bluuebunny/crossref_metadata_2025_split huggingface dataset:
99: PREVALENCE OF METHYLPHENIDATE (RITALIN) MISUSE AMONG STUDENTS OF IRAN: A SYSTEMATIC REVIEW
Authors: Amirzade-Iranaq Mohammad Hossein , Masoumi Seyyed Mohammad Reza 
Published: May 2024

Background and aims:Methylphenidate (Ritalin) is a medication prescribed for hyperactive children known as ADHS disorder. But the rate of misuse of this drug among students is critical. The purpose of this study was to evaluate the prevalence of misuse of methylphenidate among students of Iran.Methods:Electronic search performed based on PubMed, Scopus, PsycINFO and Web of Science for relevant studies and also hand-searching for recognizing non-indexed sources. English and Persian languages restriction included and only cross sectional studies entered to this study.Data extraction: 28 articles found through databases searching and also 3 Additional records identified by hand-searching. After excluding of duplicates and studies not meeting inclusion criteria like knowledge attitude studies, at last 7 Full-text articles assessed for eligibility. Quality assessment of this study was executed by using the Critical Appraisal Skills Programme (CASP). Because of high heterogeneity among this article we decided to ignore quantitative analysis and meta-analysis.Results:The Prevalence of Methylphenidate (Ritalin) in studies were so different (5% to 43%) among students of Iran, But also the prevalence was significantly higher in men in all of studies. almost 30% of students use this drug at least one time during their life. The most time they used related to exams period and the most their reason was that it help them to more concentrate and enhance the cognition.Conclusion:This study shows us the prevalence of Methylphenidate (Ritalin) misuse among students of Iran are so high and because of its side effects it could be an alarm for youth people in Iran. Increase the awareness about the use of methylphenidate are needed critically.
Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study)
Authors: Singh Swaran P , Tuomainen Helena , Girolamo Giovanni de , Maras Athanasios , Santosh Paramala , McNicholas Fiona , Schulze Ulrike , Purper-Ouakil Diane , Tremmery Sabine , Franić Tomislav , Madan Jason , Paul Moli , Verhulst Frank C , Dieleman Gwen C , Warwick Jane , Wolke Dieter , Street Cathy , Daffern Claire , Tah Priya , Griffin James , Canaway Alastair , Signorini Giulia , Gerritsen Suzanne , Adams Laura , O’Hara Lesley , Aslan Sonja , Russet Frédérick , Davidović Nikolina , Tuffrey Amanda , Wilson Anna , Gatherer Charlotte , Walker Leanne 
Published: May 2024

IntroductionDisruption of care during transition from child and adolescent mental health services (CAMHS) to adult mental health services may adversely affect the health and well-being of service users. The MILESTONE (Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare) study evaluates the longitudinal course and outcomes of adolescents approaching the transition boundary (TB) of their CAMHS and determines the effectiveness of the model of managed transition in improving outcomes, compared with usual care.Methods and analysisThis is a cohort study with a nested cluster randomised controlled trial. Recruited CAMHS have been randomised to provide either (1) managed transition using the Transition Readiness and Appropriateness Measure score summary as a decision aid, or (2) usual care for young people reaching the TB. Participants are young people within 1 year of reaching the TB of their CAMHS in eight European countries; one parent/carer and a CAMHS clinician for each recruited young person; and adult mental health clinician or other community-based care provider, if young person transitions. The primary outcome is Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) measuring health and social functioning at 15 months postintervention. The secondary outcomes include mental health, quality of life, transition experience and healthcare usage assessed at 9, 15 and 24 months postintervention. With a mean cluster size of 21, a total of 840 participants randomised in a 1:2 intervention to control are required, providing 89% power to detect a difference in HoNOSCA score of 0.30 SD. The addition of 210 recruits for the cohort study ensures sufficient power for studying predictors, resulting in 1050 participants and an approximate 1:3 randomisation.Ethics and disseminationThe study protocol was approved by the UK National Research Ethics Service (15/WM/0052) and equivalent ethics boards in participating countries. Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups.Trial registration numberISRCTN83240263;NCT03013595(pre-results).
The CLIMB (Complex Lipids In Mothers and Babies) study: protocol for a multicentre, three-group, parallel randomised controlled trial to investigate the effect of supplementation of complex lipids in pregnancy, on maternal ganglioside status and subsequent cognitive outcomes in the offspring
Authors: Huang Shuai , Mo Ting-Ting , Norris Tom , Sun Si , Zhang Ting , Han Ting-Li , Rowan Angela , Xia Yin-Yin , Zhang Hua , Qi Hong-Bo , Baker Philip N 
Published: May 2024

