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  1. Content type: Study protocol

    Depressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, remission rates are low. Without early treatment, de...

    Authors: Martin Holtmann, Laura Mokros, Inken Kirschbaum-Lesch, Michael Kölch, Paul L. Plener, Christian Ruckes, Michael Schulte-Markwort and Tanja Legenbauer

    Citation: Trials 2018 19:568

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  2. Content type: Study protocol

    Video clinics, where patients can have a hospital appointment with their clinician from home, are emerging in practice, but their effectiveness is unclear. This study will evaluate whether a video clinic imple...

    Authors: Elaine O’Connell Francischetto, Sarah Damery, James Ferguson and Gill Combes

    Citation: Trials 2018 19:574

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  3. Content type: Study protocol

    Although children have historically been excluded from clinical trials (CTs), many require medicines tested and approved in CTs, forcing health care providers to treat their pediatric patients based on extrapo...

    Authors: Lauren E Kelly, Michele P Dyson, Nancy J Butcher, Robert Balshaw, Alex John London, Christine J Neilson, Anne Junker, Salaheddin M Mahmud, S Michelle Driedger and Xikui Wang

    Citation: Trials 2018 19:572

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  4. Content type: Study protocol

    Amnestic mild cognitive impairment (aMCI) is considered a risk state for the development of dementia due to Alzheimer’s disease. It is also a period in which interventions may be most effective in slowing prog...

    Authors: Liselotte De Wit, Deirdre O’Shea, Melanie Chandler, Tripti Bhaskar, Jared Tanner, Prashanthi Vemuri, Julia Crook, Miranda Morris and Glenn Smith

    Citation: Trials 2018 19:573

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  5. Content type: Study protocol

    Chronic obstructive pulmonary disease (COPD) is the end result of a susceptible individual being exposed to sufficiently deleterious environmental stimuli. More than 90% of COPD-related deaths occur in low- an...

    Authors: Trishul Siddharthan, Suzanne L Pollard, Shumonta A Quaderi, Andrew J Mirelman, Maria Kathia Cárdenas, Bruce Kirenga, Natalie A Rykiel, J Jaime Miranda, Laxman Shrestha, Ram K Chandyo, Adithya Cattamanchi, Susan Michie, Julie Barber, William Checkley and John R Hurst

    Citation: Trials 2018 19:571

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  6. Content type: Study protocol

    The efficacy of attentional bias modification (ABM) as a treatment for anxiety and depression has been extensively studied with promising results. Despite some evidence of sleep-related attentional biases in i...

    Authors: Umair Akram, Bronwyn Milkins, Antonia Ypsilanti, John Reidy, Lambros Lazuras, Jodie Stevenson, Lies Notebaert and Nicola L. Barclay

    Citation: Trials 2018 19:567

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  7. Content type: Study protocol

    Attempts to design services to support the delivery of healthcare closer to home have taken various forms as countries respond to an increase in hospital admission rates for older people, who are at risk of ho...

    Authors: Petra Mäkelä, Mary Godfrey, Andrea Cradduck-Bamford, Graham Ellis and Sasha Shepperd

    Citation: Trials 2018 19:569

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  8. Content type: Research

    Peripheral intravenous catheters (PVCs) are essential invasive devices, with 2 billion PVCs sold each year. The comparative efficacy of expert versus generalist inserter models for successful PVC insertion and...

    Authors: Nicole Marsh, Joan Webster, Emily Larsen, Jodie Genzel, Marie Cooke, Gabor Mihala, Sue Cadigan and Claire M Rickard

    Citation: Trials 2018 19:564

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  9. Content type: Study protocol

    Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., A...

    Authors: Romy Scholz, Johannes Lemcke, Ullrich Meier and Dirk Stengel

    Citation: Trials 2018 19:566

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  10. Content type: Study protocol

    In the Swedish population aged between 50 and 64 years only 7.1% reach the recommended level of physical activity. Physical activity on prescription (PAP) has been used in Sweden since the beginning of the twe...

    Authors: Peter Nymberg, Eva Ekvall Hansson, Emelie Stenman, Susanna Calling, Kristina Sundquist, Jan Sundquist and Bengt Zöller

    Citation: Trials 2018 19:563

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  11. Content type: Study protocol

    To date, there is no consensus on the ideal management strategy of patients with poor ovarian response (POR) to controlled ovarian stimulation (COS) for in vitro fertilization (IVF). Currently, these patients ...

