Articles

Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial

SARS-CoV-2 infection presents a high transmission in the group of health professionals in Spain (12-15% infected). Currently there is no accepted chemoprophylaxis but hydroxychloroquine (HDQ) is known to inhib...

Authors: Antonio Cuadrado-Lavín, José Manuel Olmos, José Manuel Cifrian, Teresa Gimenez, Marco Antonio Gandarillas, Mar García-Saiz, Maria Henar Rebollo, Victor Martínez-Taboada, Marcos López-Hoyos, María Carmen Fariñas and Javier Crespo

Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial

Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have

Authors: Z. Q. Ren, Y. F. Wang, G. F. Ao, H. X. Chen, M. Huang, M. X. Lai, H. D. Zhao and R. Zhao

The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial

Dentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms ca...

Authors: Takashi Matsuura, Megumi Mae, Masayuki Ohira, Yasunori Yamashita, Ayako Nakazono, Kouji Sugimoto, Kajiro Yanagiguchi and Shizuka Yamada

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol

Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general prac...

Authors: Kathryn Curtis, Michael Moore, Christie Cabral, Vasa Curcin, Jeremey Horwood, Richard Morris, Vibhore Prasad, Anne Schilder, Nicholas Turner, Scott Wilkes, Alastair D. Hay and Jodi Taylor

Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial

Transcranial direct current stimulation (tDCS) is promising for improving motor and cognitive performance. Nevertheless, its mechanisms of action are unclear and need to be better characterised according to th...

Authors: Yohan Grandperrin, Sidney Grosprêtre, Magali Nicolier, Philippe Gimenez, Chrystelle Vidal, Emmanuel Haffen and Djamila Bennabi

Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan

The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to...

Authors: Alysha M. De Livera, Anne Reutens, Mark Cooper, Merlin Thomas, Karin Jandeleit-Dahm, Jonathan E. Shaw and Agus Salim

MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial

In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis a...

Authors: Anne-Laure Philippon, Margaux Dumont, Sonia Jimenez, Sarah Salhi, Marine Cachanado, Isabelle Durand-Zaleski, Tabassome Simon and Yonathan Freund

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial

Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to im...

Authors: William J. Meurer, Mackenzie Dinh, Kelley M. Kidwell, Adam Flood, Emily Champoux, Candace Whitfield, Deborah Trimble, Joan Cowdery, Dominic Borgialli, Sacha Montas, Rebecca Cunningham, Lorraine R. Buis, Devin Brown and Lesli Skolarus

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. ...

Authors: Caroline Trang-Poisson, Elise Kerdreux, Alexandra Poinas, Lucie Planche, Harry Sokol, Pascale Bemer, Karine Cabanas, Eliane Hivernaud, Laetitia Biron, Laurent Flet, Emmanuel Montassier, Ghislaine Le Garcasson, Anne Chiffoleau, Alexandra Jobert, Didier Lepelletier, Jocelyne Caillon…

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study)

Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and...

Authors: Caroline Gronnier, Cécile Chambrier, Alain Duhamel, Benoît Dervaux, Denis Collet, Delphine Vaudoyer, Jean-Marc Régimbeau, Jacques Jougon, Jérémie Théréaux, Gil Lebreton, Julie Veziant, Alain Valverde, Pablo Ortega-Deballon, François Pattou, Muriel Mathonnet, Julie Perinel…

Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial

In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women’s physical and mental health, IPV also incr...

Authors: Roxanne C. Keynejad, Tesera Bitew, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Negussie Deyessa, Nick Sevdalis, Wietse A. Tol, Louise Howard and Charlotte Hanlon

Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study

Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is ...

Authors: Anna Ozaki, Takaomi Kessoku, Michihiro Iwaki, Takashi Kobayashi, Tsutomu Yoshihara, Takayuki Kato, Yasushi Honda, Yuji Ogawa, Kento Imajo, Takuma Higurashi, Masato Yoneda, Masataka Taguri, Takeharu Yamanaka, Hiroto Ishiki, Noritoshi Kobayashi, Satoru Saito…

Genetic basis for prediction of non-responders to dietary plant sterol intervention (GenePredict-PS): a study protocol for a double-blind, placebo-controlled, randomized two-period crossover study

Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases...

Authors: Maryam Shamloo, Matthew J. Granger, Elke A. Trautwein, James D. House and Dylan MacKay

The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study)

Approximately 30% of appendectomies are for complicated acute appendicitis (CAA). With laparoscopy, the main post-operative complication is deep abscesses (12% of cases of CAA, versus 4% for open surgery). A r...

