bluuebunny/crossref_metadata_2025_split huggingface dataset:
Electroacupuncture as a complement to usual care for patients with non-acute low back pain after back surgery: a pilot randomised controlled trial
Authors: Heo In , Hwang Man-Suk , Hwang Eui-Hyoung , Cho Jae-Heung , Ha In-Hyuk , Shin Kyung-Min , Lee Jun-Hwan , Kim Nam-Kwen , Son Dong-Wuk , Shin Byung-Cheul 
Published: April 2023

ObjectivesThe aim of this pilot study was to estimate the sample size for a large pragmatic study of the comparative effectiveness of electroacupuncture (EA) for low back pain (LBP) after back surgery.DesignA randomised, active-controlled, assessor-blinded trial.ParticipantsPatients with recurrent or persistent LBP, defined as a Visual Analogue Scale (VAS) score of ≥50 mm, with or without leg pain after back surgery.InterventionsPatients were randomised to an EA plus usual care (UC) group or to a UC alone group at a 1:1 ratio. Patients assigned to each group received UC, including drug therapy, physical therapy and back pain education, twice a week for 4 weeks; those assigned to the EA plus UC group additionally received EA.Outcome measuresThe primary outcome was severity of LBP as measured by VAS. Secondary outcomes included back pain-related disability, assessed using the Oswestry Disability Index (ODI) and quality of life, assessed using the EuroQol Five Dimensions (EQ-5D) questionnaire. Statistical analysis was performed using paired and independent t-tests. A p value of <0.05 was considered statistically significant.ResultsThirty-nine patients were allocated to receive EA plus UC (n=18) or UC alone (n=21). There was no statistically significant difference in VAS or EQ-5D scores between the two groups, but there was a significant decrease in ODI scores (p=0.0081). Using G*Power, it was calculated that 40 participants per group would be needed for a future trial according to VAS scores. Considering for a 25% dropout rate, 108 participants (54 per group) would be needed.ConclusionsA future trial addressing the risk of bias and including the estimated sample size would allow for better clinical assessment of the benefits of EA plus UC in treatment of patients with non-acute pain after back surgery.Trial registration numberNCT01966250.
How does exercise dose affect patients with long-term osteoarthritis of the knee? A study protocol of a randomised controlled trial in Sweden and Norway: the SWENOR Study
Authors: Torstensen Tom Arild , Grooten Wilhelmus J A , Østerås Håvard , Heijne Annette , Harms-Ringdahl Karin , Äng Björn Olov 
Published: April 2023

IntroductionOsteoarthritis (OA) of the knee is characterised by knee pain, disability and degenerative changes, and places a burden on societies all over the world. Exercise therapy is an often-used modality, but there is little evidence of what type of exercise dose is the most effective, indicating a need for controlled studies of the effect of different dosages. Thus, the aim of the study described in this protocol is to evaluate the effects of high-dose versus low-dose medical exercise therapy (MET) in patients with knee OA.Methods and analysisThis is a multicentre prospective randomised two-arm trial with blinded assessment and data analysis. We are planning to include 200 patients aged 45–85 years with symptomatic (pain and decreased functioning) and X-ray verified diagnosis of knee OA. Those eligible for participation will be randomly allocated to either high-dose (n=100) or low-dose (n=100) MET. All patients receive three supervised treatments each week for 12 weeks, giving a total of 36 MET sessions. The high-dose group exercises for 70–90 min compared with 20–30 min for the low-dose group. The high-dose group exercises for a longer time, and receives a greater number of exercises with more repetitions and sets. Background and outcome variables are recorded at inclusion, and outcome measures are collected after every sixth treatment, at the end of treatment, and at 6-month and 12-month follow-ups. Primary outcome is self-rated knee functioning and pain using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The primary end point is at the end of treatment after 3 months, and secondary end points are at 6 months and 12 months after the end of treatment.Ethics and disseminationThis project has been approved by the Regional Research Ethics Committees in Stockholm, Sweden, and in Norway. Our results will be submitted to peer-reviewed journals and presented at national and international conferences.Trial registration numberNCT02024126
IndEcho study: cohort study investigating birth size, childhood growth and young adult cardiovascular risk factors as predictors of midlife myocardial structure and function in South Asians
Authors: Vasan Senthil K , Roy Ambuj , Samuel Viji Thomson , Antonisamy Belavendra , Bhargava Santosh K , Alex Anoop George , Singh Bhaskar , Osmond Clive , Geethanjali Finney S , Karpe Fredrik , Sachdev Harshpal , Agrawal Kanhaiya , Ramakrishnan Lakshmy , Tandon Nikhil , Thomas Nihal , Premkumar Prasanna S , Asaithambi Prrathepa , Princy Sneha F X , Sinha Sikha , Paul Thomas Vizhalil , Prabhakaran Dorairaj , Fall Caroline H D 
Published: April 2023

