bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study
Authors: Quist Jonas S , Jensen Marie M , Clemmensen Kim K B , Pedersen Hanne , Bjerre Natasja , Størling Joachim , Blond Martin B , Wewer Albrechtsen Nicolai J , Holst Jens J , Torekov Signe S , Vistisen Dorte , Jørgensen Marit E , Panda Satchidananda , Brock Christina , Finlayson Graham , Færch Kristine 
Published: August 2020

IntroductionThe aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.Methods and analysisThe REStricted Eating Time (RESET) study is a randomised controlled parallel-group open-label trial. 100 women and men with (1) overweight (body mass index (BMI)≥25 kg/m2) and prediabetes (glycated haemoglobin 39–47 mmol/mol); or (2) obesity (BMI≥30 kg/m2) will be randomised to a control group (habitual living) or TRE (self-selected 10-hours eating window within the period from 06:00 to 20:00 in a 1:1 ratio. Testing is scheduled at baseline and after 6 weeks (mid-intervention), 3 months (post-intervention) and 6 months (follow-up). The primary outcome is change in body weight after 3 months of intervention. Secondary outcomes include changes in body composition; measures of glucose metabolism including glycaemic variability, hormones and metabolites; subjective and metabolic markers of appetite, food preferences and reward; dietary intake; physical activity, sleep, chronotype; gastric emptying, gastrointestinal transit time and motility; respiratory and glycolytic capacities; the plasma proteome and metabolome; blood pressure, resting heart rate and heart rate variability; and resting energy expenditure and substrate oxidation. Motivation and feasibility will be examined based on interviews at baseline and after 3 months. After the 3-month intervention, a 3-month follow-up period and subsequent testing are scheduled to assess maintenance and longer-term effects.Ethics and disseminationThe study has been approved by the Ethics Committee of the Capital Region of Denmark (H-18059188) and the Danish Data Protection Agency. The study will be conducted in accordance with the Declaration of Helsinki. Results from the study will address whether TRE is effective and feasible in improving health outcomes in individuals at risk of lifestyle-related diseases and can potentially inform the design of feasible health recommendations.Trial registration numberNCT03854656.
Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial
Authors: Mansfield Avril , Inness Elizabeth L , Danells Cynthia J , Jagroop David , Bhatt Tanvi , Huntley Andrew H 
Published: August 2020

IntroductionFalls risk poststroke is highest soon after discharge from rehabilitation. Reactive balance training (RBT) aims to improve control of reactions to prevent falling after a loss of balance. In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life. While increasing the dose of RBT does not appear to lead to additional benefit for healthy older adults, stroke survivors, who have more severely impaired balance control, may benefit from a higher RBT dose. Our long-term goal is to determine the optimal dose of RBT in people with subacute stroke. This assessor-blinded pilot randomised controlled trial aims to inform the design of a larger trial to address this long-term goal.Methods and analysisParticipants (n=36) will be attending out-patient stroke rehabilitation, and will be randomly allocated to one of three groups: one, three or six RBT sessions. RBT will replace a portion of participants’ regular physiotherapy so that the total physical rehabilitation time will be the same for the three groups. Balance and balance confidence will be assessed at: (1) study enrolment; (2) out-patient rehabilitation discharge; and (3) 6 months postdischarge. Participants will report falls and physical activity for 6 months postdischarge. Pilot data will be used to plan the larger trial (ie, sample size estimate using fall rates, and which groups should be included based on between-group trends in pre-to-post training effect sizes for reactive balance control measures). Pilot data will also be used to assess the feasibility of the larger trial (ie, based on the accrual rate, outcome completion rate and feasibility of prescribing specific training doses).Ethics and disseminationInstitutional research ethics approval has been received. Study participants will receive a lay summary of results. We will also publish our findings in a peer-reviewed journal.Trial registration numberNCT04219696; Pre results.
Efficacy and safety of high-dose Xueshuantong injection (lyophilised) in reducing the incidence of major adverse cardiovascular events in patients with unstable angina: a protocol of a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial based on dual antiplatelet therapy
Authors: Long Wenjie , Liao Huili , Huang Xi , Liu Qingqing , Tang Yaqing , Lu Liming , Liu Jianhong , Yuan Tianhui , Ling Yan , Hong Yu , Duan Jiao , Lin Weiji , Xian Shaoxiang , Yang Zhongqi 
Published: August 2020

