Articles

Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial

Localization of small and/or deep pulmonary nodules before thoracoscopic exploration is paramount to minimize the likelihood of unplanned conversion to thoracotomy. As far as the percutaneous approach is conce...

Authors: Yin-Kai Chao, Kuang-Tse Pan, Chih-Tsung Wen, Hsin-Yueh Fang and Ming-Ju Hsieh

Analgesia effect of premixed nitrous oxide/oxygen during the rehabilitation after total knee arthroplasty: a study protocol for a randomized controlled trial

The morbidity of knee arthritis is increasing among aged people and total knee arthroplasty has been its mainstream treatment to date. Postoperative rehabilitation is an important part of the procedure. Howeve...

Authors: Ya-Liang Dai, Xiao-Min Chai, Ning Zhu, Kai-Bin Wang, Wen-Qiang Bao, Xue-Sen Zhang, Lu-Lu Gao, Qiang Liu, Dong-Mei Bao, Li-Ting Wang, Yi-Ling Wang, Jun-Jun Zhang, Yu-Xiang Li and Jian-Qiang Yu

Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial

Distortion of taste sensations is a common chemotherapy-induced side effect; however, treatment evidence is limited. Pilot data indicated that acupuncture might be able to improve symptoms of dysgeusia. Thus, ...

Authors: Heidemarie Haller, Taige Wang, Romy Lauche, Kyung-Eun Choi, Petra Voiß, Sabine Felber, Holger Cramer, Beyhan Ataseven, Sherko Kümmel, Anna Paul and Gustav Dobos

Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial

Vaccination is a cost-effective strategy for reducing morbidity and mortality among children under 5 years old. To be fully protected from diseases such as tuberculosis, diphtheria, pertussis, and polio, child...

Authors: Jan Ostermann, Lavanya Vasudevan, Joy Noel Baumgartner, Esther Ngadaya and Sayoki Godfrey Mfinanga

HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya

The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP deliver...

Authors: Katrina F. Ortblad, John E. Kearney, Kenneth Mugwanya, Elizabeth M. Irungu, Jessica E. Haberer, Ruanne V. Barnabas, Deborah Donnell, Nelly Rwamba Mugo, Jared M. Baeten and Kenneth Ngure

Study protocol for a randomised controlled trial of CBT vs antipsychotics vs both in 14–18-year-olds: Managing Adolescent first episode Psychosis: a feasibility study (MAPS)

Adolescent-onset psychosis is associated with more severe symptoms and poorer outcomes than adult-onset psychosis. The National Institute for Clinical Excellence (NICE) recommend that adolescents with first ep...

Authors: Melissa Pyle, Matthew R. Broome, Emmeline Joyce, Graeme MacLennan, John Norrie, Daniel Freeman, David Fowler, Peter M. Haddad, David Shiers, Chris Hollis, Jo Smith, Ashley Liew, Rory E. Byrne, Paul French, Sarah Peters, Jemma Hudson…

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

Acupuncture is widely used for knee osteoarthritis (KOA), despite contradictory evidence. This study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture ...

Authors: Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang, Yang Wang, Jin-ling Li, Na Zhang, Lu-Lu Lin, Zhang-Sheng Yu and Cun-Zhi Liu

Inhaled methoxyflurane (Penthrox®) versus placebo for injury-associated analgesia in children—the MAGPIE trial (MEOF-002): study protocol for a randomised controlled trial

Pain from injuries is one of the commonest symptoms in children attending emergency departments (EDs), and this is often inadequately treated in both the pre-hospital and ED settings, in part due to challenges...

Authors: Stuart Hartshorn, Michael J. Barrett, Mark D. Lyttle, Sue Anne Yee and Alan T. Irvine

Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial

Ambulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attem...

Authors: Amjad Belramman, Roshan Bootun, Tristan R. A. Lane and Alun H. Davies

Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial

Transversus abdominis plane (TAP) block and wound infiltration (WI) are common locoregional anesthesia techniques for pain management in patients undergoing colorectal laparoscopic surgery. Comparative data be...

Authors: Corrado Pedrazzani, Soo Yeun Park, Giovanni Scotton, Jun Seok Park, Hye Jin Kim, Enrico Polati, Alfredo Guglielmi and Gyu Seog Choi

Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial

Surgical site infections (SSI) remain one of the most common complications in conventional abdominal surgery with an incidence between 4% and 19% (Sandini et al., Medicine (Baltimore) 95:e4057, 2016) in the li...

