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  1. Content type: Study protocol

    Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilizat...

    Authors: Enrique Lluch-Girbés, Lirios Dueñas, Silvia Mena-del Horno, Alejandro Luque-Suarez, Santiago Navarro-Ledesma and Adriaan Louw

    Citation: Trials 2019 20:498

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  2. Content type: Study protocol

    Chronic spinal cord injury (SCI) increases morbidity and mortality associated with cardiometabolic diseases, secondary to increases in central adiposity, hyperlipidaemia and impaired glucose tolerance. While u...

    Authors: David W. McMillan, Jennifer L. Maher, Kevin A. Jacobs, Armando J. Mendez, Mark S. Nash and James L. J. Bilzon

    Citation: Trials 2019 20:497

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  3. Content type: Study protocol

    HIV-testing coverage remains below the targeted 90% despite efforts and resources invested. Home-based HIV-testing is a key approach endorsed by the World Health Organization (WHO), especially to reach individ...

    Authors: Alain Amstutz, Thabo Ishmael Lejone, Lefu Khesa, Josephine Muhairwe, Bienvenu Lengo Nsakala, Katleho Tlali, Moniek Bresser, Fiona Vanobberghen, Mathebe Kopo, Mpho Kao, Thomas Klimkait, Manuel Battegay, Niklaus Daniel Labhardt and Tracy Renée Glass

    Citation: Trials 2019 20:496

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  4. Content type: Study protocol

    Although anterior cruciate ligament (ACL) tear-prevention programs may be effective in the (secondary) prevention of a subsequent ACL injury, little is known, yet, on their effectiveness and feasibility. This ...

    Authors: Daniel Niederer, Matthias Keller, Andrea Achtnich, Ralph Akoto, Atesch Ateschrang, Winfried Banzer, Alexander Barié, Raymond Best, Andree Ellermann, Andreas Fischer, Daniel Guenther, Mirco Herbort, Jürgen Höher, Maren Janko, Tobias M. Jung, Matthias Krause…

    Citation: Trials 2019 20:495

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  6. Content type: Research

    Qualitative research has been used to explore patients’ and healthcare professionals’ experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline par...

    Authors: Emma Elizabeth Phelps, Elizabeth Tutton, Xavier Griffin and Janis Baird

    Citation: Trials 2019 20:492

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  7. Content type: Study protocol

    Recurrent stroke is a major contributor to stroke-related disability and costs. Improving health-risk behaviours and mental health has the potential to significantly improve recovery, enhance health-related qu...

    Authors: Ashleigh Guillaumier, Sam McCrabb, Neil J. Spratt, Michael Pollack, Amanda L. Baker, Parker Magin, Alyna Turner, Christopher Oldmeadow, Clare Collins, Robin Callister, Chris Levi, Andrew Searles, Simon Deeming, Olivia Wynne, Alexandra M. J. Denham, Brigid Clancy…

    Citation: Trials 2019 20:491

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  8. Content type: Study protocol

    Partial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (P...

    Authors: Kazuto Shibuya, Jin-Young Jang, Sohei Satoi, Masayuki Sho, Suguru Yamada, Manabu Kawai, Hongbeom Kim, Song Cheol Kim, Jin Seok Heo, Yoo-Seok Yoon, Joon Seong Park, Ho Kyoung Hwang, Isaku Yoshioka, Toshio Shimokawa, Hiroki Yamaue and Tsutomu Fujii

    Citation: Trials 2019 20:490

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  9. Content type: Study protocol

    Human papilloma viruses (HPVs) infect squamous epithelial cells and form verrucous lesions, or warts. Besides the psychosocial problems caused by the disfiguring warts, a subset of HPVs can be the primary etio...

    Authors: Takashi Nomura, Eriko Sumi, Gyohei Egawa, Saeko Nakajima, Eiko Toichi, Ryuji Uozumi, Harue Tada, Takayuki Nakagawa, Masatoshi Hagiwara and Kenji Kabashima

    Citation: Trials 2019 20:489

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  10. Content type: Study protocol

    The objective of this study is to evaluate the effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health-related quality of life (HRQoL) and direct cost of treatme...

    Authors: Atta Abbas Naqvi, Mohamed Azmi Hassali, Syed Baqir Shyum Naqvi and Muhammad Tariq Aftab

    Citation: Trials 2019 20:488

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  11. Content type: Study protocol

    The underlying mechanisms of non-specific chronic neck pain relapses are not clear, but they could be associated with a deficit and alteration of neck muscles propioception that play a decisive role in cervica...

