Saturday, September 7, 2019

Trials | Articles

Trials | Articles



Trials

  1. Study Protocol

    There is a global pandemic of type 2 diabetes mellitus (T2DM), especially in Asia. Singapore has a prevalence of T2DM at 10.5%, which is higher than the world average of 8.8%. Multiple studies have shown that ...
    Authors:Eberta Tan, Joan Khoo, Linsey Utami Gani, Roy Debajyoti Malakar, Tunn Lin Tay, Prasanna Sivanath Tirukonda, Jia Wen Kam, Aung Soe Tin and Tjun Yip Tang
    Citation:Trials 2019 20:549
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  2. Content Type:Study Protocol

    Diabetes is an important health burden in Indonesia. However, diabetes management and treatment remain poor, with most people with diabetes in Indonesia not achieving the recommended blood glucose levels. Peer...
    Authors:Till Seuring, Marthoenis, Sabrina Rhode, Lisa Rogge, Holger Rau, Stéphane Besançon, Hendra Zufry, Hizir Sofyan and Sebastian Vollmer
    Citation:Trials 2019 20:548
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  3. Content Type:Research

    Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2...
    Authors:Aleksandra Herbec, Jamie Brown, Lion Shahab, Robert West and Tobias Raupach
    Citation:Trials 2019 20:547
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  4. Content Type:Study Protocol

    Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men p...
    Authors:Jessica Frost, J. Athene Lane, Nikki Cotterill, Mandy Fader, Lucy Hackshaw-McGeagh, Hashim Hashim, Margaret Macaulay, Stephanie J. MacNeill, Sian Noble, Jonathan Rees, Matthew J. Ridd, Luke Robles, Gordon Taylor, Jodi Taylor, Marcus J Drake and Jo Worthington
    Citation:Trials 2019 20:546
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  5. Content Type:Study Protocol

    There are significant barriers to providing accessible, quality mental health care for young adolescents affected by adversity. In an attempt to overcome this, the World Health Organization (WHO) has developed...
    Authors:Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts and Aemal Akhtar
    Citation:Trials 2019 20:545
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  6. Content Type:Study Protocol

    Large field irradiation had been standard for early-stage follicular lymphoma (FL) for a long time. Although involved field radiotherapy (IF-RT) was recently favored because of the toxicity of large field irra...
    Authors:Laila König, Martin Dreyling, Jan Dürig, Marianne Engelhard, Karin Hohloch, Andreas Viardot, Mathias Witzens-Harig, Meinhard Kieser, Wolfram Klapper, Christiane Pott and Klaus Herfarth
    Citation:Trials 2019 20:544
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  7. Content Type:Study Protocol

    The sectorization of health-care systems leads to inefficient treatment, especially for elderly people with cognitive impairment. The transition from hospital care to primary care is insufficiently coordinated...
    Authors:Angela Nikelski, Armin Keller, Fanny Schumacher-Schönert, Terese Dehl, Jessica Laufer, Ulf Sauerbrey, Diana Wucherer, Adina Dreier-Wolfgramm, Bernhard Michalowsky, Ina Zwingmann, Horst Christian Vollmar, Wolfgang Hoffmann, Stefan H. Kreisel and Jochen René Thyrian
    Citation:Trials 2019 20:543
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  8. Content Type:Study Protocol

    The optimal vitamin D intake for nursing mothers with overweight or obesity has not been defined. Vitamin D concentrations are associated with body composition indices, particularly body fat mass. Few studies ...
    Authors:Zohre Gerveieeha, Fereydoun Siassi, Mostafa Qorbani, Farzaneh Ziaeian and Gity Sotoudeh
    Citation:Trials 2019 20:542
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  9. Content Type:Study Protocol

