Articles

The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age)

In the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units’ workload. Neonato...

Authors: Eleanor J. Mitchell, Garry Meakin, Josie Anderson, Jon Dorling, Chris Gale, Rachel Haines, Charlotte Kenyan, Mark J. Johnson, William McGuire, Hema Mistry, Alan Montgomery, Sam Oddie, Reuben Ogollah, Phoebe Pallotti, Christopher Partlett, Kate F. Walker…

Individualized positive end-expiratory pressure guided by end-expiratory lung volume in early acute respiratory distress syndrome: study protocol for the multicenter, randomized IPERPEEP trial

In acute respiratory distress syndrome (ARDS), response to positive end-expiratory pressure (PEEP) is variable according to different degrees of lung recruitability. The search for a tool to individualize PEEP...

Authors: Domenico Luca Grieco, Salvatore Maurizio Maggiore, Giacomo Bellani, Savino Spadaro, Elena Spinelli, Tommaso Tonetti, Luca S. Menga, Marco Pozzi, Denise Battaglini, Rosa Di Mussi, Andrea Bruni, Andrea De Gaetano, Carmine Giovanni Iovino, Matteo Brioni, Francesco Mojoli, Giuseppe Foti…

Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments

The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epid...

Authors: Caroline Cake, Emma Ogburn, Heather Pinches, Garry Coleman, David Seymour, Fran Woodard, Sinduja Manohar, Marjia Monsur, Martin Landray, Gaynor Dalton, Andrew D. Morris, Patrick F. Chinnery, F. D. Richard Hobbs and Christopher Butler

Effectiveness of the Shenzhuo formula in the treatment of patients with macroalbuminuria secondary to diabetic kidney disease: protocol update and statistical analysis plan

Diabetic kidney disease (DKD) is a significant complication of diabetes and has garnered considerable attention. Our previous retrospective study indicated that Shenzhuo formula (SZF) potentially reduces macro...

Authors: Yu Wei, Yi-Shan Huang, Ze Yang, Xinmiao Wang, Yanbo Li, Ying Zhang, Lin-Hua Zhao and Xiaolin Tong

Primary care disease management for venous leg ulceration—study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126)

Venous leg ulcers (VLU) have a prevalence of 1–2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation. Evidence-based outpatien...

Authors: Jonas D. Senft, Thomas Fleischhauer, Jona Frasch, Wiebke van Rees, Manuel Feißt, Simon Schwill, Christine Fink, Regina Poß-Doering, Michel Wensing, Uwe Müller-Bühl and Joachim Szecsenyi

Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial

Alcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available treatments. Insomnia is a robust predictor of relapse and pilot studies have...

Authors: J. Todd Arnedt, M. Elizabeth Cardoni, Deirdre A. Conroy, Mandilyn Graham, Sajni Amin, Kipling M. Bohnert, Andrew D. Krystal and Mark A. Ilgen

Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial

Coronavirus disease 2019 (COVID-19) caused by the novel coronavirus-infected millions globally. Despite a wide range of advised options for the treatment of COVID-19, a single strategy to tackle this pandemic ...

Authors: Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Iqra Farooq, Rutaba Akmal, Muhammad Ahmad Imran, Larab Kalsoom, Sidra Ashraf, Sundas Rafique, Muhammad Ghufran, Muhammad Kiwan Akram, Sohaib-ur-Rehman, Muhammad Faisal Nadeem, Nazish Matti, Uzma Nasim Siddiqui, Ayesha Humayun…

Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy—the MecMeth/NOA-24 trial

Glioblastoma is the most frequent and malignant primary brain tumor. Even in the subgroup with O-6-methylguanine-DNA methyltransferase (MGMT) promoter methylation and favorable response to first-line therapy, ...

Authors: Thomas Zeyen, Anna-Laura Potthoff, Robert Nemeth, Dieter H. Heiland, Michael C. Burger, Joachim P. Steinbach, Peter Hau, Ghazaleh Tabatabai, Martin Glas, Uwe Schlegel, Oliver Grauer, Dietmar Krex, Oliver Schnell, Roland Goldbrunner, Michael Sabel, Niklas Thon…

Tranexamic acid to prevent operation in chronic subdural haematoma (TORCH): study protocol for a randomised placebo-controlled clinical trial

Chronic subdural haematoma (cSDH) occurs mainly in the elderly. Surgical evacuation is effective, but in these old, often frail, patients with multi-comorbidity, surgery carries significant risks for future co...

