Articles

Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation

Non-inferiority trials are increasingly used to evaluate new treatments that are expected to have secondary advantages over standard of care, but similar efficacy on the primary outcome. When designing a non-i...

Authors: Matteo Quartagno, A. Sarah Walker, Abdel G. Babiker, Rebecca M. Turner, Mahesh K. B. Parmar, Andrew Copas and Ian R. White

Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials)

There are several open scientific questions regarding the optimal antibiotic treatment of spinal infections (SIs) with or without an implant. The duration of postsurgical antibiotic therapy is debated.

Authors: Michael Betz, Ilker Uçkay, Regula Schüpbach, Tanja Gröber, Sander M. Botter, Jan Burkhard, Dominique Holy, Yvonne Achermann and Mazda Farshad

Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial

Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder...

Authors: Yunxuan Huang, Jiabi Zhang, Buhui Xiong, Ruina Huang, Wenjing Zhao, Mengxue Zhou, Qi Chen, Danghan Xu and Xinghua Chen

Anterior quadratus lumborum block for postoperative recovery after total hip arthroplasty: a study protocol for a single-center, double-blind, randomized controlled trial

Appropriate pain management is essential to improve the postoperative recovery after total hip arthroplasty (THA). Various case reports have indicated that anterior quadratus lumborum block (QLB) provides effe...

Authors: Masaru Kikuchi, Takahiro Mihara, Yusuke Mizuno, Hiroko Fujimoto, Sachiko Arai, Takeshi Nomura and Takahisa Goto

Intra-arterial versus standard intravenous administration of lutetium-177-DOTA-octreotate in patients with NET liver metastases: study protocol for a multicenter, randomized controlled trial (LUTIA trial)

Lutetium-177-DOTA-octreotate (¹⁷⁷Lu-DOTATATE) significantly increases survival and response rates in patients with grade I and grade II neuroendocrine tumors (NETs). However, survival and response rates are signi...

Authors: Sander C. Ebbers, Arthur J. A. T. Braat, Adriaan Moelker, Marcel P. M. Stokkel, Marnix G. E. H. Lam and Maarten W. Barentsz

Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial

Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies have suggested that it might exert a preventive effect in managing ECC. However, no well-designed...

Authors: Sherry Shiqian Gao, Kitty Jieyi Chen, Duangporn Duangthip, May Chun Mei Wong, Edward Chin Man Lo and Chun Hung Chu

Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand

A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Māori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training...

Authors: Ralph Maddison, Elaine Anne Hargreaves, Yannan Jiang, Amanda Jane Calder, Sally Wyke, Cindy M. Gray, Kate Hunt, David Lubans, Helen Eyles, Nick Draper, Ihirangi Heke, Stephen Kara, Gerhard Sundborn, Claire Arandjus, Matthew Jenkins and Samantha Marsh

Intravenous versus subcutaneous route pharmacokinetics of paracetamol (acetaminophen) in palliative care patients: study protocol for a randomized trial (ParaSCIVPallia)

Among palliative care (PC) patients who are administered paracetamol, the subcutaneous (SC) route is often an alternative to the intravenous (IV) route. Yet pharmacological and clinical data on whether these a...

Authors: Marine Vernant, Marie Lepoupet, Christian Creveuil, Antoine Alix, Charlotte Gourio, Laure Peyro-Saint-Paul, Veronique Lelong-Boulouard and Cyril Guillaumé

Prevention of doxorubicin-induced Cardiotoxicity by pharmacological non-hypoxic myocardial preconditioning based on Docosahexaenoic Acid (DHA) and carvedilol direct antioxidant effects: study protocol for a pilot, randomized, double-blind, controlled trial (CarDHA trial)

Anthracycline-induced cardiotoxicity (AIC), a condition associated with multiple mechanisms of damage, including oxidative stress, has been associated with poor clinical outcomes. Carvedilol, a β-blocker with ...

