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  1. Study protocol

    Ciprofloxacin for contacts of cases of meningococcal meningitis as an epidemic response: study protocol for a cluster-randomized trial

    Epidemics of meningococcal meningitis are common in the “African meningitis belt.” Current response strategies include reactive vaccination campaigns, which are often organized too late to have maximal impact....

    Matthew E. Coldiron, Gabriel Alcoba, Iza Ciglenecki, Matt Hitchings, Ali Djibo, Anne-Laure Page, Celine Langendorf and Rebecca F. Grais

    Trials 2017 18:294

    Published on: 24 June 2017

  2. Study protocol

    Effect of acupuncture on cerebrovascular reserve in patients with acute cerebral infarction: protocol for a randomized controlled pilot study

    The incidence of cerebral infarction has been growing year by year in China and around the world. According to clinical observation, acupuncture utilizing the “waking up the spirit” needling method is widely u...

    Shaosong Wang, Tingting Ma, Linpeng Wang, Lu Liu, Huilin Liu, Bin Li and Yuanbo Fu

    Trials 2017 18:292

    Published on: 24 June 2017

  3. Study protocol

    Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial

    A randomized controlled trial of adults with empyema recently demonstrated decreased length of stay in hospital in patients treated with intrapleurally administered dornase alfa and fibrinolytics compared to f...

    Michael H. Livingston, Sanjay Mahant, Felix Ratjen, Bairbre L. Connolly, Kevin Thorpe, Muhammad Mamdani, Ian Maclusky, Sophie Laberge, Lucy Giglia, J. Mark Walton, Connie L. Yang, Ashley Roberts, Anna C. Shawyer, Mary Brindle, Simon J. Parsons, Cristina A. Stoian…

    Trials 2017 18:293

    Published on: 24 June 2017

  4. Study protocol

    The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) – standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial

    The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is l...

    Md Ali Katijjahbe, Linda Denehy, Catherine L. Granger, Alistair Royse, Colin Royse, Rebecca Bates, Sarah Logie, Sandy Clarke and Doa El-Ansary

    Trials 2017 18:290

    Published on: 23 June 2017

  5. Study protocol

    Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial

    Obesity is a public health concern in many countries due to its increasing prevalence. Euiiyin-tang is an herbal medicine formula often used as a clinical treatment for obesity. It acts to eliminate humidity a...

    Chunhoo Cheon, Soobin Jang, Jeong-Su Park, Youme Ko, Doh Sun Kim, Byung Hoon Lee, Hyun Jong Song, Yun-Kyung Song, Bo-Hyoung Jang, Yong-Cheol Shin and Seong-Gyu Ko

    Trials 2017 18:289

    Published on: 21 June 2017

  6. Research

    Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013

    Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle ...

    Sohyun Jeong, Minji Sohn, Jae Hyun Kim, Minoh Ko, Hee-won Seo, Yun-Kyoung Song, Boyoon Choi, Nayoung Han, Han-Sung Na, Jong Gu Lee, In-Wha Kim, Jung Mi Oh and Euni Lee

    Trials 2017 18:288

    Published on: 21 June 2017

  7. Review

    The COMET Handbook: version 1.0

    The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outco...

    Paula R. Williamson, Douglas G. Altman, Heather Bagley, Karen L. Barnes, Jane M. Blazeby, Sara T. Brookes, Mike Clarke, Elizabeth Gargon, Sarah Gorst, Nicola Harman, Jamie J. Kirkham, Angus McNair, Cecilia A. C. Prinsen, Jochen Schmitt, Caroline B. Terwee and Bridget Young

    Trials 2017 18(Suppl 3):280

    Published on: 20 June 2017

    This article is part of a Supplement: Volume 18 Supplement 3

  8. Study protocol

    Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

    Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in patients with stroke in China, especially the motor area of Jiao’s scalp acupuncture, which is the most widely used treatment...

    Jun Wang, Jian Pei, Dhiaedin Khiati, Qinhui Fu, Xiao Cui, Yi Song, Minghang Yan, Lijun Shi, Yiwen Cai and Yuhong Ma

    Trials 2017 18:287

    Published on: 20 June 2017

  9. Study protocol

    Improving child nutrition and development through community-based childcare centres in Malawi – The NEEP-IE study: study protocol for a randomised controlled trial

    The Nutrition Embedded Evaluation Programme Impact Evaluation (NEEP-IE) study is a cluster randomised controlled trial designed to evaluate the impact of a childcare centre-based integrated nutritional and agr...

    Aulo Gelli, Amy Margolies, Marco Santacroce, Katie Sproule, Sophie Theis, Natalie Roschnik, Aisha Twalibu, George Chidalengwa, Amrik Cooper, Tyler Moorhead, Melissa Gladstone, Patricia Kariger and Mangani Kutundu

    Trials 2017 18:284

    Published on: 19 June 2017

  10. Study protocol

    Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial

    Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the famil...

    Mark D. Lyttle, Carrol Gamble, Shrouk Messahel, Helen Hickey, Anand Iyer, Kerry Woolfall, Amy Humphreys, Naomi E. A. Bacon, Louise Roper, Franz E. Babl, Stuart R. Dalziel, Mary Ryan and Richard E. Appleton

    Trials 2017 18:283

    Published on: 19 June 2017

  11. Study protocol

    Effects of digital Cognitive Behavioural Therapy for Insomnia on cognitive function: study protocol for a randomised controlled trial

    The daytime effects of insomnia pose a significant burden to patients and drive treatment seeking. In addition to subjective deficits, meta-analytic data show that patients experience reliable objective impair...