Authors: C. Sabbagh, N. Siembida, H. Dupont, M. Diouf, J. L. Schmit, S. Boddaert and J. M. Regimbeau

Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial

Rhizarthrosis (trapeziometacarpal osteoarthritis) is the second most common site of osteoarthritis in the hand affecting 10–30% of adults over the age of 50. Up to four times as many women as men have rhizarth...

Authors: Markus Bock, Andreas Eisenschenk, Heiko Lorenzen and Martin Lautenbach

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population

Smartphone-based support can reach thousands of smokers and help those who would otherwise try to quit smoking by themselves with little chance of success. Nicotine medications double the chances of quitting s...

Authors: Jean-François Etter and Yasser Khazaal

Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial

Coronary artery diseases (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in progressive replacement of contractile myocardium w...

Authors: Leo Pölzl, Felix Nägele, Michael Graber, Jakob Hirsch, Daniela Lobenwein, Martina Mitrovic, Agnes Mayr, Markus Theurl, Michael Schreinlechner, Matthias Pamminger, Christian Dorfmüller, Michael Grimm, Can Gollmann-Tepeköylü and Johannes Holfeld

Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial

Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could...

Authors: Sanmy Rocha Nóbrega, Silvana Gama Florencio Chachá and Cleiton Augusto Libardi

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide infor...

Authors: Victoria Shepherd

High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial

Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly common intervention in the treatment of pancreaticobiliary disorders. Patients are often elderly with complex co-morbidities. While moni...

Authors: Venkatesan Thiruvenkatarajan, Ashok Dharmalingam, Gilberto Arenas, Medhat Wahba, Reinhard Steiner, Vasanth Rao Kadam, Andre Tran, John Currie, Roelof Van Wijk, Anthony Quail and Guy Ludbrook

Evaluation of an intervention to support decisions on disclosure in the employment setting (DECIDES): study protocol of a longitudinal cluster-randomized controlled trial

Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searchi...

Authors: K. M. E. Janssens, J. van Weeghel, C. Henderson, M. C. W. Joosen and E. P. M. Brouwers

NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial

The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awarenes...

Authors: Dong ( Roman) Xu, Rubee Dev, Abha Shrestha, Lingling Zhang, Archana Shrestha, Pushpanjali Shakya, James P. Hughes, Prabin Raj Shakya, Jinghua Li, Jing Liao and Biraj Man Karmacharya

Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial

Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not y...

Authors: Tony Kendrick, Michael Moore, Geraldine Leydon, Beth Stuart, Adam W. A. Geraghty, Guiqing Yao, Glyn Lewis, Gareth Griffiths, Carl May, Rachel Dewar-Haggart, Samantha Williams, Shihua Zhu and Christopher Dowrick

Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial

More than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-li...

Authors: K. M. Latocha, K. B. Løppenthin, M. Østergaard, P. J. Jennum, R. Christensen, M. Hetland, H. Røgind, T. Lundbak, J. Midtgaard and B. A. Esbensen

Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study

Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharm...

Authors: Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Linda Birt, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris…

Correction to: Effects of robot-assisted gait training in patients with Parkinson’s disease: study protocol for a randomized controlled trial

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

Authors: Min-Gu Kang, Seo Jung Yun, Hyun Iee Shin, Eunkyung Kim, Hyun Haeng Lee, Byung-Mo Oh and Han Gil Seo

Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

Acute myeloid leukemia (AML) is the most common acute leukemia in adults and has an unacceptably low cure rate. In recent years, a number of new treatment strategies and compounds were developed for the treatm...

Authors: Katharina M. Lang, Kathryn L. Harrison, Paula R. Williamson, Brian J. P. Huntly, Gert Ossenkoppele, Jan Geissler, Tamàs Bereczky, Jesús M. Hernández-Rivas, Hélène Chevrou-Séverac, Rory Goodbody, Renate Schulze-Rath and Lars Bullinger

A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial

Parkinson’s disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, relianc...

Authors: C. M. Sackley, C. Rick, P. Au, M. C. Brady, G. Beaton, C. Burton, M. Caulfield, S. Dickson, F. Dowling, M. Hughes, N. Ives, S. Jowett, P. Masterson-Algar, A. Nicoll, S. Patel, C. H. Smith…

Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial

There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, ...

