Articles

Modulation of frontal EEG alpha oscillations during maintenance and emergence phases of general anaesthesia to improve early neurocognitive recovery in older patients: protocol for a randomised controlled trial

Postoperative delirium may manifest in the immediate post-anaesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Frontal elect...

Authors: Amy Gaskell, Rebecca Pullon, Darren Hight, Jonathan Termaat, Gay Mans, Logan Voss, Matthias Kreuzer, Sebastian Schmid, Stephan Kratzer, Amy Rodriguez, Gerhard Schneider, Paul Garcia and Jamie Sleigh

Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial

The prevalence of methamphetamine use disorder (MUD) in the United States has risen dramatically in the past four decades and is concentrated in populations such as men who have sex with men (MSM). Despite the...

Authors: Christopher S. Stauffer, Jenna M. Moschetto, Scott M. McKernan, Elaine Hsiang, Brian Borsari and Joshua D. Woolley

Evaluation of the effect of an antenatal pelvic floor muscle exercise programme on female sexual function during pregnancy and the first 3 months following birth: study protocol for a pragmatic randomised controlled trial

Sexual dysfunction can have a negative impact on women’s quality of life and relationships. There is limited information about female sexual function and treatment, particularly during pregnancy and the postpa...

Authors: Sahar Sadat Sobhgol, Holly Priddis, Caroline A. Smith and Hannah Grace Dahlen

Efficacy and safety of levothyroxine (L-T4) replacement on the exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism: Study protocol for a multi-center, open label, randomized, parallel group trial (ThyroHeart-CHF)

Subclinical hypothyroidism is a common condition in patients with heart failure and is defined as elevated serum thyroid hormone (TSH) with normal circulating free thyroxine (FT4). Evidence on the effect of th...

Authors: Xuan Zhang, Wen-yao Wang, Kuo Zhang, Jian Tian, Ji-lin Zheng, Jing Chen, Shi-min An, Si-yuan Wang, Yu-peng Liu, Yan Zhao, Jing-jia Wang, Min Yang and Yi-da Tang

Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial)

Transurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is r...

Authors: Benjamin Speich, Kathrin Bausch, Jan A. Roth, Lars G. Hemkens, Hannah Ewald, Deborah R. Vogt, Nicole Bruni, Stefanie Deuster, Hans-H. Seifert and Andreas F. Widmer

SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials

Randomised controlled trials are considered the best method for determining the effectiveness and safety of health interventions. Trials involving children are essential to ensure that treatments are safe and ...

Authors: Jacqueline Martin-Kerry, Adwoa Parker, Peter Bower, Ian Watt, Shaun Treweek, David Torgerson, Catherine Arundel and Peter Knapp

Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial

Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended...

Authors: Jae-Uk Sul, Myung Kwan Kim, Jungtae Leem, Hee-Geun Jo, Sang-hoon Yoon, Jeeyong Kim, Eun-Jung Lee, Jeong-Eun Yoo, So Jung Park, Young Il Kim, Eunseok Kim, In Chul Jung, Ju-Hyun Jeon and Yang-Chun Park

The SURV1VE trial—sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial

The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best m...

Authors: Georg M. Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Caroline Fray, Sylvia van Os and Po-Yin Cheung

Impact of two oral doses of 100,000 IU of vitamin D₃ in preschoolers with viral-induced asthma: a pilot randomised controlled trial

New evidence supports the use of supplemental vitamin D in the prevention of exacerbation of asthma; however, the optimal posology to sufficiently raise serum levels while maximising adherence is unclear. The ...

Authors: Francine Monique Ducharme, Megan Jensen, Geneviève Mailhot, Nathalie Alos, John White, Elizabeth Rousseau, Sze Man Tse, Ali Khamessan and Benjamin Vinet

A parent-led intervention to promote recovery following pediatric injury: study protocol for a randomized controlled trial

Injury is one of the most prevalent potentially emotionally traumatic events that children experience and can lead to persistent impaired physical and emotional health. There is a need for interventions that p...

Authors: Meghan L. Marsac, Ginny Sprang, Leila Guller, Kristen L. Kohser, John M. Draus Jr and Nancy Kassam-Adams

Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used i...