    Authors: Carlos Bernal-Utrera, Juan José González-Gerez, Manuel Saavedra-Hernandez, Miguel Ángel Lérida-Ortega and Cleofás Rodríguez-Blanco

    Citation: Trials 2019 20:487

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  12. Content type: Study protocol

    The treatment of mental health issues among people living with HIV (PLH) in Botswana is yet to be addressed. A recent study revealed that depressive symptoms are highly prevalent in a sample of PLH in Botswana...

    Authors: Boitumelo Vavani, Vivian Kraaij, Phillip Spinhoven and Nadia Garnefski

    Citation: Trials 2019 20:486

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  14. Content type: Study protocol

    African Americans have a disproportionate prevalence and incidence of type 2 diabetes compared with Caucasians. Recent evidence indicates that low cardiorespiratory fitness (CRF) level, an independent risk fac...

    Authors: Joshua E. McGee, Savanna G. Barefoot, Nicole R. Gniewek, Patricia M. Brophy, Angela Clark, Gabriel S. Dubis, Terence E. Ryan, Joseph A. Houmard, Paul Vos, Thomas D. Raedeke and Damon L. Swift

    Citation: Trials 2019 20:484

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  15. Content type: Study protocol

    Prolonged acute hospital stays are a major problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hos...

    Authors: Jane Walker, Katy Burke, Mark Toynbee, Maike van Niekerk, Chris Frost, Nicholas Magill, Simon Walker, Mark Sculpher, Ian R. White and Michael Sharpe

    Citation: Trials 2019 20:483

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  16. Content type: Study protocol

    Neuralgic amyotrophy (NA) is a distinct peripheral neurological disorder of the brachial plexus with a yearly incidence of 1/1000, which is characterised by acute severe upper extremity pain. Weakness of the s...

    Authors: Renee Lustenhouwer, Nens van Alfen, Ian G. M. Cameron, Ivan Toni, Alexander C. H. Geurts, Rick C. Helmich, Baziel G. M. van Engelen and Jan T. Groothuis

    Citation: Trials 2019 20:482

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  17. Content type: Study protocol

    Autosomal dominant polycystic kidney disease (ADPKD) is one of the most common potentially life-threatening inherited kidney diseases. It is the fourth most common cause of end-stage renal disease requiring re...

    Authors: Jing Gan, Yansheng Wu, Xuezhong Gong, Yiyi Ma, Shengqiang Yu and Jiandong Gao

    Citation: Trials 2019 20:481

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  18. Content type: Study protocol

    Heel pain is a common foot disorder that causes pain and functional limitations. The prevalence of disabling foot pain will increase as the population ages. Previous studies have reported the positive therapeu...

    Authors: Lai Fun Ho, Yuanqi Guo, Jessica Yuet-Ling Ching, Kam Leung Chan, Ping Him Tsang, Man Hin Wong, Liyi Chen, Bacon Fung-Leung Ng and Zhi-Xiu Lin

    Citation: Trials 2019 20:480

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  19. Content type: Study protocol

    A disturbance in the early colonisation of the gut by microorganisms is associated with an aberrant innate immune system and a variety of clinical conditions later in life. Several factors are considered to in...

    Authors: Thomas H. Dierikx, Daniel J. C. Berkhout, Laura Visser, Marc A. Benninga, Guus Roeselers, Nanne K. H. de Boer, Johanna I. P. de Vries and Tim G. J. de Meij

    Citation: Trials 2019 20:479

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  20. Content type: Study protocol

    Mild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer’s disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necess...

    Authors: Jae-Hong Kim, Jae-Young Han, Gwang-Cheon Park and Jeong-Soon Lee

    Citation: Trials 2019 20:478

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  21. Content type: Update

    The WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metasta...

    Authors: Serigne N. Lo, Angela M. Hong, Lauren E. Haydu, Tasnia Ahmed, Elizabeth J. Paton, Victoria Steel, George Hruby, Anh Tran, Rachael L. Morton, Anna K. Nowak, Janette L. Vardy, Katharine J. Drummond, Haryana M. Dhillon, Catherine Mandel, Richard A. Scolyer, Mark R. Middleton…

    Citation: Trials 2019 20:477

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    The Study protocol to this article has been published in BMC Cancer 2011 11:142

  22. Content type: Update

    Chronic rejection is the single biggest cause of premature kidney graft failure. HLA antibodies (Ab) are an established prognostic biomarker for premature graft failure so there is a need to test whether treat...