Authors: Rodrigo Carrasco, María Cristina Ramirez, Kjersti Nes, Andrés Schuster, Rubén Aguayo, Marcelo Morales, Cristobal Ramos, Daniel Hasson, Camilo G. Sotomayor, Pablo Henriquez, Ignacio Cortés, Marcia Erazo, Claudio Salas and Juan G. Gormaz

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study

The GABA_A-α5 receptor antagonist S44819 is a promising candidate to enhance functional recovery after acute ischemic stroke (IS). S44819 is currently evaluated in this indication; RESTORE brain study started in D...

Authors: Hugues Chabriat, Claudio L. Bassetti, Ute Marx, Françoise Picarel-Blanchot, Aurore Sors, Celine Gruget, Barbara Saba, Marine Wattez, Marie-Laure Audoli and Dirk M. Hermann

Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial

Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. T...

Authors: Weiqiang Yang, Xiaoling Li, Jiatao Zhong, Xueshuang Mei, Hongyu Liu, Le Yang, Liming Lu and Hongyi Hu

Financial incentives for hypertension control: rationale and study design

Even though the effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention of hypertension and its complications have been demonstrated in randomized controlled t...

Authors: Liqiang Zheng, Yali Wang, Sitong Liu, Rui Zheng, Dongmei Pei, Yingxian Sun and Zhaoqing Sun

Doll therapy intervention for women with dementia living in nursing homes: a randomized single-blind controlled trial protocol

Doll therapy is a non-pharmacological intervention for people with dementia aimed to reduce distressing behaviours. Reliable results on the efficacy of Doll therapy for people with dementia are needed. The con...

Authors: Roberta Vaccaro, Roberta Ballabio, Valentina Molteni, Laura Ceppi, Benedetta Ferrari, Marco Cantù, Daniele Zaccaria, Carla Vandoni, Rita Bianca Ardito, Mauro Adenzato, Barbara Poletti, Antonio Guaita and Rita Pezzati

Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial

The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyl...

Authors: Louise C. Mâsse, Janae Vlaar, Janice Macdonald, Jennifer Bradbury, Tom Warshawski, E. Jean Buckler, Jill Hamilton, Josephine Ho, Annick Buchholz, Katherine M. Morrison and Geoff D. C. Ball

Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease

Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. For patients with heart failure, atrial fibrillation or therapy-resistant hypertensio...

Authors: Andreas Ziegler, Miriam Mann, Bernard Brandewiede, Hermann Dittrich, Sissy Hintz, Katja Krockenberger, Alper Öner, Marcos Oliviera de Sousa and Christian Schmidt

Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial

Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. The...

Authors: Kyeong Tae Kim, Sophie Morton, Sarah Howe, Yeong Shiong Chiew, Jennifer L. Knopp, Paul Docherty, Christopher Pretty, Thomas Desaive, Balazs Benyo, Akos Szlavecz, Knut Moeller, Geoffrey M. Shaw and J. Geoffrey Chase

Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I)

In acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sl...

Authors: Henrik Fox, Andrea Hetzenecker, Stefan Stadler, Olaf Oldenburg, Okka W. Hamer, Florian Zeman, Leonhard Bruch, Mirko Seidel, Stefan Buchner and Michael Arzt

Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial

The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liv...

Authors: Kyungsun Han, Ojin Kwon, Hyo-ju Park, So-Young Jung, Changsop Yang and Chang-Gue Son

Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India

The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and dur...

Authors: Sunita Taneja, Ranadip Chowdhury, Neeta Dhabhai, Sarmila Mazumder, Ravi Prakash Upadhyay, Sitanshi Sharma, Rupali Dewan, Pratima Mittal, Harish Chellani, Rajiv Bahl, Maharaj Kishan Bhan and Nita Bhandari

Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda

There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in ...

Authors: Melissa M. Medvedev, Victor Tumukunde, Ivan Mambule, Cally J. Tann, Peter Waiswa, Ruth R. Canter, Christian H. Hansen, Elizabeth Ekirapa-Kiracho, Kenneth Katumba, Catherine Pitt, Giulia Greco, Helen Brotherton, Diana Elbourne, Janet Seeley, Moffat Nyirenda, Elizabeth Allen…

Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial)

Bronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors and one of the most common chronic lung diseases. It has a poor prognosis, especially in preterm infants. Ho...

