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  1. Cardiovascular disease remains the leading cause of morbidity and mortality worldwide, and there is a rising global burden. The effects of diet on cardiometabolic risk factors have been studied extensively. He...

    Authors: Ranil Jayawardena, Pasindu Fernando, Niroshan Lokunarangoda and Anidu Keerthi Pathirana
    Citation: Trials 2017 18:314
  2. This study aims to investigate the effects of a modified, balanced crystalloid including phosphate in a perioperative setting in order to maintain a stable electrolyte and acid-base homeostasis in the patient.

    Authors: Judith-Irina Pagel, Nikolai Hulde, Tobias Kammerer, Michaela Schwarz, Daniel Chappell, Alexander Burges, Klaus Hofmann-Kiefer and Markus Rehm
    Citation: Trials 2017 18:313
  3. A large number of randomized trials on the use of acupuncture to treat chronic pain have been conducted. However, there is considerable controversy regarding the effectiveness of acupuncture. We designed a ran...

    Authors: Yiling Yang, Xiaoxia Yan, Hongmei Deng, Dian Zeng, Jianpeng Huang, Wenbin Fu, Nenggui Xu and Jianhua Liu
    Citation: Trials 2017 18:312
  4. Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to th...

    Authors: Petter Viksveen, Clare Relton and Jon Nicholl
    Citation: Trials 2017 18:308
  5. Postpartum haemorrhage complicates approximately 10% of all deliveries and contributes to at least a quarter of all maternal deaths worldwide. The competency-based Helping Mothers Survive Bleeding after Birth ...

    Authors: Claudia Hanson, Andrea B. Pembe, Fadhlun Alwy, Susan Atuhairwe, Sebalda Leshabari, Jessica Morris, Frank Kaharuza and Gaetano Marrone
    Citation: Trials 2017 18:307
  6. Interventional radiology includes a range of minimally invasive image-guided diagnostic and therapeutic procedures that have become routine clinical practice. Each procedure involves a percutaneous needle inse...

    Authors: RC. Rouchy, A. Moreau-Gaudry, E. Chipon, S. Aubry, L. Pazart, B. Lapuyade, M. Durand, M. Hajjam, S. Pottier, B. Renard, R. Logier, X. Orry, A. Cherifi, E. Quehen, G. Kervio, O. Favelle…
    Citation: Trials 2017 18:306
  7. There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical...

    Authors: Olamide Ojo-Fati, Anne M. Joseph, Jed Ig-Izevbekhai, Janet L. Thomas, Susan A. Everson-Rose, Rebekah Pratt, Nancy Raymond, Ned L. Cooney, Xianghua Luo and Kolawole S. Okuyemi
    Citation: Trials 2017 18:305
  8. Randomized controlled trials (RCTs) are needed to improve health care in Sub-Saharan Africa (SSA). However, inadequate methods and incomplete reporting of interventions can prevent the transposition of researc...

    Authors: Lee Aymar Ndounga Diakou, Francine Ntoumi, Philippe Ravaud and Isabelle Boutron
    Citation: Trials 2017 18:291

    The Correction to this article has been published in Trials 2018 19:42

  9. Approximately 80% of global tuberculosis (TB) cases occur in low-resource settings, with little opportunity for TB control. We hypothesized that the rapid increase in smartphone users and advances in digital t...

    Authors: Ruixue Huang, Guofeng Ren and Jianan Hu
    Citation: Trials 2017 18:286
  10. Family caregivers (FC) often experience higher distress levels than their relative with cancer. Many cancer centers have implemented distress screening programs, but most of them concentrate their efforts on p...

    Authors: Michèle Aubin, Lucie Vézina, René Verreault, Sébastien Simard, Jean-François Desbiens, Lise Tremblay, Serge Dumont, Lise Fillion, Maman Joyce Dogba and Pierre Gagnon
    Citation: Trials 2017 18:304
  11. Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvulop...

    Authors: Florence Leclercq, Pierre Robert, Jessica Labour, Benoit Lattuca, Mariama Akodad, Jean-Christophe Macia, Richard Gervasoni, Francois Roubille, Thomas Gandet, Laurent Schmutz, Erika Nogue, Nicolas Nagot, Bernard Albat and Guillaume Cayla
    Citation: Trials 2017 18:303
  12. Metabolic syndrome (MetS) refers to clustered cardiovascular risk factors (abdominal obesity, pre-diabetes, high blood pressure, dyslipidaemia). Therapies targeting oxidative stress ma...