    Early childhood is a critical period of development. Caregivers, including providers of early care and education (ECE), have a substantial influence on the health of young children. Family child care homes (FC...
    Authors:Susan B. Sisson, Alicia L. Salvatore, Deana Hildebrand, Tiffany Poe, Cady Merchant, Megan Slawinski, Chelsea L. Kracht, Julie A. Stoner, Naneida Alcala Lazarte, Lu Ann Faulkner Schneider, Jennifer Weber, Felecia Jones and Dianne Ward
    Citation:Trials 2019 20:541
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  10. Content Type:Study Protocol

    In Hong Kong, one of six couples is affected by subfertility problems. Male infertility contributes to half of the infertility cases. In male infertility, there is no effective treatment for patients with idio...
    Authors:Mingpeng Zhao, Carol Pui Shan Chan, Cosy Wing Ching Cheung, Odai Alqawasmeh, Ronald Chi Chiu Wang, Justin Che Yuen Wu, Zhi Xiu Lin, Tin Chiu Li, Jacqueline Pui Wah Chung, Jennifer Sze Man Mak, Tracy Sze Man Law and David Yiu Leung Chan
    Citation:Trials 2019 20:540
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  11. Content Type:Study Protocol

    Cardiotocography is almost ubiquitous in its use in intrapartum care. Although it has been demonstrated that there is some benefit from continuous intrapartum fetal monitoring using cardiotocography, there is ...
    Authors:D. Turnbull, A. Salter, B. Simpson, B. W. Mol, E. Chandraharan, A. McPhee, I. Symonds, M. Benton, S. Kuah, G. Matthews, K. Howard and C. Wilkinson
    Citation:Trials 2019 20:539
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  12. Content Type:Study Protocol

    Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. Currently, the treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes...
    Authors:Ying Ding, Xia Zhang, Xianqing Ren, Wensheng Zhai, Liyun He, Jianping Liu, Chen Yao, Shanshan Han and Long Wang
    Citation:Trials 2019 20:538
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  13. Content Type:Study Protocol

    Immunologic derangement may be the critical pathophysiologic mechanism in sepsis, and immunotherapy might be a potential new treatment. Si-ni-tang (SNT), an ancient Chinese herbal formula documented in Shanghan L...
    Authors:Ruifeng Zeng, Yi Zheng, Rongrong Fan, Gengbiao Zhou, Yan Zhang, Shutao Mai, Dongping Xie, Yanna Weng, Jiongdong Du, Yun Han and Fang Lai
    Citation:Trials 2019 20:537
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  14. Content Type:Study Protocol

    Tuberculosis is one of the greatest global health concerns and disease management is challenging particularly in low- and middle-income countries. Despite improvements in addressing this epidemic in Georgia, t...
    Authors:Ivdity Chikovani, Karin Diaconu, Predrag Duric, Lela Sulaberidze, Maia Uchaneishvili, Nuredin Ibrahim Mohammed, Akaki Zoidze and Sophie Witter
    Citation:Trials 2019 20:536
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  16. Content Type:Study Protocol

    Accidental Accidental awareness during general anesthesia (AAGA) occurs in 1–2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Howev...
    Authors:Sébastien Rimbert, Denis Schmartz, Laurent Bougrain, Claude Meistelman, Cédric Baumann and Philippe Guerci
    Citation:Trials 2019 20:534
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  17. Content Type:Study Protocol

    A classical approach to produce interscalene brachial plexus block (ISBPB) consistently spares the posterior aspect of the shoulder and ulnar sides of the elbow, forearm, and hand, which are innervated by the ...
    Authors:Eugene Kim, Chang Hyuk Choi and Jong Hae Kim
    Citation:Trials 2019 20:533
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  18. Content Type:Methodology

    Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early...
    Authors:Devin S. McCaskell, Alexander J. Molloy, Laura Childerhose, F. Aileen Costigan, Julie C. Reid, Magda McCaughan, France Clarke, Deborah J. Cook, Jill C. Rudkowski, Christopher Farley, Tim Karachi, Bram Rochwerg, Anastasia Newman, Alison Fox-Robichaud, Margaret S. Herridge, Vincent Lo…
    Citation:Trials 2019 20:532
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  19. Content Type:Study Protocol

