bluuebunny/crossref_metadata_2025_split huggingface dataset:
The HARMONIC trial: study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds—a modular transdiagnostic intervention for mood, stressor-related and anxiety disorders in adults
Authors: Black Melissa , Hitchcock Caitlin , Bevan Anna , O Leary Cliodhna , Clarke James , Elliott Rachel , Watson Peter , LaFortune Louise , Rae Sarah , Gilbody Simon , Kuyken Willem , Johnston David , Newby Jill M , Dalgleish Tim 
Published: May 2020

IntroductionAnxiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The Healthy and Resilient Mind Programme: Building Blocks for Mental Wellbeing (HARMONIC) trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds (SHM)), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change.Methods/analysisWe outline a patient-level two-arm randomised controlled trial (HARMONIC) that comparesSHMto treatment-as-usual for individuals aged >18 years (n=50) with comorbid mood, anxiety, obsessive-compulsive or trauma/stressor disorders diagnoses, recruited from outpatient psychological services within the UK National Health Service (NHS). The co-primary outcomes will be 3-month follow-up scores on self-report measures of depressive symptoms, anxiety symptoms, and disability and functional impairment. Secondary outcomes include changes in symptoms linked to individual disorders. We will assess the feasibility and acceptability ofSHM, the utility of proposed outcome measures, and refine the treatment manuals in preparation for a later-phase trial.Ethics and disseminationThis trial protocol has been approved by the Health Research Authority of the NHS of the UK (East of England, Reference: 16/EE/0095). We anticipate that trial findings will inform future revisions of clinical guidelines for numerous forms of mood, anxiety and stressor-related disorders. Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, clinical workshops and a trial website.Trial registrationNCT03143634; Pre-results.
Barriers to accessing mental health services for women with perinatal mental illness: systematic review and meta-synthesis of qualitative studies in the UK
Authors: Sambrook Smith Megan , Lawrence Vanessa , Sadler Euan , Easter Abigail 
Published: May 2020

ObjectiveLack of access to mental health services during the perinatal period is a significant public health concern in the UK. Barriers to accessing services may occur at multiple points in the care pathway. However, no previous reviews have investigated multilevel system barriers or how they might interact to prevent women from accessing services. This review examines women, their family members’ and healthcare providers’ perspectives of barriers to accessing mental health services for women with perinatal mental illness in the UK.DesignA systematic review and meta-synthesis of qualitative studies.Data sourcesQualitative studies, published between January 2007 and September 2018, were identified in MEDLINE, PsycINFO, EMBASE and CINAHL electronic databases, handsearching of reference lists and citation tracking of included studies. Papers eligible for inclusion were conducted in the UK, used qualitative methods and were focused on women, family or healthcare providers working with/or at risk of perinatal mental health conditions. Quality assessment was conducted using the Critical Appraisal Skills Programme for qualitative studies.ResultsOf 9882 papers identified, 35 studies met the inclusion criteria. Reporting of emergent themes was informed by an existing multilevel conceptual model. Barriers to accessing mental health services for women with perinatal mental illness were identified at four levels: Individual (eg, stigma, poor awareness), organisational (eg, resource inadequacies, service fragmentation), sociocultural (eg, language/cultural barriers) and structural (eg, unclear policy) levels.ConclusionsComplex, interlinking, multilevel barriers to accessing mental health services for women with perinatal mental illness exist. To improve access to mental healthcare for women with perinatal mental illness multilevel strategies are recommended which address individual, organisational, sociocultural and structural-level barriers at different stages of the care pathway.PROSPERO registration numberCRD42017060389.
Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial
Authors: Wu Peixia , Cao Wenzhu , Hu Yan , Li Huawei 
Published: May 2020

IntroductionBenign paroxysmal positional vertigo (BPPV) is recognised as the leading cause of peripheral vertigo in adults. The canalith repositioning procedure (CRP) can be used for effective treatment of BPPV. However, some patients experience residual dizziness (RD) even after successful CRP, resulting in a significant negative impact on their daily function and quality of life. Exercise-based vestibular rehabilitation (VR) has been proven as an effective method for managing dizziness and has been applied in patients with various vestibular disorders. However, the efficacy of VR to specifically target RD post-BPPV is unknown. This study aims to investigate the efficacy of VR, compared with betahistine or VR plus betahistine treatment, in the treatment of patients experiencing RD after successful CRP.Methods and analysisA randomised single-blinded controlled trial will be carried out to determine the efficacy of VR compared with betahistine or VR plus betahistine treatment in mitigating RD and improving balance function. Patients with BPPV who experience RD after successful CRP will be recruited. Participants will be randomised into one of three groups to receive VR, betahistine or VR plus betahistine. There will be 61 participants in each group. The primary outcomes will be changes in the patient’s daily function as measured by the Vestibular Activities and Participation questionnaire and balance ability assessed by computerised dynamic posturography. The secondary outcomes will be dizziness-related handicap, otolith function and duration of RD symptoms. Outcome measures will be noted at baseline and at 2, 4 and 8 weeks post-randomisation. This study has the potential to reduce unnecessary anti-vertigo drug prescriptions and may lead to a general consensus regarding the use of VR as a first-line treatment for RD in patients with BPPV.Ethics and disseminationThis trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2017046). The study results will be disseminated via peer-reviewed journals and conferences.Trial registration numberNCT03624283; Pre-results.
Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching
Authors: Battersby Cheryl , Longford Nick , Patel Mehali , Selby Ella , Ojha Shalini , Dorling Jon , Gale Chris 
Published: May 2020

IntroductionTherapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia.Methods and analysisWe will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching.Ethics and disseminationIn this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby’s data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; results will be disseminated through conferences, scientific publications and parent-centred information produced in partnership with parents.Trial registration numberNCT03278847; pre-results,ISRCTN47404296; pre-results.
Surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: protocol for Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT 2)
Authors: Achten Juul , Sones William , Dias Joseph , Hedley Helen , Cook Jonathan A , Dritsaki Melina , Png May Ee , Gray Alastair , Lamb Sarah E , Costa Matthew L 
Published: May 2020

IntroductionOptimal management of distal radius fractures in adults remains controversial. Previous evidence and current clinical guidelines tell us that, if a closed reduction of a dorsally displaced fracture is possible, Kirschner wires (K-wires) are the preferred form of surgical fixation. However, the question remains whether there is any need to perform surgical fixation following a successful closed reduction, or is a simple plaster cast as effective? This is the protocol for a randomised controlled trial of manipulation and surgical fixation with K-wires versus manipulation and casting in the treatment of dorsally displaced distal radius fractures.Methods and analysisAdult patients with an acute dorsally displaced fracture of the distal radius are potentially eligible to take part. Prior to surgery, baseline demographic data, radiographs, data on pain/function using the Patient-Rated Wrist Evaluation Score (PRWE) and health-related quality of life (HRQoL) using the EuroQoL 5-dimension 5-level (EQ-5D-5L) will be collected. A randomisation sequence, stratified by centre, intra-articular extension of the fracture and age, will be administered via a secure web-based service. Each patient will be randomly allocated to either ‘manipulation and surgical fixation with K-wires’ or ‘manipulation and plaster casting’. A clinical assessment, radiographs and records of early complications will be recorded at 6 weeks. PRWE and HRQoL outcome data will be collected at 3, 6 and 12 months post-randomisation. Further information will be requested with regard to healthcare resource use and any complications.Ethics and DisseminationThe National Research Ethic Committee approved this study on 6 October 2016 (16/SC/0462).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury.Trial registration numberISRCTN11980540; Pre-results.
Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial
Authors: Veneva Elitsa , Cholakova Radka , Raycheva Ralitsa , Belcheva Ani 
Published: May 2020

IntroductionA current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients.Methods and analysisThe proposed study is a randomised controlled clinical trial with split-mouth design. Included are positive patients aged 8–12 years, requiring buccal infiltration for extraction of two bilateral primary maxillary molars. After dental fear measurement, eligible patients undergo two single-visit treatments with DV device allocated to either first or second LA via computer-generated randomisation sequence. Outcome measures will be self-reported pain felt during LA on Visual Analogue Scale; self-reported anxiety on Facial Image Scale; pain-related behaviour according to Faces, Legs, Activity, Cry, Consolability Scale; heart rate; patient preference to LA technique.Data will be analysed with intention-to-treat concept by Student’s t-test for paired samples, Wilcoxon signed-rank test, p<0.05. Pretest on 20 subjects resulted in n=41 patients sample size.Ethics and disseminationThis study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval No. 6/23.11.2017) and registered on a publicly accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria, under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants.Trial registration numberNCT03445182; Pre-results.
Study protocol for a randomised double-blinded, sham-controlled, prospective, cross-over clinical trial of vagal neuromodulation for pain treatment in patients with chronic pancreatitis
Authors: Muthulingam Janusiya Anajan , Olesen Søren Schou , Hansen Tine Maria , Brock Christina , Drewes Asbjørn Mohr , Frøkjær Jens Brøndum 
Published: May 2020

