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  1. Content type: Study protocol

    Early mother–child skin-to-skin contact (SSC) in the first 2 h postpartum is highly beneficial for both mother and child. However, cases have been reported of newborns who have experienced apparently life-thre...

    Authors: Jesús Rodríguez López, Nadia Raquel García Lara, María López Maestro, Javier De la Cruz Bértolo, José Carlos Martínez Ávila, Máximo Vento, Ana Parra Llorca, Isabel Izquierdo Macián, Adelina Pellicer, Natalia Marín Huarte, Izaskun Asla Elorriaga, Lourdes Román Echevarría, Cristina Copons Fernández, Ana Martín Ancel, Fernando Cabañas, Óscar García Algar…

    Citation: Trials 2019 20:179

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  2. Content type: Study protocol

    Estimates of multimorbidity, defined as the presence of at least two chronic conditions, some of which attributable to modifiable behaviours, are high in adults with cerebral palsy (CP). An assessment protocol...

    Authors: Patrick G. McPhee, Joyce L. Benner, Astrid C. J. Balemans, Olaf Verschuren, Rita J. G. van den Berg-Emons, Edward A. Hurvitz, Mark D. Peterson, Wilma M. A. van der Slot, Marij E. Roebroeck and Jan Willem Gorter

    Citation: Trials 2019 20:176

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  3. Content type: Correction

    After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled.

    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 2019 20:175

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    The original article was published in Trials 2018 19:670

  4. Content type: Study protocol

    Generalised anxiety disorder (GAD) is a frequent and severe anxiety disorder among older adults. GAD increases the risk of developing other disorders such as depression and coronary heart disease. Older adults...

    Authors: Silje Haukenes Stavestrand, Kristine Sirevåg, Inger Hilde Nordhus, Trond Sjøbø, Trygve Bruun Endal, Hans M. Nordahl, Karsten Specht, Åsa Hammar, Anne Halmøy, Egil W. Martinsen, Eva Andersson, Helene Hjelmervik, Jan Mohlman, Julian F. Thayer and Anders Hovland

    Citation: Trials 2019 20:174

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  5. Content type: Study protocol

    A long-acting prodrug of nalbuphine, nalbuphine sebacate, has been developed for meeting the unmet medical need of long-acting analgesics. Naldebain® (nalbuphine sebacate) has been developed as a new premedicatio...

    Authors: Hsiang-Lin Tsai, Tsung-Kun Chang, Wei-Chih Su, Yung-Sung Yeh, Ching-Wen Huang, Cheng-Jen Ma and Jaw-Yuan Wang

    Citation: Trials 2019 20:173

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  6. Content type: Methodology

    The logrank test and the Cox proportional hazards model are routinely applied in the design and analysis of randomised controlled trials (RCTs) with time-to-event outcomes. Usually, sample size and power calcu...

    Authors: Patrick Royston, Babak Choodari-Oskooei, Mahesh K. B. Parmar and Jennifer K. Rogers

    Citation: Trials 2019 20:172

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  7. Content type: Study protocol

    Diabetes mellitus is rapidly becoming one of the leading causes of morbidity and mortality worldwide. Preventive measures have become important, especially in the South Asian region and other parts of the worl...

    Authors: Priyanga Ranasinghe, Ranil Jayawardena, Lal Chandrasena, Vivianne Noetzel and John Burd

    Citation: Trials 2019 20:171

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  8. Content type: Research

    It was reported that prolonging the injection time or diluting administration can reduce the incidence of opioid-induced cough. However, the incidence of sufentanil-induced cough (SIC) via a standardized infus...

    Authors: Minqiang Liu, Zhichao Li, Song Wang, Yong Liu, Xiangpeng Zhong, Renliang He and Fengxian Li

    Citation: Trials 2019 20:170

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  9. Content type: Review

    Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositori...

    Authors: Rita Banzi, Steve Canham, Wolfgang Kuchinke, Karmela Krleza-Jeric, Jacques Demotes-Mainard and Christian Ohmann

    Citation: Trials 2019 20:169

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  10. Content type: Study protocol

    Stroke patients are often affected by arm paresis, have functional impairments and receive help from professional or informal caregivers. Progressive resistance training is a common intervention for functional...

    Authors: Susan Högg, Manfred Holzgraefe, Insa Wingendorf, Jan Mehrholz, Christoph Herrmann and Mark Obermann

    Citation: Trials 2019 20:168

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  11. Content type: Study protocol

    Remote ischemic postconditioning (rIPostC) refers to the observation that repeated, short periods of ischemia protect remote areas against tissue damage during and after prolonged ischemia. Based on previous o...

