Articles

Ultrasound-guided quadratus lumborum block for perioperative analgesia in robot-assisted partial nephrectomy: a randomized controlled trial

Recently, several case reports and limited randomized studies have shown that quadratus lumborum blocks (QLB) are effective in providing pain relief after intra-abdominal and retroperitoneal operations. Additi...

Authors: Renchun Lai, Quehua Luo, Jielan Lai, Xiaoyun Lu and Mei Xu

The ACAMTO study—impact of add-on osteopathic treatment on adolescent patients with anorexia nervosa: study protocol for a randomized controlled trial

Anorexia nervosa (AN) mainly affects women (sex ratio 1/10) and most often starts during adolescence. The prognosis of AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturb...

Authors: Aurélie Letranchant, Yunkyung Kim-de Montebello, Corinne Dugré-Le bigre, Agathe Wagner, Florence Curt, Jérôme Silva, Isabelle Nicolas, Pablo Votadoro, Nina Kalindjian, Anna Korchonnoff, Andréa Gutierre, Ana Beatriz Novelli, Alexandra Pham-Scottez and Maurice Corcos

Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania

Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality, as well as preterm birth, the leading cause of death for children under 5 years globally. The World Health Organiza...

Authors: Pratibha Dwarkanath, Alfa Muhihi, Christopher R. Sudfeld, Shobha Rani, Christopher P. Duggan, Mary M. Sando, Blair J. Wylie, Ryan Fernandez, Shabani Kinyogoli, Cristina Munk, Nandita Perumal, John Michael Raj, Nirmala Buggi, Ndeniria Swai, Tinku Thomas, Molin Wang…

Augmentative and alternative communication intervention for in-patient individuals with post-stroke aphasia: study protocol of a parallel-group, pragmatic randomized controlled trial

People with post-stroke aphasia commonly receive speech-language therapy (SLT) when they are admitted to hospitals. Commonly, these patients reported communication difficulties in in-patient settings. Augmenta...

Authors: Li Huang, Szu-Han Kay Chen, Shutian Xu, Yongli Wang, Xing Jin, Ping Wan, Jikang Sun, Jiming Tao, Sicong Zhang, Guohui Zhang and Chunlei Shan

Using a WeChat mini-program-based lactation consultant intervention to increase the consumption of mother’s own milk by preterm infants in the neonatal intensive care unit: a study protocol for a cluster randomized controlled trial

The benefits of mother’s own milk (MOM) for preterm infants have been widely recognized. Many studies have shown that the rate of breastfeeding of premature infants remains very low. Although many studies use ...

Authors: Jie Huo, Xinping Wu, Chuanli Gu, Zhangbin Yu, Jun Zhang, Xiaohui Chen, Jingai Zhu, Feng Liu, Beibei Liu, Qianqian Li and Shuping Han

Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial

This study is designed to evaluate the main hypothesis that nafamostat mesilate with standard therapy improves the severity and mortality rate in patients with COVID-19 pneumonia.

Authors: Kyunglan Moon, Kyung-Wook Hong and In-Gyu Bae

An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR)

Remdesivir is a novel broad-spectrum antiviral therapeutic with activity against several viruses that cause emerging infectious diseases. The purpose of this study is to explore how commonly utilized antiretro...

Authors: Stephen I. Walimbwa, Julian P. Kaboggoza, Catriona Waitt, Pauline Byakika-Kibwika, Antonio D’Avolio and Mohammed Lamorde

Effect of fermented Rhus verniciflua stokes extract on liver function parameters in healthy Korean adults: a double-blind randomized controlled trial

Fermented Rhus verniciflua Stokes extract (FRVE) reported an anti-hepatic lipidemic property mediated by the upregulation of AMP-activated protein kinase (AMPK) in cell and animal models. However, it remains uncl...

Authors: Jung Hyun Kwak, Hyo-Jeong Lee, Seok-Tae Jeong, Ju Yeon Lee, Minho Lee and Jean Kyung Paik

Testing the effects of the Shamiri Intervention and its components on anxiety, depression, wellbeing, and academic functioning in Kenyan adolescents: study protocol for a five-arm randomized controlled trial

Treatments for youth mental disorders are a public health priority, especially in sub-Saharan Africa (SSA), where treatment options remain limited due to high cost, elevated stigma, and lack of trained mental ...

Authors: Katherine E. Venturo-Conerly, Tom L. Osborn, Akash R. Wasil, Huong Le, Emily Corrigan, Christine Wasanga and John R. Weisz

Statistical analysis plan for the Stepped-wedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)

It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notificatio...