IntroductionUnstable angina (UA), referred to as acute coronary syndrome (ACS), causes unexpected chest pain. Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS. However, no clinical trial has been performed in this field. This clinical trial aims to examine the efficacy and safety of XST.Methods and analysisThis is a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial. A total of 1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group. The efficacy assessment and major adverse cardiovascular events will be observed, and the frequency of angina attack, angina pectoris will be examined at the start and end of the run-in period. All adverse events will be recorded, regardless of the severity, to assess the safety of XST. The baseline characteristics of patients will be summarised and compared using the t test or non-parametric statistical test. Qualitative data will be analysed using the χ2 or Fisher exact tests, Cochran–Mantel–Hasenszel test and Wilcoxon test.Ethics and disseminationThis trial has been approved by the Research Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2017] 0021). Written informed consent will be obtained from all participants. The results of this trial will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registrationThis study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the ID ChiCTR1800015911.
Cohort profile: Norwegian youth study on child maltreatment (the UEVO study)
Authors: Hafstad Gertrud Sofie , Sætren Sjur Skjørshammer , Myhre Mia Cathrine , Bergerud-Wichstrøm Marianne , Augusti Else-Marie 
Published: August 2020

PurposeExposure to childhood maltreatment is not uncommon, and is linked to both short-term and long-term health problems. Population-based surveys for adolescent samples provide excellent opportunities for addressing the substantial burden of early-life adversities, because collecting information close in time to exposure may increase accuracy of assessment. Still few large studies have been conducted, following individuals through adolescence. Therefore, the UEVO cohort was created with the aim of investigating prevalence of child maltreatment throughout childhood and adolescence, and its effects on health and functioning in a long-term perspective in a representative sample of Norwegian adolescents.ParticipantsThe baseline for the cohort includes a representative sample of 9240 Norwegian adolescents (response rate 86.6%) aged 12–16 years, surveyed in January and February 2019. The cohort to be followed over time comprises the 5502 adolescents who agreed to be recontacted for subsequent data collection waves.Findings to dateThe overall prevalence figures from the first wave of measurement have been published in a comprehensive national report on child maltreatment in Norway.Future plansA second study wave will commence in 2021, including about half of the original cohort (longitudinal), as well as a new sample starting at age 12. For participants above age 16, original survey data will be connected to national registries (pending indvidual consent), enabling the study of real-life functioning within the areas of healthcare utilisation, school drop-out, work-force participation and prescription of medication.
Protocol for a scoping review of digital health for older adults with cancer and their families
Authors: Cheng Karis Kin-Fong , Siah Rosalind Chiew-Jiat , Ream Emma , Kanesvaran Ravindran , Armes Jo 
Published: August 2020

IntroductionThe potential for digital medicine and healthcare in geriatric oncology settings has received much attention. This scoping review will summarise the nature and extent of the existing literature that describes and examines digital health development, implementation, evaluation, outcome and experience for older adults with cancer, their families and their healthcare providers.Methods and analysisArksey and O'Malley’s six stages of scoping review methodology framework will be used. Searches will be conducted in Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase via OvidSP, Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus via EBSCO, Scopus and PsycINFO via OvidSP for published articles in peer-reviewed scientific journals from year 2000 onwards. In addition, we will screen databases for all prospectively registered trials. Research articles using quantitative or qualitative study design or reviews will be included if they describe or report the design, development or usability of digital health interventions in the treatment and care of patients 65 years of age or older with cancer and their families before, during and after cancer treatment. Grey literature will not be searched and included. Two investigators will independently perform the literature search, eligibility assessments and study selection. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram for the scoping reviews (PRISMA-ScR) will be used to delineate the search decision process. For included articles, the extracted results will be synthesised both quantitatively and qualitatively and reported under key conceptual categories of this scoping review. Research gaps and opportunities will be identified and summarised.Ethics and disseminationSince this review will only include published data, ethics approval will not be sought. The results of the review will be published in peer-reviewed scientific journals. We will also engage with relevant stakeholders within research team’s networks to determine suitable approaches for dissemination.
‘There were some clues’: a qualitative study of heuristics used by parents of adolescents to make credibility judgements of online health news articles citing research
Authors: Maggio Lauren A , Krakow Melinda , Moorhead Laura L 
Published: August 2020

