bluuebunny/crossref_metadata_2025_split huggingface dataset:
Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial
Authors: Rimmer James H , Mehta Tapan , Wilroy Jereme , Lai Byron , Young Hui-Ju , Kim Yumi , Pekmezi Dorothy , Thirumalai Mohanraj 
Published: April 2023

IntroductionRates of physical inactivity among people with physical disabilities are substantially higher than in the general population and access to home-based tailored exercise programmes is almost non-existent. Using a theory-driven eHealth platform, an innovative exercise programme referred to as movement-to-music (M2M) will be delivered as a customised, home-based exercise intervention for adults with mobility disabilities.Methods and analysisParticipants are being recruited for this type 1 hybrid design based effectiveness trial through outpatient clinics at a large rehabilitation centre and randomised to one of three groups: (1) M2M, (2) M2M plus social networking (M2Mplus) and (3) attention control (AC). The intervention includes a 12-week adoption phase, 12-week transition phase and 24-week maintenance phase, at which the collection of objective measures on exercise, fitness and self-reported measures on health will be obtained at the start of each phase and at follow-up. The study compares the effectiveness of M2M and M2Mplusin increasing physical activity (primary outcome), adherence, fitness and physical functioning compared with the AC group and examines the mediators and moderators of the treatment effect.Ethics and disseminationThe Institutional Review Board of The University of Alabama at Birmingham granted full approval: (IRB-160923002). Dissemination of findings will include publication in peer-reviewed journals, presentations at regional, national and/or international meetings, and the National Center on Health, Physical Activity and Disability (NCHPAD,www.nchpad.org). This study will strengthen our understanding of the potential benefits of eHealth exercise interventions for people with physical disabilities and build on strategies that aim to recruit larger samples in exercise trials.Trial registration numberNCT03024320; Pre-results.
Heart failure with preserved ejection fraction (HFpEF) pathophysiology study (IDENTIFY-HF): does increased arterial stiffness associate with HFpEF, in addition to ageing and vascular effects of comorbidities? Rationale and design
Authors: Ali Danish , Callan Nualla , Ennis Stuart , Powell Richard , McGuire Scott , McGregor Gordon , Weickert Martin O , Miller Michelle A , Cappuccio Francesco P , Banerjee Prithwish 
Published: April 2023

AimsThere has been a paradigm shift proposing that comorbidities are a major contributor towards the heart failure with preserved ejection fraction (HFpEF) syndrome. Furthermore, HFpEF patients have abnormal macrovascular and microvascular function, which may significantly contribute towards altered ventricular-vascular coupling in these patients. The IDENTIFY-HF study will investigate whether gradually increased arterial stiffness (in addition to ageing) as a result of increasing common comorbidities, such as hypertension and diabetes, is associated with HFpEF.Methods and analysisIn our observational study, arterial compliance and microvascular function will be assessed in five groups (Groups A to E) of age, sex and body mass index matched subjects (age ≥70 years in all groups):Group A; normal healthy volunteers without major comorbidities such as hypertension and diabetes mellitus (control). Group B; patients with hypertension without diabetes mellitus or heart failure (HF). Group C; patients with hypertension and diabetes mellitus without HF. Group D; patients with HFpEF. Group E; patients with heart failure and reduced ejection fraction (parallel group). Vascular function and arterial compliance will be assessed using pulse wave velocity, as the primary outcome measure. Further outcome measures include cutaneous laser Doppler flowmetry as a measure of endothelial function, transthoracic echocardiography and exercise tolerance measures. Biomarkers include NT-proBNP, high-sensitivity troponin T, as well as serum galectin-3 as a marker of fibrosis.Ethics and disseminationThe study was approved by the regional research ethics committee (REC), West Midland and Black Country 17/WM/0039, UK, and permission to conduct the study in the hospital was also obtained from the RDI, UHCW NHS Trust. The results will be published in peer-reviewed journals and presented in local, national and international medical society meetings.Trial registration numberNCT03186833
Evaluation of the ‘Colli-Pee’, a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium
Authors: De Baetselier Irith , Smet Hilde , Abdellati Said , De Deken Bénédicte , Cuylaerts Vicky , Reyniers Thijs , Vuylsteke Bea , Crucitti Tania 
Published: April 2023