Authors: Yaseen M. Arabi, Ramesh Kumar Vishwakarma, Hasan M. Al-Dorzi, Eman Al Qasim, Sheryl Ann Abdukahil, Fawaz K. Al-Rabeah, Huda Al Ghamdi and Ebtisam Al Ghamdi

Effects of an exercise and sport intervention among refugees living in a Greek refugee camp on mental health, physical fitness and cardiovascular risk markers: study protocol for the SALEEM pragmatic randomized controlled trial

Due to ongoing political and social conflicts, the number of international refugees has been increasing. Refugees are exposed to severe mental and physical strain, as well as traumatic experiences during their...

Authors: Markus Gerber, Flora Colledge, Dominique de Quervain, Konstantinia Filippou, Elsa Havas, Florian Knappe, Sebastian Ludyga, Marianne Meier, Ioannis D. Morres, Alexandros Panagos, Uwe Pühse, Karim Ramadan, Harald Seelig, Yannis Theodorakis, Roland von Känel and Antonis Hatzigeorgiadis

Mindfulness-based stress reduction intervention for elementary school teachers: a mixed method study

In the Netherlands, more than half of the teachers working in primary education experience high levels of work stress. Compared to other professions, teachers are more likely to drop out from work and develop ...

Authors: J. H. Lensen, S. E. M. J. Stoltz, M. Kleinjan, A. E. M. Speckens, J. T. Kraiss and R. H. J. Scholte

Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent

While there is strong evidence that bite protection methods such as permethrin-treated clothing and topical insect repellents are protective against insect bites, there are few studies assessing the impact on ...

Authors: Daniel Msellemu, Amanda Ross, Lucky Temu, Irene Moshi, Lorenz Hofer, Charles Mwanziva, Yadon M. Kohi and Sarah J. Moore

Effectiveness and safety of acupotomy for knee osteoarthritis: study protocol for a randomized controlled trial

Knee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Acupotomy may be effective for KOA, but the evidence is limited. This trial aims to determine the effectiveness and safety of acup...

Authors: Shu-Ming Li, Tian-Li Li, Ren Guo, Ping Chen, Wei-Shuai Du, Si-Bo Kang, Ming-Zhe Yan and Wu-Zhong Cheng

Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: study protocol for a randomized controlled trial with economic evaluation

Pelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, ...

Authors: Bianca Manzan Reis, Jordana Barbosa da Silva, Ana Paula Rodrigues Rocha, Richard Eloin Liebano and Patricia Driusso

A cluster randomized controlled trial for assessing POC-CCA test based praziquantel treatment for schistosomiasis control in pregnant women and their young children: study protocol of the freeBILy clinical trial in Madagascar

Mass drug administration (MDA) of praziquantel is one of the main control measures against human schistosomiasis. Although there are claims for including pregnant women, infants and children under the age of 5...

Authors: Daniela Fusco, Raphäel Rakotozandrindrainy, Rivo Andry Rakotoarivelo, Mala Rakoto Andrianarivelo, Njary Rakotozandrindrainy, Tahinamandranto Rasamoelina, Dewi Ismajani Puradiredja, Philipp Klein, Karl Stahlberg, Marie Dechenaud, Eva Lorenz, Anna Jaeger, Andrea Kreidenweiss, Pytsje T. Hoekstra, Akim Ayola Adegnika, Elisa Sicuri…

A randomized controlled trial of self-management for people with epilepsy and a history of negative health events (SMART) targeting rural and underserved people with epilepsy: a methodologic report

Many people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities. A prior randomized control trial of a...

Authors: Gena R. Ghearing, Farren Briggs, Kristin Cassidy, Michael Privitera, Carol Blixen and Martha Sajatovic

Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized controlled trial

Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by the World Health Organization for the prevention of malaria in pregnancy (MIP)-associated adverse out...

Authors: Jean-Bertin Bukasa Kabuya, Matthew M. Ippolito, Jay Sikalima, Clifford Tende, Davies Champo, David Mwakazanga, Anna Marie P. Young, Modest Mulenga, Gershom Chongwe and Christine Manyando

Correction to: Complementary feeding methods in the first year of life: a study protocol for a randomized clinical trial

Authors: Leandro Meirelles Nunes, Jordana Führ, Christy Hannah Sanini Belin, Paula Ruffoni Moreira, Renata Oliveira Neves, Mariana Lopes de Brito, Lorenzo Andreazza Morando, Adriela Azevedo Souza Mariath, Erissandra Gomes and Juliana Rombaldi Bernardi

The Positive Choices trial: study protocol for a Phase-III RCT trial of a whole-school social marketing intervention to promote sexual health and reduce health inequalities

Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students co...

