bluuebunny/crossref_metadata_2025_split huggingface dataset:
Unravelling age-related gait decline in cerebral palsy: insights into physiological changes and functional implications through an observational study—a French study protocol in a laboratory setting
Authors: Gravholt Anders , Fernandez Bruno , Rimaud Diana , Zeghoudi Narimane , Bessaguet Hugo , Espeit Loic , FEASSON Léonard , Millet Guillaume Y , Buizer Annemieke I. , Lapole Thomas 
Published: November 2024

IntroductionCerebral palsy (CP) presents a complex neurodevelopmental disorder with a spectrum of motor impairments stemming from early brain injury. Whereas CP is traditionally viewed as a non-progressive condition, emerging evidence suggests a progressive decline in mobility and function, particularly in adulthood. Despite the prevalence of self-reported age-related gait decline in adults with CP, objective evidence supporting this phenomenon remains limited. Moreover, mechanistic insights into these functional alterations and their comparison with typically developing (TD) peers are lacking. To address this gap, our study aims to objectively assess age-related changes in gait performance among individuals with CP while examining physiological differences compared with TD peers.Methods and analysisThis protocol will compare the mobility of individuals with and without CP within two age groups (18–25 and 35–50 years old). Participants at Gross Motor Function Classification System levels I–II at age 18 will be invited to partake in the study. Every participant will be invited to complete four visits investigating a wide range of mobility related measures: walking performance, muscle strength, cardiopulmonary performance, fatigability, cost of walking and quantitative gait analysis. Through this comprehensive analysis encompassing gait performance metrics, self-reported outcomes, muscle strength, biomechanics and metabolical cost of walking, and fatigability, we seek to elucidate the underlying mechanisms driving age-related gait decline in adults with CP and inform targeted interventions to maintain function and quality of life.Ethics and disseminationThe study has been approved by the French ethics board (#2022-A02510-43) and will be communicated through conferences, articles and to participants through layman terms.Trial registration numberNCT06163950.
Codesign with citizens to prevent cardiometabolic diseases in disadvantaged neighbourhoods: an interview study on needs and priorities among stakeholders in Sweden
Authors: Ottesen Hedda , Alvesson Helle Mölsted , Idevall Hagren Jonas , Martinell Mats , Matta Laran , McAleenan Pia , Daivadanam Meena 
Published: November 2024

ObjectivesCardiometabolic diseases are a global health concern, affecting socioeconomically disadvantaged groups more adversely. Effective public health interventions targeting preventable risk factors like physical inactivity and unhealthy diets are needed. Codesign with citizens presents a promising opportunity for developing context-relevant and population-relevant interventions, with high chances of adoption by the target population. This study aimed to understand the needs and priorities of key stakeholders to engage in codesign with citizens for the prevention of cardiometabolic diseases, focusing on socioeconomically disadvantaged groups in Uppsala, Sweden.DesignA qualitative case study was conducted using semistructured interviews with stakeholders working with prevention and and promotion of healthy and active living in public, private and civil society sectors. The interviews were audio recorded, transcribed verbatim and analysed using reflexive thematic analysis.SettingUppsala, Sweden.ParticipantsA total of 24 participants were purposively sampled.ResultsWhile participants described the critical value of participatory processes to achieve goals in their work, they struggled to prioritise prevention efforts over time. This adversely affected the continuity of public health interventions and collaborations with other stakeholders. They also described resistance towards inclusive processes from within their organisations, as they were seen as time-consuming and generating unpredictable outcomes. Additionally, the persistence of a siloed system structure of organisations and the risks associated with accessing target populations through local intermediaries added to the challenges.ConclusionThis study highlights the lack of integration of organisational values and functions within and across organisations, hindering cross-sector collaboration and citizen engagement in prevention and health promotion activities. Additionally, the low priority of prevention and ineffective use of codesign hampers continuity and long-term perspectives of prevention and health promotion. To create more conducive conditions for codesign, facilitating intersectoral activities and more inclusive processes is needed and may be enabled by explicit and systematic support.
Efficacy of acupuncture for pregnancy with early-onset ovarian hyperstimulation syndrome: study protocol for a randomised controlled clinical trial
Authors: Wen Kaoling , Sun Dejuan , Wang Dongying , Li Yu , Wang Jue , Wang Bo , Zhan Meiqi , Tan Hongyu , Su Ting , Lu Liming , Liang Xiaoyan , Lin Jinglin , Tang Chunzhi , Lai Xin 
Published: November 2024

