Articles

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

The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam

Eliminating hepatitis C is hampered by the costs of direct-acting antiviral treatment and the need to treat hard-to-reach populations. Access could be widened by shortening or simplifying treatment, but limite...

Authors: Leanne McCabe, Ian R. White, Nguyen Van Vinh Chau, Eleanor Barnes, Sarah L. Pett, Graham S. Cooke and A. Sarah Walker

Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE)

Febrile neutropaenia (FN) is a very common complication in patients with haematological malignancies and is associated with considerable morbidity and mortality. Broad-spectrum antipseudomonal β-lactam antibio...

Authors: J. Laporte-Amargos, C. Gudiol, M. Arnan, P. Puerta-Alcalde, F. Carmona-Torre, M. Huguet, A. Albasanz-Puig, R. Parody, C. Garcia-Vidal, J. L. del Pozo, M. Batlle, C. Tebé, R. Rigo-Bonnin, C. Muñoz, A. Padullés, F. Tubau…

Effect of an interprofessional care concept on the hospitalization of nursing home residents: study protocol for a cluster-randomized controlled trial

The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for...

Authors: Alexandra Piotrowski, Martha Meyer, Iris Burkholder, Dagmar Renaud, Markus Alexander Müller, Thorsten Lehr, Sonja Laag, Joachim Meiser, Lisa Manderscheid and Juliane Köberlein-Neu

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal pre...

Authors: Kyou-Young Lee, In-Sik Han, Ho-Yeon Go, Dong-Nyung Lee, Jun-Sang Yu and Seung-Ho Sun

Steps to recovery: body weight-supported treadmill training for critically ill patients: a randomized controlled trial

Early mobilization has been proven effective for patients in intensive care units (ICUs) to improve functional recovery. However, early mobilization of critically ill, often mechanically ventilated, patients i...

Authors: Robin C. H. Kwakman, Juultje Sommers, Janneke Horn, Frans Nollet, Raoul H. H. Engelbert and Marike van der Schaaf

Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliora...

Authors: Congcong Zeng, Xi Liu, Lufeng Hu, Yuan Feng, Nengzhi Xia, Haihuan Zeng, Lin Luo, Ren Ye and Zhengzhong Yuan

OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) trial—statistical analysis plan

A chest X-ray is a standard imaging procedure in the diagnostic work-up of patients suspected of having non-traumatic pulmonary disease. Compared to a chest X-ray, an ultra-low-dose (ULD) chest computed tomogr...

Authors: Maadrika M. N. P. Kanglie, Shandra Bipat, Inge A. H. van den Berk, Tjitske S. R. van Engelen, Marcel G. W. Dijkgraaf, Jan M. Prins, Jaap Stoker and Patrick M. M. Bossuyt

Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial

Previous studies suggested that acupuncture was a promising adjunctive treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The aim of the present trial is to expl...

Authors: Siyi Yu, Xiaohui Dong, Ruirui Sun, Zhaoxuan He, Chuantao Zhang, Mei Chen, Xiaojuan Hong, Lei Lan and Fang Zeng

Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial

Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients wit...

Authors: Loretta Davies, Jonathan Cook, Jose Leal, Carlos Morgado Areia, Beverly Shirkey, William Jackson, Helen Campbell, Heidi Fletcher, Andrew Carr, Karen Barker, Sarah E. Lamb, Paul Monk, Sean O’Leary, Fares Haddad, Chris Wilson, Andrew Price…

Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial

Previous research suggests that both cognitive training and physical exercise help to maintain brain health and cognitive functions that decline with age. Some studies indicate that combined interventions may ...

Authors: Soledad Ballesteros, Jennifer A. Rieker, Julia Mayas, Antonio Prieto, Pilar Toril, María Pilar Jiménez and José Manuel Reales

Reducing sitting at work: process evaluation of the SMArT Work (Stand More At Work) intervention

Office-based workers accumulate high amounts of sitting time. Stand More At Work (SMArT Work) aimed to reduce occupational sitting time and a cluster randomised controlled trial demonstrated it was successful ...

Authors: Stuart J. H. Biddle, Sophie E. O’Connell, Melanie J. Davies, David Dunstan, Charlotte L. Edwardson, Dale W. Esliger, Laura J. Gray, Thomas Yates and Fehmidah Munir

An online solution focused brief therapy for adolescent anxiety during the novel coronavirus disease (COVID-19) pandemic: a structured summary of a study protocol for a randomised controlled trial

This study aims to assess the effectiveness of delivering Solution Focused Brief Therapy (SFBT) through telecommunication with a group of adolescents who present anxiety symptoms during the COVID-19 outbreak. ...

Authors: Shitao Chen

Propranolol for familial cerebral cavernous malformation (Treat_CCM): study protocol for a randomized controlled pilot trial

Cerebral cavernous malformations (CCMs) are vascular malformations characterized by clusters of enlarged leaky capillaries in the central nervous system. They may result in intracranial haemorrhage, epileptic ...

Authors: Silvia Lanfranconi, Elisa Scola, Giulio Andrea Bertani, Barbara Zarino, Roberto Pallini, Giorgio d’Alessandris, Emanuela Mazzon, Silvia Marino, Maria Rita Carriero, Emma Scelzo, Giuseppe Faragò, Marco Castori, Carmela Fusco, Antonio Petracca, Leonardo d’Agruma, Laura Tassi…

Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial

An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select ...

Authors: Maria Swennergren Hansen, Marianne Toft Vestermark, Per Hölmich, Morten Tange Kristensen and Kristoffer Weisskirchner Barfod

Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial)

Atrial fibrillation (AF) is the most frequent cardiac arrhythmia which increases the risk of thromboembolic complications and impairs quality of life. An important part of a therapeutic approach for AF is sinu...

Authors: Rafał Dąbrowski, Paweł Syska, Justyna Mączyńska, Michał Farkowski, Stefan Sawicki, Agata Kubaszek-Kornatowska, Piotr Michałek, Ilona Kowalik, Hanna Szwed and Tomasz Hryniewiecki

Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials

Modified Sijunzi decoction (SJZD) has been used to treat ulcerative colitis (UC) in remission. However, more rigorous clinical trials are necessary to evaluate its effectiveness. Therefore, a series of single-cas...

Authors: Yi-ming Chen, Jie-min Deng, Yi Wen, Bin Chen, Jiang-tao Hou, Bin Peng, Shi-jing Zhang, Hong Mi, Qi-long Jiang, Xia-lin Wu, Feng-bin Liu and Xin-lin Chen