Authors: Ruth Ponsford, Rebecca Meiksin, Elizabeth Allen, G. J. Melendez-Torres, Steve Morris, Catherine Mercer, Rona Campbell, Honor Young, Maria Lohan, Karin Coyle and Chris Bonell

Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and...

Authors: Matthew J. Swanson, James L. Johnston and Joseph S. Ross

Establishing a core outcome set for mucopolysaccharidoses (MPS) in children: study protocol for a rapid literature review, candidate outcomes survey, and Delphi surveys

Mucopolysaccharidoses (MPS) are a group of inherited metabolic diseases characterized by chronic, progressive multi-system manifestations with varying degrees of severity. Disease-modifying therapies exist to ...

Authors: Alison H. Howie, Kylie Tingley, Michal Inbar-Feigenberg, John J. Mitchell, Nancy J. Butcher, Martin Offringa, Maureen Smith, Kim Angel, Jenifer Gentle, Alexandra Wyatt, Philippe M. Campeau, Alicia Chan, Pranesh Chakraborty, Farah El Turk, Eva Mamak, Aizeddin Mhanni…

Effects of free range-of-motion upper limb exercise based on mirror therapy on shoulder function in patients after breast cancer surgery: study protocol for a randomized controlled trial

Shoulder function complications are common after treatment for breast cancer. Quite a few survivors still report a limited shoulder range of motion, even though the free range-of-motion upper limb exercise is ...

Authors: Ru-Zhen Yuan, Kun-Peng Li, Xiao-Lin Wei, Wei Zheng, Yi Ye, Ming-Yue Wang, Jie-Ting Jiang and Cai-Qin Wu

Evaluating Diuretics in Normal Care (EVIDENCE): protocol of a cluster randomised controlled equivalence trial of prescribing policy to compare the effectiveness of thiazide-type diuretics in hypertension

Healthcare systems must use treatments that are effective and safe. Regulators licensed many currently used older medications before introducing the stringent evidential requirements imposed on modern treatmen...

Authors: Amy Rogers, Angela Flynn, Isla S. Mackenzie, Lewis McConnachie, Rebecca Barr, Robert W. V. Flynn, Steve Morant, Thomas M. MacDonald and Alexander Doney

A protocol for developing a core outcome set for ectopic pregnancy

Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an i...

Authors: Krystle Y. Chong, Sarah Solangon, James Kemper, Kurt Barnhart, Pamela Causa Andrieu, Perrine Capmas, Carolina Chacon, George Condous, Liesl de Waard, James M. N. Duffy, Andrew Horne, Maria Memtsa, Femke Mol, Munira Oza, Annika Strandell, Madelon van Wely…

A protocol for the Development of Core Outcome Sets for Endodontic Treatment modalities (COSET): an international consensus process

The outcome of endodontic treatment is generally assessed using a range of patient and clinician-centred, non-standardised clinical and radiographic outcome measures. This makes it difficult to synthesise evid...

Authors: I. A. El Karim, H. F. Duncan, S. Cushley, V. Nagendrababu, L. L. Kirkevang, C. Kruse, B. S. Chong, P. K. Shah, M. Lappin, C. McLister, F. T. Lundy and M. Clarke

Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)

Emergence agitation (EA) after general anesthesia is a common complication in the post-anesthesia care unit (PACU). Once EA occurs, there are still no guidelines established for the treatment in adults. Propof...

Authors: Zhaoyan Feng, Xiao Shi, Xue Yan, Yamin Zhu, Juan Gu, Hao Zhu, Weifeng Yu and Song Zhang

The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care

Unhealthy alcohol use is a leading cause of preventable deaths in the USA and is associated with many societal and health problems. Less than a third of people who visit primary care providers in the USA are a...

Authors: Daniel E. Jonas, Colleen Barclay, Debbie Grammer, Chris Weathington, Sarah A. Birken, Darren A. DeWalt, Kimberly A. Shoenbill, Marcella H. Boynton, Monique Mackey, Sean Riley and Samuel Cykert

Working to Increase Stability through Exercise (WISE): screening, recruitment, and baseline characteristics

The aim of this paper is to describe the utility of various recruitment modalities utilized in the Working to Increase Stability through Exercise (WISE) study. WISE is a pragmatic randomized trial that is test...

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…

Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial

Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 P...