IntroductionAlthough ovarian hyperstimulation syndrome (OHSS) is a common complication primarily seen in patients undergoing in vitro fertilisation-embryo transfer, there is no recognised effective treatment to manage it, especially for pregnant patients. As an alternative non-pharmacological treatment, acupuncture presents itself as a promising, safe and effective intervention for those suffering from OHSS. Despite its potential, there is a noticeable absence of randomised controlled trials providing solid evidence on the efficacy of acupuncture in the management of pregnancy with OHSS. Therefore, the primary objective of this study is to conduct an initial investigation into the efficacy of acupuncture in pregnant patients with OHSS, hoping to contribute valuable insights from a medical-scientific perspective.Methods and analysisThis is a three-arm, single-blind, parallel-design, randomised controlled clinical trial. A total of 384 patients will be enrolled and randomised in a ratio of 1:1:1 into acupuncture group (MA group), sham acupuncture group (SA group) and control group (C group) for a 20-day treatment period. The primary outcomes include 24-hour urine output, amount of ascites shown on ultrasound, abdominal circumference, degree of abdominal distension and chest tightness. The secondary outcomes are weight, ovarian size, rate of ascites drainage by tube placement and serum hCG. Besides, the study will consider changes in blood counts and hormonal levels as additional outcomes.Ethics and disseminationThis study received authorisation from the Institutional Review Board of the Sixth Affiliated Hospital of Sun Yat-sen University on 4 February 2024 (Approval No. 2024ZSLYFEC-084). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.Trial registration numberChinese Clinical Trial Registry ChiCTR2400081751.
Impact of longitudinal changes in serum uric acid levels and weight gain on new-onset atrial fibrillation—The Nishimura Health Survey: a retrospective cohort study
Authors: Munakata Jun , Senoo Keitaro , Nakata Mitsuko , Teramukai Satoshi , Kumagai Muneaki , Yamaoka Miyoko , Nishimura Hiromi , Matoba Satoaki 
Published: November 2024

ObjectiveUric acid (UA) and obesity are significant risk factors for new-onset atrial fibrillation (AF). Based on the pathogenesis mechanisms of new-onset AF involving obesity and UA, it is possible that UA and weight gain may interact with each other. We investigated the impact of UA and weight gain on new-onset AF using a simple measure of weight change over time, ‘weight gain of ≥10 kg after age 20’.DesignA retrospective cohort study.Setting and participantsWe retrospectively analysed 16 444 Japanese aged over 30 without AF from a cohort of employees undergoing annual health check-up from 2 April 2013 to 30 April 2022. We conducted a landmark survival analysis to assess the impact of longitudinal changes in UA and obesity on new-onset AF. Weight gain was defined as ‘weight gain of≥10 kg after age 20’ using a standardised self-administered questionnaire.Primary outcome measureSubjects were diagnosed with AF when AF was present in the electrocardiogram or when indicated in a patient interview.ResultDuring a median follow-up period of 3.91 years, 69 new-onset AF occurred (incidence; 1.12/1000 person-years). UA levels were 5.76 (±1.37) in the weight gain group and 4.87 (±1.31) in the no weight gain group, both within normal limits. A multivariable landmark survival analysis including interaction term showed that new-onset AF was significantly associated with age, sex, baseline systolic blood pressure, baseline UA and the interaction term between UA change and weight gain. The interaction term between weight gain and UA change indicates that HR for every UA 1 mg/dL increase was 1.96 (95% CI 1.38 to 2.77) in subjects with weight gain and 0.95 (95% CI 0.61 to 1.48) in those without.ConclusionEven if UA levels are within the normal range, subsequent UA change and weight gain in adulthood have an interactive effect on new-onset AF.
Sintilimab plus HPV vaccine for recurrent or metastatic cervical cancer
Authors: Wang Buhai , Liang Yichen , Wu Yuechao , Li Qiuxian , Zeng Yichun , Liu Liqin , Cao Wenmiao , Geng Xiaoru , Huang Yuxiang , Wu Yinxia , Pan Jiulin , Zhang Xian , Gu J Juan 
Published: November 2024