Authors: S. Immenga, R. Lodewijkx, Y. B. W. E. M. Roos, S. Middeldorp, C. B. L. M. Majoie, H. C. Willems, W. P. Vandertop and D. Verbaan

Laparoscopically guided transversus abdominis plane block versus local wound analgesia in laparoscopic surgery for peritoneal endometriosis: study protocol for a prospective randomized controlled double-blinded LTAP-trial

Ultrasound-guided transversus abdominis plane block (TAP) performed by anesthesiologist has been shown to be an effective and safe analgesia method in abdominal surgery, reducing postoperative opioid consumpti...

Authors: Anna Terho, Terhi Puhto, Johanna Laru, Outi Uimari, Pasi Ohtonen, Tero Rautio and Sari Koivurova

Achieving Quality and Effectiveness in Dementia Using Crisis Teams (AQUEDUCT): a study protocol for a randomised controlled trial of a Resource Kit

Improving care at home for people with dementia is a core policy goal in the dementia strategies of many European countries. A challenge to effective home support is the occurrence of crises in the care of peo...

Authors: Donna Maria Coleston-Shields, David Challis, Angela Worden, Emma Broome, Tom Dening, Boliang Guo, Juanita Hoe, Brynmor Lloyd-Evans, Esme Moniz-Cook, Steve Morris, Fiona Poland, David Prothero and Martin Orrell

10.6-μm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial

Diabetic peripheral neuropathy (DPN) is the most common chronic neurological complication. It is the main cause of disability in diabetes mellitus (DM) patients and seriously affects the quality of life of pat...

Authors: Lin Lin, Yi Chen, Yuxia Li, Ke Cheng, Haiping Deng, Jianping Lu, Ling Zhao and Xueyong Shen

Statistical analysis plan for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation

Delayed graft function, or the requirement for dialysis due to poor kidney function, is a frequent complication of deceased donor kidney transplantation that is associated with inferior outcomes. Intravenous f...

Authors: Elaine M. Pascoe, Steven J. Chadban, Magid A. Fahim, Carmel M. Hawley, David W. Johnson and Michael G. Collins

Mental imagery interventions to promote face covering use among UK university students and employees during the COVID-19 pandemic: study protocol for a randomized controlled trial.

The 2020 COVID-19 pandemic has witnessed wide-ranging efforts to minimize the spread of the virus and to protect those most vulnerable to becoming unwell following viral infection. Core COVID-19 preventive mea...

Authors: Dominic Conroy

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

It is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that partic...

Authors: Lydia O’Sullivan, Stefano Savinelli, Stephen O’Hare, Sinéad Holden, Ciara McHugh, Patrick Mallon and Peter Doran

Effectiveness of referral to a population-level telephone coaching service for improving health risk behaviours in people with a mental health condition: study protocol for a randomised controlled trial

People with a mental health condition have a shorter life expectancy than the general population. This is largely attributable to higher rates of chronic disease and a higher prevalence of modifiable health ri...

Authors: Grace Hanly, Elizabeth Campbell, Kate Bartlem, Julia Dray, Caitlin Fehily, Tegan Bradley, Sonya Murray, Christophe Lecathelinais, John Wiggers, Luke Wolfenden, Kate Reid, Tahlia Reynolds and Jenny Bowman

Correction to: The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial

Authors: Phepo Mogoba, Maia Lesosky, Allison Zerbe, Joana Falcao, Claude Ann Mellins, Christopher Desmond, Carlos Arnaldo, Bill Kapogiannis, Landon Myer and Elaine J. Abrams

Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)—trial protocol

The acute respiratory distress syndrome (ARDS) occurs in response to a variety of insults, and mechanical ventilation is life-saving in this setting, but ventilator-induced lung injury can also contribute to t...

Authors: Brijesh Patel, Sharon Mumby, Nicholas Johnson, Emanuela Falaschetti, Jorgen Hansen, Ian Adcock, Danny McAuley, Masao Takata, Dan S. Karbing, Matthieu Jabaudon, Peter Schellengowski and Stephen E. Rees

Effectiveness of a high-intensive trauma-focused, family-based therapy for youth exposed to family violence: study protocol for a randomized controlled trial

Family violence is a common problem with direct adverse effects on children as well as indirect effects through disruption of parenting and parent-child relationships. The complex interrelationships between fa...

Authors: Caroline Jonkman, Margreet Visser, Marjolein Vandenbosch, Majone Steketee, Carlo Schuengel and Valerie Fictorie

Nicotinamide riboside as a neuroprotective therapy for glaucoma: study protocol for a randomized, double-blind, placebo-control trial

Whereas lowering the intraocular pressure (IOP) can slow optic nerve degeneration in glaucoma, many patients with glaucoma continue to develop progressive loss in vision despite a significant reduction in IOP....

