Articles

Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial

Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages...

Authors: Benjamin Gaborit, Bernard Vanhove, Marie-Anne Vibet, Aurélie Le Thuaut, Karine Lacombe, Vincent Dubee, Florence Ader, Virginie Ferre, Eric Vicaut, Jéremie Orain, Morgane Le Bras, Anne Omnes, Laetitia Berly, Alexandra Jobert, Pascale Morineau-Le Houssine, Karine Botturi…

A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia

This study aims to analyze the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of fibromyalgia (FM) patients.

Authors: Ana Rita Silva, Alexandra Bernardo, Maria Fernanda de Mesquita, José Vaz Patto, Pedro Moreira, Maria Leonor Silva and Patrícia Padrão

Importance of swift event adjudication of endpoints for adequate reporting to data and safety monitoring boards in clinical trials—lessons from CULPRIT-SHOCK

Authors: Peter Clemmensen, Benedikt Schrage, Uwe Zeymer, Holger Thiele and Karl Wegscheider

Correction to: Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

An amendment to this paper has been published and can be accessed via the original article.

Authors: Anne Christin Rahn, Lisa Wenzel, Andrea Icks, Alexander Stahmann, Jutta Scheiderbauer, Kristina Grentzenberg, Markus Vomhof, Joseph Montalbo, Tim Friede, Christoph Heesen and Sascha Köpke

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript ...

Authors: Sophie Relph, Maria Elstad, Bolaji Coker, Matias C. Vieira, Natalie Moitt, Walter Muruet Gutierrez, Asma Khalil, Jane Sandall, Andrew Copas, Deborah A. Lawlor and Dharmintra Pasupathy

Evaluation of the effect of melatonin in patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit: A structured summary of a study protocol for a randomized controlled trial

We investigate the effects of melatonin, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in severely ill patients with confirmed COVID-19 who are admitted to the Intensive C...

Authors: Ali Ameri, Masoomeh Frouz Asadi, Manoochehr Kamali, Majid Vatankhah, Ava Ziaei, Omid Safa, Masoomeh Mahmudi and Mohammad Fathalipour

Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial

The objective of this trial is to assess whether early antiviral therapy in outpatients with COVID-19 with either favipiravir plus lopinavir/ritonavir, lopinavir/ritonavir alone, or favipiravir alone, is assoc...

Authors: Li-An K. Brown, Nick Freemantle, Judy Breuer, Hakim-Moulay Dehbi, Kashfia Chowdhury, Gemma Jones, Felicia Ikeji, Amalia Ndoutoumou, Krishneya Santhirakumar, Nicky Longley, Anna M. Checkley, Joseph F. Standing and David M. Lowe

Effects of salvianolate on microcirculatory disturbance in patients with stable coronary heart disease: study protocol for a randomized controlled trial

Obstruction of coronary microcirculation can lead to myocardial ischemia and poor prognosis. Salvianolate exerts cardiovascular protection at cellular levels. However, no studies have confirmed the effect of s...

Authors: Zhanlu Li, Yi Luan, Min Wang, Ya Li, Xiaohua Shen, Guosheng Fu and Wenbin Zhang

A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial

Enhanced parenting self-efficacy (PSE) contributes to positive parenting and future parental-child health. First-time parents, in particular, are in need of support since the pregnancy until post-delivery to s...

Authors: See Ling Loy, Thilagamangai, Joyce Teo, Sze Wern Chan, Nurul Khairani Abdul Razak, Oh. Moh Chay and Kee Chong Ng

Using the half normal distribution to quantify covariate balance in cluster-randomized pragmatic trials

Pragmatic trials often consist of cluster-randomized controlled trials (C-RCTs), where staff of existing clinics or sites deliver interventions and randomization occurs at the site level. Covariate-constrained...

Authors: Jin Huang and David L. Roth

Concept and development of an interactive tool for trial recruitment planning and management

Predicting and monitoring recruitment in large, complex trials is essential to ensure appropriate resource management and budgeting. In a novel partnership between clinical trial investigators of the South Afr...

Authors: Ruan Spies, Nandi Siegfried, Bronwyn Myers and Sara S. Grobbelaar

Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS.

