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  1. Content type: Study protocol

    Postoperative pulmonary complications (PPC) and peri-operative myocardial infarction (MI) have a significant impact on the long-term mortality of surgical patients. Patients undergoing one-lung ventilation (OL...

    Authors: Murali Shyamsundar, Cecilia O’Kane, Gavin D. Perkins, Gavin Kennedy, Christina Campbell, Ashley Agus, Glenn Phair and Danny McAuley

    Citation: Trials 2018 19:690

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  2. Content type: Methodology

    Few papers discuss the pragmatics of conducting large, cluster randomized clinical trials. Here we describe the sequential steps taken to develop methods to implement the Randomized Evaluation of Sedation Titr...

    Authors: Martha A. Q. Curley, Rainer G. Gedeit, Brenda L Dodson, June K. Amling, Deborah J. Soetenga, Christiane O. Corriveau, Lisa A. Asario and David Wypij

    Citation: Trials 2018 19:687

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  3. Content type: Study protocol

    A wide range of prophylactic antibiotic regimens are used for patients undergoing open-heart cardiac surgery. This reflects clinical equipoise in choice and duration of antibiotic agents. Although individual-l...

    Authors: Rachel B. van Oostveen, Alberto Romero-Palacios, Richard Whitlock, Shun Fu Lee, Stuart Connolly, Alex Carignan, C. David Mazer, Mark Loeb and Dominik Mertz

    Citation: Trials 2018 19:688

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  4. Content type: Study protocol

    Accelerated partial breast irradiation (APBI) is a treatment option for selected early stage breast cancer patients. Some APBI techniques lead to skin toxicity with the skin dose as main risk factor. We hypoth...

    Authors: Gerson M. Struik, Jeremy Godart, Gerda M. Verduijn, Inger-Karine Kolkman-Deurloo, Kim C. de Vries, Raymond de Boer, Linetta B. Koppert, Erwin Birnie, Ali Ghandi, Taco M. Klem and Jean-Philippe Pignol

    Citation: Trials 2018 19:689

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  5. Content type: Study protocol

    Chronic low back pain (CLBP) is the most common chronic pain condition and is often resistant to conventional treatments. Acupuncture is a popular alternative for treating CLBP but its mechanisms of action rem...

    Authors: Jiang-Ti Kong, Brandon MacIsaac, Ruti Cogan, Amanda Ng, Christine Sze Wan Law, Joseph Helms, Rosa Schnyer, Nicholas Vasilis Karayannis, Ming-Chih Kao, Lu Tian, Beth D. Darnall, James J. Gross, Sean Mackey and Rachel Manber

    Citation: Trials 2018 19:685

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  6. Content type: Correction

    After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2].

    Authors: Carinne Brody, Sovannary Tuot, Pheak Chhoun, Dallas Swendenman, Kathryn C. Kaplan and Siyan Yi

    Citation: Trials 2018 19:686

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    The original article was published in Trials 2018 19:235

  7. Content type: Study protocol

    Alzheimer’s disease and related dementias (ADRD) impact a woman’s life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of famil...

    Authors: Nicole R. Fowler, Mara A. Schonberg, Greg A. Sachs, Peter H. Schwartz, Sujuan Gao, Kathleen A. Lane, Lev Inger and Alexia M. Torke

    Citation: Trials 2018 19:678

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  8. Content type: Study protocol

    Suspicion of acute myocardial infarction (AMI) is among the most common reasons for admission to hospital in Denmark. Owing to this suspicion, an estimated 50,000 patients are admitted every year. Only 15–20% ...

    Authors: Claus Kjær Pedersen, Carsten Stengaard, Hanne Søndergaard, Karen Kaae Dodt, Jakob Hjort, Morten Thingemann Bøtker and Christian Juhl Terkelsen

    Citation: Trials 2018 19:683

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  9. Content type: Study protocol

    A diagnosis of gestational diabetes (GDM) is associated with an over sevenfold increase in the risk of developing type 2 diabetes (T2D), while among parous women with T2D, up to 30% have a history of GDM. Life...