IntroductionSouth Asians have high rates of cardiovascular disease (CVD) and its risk factors (hypertension, diabetes, dyslipidaemia and central obesity). Left ventricular (LV) hypertrophy and dysfunction are features of these disorders and important predictors of CVD mortality. Lower birth and infant weight and greater childhood weight gain are associated with increased adult CVD mortality, but there are few data on their relationship to LV function. The IndEcho study will examine associations of birth size, growth during infancy, childhood and adolescence and CVD risk factors in young adulthood with midlife cardiac structure and function in South Asian Indians.Methods and analysisWe propose to study approximately 3000 men and women aged 43–50 years from two birth cohorts established in 1969–1973: the New Delhi Birth Cohort (n=1508) and Vellore Birth Cohort (n=2156). They had serial measurements of weight and height from birth to early adulthood. CVD risk markers (body composition, blood pressure, glucose tolerance and lipids) and lifestyle characteristics (tobacco and alcohol consumption, physical activity, socioeconomic status) were assessed at age ~30 years. Clinical measurements in IndEcho will include anthropometry, blood pressure, biochemistry (glucose, fasting insulin and lipids, urinary albumin/creatinine ratio) and body composition by dual energy X-ray absorptiometry and bioelectrical impedance. Outcomes are LV mass and indices of LV systolic and diastolic function assessed by two-dimensional and Doppler echocardiography, carotid intimal-media thickness and ECG indicators of ischaemia. Regression and conditional growth models, adjusted for potential confounders, will be used to study associations of childhood and young adult exposures with these cardiovascular outcomes.Ethics and disseminationThe study has been approved by the Health Ministry Steering Committee, Government of India and institutional ethics committees of participating centres in India and the University of Southampton, UK. Results will be disseminated through scientific meetings and peer-reviewed journals.TrialregistrationnumberNCT13432279.
Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR)
Authors: Baldi Enrico , Contri Enrico , Burkart Roman , Borrelli Paola , Ferraro Ottavia Eleonora , Tonani Michela , Cutuli Amedeo , Bertaia Daniele , Iozzo Pasquale , Tinguely Caroline , Lopez Daniel , Boldarin Susi , Deiuri Claudio , Dénéréaz Sandrine , Dénéréaz Yves , Terrapon Michael , Tami Christian , Cereda Cinzia , Somaschini Alberto , Cornara Stefano , Cortegiani Andrea 
Published: April 2023

IntroductionOut-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR.Methods and analysisThis is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR).Ethics and dissemination. Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository.Trial registration numberNCT02632500.
Efficacy of practising Tai Chi for older people with mild dementia: protocol for a randomised controlled study
Authors: Lyu Jihui , Li Wenjie , Rong Xiangjiang , Wei Lian , Huang Nayan , Champ Mei , Xiong Qian , Chen Xueli , Li Mo , Li Fangling 
Published: April 2023