Authors: Xian Wu, Yunqiu Xia, Ou Zhou, Yan Song, Xianhong Zhang, Daiyin Tian, Qubei Li, Chang Shu, Enmei Liu, Xiaoping Yuan, Ling He, Chengjun Liu, Jing Li, Xiaohua Liang, Ke Yang, Zhou Fu…

Efficacy and cost-utility of the eHealth self-management application 'Oncokompas', helping partners of patients with incurable cancer to identify their unmet supportive care needs and to take actions to meet their needs: a study protocol of a randomized controlled trial

Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with ph...

Authors: Anouk S. Schuit, Karen Holtmaat, Nienke Hooghiemstra, Femke Jansen, Birgit I. Lissenberg-Witte, Veerle M. H. Coupé and Irma M. Verdonck-de Leeuw

Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) – Study protocol from a randomized controlled trial

Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascula...

Authors: Josefin Sundh, Anders Magnuson, Scott Montgomery, Pontus Andell, Gustaf Rindler and Ole Fröbert

Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults

Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for...

Authors: Anu Kemppinen, Carol Howell, Victoria Allgar, Matthew Dodd, John Gregson, Charles Knowles, John McLaughlin, Preeti Pandya, Peter Whorwell, Elena Markaryan and Yan Yiannakou

Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial

Preterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. For a singleton pregnancy, progesterone treatment is effective in prevention of preterm birth in wom...

Authors: Ka Wang Cheung, Mimi Tin Yan Seto and Ernest Hung Yu Ng

Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): study protocol for a multicenter randomized controlled trial

Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in u...

Authors: Jin Ho Choi, Woo Hyun Paik, Min Su You, Kyong Joo Lee, Young Hoon Choi, Bang-sup Shin, Sang Hyub Lee, Ji Kon Ryu and Yong-Tae Kim

An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study

In Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary ca...

Authors: Dan Schwarz, Santosh Dhungana, Anirudh Kumar, Bibhav Acharya, Pawan Agrawal, Anu Aryal, Aaron Baum, Nandini Choudhury, David Citrin, Binod Dangal, Meghnath Dhimal, Bikash Gauchan, Tula Gupta, Scott Halliday, Biraj Karmacharya, Sandeep Kishore…

Efficacy and safety of Ojeok-san plus Saengmaek-san for gastroesophageal reflux-induced chronic cough: protocol for a pilot, randomized, double-blind, placebo-controlled trial

Gastroesophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms....

Authors: Yeon Hee Bhang, Kwan-Il Kim, Jaehyo Kim, Junmo Ahn, Hwan-Su Jung, Changsop Yang, Seok-Jae Ko, Youngmin Bu, Jae-Woo Park, Kyoung Sun Park, Hee-Jae Jung, Jun-Hwan Lee and Beom-Joon Lee

Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors

Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acut...

Authors: Franziska Holtdirk, Anja Mehnert, Mario Weiss, Björn Meyer and Carsten Watzl

Challenges in the design, planning and implementation of trials evaluating group interventions

Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or heal...

Authors: Katie Biggs, Daniel Hind, Rebecca Gossage-Worrall, Kirsty Sprange, David White, Jessica Wright, Robin Chatters, Katherine Berry, Diana Papaioannou, Mike Bradburn, Stephen J. Walters and Cindy Cooper

Streamlining and cycle time reduction of the startup phase of clinical trials

The startup phase of a clinical trial (CT) plays a vital role in the execution of new drug development. Hence, the aim of this study is to identify the factors responsible for delaying the CT startup phase. Fu...

Authors: Amani Abu-Shaheen, Ahmad Al Badr, Isamme Al Fayyad, Adel Al Qutub, Eissa Ali Faqeih and Mohamad Al-Tannir

Does a mindfulness-augmented version of the German Strengthening Families Program reduce substance use in adolescents? Study protocol for a randomized controlled trial

Mindfulness training (MT) for parents of adolescents has been shown to improve mental health and stress-related outcomes in individuals and their families. Studies of MT among young people are mainly delivered...

