bluuebunny/crossref_metadata_2025_split huggingface dataset:
The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective heart failure study design
Authors: Yu Yuan , Zhang Hongzhao , Li Xi , Lu Yuan , Masoudi Frederick A , Krumholz Harlan M , Li Jing 
Published: April 2023

IntroductionHeart failure (HF) is a leading cause of hospitalisation in China, which is experiencing a rapid increase in cardiovascular disease prevalence. Yet, little is known about current burden of disease, quality of care and treatment outcomes of HF in China. The objective of this paper is to describe the study methodology, data collection and abstraction, and progress to date of the China Patient-centered Evaluative Assessment of Cardiac Events 5 Retrospective Heart Failure Study (China PEACE 5r-HF).Methods and analysisThe China PEACE 5r-HF Study will examine a nationally representative sample of more than 10 000 patient records hospitalised for HF in 2015 in China. The study is a retrospective cohort study. Patients have been selected using a two-stage sampling design stratified by economic–geographical regions. We will collect patient characteristics, diagnostic testing, treatments and in-hospital outcomes, including death and complications, and charges of hospitalisation. Data quality will be monitored by a central coordinating centre and will address case ascertainment, data abstraction and data management. As of October 2017, we have sampled 15 538 medical records from 189 hospitals, and have received 15 057 (96.9%) of these for data collection, and completed data abstraction and quality control on 7971.Ethics and disseminationThe Central Ethics Committee at the Chinese National Center for Cardiovascular Diseases approved the study. All collaborating hospitals accepted central ethics committee approval with the exception of 15 hospitals, which obtained local approval by internal ethics committees. Findings will be disseminated in future peer-reviewed papers and will serve as a foundation for improving the care for HF in China.Trial registration numberNCT02877914.
Study protocol for a randomised controlled trial examining the association between physical activity and sleep quality in children with autism spectrum disorder based on the melatonin-mediated mechanism model
Authors: Tse Andy C Y , Lee Paul H , Zhang Jihui , Lai Elvis W H 
Published: April 2023

IntroductionSleep disturbance is commonly observed in children with autism spectrum disorders (ASD). Disturbed sleep may exacerbate the core symptoms of ASD. Behavioural interventions and supplemental melatonin medication are traditionally used to improve sleep quality, but poor sustainability of behavioural intervention effects and use of other medications that metabolise melatonin may degrade the effectiveness of these interventions. However, several studies have suggested that physical activity may provide an effective intervention for treating sleep disturbance in typically developing children. Thus, we designed a study to examine whether such an intervention is also effective in children with ASD. We present a protocol (4 December 2017) for a jogging intervention with a parallel and two-group randomised controlled trial design using objective actigraphic assessment and 6-sulfatoxymelatonin measurement to determine whether a 12-week physical activity intervention elicits changes in sleep quality or melatonin levels.Methods and analysisAll eligible participants will be randomly allocated to either a jogging intervention group or a control group receiving standard care. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. All participants will also be instructed to collect a 24-hour urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin representative of the participant’s melatonin levels, will be measured from the sample. All assessments will be carried out before the intervention (T1), immediately after the 12-week intervention or regular treatment (T2), 6 weeks after the intervention (T3) and 12 weeks after the intervention (T4) to examine the sustainability of the intervention effects. The first enrolment began in February 2018.Ethics and disseminationEthical approval was obtained through the Human Research Ethics Committee, Education University of Hong Kong. The results of this trial will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03348982.
Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany
Authors: Krüger Klaus , Burmester Gerd R , Wassenberg Siegfried , Bohl-Bühler Martin , Thomas Matthias H 
Published: April 2023