IntroductionMany studies suggest that Tai Chi exercise is a safe and appropriate mind-body exercise for older people and effectively slows down age-related cognitive decline. A set of bespoke Tai Chi exercise named ‘Cognition Protecting Tai Chi’ (CPT) has been created for older people with cognitive impairments by the research team of geriatricians, neurologists, rehabilitation specialists, experts of sports medicine and experienced practitioners of traditional Chinese medicine. This trial is designed to evaluate its effects on cognitive function, behaviour/moods, risk of falls and activities of daily living of the participants with mild dementia.Methods and analysisA randomised controlled study will be conducted. Eighty participants with mild dementia will be recruited and randomly allocated to an intervention group and a control group. The intervention group will practice the CPT exercise three times a week for 20 min each time under the guidance of professional therapists. The control group will continue receiving their routine treatments. The duration of this study will be 10 months. All participants will be assessed with a battery of neuropsychological and functional evaluations, which include Mini Mental State Examination, Montreal Cognitive Assessment, the WHO-University of California Los Angeles-Auditory Verbal Learning test (WHO-UCLA-AVLT), Trail Making Test (TMT), Geriatric Depression Scale, Neuropsychological Inventory and Barthel Index, at the baseline, 5 and 10 months during the study period. Fall incident will also be recorded. The primary outcome will be the WHO-UCLA-AVLT delayed recall score. The secondary outcome will be the TMT score.Ethics and disseminationThis study has been approved by the ethical review committee of the Beijing Geriatric Hospital (protocol number: 2015–021). Informed consent will be obtained from all participants or their guardians. The authors intend to submit the findings of the study to peer-reviewed journals or academic conferences to be published.Trial registration numberNCT16009872; Pre-results.
Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol
Authors: McAuley Sybil A , de Bock Martin I , Sundararajan Vijaya , Lee Melissa H , Paldus Barbora , Ambler Geoff R , Bach Leon A , Burt Morton G , Cameron Fergus J , Clarke Philip M , Cohen Neale D , Colman Peter G , Davis Elizabeth A , Fairchild Jan M , Hendrieckx Christel , Holmes-Walker D Jane , Horsburgh Jodie C , Jenkins Alicia J , Kaye Joey , Keech Anthony C , King Bruce R , Kumareswaran Kavita , MacIsaac Richard J , McCallum Roland W , Nicholas Jennifer A , Sims Catriona , Speight Jane , Stranks Stephen N , Trawley Steven , Ward Glenn M , Vogrin Sara , Jones Timothy W , O’Neal David N 
Published: April 2023

IntroductionManual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective of the present study is to determine the effectiveness of 6 months’ closed-loop compared with manually determined insulin dosing on time-in-target glucose range in adults with type 1 diabetes.Methods and analysisThis open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. Participants will then be randomised 1:1 either to 26 weeks of MiniMed 670G hybrid closed-loop system therapy (Medtronic, Northridge, CA, USA) or continuation of their current diabetes therapy. The hybrid closed-loop system delivers insulin automatically to address basal requirements and correct to target glucose level, while bolus doses for meals require user initiation and carbohydrate estimation. Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9–10.0 mmol/L) during the final 3 weeks of intervention. Secondary outcomes include: other CGM parameters, HbA1c, severe hypoglycaemia, psychosocial well-being, sleep, cognition, electrocardiography, costs, quality of life, biomarkers of vascular health and hybrid closed-loop system performance. Semistructured interviews will assess the expectations and experiences of a subgroup of hybrid closed-loop users.Ethics and disseminationThe study has Human Research Ethics Committee approval. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated at scientific conferences and via peer-reviewed publications.Trial registration numberNCT12617000520336.
A Reduction in Time with Electronic Monitoring In Stroke (ARTEMIS): study protocol for a randomised multicentre trial
Authors: Koster Gaia T , Nguyen T Truc My , Groot Adrien E D , Coutinho Jonathan M , Bosch Jan , den Hertog Heleen M , van Walderveen Marianne A A , Algra Ale , Wermer Marieke J H , Roos Yvo B , Kruyt Nyika D 
Published: April 2023