Authors: Berta Grau-Pujol, Daniel Camprubí-Ferrer, Helena Marti-Soler, Marc Fernández-Pardos, Clara Carreras-Abad, Maria Velasco-de Andrés, Elisabet Ferrer, Magdalena Muelas-Fernandez, Sophie Jullien, Giuseppe Barilaro, Sara Ajanovic, Isabel Vera, Laura Moreno, Eva Gonzalez-Redondo, Núria Cortes-Serra, Montserrat Roldán…

Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial

Gas embolism induced by CO₂ pneumoperitoneum is commonly identified as a risk factor for morbidity, especially cardiopulmonary morbidity, after laparoscopic liver resection (LLR) in adults. Increasing pneumoperit...

Authors: Danfeng Jin, Mingyue Liu, Jian Huang, Yongfeng Xu, Luping Liu, Changhong Miao and Jing Zhong

Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial

Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The basic principle is to create a narrow stomach along the lesser curvature, using a calibration bougie as a template to per...

Authors: Martin Gaillard, Panagiotis Lainas, Hélène Agostini, Ibrahim Dagher and Hadrien Tranchart

Cone beam computed tomography for detecting residual stones in percutaneous nephrolithotomy, a randomized controlled trial (CAPTURE) protocol

Percutaneous nephrolithotomy (PCNL) is the standard surgical treatment method for large kidney stones. Its aim is to achieve a stone-free status, since any residual fragments (RFs) after PCNL are likely to cau...

Authors: R. A. Kingma, I. J. de Jong, M. J. W. Greuter and S. Roemeling

Low-dose naltrexone for the treatment of fibromyalgia: protocol for a double-blind, randomized, placebo-controlled trial

Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pa...

Authors: Karin Due Bruun, Kirstine Amris, Henrik Bjarke Vaegter, Morten Rune Blichfeldt-Eckhardt, Anders Holsgaard-Larsen, Robin Christensen and Palle Toft

Effect of acupuncture at Zusanli (ST36) point on antral contraction function under ultrasound guidance: study protocol of a randomized controlled trial

Although the relationship between deqi sensations and curative effect has always been controversial, deqi sensations has been regarded as the key indicator of clinical efficacy of acupuncture therapy. There is li...

Authors: Yingqi Chen, Yu Bian, Shanshan Li, Yuanyuan Zhao, Jiaying Li, Yuanyi Zheng, Jie Chen, Shifen Xu and Yiqun Mi

The effect of supplementation with vitamins A, B, C, D, and E on disease severity and inflammatory responses in patients with COVID-19: a randomized clinical trial

Because of the effect of vitamins on modulating the immune system function, we have evaluated the effect of supplementation with vitamins A, B, C, D, and E in ICU-admitted patients with COVID-19.

Authors: Mohammad Taghi Beigmohammadi, Sama Bitarafan, Azin Hoseindokht, Alireza Abdollahi, Laya Amoozadeh and Danesh Soltani

Effects of naringenin supplementation in overweight/obese patients with non-alcoholic fatty liver disease: study protocol for a randomized double-blind clinical trial

Non-alcoholic fatty liver disease (NAFLD) is one of the main causes of chronic liver disease worldwide. Flavonoids, a group of natural compounds, have garnered a great deal of attention in the management of NA...

Authors: Fatemeh Naeini, Zahra Namkhah, Helda Tutunchi, Seyed Mahdi Rezayat, Siavash Mansouri, Seyed Ali Jazayeri-Tehrani, Mehdi Yaseri and Mohammad Javad Hosseinzadeh-Attar

Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial

Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing ...

Authors: Yuan Zhang, Di Bao, Dongmei Chi, Lu Li, Bin Liu, Di Zhang, Lanxin Qiao, Yi Liang, Yaxin Wang and Xu Jin

Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial

Painful diabetic peripheral neuropathy (PDPN) has a great impact on an individual’s quality of life. The current researchers’ previous trial suggested that acupuncture was a promising adjunctive treatment for ...

Authors: Mengyuan Li, Lin Yao, Haipeng Huang, Liying Zhang, Haizhu Zheng, Guan Wang, Zhen Zhong, Shiqi Ma, Shuo Yu and Hongfeng Wang

Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recur...

Authors: Pan-pan Tian, Qing-juan Wu, Jun Li, Heng-wen Chen, Ji Wu, Ya-wen Deng, Zi-cong Xie, Wei Zhao and Yu-qing Tan

Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial

Pressure dressings have been used after open hemorrhoidectomy to protect surgical wounds and manage postoperative bleeding for many years. However, pressure dressings may increase the incidence of postoperativ...

