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  1. Study protocol

    The Pocket-4-Life project, bioavailability and beneficial properties of the bioactive compounds of espresso coffee and cocoa-based confectionery containing coffee: study protocol for a randomized cross-over trial

    Coffee is an important source of bioactive compounds, including caffeine, phenolic compounds (mainly chlorogenic acids), trigonelline, and diterpenes. Several studies have highlighted the preventive effects of...

    Pedro Mena, Michele Tassotti, Daniela Martini, Alice Rosi, Furio Brighenti and Daniele Del Rio

    Trials 2017 18:527

    Published on: 9 November 2017

  2. Study protocol

    Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial

    Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiothe...

    Jordan Miller, David Barber, Catherine Donnelly, Simon French, Michael Green, Jonathan Hill, Joy MacDermid, Jacquelyn Marsh, Kathleen Norman, Julie Richardson, Monica Taljaard, Timothy Wideman, Lynn Cooper and Colleen McPhee

    Trials 2017 18:526

    Published on: 9 November 2017

  3. Study protocol

    A multicomponent intervention for the management of chronic pain in older adults: study protocol for a randomized controlled trial

    Studies have shown that physical interventions and psychological methods based on the cognitive behavioral approach are efficacious in alleviating pain and that combining both tends to yield more benefits than...

    Sheung-Tak Cheng, Ka Long Chan, Rosanna W. L. Lam, Monique H. T. Mok, Phoon Ping Chen, Yu Fat Chow, Joanne W. Y. Chung, Alexander C. B. Law, Jenny S. W. Lee, Edward M. F. Leung and Cindy W. C. Tam

    Trials 2017 18:528

    Published on: 9 November 2017

  4. Study protocol

    Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial

    Chronic childhood malnutrition, as manifested by stunted linear growth, remains a persistent barrier to optimal child growth and societal development. Environmental enteric dysfunction (EED) is a significant u...

    William D. Cheng, Karl J. Wold, Nicole S. Benzoni, Chrissie Thakwalakwa, Kenneth M. Maleta, Mark J. Manary and Indi Trehan

    Trials 2017 18:523

    Published on: 6 November 2017

  5. Study protocol

    Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial

    Repetitive transcranial magnetic stimulation (rTMS) has been investigated as a new tool in neurological rehabilitation of individuals with spinal cord injury (SCI). However, due to the inconsistent results reg...

    Amanda Vitória Lacerda de Araújo, Valéria Ribeiro Nogueira Barbosa, Gilma Serra Galdino, Felipe Fregni, Thais Massetti, Sara Lynn Fontes, Danilo de Oliveira Silva, Talita Dias da Silva, Carlos Bandeira de Mello Monteiro, James Tonks and Fernando Henrique Magalhães

    Trials 2017 18:522

    Published on: 6 November 2017

  6. Study protocol

    Autologous-cell-derived, tissue-engineered cartilage for repairing articular cartilage lesions in the knee: study protocol for a randomized controlled trial

    Spontaneous recovery from articular cartilage injury is difficult, and the ongoing progression of disease can eventually lead to osteoarthritis. Currently, there is no effective non-surgical treatment for arti...

    Ning Ma, Hongxia Wang, Xian Xu, Yiqun Wan, Yufeng Liu, Mingjie Wang, Wen Yu, Yongjing Dai, Jiang Peng, Quanyi Guo, Changlong Yu and Shibi Lu

    Trials 2017 18:519

    Published on: 6 November 2017

  7. Study protocol

    Impact of radiographer immediate reporting of chest X-rays from general practice on the lung cancer pathway (radioX): study protocol for a randomised control trial

    Diagnostic capacity and suboptimal logistics are consistently identified as barriers to timely diagnosis of cancer, especially lung cancer. Immediate chest X-ray (CXR) reporting for patients referred from gene...

    Nick Woznitza, Anand Devaraj, Samuel M. Janes, Stephen W. Duffy, Angshu Bhowmik, Susan Rowe, Keith Piper, Sue Maughn and David R. Baldwin

    Trials 2017 18:521

    Published on: 6 November 2017

  8. Study protocol

    Effects of a liquefied petroleum gas stove intervention on pollutant exposure and adult cardiopulmonary outcomes (CHAP): study protocol for a randomized controlled trial

    Biomass fuel smoke is a leading risk factor for the burden of disease worldwide. International campaigns are promoting the widespread adoption of liquefied petroleum gas (LPG) in resource-limited settings. How...