Authors: Sheling Xie, Peng Yan, Chen Yao, Xiaoyan Yan, Yuliang Huo, Junhua Zhang, Si Liu, Zhiqiao Feng, Hongcai Shang and Lixin Xie

Effects of blood flow restriction exercise with very low load and low volume in patients with knee osteoarthritis: protocol for a randomized trial

Knee osteoarthritis (OA) is characterized by chronic pain, physical dysfunction, and reduced quality of life. Low-load resistance exercises with blood flow restriction (BFR) have presented results similar to t...

Authors: Mikhail Santos Cerqueira and Wouber Hérickson de Brito Vieira

Acceptability and feasibility of a 12-week yoga vs. educational film program for the management of restless legs syndrome (RLS): study protocol for a randomized controlled trial

Restless legs syndrome (RLS) is a common and burdensome sleep disorder associated with profound impairment of health, well-being, and quality of life. Unfortunately, the medications used for RLS management car...

Authors: Terry Kit Selfe, Sijin Wen, Karen Sherman, Maryanna Klatt and Kim E. Innes

A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial

Urinary catheter placement is essential before laparoscopic anterior resection for rectal cancer. Whether early removal of the catheter increases the incidence of urinary retention and urinary tract infection ...

Authors: Lai Xu, Zhi-Yan Tao, Jun-Yang Lu, Guan-Nan Zhang, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Tao Xu and Yi Xiao

Pulmonary rehabilitation in patients with mustard gas lung disease: a study protocol for a randomized controlled trial

More than 60,000 people have health problems due to chemical weapons exposure during the Iran–Iraq war. Respiratory consequences of mustard gas exposure are common and disabling; medical interventions have lim...

Authors: Mohamad Reza Sedighi Moghadam, Mostafa Ghanei, Klaus Kenn and Nicholas S. Hopkinson

COMPare: Qualitative analysis of researchers’ responses to critical correspondence on a cohort of 58 misreported trials

Discrepancies between pre-specified and reported outcomes are an important and prevalent source of bias in clinical trials. COMPare (Centre for Evidence-Based Medicine Outcome Monitoring Project) monitored all...

Authors: Ben Goldacre, Henry Drysdale, Cicely Marston, Kamal R. Mahtani, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley and Carl Heneghan

COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time

Discrepancies between pre-specified and reported outcomes are an important source of bias in trials. Despite legislation, guidelines and public commitments on correct reporting from journals, outcome misreport...

Authors: Ben Goldacre, Henry Drysdale, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Cicely Marston, Anna Powell-Smith, Carl Heneghan and Kamal R. Mahtani

How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the ‘CLASSIC’ trial)

There are enormous problems in recruiting depressed people into randomised controlled trials (RCTs), with numerous studies consistently failing to recruit to target (Sully et al., Trials 14:166, 2013). Given t...

Authors: June S. L. Brown, Caroline Murphy, Joanna Kelly and Kimberley Goldsmith

Study of negative pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): protocol for a randomised controlled trial

Although negative pressure wound therapy (NPWT) is widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has not yet been adequately investigated, with researc...

Authors: Cody C. Frear, Bronwyn Griffin, Leila Cuttle, Steven M. McPhail and Roy Kimble

Anaesthetist-controlled versus patient-maintained effect-site targeted propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia (ACCEPTS): study protocol for a parallel-group randomised comparison trial

The clinical efficacy of effect-site targeted patient-maintained propofol sedation (PMPS) compared to anaesthetist-controlled propofol sedation (ACPS) for patients undergoing awake joint replacement surgery is...

Authors: David W. Hewson, Frank Worcester, James Sprinks, Murray D. Smith, Heather Buchanan, Philip Breedon, Jonathan G. Hardman and Nigel M. Bedforth

Binge-eating disorder treatment goes online – feasibility, usability, and treatment outcome of an Internet-based treatment for binge-eating disorder: study protocol for a three-arm randomized controlled trial including an immediate treatment, a waitlist, and a placebo control group

Binge-eating disorder (BED) is characterized by recurrent episodes of loss of control over eating and is related to a higher prevalence of other mental disorders and somatic consequences associated with overwe...