    Authors: Nina Hermans, Anastasia Van der Auwera, Annelies Breynaert, Annelies Verlaet, Tess De Bruyne, Luc Van Gaal, Luc Pieters and Veronique Verhoeven
    Citation: Trials 2017 18:302
  13. Alzheimer’s disease is a progressive neurodegenerative disease. Although some of the current treatments offer some symptomatic relief, this disease cannot be cured at present. Electroacupuncture may be effecti...

    Authors: Weina Peng, Jing Zhou, Min Xu, Qing Feng, Lulu Bin and Zhishun Liu
    Citation: Trials 2017 18:301
  14. The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major s...

    Authors: Nicolle M. Krebs, Sophia I. Allen, Susan Veldheer, Diane J. Martinez, Kimberly Horn, Craig Livelsberger, Jennifer Modesto, Robin Kuprewicz, Ashley Wilhelm, Shari Hrabovsky, Abid Kazi, Alyse Fazzi, Jason Liao, Junjia Zhu, Emily Wasserman, Samantha M. Reilly…
    Citation: Trials 2017 18:300

    The Correction to this article has been published in Trials 2017 18:598

  15. Despite controversy regarding homeopathy, some patients consult homeopaths for depression. Evidence is required to determine whether this is an effective, acceptable and safe intervention for these patients.

    Authors: Petter Viksveen, Clare Relton and Jon Nicholl
    Citation: Trials 2017 18:299
  16. Persecutory delusions are the most common type of delusions in psychosis and present in around 10–15% of the general population. Persecutory delusions are thought to be sustained by biased cognitive and emotio...

    Authors: Jenny Yiend, Antonella Trotta, Christopher Meek, Ilvana Dzafic, Nora Baldus, Bryony Crane, Thomas Kabir, Daniel Stahl, Margaret Heslin, Sukhwinder Shergill, Philip McGuire and Emmanuelle Peters
    Citation: Trials 2017 18:298
  17. Type-2 diabetes has become a major disease and is known to seriously impair people’s health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most c...

    Authors: Xinger Li, Haiyan Liu, Huiping Feng, Zhongren Xian, Yanhong Chen, Jianping Chen, Chunzhi Tang, Xinsheng Lai, Xiaoling Lan, Huanzhen Huang and Dongdong Yu
    Citation: Trials 2017 18:297
  18. Hypertensive intracerebral haemorrhage (HICH) is the most common form of haemorrhagic stroke with the highest morbidity and mortality of all stroke types. The choice of surgical or conservative treatment for p...

    Authors: Xinghua Xu, Yi Zheng, Xiaolei Chen, Fangye Li, Huaping Zhang and Xin Ge
    Citation: Trials 2017 18:296
  19. Anesthesiologists administer excess supplemental oxygen (hyper-oxygenation) to patients during surgery to avoid hypoxia. Hyper-oxygenation, however, may increase the generation of reactive oxygen species and c...

    Authors: Marcos G. Lopez, Mias Pretorius, Matthew S. Shotwell, Robert Deegan, Susan S. Eagle, Jeremy M. Bennett, Bantayehu Sileshi, Yafen Liang, Brian J. Gelfand, Adam J. Kingeter, Kara K. Siegrist, Frederick W. Lombard, Tiffany M. Richburg, Dane A. Fornero, Andrew D. Shaw, Antonio Hernandez…
    Citation: Trials 2017 18:295
  20. 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....

    Authors: Matthew E. Coldiron, Gabriel Alcoba, Iza Ciglenecki, Matt Hitchings, Ali Djibo, Anne-Laure Page, Celine Langendorf and Rebecca F. Grais
    Citation: Trials 2017 18:294
  21. 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...

    Authors: 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…
    Citation: Trials 2017 18:293
  22. 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...

    Authors: Shaosong Wang, Tingting Ma, Linpeng Wang, Lu Liu, Huilin Liu, Bin Li and Yuanbo Fu
    Citation: Trials 2017 18:292
  23. 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...

    Authors: Md Ali Katijjahbe, Linda Denehy, Catherine L. Granger, Alistair Royse, Colin Royse, Rebecca Bates, Sarah Logie, Sandy Clarke and Doa El-Ansary
    Citation: Trials 2017 18:290
  24. 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...

    Authors: 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
    Citation: Trials 2017 18:289
  25. 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 ...

    Authors: 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
    Citation: Trials 2017 18:288
  26. 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...