Authors: Stephen B. Freedman, Sarah Williamson-Urquhart, Anna Heath, Petros Pechlivanoglou, Gareth Hopkin, Serge Gouin, Amy C. Plint, Andrew Dixon, Darcy Beer, Gary Joubert, Christopher McCabe, Yaron Finkelstein and Terry P. Klassen

Glioma patients in outpatient care—optimization of psychosocial care in neuro-oncological patients (GLIOPT): Protocol for a cluster randomized controlled trial

Patients with high-grade gliomas (HGG) often suffer from high distress and require psychosocial support. However, due to neurological and neurocognitive deficits, adequate assessment of distress and support ne...

Authors: Mirjam Renovanz, Melina Hippler, Martin Voss, Jens Wehinger, Almuth F. Keßler, Jens Gempt, Minou Nadji-Ohl, Carolin Weiß Lucas, Marion Rapp, Martin Misch, Jan Coburger, Marcus Mehlitz, Jürgen Meixensberger, Naureen Keric, Ghazaleh Tabatabai, Maria Blettner…

Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice

Patient outcomes can depend on the treating centre, or health professional, delivering the intervention. A health professional’s skill in delivery improves with experience, meaning that outcomes may be associa...

Authors: Elizabeth J. Conroy, Jane M. Blazeby, Girvan Burnside, Jonathan A. Cook and Carrol Gamble

A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care – a study protocol for a randomized controlled trial

Suffering linked to previous interpersonal trauma is common among patients in mental health care. Diagnostic labels may vary, but the clinical picture is often characterized by long-lasting and complex psychol...

Authors: K. H. Holgersen, I. Brønstad, M. Jensen, H. Brattland, S. K. Reitan, A. M. Hassel, M. Arentz, M. Lara-Cabrera and A. E. Skjervold

Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial

Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from em...

Authors: Caroline Forde, Ronan McMullan, Mike Clarke, Richard H. Wilson, Ruth Plummer, Margaret Grayson, Cliona McDowell, Ashley Agus, Annmarie Doran, Danny F. McAuley, Anne L. Thomas, Rosemary A. Barnes, Richard Adams, Ian Chau and Vicky Coyle

The COVIRL-001 Trial: A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: A structured summary of a study protocol for a randomised controlled trial

Authors: Eoin Feeney, Deborah Wallace, Aoife Cotter, Willard Tinago, Cormac McCarthy, David Keane, Rabia Hussain, Elena Alvarez Barco, Peter Doran and Patrick Mallon

Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia

The AWED (Applying Wolbachia to Eliminate Dengue) trial is a parallel, two-arm, non-blinded cluster randomised controlled trial that is under way in Yogyakarta, Indonesia, with the aim of measuring the efficacy o...

Authors: Katherine L. Anders, Citra Indriani, Riris Andono Ahmad, Warsito Tantowijoyo, Eggi Arguni, Bekti Andari, Nicholas P. Jewell, Suzanne M. Dufault, Peter A. Ryan, Stephanie K. Tanamas, Edwige Rancès, Scott L. O’Neill, Cameron P. Simmons and Adi Utarini

Study Protocol for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a pragmatic, registry-based, multi-center, double-blind, randomized controlled trial evaluating the effect of intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline on delayed graft function in deceased donor kidney transplantation

Delayed graft function, the requirement for dialysis due to poor kidney function post-transplant, is a frequent complication of deceased donor kidney transplantation and is associated with inferior outcomes an...

Authors: Michael G. Collins, Magid A. Fahim, Elaine M. Pascoe, Kathryn B. Dansie, Carmel M. Hawley, Philip A. Clayton, Kirsten Howard, David W. Johnson, Colin J. McArthur, Rachael C. McConnochie, Peter F. Mount, Donna Reidlinger, Laura Robison, Julie Varghese, Liza A. Vergara, Laurence Weinberg…

Analysis of responder-based endpoints: improving power through utilising continuous components

Clinical trials and other studies commonly assess the effectiveness of an intervention through the use of responder-based endpoints. These classify patients based on whether they meet a number of criteria whic...

Authors: James Wason, Martina McMenamin and Susanna Dodd

Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial

Cochrane, an organization dedicated to the production and dissemination of high-quality evidence on health, endeavors to reach consumers by developing appropriate summary formats of its systematic reviews. How...

Authors: Ivan Buljan, Ružica Tokalić, Marija Roguljić, Irena Zakarija-Grković, Davorka Vrdoljak, Petra Milić, Livia Puljak and Ana Marušić

Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial

The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline addresses pr...

Authors: Julia Lühnen, Birte Berger-Höger, Burkhard Haastert, Jana Hinneburg, Jürgen Kasper and Anke Steckelberg

Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis

Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated wit...