Authors: Daniel Matz, Saskia Teuteberg, Andrea Wiencierz, Savas Deniz Soysal and Oleg Heizmann

Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial

Hypertension is an important risk factor for cardiovascular disease, even in the elderly. Fimasartan is a new non-peptide angiotensin II receptor blocker with a selective type I receptor blocking effect. The o...

Authors: Min-gu Kang, Kwang-il Kim, Sang Hyun Ihm, Moo-Yong Rhee, Il Suk Sohn, Hae-Young Lee, Sungha Park, Eun-Seok Jeon, Jong-Min Song, Wook Bum Pyun, Ki-Chul Sung, Moo Hyun Kim, Sang-Hyun Kim, Seok-Yeon Kim, Shin-Jae Kim, Eung Ju Kim…

PULSE-I - Is rePetitive Upper Limb SEnsory stimulation early after stroke feasible and acceptable? A stratified single-blinded randomised controlled feasibility study

Reduction in sensorimotor function of the upper limb is a common and persistent impairment after stroke, and less than half of stroke survivors recover even basic function of the upper limb after a year. Previ...

Authors: Kausik Chatterjee, Rachel C. Stockley, Steven Lane, Caroline Watkins, Katy Cottrell, Brenda Ankers, Sioned Davies, Mary Fisher Morris, Nick Fallon and Turo Nurmikko

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

The purpose of the study was to compare the safety and efficacy of autologous mesenchymal stem cells (MSCs) embedded in a xenogenic scaffold for repairing the supraspinatus tendon.

Authors: José Ramón Lamas, Carlos García-Fernández, Pilar Tornero-Esteban, Yaiza Lópiz, Luis Rodriguez-Rodriguez, Luis Ortega, Benjamín Fernández-Gutiérrez and Fernando Marco

Piloting and evaluating feasibility of a training program to improve patient safety for inter-professional inpatient care teams – study protocol of a cluster randomized controlled trial

Improving patient safety is a major goal in healthcare systems worldwide. There are several international training programs to improve patient safety, but they are often focused on single topics and profession...

Authors: Julia Dinius, Antje Hammer, Tanja Manser, Corinna Bergelt, Levente Kriston and Mirjam Körner

Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial

Anxiety is a common diagnosis in children with autism spectrum disorder (ASD). One key mechanism underlying anxiety is intolerance of uncertainty, which is a tendency to react negatively on an emotional, cogni...

Authors: Jacqui Rodgers, Jane Goodwin, Jeremy R. Parr, Victoria Grahame, Catharine Wright, John Padget, Deborah Garland, Malcolm Osborne, Marie Labus, Ashleigh Kernohan and Mark Freeston

Safety of early oral feeding after total laparoscopic radical gastrectomy for gastric cancer (SOFTLY): Study protocol for a randomized controlled trial

Gastric cancer is the third most common cause of cancer-related deaths and has the fifth highest incidence worldwide, especially in eastern Asia, central and Eastern Europe, and South America. Currently, surge...

Authors: Quan Wang, Bo-Yang Guo, Qing-Chuan Zhao, Zun-Dong Yan, Li-Feng Shang, Juan Yu and Gang Ji

Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch (MR ASAP): study protocol for a randomised controlled trial

Some studies have suggested that transdermal administration of glyceryl trinitrate (GTN; nitroglycerin) in the first few hours after symptom onset increases the chance of a favourable outcome after ischaemic s...

Authors: Sophie A. van den Berg, Diederik W. J. Dippel, Jeannette Hofmeijer, Puck S. S. Fransen, Klaartje Caminada, Arjen Siegers, Nyika D. Kruyt, Henk Kerkhoff, Frank-Erik de Leeuw, Paul J. Nederkoorn and H. Bart van der Worp

Self-administered acupressure for allergic rhinitis: study protocol for a randomized, single-blind, non-specific controlled, parallel trial

Allergic rhinitis (AR) is an IgE-mediated inflammatory disease. Current conventional therapies for AR are unsatisfactory. Acupuncture has been recommended as an optional treatment for AR patients who are inter...

Authors: Yaqun Liang, George Binh Lenon and Angela Wei Hong Yang

Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials

Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fa...