IntroductionThe management of chronic pancreatitis (CP) is challenging and requires a personalised approach focused on the individual patient’s main symptoms. Abdominal pain is the most prominent symptom in CP, where central pain mechanisms, including sensitisation and impaired pain modulation, often are involved. Recent clinical studies suggest that vagal nerve stimulation (VNS) induces analgesic effects through the modulation of central pain pathways. This study aims to investigate the effect of 2 weeks transcutaneous VNS (t-VNS) on clinical pain in patients with CP, in comparison to the effect of sham treatment.Methods and analysisTwenty-one patients with CP will be enrolled in this randomised, double-blinded, single-centre, sham-controlled, cross-over study. The study has two treatment periods: A 2-week active t-VNS using GammaCore device and a 2-week treatment with a sham device. During both treatment periods, the patients are instructed to self-administer VNS bilaterally to the cervical vagal area, three times per day. Treatment periods will be separated by 2 weeks. During the study period, patients will record their daily pain experience in a diary (primary clinical endpoint). In addition, all subjects will undergo testing which will include MRI, quantitative sensory testing, cardiac vagal tone assessment and collecting blood samples, before and after the two treatments to investigate mechanisms underlying VNS effects. The data will be analysed using the principle of intention to treat.Ethics and disseminationThe regional ethics committee has approved the study: N-20170023. Results of the trial will be submitted for publication in peer-reviewed journals.Trial registration numberThe study is registered at www.clinicaltrials.gov:NCT03357029.
Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions
Authors: Amiel Stephanie A , Choudhary Pratik , Jacob Peter , Smith Emma Lauretta , De Zoysa Nicole , Gonder-Frederick Linda , Kendall Mike , Heller Simon , Brooks Augustin , Toschi Elena , Kariyawasam Dulmini , Potts Laura , Healy Andy , Rogers Helen , Sevdalis Nick , Stadler Marietta , Qayyum Mustabshira , Bakolis Ioannis , Goldsmith Kimberley 
Published: May 2020

IntroductionSevere hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence.Methods and analysisA randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol.Ethics and disseminationThe protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups.Trial registration numberNCY02940873; Pre-results.
Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial
Authors: Li Wenqiang , Zhang Yisen , Tian Zhongbin , Zhu Wei , Liu Jian , Zhang Ying , Yang Xinjian , Tian De-Cai 
Published: May 2020

Background and purposeA large proportion of patients with unruptured intracranial aneurysm (IA) are not suitable for surgical clipping and endovascular treatment. For these patients, anti-inflammatory medications are worth exploring due to inflammation of aneurysmal wall being a major factor in higher risk of rupture. Statin has been proven to reduce inflammation of atherosclerosis and maybe a suitable candidate. This study aimed to evaluate whether atorvastatin will reduce inﬂammatory of the aneurysm wall measured by the signal index of aneurysm wall enhancement.Methods and analysisThe Statin Treatment for UnruptureD Intracranial anEurysms Study is a single-centre, phase 2, randomised, controlled, double-blind clinical trial. 60 patients with unruptured IAs with aneurysm wall enhancement will be enrolled in Beijing Tiantan Hospital. The patients will be randomised to receive atorvastatin 20 mg or placebo orally per day for 12 months. The primary outcome will be the change in aneurysm wall enhancement measured by the signal index during the 12 months treatment with atorvastatin. The secondary study outcomes will be the change in aneurysm wall enhancement measured by the signal index at 3 months, the changes in aneurysmal morphology and inflammation-related factors (C reactive protein, tumour necrosis factor-α, interleukin-1β and interleukin-6) at 3 and 12 months. This study is the first to explore the role of atorvastatin in reducing inflammation in unruptured IA, which could lay the groundwork for future phase III trial.Ethics and disseminationBeijing Tiantan Hospital’s Ethics committee approved the research and written informed consents would be obtained from all participant or representative included in this study.Trial registration numberNCT04149483
Dietary nitrate does not alter cardiac function, calcium handling proteins, or SERCA activity in the left ventricle of healthy rats
Authors: Kirsh Aleah J. , Juracic Emma S. , Petrick Heather L. , Monaco Cynthia M.F. , Barbeau Pierre-Andre , Tupling A. Russell , Holloway Graham P. 
Published: May 2020

Dietary nitrate has been shown to increase cytosolic calcium concentrations within the heart, which would necessitate greater calcium sequestration for relaxation. In the present study we demonstrate that while nitrate supplementation reduced blood pressure, calcium-handling protein content, sarco(endo)plasmic reticulum Ca-ATPase 2a (SERCA) enzymatic properties, and left ventricular function were not altered. In addition, nitrite did not alter in vitro SERCA activity. Combined, these data suggest that in healthy rats, dietary nitrate does not increase left ventricle SERCA-related calcium-handling properties. Novelty Dietary nitrate decreases blood pressure but does not alter left ventricular calcium-handling protein content or SERCA activity in healthy rats.