ObjectivesPre-exposure prophylaxis (PrEP) users are screened bi-annual for sexually transmitted infections (STIs). A novel device, called the Colli-Pee, collects first-void urine in a standardised way and the collector tube can be easily delivered by regular post to a certified laboratory. The aim of the study was a one-to-one comparison between the STI test results obtained with the urine collected in the clinic, versus urine collected at home in a real-life setting by Men who have Sex with Men (MSM) in Belgium. The user-friendliness and acceptability of the Colli-Pee device by the users was also evaluated.DesignA single-site nested substudy in a prospective PrEP demonstration project (Be-PrEP-ared) among MSM in Belgium.ParticipantsA total of 473 home-based samples from 213 MSM were received with a mean age of 38.5 years.InterventionsParticipants were requested to collect a urine sample at home using the Colli-Pee device and to send it to the laboratory via regular mail.Primary and secondary outcome measuresThe presence ofChlamydia trachomatis(CT), Neisseria gonorrhoeae(NG), Mycoplasma genitalium(MG) andTrichomonas vaginalis(TV) was determined using molecular amplification assays. Agreement between test results of samples collected at the clinic and collected at home were evaluated using Cohen’s kappa statistic.Results: TV was not detected. A very good to almost perfect agreement was found for CT, NG and MG of κ=0.75, 0.87 and 0.85, respectively. Using the Colli-Pee device only one low positive CT and two MG infections were missed, however, three additional CT, two NG and six MG infections were detected.ConclusionsThe Colli-Pee device is a feasible and convenient way to collect urine at home for STI testing. This may be particularly relevant for populations that need frequent STI testing, such as PrEP users and patients who prefer home-sampling.Trial registration numberNCT02552914; Pre-results.
Evaluation of a personalised adherence intervention to improve photoprotection in adults with Xeroderma Pigmentosum (XP): protocol for the trial of XPAND
Authors: Walburn Jessica , Norton Sam , Sarkany Robert , Sainsbury Kirby , Araújo-Soares Vera , Morgan Myfanwy , Canfield Martha , Foster Lesley , Heydenreich Jakob , McCrone Paul , Mander Adrian , Sniehotta Falko F , Wulf Hans Christian , Weinman John 
Published: April 2023

IntroductionPoor adherence to photoprotection for people with xeroderma pigmentosum (XP) can be life-threatening. A randomised controlled trial (RCT) is being conducted to test the efficacy of a personalised adherence intervention (XPAND) to reduce the level of ultraviolet radiation (UVR) reaching the face, by improving photoprotection activities in adults with XP.Methods and analysisA two-armed parallel groups RCT, where we randomised 24 patients with suboptimal adherence to either an intervention group who received XPAND in 2018 or a delayed intervention group who will receive XPAND in 2019. XPAND involves seven sessions, one-to-one with a facilitator, using behaviour change techniques and specially designed materials to target barriers to photoprotection. Following baseline assessment in April 2018 (t0) and intervention, the primary outcome will be measured across 21 consecutive days in June and July 2018 (t1). The primary outcome is the average daily UVR dose to the face (D-to-F), calculated by combining objective UVR exposure at the wrist (measured by a dosimeter) with face photoprotection activities recorded on a daily UVR protection diary. Secondary outcomes include average daily UVR D-to-F across 21 days in August (t2); psychosocial process variables measured by daily questions (t0, t1, t2) and self-report questionnaires (t0, t1, t2, December 2018 (t3)). Intervention cost-utility is assessed by service use and personal cost questionnaires (t0, t3). The delayed intervention control arm participants will complete three further assessments in April 2019 (t4) and June–July 2019 (t5), and December 2019 (t6) with dosimetry and UVR protection diary completed for 21 days at t4 and t5. A process evaluation will be conducted using mixed methods.Ethics and disseminationEthical approval has been received from West London & GTAC REC 17/LO/2110. Results will be disseminated in peer-reviewed journals and at conferences. This study tests a novel intervention, which, if successful, will be integrated into routine care.Trial registration numberNCT03445052
A Randomised Trial Examining Cardiovascular Morbidity and All-Cause Mortality 24 years Following General Health Checks: the Ebeltoft Health Promotion Project (EHPP)
Authors: Bernstorff Martin , Deichgræber Pia , Bruun Niels Henrik , Dalsgaard Else-Marie , Fenger-Grøn Morten , Lauritzen Torsten 
Published: April 2023