    Authors: Léa Delbos, Elsa Parot-Schinkel, Hady El Hachem, Guillaume Legendre, Philippe Descamps, Lisa Boucret, Véronique Ferré-L’Hotellier, Pauline Jeanneteau, Cécile Dreux, Catherine Morinière, Pascale May-Panloup and Pierre-Emmanuel Bouet

    Citation: Trials 2018 19:565

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  12. Content type: Study protocol

    Malaria remains a critical public health problem in Southeast Asia despite intensive containment efforts. The continued spread of multi-drug-resistant Plasmodium falciparum has led to calls for malaria eliminatio...

    Authors: Jessica Manning, Chanthap Lon, Michele Spring, Mariusz Wojnarski, Sok Somethy, Soklyda Chann, Panita Gosi, Kin Soveasna, Sabaithip Sriwichai, Worachet Kuntawunginn, Mark M Fukuda, Philip L Smith, Huy Rekol, Muth Sinoun, Mary So, Jessica Lin…

    Citation: Trials 2018 19:558

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  13. Content type: Study protocol

    Chronic migraine is a chronic medical condition associated with resistance to pharmacological treatment and poor benefits from the psychological interventions studied to date, including acceptance and commitme...

    Authors: Giovanni Mansueto, Francesco De Cesaris, Pierangelo Geppetti and Fiammetta Cosci

    Citation: Trials 2018 19:561

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  14. Content type: Research

    Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution...

    Authors: Diane Whitham, Julie Turzanski, Lucy Bradshaw, Mike Clarke, Lucy Culliford, Lelia Duley, Lisa Shaw, Zoe Skea, Shaun P. Treweek, Kate Walker, Paula R. Williamson and Alan A. Montgomery

    Citation: Trials 2018 19:557

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  15. Content type: Study protocol

    In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to add...

    Authors: Kim Wright, Alyson Dodd, Fiona C Warren, Antonieta Medina-Lara, Rod Taylor, Steven Jones, Christabel Owens, Mahmood Javaid, Barney Dunn, Julie E Harvey, Alexandra Newbold and Tom Lynch

    Citation: Trials 2018 19:560

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  16. Content type: Research

    Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collec...

    Authors: Kate F. Walker, Julie Turzanski, Diane Whitham, Alan Montgomery and Lelia Duley

    Citation: Trials 2018 19:562

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  17. Content type: Study protocol

    Acupuncture has been widely applied in the clinic to treat irritable bowel syndrome (IBS), but the underlying mechanism remains unknown. Diffuse noxious inhibitory control (DNIC) is deficient in patients with ...

    Authors: Yanhui Peng, Hui You, Xiaoman Chen, Yanbing Chen, Yiling Yang, Jianpeng Huang, Nenggui Xu and Jianhua Liu

    Citation: Trials 2018 19:559

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  18. Content type: Correction

    Following publication of the original article [1], the authors requested a correction be made, indicating L. Bates as the first author only. There is no joint first authorship.

    Authors: Laura A. Bates, Joseph P. Hicks, John Walley and Emily Robinson

    Citation: Trials 2018 19:556

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    The original article was published in Trials 2018 19:420

  19. Content type: Study protocol

    Tinnitus is a highly prevalent symptom affecting 10–15% of the adult population. It often affects patient quality of life and frequently causes distress. When subjective tinnitus can be elicited by the somatos...

    Authors: Sarah Michiels, Annemarie Christien van der Wal, Evelien Nieste, Paul Van de Heyning, Marc Braem, Corine Visscher, Vedat Topsakal, Annick Gilles, Laure Jacquemin, Marianne Hesters and Willem De Hertogh

    Citation: Trials 2018 19:554

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  20. Content type: Study protocol

    Recent data suggest that 10–20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decl...

    Authors: Cédric Gil-Jardiné, Samantha Al Joboory, Juliane Tortes Saint Jammes, Guillaume Durand, Régis Ribéreau-Gayon, Michel Galinski, Louis-Rachid Salmi, Philippe Revel, Cyril Alexandre Régis, Guillaume Valdenaire, Emmanuel Poulet, Karim Tazarourte and Emmanuel Lagarde

    Citation: Trials 2018 19:555

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  22. Content type: Study protocol

    Cardiovascular diseases (CVDs) increasingly contribute to morbidity and mortality in Tanzania. Public knowledge about CVD risk factors is important for the primary prevention of CVDs and can be improved throug...