Authors: Christopher Kai Shun Leung, Seraph Tianmin Ren, Poemen Pui Man Chan, Kelvin Ho Nam Wan, Aziz Ka Wai Kam, Gilda Wing Ki Lai, Vivian Sheung Man Chiu, Match Wai Lun Ko, Cedric Ka Fai Yiu and Marco Chak Yan Yu

Effects of the addition of transcutaneous electrical stimulation to non-pharmacological measures in labor pain: study protocol for a randomized controlled trial

Labor, although natural and physiological, is a period that can be marked by stress, pain, anxiety, suffering, fear, and anguish for a woman. Thus, non-pharmacological methods that reduce pain during labor are...

Authors: Naiara Toledo Dias, Patrícia Roberta Santos, Thais Alves Cândido, Rogério de Melo Costa Pinto, Ana Paula Magalhães Resende and Vanessa Santos Pereira-Baldon

Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach

In pragmatic trials, on-site partners, rather than researchers, lead intervention delivery, which may result in implementation variation. There is a need to quantitatively measure this variation. Applying the ...

Authors: Miranda B. Olson, Ellen M. McCreedy, Rosa R. Baier, Renée R. Shield, Esme E. Zediker, Rebecca Uth, Kali S. Thomas, Vincent Mor, Roee Gutman and James L. Rudolph

Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance

Tissue-agnostic drug development provides a paradigm shift in precision medicine and requires innovative trial designs. However, outcome selection for such trials can prove challenging. The objectives of this ...

Authors: Olalekan Lee Aiyegbusi, Lavinia Ferrante di Ruffano, Ameeta Retzer, Philip N. Newsome, Christopher D. Buckley and Melanie J. Calvert

Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial

The effectiveness of blood flow restriction training (BFR) in elderly with knee osteoarthritis (OA) is comparable to performing high-intensity protocols (70 to 80% of 1 RM [repetition maximum]) that are known ...

Authors: Roger Andrey Carvalho Jardim, Tamara Silva de Sousa, Wueyla Nicoly Nascimento dos Santos, Areolino Pena Matos and Natália Camargo Rodrigues Iosimuta

Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial

There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid...

Authors: Siobhan Wong, Leanne Hassett, Harriet Koorts, Anne Grunseit, Allison Tong, Anne Tiedemann, Colin J. Greaves, Abby Haynes, Andrew Milat, Lisa A. Harvey, Nicholas F. Taylor, Rana S. Hinman, Marina De Barros Pinherio, Matthew Jennings, Daniel Treacy, Sandra O’Rourke…

Pneumococcal conjugate vaccination schedules in infants—acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study

Pneumococcal conjugate vaccines (PCVs) effectively prevent pneumococcal disease, but the global impact of pneumococcal vaccination is hampered by its cost. The evaluation of reduced dose schedules of PCV inclu...

Authors: Grant A. Mackenzie, Isaac Osei, Rasheed Salaudeen, Ousman Secka, Umberto D’Alessandro, Ed Clarke, Jonas Schmidt-Chanasit, Paul V. Licciardi, Cattram Nguyen, Brian Greenwood and Kim Mulholland

Association between blood glucose levels and Glasgow Outcome Score in patients with traumatic brain injury: secondary analysis of a randomized trial

Blood glucose levels that are too high or too low after traumatic brain injury (TBI) negatively affect patient prognosis. This study aimed to demonstrate the relationship between blood glucose levels and the G...

Authors: Tao Yuan, Hongyu He, Yuepeng Liu, Jianwei Wang, Xin Kang, Guanghui Fu, Fangfang Xie, Aimin Li, Jun Chen and Wenxue Wang

Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial

Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed...

Authors: Xiaochen Yang, Lanping Liu, Xingjiang Xiong, Yun Zhang, Yongmei Liu, Hongzheng Li, Kuiwu Yao and Jie Wang

Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial

Dilated cardiomyopathy (DCMP) is characterized by ventricular chamber enlargement and systolic dysfunction which may cause heart failure. Patients with DCMP have overactivation of the renin-angiotensin-aldoste...

Authors: Sua Jo, Hyeyeon Moon, Kyungil Park, Chang-Bae Sohn, Jeonghwan Kim, Yong-Seop Kwon and Su Hong Kim

Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)—study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial

Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently...