    Authors: Thijs Landman, Yvonne Schoon, Michiel Warlé, Frank-Erik De Leeuw and Dick Thijssen

    Citation: Trials 2019 20:167

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  12. Content type: Study protocol

    Tracheal intubation with the patient in the lateral position is difficult because the laryngeal view is compromised during direct laryngoscopy. Flexible video endoscopes may facilitate intubation even when lar...

    Authors: Youguang Gao, Bo Lin, Jinghao Huang, Xianzhong Lin and Caizhu Lin

    Citation: Trials 2019 20:166

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  13. Content type: Study protocol

    Shoulder pain is reported to be one of the major challenges faced in the functional recovery of patients in rehabilitation following a stroke. In such cases, transcranial direct current stimulation (tDCS) has ...

    Authors: Janaina Andressa de Souza, João Carlos Ferrari Corrêa, Letizzia Dall’ Agnol, Filipe Ribeiro dos Santos, Márcia Rafaella Pereira Gomes and Fernanda Ishida Corrêa

    Citation: Trials 2019 20:165

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  14. Content type: Study protocol

    Axonal degeneration is related to long-term disability in patients with multiple sclerosis (MS). The underlying mechanism remains ill understood but appears to involve axonal energetic dysfunction. A globally ...

    Authors: Stéphanie Hostenbach, Ayla Pauwels, Veronique Michiels, Hubert Raeymaekers, Anne-Marie Van Binst, Annick Van Merhaeghen-Wieleman, Peter Van Schuerbeek, Jacques De Keyser and Miguel D’Haeseleer

    Citation: Trials 2019 20:164

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  15. Content type: Study protocol

    Ageing is associated with a range of anatomical and physiological changes. Establishing whether a change is part of ‘normal’ ageing or the early signs of disease will affect management strategies. Progressive ...

    Authors: Roger Engel, Sandra Grace and Suzanne Broadbent

    Citation: Trials 2019 20:163

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  16. Content type: Study protocol

    Primary percutaneous coronary intervention (PCI) for patients presenting with acute myocardial infarction (AMI) caused by left main coronary artery occlusion is associated with significantly higher mortality a...

    Authors: Yang Gao, Feng Zhang, Chenguang Li, Yuxiang Dai, Ji’e Yang, Ya’nan Qu, Juying Qian and Junbo Ge

    Citation: Trials 2019 20:162

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  17. Content type: Study protocol

    Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impac...

    Authors: Nancy J. Butcher, Andrea Monsour, Emma J. Mew, Peter Szatmari, Agostino Pierro, Lauren E. Kelly, Mufiza Farid-Kapadia, Alyssandra Chee-a-tow, Leena Saeed, Suneeta Monga, Wendy Ungar, Caroline B. Terwee, Sunita Vohra, Dean Fergusson, Lisa M. Askie, Paula R. Williamson…

    Citation: Trials 2019 20:161

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  18. Content type: Study protocol

    Chronic treatment of hypertension or heart failure very often includes an angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs) as renin-angiotensin system inhibitors (RASi)...

    Authors: Matthieu Legrand, Emmanuel Futier, Marc Leone, Benjamin Deniau, Alexandre Mebazaa, Benoît Plaud, Pierre Coriat, Patrick Rossignol, Eric Vicaut and Etienne Gayat

    Citation: Trials 2019 20:160

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  19. Content type: Study protocol

    Assisted vaginal birth is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for assi...

    Authors: Stephen O’Brien, Emily J. Hotton, Erik Lenguerrand, Julia Wade, Cathy Winter, Tim J. Draycott and Joanna F. Crofts

    Citation: Trials 2019 20:159

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  20. Content type: Study protocol

    Difficulties with delaying gratification, coping with frustration, and regulating emotions are significant predictors of aggression and behavioural and interpersonal problems early in life and mental health di...

    Authors: Jorge Gaete, Marcelo Sánchez, Lorena Nejaz and Mikele Otegui

    Citation: Trials 2019 20:158

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  21. Content type: Methodology

    Complex health interventions must incorporate user preferences to maximize their potential effectiveness. Discrete choice experiments (DCEs) quantify the strength of user preferences and identify preference he...

    Authors: Fern Terris-Prestholt, Nyasule Neke, Jonathan M. Grund, Marya Plotkin, Evodius Kuringe, Haika Osaki, Jason J. Ong, Joseph D. Tucker, Gerry Mshana, Hally Mahler, Helen A. Weiss and Mwita Wambura

    Citation: Trials 2019 20:157

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  22. Content type: Study protocol

    Peritonitis is responsible for thousands of deaths annually in Germany alone. Even source control (SC) and antibiotic treatment often fail to prevent severe sepsis or septic shock, and this situation has hardl...