Authors: Ping Xue, Jing Wu, Ping Zhu, Dan Wang, Mei Xu, Yi Zhang, Guanmao Lu, Quanyi Chen, Qin Zhang, Renjin Tang and Jinbo Fang

Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)

The advised standard treatment for bacterial brain abscess following surgery is 6 to 8 weeks of intravenous (IV) antibiotic treatment, but an early switch to oral antibiotic treatment has been suggested to be ...

Authors: Jacob Bodilsen, Matthijs C. Brouwer, Diederik van de Beek, Pierre Tattevin, Steven Tong, Pontus Naucler and Henrik Nielsen

The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial

Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secon...

Authors: Ana I. Fernández, Javier Bermejo, Raquel Yotti, Miguel Ángel Martínez-Gonzalez, Alex Mira, Uri Gophna, Roger Karlsson, Reem Al-Daccak, Irene Martín-Demiguel, Enrique Gutiérrez-Ibanes, Dominique Charron and Francisco Fernández-Avilés

The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation

Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strat...

Authors: Raíza Dias Freitas, Bruna Lorena Pereira Moro, Laura Regina Antunes Pontes, Haline Cunha Medeiros Maia, Ana Laura Passaro, Rodolfo Carvalho Oliveira, Jonathan Rafael Garbim, Maria Eduarda Franco Vigano, Tamara Kerber Tedesco, Christopher Deery, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes and Mariana Minatel Braga

Auditory-cognitive training for adult cochlear implant recipients: a study protocol for a randomised controlled trial

There is an urgent need to develop new therapies to improve cognitive function in adults following cochlear implant surgery. This study aims to determine if completing at-home computer-based brain training act...

Authors: Blake J. Lawrence, Robert H. Eikelboom and Dona M. P. Jayakody

IL-1 Signal Inhibition In Alcoholic Hepatitis (ISAIAH): a study protocol for a multicentre, randomised, placebo-controlled trial to explore the potential benefits of canakinumab in the treatment of alcoholic hepatitis

Alcohol consumption causes a spectrum of liver abnormalities and leads to over 3 million deaths per year. Alcoholic hepatitis (AH) is a florid presentation of alcoholic liver disease characterized by liver fai...

Authors: N. Vergis, V. Patel, K. Bogdanowicz, J. Czyzewska-Khan, F. Fiorentino, E. Day, M. Cross, N. Foster, E. Lord, R. Goldin, E. Forrest and M. Thursz

Improving peer review of systematic reviews by involving librarians and information specialists: protocol for a randomized controlled trial

Problems continue to exist with the reporting quality and risk of bias in search methods and strategies in systematic reviews and related review types. Peer reviewers who are not familiar with what is required...

Authors: Melissa L. Rethlefsen, Sara Schroter, Lex M. Bouter, David Moher, Ana Patricia Ayala, Jamie J. Kirkham and Maurice P. Zeegers

Parenting interventions for families with refugee backgrounds: a randomized factorial, mixed-methods design study protocol

Raising children in new social and cultural contexts can be challenging for parents. In order to help parents address these challenges, the Norwegian government has instituted a policy of mandatory parent trai...

Authors: Joshua Patras, Merete Saus, Marcela Douglas, Ragnhild Bjørknes, Siri Gammelsæter, Lene-Mari Potulski Rasmussen, Therese Halvorsen, Ida Mari Haug, Ragnhild Risholm, Tuva Øktedalen, Reidar Jakobsen and Simon Peter Neumer

Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views

Evidence from previous studies is often used relatively informally in the design of clinical trials: for example, a systematic review to indicate whether a gap in the current evidence base justifies a new tria...

Authors: Gemma L. Clayton, Daisy Elliott, Julian P. T. Higgins and Hayley E. Jones

Home-based Extended Rehabilitation for Older people (HERO): study protocol for an individually randomised controlled multi-centre trial to determine the clinical and cost-effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation

The majority of older people (> 65 years) in hospital have frailty and are at increased risk of readmission or death following discharge home. In the UK, following acute hospitalisation, around one third of ol...

Authors: Matthew Prescott, Amanda Lilley-Kelly, Bonnie Cundill, David Clarke, Sian Drake, Amanda J. Farrin, Anne Forster, Madeline Goodwin, Victoria A. Goodwin, Abi J. Hall, Suzanne Hartley, Mike Holland, Claire Hulme, Silviya Nikolova, Catriona Parker, Phil Wright…