    Simon D. Kyle, Madeleine E. D. Hurry, Richard Emsley, Annemarie I. Luik, Ximena Omlin, Kai Spiegelhalder, Colin A. Espie and Claire E. Sexton

    Trials 2017 18:281

    Published on: 17 June 2017

  12. Study protocol

    The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial

    Chronic obstructive pulmonary disease (COPD) is a major cause of disability and hospital admission. Current management strategies have not been successful in altering the loss of lung function typically seen a...

    Roger M. Engel, Jaxson Wearing, Peter Gonski and Subramanyam Vemulpad

    Trials 2017 18:282

    Published on: 17 June 2017

  13. Study protocol

    Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients: study protocol for a randomised controlled trial

    People with a mental illness experience a greater morbidity and mortality from chronic diseases relative to the general population. A higher prevalence of modifiable health risk behaviours such as smoking, poo...

    Caitlin Fehily, Kate Bartlem, John Wiggers, Paula Wye, Richard Clancy, David Castle, Sonia Wutzke, Chris Rissel, Andrew Wilson, Paul McCombie, Fionna Murphy and Jenny Bowman

    Trials 2017 18:276

    Published on: 15 June 2017

  14. Study protocol

    Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment – the RADMIS trials: study protocol for two randomized controlled trials

    Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric...

    Maria Faurholt-Jepsen, Mads Frost, Klaus Martiny, Nanna Tuxen, Nicole Rosenberg, Jonas Busk, Ole Winther, Jakob Eyvind Bardram and Lars Vedel Kessing

    Trials 2017 18:277

    Published on: 15 June 2017

  15. Study protocol

    Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial

    Interstitial lung disease (ILD) frequently complicates systemic autoimmune disorders resulting in considerable morbidity and mortality. The connective tissue diseases (CTDs) most frequently resulting in ILD in...

    Peter Saunders, Vicky Tsipouri, Gregory J. Keir, Deborah Ashby, Marcus D. Flather, Helen Parfrey, Daphne Babalis, Elisabetta A. Renzoni, Christopher P. Denton, Athol U. Wells and Toby M. Maher

    Trials 2017 18:275

    Published on: 15 June 2017

  16. Research

    Exploring patients’ treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets

    The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not...

    Katrina M. Turner, John Percival, David Kessler and Jenny Donovan

    Trials 2017 18:279

    Published on: 15 June 2017

  17. Research

    BADERI: an online database to coordinate handsearching activities of controlled clinical trials for their potential inclusion in systematic reviews

    Systematic reviews provide the best evidence on the effect of health care interventions. They rely on comprehensive access to the available scientific literature. Electronic search strategies alone may not suf...

    Hector Pardo-Hernandez, Gerard Urrútia, Leticia A. Barajas-Nava, Diana Buitrago-Garcia, Julieth Vanessa Garzón, María José Martínez-Zapata and Xavier Bonfill

    Trials 2017 18:273

    Published on: 13 June 2017

  18. Study protocol

    Choosing the target difference (‘effect size’) for a randomised controlled trial - DELTA2 guidance protocol

    A key step in the design of a randomised controlled trial (RCT) is the estimation of the number of participants needed. By far the most common approach is to specify a target difference and then estimate the c...

    Jonathan A. Cook, Steven A. Julious, William Sones, Joanne C. Rothwell, Craig R. Ramsay, Lisa V. Hampson, Richard Emsley, Stephen J. Walters, Catherine Hewitt, Martin Bland, Dean A. Fergusson, Jesse A. Berlin, Doug Altman and Luke D. Vale

    Trials 2017 18:271

    Published on: 12 June 2017

  19. Study protocol

    Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial

    High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates...

    Tazeen H. Jafar, Imtiaz Jehan, H. Asita de Silva, Aliya Naheed, Mihir Gandhi, Pryseley Assam, Eric A. Finkelstein, Helena Legido Quigley, Marcel Bilger, Aamir Hameed Khan, John David Clemens, Shah Ebrahim, Elizabeth L. Turner and Anuradhani Kasturiratne

    Trials 2017 18:272

    Published on: 12 June 2017

  20. Study protocol

    Cluster randomized trial of a mHealth intervention “ImTeCHO” to improve delivery of proven maternal, neonatal, and child care interventions through community-based Accredited Social Health Activists (ASHAs) by enhancing their motivation and strengthening supervision in tribal areas of Gujarat, India: study protocol for a randomized controlled trial

    To facilitate the delivery of proven maternal, neonatal, and child health (MNCH) services, a new cadre of village-based frontline workers, called the Accredited Social Health Activists (ASHAs), was created in ...

    Dhiren Modi, Shrey Desai, Kapilkumar Dave, Shobha Shah, Gayatri Desai, Nishith Dholakia, Ravi Gopalan and Pankaj Shah

    Trials 2017 18:270

    Published on: 9 June 2017

  21. Erratum

    Erratum to 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

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

    Trials 2017 18:269

    Published on: 8 June 2017

    The original article was published in Trials 2017 18:208

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