Authors: Zhuoran Kuang, Xiaoyan Li, Jianxiong Cai, Yaolong Chen, Xiaoyuan Qiu and Xiaojia Ni

Correction to: Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

An amendment to this paper has been published and can be accessed via the original article.

Authors: Iwein Gyselinck, Laurens Liesenborghs, Ewout Landeloos, Ann Belmans, Geert Verbeke, Peter Verhamme, Robin Vos and W. Janssens

Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial

Depression and anxiety impact up to 1 in 5 pregnant and postpartum women worldwide. Yet, as few as 20% of these women are treated with frontline interventions such as evidence-based psychological treatments. M...

Authors: D. R. Singla, S. E. Meltzer-Brody, R. K. Silver, S. N. Vigod, J. J. Kim, L. M. La Porte, P. Ravitz, C. E. Schiller, N. Schoueri-Mychasiw, S. D. Hollon, A. Kiss, D. Clark, A. K. Dalfen, S. Dimidjian, B. N. Gaynes, S. R. Katz…

Treating to target in psoriatic arthritis: assessing real-world outcomes and optimising therapeutic strategy for adults with psoriatic arthritis—study protocol for the MONITOR-PsA study, a trials within cohorts study design

The Tight Control of psoriatic arthritis (TICOPA) trial confirmed improved clinical outcomes with a treat to target (T2T) strategy in psoriatic arthritis (PsA). This consisted of 4-weekly review and escalation...

Authors: Ines Rombach, William Tillett, Deepak Jadon, Laura Tucker, Marion Watson, Anne Francis, Yvonne Sinomati, Lucy Eldridge, Melina Dritsaki, Susan J. Dutton, Hussein Al-Mossawi, Nicola Gullick, Ben Thompson and Laura C. Coates

Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial

Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. ...

Authors: Jae-Hong Kim, Cham-Kyul Lee, Eun-Yong Lee, Myoung-Rae Cho, Young-Su Lee and Jeong-Soon Lee

Systematic review of available software for multi-arm multi-stage and platform clinical trial design

In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics sh...

Authors: Elias Laurin Meyer, Peter Mesenbrink, Tobias Mielke, Tom Parke, Daniel Evans and Franz König

Retraction Note: Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial

This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1186/s13063-021-05154-3.

Authors: Christoph Schnelle, Steffen Messerschmidt, Eunice J. Minford, Kate Greenaway-Twist, Maxine Szramka, Marianna Masiorski, Michelle Sheldrake and Mark Jones

Eye Movement Desensitization (EMD) to reduce posttraumatic stress disorder-related stress reactivity in Indonesia PTSD patients: a study protocol for a randomized controlled trial

Posttraumatic stress disorder (PTSD) may develop after exposure to a traumatic event. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based psychological treatment for PTSD. It is yet uncle...

Authors: Eka Susanty, Marit Sijbrandij, Wilis Srisayekti and Anja C. Huizink

Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the...

Authors: Anca Vasiliu, Sabrina Eymard-Duvernay, Boris Tchounga, Daniel Atwine, Elisabete de Carvalho, Sayouba Ouedraogo, Michael Kakinda, Patrice Tchendjou, Stavia Turyahabwe, Albert Kuate Kuate, Georges Tiendrebeogo, Peter J. Dodd, Stephen M. Graham, Jennifer Cohn, Martina Casenghi and Maryline Bonnet

An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: protocol for the SMART Mental Health programme

Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75–95%. Health care systems, especially in rural regions in India, face substantia...

Authors: Mercian Daniel, Pallab K. Maulik, Sudha Kallakuri, Amanpreet Kaur, Siddhardha Devarapalli, Ankita Mukherjee, Amritendu Bhattacharya, Laurent Billot, Graham Thornicroft, Devarsetty Praveen, Usha Raman, Rajesh Sagar, Shashi Kant, Beverley Essue, Susmita Chatterjee, Shekhar Saxena…

“Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial

Low recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-c...