    Authors: Dominic Stringer, Leanne M. Gardner, Janet L. Peacock, Irene Rebollo-Mesa, Rachel Hilton, Olivia Shaw, Richard Baker, Brendan Clark, Raj C. Thuraisingham, Matthew Buckland, Michael Picton, Judith Worthington, Richard Borrows, David Briggs, Sapna Shah, Kin Yee Shiu…

    Citation: Trials 2019 20:476

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    The Study protocol to this article has been published in Trials 2014 15:30

  23. Content type: Study protocol

    Humeral shaft fractures constitute around 1% of adult fractures in the UK, with an annual incidence of approximately 13 per 100,000 population. Historically, these injuries have been primarily managed non-oper...

    Authors: William M. Oliver, Thomas H. Carter, Catriona Graham, Timothy O. White, Nicholas D. Clement, Andrew D. Duckworth and Samuel G. Molyneux

    Citation: Trials 2019 20:475

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  24. Content type: Commentary

    Around two million adults in the UK have significantly impaired decision-making capacity. However, there are concerns that this population is under-represented in research, due in part to the challenges around...

    Authors: Victoria Shepherd, Fiona Wood, Richard Griffith, Mark Sheehan and Kerenza Hood

    Citation: Trials 2019 20:474

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  25. Content type: Study protocol

    Condom use can reduce the risk of infection by human papillomavirus (HPV). Furthermore, it has been suggested that condom use can increase the regression rate of cervical lesions. In Denmark, women with cervic...

    Authors: Malene Skorstengaard, Julie Suhr and Elsebeth Lynge

    Citation: Trials 2019 20:473

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  26. Content type: Study protocol

    There is increasing recognition of the need to stabilize sleep-wake cycles in individuals with major mental disorders. As such, clinicians and researchers advocate the use of interventions targeted at sleep an...

    Authors: Jan Scott, Knut Langsrud, Daniel Vethe, Kaia Kjørstad, Cecilie L. Vestergaard, Patrick Faaland, Stian Lydersen, Arne Vaaler, Gunnar Morken, Terje Torgersen and Håvard Kallestad

    Citation: Trials 2019 20:472

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  27. Content type: Study protocol

    Chronic tinnitus is a highly prevalent symptom, with many patients reporting considerable effects of tinnitus on quality of life. No clear evidence-based treatment options are currently available. While counse...

    Authors: E. Cardon, V. Van Rompaey, L. Jacquemin, G. Mertens, H. Vermeersch, I. Joossen, J. Beyers, O. M. Vanderveken, P. Van de Heyning, V. Topsakal and A. Gilles

    Citation: Trials 2019 20:471

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  28. Content type: Study protocol

    As a common cause of low back pain, lumbosacral disc herniation (LDH) is usually dealt with using non-surgical interventions. In the face of concerns about prescription opioid abuse, alternative and complement...

    Authors: Tian Li, Siyao Wang, Shen Zhang, Xueyong Shen, Yanwen Song, Zhen Yang and Zouqin Huang

    Citation: Trials 2019 20:470

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  29. Content type: Study protocol

    Muscle satellite cells (SCs) are crucial for muscle regeneration following muscle trauma. Acute skeletal muscle damage results in inflammation and the production of reactive oxygen species (ROS) which may be i...

    Authors: Konstantinos Papanikolaou, Dimitrios Draganidis, Athanasios Chatzinikolaou, Vassiliki C. Laschou, Kalliopi Georgakouli, Panagiotis Tsimeas, Alexios Batrakoulis, Chariklia K. Deli, Athanasios Z. Jamurtas and Ioannis G. Fatouros

    Citation: Trials 2019 20:469

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  31. Content type: Update

    Acute gastrointestinal (GI) bleeding is an important cause of mortality worldwide. Bleeding can occur from the upper or lower GI tract, with upper GI bleeding accounting for most cases. The main causes include...

