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  1. Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of th...

    Authors: Talia Palacios, Luis Vitetta, Samantha Coulson, Claire D. Madigan, Gareth S. Denyer and Ian D. Caterson
    Citation: Trials 2017 18:7
  2. Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty. It was hypothesised that the use of a short-stretch, inelastic compression bandage would reduce...

    Authors: T. M. Brock, A. P. Sprowson, S. Muller and M. R. Reed
    Citation: Trials 2017 18:6
  3. Delirium is an acute state of brain dysfunction characterised by fluctuating inattention and cognitive disturbances, usually due to illness. It occurs commonly in the intensive care unit (ICU), and it is assoc...

    Authors: F. Eduardo Martinez, Matthew Anstey, Andrew Ford, Brigit Roberts, Miranda Hardie, Robert Palmer, Lynn Choo, David Hillman, Michael Hensley, Erin Kelty, Kevin Murray, Bhajan Singh and Bradley Wibrow
    Citation: Trials 2017 18:4

    The Update to this article has been published in Trials 2021 22:7

  4. Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the...

    Authors: Jennifer Fleming, Tamara Ownsworth, Emmah Doig, Lauren Hutton, Janelle Griffin, Melissa Kendall and David H. K. Shum
    Citation: Trials 2017 18:3
  5. The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; ...

    Authors: Shengjun Wang, Hongli Jiang, Qin Yu, Bin She and Bing Mao
    Citation: Trials 2017 18:2
  6. Abdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery. Experimental studies indicate that fibrates exert beneficial effects on AAAs by mechanisms involving bo...

    Authors: Sophie E. Rowbotham, Doug Cavaye, Rene Jaeggi, Jason S. Jenkins, Corey S. Moran, Joseph V. Moxon, Jenna L. Pinchbeck, Frank Quigley, Christopher M. Reid and Jonathan Golledge
    Citation: Trials 2017 18:1
  7. Depression is a major challenge worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for p...

    Authors: Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentágotai Tătar, Vlad Mureşan and Rareș Boian
    Citation: Trials 2016 17:609
  8. Attention deficit hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder that can negatively impact on an individual’s quality of life. It is pathophysiologically complex and heterogeneous wi...

    Authors: Amy Goodwin, Simona Salomone, Patrick Bolton, Tony Charman, Emily J. H. Jones, Andrew Pickles, Emily Robinson, Tim Smith, Edmund J. S. Sonuga-Barke, Sam Wass and Mark H. Johnson
    Citation: Trials 2016 17:608

    The Erratum to this article has been published in Trials 2017 18:419

  9. Severe mental illness (SMI) is common, chronic and difficult to treat. Sleep and circadian dysfunctions are prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of t...

    Authors: Allison G. Harvey, Kerrie Hein, Lu Dong, Freddie L. Smith, Michael Lisman, Stephanie Yu, Sophia Rabe-Hesketh and Daniel J. Buysse
    Citation: Trials 2016 17:606
  10. Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual’s functiona...

    Authors: Sarah Brown, Isabelle L. Smith, Julia M. Brown, Claire Hulme, Elizabeth McGinnis, Nikki Stubbs, E. Andrea Nelson, Delia Muir, Claudia Rutherford, Kay Walker, Valerie Henderson, Lyn Wilson, Rachael Gilberts, Howard Collier, Catherine Fernandez, Suzanne Hartley…
    Citation: Trials 2016 17:604
  11. Hospital readmissions remain highly prevalent despite being the target of policies and financial penalties. Evidence comparing the effectiveness and costs of interventions to reduce readmissions is lacking, le...

    Authors: Andrew McWilliams, Jason Roberge, Charity G. Moore, Avery Ashby, Whitney Rossman, Stephanie Murphy, Stephannie McCall, Ryan Brown, Shannon Carpenter, Scott Rissmiller and Scott Furney
    Citation: Trials 2016 17:603
  12. A substantial research base documents the benefits of attendance at high-quality early childhood education and care (ECEC) for positive behavioural and learning outcomes. Research has also found that the quali...