    Authors: Nithya Sukumar, Helen Dallosso, Ponnusamy Saravanan, Tom Yates, Carol Telling, Karen Shorthose, Alison Northern, Sally Schreder, Christopher Brough, Laura J. Gray, Melanie J. Davies and Kamlesh Khunti

    Citation: Trials 2018 19:682

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  10. Content type: Study protocol

    Elderly people have high rates of functional decline, which compromises independence, self-confidence, and quality of life (QoL). Physical exercise leads to significant improvements in strength, balance, funct...

    Authors: Glauber Sá Brandão, Luís Vicente Franco Oliveira, Glaudson Sá Brandão, Anderson Soares Silva, Antônia Adonis Callou Sampaio, Jessica Julioti Urbano, Alyne Soares, Newton Santos Faria Jr, Luisa Teixeira Pasqualotto, Ezequiel Fernandes Oliveira, Rodrigo Franco Oliveira, Deise A. A. Pires-Oliveira and Aquiles Assunção Camelier

    Citation: Trials 2018 19:684

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  11. Content type: Research

    We investigated the efficacy and safety of thread-embedding acupuncture (TEA) for chronic low back pain (LBP) in a randomized controlled pilot trial with the aim of laying the foundation for a large-scale rand...

    Authors: Hyun-Jong Lee, Byung Il Choi, Seungah Jun, Mu Seob Park, Se Jung Oh, Jung Hee Lee, Han Mi Gong, Jae Soo Kim, Young Joon Lee, So-Young Jung and Chang Hyun Han

    Citation: Trials 2018 19:680

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  12. Content type: Research

    Lozenges containing lidocaine and cetylpyridinium chloride (CPC) are commonly used for the treatment of sore throat. The lidocaine acts locally to provide pain relief and the CPC has an antiseptic effect. Mebu...

    Authors: Frank Donath, Pascal Mallefet, Stephen Garreffa and Rowland Furcha

    Citation: Trials 2018 19:679

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  13. Content type: Study protocol

    Despite recent technical advances in the management of acute kidney injury (AKI), such as continuous renal replacement therapy (CRRT), intensive care unit mortality is still high, at approximately 40 to 50%. A...

    Authors: Hyung Jung Oh, Jung Nam An, Sohee Oh, Harin Rhee, Jung Pyo Lee, Dong Ki Kim, Dong-Ryeol Ryu and Sejoong Kim

    Citation: Trials 2018 19:681

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  14. Content type: Correction

    Following publication of the original article [1], the authors reported a typing mistake in the spelling of author Iain O’Leary. The original article has been corrected.

    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 19:677

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    The original article was published in Trials 2018 19:644

  15. Content type: Study protocol

    Delirium is associated with a significantly increased risk of postoperative morbidity and mortality. Furthermore, delirium has been associated with an increased risk of prolonged cognitive deficits and acceler...

    Authors: Brian O’Gara, Edward R. Marcantonio, Alvaro Pascual-Leone, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed, Daniel Talmor and Balachundhar Subramaniam

    Citation: Trials 2018 19:676

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  16. Content type: Research

    Opioid use disorder is one of the most prevalent addiction problems worldwide. Buprenorphine is used as a medication to treat this disorder, but in countries where buprenorphine is unavailable in combination w...

    Authors: Jamshid Ahmadi, Mina Sefidfard Jahromi, Dara Ghahremani and Edythe D. London

    Citation: Trials 2018 19:675

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  17. Content type: Study protocol

    This study aims to evaluate the efficacy and safety of thread-embedding acupuncture (TEA) with polydioxanone thread embedded at various acupoints, compared with sham TEA, for the treatment of non-specific chro...

    Authors: Eunseok Kim, Hye Su Kim, So-Young Jung, Chang Hyun Han and Young-Il Kim

    Citation: Trials 2018 19:672

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  18. Content type: Study protocol

    Currently, the number of children living with HIV is the highest ever. This has led to an increased focus on a healthy life expectancy in this population. Improving oral health status may contribute to improve...