    Carpal tunnel syndrome (CTS) is a common cause of pain, weakness, sensory loss, and activity limitations. Currently, the most common initial treatment is use of a rigid splint immobilizing the wrist, usually d...
    Authors:Isam Atroshi, Kamelia Tadjerbashi, Steven J. McCabe and Jonas Ranstam
    Citation:Trials 2019 20:531
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  20. Content Type:Study Protocol

    Guidelines in pediatric restorative dentistry recommend the use of preformed pediatric stainless steel crowns (SSCs) in cases of severe tooth decay of at least two surfaces. This clinically effective and safe ...
    Authors:Serena Lopez-Cazaux, Elody Aiem, Ana Miriam Velly and Michèle Muller-Bolla
    Citation:Trials 2019 20:530
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  21. Content Type:Study Protocol

    Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with increased morbidity, mortality, healthcare costs and decreased quality of life. African Americans in the USA ...
    Authors:Edith M. Williams, Leonard Egede, Jim C. Oates, Clara L. Dismuke, Viswanathan Ramakrishnan, Trevor D. Faith, Hetlena Johnson and Jillian Rose
    Citation:Trials 2019 20:529
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  22. Content Type:Study Protocol

    The prognostic benefits and safety of extended lymphadenectomy for hilar cholangiocarcinoma remain uncertain. The available evidence is still insufficient concerning its retrospective aspect. The aim of this s...
    Authors:Min He, Xinsen Xu, Hao Feng, Wei Chen, Houbao Liu, Yongjie Zhang, Jianming Wang, Zhimin Geng, Yudong Qiu, Weidong Duan, Xiangcheng Li, Xuting Zhi, Weihua Zhu, Fuyu Li, Jiangtao Li, Shengping Li…
    Citation:Trials 2019 20:528
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  24. Content Type:Study Protocol

    Persons with spinal cord injury (SCI) are at heightened risks of developing unfavorable cardiometabolic consequences due to physical inactivity. Functional electrical stimulation (FES) and surface neuromuscula...
    Authors:Ashraf S. Gorgey, Refka E. Khalil, John C. Davis, William Carter, Ranjodh Gill, Jeannie Rivers, Rehan Khan, Lance L. Goetz, Teodoro Castillo, Timothy Lavis, Adam P. Sima, Edward J. Lesnefsky, Christopher C. Cardozo and Robert A. Adler
    Citation:Trials 2019 20:526
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  25. Content Type:Research

    Unanticipated responses by research participants can influence randomised controlled trials (RCTs) in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an em...
    Authors:Meriel Norris, Leon Poltawski, Raff Calitri, Anthony I. Shepherd and Sarah G. Dean
    Citation:Trials 2019 20:525
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  26. Content Type:Methodology

    In some randomised trials, the primary interest is in the mechanisms by which an intervention exerts its effects on health outcomes. That is, clinicians and policy-makers may be interested in how the intervent...
    Authors:Hopin Lee, Robert D. Herbert, Sarah E. Lamb, Anne M. Moseley and James H. McAuley
    Citation:Trials 2019 20:524
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  27. Content Type:Study Protocol

    The global prevalence of diabetes mellitus (DM) has been increasing over recent decades. In Germany, the prevalence for DM type 1 and type 2 in adults is estimated at about 7.7%. Hence, diabetes has to be clas...
    Authors:M. Bernard, N. Müller, L. Hecht, G. Fabisch, A. Harder and C. Luck-Sikorski
    Citation:Trials 2019 20:523
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  28. Content Type:Study Protocol

    There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access cont...
    Authors:Alain Amstutz, Thabo Ishmael Lejone, Lefu Khesa, Josephine Muhairwe, Bienvenu Lengo Nsakala, Katleho Tlali, Moniek Bresser, Fabrizio Tediosi, Mathebe Kopo, Mpho Kao, Thomas Klimkait, Manuel Battegay, Tracy Renée Glass and Niklaus Daniel Labhardt
    Citation:Trials 2019 20:522
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  29. Content Type:Study Protocol