    Authors: Edward Melhuish, Steven J. Howard, Iram Siraj, Cathrine Neilsen-Hewett, Denise Kingston, Marc de Rosnay, Elisabeth Duursma and Betty Luu
    Citation: Trials 2016 17:602
  13. There is individual variability to cardiorespiratory fitness (CRF) training, but the underlying cause is not well understood. Traditionally, a standardized approach to exercise prescription has utilized relati...

    Authors: Ryan M. Weatherwax, Nigel K. Harris, Andrew E. Kilding and Lance C. Dalleck
    Citation: Trials 2016 17:601
  14. Increasing rates of type 2 diabetes mellitus place a substantial burden on health care services, communities, families and individuals living with the disease or at risk of developing it. Estimates of the comb...

    Authors: Edward Fottrell, Hannah Jennings, Abdul Kuddus, Naveed Ahmed, Joanna Morrison, Kohenour Akter, Sanjit Kumar Shaha, Badrun Nahar, Tasmin Nahar, Hassan Haghparast-Bidgoli, A. K. Azad Khan, Anthony Costello and Kishwar Azad
    Citation: Trials 2016 17:600
  15. Trials has 10 years of experience in providing open access publication of protocols for randomised controlled trials. In this editorial, the senior editors and editors-in-chief of Trials ...

    Authors: Tianjing Li, Isabelle Boutron, Rustam Al-Shahi Salman, Erik Cobo, Ella Flemyng, Jeremy M. Grimshaw and Douglas G. Altman
    Citation: Trials 2016 18:34
  16. The Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9–10 year-old children. This art...

    Authors: Siobhan Creanor, Jenny Lloyd, Melvyn Hillsdon, Sarah Dean, Colin Green, Rod S. Taylor, Emma Ryan and Katrina Wyatt
    Citation: Trials 2016 17:599
  17. The evidence for the benefits of online cognitive behaviour therapy (CBT)-based programmes delivered in a clinical context is clear, but this evidence does not translate to online CBT-based stress management p...

    Authors: Stephany Carolan, Peter R. Harris, Kathryn Greenwood and Kate Cavanagh
    Citation: Trials 2016 17:598
  18. Globally, 220 million women experience an unmet need for family planning. A newly designed female condom, the Woman’s Condom (WC), has been developed featuring an improved design. It is the first dual-protecti...

    Authors: Jessie Pinchoff, Rachna Nag Chowdhuri, Noah Taruberekera and Thoai D. Ngo
    Citation: Trials 2016 17:596
  19. People with serious mental illness (SMI) (psychosis, bipolar disorder and major depressive disorder) experience a considerable risk of premature mortality because of cardiovascular disease. Recent research has...

    Authors: Julie Williams, Brendon Stubbs, Fiona Gaughran and Tom Craig
    Citation: Trials 2016 17:594
  20. Skin-to-skin care immediately following delivery is a common practice for term infants and has been shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since 2007...

    Authors: Laila Kristoffersen, Ragnhild Støen, Hilde Rygh, Margunn Sognnæs, Turid Follestad, Hilde S. Mohn, Ingrid Nissen and Håkon Bergseng
    Citation: Trials 2016 17:593
  21. Opioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for ...

    Authors: David H. Gustafson Sr, Gina Landucci, Fiona McTavish, Rachel Kornfield, Roberta A. Johnson, Marie-Louise Mares, Ryan P. Westergaard, Andrew Quanbeck, Esra Alagoz, Klaren Pe-Romashko, Chantelle Thomas and Dhavan Shah
    Citation: Trials 2016 17:592
  22. The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and po...

    Authors: Matthew Wilson, Christine MacArthur, Fang Gao Smith, Leanne Homer, Kelly Handley and Jane Daniels
    Citation: Trials 2016 17:591
  23. Several heart failure studies have shown promising results for implementing telehealthcare. These studies have led to clinical and political interest in telehealthcare as a way to improve heart failure outcome...

    Authors: Simon Lebech Cichosz, Lars Holger Ehlers and Ole Hejlesen
    Citation: Trials 2016 17:590
  24. Understanding changes in the placebo arm is essential for correct design and interpretation of randomized controlled trials (RCTs). It is assumed that placebo response, defined as the total improvement in the ...

