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  1. Content type: Study protocol

    Lung dysfunction commonly occurs after cardiopulmonary bypass (CPB). Randomized evidence suggests that the presence of expiratory flow limitation (EFL) in major abdominal surgery is associated with postoperati...

    Authors: Elena Bignami, Savino Spadaro, Francesco Saglietti, Antonio Di Lullo, Francesca Dalla Corte, Marcello Guarnieri, Giulio de Simone, Ilaria Giambuzzi, Alberto Zangrillo and Carlo Alberto Volta

    Citation: Trials 2018 19:654

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  2. Content type: Study protocol

    There is now clear systematic review evidence that measurement can affect the people being measured; much of this evidence focusses on how asking people to complete a questionnaire can result in changes in beh...

    Authors: Lisa M. Miles, Diana Elbourne, Andrew Farmer, Martin Gulliford, Louise Locock, Jim McCambridge, Stephen Sutton and David P. French

    Citation: Trials 2018 19:653

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  3. Content type: Research

    Pain during labour is one of the most intense pain that women may experience in their lifetime. There are several non-pharmacological analgesic methods to relieve pain during labour, among them transcutaneous ...

    Authors: Aníbal Báez-Suárez, Estela Martín-Castillo, Josué García-Andújar, José Ángel García-Hernández, María P. Quintana-Montesdeoca and Juan Francisco Loro-Ferrer

    Citation: Trials 2018 19:652

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  4. Content type: Study protocol

    The rapid control of patients presenting to the emergency department (ED) with psychomotor agitation and violent behavior is paramount for the safety of patients and ED staff. The use of intramuscular (IM) ket...

    Authors: David Barbic, Gary Andolfatto, Brian Grunau, Frank X. Scheuermeyer, William MacEwan, William G. Honer, Hubert Wong and Skye P. Barbic

    Citation: Trials 2018 19:651

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  5. Content type: Study protocol

    Cryptococcal meningitis (CM) is a major cause of mortality in HIV programmes in Africa despite increasing access to antiretroviral therapy (ART). Mortality is driven in part by limited availability of amphoter...

    Authors: David S. Lawrence, Nabila Youssouf, Síle F. Molloy, Alexandre Alanio, Melanie Alufandika, David R. Boulware, Timothée Boyer-Chammard, Tao Chen, Francoise Dromer, Admire Hlupeni, William Hope, Mina C. Hosseinipour, Cecilia Kanyama, Oliver Lortholary, Angela Loyse, David B. Meya…

    Citation: Trials 2018 19:649

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    The Correction to this article has been published in Trials 2019 20:48

  6. Content type: Study protocol

    Mobile health (mHealth) interventions, using text messages to support high-school pupils to quit smoking, could be a novel and cost-effective approach. However, more research is needed, specifically to investi...

    Authors: Kristin Thomas, Marcus Bendtsen, Catharina Linderoth and Ulrika Müssener

    Citation: Trials 2018 19:648

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  7. Content type: Study protocol

    Raynaud’s phenomenon is one of the first clinical manifestations observed in systemic sclerosis (SSc). This microvasculature disorder affects mostly the digits in over 95% of SSc patients, significantly affect...

    Authors: Alexandros Mitropoulos, Anil Gumber, Helen Crank, Mohammed Akil and Markos Klonizakis

    Citation: Trials 2018 19:647

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  8. Content type: Study protocol

    Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increa...

    Authors: Katherine M. French, Sasha Z. Gonzalez, Scott E. Sherman, Alissa R. Link, Sadozai Zoe Malik, Chi-Hong Tseng, Saahil A. Jumkhawala, Briesny Tejada, Andrew White and Joseph A. Ladapo

    Citation: Trials 2018 19:646

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  9. Content type: Study protocol

    Despite the positive outcomes of the use of noninvasive positive pressure ventilation (NPPV) in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), NPPV fails in approximately 1...

    Authors: Zujin Luo, Chao Wu, Qi Li, Jian Zhu, Baosen Pang, Yan Shi, Yingmin Ma and Zhixin Cao

    Citation: Trials 2018 19:645

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  10. Content type: Study protocol

    At least 40% of people with psychosis have persistent distressing symptoms despite optimal medication treatment. Cognitive behaviour therapy for psychosis (CBTp) is the only NICE-recommended individual therapy...

    Authors: Kathryn Greenwood, Katie Alford, Iain O’Leary, Emmanuelle Peters, Amy Hardy, Kate Cavanagh, Andy P. Field, Richard de Visser, David Fowler, Matthew Davies, Alexandra Papamichail and Philippa Garety

    Citation: Trials 2018 19:644

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    The Correction to this article has been published in Trials 2018 19:677

  11. Content type: Study protocol

    Tubal ectopic pregnancy (tEP) is the most common life-threatening condition in gynaecology. Treatment options include surgery and medical management. Stable women with tEPs with pre-treatment serum human chori...