Authors: Nicolas Arnaud, Christiane Baldus, Léa Josette Laurenz, Sonja Bröning, Maja Brandt, Sabrina Kunze, Maria Austermann, Linda Zimmermann, Anne Daubmann and Rainer Thomasius

Clinical evaluation of ultrasonic subgingival debridement versus ultrasonic subgingival scaling combined with manual root planing in the treatment of periodontitis: study protocol for a randomized controlled trial

Periodontal diseases are regarded as the most common diseases of mankind. The prevalence rate of periodontal disease assumes a clear growth tendency, increasing by 57.3% from 1990 to 2010. Thereby, effective p...

Authors: Yue Yan, Yalin Zhan, Xian’e Wang and Jianxia Hou

Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)

After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of th...

Authors: A.J. Kalkdijk-Dijkstra, J.A.G. van der Heijden, H.L. van Westreenen, P.M.A. Broens, M. Trzpis, J.P.E.N. Pierie and B.R. Klarenbeek

Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol

Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation...

Authors: Adnan Al-Kaisy, Jonathan Royds, Stefano Palmisani, David Pang, Samuel Wesley, Rod S. Taylor, Andrew Cook, Sam Eldabe, Lance McCracken, Rui Duarte and Jeremy Fairbank

Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol

Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupunct...

Authors: Yin Shou, Li Hu, Cuihong Zhang, Shifen Xu, Qi Jin, Li Huang, Bingrong Li, Long Yuan, Siwei Xu, Kaiyong Zhang, Huiru Jiang and Bimeng Zhang

Point OutWords: protocol for a feasibility randomised controlled trial of a motor skills intervention to promote communicative development in non-verbal children with autism

Point OutWords is a caregiver-delivered, iPad-assisted intervention for non-verbal or minimally verbal children with autism. It aims to develop prerequisite skills for communication such as manual and oral motor ...

Authors: Ailbhe McKinney, Kathryn L. Hotson, Alicia Rybicki, Emma J. L. Weisblatt, Claudia Días, Juliet Foster, Sofía S. Villar, Suzanne Murphy and Matthew K. Belmonte

Improving risk perception and uptake of voluntary medical male circumcision with peer-education sessions and incentives, in Manicaland, East Zimbabwe: study protocol for a pilot randomised trial

Voluntary medical male circumcision (VMMC) is a key component of combination HIV-prevention programmes. Several high-HIV-prevalence countries in sub-Saharan Africa, including Zimbabwe, are looking to scale up ...

Authors: Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett and Simon Gregson

The efficacy and safety of 'antianxiety granule' for anxiety disorder: a multicentre, randomized, double-blind, placebo-controlled, parallel-group trial

Anxiety disorders are the most prevalent class of lifetime disorders in China, and generalized anxiety disorder (GAD) is one of the most common but frequently overlooked anxiety disorders. Conventional pharmac...

Authors: Zhongwei Sha, Yiping Hou, Chunchun Xue, Ou Li, Zhimin Li, Huiru Wang, Wenjing Zhang and Jian Xu

French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial

Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy ...

Authors: Daniel Jost, Sabine Lemoine, Frederic Lemoine, Vincent Lanoe, Olga Maurin, Clément Derkenne, Marilyn Franchin Frattini, Maëlle Delacote, Edouard Seguineau, Anne Godefroy, Nicolas Hervault, Ludovic Delhaye, Nicolas Pouliquen, Emilie Louis-Delauriere, Julie Trichereau, Florian Roquet…

Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - the CIPIC Rehab Study: study protocol for a randomised controlled trial

Intermittent claudication (IC) caused by peripheral artery disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced...

Authors: Maj Siercke, Lise Pyndt Jørgensen, Malene Missel, Lau Caspar Thygesen, Pernille Peppercorn Blach, Henrik Sillesen and Selina Kikkenborg Berg

Letter on “Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK”

Authors: Sarah Griffiths, Lorna Manger, Rebecca Chapman, Lauren Weston, Ian Sherriff, Cath Quinn, Paul Clarkson, Caroline Sutcliffe, Karen Davies and Richard Byng

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

Prescribing, monitoring and administration of medicines in care homes could be improved. Research has identified the need for one person to assume overall responsibility for the management of medicines within ...