Authors: Dirk Rades, Carlos Andres Narvaez, Claudia Doemer, Stefan Janssen, Denise Olbrich, Soeren Tvilsted, Antonio J. Conde-Moreno and Jon Cacicedo

Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial

As an irreversible, intractable disease with vision loss, glaucoma leads to permanent and progressive damage of visual function. Lowering high intraocular pressure (HIOP) is the first choice for treating glauc...

Authors: Hongji Liu, Xiang Li, Zongduan Zhang, Jieping Zeng, Yan Dai, Chao Wang, Zhao Xie, Lin Cheng and Linru Cui

Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial

Coronavirus disease 2019 (COVID-19), caused by a novel corinavirus (later named SARS-CoV-2 virus), was fistly reported in Wuhan, Hubei Province, China towards the end of 2019. Large-scale spread within China a...

Authors: Yeming Wang, Fei Zhou, Dingyu Zhang, Jianping Zhao, Ronghui Du, Yi Hu, Zhenshun Cheng, Ling Gao, Yang Jin, Guangwei Luo, Shouzhi Fu, Qiaofa Lu, Guanhua Du, Ke Wang, Yang Lu, Guohui Fan…

The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial

Chronic pain is highly prevalent in the working population. People tend to attempt self-initiated treatments to manage their pain. The self-efficacy of behavioural change is a suitable model for guiding the de...

Authors: Shuk Kwan Tang, Mimi Mun Yee Tse, Sau Fong Leung and Theofanis Fotis

Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial

The emergence of new molecular targeted drugs provides new prospects for the treatment of advanced breast cancer; the future therapeutic trend includes chemotherapy combined ...

Authors: Shuo Wu, Liang Zhang, Huan Li, Junnan Xu, Cui Jiang and Tao Sun

REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial

Around one in ten adults take antidepressants for depression in England, and their long-term use is increasing. Some need them to prevent relapse, but 30–50% could possibly stop them without relapsing and avoi...

Authors: Tony Kendrick, Adam W. A. Geraghty, Hannah Bowers, Beth Stuart, Geraldine Leydon, Carl May, Guiqing Yao, Wendy O’Brien, Marta Glowacka, Simone Holley, Samantha Williams, Shihua Zhu, Rachel Dewar-Haggart, Bryan Palmer, Margaret Bell, Sue Collinson…

Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study

Subacute thyroiditis (SAT) is the most common cause of thyroid pain. Several clinical guidelines recommend that patients who fail to respond to full doses of non-steroidal anti-inflammatory drugs (NSAIDs) shou...

Authors: Shaoyong Xu, Yuxin Jiang, Aihua Jia, Juan Zhang, Bin Gao, Jing Xu, Xiaorui Jing, Yang Jiao, Jia Wei, Wenlei Xu, Ruikun Chen, Ling Gao and Lei Shang

The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial

Disruptive behavior in hospitalized patients has become a priority area of safety concern for clinical staff, and also has consequences for patient management and hospital course. Proactive screening and inter...

Authors: Jay Morrison, Michele Hasselblad, Ruth Kleinpell, Reagan Buie, Deborah Ariosto, Erin Hardiman, Stephen W. Osborn and Christopher J. Lindsell

Efficacy of Liu-zi-jue in Patients with 2019 Novel Coronavirus Pneumonia (COVID-19): structured summary of a study protocol for a randomized controlled trial

Efficacy of conventional treatment plus the complementary therapy Liu-zi-jue (a mind-body exercise) to treat patients with mild COVID-19.

Authors: Shuaipan Zhang, Zhizhen Lv, Qingguang Zhu, Wuquan Sun, Fei Yao, Lei Fang, Yanbin Cheng, Zhiwei Wu and Min Fang

Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial

Treatment with beta-blockers is currently recommended after myocardial infarction (MI). The evidence relies on trials conducted decades ago before implementation of revascularization and contemporary medical t...

Authors: Anna Meta Dyrvig Kristensen, Ann Bovin, Ann Dorthe Zwisler, Charlotte Cerquira, Christian Torp-Pedersen, Hans Erik Bøtker, Ida Gustafsson, Karsten Tange Veien, Kristian Korsgaard Thomsen, Michael Hecht Olsen, Mogens Lytken Larsen, Olav Wendelboe Nielsen, Per Hildebrandt, Sussie Foghmar, Svend Eggert Jensen, Theis Lange…

Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial

Chronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities...

Authors: Esther Fernandes Tinoco Volpe, Vanessa R. Resqueti, Ana Aline Marcelino da Silva, Lucien Peroni Gualdi and Guilherme A. F. Fregonezi