Authors: Simone Munsch, Andrea Wyssen, Pierre Vanhulst, Denis Lalanne, Sharon T. Steinemann and Alexandre Tuch

Efficacy and safety of umbilical therapy with the traditional Chinese medicine formulation Lishui Xiaogu cataplasm for cirrhotic ascites: protocol for a randomized controlled trial

Ascites is one of the most common complications of cirrhosis. Umbilical therapy with traditional Chinese medicines has been increasingly prescribed to treat cirrhotic ascites. However, high-quality evidence fr...

Authors: Xianzhao Yang, Shuying Ru, Lin Luo, Xiaoying Lv, Wenjing Bai, Fuwen Zhang and Feng Jiang

The cerebral mechanism of acupuncture for treating knee osteoarthritis: study protocol for a randomized controlled trial

Acupuncture is safe and effective for reducing the symptoms of knee osteoarthritis (KOA), but the underlying mechanisms of acupuncture for treating KOA are not fully understood.

Authors: Jing Guo, Yang Chen, Zhengjie Li, Shirui Cheng, Chenjian Tang, Xiaohui Dong, Wenhua He, Yong Huang, Bao Yin, Yu Sheng, Jun Zhou, Aijia Li, Fang Zeng, Lei Lan and Fanrong Liang

Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS): study protocol for a prospective, randomized, double-blind, non-inferiority trial

Tranexamic acid (TXA) has been routinely delivered in multisegmental spinal decompression and bone graft fusion surgeries with satisfactory outcomes in minimizing gross blood loss and transfusion demands. Howe...

Authors: Shangyi Hui, Liyuan Tao, Feroze Mahmood, Derong Xu, Zhinan Ren, Xin Chen, Lin Sheng, Qianyu Zhuang, Shugang Li and Yuguang Huang

Comment on the trial protocol “Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial”

Authors: Sanne Marie Thysen and Ane Bærent Fisker

Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial

In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) < 400 μm, as per National Institute for Health and Care Excellence guid...

Authors: Noemi Lois, Evie Gardner, Norman Waugh, Augusto Azuara-Blanco, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M. Aslam, Clare Bailey, Victor Chong, Louise Downey, Haralabos Eleftheriadis, Samia Fatum, Sheena George, Faruque Ghanchi, Markus Groppe…

Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial

Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis...

Authors: Christopher I. Price, Lisa Shaw, Peter Dodd, Catherine Exley, Darren Flynn, Richard Francis, Saiful Islam, Mehdi Javanbakht, Rachel Lakey, Joanne Lally, Graham McClelland, Peter McMeekin, Helen Rodgers, Helen Snooks, Louise Sutcliffe, Pippa Tyrell…

The Oxford study of Calcium channel Antagonism, Cognition, Mood instability and Sleep (OxCaMS): study protocol for a randomised controlled, experimental medicine study

The discovery that voltage-gated calcium channel genes such as CACNA1C are part of the aetiology of psychiatric disorders has rekindled interest in the therapeutic potential of L-type calcium channel (LTCC) antag...

Authors: Lauren Z. Atkinson, Lucy Colbourne, Alexander Smith, Catherine H. Harmer, Anna C. Nobre, Jennifer Rendell, Helen Jones, Christopher Hinds, Arne Mould, Elizabeth M. Tunbridge, Andrea Cipriani, John R. Geddes, Kate E. A. Saunders and Paul J. Harrison

Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences

Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We ai...

Authors: Joanna C. Crocker, Keira Pratt-Boyden, Jenny Hislop, Sian Rees, Louise Locock, Sophie Olszowski, Alan Chant, Shaun Treweek, Jonathan A. Cook, Kerry Woolfall, Nicola Farrar, Jennifer Bostock and Richard Bulbulia

Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial

Mild cognitive impairment (MCI) is known as a transitional status between normal cognitive function and Alzheimer’s disease (AD). Acupuncture and Chinese herbal medicines (CHMs) are considered to be beneficial...

Authors: Yueqi Chen, Wenjing Zhang, Huangan Wu, Lixing Lao, Jian Xu and Shifen Xu

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to u...