    Authors: Amy Brenner, Adefemi Afolabi, Syed Masroor Ahmad, Monica Arribas, Rizwana Chaudhri, Timothy Coats, Jack Cuzick, Ian Gilmore, Christopher Hawkey, Vipul Jairath, Kiran Javaid, Aasia Kayani, Muttiullah Mutti, Muhammad Arif Nadeem, Haleema Shakur-Still, Simon Stanworth…

    Citation: Trials 2019 20:467

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  32. Content type: Study protocol

    Metabolic disorders (e.g., impaired glucose tolerance, insulin resistance, and type 2 diabetes) are more prevalent in people with spinal cord injury (SCI) than able-bodied individuals. Dietary modification is ...

    Authors: Ceren Yarar-Fisher, Jia Li, Amie McLain, Barbara Gower, Robert Oster and Casey Morrow

    Citation: Trials 2019 20:466

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  33. Content type: Study protocol

    Chronic obstructive pulmonary disease (COPD) is a common cause of chronic respiratory failure and its course is punctuated by a series of acute exacerbations which commonly lead to hospital admission. Exacerba...

    Authors: Nicholas A. Barrett, Eirini Kostakou, Nicholas Hart, Abdel Douiri and Luigi Camporota

    Citation: Trials 2019 20:465

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  34. Content type: Study protocol

    The rates of pre-diabetes and type 2 diabetes mellitus are increasing worldwide, producing significant burdens for individuals, families, and healthcare systems. In New Zealand, type 2 diabetes mellitus and pr...

    Authors: Christine Barthow, Fiona Hood, Eileen McKinlay, Jo Hilder, Christine Cleghorn, Mark Huthwaite, Mark Weatherall, Amber Parry-Strong, Sue Pullon, Ben Gray, Kristin Wickens, Julian Crane and Jeremy Krebs

    Citation: Trials 2019 20:464

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  35. Content type: Study protocol

    Differentiating infection from inflammation in acute pancreatitis is difficult, leading to overuse of antibiotics. Procalcitonin (PCT) measurement is a means of distinguishing infection from inflammation as le...

    Authors: Ajith K. Siriwardena, Santhalingam Jegatheeswaran, James M. Mason, Minas Baltatzis, Anthony Chan, Aali J. Sheen, Derek O’Reilly, Saurabh Jamdar, Rahul Deshpande, Nicola de Liguori Carino, Thomas Satyadas, Ahmed Qamruddin, Katharine Hayden, Michael J. Parker, John Butler, Azita Rajai…

    Citation: Trials 2019 20:463

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  36. Content type: Study protocol

    Acupuncture-balanced anesthesia has been found to offer protective benefits. Electrical stimulation at certain acupoints can potentially promote perioperative gastrointestinal function recovery. The purpose of...

    Authors: Yuantao Hou, Qi Yan, Haiyan An, Junlu Wang, Ming Tian, Wensheng Zhao, Anshi Wu and Yi Feng

    Citation: Trials 2019 20:462

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  37. Content type: Research

    Periodontal intrabony defects are usually treated surgically with the aim of increasing attachment and bone levels and reducing risk of progression. However, recent studies have suggested that a minimally inva...

    Authors: L. Nibali, V. Koidou, S. Salomone, T. Hamborg, R. Allaker, R. Ezra, L. Zou, G. Tsakos, N. Gkranias and N. Donos

    Citation: Trials 2019 20:461

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  38. Content type: Study protocol

    Sickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub-Saharan Africa where an estimated 50–90...

    Authors: Dibyadyuti Datta, Ruth Namazzi, Andrea L. Conroy, Sarah E. Cusick, Heather A. Hume, Abner Tagoola, Russell E. Ware, Robert O. Opoka and Chandy C. John

    Citation: Trials 2019 20:460

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  39. Content type: Research

    Venous leg ulcers (VLUs) can take many months to heal and 25% fail to heal. The main treatment for venous leg ulcers is compression therapy and few additional therapies exist. Two previous trials indicated tha...

    Authors: Tilbrook Helen, Cook Liz, Clark Laura, Sbizzera Illary, Bland Martin, Buckley Hannah, Chetter Ian, Dumville Jo, Fenner Chris, Forsythe Rachael, Gabe Rhian, Harding Keith, Layton Alison, Lindsay Ellie, Mc Daid Catriona, Moffatt Christine…

    Citation: Trials 2019 20:459

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  40. Content type: Research

    The term “nocebo effect” describes the phenomenon that the mere knowledge and anticipation of possible negative consequences of an intervention can increase the probability of experiencing these consequences. ...