    Authors: James May, Colin Duncan, Ben Mol, Siladitya Bhattacharya, Jane Daniels, Lee Middleton, Catherine Hewitt, Arri Coomarasamy, Davor Jurkovic, Tom Bourne, Cecilia Bottomley, Alexandra Peace-Gadsby, Ann Doust, Stephen Tong and Andrew W. Horne

    Citation: Trials 2018 19:643

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  12. Content type: Research

    In recent years, experience on the application of adaptive designs in confirmatory clinical trials has accumulated. Although planning such trials comes at the cost of additional operational complexity, adaptiv...

    Authors: Olivier Collignon, Franz Koenig, Armin Koch, Robert James Hemmings, Frank Pétavy, Agnès Saint-Raymond, Marisa Papaluca-Amati and Martin Posch

    Citation: Trials 2018 19:642

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  13. Content type: Study protocol

    Caesarean sections (CSs) are associated with increased risk for maternal morbidity and mortality. The recommendations of the recently published German national health goal ‘Health in Childbirth’ (Gesundheit rund ...

    Authors: Gertrud M. Ayerle, Rainhild Schäfers, Elke Mattern, Sabine Striebich, Burkhard Haastert, Markus Vomhof, Andrea Icks, Yvonne Ronniger and Gregor Seliger

    Citation: Trials 2018 19:641

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  14. Content type: Study protocol

    Approximately 70,000 to 75,000 proximal femoral fracture repairs take place in the UK each year. Hemiarthroplasty is the preferred treatment for adults aged over 60 years. Postoperative infection affects up to...

    Authors: Michelle Kümin, Christopher Mark Harper, Mike Reed, Stephen Bremner, Nicky Perry and Matthew Scarborough

    Citation: Trials 2018 19:640

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  15. Content type: Study protocol

    Elderly people represent the majority of stroke cases worldwide. Post-stroke sequelae frequently lead to a more isolated life. Restricted social relations render older individuals with stroke a vulnerable grou...

    Authors: Hanne Pallesen, Erhard Trillingsgaard Næss-Schmidt, Simon Svanborg Kjeldsen, Sedsel Kristine Stage Pedersen, Susanne Lillelund Sørensen, Iris Brunner and Jørgen Feldbæk Nielsen

    Citation: Trials 2018 19:639

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  16. Content type: Update

    About 15% of patients fail to achieve a satisfactory clinical outcome following knee replacement, which may indicate the existing model of rehabilitation after surgery is possibly not the most efficacious. The...

    Authors: Karan Vadher, Ruth Knight, Karen L. Barker and Susan J. Dutton

    Citation: Trials 2018 19:638

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    The Study protocol to this article has been published in Trials 2016 17:501

  17. Content type: Study protocol

    In patients with septic shock, the presence of an elevated heart rate (HR) after fluid resuscitation marks a subgroup of patients with a particularly poor prognosis. Several studies have shown that HR control ...

    Authors: Martin Unger, Andrea Morelli, Mervyn Singer, Peter Radermacher, Sebastian Rehberg, Helmut Trimmel, Michael Joannidis, Gottfried Heinz, Vladimír Cerny, Pavel Dostál, Christian Siebers, Fabio Guarracino, Francesca Pratesi, Gianni Biancofiore, Massimo Girardis, Pavla Kadlecova…

    Citation: Trials 2018 19:637

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  18. Content type: Update

    Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are s...

    Authors: Daniel Sganzerla, Cassiano Teixeira, Caroline Cabral Robinson, Renata Kochhann, Mariana Martins Siqueira Santos, Rafaela Moraes de Moura, Mirceli Goulart Barbosa, Daiana Barbosa da Silva, Tarissa Ribeiro, Cláudia Eugênio, Daniel Schneider, Débora Mariani, Rodrigo Wiltgen Jeffman, Fernando Bozza, Alexandre Biasi Cavalcanti, Luciano Cesar Pontes Azevedo…

    Citation: Trials 2018 19:636

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  19. Content type: Study protocol

    Whiplash-associated disorders (WAD) as a consequence of a motor vehicle crash are a costly health burden in Western societies. Up to 50% of injured people do not fully recover. There have been numerous clinica...