    Authors: Kimiyo Kikuchi, Junko Yasuoka, Sovannary Tuot, Sokunthea Yem, Pheak Chhoun, Sumiyo Okawa, Makoto Murayama, Chantheany Huot and Siyan Yi

    Citation: Trials 2018 19:673

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  19. Content type: Study protocol

    Low back pain (LBP) is a common cause of disability among U.S. military personnel. Approximately 20% of all diagnoses resulting in disability discharges are linked to back-related conditions. Because LBP can n...

    Authors: Robert Vining, Amy Minkalis, Cynthia R. Long, Lance Corber, Crystal Franklin, M. Ram Gudavalli, Ting Xia and Christine M. Goertz

    Citation: Trials 2018 19:671

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  20. Content type: Study protocol

    The aim of this open-label, randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic, and Senegal) is to compare three strategies of renutrition for moderate...

    Authors: Muriel Vray, Boris G. Hedible, Pierrick Adam, Laura Tondeur, Alexandre Manirazika, Rindra Randremanana, Halima Mainassara, André Briend, Cecile Artaud, Cassandre von Platen, Mathias Altmann and Ronan Jambou

    Citation: Trials 2018 19:666

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  21. Content type: Study protocol

    Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20...

    Authors: Angelos G. Kolias, Ellie Edlmann, Eric P. Thelin, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z. Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A. Anderson, Oliver Richards, Peter Whitfield, Monica Gherle, Karen Caldwell, Carol Davis-Wilkie…

    Citation: Trials 2018 19:670

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  22. Content type: Study protocol

    Complete lymph node removal through conventional axillary dissection (ALND) has been standard treatment for breast cancer patients for almost a century. In the 1990s, however, and in parallel with the advent o...

    Authors: Guido Henke, Michael Knauer, Karin Ribi, Stefanie Hayoz, Marie-Aline Gérard, Thomas Ruhstaller, Daniel R. Zwahlen, Simone Muenst, Markus Ackerknecht, Hanne Hawle, Florian Fitzal, Michael Gnant, Zoltan Mátrai, Bettina Ballardini, Andreas Gyr, Christian Kurzeder…

    Citation: Trials 2018 19:667

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  23. Content type: Study protocol

    Community-dwelling older persons with complex care needs may deteriorate rapidly and require hospitalisation if they receive inadequate support for their conditions in the community.

    Authors: Irina Kinchin, Susan Jacups, Jennifer Mann, Rachel Quigley, Desley Harvey, Christopher M. Doran and Edward Strivens

    Citation: Trials 2018 19:668

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  24. Content type: Study protocol

    In attempting to achieve optimal metabolic control, the day-to-day management is challenging for a child with type 1 diabetes (T1D) and his family and can have a major negative impact on their quality of life....

    Authors: Ulrike Schierloh, Gloria A. Aguayo, Muriel Fichelle, Cindy De Melo Dias, Aljosa Celebic, Michel Vaillant, Katharine Barnard, Ohad Cohen and Carine de Beaufort

    Citation: Trials 2018 19:665

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  25. Content type: Study protocol

    Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the pro...

    Authors: Zhi-hong Lu, Hai-long Dong, Jia-wen Huang-fu, Xiao-jian Fan, Wei-xian Zhao, Su Min, Wei Zhang, Ming-fu Liu, Yong-hui Wang, Li-ni Wang and Li-ze Xiong

    Citation: Trials 2018 19:669

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  26. Content type: Study protocol

    Obesity and the state of being overweight are increasing steadily and becoming a global epidemic. Recent research reports 64% of the adult population as overweight in Europe and the USA. The social and economi...