Authors: Jan Maláska, Jan Stašek, František Duška, Martin Balík, Jan Máca, Jan Hruda, Tomáš Vymazal, Olga Klementová, Jan Zatloukal, Tomáš Gabrhelík, Pavel Novotný, Regina Demlová, Jana Kubátová, Jana Vinklerová, Adam Svobodník, Milan Kratochvíl…

Correction to: Working to increase stability through exercise (WISE): screening, recruitment, and baseline characteristics

Authors: Christopher N. Sciamanna, Noel H. Ballentine, Melissa Bopp, Vernon M. Chinchilli, Joseph T. Ciccolo, Gabrielle Delauter, Abigail Fisher, Edward J. Fox, Suzanne M. Jan De Beur, Kalen Kearcher, Jennifer L. Kraschnewski, Erik Lehman, Kathleen M. McTigue, Edward McAuley, Anuradha Paranjape, Sol Rodriguez-Colon…

Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial

The number of people with an alcohol use disorder (AUD) was recently estimated to be 63.5 million worldwide. The global burden of disease and injury attributable to alcohol is considerable: about 3 million dea...

Authors: Benjamin Petit, Agnès Soudry-Faure, Ludovic Jeanjean, Jack Foucher, Laurence Lalanne, Maud Carpentier, Lysiane Jonval, Coralie Allard, Mathilde Ravier, Amine Ben Mohamed, Vincent Meille and Benoit Trojak

Effects of acceptance and commitment therapy on self-management skills and psychological resilience of young and middle-aged patients underwent percutaneous transluminal coronary intervention for primary myocardial infarction: a pilot study

Acceptance and commitment therapy (ACT) is an intervention focusing on altering how patients relate to their thoughts. This study aimed to investigate the effects of ACT on self-management ability and psycholo...

Authors: Jiaoyu Cao, Panpan Sun, Lixiang Zhang, Xia Chen, Wenjuan Gui, Anping Ou, Kaibing Chen and Likun Ma

The SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program

Increasing participation in the Australian National Bowel Cancer Screening Program (NBCSP) is the most efficient and cost-effective way of reducing mortality associated with colorectal cancer by detecting and ...

Authors: Anna Wood, Jon D. Emery, Mark Jenkins, Patty Chondros, Tina Campbell, Edweana Wenkart, Clare O’Reilly, Tony Cowie, Ian Dixon, Julie Toner, Hourieh Khalajzadeh, Javiera Martinez Gutierrez, Linda Govan, Gemma Buckle and Jennifer G. McIntosh

Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)—protocol for a randomized clinical trial

It is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positionin...

Authors: L. Morales-Quinteros, M. J. Schultz, A. Serpa-Neto, M. Antonelli, D. L. Grieco, O. Roca, N. P. Juffermans, C. de Haro, D. de Mendoza, Ll. Blanch, M. Camprubí-Rimblas, Gemma Gomà and A. Artigas-Raventós

Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial

Currently, the standard treatment for locally advanced cervical cancer is concurrent chemoradiation (CCRT). The effect of neoadjuvant chemotherapy in advanced cervical cancer is controversial. Studies have sho...

Authors: Jing Li, Hua Liu, Ya Li, Jian Li, Lifei Shen, Wenqing Long, Chenmin Yang, Haoping Xu, Wenqi Xi, Rong Cai and Weiwei Feng

Nasal high-flow compared to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease—protocol for a randomized controlled noninferiority trial (ELVIS)

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a major negative impact on health status, rates of hospitalization, readmission, disease progression and mortality. Non-invasive venti...

Authors: Jens Bräunlich, Nicole Köppe-Bauernfeind, David Petroff, Annegret Franke and Hubert Wirtz

Multiple secondary outcome analyses: precise interpretation is important

Analysis of multiple secondary outcomes in a clinical trial leads to an increased probability of at least one false significant result among all secondary outcomes studied. In this paper, we question the notio...

Authors: Richard A. Parker and Christopher J. Weir

PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial

Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built ...

Authors: Krithika Suresh, Jodi Summers Holtrop, L. Miriam Dickinson, Emileigh Willems, Peter C. Smith, R. Mark Gritz and Leigh Perreault

Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study

An often heard and justifiable concern of ethnic minorities is related to researchers’ lack of attention to sharing the results of a study with participants after the study has concluded. Few studies have exam...

Authors: Jackie Bonilla, Alia Alhomsi, Jasmine Santoyo-Olsson, Anita L. Stewart, Carmen Ortiz, Cathy Samayoa, Alma Torres-Nguyen, Helen Palomino, La Verne Coleman, Aday Urias, Nayeli Gonzalez, Silvia Araceli Cervantes, Ysabel Duron and Anna María Nápoles

Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial

Knee osteoarthritis is a common disease with pain as the most prevalent symptom. Previous cohort studies have shown genicular artery embolization to reduce pain symptoms in patients with mild to moderate knee ...