    Authors: Annick Maujean, Linda Carroll, Michele Curatolo, James Elliott, Helge Kasch, David Walton and Michele Sterling

    Citation: Trials 2018 19:635

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  20. Content type: Study protocol

    Excessive hepatic fat is associated with increased metabolic risk factors, production of inflammatory factors, and oxidative stress. High protein intake might trigger an increased hepatic lipid oxidation throu...

    Authors: Fatemeh Haidari, Abdollah Hojhabrimanesh, Bizhan Helli, Seyed Saeid Seyedian and Kambiz Ahmadi-Angali

    Citation: Trials 2018 19:634

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  21. Content type: Study protocol

    The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device.

    Authors: Sam Eldabe, Ashish Gulve, Simon Thomson, Ganesan Baranidharan, Rui Duarte, Susan Jowett, Harbinder Sandhu, Raymond Chadwick, Morag Brookes, Anisah Tariq, Jenny Earle, Jill Bell, Anu Kansal, Shelley Rhodes and Rod S. Taylor

    Citation: Trials 2018 19:633

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  22. Content type: Study protocol

    Polycystic ovary syndrome (PCOS) affects between 8 and 18% of women and is the leading cause of female anovulatory infertility. Unfortunately, common treatments for women trying to conceive can be ineffective ...

    Authors: Dylan A. Cutler, Alana K. Shaw, Sheila M. Pride, Mohamed A. Bedaiwy and Anthony P. Cheung

    Citation: Trials 2018 19:632

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  23. Content type: Study protocol

    The consumption of edible oils in China has increased rapidly in recent years, and the total amount of edible-oil intake in the country has ranked first in the world. The choice and intake of edible oils, as a...

    Authors: Rui Zhu, Xianglong Xu, Yong Zhao, Manoj Sharma and Zumin Shi

    Citation: Trials 2018 19:631

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  24. Content type: Commentary

    Recruitment of sufficient patients with Parkinson disease into clinical trials is a barrier to successful, timely study completion. Non-pharmacologic studies have shown to be even more challenging for recruitm...

    Authors: Deborah A. Hall, Charity Moore and Cynthia Comella

    Citation: Trials 2018 19:630

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  25. Content type: Study protocol

    This cluster-randomised monocentric controlled trial focuses on improving the uptake symptoms of mental health care in adolescents with chronic medical conditions who have been identified by screening to have ...

    Authors: Christina Reinauer, Rabea Viermann, Katharina Förtsch, Hannah Linderskamp, Petra Warschburger, Reinhard W. Holl, Doris Staab, Kirsten Minden, Rainer Muche, Matthias Domhardt, Harald Baumeister and Thomas Meissner

    Citation: Trials 2018 19:629

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  26. Content type: Study protocol

    Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening condition that results from a ruptured cerebral vessel. Cerebral edema and vasospasm are common complications and frequently require treatment wi...

    Authors: Ofer Sadan, Owen Samuels, William H. Asbury, John J. Hanfelt and Kai Singbartl

    Citation: Trials 2018 19:628

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  27. Content type: Study protocol

    Bronchiolitis is an acute lower respiratory infection which predominantly affects young children. Treatment for bronchiolitis is limited to supportive therapy. Nasal oxygen therapy is part of routine care, and...

    Authors: Clare van Miert, Ricardo M. Fernandes, Helen Eccleson, Emma Bedson, Steven Lane, Matthew Peak, Kent Thorburn, Vanessa Compton, Kerry Woolfall, David Lacy, Paula Williamson and Paul S. McNamara

    Citation: Trials 2018 19:627

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  28. Content type: Study protocol

    Severe, chronic, and impairing irritability is a common presenting clinical problem in youth. Indeed, it was recently operationalized as disruptive mood dysregulation disorder (DMDD) in the DSM-5. However, to ...

    Authors: Simone P. Haller, Joel Stoddard, Caroline MacGillivray, Kelsey Stiles, Gretchen Perhamus, Ian S. Penton-Voak, Yair Bar-Haim, Marcus R. Munafò and Melissa A. Brotman

    Citation: Trials 2018 19:626

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  29. Content type: Study protocol

    The expansion of digital devices and widespread access to the Internet has opened up opportunities to provide patients with more personal information. It can be hypothesized that eHealth in addition to standar...

    Authors: Dirk P. A. Versteegden, Magaly J. J. Van himbeeck and Simon W. Nienhuijs

    Citation: Trials 2018 19:625

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  30. Content type: Study protocol

    Postoperative pulmonary complications (PPCs) are frequent after on-pump cardiac surgery. Cardiac surgery results in a complex pulmonary insult leading to high susceptibility to perioperative pulmonary atelecta...