    Authors: Jun Wang, Jian Pei, Dhiaedin Khiati, Qinhui Fu, Xiao Cui, Yi Song, Minghang Yan, Lijun Shi, Yiwen Cai and Yuhong Ma
    Citation: Trials 2017 18:287
  27. 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...

    Authors: 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
    Citation: Trials 2017 18(Suppl 3):280

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

  28. 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...

    Authors: 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
    Citation: Trials 2017 18:284
  29. 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...

    Authors: 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
    Citation: Trials 2017 18:283
  30. 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...

    Authors: Roger M. Engel, Jaxson Wearing, Peter Gonski and Subramanyam Vemulpad
    Citation: Trials 2017 18:282
  31. 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...

    Authors: Simon D. Kyle, Madeleine E. D. Hurry, Richard Emsley, Annemarie I. Luik, Ximena Omlin, Kai Spiegelhalder, Colin A. Espie and Claire E. Sexton
    Citation: Trials 2017 18:281
  32. 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...

    Authors: Katrina M. Turner, John Percival, David Kessler and Jenny Donovan
    Citation: Trials 2017 18:279
  33. 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...

    Authors: Maria Faurholt-Jepsen, Mads Frost, Klaus Martiny, Nanna Tuxen, Nicole Rosenberg, Jonas Busk, Ole Winther, Jakob Eyvind Bardram and Lars Vedel Kessing
    Citation: Trials 2017 18:277
  34. 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...

    Authors: 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
    Citation: Trials 2017 18:276
  35. 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...

    Authors: 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
    Citation: Trials 2017 18:275
  36. The treatment of idiopathic full-thickness macular holes involves surgery to close the hole. Some surgeons advise patients to adopt a face-down position to increase the likelihood of successful macular hole cl...

    Authors: Lauren Bell, Richard Hooper, Catey Bunce, Saruban Pasu and James Bainbridge
    Citation: Trials 2017 18:274
  37. 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...

    Authors: Hector Pardo-Hernandez, Gerard Urrútia, Leticia A. Barajas-Nava, Diana Buitrago-Garcia, Julieth Vanessa Garzón, María José Martínez-Zapata and Xavier Bonfill
    Citation: Trials 2017 18:273
  38. 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...

    Authors: 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
    Citation: Trials 2017 18:272

    The Update to this article has been published in Trials 2018 19:658

  39. 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...

    Authors: 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
    Citation: Trials 2017 18:271
  40. 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 ...

    Authors: Dhiren Modi, Shrey Desai, Kapilkumar Dave, Shobha Shah, Gayatri Desai, Nishith Dholakia, Ravi Gopalan and Pankaj Shah
    Citation: Trials 2017 18:270
  41. Authors: 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
    Citation: Trials 2017 18:269

    The original article was published in Trials 2017 18:208

  42. In recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea. It can lead to gynecological problems such as irregular menstruation, miscarriage, and infertility. Trad...

    Authors: Youme Ko, Ho-Yeon Go, Yoon-Young Cho, Ji-Hye Shin, Tae-Hoon Kim, Dong-Jun Choi, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seong-Gyu Ko, Seung-Ho Sun and Chan-Yong Jeon
    Citation: Trials 2017 18:268
  43. Patients’ evolving critical illness can be predicted and prevented. However, failure to identify the signs of critical illness and subsequent lack of appropriate action for patients developing acute and critic...

    Authors: Claus Sixtus Jensen, Hanne Aagaard, Hanne Vebert Olesen and Hans Kirkegaard
    Citation: Trials 2017 18:267
  44. Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in heal...

    Authors: Jacqueline Martin-Kerry, Peter Bower, Bridget Young, Jonathan Graffy, Rebecca Sheridan, Ian Watt, Paul Baines, Catherine Stones, Jennifer Preston, Steven Higgins, Carrol Gamble and Peter Knapp
    Citation: Trials 2017 18:265
  45. Despite the lack of scientific studies on biofield therapies, they are widely acclaimed by patients. The mechanisms of action are not explained by current allopathic medical approaches. Warts are common and co...

    Authors: Cathy Gaillard, Laure Allain, Hélène Legros, Sylvie Brucato, Yohann Desgue, Christophe Rouillon, Laure Peyro-Saint-Paul and Anne Dompmartin
    Citation: Trials 2017 18:263
  46. Therapeutic drug monitoring (TDM) is essential practice when dosing drugs with a narrow therapeutic index in order to achieve a plasma drug concentration within a narrow target range above the efficacy concent...

    Authors: Maia Lesosky, John Joska and Eric Decloedt
    Citation: Trials 2017 18:261

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