Authors: Larissa Niemeyer, Konstantin Mechler, Jan Buitelaar, Sarah Durston, Bram Gooskens, Bob Oranje, Tobias Banaschewski, Ralf W. Dittmann and Alexander Häge

Blended cognitive behaviour therapy for children and adolescents with mitochondrial disease targeting fatigue (PowerMe): study protocol for a multiple baseline single case experiment

Mitochondrial disease is a rare, hereditary disease with a heterogeneous clinical presentation. However, fatigue is a common and burdensome complaint in children and adolescents with mitochondrial disease. No ...

Authors: I. L. Klein, K. F. E. van de Loo, T. J. Hoogeboom, M. C. H. Janssen, J. A. M. Smeitink, E. van der Veer, C. M. Verhaak and J. A. E. Custers

Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis

The dropout rate is an important determinant of outcomes in randomized controlled trials (RCTs) and should be carefully controlled. This study explored the current dropout rate in studies of Korean medicine (K...

Authors: Sae-rom Jeon, Dongwoo Nam and Tae-Hun Kim

Effect of patient-controlled intravenous analgesia combined with flurbiprofen axetil and dezocine on postoperative analgesia for lobectomy (EPIC-FAD): a trial protocol

The optimal analgesic strategy for surgical pain after lobectomy remains undefined. To compare the combination of flurbiprofen axetil and dezocine with flurbiprofen axetil alone and dezocine alone, in post-lob...

Authors: Jian Zhou, Qiang Pu, Lin Lin, Weelic Chong, Boran Chen, Yang Hai, Fei Liu and Lunxu Liu

Virtual reality stimulation to reduce the incidence of delirium in critically ill patients: study protocol for a randomized clinical trial

Delirium has been long considered as a major contributor to cognitive impairments and increased mortality following a critical illness. Pharmacologic and non-pharmacologic strategies are used against delirium ...

Authors: Aileen C. Naef, Marie-Madlen Jeitziner, Stephan M. Gerber, Béatrice Jenni-Moser, René M. Müri, Stephan M. Jakob, Tobias Nef and Matthias Hänggi

UKCTOCS update: applying insights of delayed effects in cancer screening trials to the long-term follow-up mortality analysis

During trials that span decades, new evidence including progress in statistical methodology, may require revision of original assumptions. An example is the continued use of a constant-effect approach to analy...

Authors: Matthew Burnell, Aleksandra Gentry-Maharaj, Steven J. Skates, Andy Ryan, Chloe Karpinskyj, Jatinderpal Kalsi, Sophia Apostolidou, Naveena Singh, Anne Dawnay, Robert Woolas, Lesley Fallowfield, Stuart Campbell, Alistair McGuire, Ian J. Jacobs, Mahesh Parmar and Usha Menon

Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The...

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…

An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and p...

Authors: Noemi Anja Brog, Julia Katharina Hegy, Thomas Berger and Hansjörg Znoj

Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial

As of mid-June 2020, 7,500,000 people were infected with SARS-CoV-2 worldwide and 420,000 people died, mainly from coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS). COVID-...

Authors: Aurélien Mazeraud, Bruno Gonçalves, Philippe Aegerter, Letizia Mancusi, Christine Rieu, Fernando Bozza, Khaoussou Sylla, Shidasp Siami and Tarek Sharshar

iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol

Although tube feeding routinely saves the lives of children who do not eat by mouth, chronic tube feeding can be a burden to patients, caregivers, and families. Very few randomized trials exist regarding the b...

Authors: Sarah Edwards, Paul E. Hyman, Hayat Mousa, Amanda Bruce, Jose Cocjin, Kelsey Dean, Kandace Fleming, Rebecca Swinburne Romine and Ann M. Davis

MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan

Invasive mediastinal nodal staging is recommended by guidelines in selected patients with resectable non-small cell lung cancer (NSCLC). Endosonography is recommended as initial staging technique, followed by ...

Authors: Jelle E. Bousema, Jouke T. Annema, Erik H. F. M. van der Heijden, Ad F. T. M. Verhagen, Marcel G. W. Dijkgraaf and Frank J. C. van den Broek

Watchful waiting as a strategy to reduce low-value spinal imaging: study protocol for a randomized trial

Patients with acute low back pain frequently request diagnostic imaging, and clinicians feel pressure to acquiesce to such requests to sustain patient trust and satisfaction. Spinal imaging in patients with ac...