IntroductionTime is the most crucial factor limiting efficacy of intravenous thrombolysis (IVT) and intra-arterial thrombectomy (IAT). The delay between alarming the Emergency Medical Services (EMS) dispatch office and IVT/IAT initiation, that is, the‘total system delay’(TSD), depends on logistics and team effort. A promising method to reduce TSD is real-time audio-visual feedback to caregivers involved. With ‘A Reduction in Time with Electronic Monitoring in Stroke’ (ARTEMIS), we aim to investigate the effect of real-time audio-visual feedback on actual TSD to IVT/IAT to caregivers.Methods and analysisARTEMIS is a multiregional, multicentre, randomised open end-point trial including patients ≥18 years considered IVT/IAT-eligible by the EMS dispatch office or on-site EMS personnel. Patients are electronically tracked and randomised for real-time audio-visual feedback on TSD to caregivers via premounted handhelds and tablets throughout the TSD trajectory. Primary outcome is TSD to IVT/IAT. Secondary outcomes comprise proportion of IVT/IAT-treated patients, symptomatic intracerebral haemorrhage, IVT/IAT-treated stroke mimics, clinical outcome after three months and cost-effectiveness. Separate analyses for IAT-patients with or without prior IVT, within or out of office hours and EMS region will be performed. With 75 IAT-patients and 225 IVT-patients in each arm, we will be able to demonstrate a 20 min difference in TSD to IAT and a 10 min difference in TSD to IVT (p=0.05 and power=0.8).Ethics and disseminationStudy findings will be disseminated through peer-reviewed journals and (inter)national conference presentations.Trial registration numberNCT02808806
Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL)
Authors: Hjelmesæth Jøran , Åsberg Anders , Andersson Shalini , Sandbu Rune , Robertsen Ida , Johnson Line Kristin , Angeles Philip Carlo , Hertel Jens Kristoffer , Skovlund Eva , Heijer Maria , Ek Anna-Lena , Krogstad Veronica , Karlsen Tor-Ivar , Christensen Hege , Andersson Tommy B , Karlsson Cecilia 
Published: April 2023

IntroductionRoux-en-Y gastric bypass (GBP) is associated with changes in cardiometabolic risk factors and bioavailability of drugs, but whether these changes are induced by calorie restriction, the weight loss or surgery per se, remains uncertain. The COCKTAIL study was designed to disentangle the short-term (6 weeks) metabolic and pharmacokinetic effects of GBP and a very low energy diet (VLED) by inducing a similar weight loss in the two groups.Methods and analysisThis open, non-randomised, three-armed, single-centre study is performed at a tertiary care centre in Norway. It aims to compare the short-term (6 weeks) and long-term (2 years) effects of GBP and VLED on, first, bioavailability and pharmacokinetics (24 hours) of probe drugs and biomarkers and, second, their effects on metabolism, cardiometabolic risk factors and biomarkers. The primary outcomes will be measured as changes in: (1) all six probe drugs by absolute bioavailability area under the curve (AUCoral/AUCiv) of midazolam (CYP3A4 probe), systemic exposure (AUCoral) of digoxin and rosuvastatin and drug:metabolite ratios for omeprazole, losartan and caffeine, levels of endogenous CYP3A biomarkers and genotypic variation, changes in the expression and activity data of the drug-metabolising, drug transport and drug regulatory proteins in biopsies from various organs and (2) body composition, cardiometabolic risk factors and metabolic biomarkers.Ethics and disseminationThe COCKTAIL protocol was reviewed and approved by the Regional Committee for Medical and Health Research Ethics (Ref: 2013/2379/REK sørøst A). The results will be disseminated to academic and health professional audiences and the public via presentations at conferences, publications in peer-reviewed journals and press releases and provided to all participants.Trial registration numberNCT02386917.
Using mobile health technology and community health workers to identify and refer caesarean-related surgical site infections in rural Rwanda: a randomised controlled trial protocol
Authors: Sonderman Kristin A , Nkurunziza Theoneste , Kateera Fredrick , Gruendl Magdalena , Koch Rachel , Gaju Erick , Habiyakare Caste , Matousek Alexi , Nahimana Evrard , Ntakiyiruta Georges , Riviello Robert , Hedt-Gauthier Bethany L 
Published: April 2023