    Authors: Alfa J Muhihi, David P Urassa, Rose N M Mpembeni, Germana H Leyna, Bruno F Sunguya, Deodatus Kakoko, Anna Tengia Kessy and Marina A Njelekela

    Citation: Trials 2018 19:552

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  23. Content type: Research

    In Traditional Chinese Medicine (TCM) theories, the typical clinical manifestations of gout are attributed to the “dampness-heat pouring downward.” Therefore, TCM practitioners always consider prescribing the ...

    Authors: Xiao Ning Yu, Hai Yan Wu, Yuan Ping Deng, Guang Tong Zhuang, Bang Huan Tan, Yan Zhou Huang, Shi Yun Tang, Xiang Tu, James B Jordan and Sen Zhong

    Citation: Trials 2018 19:551

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  24. Content type: Study protocol

    Children and young people of parents with mental illness (COPMI) are at risk of poor mental, physical and emotional health, which can persist into adulthood. They also experience poorer social outcomes and wel...

    Authors: Judith Gellatly, Penny Bee, Lina Gega, Peter Bower, Diane Hunter, Paul Stewart, Nicky Stanley, Rachel Calam, Kim Holt, Miranda Wolpert, Simon Douglas, Jonathan Green, Adekeye Kolade, Craig Callender and Kathryn M Abel

    Citation: Trials 2018 19:550

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  25. Content type: Study protocol

    The World Health Organization recommends rapid (≤ 7 days) or same-day initiation of antiretroviral treatment (ART) for HIV-positive patients. South Africa adopted this recommendation in 2017, but multiple clin...

    Authors: S Rosen, M Maskew, A T Brennan, M P Fox, L Vezi, P D Ehrenkranz and W D F Venter

    Citation: Trials 2018 19:548

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  26. Content type: Study protocol

    Endoscopic ultrasonography (EUS)-guided drainage has become the first-line therapy for late peri-pancreatic fluid collection (PFC). Double pigtail plastic stents (DPPS) and lumen-apposing metal stents (LAMS) a...

    Authors: Hui-Yun Zhu, Pei Xie, Ying-Xiao Song, Zhao-Shen Li, Zhen-Dong Jin and Yi-Qi Du

    Citation: Trials 2018 19:549

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  27. Content type: Study protocol

    Colorectal cancer screening participation is a preference-sensitive choice, in which trade-offs between benefits and harms must be made by individual citizens. Often the decision is made without any contact wi...

    Authors: Pernille Gabel, Mette Bach Larsen, Pia Kirkegaard, Adrian Edwards and Berit Andersen

    Citation: Trials 2018 19:543

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  28. Content type: Research

    A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target difference in the primary outcome between the r...

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

    Citation: Trials 2018 19:542

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  29. Content type: Study protocol

    There is a growing need for an evidence-based approach to home support for people with dementia and their carers following diagnosis but research on the effectiveness and cost-effectiveness of different approa...

    Authors: Helen Chester, Paul Clarkson, Linda Davies, Jane Hughes, Muhammad Saiful Islam, Narinder Kapur, Martin Orrell, Julie Peconi, Rosa Pitts, Fiona Poland, Ian Russell and David Challis

    Citation: Trials 2018 19:546

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  30. Content type: Study protocol

    Patients with major depression disorder presents increased rates of cognitive decline, reduced hippocampal volume, poor sleep quality, hypertension, obesity, suicidal ideation and behavior, and decreased funct...

    Authors: Lucas Melo Neves, Carla Silva-Batista, Raquel Marquesini, Telma Fátima da Cunha, Elisa Dimateo, Luciana Nascimento, Acácio Moreira-Neto, Angelo Corrêa de Lima Miliatto, Sheila das Chagas Mendes, Flavia Saad, Jamile Sanches Codogno, Renato Hoffmann Nunes, Raphael Mendes Ritti-Dias, Valeria Juday, Beny Lafer and Carlos Ugrinowitsch

    Citation: Trials 2018 19:545

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  31. Content type: Research

    When designing a randomised controlled trial (RCT), an important consideration is the sample size required. This is calculated from several components; one of which is the target difference. This study aims to...

