain undefined.

Objective: To explore the baseline relationships between clinical examination findings, subjective reported symptoms and objective nasal patency measures in nasal obstruction.

Methods: This is a sub-study of the NAIROS trial.

Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT.

Background: The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking.

Objective: The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum.

Promoting Alcohol Reduction in Non-Treatment Seeking parents (PAReNTS): a pilot feasibility cluster randomized controlled trial of brief alcohol interventions with parents in contact with child safeguarding services.

Many parents who come into contact with early help and children's social care services are risky drinkers. This study aimed to investigate the feasibility and acceptability of conducting a trial of brief alcohol interventions within this setting. We conducted a three-arm pilot feasibility cluster randomised controlled trial in the North-East of England.

Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial.

Objective: To assess the clinical effectiveness of septoplasty.

Design: Multicentre, randomised controlled trial.

Setting: 17 otolaryngology clinics in the UK's National Health Service.

Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trial.

Background: Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis.

Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study).

Background: Treatment Resistant Bipolar Depression (TRBD) is a major contributor to the burden of disease associated with Bipolar Disorder (BD). Treatment options for people experiencing bipolar depression are limited to three interventions listed by National Institute for Health and Care: lamotrigine, quetiapine and olanzapine, of which the latter two are often not well tolerated. The majority of depressed people with BD are therefore prescribed antidepressants despite limited efficacy.

Lansoprazole for persistent throat symptoms in secondary care: the TOPPITS RCT.

Background: Persistent throat symptoms are commonly attributed to 'laryngopharyngeal reflux'. Despite a limited evidence base, these symptoms are increasingly being treated in primary care with proton pump inhibitors.

Objective: To assess the value of proton pump inhibitor therapy in patients with persistent throat symptoms.

Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial.

Objective: To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms.

Design: Pragmatic, double blind, placebo controlled, randomised trial.

Setting: Eight ear, nose, and throat outpatient clinics, United Kingdom.

A pilot feasibility randomised controlled trial of two behaviour change interventions compared to usual care to reduce substance misuse in looked after children and care leavers aged 12-20 years: The SOLID study.

Background: Young people in state care, often due to abuse or neglect, have a four-fold increased risk of drug and alcohol use compared to their peers.

Aim: The SOLID study aimed to investigate the feasibility of a definitive randomised controlled trial, comparing two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol), and improve mental health, in young people in care.

Methods: We recruited young people in care aged 12-20 years, self-reporting substance use within the previous 12 months and residing in 1 of 6 participating local authority sites in the North East of England.

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction.

Background: Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited.

Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study.

Background: Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention.

Methods: Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care.

Randomised controlled trial of GM-CSF in critically ill patients with impaired neutrophil phagocytosis.

Background: Critically ill patients with impaired neutrophil phagocytosis have significantly increased risk of nosocomial infection. Granulocyte-macrophage colony-stimulating factor (GM-CSF) improves phagocytosis by neutrophils ex vivo. This study tested the hypothesis that GM-CSF improves neutrophil phagocytosis in critically ill patients in whom phagocytosis is known to be impaired.

Use of primary care and other healthcare services between age 85 and 90 years: longitudinal analysis of a single-year birth cohort, the Newcastle 85+ study.

Objective: To describe, using data from the Newcastle 85+ cohort study, the use of primary care and other healthcare services by 85-year-olds as they age.

Design: Longitudinal population-based cohort study.

Setting: Newcastle on Tyne and North Tyneside, UK.

An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

Background: Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective.

Objectives: To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids.

Supporting Looked After Children and Care Leavers In Decreasing Drugs, and alcohol (SOLID): protocol for a pilot feasibility randomised controlled trial of interventions to decrease risky substance use (drugs and alcohol) and improve mental health of looked after children and care leavers aged 12-20 years.

Background: Looked after children (LAC) and care leavers are young people who have been placed under the legal care of local authorities, in many instances due to a history of abuse and/or neglect. These young people have a significantly increased risk of substance use and mental disorder compared to their peers. The aim of the SOLID study is to assess the feasibility and acceptability of a definitive three-arm multi-centre randomised controlled trial (RCT) that compares the effectiveness of two interventions that aim to reduce risky drug and alcohol use and improve mental health among LAC aged 12 to 20 years with usual care.

Autologous tolerogenic dendritic cells for rheumatoid and inflammatory arthritis.

Objectives: To assess the safety of intra-articular (IA) autologous tolerogenic dendritic cells (tolDC) in patients with inflammatory arthritis and an inflamed knee; to assess the feasibility and acceptability of the approach and to assess potential effects on local and systemic disease activities.

Methods: An unblinded, randomised, controlled, dose escalation Phase I trial. TolDC were differentiated from CD14+ monocytes and loaded with autologous synovial fluid as a source of autoantigens.

TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial.

Background: Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely.

A comparison of health expectancies over two decades in England: results of the Cognitive Function and Ageing Study I and II.

Background: Whether rises in life expectancy are increases in good-quality years is of profound importance worldwide, with population ageing. We investigate how various health expectancies have changed in England between 1991 and 2011, with identical study design and methods in each decade.

Methods: Baseline data from the Cognitive Function and Ageing Studies in populations aged 65 years or older in three geographically defined centres in England (Cambridgeshire, Newcastle, and Nottingham) provided prevalence estimates for three health measures: self-perceived health (defined as excellent-good, fair, or poor); cognitive impairment (defined as moderate-severe, mild, or none, as assessed by Mini-Mental State Examination score); and disability in activities of daily living (defined as none, mild, or moderate-severe).

Comparison of socio-economic indicators explaining inequalities in Healthy Life Years at age 50 in Europe: 2005 and 2010.

Background: The first estimates of Healthy Life Years at age 50 (HLY50) across the EU25 countries in 2005 showed substantial variation in healthy ageing. We investigate whether factors contributing to HLY50 inequalities have changed between 2005 and 2010.

Methods: HLY50 for each country and year were calculated using Sullivan's method, applying the age-specific prevalence of activity limitation from the European Union Statistics on Income and Living Conditions (EU-SILC) survey to life tables.

Life expectancy with and without cognitive impairment in seven Latin American and Caribbean countries.

Background: The rising prevalence of cognitive impairment is an increasing challenge with the ageing of our populations but little is known about the burden in low- and middle- income Latin American and Caribbean countries (LAC) that are aging more rapidly than their developed counterparts. We examined life expectancies with cognitive impairment (CILE) and free of cognitive impairment (CIFLE) in seven developing LAC countries.

Methods: Data from The Survey on Health, Well-being and Ageing in LAC (N = 10,597) was utilised and cognitive status was assessed by the Mini-Mental State Examination (MMSE).