IntroductionComplex lipids are important constituents of the central nervous system. Studies have shown that supplementation with complex milk lipids (CML) in pregnancy may increase the level of fetal gangliosides (GA), with the potential to improve cognitive outcomes.Methods and analysisWe aim to recruit approximately 1500 pregnant women in the first trimester (11–14 weeks) and randomise them into one of the three treatment groups: standard maternal milk formulation, CML-enhanced maternal milk formulation or no maternal milk intervention with standard pregnancy advice (ie, the standard care). Maternal lifestyle and demographic data will be collected throughout the pregnancy, as well as biological samples (eg, blood, hair, urine, buccal smear, cord blood, cord and placenta samples). Data from standard obstetric care recorded in hospital maternity notes (eg, ultrasound reports, results of oral glucose tolerance test and pregnancy outcome data) will also be extracted. Postnatal follow-up will be at 6 weeks and 12 months of age, at which point infant cognitive development will be assessed (Bayley Scales of Infant Development I).Ethics and disseminationThis project was approved by the Ethics Committee of Chongqing Medical University. Dissemination of findings will take the form of publications in peer-reviewed journals and presentations at national and international conferences.Trial registration numberChiCTR-IOR-16007700; Pre-results.
The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol
Authors: Guiu-Tula Francesc Xavier , Cabanas-Valdés Rosa , Sitjà-Rabert Mercè , Urrútia Gerard , Gómara-Toldrà Natàlia 
Published: May 2024

IntroductionProprioceptive neuromuscular facilitation (PNF) is a widely used rehabilitation concept, although its efficacy has not yet been demonstrated in stroke survivors. The aim of this systematic review is to identify, assess and synthesise the potential benefits of using PNF to improve the activities of daily living (ADL) and quality of life (QoL) of individuals with stroke.Methods and analysisA systematic electronic search will be conducted in MEDLINE, Embase, CENTRAL and PEDro. We will include randomised or quasi-randomised controlled trials of PNF interventions conducted in stroke survivors up to April 2017. Two review authors will independently select relevant studies and will extract data using the Cochrane handbook for systematic reviews of interventions approach and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The methodological quality will be assessed by using the PEDro scale. Finally, with the permitted numeric data, we will carry out a meta-analysis.Ethics and disseminationEthical considerations will not be required. Results will be disseminated in a peer-review journal. This systematic review aims to examine the effects of PNF (neurophysiological approach) in order to clarify its efficacy in improving ADL and QoL in the rehabilitation process of stroke survivors.PROSPERO registration numberCRD42016039135.
Effects of a multicomponent workplace intervention programme with environmental changes on physical activity among Japanese white collar employees: a protocol for a cluster randomised controlled trial
Authors: Watanabe Kazuhiro , Kawakami Norito 
Published: May 2024

IntroductionPhysical activity is one of the most important health behaviours as a determinant of physical and mental health. Although intervention strategies for promoting physical activity among workers are needed, evidence for the effectiveness of multilevel workplace interventions with environmental changes on the promotion of physical activity are still limited due to lack of cluster randomised controlled trials (RCTs). The aim of this study is to investigate effects of a 3-month workplace intervention programme with environmental changes on the improvement in physical activity among Japanese white collar employees.Methods and analysisThis study will be a two-arm and parallel-group cluster (worksite) RCT. Japanese worksites and employees who are employed by the worksites will be recruited through health insurance associations and chambers of commerce. Worksites that meet the inclusion criteria will be randomly allocated to intervention or control groups. The intervention worksites will be offered the original intervention programme that consists of 13 contents with environmental changes. The control worksites will be able to get three times feedback of the assessment of the amount of physical activity and basic occupational health service in each worksite. The primary outcome will be the total amount of physical activity measured by the Global Physical Activity Questionnaire at baseline, 3 months and 6 months. Multilevel latent growth modelling will be conducted to examine the effectiveness of the intervention programme.Ethics and disseminationThis study was ethically approved by the research ethics committee of the Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Japan (No. 11230). Results will be submitted and published in a scientific peer-reviewed journal.Trial registration numberUMIN000024069; Pre-results.
Viability testing and transplantation of marginal livers (VITTAL) using normothermic machine perfusion: study protocol for an open-label, non-randomised, prospective, single-arm trial
Authors: Laing Richard W , Mergental Hynek , Yap Christina , Kirkham Amanda , Whilku Manpreet , Barton Darren , Curbishley Stuart , Boteon Yuri L , Neil Desley A , Hübscher Stefan G , Perera M Thamara P R , Muiesan Paolo , Isaac John , Roberts Keith J , Cilliers Hentie , Afford Simon C , Mirza Darius F 
Published: May 2024