    Early detection of diabetic foot ulcerations (DFUs) can avoid or delay any progression into more severe stages, which may require limb amputation or lead to infectious sequelae and death. However, frequent cli...
    Authors:Antao Ming, Isabell Walter, Ahmad Alhajjar, Martin Leuckert and Peter R. Mertens
    Citation:Trials 2019 20:521
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  30. Content Type:Study Protocol

    Coronary artery disease (CAD) is one of the most common types of the cardiovascular disease. Previous pilot trials have suggested that Traditional Chinese Medicine (TCM) has brought clinical benefits for patie...
    Authors:Xiao Jin, Biqi Pan, Huanlin Wu, Bingxin Wu, Yukai Li, Xia Wang, Guoqing Liu, Xiaojing Dang and Danping Xu
    Citation:Trials 2019 20:520
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  31. Content Type:Study Protocol

    Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revasc...
    Authors:Louisa J. D. van Dijk, Jihan Harki, Desirée van Noord, Hence J. M. Verhagen, Jeroen J. Kolkman, Robert H. Geelkerken, Marco J. Bruno and Adriaan Moelker
    Citation:Trials 2019 20:519
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  32. Content Type:Study Protocol

    Amnestic mild cognitive impairment (aMCI) is a syndrome characterized by significant forgetfulness that does not meet the criteria of dementia. Individuals with aMCI are at greater risk of progressing to demen...
    Authors:Shengnan Yue, Ting He, Baiyang Li, Yanqin Qu, Hongmei Peng, Jinxin Chen, Ming Lei, Chongli Chen and Wenbin Wu
    Citation:Trials 2019 20:518
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  33. Content Type:Study Protocol

    Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4% of the general population. Symptoms include frequent, loose, or watery stools with associated urgency, resulting in marked reduction of quality ...
    Authors:David Gunn, Ron Fried, Rabia Lalani, Amanda Farrin, Ivana Holloway, Tom Morris, Catherine Olivier, Rachael Kearns, Maura Corsetti, Mark Scott, Adam Farmer, Anton Emmanuel, Peter Whorwell, Yan Yiannakou, David Sanders, John Mclaughlin…
    Citation:Trials 2019 20:517
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  34. Content Type:Correction

    Following publication of the original article [1], the authors notified us of a few requested editions that were not implemented adequately during proofing. The publisher apologizes for the inconvenience cause...
    Authors:Juan Carlos Villar, Víctor Mauricio Herrera, Juan Guillermo Pérez Carreño, Eliana Váquiro Herrera, Yeny Zulay Castellanos Domínguez, Skarlet Marcell Vásquez, Zulma Milena Cucunubá, Nilda Graciela Prado and Yolanda Hernández
    Citation:Trials 2019 20:516
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    The original article was published in Trials 2019 20:431
  35. Content Type:Study Protocol

    Current population surveys suggest around 20% of Australians meet diagnostic criteria for an alcohol use disorder. However, only a minority seek professional help due to individual and structural barriers, suc...
    Authors:Dan I. Lubman, Jasmin Grigg, Victoria Manning, Kate Hall, Isabelle Volpe, Stephanie Dias, Amanda Baker, Petra K. Staiger, John Reynolds, Anthony Harris, Jonathan Tyler and David Best
    Citation:Trials 2019 20:515
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  36. Content Type:Study Protocol

    Zygomaticomaxillary complex (ZMC) and zygomatic arch (ZA) fractures are common injuries resulting from facial trauma and frequently require surgical management (Huang et al., Craniomaxillofac Trauma Reconstr 8...
    Authors:Andrew Higgins, Michael Hurrell, Richard Harris, Geoffrey Findlay, Michael David and Martin Batstone
    Citation:Trials 2019 20:514
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  38. Content Type:Study Protocol