Authors: T. A. van Zadelhoff, A. Moelker, S. M. A. Bierma-Zeinstra, P. K. Bos, G. P. Krestin and E. H. G. Oei

The effect of obstructive jaundice on the sensitivity of intravenous anesthetic of remimazolam: study protocol for a controlled multicenter trial

It is well known that obstructive jaundice could affect the pharmacodynamics of some anesthetics, and the sensitivity of some anesthetics would increase among icteric patients. Remimazolam is a new ultra-short...

Authors: Wen Liu, Bin Yang, Jun-Wei Ji, Hua Yang, Hong-Hao Song, Hai-Bo Qiu and Jin-Chao Song

ABBaH teens: Activity Breaks for Brain Health in adolescents: study protocol for a randomized crossover trial

Physical activity breaks are widely being implemented in school settings as a solution to increase academic performance and reduce sitting time. However, the underlying physiological mechanisms suggested to im...

Authors: Emerald G. Heiland, Karin Kjellenberg, Olga Tarassova, Maria Fernström, Gisela Nyberg, Maria M. Ekblom, Björg Helgadottir and Örjan Ekblom

DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial

Communication is one of the most important predictors of social reintegration after stroke. Approximately 15–42% of stroke survivors experience post-stroke aphasia. Helping people recover from aphasia is one o...

Authors: Blanca Fuentes, Lydia de la Fuente-Gómez, Cristian Sempere-Iborra, Celia Delgado-Fernández, Aida Tarifa-Rodríguez, María Alonso de Leciñana, Elena de Celis-Ruiz, Raquel Gutiérrez-Zúñiga, José López-Tàppero, Marta Martín Alonso, Sylvia Pastor-Yborra, Ricardo Rigual, Gerardo Ruiz-Ares, Jorge Rodríguez-Pardo, Javier Virués-Ortega, Alberto M. Borobia…

Effectiveness of lumbar stabilization exercise with real-time ultrasound imaging biofeedback on lumbar multifidus muscle cross-sectional area in individuals with non-specific chronic low back pain: a study protocol for a randomized controlled trial

Structural impairment of the lumbar multifidus muscle, such as reduced cross-sectional area, is evident among individuals with chronic low back pain. Real-time ultrasound imaging (RUSI) biofeedback has been re...

Authors: Raheem Sarafadeen, Sokunbi O. Ganiyu, Aminu A. Ibrahim, Anas Ismail, Mukadas O. Akindele, Bashir Kaka and Adedapo W. Awotidebe

Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling sympt...

Authors: Francisco Mera Cordero, Sara Bonet Monne, Jesús Almeda Ortega, Ana García-Sangenís, Oriol Cunillera Puèrtolas, Sara Contreras-Martos, Gemma Alvarez Muñoz, Ramon Monfà Escolà, Marina Balanzó Joué, Rosa Morros Pedrós and Betlem Salvador-Gonzalez

Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial

One of the main effectors on the quality of life of living-kidney donors is postoperative fatigue. Caloric restriction (CR) and short-term fasting (STF) are associated with improved fitness and increased resis...

Authors: C. A. J. Oudmaijer, R. C. Minnee, R. A. Pol, W. M. C. van den Boogaard, D. S. J. Komninos, J. van de Wetering, M. H. van Heugten, E. J. Hoorn, J. S. F. Sanders, J. H. J. Hoeijmakers, W. P. Vermeij and J. N. M. IJzermans

Using mHealth to promote parents’ brushing of preschool children’s teeth: a protocol for a randomized factorial trial using the Multi-phase Optimization Strategy (MOST)

Early childhood caries is a highly prevalent disease affecting young children. Parental brushing of children’s teeth is recommended during preschool years. Interventions to promote parental brushing of childre...

Authors: Merna Ihab, Wafaa Essam El Din, Nour Ammar, Randa Yassin and Maha El Tantawi

Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such...

Authors: Yibo Li, Lili Zhu, Raoying Wang, Xingyue Yang, Xinqi Jiang and Tao Lu

Nurse-led self-management support after organ transplantation—protocol of a multicentre, stepped-wedge randomized controlled trial

Recipients of an organ transplantation face a number of challenges and often need to change their health behaviour. Good self-management skills are essential for optimal clinical outcomes. However, few interve...

Authors: Regina van Zanten, Monique van Dijk, Joost van Rosmalen, Denise Beck, Robert Zietse, Ann Van Hecke, AnneLoes van Staa and Emma K. Massey