ObjectiveTo identify how parents judge the credibility of online health news stories with links to scientific research.DesignThis qualitative study interviewed parents who read online stories about e-cigarettes and human papillomavirus (HPV) vaccination published by top-tier US news organisations. Researchers asked participants to describe elements of a story that influenced their judgement about content credibility. Researchers analysed transcripts using inductive and deductive techniques. Deductive analysis drew on cognitive heuristics previously identified as being used by the public to judge online health information. Inductive analysis allowed the emergence of new heuristics, especially relating to health.SettingThe US National Cancer Institute’s Audience Research Lab in Maryland, in August–November 2018.ParticipantsSixty-four parents with at least one child between the ages of 9 and 17 residing in Maryland, Virginia, or the District of Columbia participated. Researchers randomly assigned 31 parents to the HPV vaccination story and 33 to the e-cigarette story.ResultsEvidence of existing heuristics, including reputation, endorsement, consistency, self-confirmation, expectancy violation and persuasive intent emerged from the interviews, with participants deeming stories credible when mentioning physicians (reputation heuristic) and/or consistent with information provided by personal physicians (consistency heuristic). Participants also described making credibility judgements based on presence of statistics, links to scientific research and their general feelings about news media. In relation to presence of statistics and links, participants reported these elements increased the credibility of the news story, whereas their feelings about the news media decreased their credibility judgement.ConclusionsParents used a constellation of heuristics to judge the credibility of online health news stories. Previously identified heuristics for online health information are also applicable in the context of health news stories. The findings have implications for initiatives in education, health communication and journalism directed towards increasing the public’s engagement with health news and their credibility judgements.
Effectiveness of mass testing for control of COVID-19: a systematic review protocol
Authors: Lopes-Júnior Luís Carlos , Bomfim Emiliana , Silveira Denise Sayuri Calheiros da , Pessanha Raphael Manhães , Schuab Sara Isabel Pimentel Carvalho , Lima Regina Aparecida Garcia 
Published: August 2020

IntroductionSince March 2020, when the COVID-19 outbreak has been deemed a pandemic by the WHO, the SARS-CoV-2 spreading has been the focus of attention of scientists, authorities, public health agencies and communities around the world. One of the great concerns and challenges, mainly in low-income and middle-income countries, is the identification and monitoring of COVID-19 cases. The large-scale availability of testing is a fundamental aspect of COVID-19 control, but it is currently the biggest challenge faced by many countries around the world. We aimed to synthesise and critically evaluate the scientific evidence on the influence of the testing capacity for symptomatic individuals in the control of COVID-19.Methods and analysisA systematic review will be conducted in eight databases, such as Medical Literature Analysis and Retrieval System Online, ISI-of-Knowledge, Cochrane Central Register of Controlled Trials, Embase, SCOPUS, Latin American and Caribbean Health Sciences Literature, PsycINFO and Chinese National Knowledge Infrastructure, from inception to 30 July 2020. No restriction regarding the language, publication date or setting will be employed. Primary outcomes will include the sensitivity as well as the specificity of the tests for COVID-19. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Methodological assessment of the studies will be evaluated by the Cochrane Risk-of-Bias tool for randomised controlled trials, the MINORS for non-randomised studies and the Newcastle-Ottawa Scale for cohort or case–control studies. Findings will be structured according to the test type and target population characteristics and focused on the primary outcomes (sensitivity and specificity). Moreover, if sufficient data are available, a meta-analysis will be performed. Pooled standardised mean differences and 95% CIs will be calculated. Heterogeneity between the studies will be determined by I2statistics. Subgroup analyses will also be conducted. Publication bias will be assessed with funnel plots and Egger’s test. Heterogeneity will be explored by random effects analysis.Ethics and disseminationEthical approval is not required. The results will be disseminated widely via peer-reviewed publication and presentations at conferences related to this field.PROSPERO registration numberCRD42020182724.
Study protocol for a pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of standard and new antiepileptic drugs (SANAD-II)
Authors: Balabanova Silviya , Taylor Claire , Sills Graeme , Burnside Girvan , Plumpton Catrin , Smith Phil E M , Appleton Richard , Leach John Paul , Johnson Michael , Baker Gus , Pirmohamed Munir , Hughes Dyfrig A , Williamson Paula R , Tudur-Smith Catrin , Marson Anthony Guy 
Published: August 2020

IntroductionAntiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Over the past 20 years, a number of new drugs have been approved for National Health Service (NHS) use on the basis of information from short-term trials that demonstrate efficacy. These trials do not provide information about the longer term outcomes, which inform treatment policy. This trial will assess the long-term clinical and cost-effectiveness of the newer treatment levetiracetam and zonisamide.Methods and analysisThis is a phase IV, multicentre, open-label, randomised, controlled clinical trial comparing new and standard treatments for patients with newly diagnosed epilepsy. Arm A of the trial randomised 990 patients with focal epilepsy to standard AED lamotrigine or new AED levetiracetam or zonisamide. Arm B randomised 520 patients with generalised epilepsy to standard AED sodium valproate or new AED levetiracetam. Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics. Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs. Patients are followed up for a minimum of 2 years. The primary outcome is time to 12-month remission from seizures. Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life. All primary analyses will be on an intention to treat basis. Separate analyses will be undertaken for each arm. Health economic analysis will be conducted from the perspective of the NHS to assess the cost-effectiveness of each AED.Ethics and disseminationThis trial has been approved by the North West-Liverpool East REC (Ref. 12/NW/0361). The trial team will disseminate the results through scientific meetings, peer-reviewed publications and patient and public involvement.Trial registration numbersEudraCT 2012-001884-64; ISRCTN30294119.
Development of a computerised neurocognitive battery for children and adolescents with HIV in Botswana: study design and protocol for the Ntemoga study
Authors: Scott J Cobb , Van Pelt Amelia E , Port Allison M , Njokweni Lucky , Gur Ruben C , Moore Tyler M , Phoi Onkemetse , Tshume Ontibile , Matshaba Mogomotsi , Ruparel Kosha , Chapman Jennifer , Lowenthal Elizabeth D 
Published: August 2020

