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  1. Study protocol

    Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial

    The efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of reproducibility...

    Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Parades, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H. Hamdan, Maurizio Lunati, Angel Moya and Alessio Gargaro

    Trials 2017 18:208

    Published on: 4 May 2017

  2. Study protocol

    The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial

    Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychol...

    Kate Sitnikova, Stephanie S. Leone, Lyonne N. L. Zonneveld, Harm W. J. van Marwijk, Judith E. Bosmans, Johannes C. van der Wouden and Henriëtte E. van der Horst

    Trials 2017 18:206

    Published on: 3 May 2017

  3. Research

    Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

    This study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD).

    Young-Nim You, Myung-Rae Cho, Ju-Hyung Park, Gwang-Cheon Park, Min-Yeong Song, Jin-Bong Choi, Chang-Su Na, Jae-Young Han, Jeong-cheol Shin and Jae-Hong Kim

    Trials 2017 18:205

    Published on: 2 May 2017

  4. Research

    Comparative costs and activity from a sample of UK clinical trials units

    The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities.

    Daniel Hind, Barnaby C. Reeves, Sarah Bathers, Christopher Bray, Andrea Corkhill, Christopher Hayward, Lynda Harper, Vicky Napp, John Norrie, Chris Speed, Liz Tremain, Nicola Keat and Mike Bradburn

    Trials 2017 18:203

    Published on: 2 May 2017

  5. Study protocol

    Lymphoma InterVEntion (LIVE) – patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial

    Patients with lymphoma are at risk of experiencing adverse physical and psychosocial problems from their cancer and its treatment. Regular screening of these symptoms by the use of patient-reported outcomes (P...

    Lindy P. J. Arts, Lonneke V. van de Poll-Franse, Sanne W. van den Berg, Judith B. Prins, Olga Husson, Floortje Mols, Angelique V. M. Brands-Nijenhuis, Lidwine Tick and Simone Oerlemans

    Trials 2017 18:199

    Published on: 28 April 2017

  6. Study protocol

    Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial

    Fibrotic interstitial lung diseases (ILDs) are chronic and often progressive conditions resulting in substantial morbidity and mortality. Shortness of breath, a symptom often linked to oxygen desaturation on e...

    Dina Visca, Vicky Tsipouri, Letizia Mori, Ashi Firouzi, Sharon Fleming, Morag Farquhar, Elizabeth Leung, Toby M. Maher, Paul Cullinan, Nick Hopkinson, Athol U. Wells, Winston Banya, Jennifer A. Whitty, Huzaifa Adamali, Lisa G. Spencer, Piersante Sestini…

    Trials 2017 18:201

    Published on: 28 April 2017

  7. Study protocol

    Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

    Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improv...

    T. Bluth, R. Teichmann, T. Kiss, I. Bobek, J. Canet, G. Cinnella, L. De Baerdemaeker, C. Gregoretti, G. Hedenstierna, S. N. Hemmes, M. Hiesmayr, M. W. Hollmann, S. Jaber, J. G. Laffey, M. J. Licker, K. Markstaller…

    Trials 2017 18:202

    Published on: 28 April 2017

  8. Study protocol

    Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial

    This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reduci...

    Shannon E. Munteanu, Karl B. Landorf, Jodie A. McClelland, Edward Roddy, Flavia M. Cicuttini, Alan Shiell, Maria Auhl, Jamie J. Allan, Andrew K. Buldt and Hylton B. Menz

    Trials 2017 18:198

    Published on: 27 April 2017

  9. Erratum

    Erratum to: The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial

    U. Teichgräber, R. Aschenbach, D. Scheinert, T. Zeller, K. Brechtel, M. Thieme, E. Blessing, M. Treitl, M. Lichtenberg, P. von Flotow, B. Vogel, M. Werk, V. Riambau, A. Wienke, T. Lehmann and S. Sixt

    Trials 2017 18:193

    Published on: 26 April 2017

    The original article was published in Trials 2016 17:528

  10. Study protocol

    Ketogenic diet in the treatment of epilepsy in children under the age of 2 years: study protocol for a randomised controlled trial

    The incidence of epilepsy is greatest in the first 2 years of life, an age group where there is generally a poor prognosis for both seizure control and neurodevelopmental outcome. Early control of seizures can...

    Siobhan Titre-Johnson, Natasha Schoeler, Christin Eltze, Ruth Williams, Katharina Vezyroglou, Helen McCullagh, Nick Freemantle, Simon Heales, Rachel Kneen, Louise Marston, Tim Martland, Irwin Nazareth, Elizabeth Neal, Andrew Lux, Alasdair Parker, Shakti Agrawal…

    Trials 2017 18:195

    Published on: 26 April 2017

  11. Study protocol

    Metformin to Augment Strength Training Effective Response in Seniors (MASTERS): study protocol for a randomized controlled trial

    Muscle mass and strength are strong determinants of a person’s quality of life and functional independence with advancing age. While resistance training is the most effective intervention to combat age-associa...