Authors: Jamie J. Kirkham, Sarah Gorst, Douglas G. Altman, Jane M. Blazeby, Mike Clarke, Sean Tunis and Paula R. Williamson

Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial

Catheter-related bacteremia (CRB) is the most frequent nosocomial infection in neonatal intensive care unit (NICU) patients, especially in very low-birth-weight infants. Administration of injectable drugs in p...

Authors: Aurélie Maiguy-Foinard, Bertrand Décaudin, Pierre Tourneux, Bernard Guillois, Thierry Blanc, Sophie Galène-Gromez, Morgane Masse, Pascal Odou, Fannette Denies, Benoît Dervaux, Alain Duhamel and Laurent Storme

Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial

Cognitive impairment and cerebrovascular pathology are both frequent with ageing. Cognitive impairment due to vascular pathology of the brain, termed vascular cognitive impairment (VCI), is one of the most fre...

Authors: Ana Verdelho, Sofia Madureira, Manuel Correia, José Manuel Ferro, Mário Rodrigues, Manuel Gonçalves-Pereira, Mafalda Gonçalves, Ana Catarina Santos, Pedro Vilela, Helena Bárrios, Mariana Borges and Helena Santa-Clara

Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled trial

Autism spectrum disorder (ASD) is a common lifelong condition affecting 1 in 100 people. ASD affects how a person relates to others and the world around them. Difficulty responding to sensory information (nois...

Authors: Elizabeth Randell, Rachel McNamara, Sue Delport, Monica Busse, Richard P. Hastings, David Gillespie, Rhys Williams-Thomas, Lucy Brookes-Howell, Renee Romeo, Janet Boadu, Alka S. Ahuja, Anne Marie McKigney, Martin Knapp, Kathryn Smith, Jacqui Thornton and Gemma Warren

VIA Family—a family-based early intervention versus treatment as usual for familial high-risk children: a study protocol for a randomized clinical trial

Children born to parents with a severe mental illness, like schizophrenia, bipolar disorder, or major recurrent depression, have an increased risk of developing a mental illness themselves during life. These c...

Authors: Anne D. Müller, Ida C. T. Gjøde, Mette S. Eigil, Helle Busck, Merete Bonne, Merete Nordentoft and Anne A. E. Thorup

How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions

Context matters for the successful implementation of medical interventions, but its role remains surprisingly understudied. Against the backdrop of antimicrobial resistance, a global health priority, we invest...

Authors: Marco J. Haenssgen, Nutcha Charoenboon, Nga T. T. Do, Thomas Althaus, Yuzana Khine Zaw, Heiman F. L. Wertheim and Yoel Lubell

Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery. J-SUPPORT 1605 (ProD Study): study protocol for a randomized controlled trial

Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard prev...

Authors: Saho Wada, Ryoichi Sadahiro, Yutaka J. Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi and Ken Shimizu

Physical Activity In Renal Disease (PAIRED) and the effect on hypertension: study protocol for a randomized controlled trial

The prevalence of hypertension among people with chronic kidney disease is high with over 60% of people not attaining recommended targets despite taking multiple medications. Given the health and economic impl...

Authors: Stephanie Thompson, Natasha Wiebe, Gabor Gyenes, Rachelle Davies, Jeyasundar Radhakrishnan and Michelle Graham

Design and implementation of a large and complex trial in emergency medical services

The research study titled “Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out-of-hospital...

Authors: Maria J. Robinson, Jodi Taylor, Stephen J. Brett, Jerry P. Nolan, Matthew Thomas, Barnaby C. Reeves, Chris A. Rogers, Sarah Voss, Madeleine Clout and Jonathan R. Benger

Stroke aetiological classification reliability and effect on trial sample size: systematic review, meta-analysis and statistical modelling

Inter-observer variability in stroke aetiological classification may have an effect on trial power and estimation of treatment effect. We modelled the effect of misclassification on required sample size in a h...

Authors: Azmil H. Abdul-Rahim, David Alexander Dickie, Johann R. Selvarajah, Kennedy R. Lees and Terence J. Quinn

COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults

Urinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices ...