    Magdalena Fandiño-Del-Rio, Dina Goodman, Josiah L. Kephart, Catherine H. Miele, Kendra N. Williams, Mitra Moazzami, Elizabeth C. Fung, Kirsten Koehler, Victor G. Davila-Roman, Kathryn A. Lee, Saachi Nangia, Steven A. Harvey, Kyle Steenland, Gustavo F. Gonzales and William Checkley

    Trials 2017 18:518

    Published on: 3 November 2017

  9. Study protocol

    Effect of ketamine combined with magnesium sulfate in neuropathic pain patients (KETAPAIN): study protocol for a randomized controlled trial

    Neuropathic pain is difficult to treat, and the efficacy of recommended drugs remains limited. N-methyl-d-aspartate receptors are implicated, and antagonists are a pharmacological option. Ketamine is widely used ...

    Noémie Delage, Véronique Morel, Pascale Picard, Fabienne Marcaillou, Bruno Pereira and Gisèle Pickering

    Trials 2017 18:517

    Published on: 3 November 2017

  10. Study protocol

    Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia

    Zambia is pushing for, and has made great strides towards, the elimination of malaria transmission in Southern Province. Reactive focal test and treat (RFTAT) using rapid diagnostic tests and artemether-lumefa...

    Daniel J. Bridges, John M. Miller, Victor Chalwe, Hawela Moonga, Busiku Hamainza, Rick Steketee, Kafula Silumbe, Jenala Nyangu and David A. Larsen

    Trials 2017 18:511

    Published on: 2 November 2017

  11. Study protocol

    The effects of yoga versus stretching and resistance training exercises on psychological distress for people with mild-to-moderate Parkinson’s disease: study prxotocol for a randomized controlled trial

    Psychological distress is prevalent among people with Parkinson’s disease (PD) and aggravates their motor symptoms, thereby leading to increased disability, high healthcare costs, and poor health-related quali...

    JoJo Yan Yan Kwok, Jackie Cheuk Yin Kwan, Man Auyeung, Vincent Chung Tong Mok and Helen Yue Lai Chan

    Trials 2017 18:509

    Published on: 2 November 2017

  12. Study protocol

    SlowMo, a digital therapy targeting reasoning in paranoia, versus treatment as usual in the treatment of people who fear harm from others: study protocol for a randomised controlled trial

    Paranoia is one of the most common symptoms of schizophrenia-spectrum disorders, and is associated with significant distress and disruption to the person’s life. Developing more effective and accessible psycho...

    Philippa A. Garety, Thomas Ward, Daniel Freeman, David Fowler, Richard Emsley, Graham Dunn, Elizabeth Kuipers, Paul Bebbington, Helen Waller, Kathryn Greenwood, Mar Rus-Calafell, Alison McGourty and Amy Hardy

    Trials 2017 18:510

    Published on: 2 November 2017

  13. Study protocol

    Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial

    Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic st...

    Yang-Yang Qian, Hui Chen, Xin-Ying Tang, Xi Jiang, Wei Qian, Wen-Bin Zou, Lei Xin, Bo Li, Yan-Fen Qi, Liang-Hao Hu, Duo-Wu Zou, Zhen-Dong Jin, Dong Wang, Yi-Qi Du, Luo-Wei Wang, Feng Liu…

    Trials 2017 18:513

    Published on: 2 November 2017

  14. Study protocol

    VASO (Vitamin D and Arthroplasty Surgery Outcomes) study - supplementation of vitamin D deficiency to improve outcomes after total hip or knee replacement: study protocol for a randomised controlled feasibility trial

    Vitamin D deficiency has been linked to poor outcomes after total hip replacement (THR) or total knee replacement (TKR), including lower patient-reported outcome measures (PROMs), peri-prosthetic infection and...