    Authors: Joanne C. Rothwell, Steven A. Julious and Cindy L. Cooper

    Citation: Trials 2018 19:544

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  32. Content type: Study protocol

    Previous research has demonstrated the clinical effectiveness of long-term psychological treatment for people with some types of personality disorder. However, the high intensity and cost of these intervention...

    Authors: Mike J Crawford, Lavanya Thana, Jennie Parker, Oliver Turner, Kwek Pei Xing, Mary McMurran, Paul Moran, Timothy Weaver, Barbara Barrett, Amy Claringbold, Paul Bassett and Rahil Sanatinia

    Citation: Trials 2018 19:547

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  33. Content type: Review

    Clinical significance in a randomized controlled trial (RCT) can be determined using the minimal clinically important difference (MCID), which should inform the delta value used to determine sample size. The p...

    Authors: A. Fuchsia Howard, Karen Goddard, Shahrad Rod Rassekh, Osama A Samargandi and Haroon Hasan

    Citation: Trials 2018 19:539

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  34. Content type: Study protocol

    An increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China. However, the heterogeneity of outcomes and outc...

    Authors: Ruijin Qiu, Min Li, Xiaoyu Zhang, Shiqi Chen, Chengyu Li and Hongcai Shang

    Citation: Trials 2018 19:541

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  35. Content type: Study protocol

    Mobile Technology and Incentives (MOTIVES) is a randomized pilot study of a mobile technology-based and behavioral economics-supported HIV prevention intervention. Behavioral economics (BE) uses financial ince...

    Authors: Sebastian Linnemayr, Sarah MacCarthy, Alice Kim, Rebecca Giguere, Alex Carballo-Dieguez and Joanna L. Barreras

    Citation: Trials 2018 19:540

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  36. Content type: Study protocol

    Coronary heart disease (CHD) represents approximately 13% of deaths worldwide and is the leading cause of death in the UK with considerable associated health care costs. After a CHD event, timely cardiac rehab...

    Authors: Louisa Y Herring, Helen Dallosso, Sudesna Chatterjee, Danielle Bodicoat, Sally Schreder, Kamlesh Khunti, Tom Yates, Sam Seidu, Ian Hudson and Melanie J Davies

    Citation: Trials 2018 19:537

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  37. Content type: Study protocol

    Weight gain frequently occurs after smoking cessation (SC); the risk of new-onset diabetes mellitus increases for several years after SC. However, no large-scale, randomized controlled trials have examined the...

    Authors: Maki Komiyama, Yuka Ozaki, Hiromichi Wada, Hajime Yamakage, Noriko Satoh-Asahara, Tatsuya Morimoto, Akira Shimatsu, Yuko Takahashi and Koji Hasegawa

    Citation: Trials 2018 19:538

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  38. Content type: Study protocol

    Team-based care has been identified as a key component in transforming primary care. An important factor in implementing team-based care is the requirement for teams to have daily huddles. During huddles, the ...

    Authors: Megan E. Branda, Aravind Chandrasekaran, Marc D. Tumerman, Nilay D. Shah, Peter Ward, Bradley R. Staats, Theresa M. Lewis, Diane K. Olson, Rachel Giblon, Michelle A. Lampman and David R. Rushlow

    Citation: Trials 2018 19:536

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  39. Content type: Research

    There are more than a quarter of a million individuals aged ≥ 65 years who are resident in care homes in England and Wales. Care home residents have high levels of cognitive impairment, physical disability, mu...

    Authors: Alison Ellwood, Jennifer Airlie, Robert Cicero, Bonnie Cundill, David R Ellard, Amanda Farrin, Mary Godfrey, Liz Graham, John Green, Vicki McLellan, Najma Siddiqi and Anne Forster

    Citation: Trials 2018 19:535

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  40. Content type: Update

    Palmoplantar pustulosis (PPP) is a rare, chronic inflammatory skin disease. It is known to affect quality of life at a level comparable to that from major medical and psychiatric illness, yet current treatment...

    Authors: Suzie Cro, Catherine Smith, Rosemary Wilson and Victoria Cornelius

    Citation: Trials 2018 19:534

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    The Study protocol to this article has been published in Trials 2018 19:465

  41. Content type: Study protocol

    Forty percent of babies who are stillborn born die after 36 weeks gestation and have no lethal structural abnormality. Maternal perception of reduced fetal movement (RFM) is associated with stillbirth and is r...