    Authors: Barbara Prediger, Esther Meyer, Roland Büchter and Tim Mathes

    Citation: Trials 2019 20:458

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  41. Content type: Study protocol

    South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modificatio...

    Authors: Andrew Stephen Moriarty, Goedele Maria Louwagie, Noreen Dadirai Mdege, Neo Morojele, John Tumbo, Olufemi Babatunde Omole, Max Oscar Bachmann, Mona Kanaan, Astrid Turner, Steve Parrott, Kamran Siddiqi and Olalekan Abdulwahab Ayo-Yusuf

    Citation: Trials 2019 20:457

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  42. Content type: Study protocol

    Forty per cent of critically ill patients are affected by intensive care unit-acquired weakness (ICU-AW), to which skeletal muscle wasting makes a substantial contribution. This can impair outcomes in hospital...

    Authors: Ismita Chhetri, Julie E. A. Hunt, Jeewaka R. Mendis, Stephen D. Patterson, Zudin A. Puthucheary, Hugh E. Montgomery and Benedict C. Creagh-Brown

    Citation: Trials 2019 20:456

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  43. Content type: Study protocol

    The four-component capsular group B meningococcal vaccine (4CMenB) was introduced into the national immunisation schedule in the UK in September 2015 for infants in a 2 + 1 schedule at two, four and 12 months ...

    Authors: Kimberly Davis, Karen Ford, Rachel Craik, Ushma Galal, Christine S. Rollier and Andrew J. Pollard

    Citation: Trials 2019 20:455

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  44. Content type: Study protocol

    After root canal treatment, most tooth defects need to be restored. Onlay restoration is widely used to restore dental defects. Endocrown is a new type of onlay; however, dentists have yet to obtain a full und...

    Authors: Jieli Sun, Wenhao Ruan, Jiahui He, Xiaoyu Lin, Bowen Ci, Siye Yin and Wenjuan Yan

    Citation: Trials 2019 20:454

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  45. Content type: Research

    Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from pa...

    Authors: Kate Jolly, Manbinder Sidhu, Peter Bower and Vichithranie Madurasinghe

    Citation: Trials 2019 20:453

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  46. Content type: Study protocol

    Almost one-half of 12–15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions ...

    Authors: Zoe Marshman, Hannah Ainsworth, Ivor Gordon Chestnutt, Peter Day, Donna Dey, Sarab El Yousfi, Caroline Fairhurst, Fiona Gilchrist, Catherine Hewitt, Claire Jones, Ian Kellar, Sue Pavitt, Mark Robertson, Sarwat Shah, Katherine Stevens, David Torgerson…

    Citation: Trials 2019 20:452

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  47. Content type: Study protocol

    Surgical male circumcision (MC) safely reduces risk of female-to-male HIV-1 transmission by up to 60%. The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC witho...

    Authors: Caryl Feldacker, Vernon Murenje, Scott Barnhart, Sinokuthemba Xaba, Batsirai Makunike-Chikwinya, Isaac Holeman and Mufuta Tshimanga

    Citation: Trials 2019 20:451

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  48. Content type: Study protocol

    Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological e...

    Authors: Andrea Cortegiani, Federico Longhini, Annalisa Carlucci, Raffaele Scala, Paolo Groff, Andrea Bruni, Eugenio Garofalo, Maria Rita Taliani, Uberto Maccari, Luigi Vetrugno, Enrico Lupia, Giovanni Misseri, Vittoria Comellini, Antonino Giarratano, Stefano Nava, Paolo Navalesi…

    Citation: Trials 2019 20:450

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  49. Content type: Study protocol

    Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agr...

    Authors: Anna Lechner, Jan Kottner, Susanne Coleman, Delia Muir, Heather Bagley, Dimitri Beeckman, Wendy Chaboyer, Janet Cuddigan, Zena Moore, Claudia Rutherford, Jochen Schmitt, Jane Nixon and Katrin Balzer

    Citation: Trials 2019 20:449

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  50. Content type: Study protocol

    Mild cognitive impairment (MCI) is an intermediate phase between normal aging and dementia. Since a majority of amnestic MCI (aMCI) cases progress to Alzheimer’s disease (AD), it is considered the prodromal st...

    Authors: Hee-Yeon Shin, Jeong-Hwa Kim, Geon-Ho Jahng, Woo-Sang Jung, Seong-Uk Park, Chang-Nam Ko and Jung-Mi Park

    Citation: Trials 2019 20:448

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