    Authors: Christina Kalvelage, Kai Zacharowski, Artur Bauhofer, Ulrich Gockel, Michael Adamzik, Axel Nierhaus, Peter Kujath, Christian Eckmann, Mathias W. Pletz, Hendrik Bracht, Tim-Philipp Simon, Michael Winkler, Detlef Kindgen-Milles, Markus Albertsmeier, Markus Weigand, Björn Ellger…

    Citation: Trials 2019 20:156

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  23. Content type: Study protocol

    With an unclear pathomechanism, no confirmed treatment regimen has been established for chronic fatigue syndrome (CFS). Acupuncture is applied as an alternative therapy for CFS. As a kind of acupuncture therap...

    Authors: Wenjia Lin, Xin-lin Chen, Qi Chen, Junmao Wen and Xinghua Chen

    Citation: Trials 2019 20:155

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  24. Content type: Study protocol

    Stillbirth rates in the United Kingdom (UK) are amongst the highest of all developed nations. The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observatio...

    Authors: Matias C. Vieira, Sophie Relph, Andrew Copas, Andrew Healey, Kirstie Coxon, Alessandro Alagna, Annette Briley, Mark Johnson, Deborah A. Lawlor, Christoph Lees, Neil Marlow, Lesley McCowan, Louise Page, Donald Peebles, Andrew Shennan, Baskaran Thilaganathan…

    Citation: Trials 2019 20:154

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  25. Content type: Study protocol

    It has been suggested that vitamin D and its receptors involve in suppressing fibrogenic signaling in non-alcoholic fatty liver disease (NAFLD). However, the effect of vitamin D supplementation on fibrogenic f...

    Authors: Soraiya Ebrahimpour-Koujan, Amir Ali Sohrabpour, Farshad Foroughi, Ehsan Alvandi and Ahmad Esmaillzadeh

    Citation: Trials 2019 20:153

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  26. Content type: Study protocol

    Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven to reduce maternal and child mortality and morbidity in high-burden settings. However, few pregnant rural women use these services su...

    Authors: Caroline A. Ochieng, Hassan Haghparast-Bidgoli, Neha Batura, Aloyce Odhiambo, Geordan Shannon, Andrew Copas, Tom Palmer, Sarah Dickin, Stacey Noel, Matthew Fielding, Sangoro Onyango, Sarah Odera, Alie Eleveld, Alex Mwaki, Fedra Vanhuyse and Jolene Skordis

    Citation: Trials 2019 20:152

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  27. Content type: Study protocol

    The overall goal of the Supporting Adolescent Adherence in Vietnam (SAAV) study is to improve understanding of an adherence feedback mHealth intervention designed to help adolescents living with HIV (ALHIV) ma...

    Authors: Mary DeSilva, Cong Nguyen Vu, Rachael Bonawitz, Le Thanh Hai, Nguyen Van Lam, Le Thi Yen, Allen L. Gifford, Jessica Haberer, Dang Thuy Linh and Lora Sabin

    Citation: Trials 2019 20:150

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  28. Content type: Study protocol

    Although general anaesthesia (GA) with one-lung ventilation is the current standard of care, minor thoracoscopic surgery, i.e. treatment of pleural effusions, biopsies and small peripheral pulmonary wedge rese...

    Authors: Thomas Galetin, Pascal Bretzke, Alberto Lopez-Pastorini, Mark Schieren, Aris Koryllos, Nils Kosse, Jost Schnell, Jerome M. Defosse, Frank Wappler and Erich Stoelben

    Citation: Trials 2019 20:149

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  29. Content type: Study protocol

    Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for se...

    Authors: Silvina Arrossi, Melisa Paolino, Liliana Orellana, Laura Thouyaret, Racquel E. Kohler and Kasisomayajula Viswanath

    Citation: Trials 2019 20:148

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  30. Content type: Study protocol

    Adolescence and young adulthood are critical times of initiation and progression to daily use of tobacco. However, it is difficult to recruit young adults to traditional smoking cessation and retention rates a...

    Authors: Kar-Hai Chu, César G. Escobar-Viera, Sara J. Matheny, Esa M. Davis and Brian A. Primack

    Citation: Trials 2019 20:147

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  31. Content type: Study protocol

    Postoperative delirium may manifest in the immediate post-anaesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Frontal elect...

    Authors: Amy Gaskell, Rebecca Pullon, Darren Hight, Jonathan Termaat, Gay Mans, Logan Voss, Matthias Kreuzer, Sebastian Schmid, Stephan Kratzer, Amy Rodriguez, Gerhard Schneider, Paul Garcia and Jamie Sleigh

    Citation: Trials 2019 20:146

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  32. Content type: Study protocol

    The prevalence of methamphetamine use disorder (MUD) in the United States has risen dramatically in the past four decades and is concentrated in populations such as men who have sex with men (MSM). Despite the...