    Authors: David Lagier, François Fischer, William Fornier, Jean-Luc Fellahi, Pascal Colson, Bernard Cholley, Samir Jaber, Karine Baumstarck and Catherine Guidon

    Citation: Trials 2018 19:624

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  31. Content type: Study protocol

    Most smokers struggle to overcome tobacco addiction. Neuroscientific models of addiction emphasize the importance of brain regions associated with cognitive control and reward to understand the cycle of addict...

    Authors: Andrew T. Fox, Delwyn Catley, Kimber P. Richter, Edward F. Ellerbeck, Morgan G. Brucks, Vlad B. Papa and Laura E. Martin

    Citation: Trials 2018 19:623

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  32. Content type: Study protocol

    Premature ejaculation (PE) is the most common sexual dysfunction among men. According to patients, the general practitioner (GP) is the appropriate professional with whom to discuss this issue. However, few pa...

    Authors: Marie Barais, Hélène Vaillant Roussel, David Costa, Jérémy Derriennic, Bruno Pereira and Sébastien Cadier

    Citation: Trials 2018 19:622

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  33. Content type: Research

    Sharing interim result measures by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an important issue that can affect trial integrity. Currently, it is unclear if there are demographic factors...

    Authors: Victoria Borg Debono, Lawrence Mbuagbaw, James Paul, Norman Buckley and Lehana Thabane

    Citation: Trials 2018 19:621

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  34. Content type: Study protocol

    Community-acquired pneumonia, especially severe community-acquired pneumonia (SCAP), remains the leading cause of death in the world. Despite advances in antimicrobial therapy, the mortality rates due to SCAP ...

    Authors: Haifeng Wang, Jiansheng Li, Xueqing Yu and Su-yun Li

    Citation: Trials 2018 19:620

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  35. Content type: Study protocol

    Over 12,000 new cases of B-cell malignancies are diagnosed in the UK each year, with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) being the most common subtypes. Standard frontline therap...

    Authors: Sean H. Lim, Kim M. Linton, Graham P. Collins, Joke Dhondt, Joshua Caddy, Liz Rossiter, Karan Vadher, Keira Fines, Laura E. Rogers, Diana Fernando, Louise Stanton, Andrew J. Davies, Peter W. M. Johnson and Gareth Griffiths

    Citation: Trials 2018 19:619

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  36. Content type: Study protocol

    Smoking cessation is the most common preventative for an array of diseases, including lung cancer and chronic obstructive pulmonary disease. Although there are many efforts advocating for smoking cessation, sm...

    Authors: Santiago Hors-Fraile, Shwetambara Malwade, Dimitris Spachos, Luis Fernandez-Luque, Chien-Tien Su, Wei-Li Jeng, Shabbir Syed-Abdul, Panagiotis Bamidis and Yu-Chuan(Jack) Li

    Citation: Trials 2018 19:618

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  37. Content type: Study protocol

    A temporary loop ileostomy, which is used to decrease the risk of symptomatic anastamotic leakage after anterior resection and total mesorectal excision (TME), is traditionally closed without any mesh. However...

    Authors: Elisa Mäkäräinen-Uhlbäck, Heikki Wiik, Jyrki Kössi, Pasi Ohtonen and Tero Rautio

    Citation: Trials 2018 19:617

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  38. Content type: Study protocol

    At least half of all adult women will experience infective cystitis (urinary tract infection: UTI) at least once in their life and many suffer from repeated episodes. Recurrent urinary tract infection (rUTI) i...

    Authors: Rebecca Forbes, Ased Ali, Alaa Abouhajar, Catherine Brennand, Heather Brown, Sonya Carnell, Thomas Chadwick, Ian Eardley, Jan Lecouturier, Helen Mossop, Ian Pearce, Robert Pickard, Nikesh Thiruchelvam, Katherine Walton, Jennifer Wilkinson and Chris Harding

    Citation: Trials 2018 19:616

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  39. Content type: Research

    Mild cognitive impairment (MCI) is a phase in cognitive decline when it is still possible to intervene to reverse the decline. Cognitive stimulation delivered through psychosocial interventions provides both p...

    Authors: Rathi Mahendran, Mihir Gandhi, Rajesh Babu Moorakonda, Jonathan Wong, Madhu Mathi Kanchi, Johnson Fam, Iris Rawtaer, Alan Prem Kumar, Lei Feng and Ee Heok Kua

    Citation: Trials 2018 19:615

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  40. Content type: Study protocol

    Optimising the use of antibiotic agents is a pressing challenge to overcoming the rapid emergence and spread of multidrug-resistant pathogens in intensive care units (ICUs). Although Gram staining may possibly...