ObjectiveThe Non Interventional Evaluation with Golumimab (GO-NICE) study aimed to document patient and treatment characteristics as well as clinical effectiveness and safety in adult patients newly treated with the tumour necrosis factor inhibitor golimumab (GLM).DesignProspective non-interventional study with 24-month observation per patient.Setting158 office-based and clinical-based physicians in Germany.InterventionGLM administered in the 50 mg dose subcutaneously in monthly intervals under real-life conditions.ResultsOf the 1613 included patients, 1458 patients were eligible for final analysis: 474 patients with rheumatoid arthritis (RA, 54.9±13.4 years, 72.8% women, 64.7% biologic-naïve), 501 with psoriatic arthritis (PsA, 50.5±12.1 years, 54.1% women, 56.5% biologic-naïve) and 483 with ankylosing spondylitis (AS, 43.6±12.3 years, 66.5% men, 61.0% biologic-naïve). 664 patients completed follow-up (2-year retention rate 45.5%). Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR) decreased from 5.0 to 2.9 after 24 months (p<0.0001) in patients with RA, and Bath Ankylosing Spondylitis Disease Index score decreased from 5.1 to 2.4 (p<0.0001) in patients with AS. Response rate calculated in patients with PsA by modified Psoriatic Arthritis Response Criteria was 67.9% after 24 months. Most adverse events were of mild or moderate nature, and no new safety signals were detected. According to the physicians’ clinical assessments, treatment with GLM was successful (no adverse drug reaction and a clear or moderate therapeutic effect in an individual patient) in 55.0%–56.6% of patients with RA, PsA and AS, respectively, at month 3, increasing from 74.5% to 76.1% at month 24.ConclusionsGLM subcutaneously once monthly led to substantial improvements in clinical effectiveness in patients with various inflammatory rheumatic diseases who could be followed up in a real-life setting in Germany. The treatment was well tolerated, and the safety profile of GLM was consistent with that observed in the previous randomised controlled trials.Trial registration numberNCT01313858.
Integrating culturally informed approaches into physiotherapy assessment and treatment of chronic pain: a pilot randomised controlled trial
Authors: Brady Bernadette , Veljanova Irena , Schabrun Siobhan , Chipchase Lucinda 
Published: April 2023

ObjectiveTo evaluate patient engagement with, and the feasibility of, a novel, culturally adapted physiotherapy pain management approach.DesignA participant-blinded and assessor-blinded pilot randomised controlled trial.SettingOutpatient physiotherapy departments at two public hospitals and one district pain clinic.ParticipantsAdults (n=48) with chronic musculoskeletal pain (daily pain >3 months), who self-identified as Mandaean, Assyrian or Vietnamese, were randomised to one of two physiotherapy treatment conditions.Interventions24 participants underwent combined group and individualised treatment described as ‘culturally adapted physiotherapy’, while 24 underwent evidence-informed ‘usual physiotherapy care’. Both treatment arms consisted of up to 10 sessions over a 3-month period.Outcome measuresPatient engagement was measured via participant attendance, adherence and satisfaction data. Secondary outcomes included clinical measures of pain severity, interference and suffering, physical function and negative emotional state.Results96% of participants undergoing culturally adapted physiotherapy completed treatment, compared with 58% of the usual physiotherapy group. For the culturally adapted group attendance (87%±18%) and adherence (68%±32%) were higher relative to usual care (68%±32% and 55%±43%). Satisfaction was similar for the culturally adapted (82.7%±13.4%) and usual care (79.3±17.3) groups. For secondary outcomes, a significant between-group effect for pain-related suffering in favour of the culturally adapted group was observed with a medium effect size (partial η20.086, mean 3.56, 95% CI 0.11 to 7), while results for pain severity, interference, physical function and negative emotional state were similar.ConclusionsAligning treatment with the beliefs and values of culturally and linguistically diverse communities enhances patient engagement with physiotherapy. These results support the feasibility of a larger, multisite trial to determine if improved engagement with culturally adapted physiotherapy translates to improved clinical outcomes.Trial registration numberNCT12616000857404
Multicentre randomised controlled trial protocol of urine CXCL10 monitoring strategy in kidney transplant recipients
Authors: Ho Julie , Sharma Atul , Kroeker Kristine , Carroll Robert , De Serres Sacha , Gibson Ian W , Hirt-Minkowski Patricia , Jevnikar Anthony , Kim S Joseph , Knoll Greg , Rush David N , Wiebe Chris , Nickerson Peter 
Published: April 2023