    Authors: Karolina A. Wartolowska, Benjamin G. Feakins, Gary S. Collins, Jonathan Cook, Andrew Judge, Ines Rombach, Benjamin J. F. Dean, James A. Smith and Andrew J. Carr
    Citation: Trials 2016 17:589
  25. Adolescent pregnancies pose a risk to the young mothers and their babies. In Zambia, 35% of young girls in rural areas have given birth by the age of 18 years. Pregnancy rates are particularly high among out-o...

    Authors: Ingvild Fossgard Sandøy, Mweetwa Mudenda, Joseph Zulu, Ecloss Munsaka, Astrid Blystad, Mpundu C. Makasa, Ottar Mæstad, Bertil Tungodden, Choolwe Jacobs, Linda Kampata, Knut Fylkesnes, Joar Svanemyr, Karen Marie Moland, Richard Banda and Patrick Musonda
    Citation: Trials 2016 17:588
  26. Severe sepsis and septic shock are common in intensive care and carry high mortality rates. In patients with Gram-negative infections, early and extensive removal of endotoxin may limit the inflammatory respon...

    Authors: Miklos Lipcsey, Jyrki Tenhunen, Jan Sjölin, Robert Frithiof, Stepani Bendel, Hans Flaatten, Rafael Kawati, Anne Kuitunen, Tor Inge Tønnessen and Sten Rubertsson
    Citation: Trials 2016 17:587
  27. Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potent...

    Authors: Adwoa Hughes-Morley, Mark Hann, Claire Fraser, Oonagh Meade, Karina Lovell, Bridget Young, Chris Roberts, Lindsey Cree, Donna More, Neil O’Leary, Patrick Callaghan, Waquas Waheed and Peter Bower
    Citation: Trials 2016 17:586
  28. Obstructive sleep apnea (OSA) is a sleep disorder that disproportionately affects African Americans (hereafter referred to as blacks). Moreover, blacks may underutilize sleep services including overnight polys...

    Authors: Natasha J. Williams, Rebecca Robbins, David Rapoport, John P. Allegrante, Alwyn Cohall, Gbenga Ogedgebe and Girardin Jean-Louis
    Citation: Trials 2016 17:585
  29. Despite being a core component of self-management, goal setting is rarely used in routine care. We piloted a primary care, nurse-led intervention called Achieving Good Outcomes for Asthma Living (GOAL) for adu...

    Authors: Gaylor Hoskins, Brian Williams, Purva Abhyankar, Peter Donnan, Edward Duncan, Hilary Pinnock, Marjon van der Pol, Petra Rauchhaus, Anne Taylor and Aziz Sheikh
    Citation: Trials 2016 17:584
  30. Regular physical activity has important health benefits for children with type 1 diabetes mellitus (T1DM), yet children and their parents face barriers to participation such as lack of self-efficacy or concern...

    Authors: Holly Blake, Helen Quirk, Paul Leighton, Tabitha Randell, James Greening, Boliang Guo and Cris Glazebrook
    Citation: Trials 2016 17:583
  31. The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted an...

    Authors: Jun-Yang Lu, Lai Xu, Hua-Dan Xue, Wei-Xun Zhou, Tao Xu, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin and Yi Xiao
    Citation: Trials 2016 17:582
  32. It is important that planned randomised trials are justified and placed in the context of the available evidence. The SPIRIT guidelines for reporting clinical trial protocols recommend that a recent and releva...

    Authors: Nikolaos Pandis, Padhraig S. Fleming, Despina Koletsi and Sally Hopewell
    Citation: Trials 2016 17:581
  33. Requiring individuals to obtain medical clearance to exercise prior to participation in physical activity interventions is common. The impact this has on the socio-demographic characteristic profiles of partic...

    Authors: Mitch J. Duncan, Richard R. Rosenkranz, Corneel Vandelanotte, Cristina M. Caperchione, Amanda L. Rebar, Anthony J. Maeder, Rhys Tague, Trevor N. Savage, Anetta van Itallie, W. Kerry Mummery and Gregory S. Kolt
    Citation: Trials 2016 17:580
  34. Emergency department attendances with chest pain requiring assessment for acute coronary syndrome (ACS) are a major global health issue. Standard assessment includes history, examination, electrocardiogram (EC...