    Authors: Jumpei Yoshimura, Kazuma Yamakawa, Takahiro Kinoshita, Yoshinori Ohta and Takeshi Morimoto

    Citation: Trials 2018 19:614

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  41. Content type: Study protocol

    The mesenteric approach is an artery-first approach to pancreaticoduodenectomy for pancreatic cancer, which starts with the dissection of connective tissues around the superior mesenteric artery. The procedure...

    Authors: Seiko Hirono, Manabu Kawai, Ken-ichi Okada, Tsutomu Fujii, Masayuki Sho, Sohei Satoi, Ryosuke Amano, Hidetoshi Eguchi, Yuko Mataki, Masafumi Nakamura, Ippei Matsumoto, Hideo Baba, Masaji Tani, Yasunari Kawabata, Yuichi Nagakawa, Suguru Yamada…

    Citation: Trials 2018 19:613

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  42. Content type: Study protocol

    Intensive rehabilitation of patients with severe traumatic brain injury is generally applied in the subacute stages of the hospital stay. Few studies have assessed the association between early and intensive p...

    Authors: Christian Gunge Riberholt, Jane Lindschou, Christian Gluud, Jesper Mehlsen and Kirsten Møller

    Citation: Trials 2018 19:612

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  43. Content type: Study protocol

    Bipolar disorder (BD) and unipolar disorder (UD) are associated with cognitive deficits and abnormal neural activity in a “cognitive control network.” There is an increased prevalence of cognitive dysfunction ...

    Authors: Jeff Zarp Petersen, Lejla Sjanic Schmidt, Maj Vinberg, Martin Balslev Jørgensen, Ida Hageman, Hannelore Ehrenreich, Gitte Moos Knudsen, Lars Vedel Kessing and Kamilla Woznica Miskowiak

    Citation: Trials 2018 19:611

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  44. Content type: Study protocol

    Children hospitalised with severe anaemia in malaria endemic areas in Africa are at high risk of readmission or death within 6 months post-discharge. Currently, no strategy specifically addresses this period. ...

    Authors: Titus K. Kwambai, Aggrey Dhabangi, Richard Idro, Robert Opoka, Simon Kariuki, Aaron M. Samuels, Meghna Desai, Michael Boele van Hensbroek, Chandy C. John, Bjarne Robberstad, Duolao Wang, Kamija Phiri and Feiko O. ter Kuile

    Citation: Trials 2018 19:610

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  45. Content type: Study protocol

    The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on...

    Authors: Liam J. Convie, Scott McCain, Jeffrey Campbell, Stephen J. Kirk and Mike Clarke

    Citation: Trials 2018 19:609

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  46. Content type: Study protocol

    Low-dose aspirin (LDA) has been proposed as a safe and inexpensive prophylactic agent. Studies in European/Western populations have shown promising results indicating that LDA can reduce the occurrence of pre-...

    Authors: Li Lin, Yuchun Zhu, Boya Li and Huixia Yang

    Citation: Trials 2018 19:608

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  47. Content type: Study protocol

    Spontaneous intracerebral hemorrhage (ICH) is a serious threat to human health. Although early blood pressure (BP) elevation is closely associated with a poor prognosis, the optimal antihypertensive regimen fo...

    Authors: Rui Dong, Fen Li, Ying Xu, Pingyan Chen, Marc Maegele, Hong Yang and Wenjin Chen

    Citation: Trials 2018 19:607

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  48. Content type: Methodology

    A key step in the design of a RCT is the estimation of the number of participants needed in the study. The most common approach is to specify a target difference between the treatments for the primary outcome ...

    Authors: Jonathan A. Cook, Steven A. Julious, William Sones, Lisa V. Hampson, Catherine Hewitt, Jesse A. Berlin, Deborah Ashby, Richard Emsley, Dean A. Fergusson, Stephen J. Walters, Edward C. F. Wilson, Graeme Maclennan, Nigel Stallard, Joanne C. Rothwell, Martin Bland, Louise Brown…

    Citation: Trials 2018 19:606

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  49. Content type: Update

    Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. However, persistent pain after cholecystectomy for symptomatic cholecystolithiasis is reported in up to 40% of patients. The aim ...

    Authors: Sarah Z. Wennmacker, Aafke H. van Dijk, Joost P. H. Drenth, Sandra C. Donkervoort, Djamila Boerma, Gert P. Westert, Cornelis J. H. M. van Laarhoven, Marja A. Boermeester, Marcel G. W. Dijkgraaf and Philip R. de Reuver

    Citation: Trials 2018 19:604

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    The Study protocol to this article has been published in BMC Surgery 2016 16:46

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