bluuebunny/crossref_metadata_2025_split huggingface dataset:
Associations between intravaginal practices and incidence of sexually transmitted infections and bacterial vaginosis among women enrolled in the dapivirine vaginal ring trial (The Ring Study) in southwestern Uganda: a retrospective secondary analysis
Authors: Kusemererwa Sylvia , Ruzagira Eugene , Onyango Martin , Kabarambi Anita , Abaasa Andrew 
Published: May 2024

ObjectivesWe assessed associations between intravaginal practices (IVPs) and the incidence of sexually transmitted infections (STIs) and bacterial vaginosis (BV) among women using the dapivirine vaginal ring (DVR) or placebo vaginal ring in southwestern Uganda.MethodsThis was a retrospective secondary analysis of data collected from women at risk of HIV infection recruited into the Ring Study. The latter evaluated the safety and efficacy of the DVR between 2013 and 2016. At baseline, a behavioural questionnaire was administered to obtain information on sexual activity and IVP (exposure) defined as; insertion inside the vagina of any items aimed at cleaning the vagina for any reason before, during or after sex other than practices to manage menses. Each participant self-inserted the DVR/placebo and replaced it every 4 weeks for 2 years. Outcomes were diagnosis of STIs, that is,Chlamydia trachomatis,Neisseria gonorrhoea,Trichomonas vaginalis(TV), HIV and BV. The incidence rate of STI/BV was estimated, overall, by IVP and trial arm in single-event-per-participant and multiple-event-per-participant analyses.ResultsOf the 197 women enrolled, 66 (33.5%) were <25 years of age. Overall, 93 (47.2%) practised at least one form of IVP. During the follow-up, 172 (87.3%) women were diagnosed with an STI/BV at least once. The majority had TV (73.6%, n=145). Overall rate of STI/BV was 51.9/100 person-years, 95% CI 44.7 to 60.3 (IVP: yes, 51.0 (40.8–63.8) vs no, 52.6 (43.0–64.4)). IVPs were not statistically significantly associated with rate of individual STIs/BV. Similar results were observed when the analyses were conducted separately for each trial arm.ConclusionsIVP was not associated with risk of STIs/BV in the Ring Study.Trial registration numberNCT01539226.
Combined MRI-TRUS fusion targeted and systematic biopsy versus systematic biopsy alone for the detection of prostate cancer: protocol for a prospective single-centre trial
Authors: Liu Wujianhong , Kadier Aimaitiaji , Shen Danjing , He Yanyan , Dong Shengrong , Zhu Kun , Xu Guang , Zhao Binghui , Mao Shiyu , Guo Changcheng , Yao Xudong , Wei Qin , Han Dongyan , Yang Bin 
Published: May 2024

IntroductionThe classic way of diagnosing prostate cancer (PCa) is by conducting the 12-core systematic biopsy (SB). However, it has a low detection rate for clinically significant PCa (csPCa) and can lead to the detection of clinically insignificant PCa (cisPCa). Although MRI-transrectal ultrasound (MRI-TRUS) fusion targeted biopsy (TB) can effectively improve the detection rate of csPCa, it may still miss some cases. Therefore, we propose using a combination of TB and SB methods to enhance the detection rate of csPCa while minimising the detection rate of cisPCa.Methods and analysisThis study is a prospective, single-centre investigation that aims to assess and compare the detection rate of csPCa using MRI-TRUS fusion TB combined with SB versus TRUS 12-core SB alone. Biopsy-naïve men with suspected PCa will be subjected to multiparametric MRI. Patients with Prostate Imaging Reporting and Data System (V.2.1) score ≥3 will be enrolled in the TB-SB combination group. The sample size is established as 660 participants, considering a 10% drop-out rate. The primary outcome is the detection rate of csPCa in men without prior biopsy using MRI-TRUS fusion TB combined with the standard TRUS-guided 12-core SB method. CsPCa will be defined as International Society of Urological Pathology Grade ≥2.Ethics and disseminationThis study has been approved by the Ethics Committee at the Shanghai Tenth People’s Hospital, an affiliated hospital of Tongji University School of Medicine. The research results will be published in a peer-reviewed international journal.Trial registration numberChiCTR2000036089.
Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials
Authors: Holzer Katherine J , Bartosiak Kimberly A , Calfee Ryan P , Hammill Chet W , Haroutounian Simon , Kozower Benjamin D , Cordner Theresa A , Lenard Emily M , Freedland Kenneth E , Tellor Pennington Bethany R , Wolfe Rachel C , Miller J Philip , Politi Mary C , Zhang Yi , Yingling Michael D , Baumann Ana A , Kannampallil Thomas , Schweiger Julia A , McKinnon Sherry L , Avidan Michael S , Lenze Eric J , Abraham Joanna 
Published: May 2024

IntroductionPreoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.Methods and analysisAdults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.Ethics and disseminationThe trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.Trial registration numbersNCT05575128,NCT05685511,NCT05697835, pre-results.
Effect of transcranial direct current stimulation combined with transcutaneous auricular vagus nerve stimulation on poststroke cognitive impairment: a study protocol for a randomised controlled trial
Authors: Liu Wulong , Cheng Xianglin , Zhang Yao , Liao Weijing 
Published: May 2024

IntroductionPoststroke cognitive impairment is a common complication in stroke survivors, seriously affecting their quality of life. Therefore, it is crucial to improve cognitive function of patients who had a stroke. Transcranial direct current stimulation (tDCS) and transcutaneous auricular vagus nerve stimulation (taVNS) are non-invasive, safe treatments with great potential to improve cognitive function in poststroke patients. However, further improvements are needed in the effectiveness of a single non-invasive brain stimulation technique for cognitive rehabilitation. This study protocol aims to investigate the effect and neural mechanism of the combination of tDCS and taVNS on cognitive function in patients who had a stroke.Methods and analysisIn this single-centre, prospective, parallel, randomised controlled trial, a total of 66 patients with poststroke cognitive impairment will be recruited and randomly assigned (1:1:1) to the tDCS group, the taVNS group and the combination of tDCS and taVNS group. Each group will receive 30 min of treatment daily, five times weekly for 3 weeks. Primary clinical outcome is the Montreal Cognitive Assessment. Secondary clinical outcomes include the Mini-Mental State Examination, Stroop Colour Word Test, Trail Marking Test, Symbol Digit Modalities Test and Modified Barthel Index. All clinical outcomes, functional MRI and diffusion tensor imaging will be measured at preintervention and postintervention.Ethics and disseminationThe trial has been approved by the Ethics Committee of the First Affiliated Hospital of Yangtze University (approval no: KY202390). The results will be submitted for publication in peer-reviewed journals or at scientific conferences.Trial registration numberChiCTR2300076632.
Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial
Authors: Simpson Sharon Anne , Evans Rachael A , Gilbert Hannah Rosemary , Branson Amy , Barber Shaun , McIntosh Emma , Ahmed Zahira , Dean Sarah Gerard , Doherty Patrick Joseph , Gardiner Nikki , Greaves Colin , Daw Paulina , Ibbotson Tracy , Jani Bhautesh , Jolly Kate , Mair Frances , Ormandy Paula , Smith Susan , Singh Sally J , Taylor Rod 
Published: May 2024

IntroductionPersonalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes.Methods and analysisA multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention.Ethics and disseminationThe trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public.Trial registration numberNCT68786622.Protocol version2.0 (16 May 2023).
What is the ideal time to begin tapering opioid agonist treatment? A protocol for a retrospective population-based comparative effectiveness study in British Columbia, Canada
Authors: Yan Ruyu , Kurz Megan , Guerra-Alejos B Carolina , Min Jeong Eun , Bach Paxton , Greenland Sander , Gustafson Paul , Karim Ehsan , Korthuis P Todd , Loughin Tom , McCandless Lawrence , Platt Robert W , Schnepel Kevin , Seaman Shaun , Socías M Eugenia , Wood Evan , Xie Hui , Nosyk Bohdan 
Published: May 2024