    Authors: Alasdair J. Gray, Carl Roobottom, Jason E. Smith, Steve Goodacre, Katherine Oatey, Rachel O’Brien, Robert F. Storey, Lumine Na, Steff C. Lewis, Praveen Thokala and David E. Newby
    Citation: Trials 2016 17:579
  35. Administration of fluids to restore normovolaemia is one of the most common therapeutic interventions performed peri-operatively and in the critically ill, but no study has evaluated the importance of infusion...

    Authors: Svajunas Statkevicius, Johan Bonnevier, Björn P. Bark, Erik Larsson, Carl M. Öberg, Päivi Kannisto, Bobby Tingstedt and Peter Bentzer
    Citation: Trials 2016 17:578
  36. Use of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschs...

    Authors: Benjamin Allin, Timothy Bradnock, Simon Kenny, Gregor Walker and Marian Knight
    Citation: Trials 2016 17:577
  37. Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes o...

    Authors: Katherine E. A. Semrau, Lisa R. Hirschhorn, Bhala Kodkany, Jonathan M. Spector, Danielle E. Tuller, Gary King, Stuart Lipsitz, Narender Sharma, Vinay Pratap Singh, Bharath Kumar, Neelam Dhingra-Kumar, Rebecca Firestone, Vishwajeet Kumar and Atul A. Gawande
    Citation: Trials 2016 17:576
  38. The cluster randomised crossover (CRXO) design is gaining popularity in trial settings where individual randomisation or parallel group cluster randomisation is not feasible or practical. Our aim is to stimula...

    Authors: Sarah J. Arnup, Andrew B. Forbes, Brennan C. Kahan, Katy E. Morgan and Joanne E. McKenzie
    Citation: Trials 2016 17:575
  39. Eight percent of people in the UK are estimated to have persistent (chronic) neuropathic pain, and for many there is no effective treatment. Medications are the most common first-line treatment but often have ...

    Authors: Selina Johnson, Roberta Richey, Emily Holmes, Dyfrig Hughes and Andreas Goebel
    Citation: Trials 2016 17:574
  40. While eating disorder not otherwise specified (EDNOS) is the most common eating disorder (ED) diagnosis in routine clinical practice, no specific treatment methods for this diagnosis have yet been developed an...

    Authors: Martie de Jong, Kees Korrelboom, Iris van der Meer, Mathijs Deen, Hans W. Hoek and Philip Spinhoven
    Citation: Trials 2016 17:573
  41. Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ ...

    Authors: Maurizio Gasparini, Paola Galimberti, Renato Bragato, Stefano Ghio, Claudia Raineri, Maurizio Landolina, Enrico Chieffo, Maurizio Lunati, Ederina Mulargia, Alessandro Proclemer, Domenico Facchin, Roberto Rordorf, Alessandro Vicentini, Lina Marcantoni, Francesco Zanon and Catherine Klersy
    Citation: Trials 2016 17:572
  42. Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventi...

    Authors: Lene Maria Ørts, Anders Løkke, Anne-Louise Bjerregaard, Helle Terkildsen Maindal and Annelli Sandbæk
    Citation: Trials 2016 17:571
  43. Self-control is an important ability in everyday life, showing associations with health-related outcomes. The aim of the Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-...

    Authors: Zarah Rowland, Mario Wenzel and Thomas Kubiak
    Citation: Trials 2016 17:570
  44. Burst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We repo...

    Authors: Konstantin V. Slavin, Richard B. North, Timothy R. Deer, Peter Staats, Kristina Davis and Roni Diaz
    Citation: Trials 2016 17:569
  45. In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great ne...

    Authors: Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M. Freitag, Robert L. Trestman and Christina Stadler
    Citation: Trials 2016 17:568

    The Erratum to this article has been published in Trials 2017 18:95

  46. The role of antibiotics in surgical procedures where the risk of surgical site infection (SSI) is low remains uncertain. There is, to date, no evidence to justify the routine use of antibiotics in postoperativ...

    Authors: Edgard Silva Garcia, Daniela Francescato Veiga, Joel Veiga-Filho, Isaías Vieira Cabral, Natália Lana Larcher Pinto, Neil Ferreira Novo, Miguel Sabino Neto and Lydia Masako Ferreira
    Citation: Trials 2016 17:567

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