PurposeRecurrent or metastatic cervical cancer (r/m CC) presents limited treatment options for patients failed or progressed quickly following first-line therapy. This study investigated the potential of sintilimab with a prophylactic human papillomavirus (HPV) quadrivalent vaccine as a second-line treatment for r/m CC.MethodsIn this phase 2 clinical trial, patients with r/m CC previously unresponsive or intolerant to standard treatments for metastatic or recurrent lesions were enrolled. Participants received sintilimab (3 mg/kg for body weight <60 kg; 200 mg for ≥60 kg) every 3 weeks until 24 months or 35 cycles and 3 doses of the HPV quadrivalent vaccine (initial dose prior to sintilimab initiation, with subsequent doses at 2 and 6 months). The primary endpoint was the objective response rate (ORR). A Simon two-stage optimal design was used.ResultsFrom October 2019 to October 2022, 13 patients with r/m CC were enrolled. ORR achieved 53.8% (95% CI 25.1% to 80.8%), and the disease control rate was 76.9% (95% CI 46.2% to 95.0%). Median follow-up duration was 16.07 months (range: 3.64–48.2 months), and median progressive free survival was 7.16 months (95% CI 1.91 –not applicable (NA)). The median overall survival (OS) was not reached (95% CI 9.89 –NA). Hypothyroidism (15.6%) was the most common treatment-related adverse event (AE). No grade 3 or above AEs were observed.ConclusionsThis study suggests the combination of sintilimab plus prophylactic HPV vaccine offers a potentially promising therapeutic strategy for patients with r/m CC unresponsive or intolerant to standard therapies.Trial registration numberNCT04096911.
Renal response status to predict long-term renal survival in patients with lupus nephritis: results from the Toronto Lupus Cohort
Authors: Urowitz Murray , Georgiou Mary E , Touma Zahi , Su Jiandong , Diaz-Martinez Juan Pablo , Fu Qinggong , Levy Roger A , Gairy Kerry , MacKinnon Anne , Anderson Nicole , Juliao Patricia C 
Published: November 2024

ObjectiveTo evaluate modified versions of the Belimumab International Study in Lupus Nephritis (BLISS-LN) belimumab study primary efficacy renal response (mPERR) and complete renal response (mCRR) criteria (excluding mandatory corticosteroid tapering) as predictors of real-world, long-term renal outcomes among patients with lupus nephritis (LN).MethodsThis retrospective, observational study (GSK Study 212866) used deidentified data between 1970 and 2015 from the University of Toronto Lupus Cohort from adults diagnosed with systemic lupus erythematosus and biopsy-proven Class III±V, IV±V or V LN. At 24 months postbiopsy, patients were retrospectively indexed as responders/non-responders based on mPERR (estimated glomerular filtration rate (eGFR) ≤20% below biopsy value/≥60 mL/min/1.73 m2and urine protein:creatinine ratio (uPCR) ≤0.7 g/day) or mCRR (eGFR ≤10% below biopsy value/≥90 mL/min/1.73 m2and uPCR ≤0.5 g/day) criteria. The association between index mPERR (primary outcome) or mCRR (secondary outcome) status and long-term (up to 25 years, until censoring or death) renal survival (no progression to end-stage kidney disease (eGFR <30 mL/min/1.73 m2, dialysis or transplant) or death) was assessed.ResultsOverall, 179 patients were included in the analysis (mPERR responders, n=128; non-mPERR responders, n=51). Most patients were female (87.2%); the mean (SD) age was 34.1 (11.3) years.Long-term renal survival was attained for 78.9% of mPERR responders and 60.8% of non-mPERR responders; achieving mPERR was associated with an increased likelihood of long-term renal survival versus not achieving mPERR (log-rank p=0.0119). Overall, 102 patients were mCRR responders, and 77 were non-mCRR responders. Long-term renal survival was attained for 80.4% of mCRR responders and 64.9% of non-mCRR responders; achieving mCRR was associated with an increased likelihood of long-term renal survival than not achieving mCRR (log-rank p=0.0259).ConclusionsAchieving mPERR or mCRR was associated with improved long-term renal survival, highlighting that these statuses are suitable predictors of long-term renal outcomes in patients with LN.
Partnering RemoTe monitoring of Implanted Cardiac devices with Intelligent PATient Engagement – PARTICIPATE trial: a protocol for a randomised controlled trial
Authors: Sheahen Brodie , Laranjo Liliana , Sivagangabalan Gopal , Shaw Tim , Thiagalingam Aravinda , Chow Clara K 
Published: November 2024