IntroductionThe use of marginal or extended criteria donor livers is increasing. These organs carry a greater risk of initial dysfunction and early failure, as well as inferior long-term outcomes. As such, many are rejected due to a perceived risk of use and use varies widely between centres. Ex situ normothermic machine perfusion of the liver (NMP-L) may enable the safe transplantation of organs that meet defined objective criteria denoting their high-risk status and are currently being declined for use by all the UK transplant centres.Methods and analysisViability testing and transplantation of marginal livers is an open-label, non-randomised, prospective, single-arm trial designed to determine whether currently unused donor livers can be salvaged and safely transplanted with equivalent outcomes in terms of patient survival. The procured rejected livers must meet predefined criteria that objectively denote their marginal condition. The liver is subjected to NMP-L following a period of static cold storage. Organs metabolising lactate to ≤2.5 mmol/L within 4 hours of the perfusion commencing in combination with two or more of the following parameters—bile production, metabolism of glucose, a hepatic arterial flow rate ≥150 mL/min and a portal venous flow rate ≥500 mL/min, a pH ≥7.30 and/or maintain a homogeneous perfusion—will be considered viable and transplanted into a suitable consented recipient. The coprimary outcome measures are the success rate of NMP-L to produce a transplantable organ and 90-day patient post-transplant survival.Ethics and disseminationThe protocol was approved by the National Research Ethics Service (London—Dulwich Research Ethics Committee, 16/LO/1056), the Medicines and Healthcare Products Regulatory Agency and is endorsed by the National Health Service Blood and Transplant Research, Innovation and Novel Technologies Advisory Group. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications.Trial registration numberNCT02740608; Pre-results.
Minimally invasive surgery versus open surgery in the treatment of lumbar spondylolisthesis: study protocol of a multicentre, randomised controlled trial (MISOS trial)
Authors: Arts Mark P , Wolfs Jasper FC , Kuijlen Jos MA , de Ruiter Godard CW 
Published: May 2024

IntroductionPatients with symptomatic spondylolisthesis are frequently treated with nerve root decompression, in addition to pedicle screw fixation and interbody fusion. Minimally invasive approaches are gaining attention in recent years, although there is no clear evidence supporting the proclamation of minimally invasive spine surgery (MISS) being better than open surgery. We present the design of the MISOS (Minimal Invasive Surgery versus Open Surgery) trial on the effectiveness of MISS versus open surgery in patients with degenerative or spondylolytic spondylolisthesis.Methods and analysisAll patients (age 18–75 years) with neurogenic claudication or radicular leg pain based on low-grade degenerative or spondylolytic spondylolisthesis with persistent complaints for at least 3 months are eligible. Patients will be randomised into mini-open decompression with bilateral interbody fusion with percutaneous pedicle screw fixation (MISS), or conventional surgery with decompression and instrumented fusion with pedicle screws and bilateral interbody fusion (open). The primary outcome measure is Visual Analogue Scale of self-reported low back pain. Secondary outcome measures include improvement of leg pain, Oswestry Disability Index, patients’ perceived recovery, quality of life, resumption of work, complications, blood loss, length of hospital stay, incidence of reoperations and documentation of fusion. This study is designed as a multicentre, randomised controlled trial in which two surgical techniques are compared in a parallel group design. Based on a 20 mm difference of low back pain score at 6 weeks (power of 90%, assuming 8% loss to follow-up), a total of 184 patients will be needed. All analyses will be performed according to the intention-to-treat principle.Ethics and disseminationThe study has been approved by the Medical Ethical Review Board Southwest Holland in August 2014 (registration number NL 49044.098.14) and subsequently approved by the board of all participating hospitals. Dissemination will include peer-reviewed publications and presentations at national and international conferences.Trial registration numberNTR 4532, pre-results.
Prevalence of pregnancy-related pelvic girdle pain and associated factors in Australia: a cross-sectional study protocol
Authors: Ceprnja Dragana , Chipchase Lucinda , Gupta Amitabh 
Published: May 2024