Authors: Joshua J. Fenton, Anthony Jerant, Peter Franks, Melissa Gosdin, Ilona Fridman, Camille Cipri, Gary Weinberg, Andrew Hudnut and Daniel J. Tancredi

StayBalanced: implementation of evidence-based fall prevention balance training for older adults—cluster randomized controlled and hybrid type 3 trial

The StayBalanced programme has shown positive effects on fall prevention, balance control and fear of falling. Despite convincing evidence on the efficacy and effectiveness of balance training, there is a gap ...

Authors: Alexandra Halvarsson, Kirsti Skavberg Roaldsen, Per Nilsen, Ing-Mari Dohrn and Agneta Ståhle

Narrative Exposure Therapy versus treatment as usual in a sample of trauma survivors who live under ongoing threat of violence in Rio de Janeiro, Brazil: study protocol for a randomised controlled trial

One in three individuals who live in Rio de Janeiro experience a traumatic event within a period of 12 months. In the favelas particularly, trauma exposure is ongoing. Psychological sequalae include posttraumatic...

Authors: Fernanda Serpeloni, Jeanine Arabella Narrog, Simone Gonçalves de Assis, Joviana Quintes Avanci, Samuel Carleial and Anke Koebach

Acupuncture in diabetic peripheral neuropathy—protocol for the randomized, multicenter ACUDPN trial

Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) ...

Authors: J. Dietzel, S. Hörder, I. V. Habermann, G. Meyer-Hamme, K. Hahn, M. Ortiz, S. Roll, K. Linde, D. Irnich, M. Hammes, R. Nögel, M. Wullinger, V. Wortman, J. Hummelsberger, S. N. Willich, S. Schröder…

Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial

Video-assisted thoracoscopic surgery (VATS) lobectomy is currently the recommended approach for treating early-stage non-small cell lung cancer (NSCLC). Different VATS approaches have been proposed so far, and...

Authors: Paolo Mendogni, Alessandra Mazzucco, Alessandro Palleschi, Lorenzo Rosso, Ilaria Righi, Rosaria Carrinola, Francesco Damarco, Emilia Privitera, Jacopo Fumagalli, Gianluca Bonitta, Mario Nosotti and Davide Tosi

Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial

To investigate if traditional Chinese medicine (TCM) auricular point acupressure (APA) can alleviate and (or) reduce the pain (including injection site pain, headache, other muscle and joint pain), fatigue, an...

Authors: Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao…

A checklist-based method for improving COPD care for the elderly in general practice: study protocol for a cluster randomized controlled trial using electronic health records

The third most frequent chronic condition, and the fourth most common cause of death, in Poland is chronic obstructive pulmonary disease (COPD). The diagnosis and treatment of COPD is the responsibility of the...

Authors: Anna Kowalczyk, Izabela Zakowska, Ewa Andrzejewska, Katarzyna Kosiek and Maciek Godycki-Cwirko

MR CLEAN-LATE, a multicenter randomized clinical trial of endovascular treatment of acute ischemic stroke in The Netherlands for late arrivals: study protocol for a randomized controlled trial

Endovascular therapy (EVT) for acute ischemic stroke due to proximal occlusion of the anterior intracranial circulation, started within 6 h from symptom onset, has been proven safe and effective. Recently, EVT...

Authors: F. A. V. ( Anne) Pirson, Wouter H. Hinsenveld, Robert-Jan B. Goldhoorn, Julie Staals, Inger R. de Ridder, Wim H. van Zwam, Marianne A. A. van Walderveen, Geert J. Lycklama à Nijeholt, Maarten Uyttenboogaart, Wouter J. Schonewille, Aad van der Lugt, Diederik W. J. Dippel, Yvo B. W. E. M. Roos, Charles B. L. M. Majoie and Robert J. van Oostenbrugge

Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial

Atypical antipsychotic medications, which are effective for the treatment of schizophrenia and bipolar disorder, are associated with features of metabolic syndrome, such as weight gain, hyperglycemia, dyslipid...

