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  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. 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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  12. 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

  13. 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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  14. 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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  15. 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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  16. 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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  17. 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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  19. 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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  20. 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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  21. 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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  22. 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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  23. 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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  24. 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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  25. 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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  26. 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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  27. 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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  28. 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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  29. 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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  30. 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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  31. 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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  32. 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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  33. 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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  34. 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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  35. 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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  36. 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

  37. 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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  38. 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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  39. 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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  40. 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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  41. 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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  42. 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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  43. 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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  44. 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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  45. 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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  46. 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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  47. 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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  48. 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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  49. 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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  50. 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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