IntroductionGlobal prevalence of risk factors for cardiovascular disease (CVD) and all-cause mortality is increasing. Treatments are available but can only be implemented if individuals at risk are identified. General health checks have been suggested to facilitate this process.ObjectivesTo examine the long-term effect of population-based general health checks on CVD and all-cause mortality.Design and settingThe Ebeltoft Health Promotion Project (EHPP) is a parallel randomised controlled trial in a Danish primary care setting.ParticipantsThe EHPP enrolled individuals registered in the Civil Registration System as (1) inhabitants of Ebeltoft municipality, (2) registered with a general practitioner (GP) participating in the study and (3) aged 30–49 on 1 January 1991. A total of 3464 individuals were randomised as invitees (n=2000) or non-invitees (n=1464). Of the invitees, 493 declined. As an external control group, we included 1 511 498 Danes living outside the municipality of Ebeltoft.InterventionsInvitees were offered a general health check and, if test-results were abnormal, recommended a 15–45 min consultation with their GP. Non-invitees in Ebeltoft received a questionnaire at baseline and were offered a general health check at year 5. The external control group, that is, the remaining Danish population, received routine care only.Outcome measuresHRs for CVD and all-cause mortality.ResultsEvery individual randomised was analysed. When comparing invitees to non-invitees within the municipality of Ebeltoft, we found no significant effect of general health checks on CVD (HR=1.11 (0.88; 1.41)) or all-cause mortality (HR=0.93 (0.75; 1.16)). When comparing invitees to the remaining Danish population, we found similar results for CVD (adjusted HR=0.99 (0.86; 1.13)) and all-cause mortality (adjusted HR=0.96 (0.85; 1.09)).ConclusionWe found no effect of general health checks offered to the general population on CVD or all-cause mortality.Trial registration numberNCT001457822015-57-0002; 62908, 187.
STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis
Authors: Quraishi Mohammed Nabil , Yalchin Mehmet , Blackwell Clare , Segal Jonathan , Sharma Naveen , Hawkey Peter , McCune Victoria , Hart Ailsa L , Gaya Daniel , Ives Natalie J , Magill Laura , Loi Shrushma , Hewitt Catherine , Gerasimidis Konstantinos , Loman Nicholas James , Hansen Richard , McMullan Christel , Mathers Jonathan , Quince Christopher , Crees Nicola , Iqbal Tariq 
Published: April 2023

IntroductionImbalance of the gut microbiome is key to the pathogenesis of ulcerative colitis (UC). Faecal microbiota transplant (FMT) is the transfer of homogenised and filtered faeces from a healthy individual to the gastrointestinal tract of a patient with disease. Published datasets show a positive signal for the use of FMT to treat UC, but the optimal route and dose of FMT remain unanswered.Methods and analysisThis prospective, multi-centre open-label, randomised pilot study will assess two possible routes of FMT delivery, via the nasogastric (NG) route or by delivery to the COLON, in 30 patients with active UC recruited from three sites in the UK. Stool will be collected from healthy screened donors, processed, frozen and stored under a Medicines and Healthcare products Regulatory Agency (MHRA) “specials” manufacturing licence held at the University of Birmingham Microbiome Treatment Centre. Thawed FMT samples will be administered to patients either via eight nasogastric infusions given initially over 4 days starting on the day of randomisation, and then again for 4 days in week 4 for foregut delivery (total of 240 g of stool) or via one colonoscopic infusion followed by seven weekly enemas according to the hindgut protocol (total of 360 g of stool). Patients will be followed up weekly for 8 weeks, and then at 12 weeks. The aims of this pilot study are (1) to determine which FMT administration route (NG or COLON) should be investigated in a randomised double-blind, placebo-controlled trial and (2) to determine if a full randomised controlled trial is feasible. The primary outcome will be a composite assessment of both qualitative and quantitative data based on efficacy (clinical response), acceptability and safety. At the end of the pilot study, decisions will be made regarding the feasibility of a full randomised double-blind, placebo-controlled trial and, if deemed feasible, which route of administration should be used in such a study.Ethics and disseminationEthical approval for this study has been obtained from the East Midlands-Nottingham Research Ethics Committee (REC 17/EM/0274). At the end of the study, findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.Trial registration numberNCT74072945
Cerebral cortex and respiratory muscles perfusion during spontaneous breathing attempts in ventilated patients and its relation to weaning outcomes: a protocol for a prospective observational study
Authors: Louvaris Zafeiris , Van Hollebeke Marine , Dhaenens Alexander , Vanhemelen Maarten , Meersseman Philippe , Wauters Joost , Gosselink Rik , Wilmer Alexander , Langer Daniel , Hermans Greet 
Published: April 2023