    Authors: Roberto Cattivelli, Gianluca Castelnuovo, Alessandro Musetti, Giorgia Varallo, Chiara A. M. Spatola, Francesco Vailati Riboni, Anna Guerrini Usubini, Fabio Tosolin, Gian Mauro Manzoni, Paolo Capodaglio, Alessandro Rossi, Giada Pietrabissa and Enrico Molinari

    Citation: Trials 2018 19:659

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  27. Content type: Study protocol

    Fibromyalgia and major depression frequently co-occur. Patients with both conditions have a worse prognosis and higher disability, and their treatment options are scarce. Behavioral activation (BA) may be an e...

    Authors: Lydia Gómez-Pérez, Alvaro Vergés, Ana Rocío Vázquez-Taboada, Josefina Durán and Matías González Tugas

    Citation: Trials 2018 19:660

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  28. Content type: Update

    In rural south Asia, hypertension remains a significant public health issue with sub-optimal blood pressure (BP) control rates. The goal of the trial is to evaluate the effectiveness and cost-effectiveness of ...

    Authors: Mihir Gandhi, Pryseley Nkouibert Assam, Elizabeth L. Turner, Donald E. Morisky, Edwin Chan and Tazeen H. Jafar

    Citation: Trials 2018 19:658

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    The Study protocol to this article has been published in Trials 2017 18:272

  29. Content type: Study protocol

    Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and...

    Authors: Ho Jeong Do, Joon-Shik Shin, Jinho Lee, Yoon Jae Lee, Me-riong Kim, Jae-Heung Cho, Koh-Woon Kim and In-Hyuk Ha

    Citation: Trials 2018 19:663

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  30. Content type: Study protocol

    Gait difficulties are common and frequently devastating to people with Parkinson’s disease (PD). These difficulties are often followed by an increased risk of falls, leading to injury, hospitalization and mort...

    Authors: Vida Alizad, Marcus Meinzer, Laurent Frossard, Remco Polman, Simon Smith and Graham Kerr

    Citation: Trials 2018 19:661

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  31. Content type: Study protocol

    This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet.

    Authors: Youme Ko, Ho-Yeon Go, In-Sik Han, Kyou-Young Lee, Tae-Hoon Kim, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seung-Ho Sun, Chan-Yong Jeon and Seong-Gyu Ko

    Citation: Trials 2018 19:662

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  32. Content type: Research

    Classroom-based stuttering intervention addressing negative peer attitudes, perceptions, teasing and bullying of children who stutter (CWS) is required as part of holistic stuttering management because of its ...

    Authors: Rizwana Mallick, Harsha Kathard, A. S. M. Borhan, Mershen Pillay and Lehana Thabane

    Citation: Trials 2018 19:664

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  33. Content type: Study protocol

    Intrahepatic cholestasis of pregnancy (ICP) is the most common liver disorder specific to pregnancy and presents with maternal pruritus, raised concentrations of serum bile acids and abnormal liver function te...

    Authors: Lucy C. Chappell, Jenny Chambers, Peter H. Dixon, Jon Dorling, Rachael Hunter, Jennifer L. Bell, Ursula Bowler, Pollyanna Hardy, Edmund Juszczak, Louise Linsell, Catherine Rounding, Anne Smith, Catherine Williamson and Jim G. Thornton

    Citation: Trials 2018 19:657

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  34. Content type: Study protocol

    Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pre...

    Authors: Rachel Dadouch, Mina Faheim, Clara Juando-Prats, Janet Parsons and Rohan D’Souza

    Citation: Trials 2018 19:655

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  35. 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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  36. 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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  37. 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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  38. 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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  39. Content type: Study protocol

    Older adults in residential aged care facilities have unnecessarily high levels of vision impairment (VI) which are largely treatable or correctable. However, no current comprehensive eye health service model ...

    Authors: Edith E. Holloway, Marios Constantinou, Jing Xie, Eva K. Fenwick, Eric A. Finkelstein, Ryan E. K. Man, Michael Coote, Jonathan Jackson, Gwyn Rees and Ecosse L. Lamoureux

    Citation: Trials 2018 19:650

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  40. 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 L. 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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  41. 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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  42. 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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  43. 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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  44. 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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  45. 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

  46. 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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  47. 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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  48. 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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