IntroductionNeurodevelopmental delays and cognitive impairments are common in youth living with HIV. Unfortunately, in resource-limited settings, where HIV infection impacts millions of children, cognitive and neurodevelopmental disorders commonly go undetected because of a lack of appropriate assessment instruments and local expertise. Here, we present a protocol to culturally adapt and validate the Penn Computerized Neurocognitive Battery (PennCNB) and examine its validity for detecting both advanced and subtle neurodevelopmental problems among school-aged children affected by HIV in resource-limited settings.Methods and analysisThis is a prospective, observational cohort study. The venue for this study is Gaborone, Botswana, a resource-limited setting with high rates of perinatal exposure to HIV and limited neurocognitive assessment tools and expertise. We aim to validate the PennCNB in this setting by culturally adapting and then administering the adapted version of the battery to 200 HIV-infected, 200 HIV-exposed uninfected and 240 HIV-unexposed uninfected children. A series of analyses will be conducted to examine the reliability and construct validity of the PennCNB in these populations.Ethics and disseminationThis project received ethical approval from local and university Institutional Review Boards and involved extensive input from local stakeholders. If successful, the proposed tools will provide practical screening and streamlined, comprehensive assessments that could be implemented in resource-limited settings to identify children with cognitive deficits within programmes focused on the care and treatment of children affected by HIV. The utility of such assessments could also extend beyond children affected by HIV, increasing general access to paediatric cognitive assessments in resource-limited settings.
Prognosis in metastatic lung cancer: vitamin D deficiency and depression—a cross-sectional analysis
Authors: McFarland Daniel C , Fernbach Madalyn , Breitbart William S , Nelson Christian 
Published: August 2020

BackgroundDepression and vitamin D deficiency are common in patients with lung cancer and have prognostic implications in cancer settings. However, their relationship and concomitant survival implications have not been evaluated in patients with metastatic lung cancer specifically. We hypothesised that vitamin D deficiency would be associated with depression and inferior cancer-related survival in patients receiving therapies for stage IV lung cancer.MethodsThis was a cross-sectional analysis of vitamin D, depression and lung cancer characteristics. Vitamin D levels were stratified by level (no deficiency ≥30 units, mild deficiency 20 to 29 units and moderate-to-severe <20 units). Depression was measured by the Hospital Anxiety and Depression Scale-Depression (HADS-D). Survival estimations were made using Cox proportional hazard model and Kaplan-Meier analyses.ResultsVitamin D deficiency was evident in almost half of the sample (n=98) and was associated with significant depression (HADS-D ≥8) (χ2=4.35, p<0.001) even when controlling for age, sex and inflammation (β=-0.21, p=0.03). Vitamin D deficiency and depression were associated with worse survival and showed evidence of an interaction effect (HR 1.5, p=0.04).ConclusionVitamin D deficiency is associated with depression in patients with metastatic lung cancer. Depression modulates the survival implications of vitamin D deficiency in this population. The role of vitamin D deficiency in cancer-related depression warrants further investigation since both are amenable to treatment. Psychological and nutritional prognostic considerations may help inform treatment paradigms that enhance quality of life and survival.
Bounds on very weakly interacting ultra light scalar and pseudoscalar dark matter from quantum gravity
Authors: Calmet Xavier , Kuipers Folkert 
Published: August 2020

AbstractIn this paper we consider very weakly interacting and ultra light scalar and pseudoscalar dark matter candidates. We show that quantum gravity has important implications for such models and that the masses of the singlet scalar and pseudoscalar fields must be heavier than $$3\times 10^{-3}$$3×10-3 eV. However, if they are gauged, their masses could be much lighter and as light as $$10^{-22}\, \mathrm{eV}$$10-22eV. The existence of new gauge forces in the dark matter sector can thus be probed by atomic clocks or quantum sensors experiments.