IntroductionIn addition to the well-documented factors that contribute to weaning failure, increased energy demands of the respiratory muscles during spontaneous breathing trials (SBTs) might not be met by sufficient increases in energy supplies. This discrepancy may deprive blood and oxygen of other tissues. In this context, restrictions in perfusion of splanchnic organs and non-working muscles during SBT have been associated with weaning failure. However, alterations in perfusion of the brain during the weaning process are less well understood.Objective and hypothesisTo investigate whether cerebral cortex perfusion evolves differentially during the transition from mechanical ventilation (MV) to spontaneous breathing between patients failing or succeeding the SBT. We hypothesise that patients failing the SBT will exhibit reduced cerebral cortex perfusion during the transition from MV to spontaneous breathing as compared with patients succeeding the SBT.Methods and analysisThis single-centre, prospective, observational study will be conducted in a medical Intensive Care unit of University Hospital Leuven, Belgium in ready to wean patients. Blood flow index in the cerebral cortex (prefrontal area), inspiratory (scalene) and expiratory muscle (upper rectus abdominis) and a non-working muscle (thenar eminence) will be simultaneously assessed by near-infrared spectroscopy (NIRS) using the tracer indocyanine green dye. Measurements will be performed on the same day during MV and during SBT. NIRS-derived tissue oxygenation index and cardiac output (by pulse contour analyses) will be recorded continuously. Twenty patients failing an SBT are estimated to be sufficient for detecting a significant difference in the change of cerebral cortex perfusion from MV to SBT (primary outcome) between SBT failure and success patients.Ethics and disseminationEthics approval was obtained from the local ethical committee (Ethische Commissie Onderzoek UZ/KU Leuven protocol ID: S60516). Results from this study will be presented at scientific meetings and congresses and published in peer-reviewed journals.Trial registration numberNCT03240263.
Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness
Authors: Noyes Jane , Allen Davina , Carter Cynthia , Edwards Deborah , Edwards Rhiannon Tudor , Russell Daphne , Russell Ian T , Spencer Llinos Haf , Sylvestre Yvonne , Whitaker Rhiannon , Yeo Seow Tien , Gregory John W 
Published: April 2023

ObjectiveTo estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.DesignPragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.Setting11 diabetes clinics in England and Wales.ParticipantsBetween February 2010 and August 2011, we validly randomised 308 children aged 6–18 years; 201 received the intervention.InterventionWe designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment.Outcome measures at 3 and 6 monthsPrimary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.ResultsOf the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=−4.68; SE=1.74; 95%CI from −8.10 to −1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=−3.20; SE=1.33; 95% CI from −5.73 to −0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.ConclusionsStandardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes.Trial registration numberNCT17551624.
Protocol for a longitudinal, prospective cohort study investigating the biology of uterine fibroids and endometriosis, and patients’ quality of life: the FENOX study
Authors: Tapmeier Thomas Theodor , Nazri Hannah Mohamed , Subramaniam Kavita S , Manek Sanjiv , Garbutt Kurtis , Flint Emma J , Cheuk Cecilia , Hubbard Carol , Barrett Kelly , Shepherd Emily , Zondervan Krina T , Becker Christian Malte 
Published: April 2023

IntroductionMillions of women suffer from the consequences of endometriosis and uterine fibroids, with fibroids the cause for over 50% of hysterectomies in the USA, and direct costs for their treatment estimated at between US$4 and US$9 billion. Endometriosis commonly affects millions of women worldwide predominantly during reproductive age, with severe menstrual and non-menstrual pain and subfertility the main symptoms. Due to the ‘unhappy triad’ of endometriosis—lack of awareness, lack of clinically relevant biomarkers and the unspecific nature of symptoms—women wait on average for 8–12 years before the definitive endometriosis diagnosis is made. Treatment options for both conditions are not satisfactory at the moment, especially with a view to preserving fertility for the women and families affected. In the Fibroids and Endometriosis Oxford (FENOX) study, we combine the investigation of fibroids and endometriosis, and plan to collect high-quality tissue samples and medical data of participants over a time frame of 5 years after surgical intervention.Methods and analysisBiological samples such as blood, saliva, urine, fat, peritoneal fluid and—if found—endometrial tissue or fibroids as well as detailed clinical and intraoperative data will be collected from women undergoing surgery and participating in the study after informed consent. We plan to recruit up to 1200 participants per disease arm (ie, endometriosis and uterine fibroids) over 5 years. Participants will fill in detailed and validated questionnaires on their medical history and quality of life, with follow-ups for 5 years. Enrolment started on 2 April 2018, and FENOX will close on 31 March 2028. We will analyse the biological samples using state-of-the-art molecular biology methods and correlate the findings with the medical records and questionnaire data.Ethics and disseminationThe findings will be published in high-ranking journals in the field and presented at national and international conferences.Trial registration numberNCT13560263.