IntroductionSubclinical inflammation is an important predictor of death-censored graft loss, and its treatment has been shown to improve graft outcomes. Urine CXCL10 outperforms standard post-transplant surveillance in observational studies, by detecting subclinical rejection and early clinical rejection before graft functional decline in kidney transplant recipients.Methods and analysisThis is a phase ii/iii multicentre, international randomised controlled parallel group trial to determine if the early treatment of rejection, as detected by urine CXCL10, will improve kidney allograft outcomes. Incident adult kidney transplant patients (n~420) will be enrolled to undergo routine urine CXCL10 monitoring postkidney transplant. Patients at high risk of rejection, defined as confirmed elevated urine CXCL10 level, will be randomised 1:1 stratified by centre (n=250). The intervention arm (n=125) will undergo a study biopsy to check for subclinical rejection and biopsy-proven rejection will be treated per protocol. The control arm (n=125) will undergo routine post-transplant monitoring. The primary outcome at 12 months is a composite of death-censored graft loss, clinical biopsy-proven acute rejection, de novo donor-specific antibody, inflammation in areas of interstitial fibrosis and tubular atrophy (Banff i-IFTA, chronic active T-cell mediated rejection) and subclinical tubulitis on 12-month surveillance biopsy. The secondary outcomes include decline of graft function, microvascular inflammation at 12 months, development of IFTA at 12 months, days from transplantation to clinical biopsy-proven rejection, albuminuria, EuroQol five-dimension five-level instrument, cost-effectiveness analysis of the urine CXCL10 monitoring strategy and the urine CXCL10 kinetics in response to rejection therapy.Ethics and disseminationThe study has been approved by the University of Manitoba Health Research Ethics Board (HS20861, B2017:076) and the local research ethics boards of participating centres. Recruitment commenced in March 2018 and results are expected to be published in 2023. De-identified data may be shared with other researchers according to international guidelines (International Committee of Medical Journal Editors [ICJME]).Trial registration numberNCT03206801; Pre-results.
Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol
Authors: Verbeek Tjitte , Arentsen Hans , Breet Evert Jan , Kuipers Machiel M , Lubbert Pieter H W , Burger Huibert 
Published: April 2023

IntroductionDiagnosis and treatment of fractures and dislocations are mostly performed in hospital settings. However, equal care for patients with non-­complex fractures or dislocations (‘minor trauma care’) may be provided in general practice. While substitution of care from secondary to primary care settings is stimulated by governments and insurers, it is unknown what the effects are on patient satisfaction level. Therefore, our primary objective is to determine the effect of minor trauma care delivered in a general practice as compared with a hospital on patient satisfaction. Secondary objectives are to assess the effects on treatment outcomes, cost-effectiveness and time consumption.Methods and analysisIn a prospective cohort study, we will include 200 patients aged 12 and over with an X-ray confirmed diagnosis of a non­-complex fracture or dislocation out of whom 100 treated in a general practice and 100 in a secondary care hospital, both located in the Netherlands. All treatment procedures and follow-up will be done in accordance to the hospital’s standards of trauma care. Study assessments will be performed pre-treatment, and 1, 6 and 12 weeks after treatment. Data collected include demographics, patient satisfaction and patient-reported outcomes including physical functioning, complications, pain scores and treatment-related costs. The primary outcome patient satisfaction measured at 12 weeks will be compared between the settings and additionally multivariable regression will be performed to assess potential confounding effects of unbalanced prognostic factors. Treatment outcomes and time consumption will be analysed following the same approach while cost-effectiveness will be assessed using an incremental cost-effectiveness ratio. Subsequently, results will be discussed using focus groups consisting of patients (n=15) and healthcare providers.Ethics and disseminationThe Medical Ethics Committee from the University Medical Center Groningen reviewed this study protocol and granted exemption from ethical approval (METc UMCG 2017/277). Study results will be presented at (inter)national conferences and published in peer-reviewed journals.Trial registration numberNCT03506958; Pre-results.
Protocol: randomised trial to compare nasoduodenal tube and nasogastric tube feeding in infants with bronchiolitis on high-flow nasal cannula; Bronchiolitis and High-flow nasal cannula with Enteral Tube feeding Randomised (BHETR) trial
Authors: Parlar-Chun Raymond , Lafferty-Prather Meaghan , Gonzalez Veronica , Pedroza Claudia , Gourishankar Anand 
Published: April 2023

IntroductionHigh-flow nasal cannula (HFNC) is a non-invasive form of respiratory support used increasingly in bronchiolitis. HFNC provides a variable amount of positive pressure similar to continuous positive airway pressure (CPAP). The positive pressure in CPAP can distend and loosen oesophageal sphincter pressure leading to increased reflux. It is unclear if HFNC causes a similar action. Feeding tubes are used to provide nutrition and hydration to patients that are unable to safely take oral feedings. If there is increased reflux from HFNC, this would increase the risk of aspiration. Our institution places nasoduodenal tubes (NDT) to eliminate this risk. The purpose of the study is to infer if there is a difference between NDT and nasogastric tube (NGT) feeding with regard to length of respiratory support, number of emesis, number of chest X-rays and readmission/emergency room revisit rates.Methods and analysisPatients with bronchiolitis, on high-flow nasal cannula, and whose primary physicians have decided on feeding tube for nutrition/hydration will be approached for consent and enrolment. Patients will be randomised to NGT or NDT in variable block sizes and stratified into low- and high-risk groups. Outcomes will be analysed by both a frequentist and Bayesian statistical approach.Ethics and disseminationThe trial was approved by local institutional review board. Every attempt will be made to reduce to an absolute minimum the interval between completion of data collection and release of study results through appropriate dissemination mediums including abstracts, poster presentations and journal publications.Trial registration numberNCT03346850; Pre-results.
Prolong: a double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia. A clinical trial protocol
Authors: Langston-Cox Annie G , Marshall Sarah A , Palmer Kirsten R , Wallace Euan M 
Published: April 2023