IntroductionCardiac implantable electronic devices (CIED) can transfer data to the healthcare team, remotely. National and international cardiac organisations recommend all patients use this technology, however patient engagement is suboptimal. Previously, in cardiovascular patients, SMS messaging services have shown improvements in patient engagement and subsequent health outcomes. This paper describes the protocol and intervention of a randomised controlled trial (RCT) to assess the feasibility of a novel CIED remote monitoring SMS patient support programme on self-efficacy in managing CIED and cardiovascular health following CIED implantation.Methods/analysisA two-arm RCT will be conducted of 100 participants with 1:1 allocation to intervention or control. Participants awaiting-CIED or immediately post-CIED implantation from sites throughout Australia will be invited to partake. The intervention group will receive regular SMS communication with a range of educational and self-efficacy resources, in conjunction with engagement initiatives following CIED clinical issue detection. The control group will receive CIED remote monitoring education and clinical issue management as per standard practice at their respective sites. The primary outcome will assess the patient’s capacity to manage their CIED as measured by the ‘Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale’. Secondary outcomes will assess participant’s ability to manage their cardiovascular condition, CIED remote monitoring, quality of life, impact on health service utilisation, cardiovascular behavioural risk factor change and motivation to improve cardiovascular health. A sample size of 100 will have a 90% power to detect a minimum difference of 1.07 in the ‘Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale’ between the intervention and control group with an alpha value of 0.05.Ethics and disseminationEthics approval for this study has been obtained from the Western Sydney Local Health District Human Research Ethics Committee. The project results will be published in peer-reviewed journals, at scientific meetings and in the media.Trial registration numberACTRN12623000702617
Characterisation of patients who develop atrial fibrillation-induced cardiomyopathy
Authors: Ahluwalia Nikhil , Honarbakhsh Shohreh , Abbass Hakam , Joshi Abhishek , Chow Anthony W C , Dhinoja Mehul , Petersen Steffen Erhard , Hunter Ross J , Lloyd Guy , Schilling Richard J 
Published: November 2024