    Rory J. M. Morrison, Deborah Bunn, William K. Gray, Paul N. Baker, Craig White, Amar Rangan, Kenneth S. Rankin and Mike R. Reed

    Trials 2017 18:514

    Published on: 2 November 2017

  15. Research

    Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE trial

    We describe the implementation of minimal sufficient balance randomization, a covariate-adaptive randomization technique, used for the “Endovascular treatment for Small Core and Anterior circulation Proximal o...

    Tolulope T. Sajobi, Gurbakhshash Singh, Mark W. Lowerison, Jordan Engbers, Bijoy K. Menon, Andrew M. Demchuk, Mayank Goyal and Michael D. Hill

    Trials 2017 18:516

    Published on: 2 November 2017

  16. Research

    Randomized controlled trial and economic evaluation of nurse-led group support for young mothers during pregnancy and the first year postpartum versus usual care

    Child maltreatment is a significant public health problem. Group Family Nurse Partnership (gFNP) is a new intervention for young, expectant mothers implemented successfully in pilot studies. This study was des...

    Jacqueline Barnes, Jane Stuart, Elizabeth Allen, Stavros Petrou, Joanna Sturgess, Jane Barlow, Geraldine Macdonald, Helen Spiby, Dipti Aistrop, Edward Melhuish, Sung Wook Kim and Diana Elbourne

    Trials 2017 18:508

    Published on: 1 November 2017

  17. Study protocol

    SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial

    Colorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects ma...

    Michael Jefford, Jon Emery, Eva Grunfeld, Andrew Martin, Paula Rodger, Alexandra M. Murray, Richard De Abreu Lourenco, Alexander Heriot, Jo Phipps-Nelson, Lisa Guccione, Dorothy King, Karolina Lisy, Niall Tebbutt, Adele Burgess, Ian Faragher, Rodney Woods…

    Trials 2017 18:506

    Published on: 30 October 2017

  18. Study protocol

    Targeting low- or high-normal Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation: study protocol for a randomized pilot trial

    Arterial carbon dioxide tension (PaCO2), oxygen tension (PaO2), and mean arterial pressure (MAP) are modifiable factors that affect cerebral blood flow (CBF), cerebral oxygen delivery, and potentially the course ...

    Pekka Jakkula, Matti Reinikainen, Johanna Hästbacka, Ville Pettilä, Pekka Loisa, Sari Karlsson, Raili Laru-Sompa, Stepani Bendel, Tuomas Oksanen, Thomas Birkelund, Marjaana Tiainen, Jussi Toppila, Antti Hakkarainen and Markus B. Skrifvars

    Trials 2017 18:507

    Published on: 30 October 2017

  19. Study protocol

    Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project)

    Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of pra...

    Ana Isabel González-González, Carola Orrego, Lilisbeth Perestelo-Perez, Carlos Jesús Bermejo-Caja, Nuria Mora, Débora Koatz, Marta Ballester, Tasmania del Pino, Jeannet Pérez-Ramos, Ana Toledo-Chavarri, Noemí Robles, Francisco Javier Pérez-Rivas, Ana Belén Ramírez-Puerta, Yolanda Canellas-Criado, Yolanda del Rey-Granado, Marcos José Muñoz-Balsa…

    Trials 2017 18:505

    Published on: 30 October 2017

  20. Study protocol

    Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial

    The diabetogenic action of statins remains a concern, particularly in patients at high risk for diabetes receiving intensive statin therapy. Despite the risk of diabetes with statin use being considered a pote...

    Jun-Bean Park, Ji-Hyun Jung, Yeonyee E. Yoon, Hack-Lyong Kim, Seung-Pyo Lee, Hyung-Kwan Kim, Yong-Jin Kim, Goo-Yeong Cho and Dae-Won Sohn

    Trials 2017 18:501

    Published on: 27 October 2017

  21. Study protocol

    The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study): study protocol for a randomized controlled trial

    Meta-analyses of randomized controlled trials (RCTs) have shown that exercise has beneficial effects on quality of life (QoL) in patients with breast cancer. However, these effects were often small. Blinding i...

    Roxanne Gal, Evelyn M. Monninkhof, Rolf H. H. Groenwold, Carla H. van Gils, Desiree H. J. G. van den Bongard, Petra H. M. Peeters, Helena M. Verkooijen and Anne M. May

    Trials 2017 18:504

    Published on: 27 October 2017

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