IntroductionPreeclampsia is a leading cause of maternal and perinatal morbidity and mortality. There is a need for adjuvant, targeted therapies to improve outcomes. Broccoli sprout extract, rich in the antioxidant sulforaphane, reduces oxidative stress and placental secretion of the antiangiogenic factors that contribute to vascular dysfunction in preeclampsia. We propose a phase III trial investigating broccoli sprout extract. We will assess broccoli sprout extract in women with early onset (<34 weeks) preeclampsia, investigating (1) the interval between enrolment and delivery (days), (2) biomarkers of placental and endothelial function and (3) maternal and fetal outcomes.MethodsA double-blind, placebo-controlled randomised trial will be conducted at Monash Health, Melbourne, Australia. One hundred and eighty women (45 each arm of each stratum) with early onset preeclampsia (defined as per Society for Obstetric Medicine of Australia and New Zealand guidelines) will be recruited. Consenting women will be randomised to receive an oral dose of either broccoli sprout extract (24 mg of activated sulforaphane) or identical placebo, twice daily until delivery. Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites. Maternal and perinatal outcomes will be monitored throughout. All clinical care decisions, including the timing of delivery, will be made by the treating team, blinded to treatment allocation. Participation in this trial will not affect routine care. At delivery, maternal and cord blood and placentae will be collected to measure sulforaphane metabolites and sFlt-1, PlGF, sEng and activin A.Ethics and disseminationApproval to conduct the trial has been granted by Monash Health Human Research and Ethics Committee (RES-18-0000-109A). Deidentified data will be published in peer-reviewed journals and presented at learnt society conferences, both nationally and internationally. This study has not yet commenced and is pre-results.Trial registration numberNCT12618000216213
Colonisation of the proximal intestinal remnant in newborn infants with enterostomy: a longitudinal study protocol
Authors: Barreiros Mota Inês , Marques Cláudia , Faria Ana , Neto Maria Teresa , Cordeiro-Ferreira Gonçalo , Virella Daniel , Pita Ana , Pereira-da-Silva Luís , Calhau Conceição 
Published: April 2023

IntroductionThe gut microbiota plays a main role in the maintenance of host’s health. Exposure to different conditions in early life contributes to distinct ‘pioneer’ bacterial communities in the intestine, which shape the newborn infant development. Newborn infants with congenital malformations of the gastrointestinal tract (CMGIT), necrotising enterocolitis (NEC) and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and enterostomy. The knowledge about the colonisation of these newborns’ intestine by microorganisms is scarce. This protocol is designed to explore the microbial colonisation over time of the proximal intestinal remnant in newborn infants who underwent surgery for CMGIT, NEC or SIP and require enterostomy.Methods and analysisThe literature about microbiota colonisation in newborn infants with enterostomy was reviewed and an observational, longitudinal, prospective study was designed. The infants will be recruited at the Neonatal Intensive Care Unit of the Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central. Samples of the enterostomy effluent will be collected every 3 days, through 21 days after the first collection. The microorganisms colonising the proximal intestinal remnant will be identified using the 16S rRNA sequence analysis and a subset of microorganisms will be quantified using real-time PCR. This protocol may serve as basis for future observational and interventional studies on the modulation of the intestinal microbiota (eg, probiotics) on short and long-term outcomes in this population.Ethics and disseminationThis study protocol was approved by the Ethics Committee of Centro Hospitalar Universitário de Lisboa Central (441/2017) and by the Ethics Committee of NOVA Medical School, Universidade Nova de Lisboa (n°50/2018/CEFCM). The results will be spread through peer-reviewed publications and presentations at international scientific meetings.Trial registration numberNCT03340259.
Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial
Authors: Orkin Aaron , Campbell Douglas , Handford Curtis , Hopkins Shaun , Klaiman Michelle , Leece Pamela , Parsons Janet A , Shahin Rita , Strike Carol , Thorpe Kevin , Sellen Kate , Milos Geoffrey , Wright Amy , Charles Mercy , Sniderman Ruby , Morrison Laurie 
Published: April 2023

IntroductionThe surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants’ performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial.Methods and analysisStrategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered.Ethics and disseminationThe study has been reviewed by ethics boards at St. Michael’s Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations.Trial registration numberClinicalTrials.gov registry (NCT03821649).