    Obesity is a major public health problem in recent decades. The accumulation of excessive fat promotes inflammatory status. Meanwhile, herbal products are marketed for their weight-loss properties, such as Nigell...
    Authors:Elham Razmpoosh, Sara Safi, Mahta Mazaheri, Amin Salehi-Abargouei, Nooshin Abdollahi, Majid Nazari, Hossein Fallahzadeh and Azadeh Nadjarzadeh
    Citation:Trials 2019 20:512
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  39. Content Type:Study Protocol

    Growth restriction in the newborn (GRN) can predispose to severe complications including hypoglycemia, sepsis, and necrotizing enterocolitis. Different interventions and treatments, such as feeding strategies,...
    Authors:Martine Knol, Helena Wang, Frank Bloomfield, Tabitha Piet, Stefanie Damhuis, Asma Khalil, Wessel Ganzevoort and Sanne Gordijn
    Citation:Trials 2019 20:511
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  40. Content Type:Study Protocol

    Opioids and acetaminophen are both widely used to relieve pain after non-operative treatment of limb fractures, but evidence for the superiority of opioids versus acetaminophen is lacking. In this study, we ai...
    Authors:Tao Gao, Hongyi Zhu, Changqing Zhang, Yimin Chai, Cheng Guo, Xiaozhong Zhu, Bingbo Bao, Xingwei Li, Junqing Lin and Xianyou Zheng
    Citation:Trials 2019 20:510
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  41. Content Type:Study Protocol

    E-mental health has become increasingly popular in interventions for individuals with eating disorders (EDs). It has the potential to offer low-threshold interventions and guide individuals to the needed care ...
    Authors:Pieter J. Rohrbach, Alexandra E. Dingemans, Philip Spinhoven, Elske Van den Akker-Van Marle, Joost R. Van Ginkel, Marjolein Fokkema, Markus Moessner, Stephanie Bauer and Eric F. Van Furth
    Citation:Trials 2019 20:509
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  42. Content Type:Study Protocol

    Beneficial effects of placebos are high in double-blind hot flush trials. Studies in various conditions suggest that honestly prescribed placebos may elicit symptom improvement.
    Authors:Yiqi Pan, Ramona Meister, Bernd Löwe, Anne Winkelmann, Ted J. Kaptchuk, Kai J. Buhling and Yvonne Nestoriuc
    Citation:Trials 2019 20:508
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  43. Content Type:Study Protocol

    Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource ...
    Authors:
    Citation:Trials 2019 20:507
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  44. Content Type:Research

    The AMBER (Assessment, Management, Best Practice, Engagement, Recovery Uncertain) care bundle is a complex intervention used in UK hospitals to support patients with uncertain recovery. However, it has yet to ...
    Authors:J. Koffman, E. Yorganci, D. Yi, W. Gao, F. Murtagh, A. Pickles, S. Barclay, H. Johnson, R. Wilson, L. Sampson, J. Droney, M. Farquhar, T. Prevost and C. J. Evans
    Citation:Trials 2019 20:506
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  45. Content Type:Research

    Public health systems in resource-constrained settings have a critical role to play in the elimination of HIV transmission but are often financially constrained. This study is an evaluation of a mother-infant-...
    Authors:Sydney Chauwa Phiri, Sandra Mudhune, Margaret L. Prust, Prudence Haimbe, Hilda Shakwelele, Tina Chisenga, Mwangelwa Mubiana-Mbewe, Maureen Mzumara, Elizabeth McCarthy and Marta R. Prescott
    Citation:Trials 2019 20:505
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  46. Content Type:Study Protocol

    Radiation-induced dysphagia is common in patients with head and neck cancer (HNC). Available evidence suggests that exercise therapy prior to oncological treatment could potentially improve deglutition and qua...
    Authors:Anna Guillen-Sola, Neus Bofill Soler, Ester Marco, Oscar Pera-Cegarra and Palmira Foro
    Citation:Trials 2019 20:503
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