Authors: Sinead Duane, Akke Vellinga, Andrew W. Murphy, Martin Cormican, Andrew Smyth, Patricia Healy, Michael Moore, Paul Little and Declan Devane

CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial

While the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them.

Authors: Marlise Poolman, Jessica Roberts, Anthony Byrne, Paul Perkins, Zoe Hoare, Annmarie Nelson, Julia Hiscock, Dyfrig Hughes, Betty Foster, Julie O’Connor, Liz Reymond, Sue Healy, Rossela Roberts, Bee Wee, Penney Lewis, Rosalynde Johnstone…

Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial

There is compelling evidence of beneficial effects of non-immersive virtual reality (VR)-based intervention in the rehabilitation of patients with stroke, whereby patients experience both the real world and th...

Authors: Qianqian Huang, Wei Wu, Xiaolong Chen, Bo Wu, Longqiang Wu, Xiaoli Huang, Songhe Jiang and Lejian Huang

Converting habits of antibiotic use for respiratory tract infections in German primary care – study protocol of the cluster-randomized controlled CHANGE-3 trial

The overuse of antibiotics is a major cause for the worldwide rise of antibiotic resistance. Although it is well known that acute respiratory tract infections (ARTI) are mainly caused by viruses and are often ...

Authors: Anja Wollny, Attila Altiner, Tonia Brand, Katharina Garbe, Martina Kamradt, Petra Kaufmann-Kolle, Mirko Leyh, Regina Poß-Doering, Joachim Szecsenyi, Lorenz Uhlmann, Arwed Voss, Dorothea Weber, Michel Wensing and Christin Löffler

Study protocol for a peer-led web-based intervention to promote safe usage of dating applications among young adults: a cluster randomized controlled trial

Dating applications are a popular platform to meet new people. At the same time, they have been associated with risks such as unsafe sexual behavior and privacy concerns in young adults. This paper presents a ...

Authors: Stephanie Tsz Hei Lau, Kitty Wai Ying Choi, Julie Chen, William Pak-hing Mak, Ho Kong Christopher Au Yeung, Joseph Tucker and William Chi-Wai Wong

Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients – the study design of the LIBERAL-Trial

Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have les...

Authors: Patrick Meybohm, Simone Lindau, Sascha Treskatsch, Roland Francis, Claudia Spies, Markus Velten, Maria Wittmann, Erdem Gueresir, Christian Stoppe, Ana Kowark, Mark Coburn, Sixten Selleng, Marcel Baschin, Gregor Jenichen, Melanie Meersch, Thomas Ermert…

Commentary: On the levels of patient selection in registry-based randomized controlled trials

Registry-based randomized controlled trials (RCTs) are presumed to include a less-selected patient population and thus to have enhanced generalizability compared to conventional RCTs. However, this view disreg...

Authors: Florian Lasch, Kristina Weber and Armin Koch

Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial

Melanoma has become a growing interdisciplinary problem in public health worldwide. According to the World Health Organization, the incidence of melanoma is increasing faster than any other cancer in the world...

Authors: Ingo Stoffels, Ken Herrmann, Jan Rekowski, Philipp Jansen, Dirk Schadendorf, Andreas Stang and Joachim Klode

Social cognitive theory-based intervention to promote physical activity among prediabetic rural people: a cluster randomized controlled trial

The present randomized controlled trial (RCT) evaluated the effectiveness of a theory-based physical activity (PA) intervention for rural patients with prediabetes. It was hypothesized that a PA intervention p...

Authors: Tahereh Shamizadeh, Leila Jahangiry, Parvin Sarbakhsh and Koen Ponnet

Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: a study protocol for a cost-effectiveness randomized clinical trial

Oral mucositis (OM) is the most frequent and debilitating acute side effect associated with head and neck cancer (HNC) treatment. When present, severe OM negatively impacts the quality of life of patients unde...

Authors: Allisson Filipe Lopes Martins, Túlio Eduardo Nogueira, Marília Oliveira Morais, Angélica Ferreira Oton-Leite, Marize Campos Valadares, Aline Carvalho Batista, Nilceana Maya Aires Freitas, Cláudio Rodrigues Leles and Elismauro Francisco Mendonça