Authors: Claire Planner, Peter Bower, Ailsa Donnelly, K. Gillies, Katrina Turner and Bridget Young

Letter in response to: “Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N acetylcysteine for paracetamol overdose—the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial”

Authors: Jan Olof G. Karlsson, Per Jynge, Ingemar Lundström and Louis J. Ignarro

The effects of probiotic Saccharomyces boulardii on the mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in patients with multiple sclerosis: study protocol for a double-blind randomized controlled clinical trial

The relationship between gut dysbiosis and inflammatory diseases including multiple sclerosis (MS) is presently recognized as an important health issue. It has been established that some bacterial probiotic st...

Authors: Dawood Aghamohammadi, Hormoz Ayromlou, Neda Dolatkhah, Fatemeh Jahanjoo and Seyed Kazem Shakouri

Some data quality issues at ClinicalTrials.gov

Clinical trial registries have been established as a form of public accountability. Sponsors ought to register their trials promptly and accurately, but this is not always done. Some of the problems include no...

Authors: Neha Chaturvedi, Bagish Mehrotra, Sangeeta Kumari, Saurabh Gupta, H. S. Subramanya and Gayatri Saberwal

Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial

Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affects quality of life. Patients with KOA frequently develop one or more of the following typical symptoms: joint pain, st...

Authors: Bao-ping Xu, Min Yao, Zi-rui Tian, Long-yun Zhou, Long Yang, Zhen-jun Li, Sen Zhu, Xiao-tao Wang, Jia-hui Lan, Yong-jun Wang and Xue-jun Cui

Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial

A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to ...

Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingberg-Allvin, Amanda Cleeve, Claudia Hanson, Nazarius Mbona Tumwesigye, Othman Kakaire and Kristina Gemzell Danielsson

PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study

Post-transplant diabetes is a frequent and serious complication of kidney transplantation. There is currently no treatment to prevent or delay the disease. Nevertheless, identification of risk factors make it ...

Authors: E. Gaiffe, T. Crepin, J. Bamoulid, C. Courivaud, M. Büchler, E. Cassuto, L. Albano, J. M. Chemouny, G. Choukroun, M. Hazzan, L. Kessler, C. Legendre, Y. Le Meur, N. Ouali, A. Thierry, A. Anota…

Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF)

Data from recent cardiovascular outcome trials in patients with type 2 diabetes (T2D) suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors can prevent development of heart failure (HF) and prolong li...

Authors: Jesper Jensen, Massar Omar, Caroline Kistorp, Mikael Kjær Poulsen, Christian Tuxen, Ida Gustafsson, Lars Køber, Finn Gustafsson, Emil Fosbøl, Niels Eske Bruun, Lars Videbæk, Peter Hartmund Frederiksen, Jacob Eifer Møller and Morten Schou

Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a cluster randomised trial protocol

Lynch syndrome (LS) is an inherited, cancer predisposition syndrome associated with an increased risk of colorectal, endometrial and other cancer types. Identifying individuals with LS allows access to cancer ...

Authors: April Morrow, Emily Hogden, Yoon-Jung Kang, Julia Steinberg, Karen Canfell, Michael J. Solomon, James G. Kench, Anthony J. Gill, Tim Shaw, Nicholas Pachter, Bonny Parkinson, Luke Wolfenden, Gillian Mitchell, Finlay Macrae, Kathy Tucker and Natalie Taylor

Impact of acupuncture for allergic rhinitis on the activity of the hypothalamus-pituitary-adrenal axis: study protocol for a randomized controlled trial

Patients with moderate and severe persistent allergic rhinitis (AR) have long-term physical and mental stress, leading to dysfunction of the hypothalamus-pituitary-adrenal (HPA) axis, which results in recurren...

Authors: Sheng Chen, Shu-Han Qu, Yi Zhang, Zhi-Hong Wen, Sheng-Nan Guo, Wei-Mei Zeng, Xue-Si Hou, Yi-Fan Jia, Yi Xiao, Federico Marmori, Jun Wang and Ji-Ping Zhao

PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial

Incisional hernia is a common complication after liver transplantation with an incidence of 5 to 46%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the inciden...

Authors: Daniela Kniepeiss, James Elvis Waha, Thomas Auer, Andrea Berghold and Peter Schemmer

Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial

Success rates with conventional transvenous endocardial pulmonary vein isolation in patients with persistent and longstanding persistent atrial fibrillation (AF) are variable due to advanced electrical and str...