IntroductionOpioid agonist treatment (OAT) tapering involves a gradual reduction in daily medication dose to ultimately reach a state of opioid abstinence. Due to the high risk of relapse and overdose after tapering, this practice is not recommended by clinical guidelines, however, clients may still request to taper off medication. The ideal time to initiate an OAT taper is not known. However, ethically, taper plans should acknowledge clients’ preferences and autonomy but apply principles of shared informed decision-making regarding safety and efficacy. Linked population-level data capturing real-world tapering practices provide a valuable opportunity to improve existing evidence on when to contemplate starting an OAT taper. Our objective is to determine the comparative effectiveness of alternative times from OAT initiation at which a taper can be initiated, with a primary outcome of taper completion, as observed in clinical practice in British Columbia (BC), Canada.Methods and analysisWe propose a population-level retrospective observational study with a linkage of eight provincial health administrative databases in BC, Canada (01 January 2010 to 17 March 2020). Our primary outcomes include taper completion and all-cause mortality during treatment. We propose a ‘per-protocol’ target trial to compare different durations to taper initiation on the likelihood of taper completion. A range of sensitivity analyses will be used to assess the heterogeneity and robustness of the results including assessment of effectiveness and safety.Ethics and disseminationThe protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.
Perceptions and experiences of paramedics managing people with non-traumatic low back pain: a qualitative study of Australian paramedics
Authors: Vella Simon P , Simpson Paul , Bendall Jason C , Pickles Kristen , Copp Tessa , Swain Michael S , Maher Christopher G , Machado Gustavo C 
Published: May 2024

BackgroundParamedics are often first providers of care to patients experiencing non-traumatic low back pain (LBP), though their perspectives and experiences with managing these cases remain unclear.ObjectivesThis study explored paramedic views of the management of non-traumatic LBP including their role and experience with LBP management, barriers to referral and awareness of ambulance service guidelines.DesignQualitative study using semistructured interviews conducted between January and April 2023.SettingNew South Wales Ambulance service.ParticipantsA purposive sample of 30 paramedics of different specialities employed by New South Wales Ambulance were recruited.ResultsParamedic accounts demonstrated the complexity, challenge, frustration and reward associated with managing non-traumatic LBP. Paramedics perceived that their primary role focused on the assessment of LBP, and that calls to ambulance services were often driven by misconceptions surrounding the management of LBP, and a person’s pain severity. Access to health services, patient factors, defensive medicine, paramedic training and education and knowledge of guidelines influenced paramedic management of LBP.ConclusionParamedics often provide care to non-traumatic LBP cases yet depending on the type of paramedic speciality find these cases to be frustrating, challenging or rewarding to manage due to barriers to referral including access to health services, location, patient factors and uncertainty relating to litigation. Future research should explore patient perspectives towards ambulance service use for the management of their LBP.
Synthesis, Structural Investigations, and Dielectric Properties of Irradiated Flexible Polymeric Composite Films
Authors: Abdelhamied M. M. , Altuijri Reem , Atta A. , Ezzeldien Mohammed 
Published: May 2024

In this research, the casting solution manufacturing approach was used to mix polyvinyl alcohol (PVA) and copper oxide (CuO) to create the composite (PVA/CuO). X-ray diffraction analysis and Fourier transform infrared spectroscopy were applied to record the successful fabrications of the composites. Next, argon ion beams at fluencies of 2.5 × 1017, 5 × 1017, and 7.5 × 1017 ions.cm−2 were used to irradiate the composites. In frequencies of 50 Hz to 6 MHz, the dielectric characteristics of PVA/CuO were modified by the ion irradiation. The dielectric constant was enhanced from 39 for unmodified PVA/CuO to 356 for the irradiated composite by 7.5 × 1017 ions.cm−2, and the conductivity changed from 0.05 × 10−6 S cm−1 to 2.9 × 10−6 S cm−1. However, the potential barrier decreased from 0.24 eV for PVA/CuO to 0.21, 0.16, and 0.15 eV, respectively, for 2.5 × 1017, 5 × 1017, and 7.5 × 1017 ions.cm−2, and the relaxation time decreased from 9.36 × 10−8 sec for PVA/CuO, to 6.58 × 10−8 sec for 7.5 × 1017 ions.cm−2. The results indicate that the irradiated PVA/CuO nanocomposite can be used in a number of devices such as capacitors and batteries.
Physical Activity Decreases Inflammation and Delays the Development of Obesity-Associated Pancreatic Ductal Adenocarcinoma
Authors: Pita-Grisanti Valentina , Velez-Bonet Ericka , Chasser Kaylin , Hurst Zachary , Liette Alexus , Vulic Grace , Dubay Kelly , Lahooti Ali , Badi Niharika , Ueltschi Olivia , Gumpper-Fedus Kristyn , Hsueh Hsiang-Yin , Lahooti Ila , Chavez-Tomar Myrriah , Terhorst Samantha , Knoblaugh Sue E. , Cao Lei , Huang Wei , Coss Christopher C. , Mace Thomas A. , Choueiry Fouad , Hinton Alice , Culp Stacey , Mitchell Jennifer M. , Schmandt Rosemarie , Onstad Grinsfelder Michaela , Basen-Engquist Karen , Cruz-Monserrate Zobeida 
Published: May 2024