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

Immersive virtual reality as analgesia for women during hysterosalpingography: study protocol for a randomized controlled trial

Hysterosalpingography (HSG) is an accepted radiologic diagnostic modality for initial infertility workup, and is generally considered uncomfortable and painful. However, the management of pain related to HSG r...

Authors: Yi-Ling Wang, Hai-Xiang Gao, Jin-She Wang, Jing-Hui Wang, Lei Bo, Ting-Ting Zhang, Ya-Liang Dai, Lu-Lu Gao, Qiang Liu, Jun-Jun Zhang, Ju-Min Cai, Jian-Qiang Yu and Yu-Xiang Li

Supervised exercise training and increased physical activity to reduce cardiovascular disease risk in women with polycystic ovary syndrome: study protocol for a randomized controlled feasibility trial

Polycystic ovary syndrome (PCOS) affects up to 20% of women and is characterised by higher amounts of visceral fat, obesity, insulin resistance, dyslipidemia and reproductive and cardiometabolic complications....

Authors: Amie Woodward, David Broom, Caroline Dalton, Mostafa Metwally and Markos Klonizakis

Comparison of the effectiveness of a tailored cognitive behavioural therapy with a supportive listening intervention for depression in those newly diagnosed with multiple sclerosis (the ACTION-MS trial): protocol of an assessor-blinded, active comparator, randomised controlled trial

Multiple sclerosis (MS) is an unpredictable, chronic neurological disease accompanied with high rates of depression and anxiety, particularly in the early stages of diagnosis. There is evidence to suggest that...

Authors: Litza Kiropoulos, Trevor Kilpatrick, Tomas Kalincek, Leonid Cherulov, Elizabeth McDonald, Tissa Wijeratne, Jennifer Threader, Vanja Rozenblat, Neil Simpson-O’Brien, Anneke Van Der Walt and Lisa Taylor

A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol

Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Despite the development of pharmacological and nonpharmacological interve...

Authors: Chao Hsing Yeh, Cuicui Li, Ronald Glick, Elizabeth A. Schlenk, Kathryn Albers, Lorna Kwai-Ping Suen, Nada Lukkahatai, Nicole Salen, Sonaali Pandiri, Weixia Ma, Nancy Perrin, Natalia E. Morone and Paul J. Christo

Testing non-inferiority of blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis and the effectiveness of blended booster sessions aimed at improving long-term outcome following both therapies: study protocol for two observer-blinded randomized clinical trials

Cognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improve...

Authors: Marieke Houniet-de Gier, Heleen Beckerman, Kimberley van Vliet, Hans Knoop and Vincent de Groot

Shortening antibiotic duration in the treatment of acute cholangitis: rationale and study protocol for an open-label randomized controlled trial

Antimicrobial therapy with appropriate biliary drainage is considered the standard of care for acute cholangitis, but the optimal duration of antimicrobial therapy remains unknown. Seven to 10 days of antimicr...

Authors: Kentaro Iwata, Asako Doi, Yuichiro Oba, Hiroo Matsuo, Kei Ebisawa, Manabu Nagata, Sho Nishimura, Kenichi Yoshimura, Atsuhiro Masuda, Hideyuki Shiomi and Yuzo Kodama

International randomised controlled trial for the treatment of newly diagnosed EWING sarcoma family of tumours – EURO EWING 2012 Protocol

Although there have been multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT) and these have been conducted over many years and involved many international cooperative groups, t...

Authors: Jennifer Anderton, Veronica Moroz, Perrine Marec-Bérard, Nathalie Gaspar, Valerie Laurence, Javier Martín-Broto, Ana Sastre, Hans Gelderblom, Cormac Owens, Sophie Kaiser, Melissa Fernández-Pinto, Nicola Fenwick, Abigail Evans, Sandra Strauss, Jeremy Whelan, Keith Wheatley…