Authors: Chenchen Liu, Dongyu Kang, Jingmei Xiao, Yuyan Huang, Xingjie Peng, Weiyan Wang, Peng Xie, Ye Yang, Jingping Zhao and Renrong Wu

Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia

Congenital diaphragmatic hernia (CDH) is, depending of the severity, a birth defect associated with significant mortality and morbidity. Prenatal screening by ultrasound may detect this condition and comprehen...

Authors: Simen Vergote, Felix De Bie, Jan Bosteels, Holly Hedrick, James Duffy, Beverley Power, Alexandra Benachi, Paolo De Coppi, Caraciolo Fernandes, Kevin Lally, Irwin Reiss and Jan Deprest

Protocol for the development of a repository of individual participant data from randomised controlled trials conducted in adult care homes (the Virtual International Care Homes Trials Archive (VICHTA))

Approximately 418,000 people live in care homes in the UK, yet accessible, robust data on care home populations and organisation are lacking. This hampers our ability to plan, allocate resources or prevent ris...

Authors: Lisa Irvine, Jennifer Kirsty Burton, Myzoon Ali, Terence J. Quinn and Claire Goodman

The effect of the SIMS Programme versus existing preschool oral healthcare programme on oral hygiene level of preschool children: study protocol for a cluster randomised controlled trial

Despite the implementation of the preschool oral healthcare programme (POHP) for 5–6-year-old children over the past 3 decades in Malaysia, dental plaque and caries levels in this age group remain high. Among ...

Authors: Zamros Yuzadi Mohd Yusof, Nurul Hayati Anwar, Nor Azlida Mohd Nor, Mariani Md Nor and Siti Ezaleila Mustafa

Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in chronic inflammatory demyelinating polyradiculoneuropathy: protocol of an international, randomised, double-blind, placebo-controlled trial (OPTIC)

International guidelines recommend either intravenous immunoglobulin (IVIg) or corticosteroids as first-line treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). IVIg treatment usual...

Authors: S. R. M. Bus, L. Zambreanu, A. Abbas, Y. A. Rajabally, R. D. M. Hadden, R. J. de Haan, C. A. J. M. de Borgie, M. P. Lunn, I. N. van Schaik and F. Eftimov

Sympathetic Nervous System and Exercise Affects Cognition in Youth (SNEACY): study protocol for a randomized crossover trial

There is an increasing prevalence of physical inactivity during childhood, which is associated with a variety of health problems. However, the mechanisms by which acute exercise benefits cognition in childhood...

Authors: Lauren B. Raine, Katherine McDonald, Tatsuya T. Shigeta, Shu-Shih Hsieh, Jennifer Hunt, Nathan A. Chiarlitti, Michelle Lim, Kristen Gebhardt, Nina Collins, Michael De Lisio, Sean P. Mullen, Arthur F. Kramer and Charles Hillman

COVID-19 trials: declarations of data sharing intentions at trial registration and at publication

The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is...

Authors: Rebecca Li, Megan von Isenburg, Marcia Levenstein, Stan Neumann, Julie Wood and Ida Sim

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain ...

Authors: J. Weindelmayer, V. Mengardo, A. Veltri, G. L. Baiocchi, S. Giacopuzzi, G. Verlato and G. de Manzoni

Efficacy of the erector spinae plane (ESP) block for quality of recovery in posterior thoraco-lumbar spinal decompression surgery: study protocol for a randomised controlled trial

Spinal surgery can be associated with significant postoperative pain. Erector spinae plane (ESP) block is a new regional anaesthesia technique, which promises effective postoperative analgesia compared with sy...

Authors: Dylan T. Finnerty and Donal J. Buggy

The effect of a topical combination of clonidine and pentoxifylline on post-traumatic neuropathic pain patients: study protocol for a randomized, double-blind placebo-controlled trial

First-line pharmacotherapy for neuropathic pain entails the use of systemic antidepressants and anticonvulsants. These drugs are not optimally effective and poorly tolerated, especially for older patients with...

Authors: Oli Abate Fulas, André Laferrière, D. Mark A. Ware, Yoram Shir and Terence J. Coderre