IntroductionSurgical site infections (SSIs) are a significant cause of morbidity and mortality in low-income and middle-income countries, where rates of SSIs can reach 30%. Due to limited access, there is minimal follow-up postoperatively. Community health workers (CHWs) have not yet been used for surgical patients in most settings. Advancements in telecommunication create an opportunity for mobile health (mHealth) tools to support CHWs. We aim to evaluate the use of mHealth technology to aid CHWs in identification of SSIs and promote referral of patients back to healthcare facilities.Methods and analysisProspective randomised controlled trial conducted at Kirehe District Hospital, Rwanda, from November 2017 to November 2018. Patients ≥18 years who undergo caesarean section are eligible. Non-residents of Kirehe District or patients who remain in hospital >10 days postoperatively will be excluded. Patients will be randomised to one of three arms. For arm 1, a CHW will visit the patient’s home on postoperative day 10 (±3 days) to administer an SSI screening protocol (fever, pain or purulent drainage) using an electronic tablet. For arm 2, the CHW will administer the screening protocol over the phone. For both arms 1 and 2, the CHW will refer patients who respond ‘yes’ to any of the questions to a health facility. For arm 3, patients will not receive follow-up care. Our primary outcome will be the impact of the mHealth-CHW intervention on the rate of return to care for patients with an SSI.Ethics and disseminationThe study has received ethical approval from the Rwandan National Ethics Committee and Partners Healthcare. Results will be disseminated to Kirehe District Hospital, Rwanda Ministry of Health, Rwanda Surgical Society, Partners In Health, through conferences and peer-reviewed publications.Trial registration numberNCT03311399.
Treatment options in idiopathic subglottic stenosis: protocol for a prospective international multicentre pragmatic trial
Authors: Gelbard Alexander , Shyr Yu , Berry Lynne , Hillel Alexander T , Ekbom Dale C , Edell Eric S , Kasperbauer Jan L , Lott David G , Donovan Donald T , Garrett C. Gaelyn , Sandhu Guri , Daniero James J , Netterville James L , Schindler Josh S , Smith Marshall E , Bryson Paul C , Lorenz Robert R , Francis David O 
Published: April 2023

IntroductionIdiopathic subglottic stenosis (iSGS) is an unexplained progressive obstruction of the upper airway that occurs almost exclusively in adult, Caucasian women. The disease is characterised by mucosal inflammation and localised fibrosis resulting in life-threatening blockage of the upper airway. Because of high recurrence rates, patients with iSGS will frequently require multiple procedures following their initial diagnosis. Both the disease and its therapies profoundly affect patients’ ability to breathe, communicate and swallow. A variety of treatments have been advanced to manage this condition. However, comparative data on effectiveness and side effects of the unique approaches have never been systematically evaluated. This study will create an international, multi-institutional prospective cohort of patients with iSGS. It will compare three surgical approaches to determine how well the most commonly used treatments in iSGS ‘work’ and what quality of life (QOL) trade-offs are associated with each approach.Methods and analysisA prospective pragmatic trial comparing the ‘Standard of Care’ for iSGS at multiple international institutions. Patients with a diagnosis of iSGS without clinical or laboratory evidence of vasculitis or a history of endotracheal intubation 2 years prior to symptom onset will be included in the study. Prospective evaluation of disease recurrence requiring operative intervention, validated patient-reported outcome (PRO) measures as well as patient-generated health data (mobile peak flow recordings and daily steps taken) will be longitudinally tracked for 36 months. The primary endpoint is treatment effectiveness defined as time to recurrent operative procedure. Secondary endpoints relate to treatment side effects and include PRO measures in voice, swallowing, breathing and global QOL as well as patient-generated health data.Ethics and disseminationThis protocol was approved by the local IRB Committee of the Vanderbilt University Medical Center in July 2015. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and directly to patient with iSGS via social media-based support groups.Trial registration numberNCT02481817.