IntroductionAtrial fibrillation (AF)-induced cardiomyopathy (AIC) is retrospectively defined after normalisation of left ventricular ejection fraction (LVEF) in sinus rhythm. It is unclear why some patients develop AIC.HypothesisPatients with AIC have a subtle cardiomyopathic process that precedes their AF-mediated LVEF reduction. Detailed assessment of cardiac function after successful catheter ablation will reveal this.ObjectiveTo evaluate the utility of measures to identify cardiomyopathic features that persist after LVEF normalisation in AIC.MethodsPatients with rate-controlled persistent AF and LVEF<50% undergoing catheter ablation (CA) were prospectively evaluated using echocardiography, cardio-pulmonary exercise testing and serum N-terminal pro b-type natriuretic peptide (NT-proBNP) at baseline and 6 months after CA. Participants with AIC, (LVEF recovery (≥50%) and no other cause for cardiac dysfunction) were evaluated using left ventricular (LV) longitudinal strain and left atrial (LA) reservoir strain (LARS). Changes in peak oxygen consumption and the minute ventilation/carbon dioxide production slope were measured as markers of functional capacity and ventilatory inefficiency. A control group of patients with persistent AF with preserved LVEF were also enrolled.Results34/41 (82.9%) participants recovered LVEF in sinus rhythm; defined as AIC. NT-proBNP levels were elevated in 18 (52.9%), and 16 reported ongoing heart failure (HF) symptoms. 10 (29.4%) had no improvement in functional capacity, and seven (20.6%) showed persistent ventilatory inefficiency. 20 (58.8%) had impaired global LV longitudinal strain with a relative apical sparing pattern. Nine (26.5%) had impaired LARS. There was an overlap of these abnormalities. 32 (94.1%) demonstrated at least one, 17 (50.0%) having no cardiovascular risk factors. Patients with preserved LVEF during persistent AF had similar demographics but a lower burden of short R-R intervals (<660 ms) on Holter monitoring.DiscussionAbnormal structural, metabolic and HF biomarkers are seen in patients with AIC in sinus rhythm. These features may represent a precedent subtle cardiomyopathic process predisposing them to left ventricular systolic dysfunction in AF.Trial registration numberNCT04987723.
The Existence of Weak Solutions for Bidirectional Fluid–Structure Coupling Problem in 2D Arterial Blood Flow
Authors: Hu Weifeng , Cheng Yunzhang 
Published: November 2024

In this paper, we study a two‐dimensional (2D) bidirectional fluid–solid coupling problem in blood vessels and prove the existence of weak solutions to this kind of problem. When studying the fluid motion of arterial blood flow in arterial vascular tissue, where the density of the vessel wall is roughly equal to that of the blood, the coupling between the blood and the vessel wall is highly nonlinear. In this case, the fluid space where the arterial blood flow is located is no longer fixed in the fluid–structure interaction (FSI) model, and its boundary position is determined by the position of the elastic vessel wall. The contact force exerted by the elastic vascular structure on the blood flow also affects the movement of the blood flow, while the position of the blood vessel is determined by the contact force exerted by the blood flow on the blood vessel; that is, two‐way coupling occurs between the vascular diameter and the blood flow space.MSC2020 Classification: 35D30, 35M31
The Effect of Remimazolam on the Baseline TOF Ratio: A Prospective, Clinical Study
Authors: Yuruki Tomoko , Fujimoto Masafumi , Hirata Naoyuki 
Published: November 2024

Background: Remimazolam is a newly developed benzodiazepine. Early recovery from anesthesia because of its ultra‐short acting effect and less hemodynamic side effects has been reported as the specific advantages of remimazolam. Therefore, the maintenance of anesthesia with propofol may be sometimes switched to remimazolam anesthesia maintenance during surgery because of the risk of delayed awakening and unstable hemodynamics. In the present study, to determine the influence of switching anesthesia from propofol to remimazolam on the baseline TOF ratio, the TOF ratio under remimazolam anesthesia maintenance without any neuromuscular blocking agents was compared to that calibrated after induction of general anesthesia with propofol.Methods: Twelve patients scheduled for elective surgery under general anesthesia in the supine position were investigated. After induction of general anesthesia with remifentanil and propofol, a supraglottic airway was inserted without neuromuscular blockade, and TOF stimulation every 15 s at the adductor pollicis muscle was started with acceleromyography. After stable baseline responses to TOF stimulation being obtained for at least 10 min under propofol anesthesia, the anesthetic agent was switched to remimazolam and TOF stimulation every 15 s was maintained for a further 60 min without any interruption. In each case, the averaged TOF ratio during the last 10 min of TOF monitoring was compared to that during the 10 min immediately before the beginning of remimazolam infusion using a paired t‐test.Results: There were no significant differences in the TOF ratios before and after switching anesthesia to remimazolam (1.07 ± 0.03 vs. 1.07 ± 0.03, p = 0.325).Conclusion: Switching anesthesia from propofol to remimazolam does not affect the baseline TOF ratio.