Authors: Mindy Vroomen, Mark La Meir, Bart Maesen, Justin G. L. Luermans, Kevin Vernooy, Brigitte Essers, Bianca T. A. de Greef, Jos G. Maessen, Harry J. Crijns and Laurent Pison

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial

Venipuncture is one of the most painful and distressing procedure experienced by pediatric patients. Evidence suggests that distraction combined with age-appropriate procedural information can effectively decr...

Authors: Cho Lee Wong, Miranda Mei Wa Lui and Kai Chow Choi

Correction to: Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial

Following publication of the original article [1], we have been notified that the tagging of one of the author names was done incorrectly in the XML version of the paper. Original and corrected tagging can be ...

Authors: Thomas G. de Leeuw, Laura Mangiarini, Rebecca Lundin, Florentia Kaguelidou, Tjitske van der Zanden, Oscar Della Pasqua, Dick Tibboel, Adriana Ceci and Saskia N. de Wildt

The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial

Major depressive disorder (MDD) is a widespread and burdensome psychiatric issue. Physical activity counselling may increase lifestyle physical activity and cardiorespiratory fitness in this specific and parti...

Authors: Markus Gerber, Johannes Beck, Serge Brand, Robyn Cody, Lars Donath, Anne Eckert, Oliver Faude, Xenia Fischer, Martin Hatzinger, Edith Holsboer-Trachsler, Christian Imboden, Undine Lang, Sarah Mans, Thorsten Mikoteit, Anja Oswald, Uwe Pühse…

Recruitment of men to a multi-centre diabetes prevention trial: an evaluation of traditional and online promotional strategies

Effective interventions are required to prevent the current rapid increase in the prevalence of Type 2 diabetes. Clinical trials of large-scale interventions to prevent Type 2 diabetes are essential but recrui...

Authors: Karen Bracken, Wendy Hague, Anthony Keech, Ann Conway, David J. Handelsman, Mathis Grossmann, David Jesudason, Bronwyn Stuckey, Bu B. Yeap, Warrick Inder, Carolyn Allan, Robert McLachlan, Kristy P. Robledo and Gary Wittert

Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial

It is widely agreed that triglyceride (TG)-lowering therapy is imperative in early hypertriglyceridemia-induced acute pancreatitis (HTG-AP). Intravenous insulin with or without heparin, and plasmapheresis are ...

Authors: Xiao Song, Di Shi, Qinghong Cui, Shanshan Yu, Jing Yang, Priscilla Song, Joseph Walline, Jun Xu, Huadong Zhu and Xuezhong Yu

Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial

Strategies to improve the care of elderly, multimorbid patients frequently focus on implementing evidence-based knowledge by structured assessments and standardization of care. In Germany, disease management p...

Authors: Cornelia Straßner, Eckhard Frick, Gabriele Stotz-Ingenlath, Nicola Buhlinger-Göpfarth, Joachim Szecsenyi, Johannes Krisam, Friederike Schalhorn, Jan Valentini, Regina Stolz and Stefanie Joos

Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol

One of the first-line options to treat keloid scars is corticosteroid injection after excision of the existing scar. A thorough literature search has shown a lack of research on the injection of corticosteroid...

Authors: Seng Chai Chua, Beata Gidaszewski and Marjan Khajehei

Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial

The benefit of physical exercise in ageing and particularly in frailty has been the aim of recent research. Moreover, physical activity in the elderly is associated with a decreased risk of mortality, of commo...

Authors: Alvaro Casas-Herrero, Ivan Anton-Rodrigo, Fabricio Zambom-Ferraresi, Mikel L. Sáez de Asteasu, Nicolás Martinez-Velilla, Jaione Elexpuru-Estomba, Itxaso Marin-Epelde, Fernanda Ramon-Espinoza, Roberto Petidier-Torregrosa, Juan L. Sanchez-Sanchez, Berta Ibañez and Mikel Izquierdo

iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy

HIV therapeutic vaccination aims to improve the immune responses against HIV in order to control viral replication without the need for combined antiretroviral therapy (cART). iHIVARNA-01 is a novel vaccine co...