    Doug E. Long, Bailey D. Peck, Jenny L. Martz, S. Craig Tuggle, Heather M. Bush, Gerald McGwin, Philip A. Kern, Marcas M. Bamman and Charlotte A. Peterson

    Trials 2017 18:192

    Published on: 26 April 2017

  12. Study protocol

    Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial

    We conducted a prospective randomized study of an adjuvant oxaliplatin-based regimen plus orally administered tegafur-uracil in patients with stage III colon cancer after radical resection to evaluate the feas...

    Yung-Sung Yeh, Hsiang-Lin Tsai, Ching-Wen Huang, Po-Li Wei, Yung-Chuan Sung, Hsiu-Chih Tang and Jaw-Yuan Wang

    Trials 2017 18:191

    Published on: 26 April 2017

  13. Research

    Clinicians’ views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

    The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent...

    Celine Y. Chhoa, Alexandra Sawyer, Susan Ayers, Angela Pushpa-Rajah and Lelia Duley

    Trials 2017 18:196

    Published on: 26 April 2017

  14. Study protocol

    The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

    Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this tr...

    Willem Kuyken, Elizabeth Nuthall, Sarah Byford, Catherine Crane, Tim Dalgleish, Tamsin Ford, Mark T. Greenberg, Obioha C. Ukoumunne, Russell M. Viner and J. Mark G. Williams

    Trials 2017 18:194

    Published on: 26 April 2017

  15. Study protocol

    Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial

    The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in huma...

    Anna Chiumento, Syed Usman Hamdani, Muhammad Naseem Khan, Katie Dawson, Richard A. Bryant, Marit Sijbrandij, Huma Nazir, Parveen Akhtar, Aqsa Masood, Duolao Wang, Mark van Ommeren and Atif Rahman

    Trials 2017 18:190

    Published on: 26 April 2017

  16. Study protocol

    Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial

    Intravenous administration of fluids is an essential part of critical care. While some fluid administration is likely beneficial, there is increasing observational evidence that the development of fluid overlo...

    Rasmus E. Berthelsen, Theis Itenov, Anders Perner, Jens-Ulrik Jensen, Michael Ibsen, Andreas Emil Kryger Jensen and Morten Bestle

    Trials 2017 18:189

    Published on: 24 April 2017

  17. Study protocol

    Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial

    Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the ...

    Lin-lin Zhu, Jian-ying Zhou, Ling Luo, Xiang Wang, Jia-xi Peng, Sha-sha Chen, Hai-Yan Yin, Qiao-Feng Wu, Cheng-shun Zhang, Peng Lv, Yong Tang and Shu-guang Yu

    Trials 2017 18:188

    Published on: 24 April 2017

  18. Study protocol

    Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial

    Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for...

    Eldré W. Beukes, David M. Baguley, Peter M. Allen, Vinaya Manchaiah and Gerhard Andersson

    Trials 2017 18:186

    Published on: 21 April 2017

  19. Study protocol

    The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial

    Vitamin B12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth. Vitamin B12 is crucial for normal cell division and differentiation, and i...

    Tor A. Strand, Manjeswori Ulak, Ram K. Chandyo, Ingrid Kvestad, Mari Hysing, Merina Shrestha, Sudha Basnet, Suman Ranjitkar, Laxman Shrestha and Prakash S. Shrestha

    Trials 2017 18:187

    Published on: 21 April 2017

  20. Study protocol

    Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial

    Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side effects in patients with cancer. The introduction and development of antiemetic drugs have significantly improved ...

    Qi-wei Li, Ming-wei Yu, Guo-wang Yang, Xiao-min Wang, Huan Wang, Chen-xi Zhang, Na Xue, Wei-ru Xu, Qi Fu, Zhong Yang and Lin Yang

    Trials 2017 18:185

    Published on: 20 April 2017

  21. Study protocol

    A multicenter randomized controlled trial of surgery alone or surgery with atrial natriuretic peptide in lung cancer surgery: study protocol for a randomized controlled trial

    Postoperative cancer recurrence is a major problem following curative surgery. In a previous retrospective study of lung cancer surgery, we reported that administration of atrial natriuretic peptide (ANP) duri...

    Takashi Nojiri, Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Kikuko Ohshima, Yasushi Shintani, Meinoshin Okumura and Kenji Kangawa

    Trials 2017 18:183

    Published on: 20 April 2017

  22. Study protocol

    Optimising conservative management of chronic low back pain: study protocol for a randomised controlled trial

    Lower back pain is a global health issue affecting approximately 80% of people at some stage in their life. The current literature suggests that any exercise is beneficial for reducing back pain. However, as p...

    Katherine J. Simson, Clint T. Miller, Jon Ford, Andrew Hahne, Luana Main, Timo Rantalainen, Wei-Peng Teo, Megan Teychenne, David Connell, Guy Trudel, Guoyan Zheng, Gary Thickbroom and Daniel L. Belavy

    Trials 2017 18:184

    Published on: 20 April 2017

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