IntroductionPregnancy-related pelvic girdle pain (PPGP) is a common musculoskeletal disorder. Women with PPGP report difficulty performing everyday functional activities, such as standing and walking. However, the magnitude of the problem remains unknown in Australia. It is important to determine how many women are affected by this condition and the factors associated with PPGP as this will direct healthcare services to being able to better manage women during pregnancy. Thus, this study aims to determine the prevalence of PPGP and associated factors in a Western Sydney population.Methods and analysisThis study is a cross-sectional study to be conducted at a single hospital in Australia. Participants will be over 18 years of age, between 14 and 38 weeks gestation and recruited randomly from all pregnant women attending antenatal care. Participants will have anthropomorphic measures recorded, such as height and body weight, and be asked to complete questionnaires about their current pregnancy, sociodemographic information, ethnoculture, occupational factors and participation in functional activities. The classification of PPGP will be made as per the published guidelines and will include a physical examination.Ethics and disseminationEthical approval has been granted by the Human Research Ethics Committees of Westmead Hospital, Sydney, and Western Sydney University, Sydney. Dissemination of results will be via journal articles and conference presentations.Trial registration numberACTRN12617000904370.
Neoadjuvant S-1 with concurrent radiotherapy followed by surgery for borderline resectable pancreatic cancer: study protocol for an open-label, multicentre, prospective phase II trial (JASPAC05)
Authors: Takahashi Shinichiro , Ohno Izumi , Ikeda Masafumi , Kobayashi Tatsushi , Akimoto Tetsuo , Kojima Motohiro , Konishi Masaru , Uesaka Katsuhiko 
Published: May 2024

IntroductionBorderline resectable pancreatic cancer (BRPC) can involve the portal vein, superior mesenteric vein, superior mesenteric artery, coeliac axis or hepatic artery, and has a high probability of positive surgical margins and poor prognosis after resection. Neoadjuvant chemoradiation is expected to provide substantial local control and prolong survival in patients with BRPC.Methods and analysisThis open-label, multicentre, prospective phase II trial will assess S-1 with concurrent radiotherapy as preoperative treatment for BRPC. Participants will receive S-1 (40 mg/m2twice daily) and concurrent radiotherapy (50.4 Gy in 28 fractions), with restaging and surgery after 3–8 weeks. Recruitment will be for a 36-month period with a minimum 24-month follow-up. The primary endpoint is the R0 resection rate for BRPC confirmed with central review. The secondary endpoints are overall survival, disease-free survival, response rate to neoadjuvant chemoradiation, pathological response rate, 2-year survival rate, surgical morbidity rate and acute and late toxicity rates. Objectives include quantifying the number of participants per year to evaluate whether randomised trials can be performed for this rare tumour.Ethics and disseminationThis trial has been approved by the National Cancer Center Institutional Review Board. Written informed consent will be obtained from all participants. Serious adverse events will be reported to the safety desk of the trial, the Data and Safety Monitoring Board and trial sites. Trial results will be submitted for peer-reviewed publication.Trial registration numberPre-results, UMIN000009172.
Stepped care approach for medial tibiofemoral osteoarthritis (STrEAMline): protocol for a randomised controlled trial
Authors: Robbins Sarah Rubia , Melo Luciano Ricardo S , Urban Hema , Deveza Leticia A , Asher Rebecca , Johnson Victoria L , Hunter David J 
Published: May 2024

IntroductionCurrent guidelines recommend tailored interventions to optimise knee osteoarthritis (OA) management. However, models of care still have a ‘one size fits all’ approach, which is suboptimal as it ignores patient heterogeneity. This study aims to compare a stepped care strategy with standard care for overweight and obese persons with medial tibiofemoral OA.Methods and analysisParticipants will be randomised into two groups (85 each). The intervention will receive a diet and exercise programme for 18 weeks in the first step of the study. Disease remission will then be assessed using the Patient Acceptable Symptom State (PASS). PASS is defined as the highest level of symptom beyond which patients consider themselves well and takes into account pain intensity, patient’s global assessment of disease activity and degree of functional impairment. In the second step, participants in remission will continue with diet and exercise. If remission is not achieved, participants will be assigned in a hierarchical order to cognitive behavioural therapy, knee brace or muscle strengthening for 12 weeks. The intervention will be decided based on their clinical presentation for symptoms of depression and varus malalignment. Participants without depression or varus malalignment will undertake a muscle strengthening programme. The control group will receive educational material related to OA management. Main inclusion criteria are age ≥50 years, radiographic medial tibiofemoral OA, body mass index (BMI) ≥28 kg/m2, knee pain ≥40 (Visual Analogue Scale, 0–100), PASS (0–100) >32 for pain and global assessment, and 31 for functional impairment. Outcomes will be measured at 20-week and 32-week visits. The primary outcome is disease remission at 32 weeks. Other outcomes include functional mobility; patient-reported outcomes; BMI; waist-hip ratio; quadriceps strength; symptoms of depression, anxiety and stress; and knee range of motion. The analysis will be performed according to the intention-to-treat principle.Ethics and disseminationThe local ethics committee approved this protocol (HREC/14/HAWKE/381). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals.Trial registration numberACTRN12615000227594.