Authors: Wesley de Jong, Joeri Aerts, Sabine Allard, Christian Brander, Jozefien Buyze, Eric Florence, Eric van Gorp, Guido Vanham, Lorna Leal, Beatriz Mothe, Kris Thielemans, Montse Plana, Félipe Garcia and Rob Gruters

The randomization-induced risk of a trial failing to attain its target power: assessment and mitigation

Health researchers are familiar with the concept of trial power, a number that prior to the start of a trial is intended to describe the probability that the results of the trial will correctly conclude that the ...

Authors: Hubert Wong, Yongdong Ouyang and Mohammad Ehsanul Karim

Comparison of two metaphyseal-fitting (short) femoral stems in primary total hip arthroplasty: study protocol for a prospective randomized clinical trial with additional biomechanical testing and finite element analysis

Total hip replacement has recently followed a progressive evolution towards principles of bone- and soft-tissue-sparing surgery. Regarding femoral implants, different stem designs have been developed as an alt...

Authors: I. Tatani, A. Panagopoulos, I. Diamantakos, G. Sakellaropoulos, Sp Pantelakis and P. Megas

Auricular acupressure as a complementary therapy for psoriasis vulgaris: study protocol for a multicenter randomized controlled trial

Psoriasis vulgaris is a common skin disease characterized by persistent localized erythematous scaly plaques, typically on the elbows, knees, and scalp. It is an immune-abnormal disease that progresses slowly ...

Authors: Jingwen Deng, Chuanjian Lu, Yu Xiang, Hao Deng, Zehuai Wen, Danni Yao, Meiling Xuan and Yuhong Yan

Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial

Intraoperative and postoperative management of cardiac surgery patients is complex, involving the application of differential vasopressors and volume therapy. It has been shown that a positive fluid balance ha...

Authors: Carmen A. Pfortmueller, Anna S. Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zuercher, Frederik Stoehr, Gabor Erdoes, Markus M. Luedi, Stephan M. Jakob, Lars Englberger and Joerg C. Schefold

Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial

Earlier nonrandomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss, and recovery. Only...

Authors: Bergthor Björnsson, Per Sandström, Anna Lindhoff Larsson, Claes Hjalmarsson and Thomas Gasslander

Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial to improve quality of life: a study protocol for a randomized clinical trial

People living with chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (ILD) suffer impaired quality of life due to burdensome symptoms and depression. The ...

Authors: Bridget A. Graney, David H. Au, Anna E. Barón, Andrew Cheng, Sara A. Combs, Thomas J. Glorioso, Grady Paden, Elizabeth C. Parsons, Borsika A. Rabin, Debra P. Ritzwoller, Jessica-Jean Stonecipher, Carolyn Turvey, Carolyn H. Welsh and David B. Bekelman

Trial management: we need a cadre of high-class triallists to deliver the answers that patients need

Expert trial managers with the training and experience to overcome operational challenges are often the difference between the success and failure of a clinical trial. Considerable importance is given to the b...

Authors: Danielle Beaumont, Monica Arribas, Lauren Frimley, Eni Balogun, Ian Roberts and Haleema Shakur-Still

CASSETTE—clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial

Exotoxins are important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infectio...

Authors: Ravindra Dotel, Steven Y. C. Tong, Asha Bowen, Jane N. Nelson, Matthew V. N. O’Sullivan, Anita J. Campbell, Brendan J. McMullan, Philip N. Britton, Joshua R. Francis, Damon P. Eisen, Owen Robinson, Laurens Manning and Joshua S. Davis

The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial

Unipolar depression is one of the most important mental disorders. Insomnia is a symptom of cardinal importance in depression. It increases the risk to develop depression, negatively affects disease trajectory...

Authors: Gavin Brupbacher, Doris Straus, Hildburg Porschke, Thea Zander-Schellenberg, Markus Gerber, Roland von Känel and Arno Schmidt-Trucksäss

A realist process evaluation of Enhanced Triple P for Baby and Mellow Bumps, within a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE): study protocol for a randomized controlled trial

THRIVE is a three-arm randomised controlled trial (RCT) that aims to evaluate whether antenatal and early postnatal interventions, Enhanced Triple B for Baby (ETPB) plus care as usual (CAU) or Mellow Bumps (MB...

Authors: Rosaleen O’Brien, Katie Buston, Daniel Wight, Elizabeth McGee, Jane White and Marion Henderson