Abstract
Obesity is a risk factor for pancreatic ductal adenocarcinoma (PDAC), a deadly disease with limited preventive strategies. Lifestyle interventions to decrease obesity represent a potential approach to prevent obesity-associated PDAC. In this study, we examined whether decreasing obesity through physical activity (PA) and/or dietary changes could decrease inflammation in humans and prevent obesity-associated PDAC in mice. Comparison of circulating inflammatory-associated cytokines in subjects (overweight and obese) before and after a PA intervention revealed PA lowered systemic inflammatory cytokines. Mice with pancreatic-specific inducible KrasG12D expression were exposed to PA and/or dietary interventions during and after obesity-associated cancer initiation. In mice with concurrent diet-induced obesity and KrasG12D expression, the PA intervention led to lower weight gain, suppressed systemic inflammation, delayed tumor progression, and decreased proinflammatory signals in the adipose tissue. However, these benefits were not as evident when obesity preceded pancreatic KrasG12D expression. Combining PA with diet-induced weight loss (DI-WL) delayed obesity-associated PDAC progression in the genetically engineered mouse model, but neither PA alone nor combined with DI-WL or chemotherapy prevented PDAC tumor growth in orthotopic PDAC models regardless of obesity status. PA led to the upregulation of Il15ra in adipose tissue. Adipose-specific overexpression of Il15 slowed PDAC growth but only in nonobese mice. Overall, our study suggests that PA alone or combined with DI-WL can reduce inflammation and delay obesity-associated PDAC development or progression. Lifestyle interventions that prevent or manage obesity or therapies that target weight loss–related molecular pathways could prevent progression of PDAC.
Significance: Physical activity reduces inflammation and induces changes to adipose-related signaling to suppress pancreatic cancer, supporting the potential of obesity management strategies to reduce the risk of developing pancreatic cancer.
See related commentary by Sogunro and Muzumdar, p. 2935
Self-Organization and Phase Transitions in Driven Cellular Automata
Authors: Rainwater J. Hank 
Published: May 2024

Abstract
The Game of Life (GoL) cellular automaton is modified to inject order during execution of the state transition algorithm by making selected stable structures permanently active while interacting with normal active sites to create novel structures. A survey of the modified automaton’s phenomenology and an analysis of its dynamics are presented in the context of the physics of the self-organization of matter by viewing the GoL as an artificial chemistry. These new structures become seeds for additional phases of structure building, analogous to nature’s gravitational and thermodynamic churning of the geosphere that created material structures in phases, beginning the transition from geochemistry to prebiotic chemistry and laying foundational substrates for life-enabling organizational processes in an emerging biosphere. Evidence of selective self-assembly during phase transitions is reported where several GoL still life structures, configured as permanently active seeds evolving with random collections of active sites, resulted in geometrically identical structures as the GoL reached an equilibrium state of static density.
Inter-States Disputes Under the Inter-American Human Rights System
Authors: Contesse Jorge 
Published: May 2024

Abstract
Under the inter-American human rights system, inter-State disputes seem largely irrelevant. Such irrelevance contrasts with the European human rights system, where the amount of inter-State disputes is significant (and growing), and is similar to the African human rights regime, where there is a very low number of inter-State disputes. In more than four decades since the entry into force of the American Convention on Human Rights, there are only two inter-State disputes brought before the Inter-American Commission on Human Rights—one of the two bodies that, along with the Inter-American Court, make up the regional human rights system. The virtual inexistence of inter-State complaints, however, does not mean an absence of human rights disputes among members of the Organization of American States (oas). In fact, States resort to other mechanisms to process their disputes. Therefore, to explore how inter-States disputes actually operate under inter-American human rights law, it is necessary to broaden the view and look beyond the specific mechanism of inter-State communications established in the American Convention. This article discusses the two inter-State communications that the Inter-American Commission on Human Rights has so far examined, and analyses other mechanisms—typically, advisory opinions by the Inter-American Court—that serve as a substitute for inter-State communications. The article shows how oas States use advisory opinions as a covert inter-State dispute mechanism and argues that the Inter-American Court should articulate a clear set of admissibility standards to address this practice.