    Authors: Lindsay Armstrong-Buisseret, Eleanor Mitchell, Trish Hepburn, Lelia Duley, Jim G. Thornton, Tracy E. Roberts, Claire Storey, Rebecca Smyth and Alexander E. P. Heazell

    Citation: Trials 2018 19:531

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  42. Content type: Research

    Following up released prisoners is demanding, particularly for those prisoners with mental health problems, for whom stigma and chaotic lifestyles are problematic. Measurement of mental health outcomes after r...

    Authors: Cath Quinn, Richard Byng, Deborah Shenton, Cordet Smart, Susan Michie, Amy Stewart, Rod Taylor, Mike Maguire, Tirril Harris and Jenny Shaw

    Citation: Trials 2018 19:530

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  43. Content type: Commentary

    Acute severe haemorrhage is a common complication of injury, childbirth, surgery, gastrointestinal pathologies and other medical conditions. Bleeding is a major cause of death, but patients also die from non-b...

    Authors: Amy Brenner, Monica Arribas, Jack Cuzick, Vipul Jairath, Simon Stanworth, Katharine Ker, Haleema Shakur-Still and Ian Roberts

    Citation: Trials 2018 19:533

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  44. Content type: Study protocol

    The gap between the supply and demand of organ donors is substantial, causing patients to suffer from long waiting times. Moreover, the lack of registrations places a burden on family members and medical profe...

    Authors: Esther Steenaart, Rik Crutzen, Math J J M Candel and Nanne K de Vries

    Citation: Trials 2018 19:532

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  45. Content type: Study protocol

    Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. A global perspective given by the World Gastroenterology...

    Authors: Li-xia Pei, Hao Geng, Hao Chen, Xiao-liang Wu, Lu Chen, Jun-ling Zhou, Lu Ju, Gao Lu, Wan-li Xu, Shan Qin, Jing Guo, Eun Mee Yang and Jian-hua Sun

    Citation: Trials 2018 19:529

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  46. Content type: Study protocol

    Acute pain is always the most common complaint in Emergency Department admissions and options for analgesia are limited. Nitrous oxide/oxygen possess many properties showing it may be an ideal analgesic method...

    Authors: Lu-Lu Gao, Li-Shan Yang, Jun-Jun Zhang, Yi-Ling Wang, Ke Feng, Lei Ma, Yuan-Yuan Yu, Qiang Li, Qing-Huan Wang, Jin-Tao Bao, Ya-Liang Dai, Qiang Liu, Yu-Xiang Li and Qiang-Jian Yu

    Citation: Trials 2018 19:527

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  47. Content type: Study protocol

    Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and sometimes irreversible neurotoxic symptom that occurs in 30–40% of chemotherapy-treated cancer patients. CIPN negatively affect...

    Authors: Chang eun Jang, Mi Sook Jung, Eun Hee Sohn, Mijung Kim, Hwa-Seung Yoo, Kyeore Bae, Je Ryong Kim and Jin Sun Lee

    Citation: Trials 2018 19:526

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  48. Content type: Research

    Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is equally crucial that patients are given the opportunity to make a well-informed decision about par...

    Authors: Pia Dellson, Kerstin Nilsson, Helena Jernström and Christina Carlsson

    Citation: Trials 2018 19:528

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  49. Content type: Study protocol

    Congenital diaphragmatic hernia is an orphan disease with high neonatal mortality and significant morbidity. An important cause for this is pulmonary hypertension, for which no effective postnatal therapy is a...

    Authors: Francesca Maria Russo, Alexandra Benachi, Tim Van Mieghem, Jan De Hoon, Kristel Van Calsteren, Pieter Annaert, Jean-Marc Tréluyer, Karel Allegaert and Jan Deprest

    Citation: Trials 2018 19:524

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  50. Content type: Study protocol

    There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availabili...

    Authors: Monica Taljaard, Charles Weijer, Jeremy M. Grimshaw, Adnan Ali, Jamie C. Brehaut, Marion K. Campbell, Kelly Carroll, Sarah Edwards, Sandra Eldridge, Christopher B. Forrest, Bruno Giraudeau, Cory E. Goldstein, Ian D. Graham, Karla Hemming, Spencer Phillips Hey, Austin R. Horn…

    Citation: Trials 2018 19:525

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