    Authors: Christopher S. Stauffer, Jenna M. Moschetto, Scott M. McKernan, Elaine Hsiang, Brian Borsari and Joshua D. Woolley

    Citation: Trials 2019 20:145

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  33. Content type: Study protocol

    Sexual dysfunction can have a negative impact on women’s quality of life and relationships. There is limited information about female sexual function and treatment, particularly during pregnancy and the postpa...

    Authors: Sahar Sadat Sobhgol, Holly Priddis, Caroline A. Smith and Hannah Grace Dahlen

    Citation: Trials 2019 20:144

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  34. Content type: Study protocol

    Subclinical hypothyroidism is a common condition in patients with heart failure and is defined as elevated serum thyroid hormone (TSH) with normal circulating free thyroxine (FT4). Evidence on the effect of th...

    Authors: Xuan Zhang, Wen-yao Wang, Kuo Zhang, Jian Tian, Ji-lin Zheng, Jing Chen, Shi-min An, Si-yuan Wang, Yu-peng Liu, Yan Zhao, Jing-jia Wang, Min Yang and Yi-da Tang

    Citation: Trials 2019 20:143

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  35. Content type: Study protocol

    Transurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is r...

    Authors: Benjamin Speich, Kathrin Bausch, Jan A. Roth, Lars G. Hemkens, Hannah Ewald, Deborah R. Vogt, Nicole Bruni, Stefanie Deuster, Hans-H. Seifert and Andreas F. Widmer

    Citation: Trials 2019 20:142

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  36. Content type: Commentary

    Randomised controlled trials are considered the best method for determining the effectiveness and safety of health interventions. Trials involving children are essential to ensure that treatments are safe and ...

    Authors: Jacqueline Martin-Kerry, Adwoa Parker, Peter Bower, Ian Watt, Shaun Treweek, David Torgerson, Catherine Arundel and Peter Knapp

    Citation: Trials 2019 20:141

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  37. Content type: Study protocol

    Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended...

    Authors: Jae-Uk Sul, Myung Kwan Kim, Jungtae Leem, Hee-Geun Jo, Sang-hoon Yoon, Jeeyong Kim, Eun-Jung Lee, Jeong-Eun Yoo, So Jung Park, Young Il Kim, Eunseok Kim, In Chul Jung, Ju-Hyun Jeon and Yang-Chun Park

    Citation: Trials 2019 20:140

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  38. Content type: Study protocol

    The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best m...

    Authors: Georg M. Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Caroline Fray, Sylvia van Os and Po-Yin Cheung

    Citation: Trials 2019 20:139

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  39. Content type: Research

    New evidence supports the use of supplemental vitamin D in the prevention of exacerbation of asthma; however, the optimal posology to sufficiently raise serum levels while maximising adherence is unclear. The ...

    Authors: Francine Monique Ducharme, Megan Jensen, Geneviève Mailhot, Nathalie Alos, John White, Elizabeth Rousseau, Sze Man Tse, Ali Khamessan and Benjamin Vinet

    Citation: Trials 2019 20:138

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  40. Content type: Study protocol

    Injury is one of the most prevalent potentially emotionally traumatic events that children experience and can lead to persistent impaired physical and emotional health. There is a need for interventions that p...

    Authors: Meghan L. Marsac, Ginny Sprang, Leila Guller, Kristen L. Kohser, John M. Draus Jr and Nancy Kassam-Adams

    Citation: Trials 2019 20:137

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  41. Content type: Study protocol

    Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used i...

    Authors: Sheling Xie, Peng Yan, Chen Yao, Xiaoyan Yan, Yuliang Huo, Junhua Zhang, Si Liu, Zhiqiao Feng, Hongcai Shang and Lixin Xie

    Citation: Trials 2019 20:136

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  42. Content type: Study protocol

    Knee osteoarthritis (OA) is characterized by chronic pain, physical dysfunction, and reduced quality of life. Low-load resistance exercises with blood flow restriction (BFR) have presented results similar to t...

    Authors: Mikhail Santos Cerqueira and Wouber Hérickson de Brito Vieira

    Citation: Trials 2019 20:135

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  43. Content type: Study protocol

    Restless legs syndrome (RLS) is a common and burdensome sleep disorder associated with profound impairment of health, well-being, and quality of life. Unfortunately, the medications used for RLS management car...

    Authors: Terry Kit Selfe, Sijin Wen, Karen Sherman, Maryanna Klatt and Kim E. Innes

    Citation: Trials 2019 20:134

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  44. Content type: Study protocol

    Urinary catheter placement is essential before laparoscopic anterior resection for rectal cancer. Whether early removal of the catheter increases the incidence of urinary retention and urinary tract infection ...

    Authors: Lai Xu, Zhi-Yan Tao, Jun-Yang Lu, Guan-Nan Zhang, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Tao Xu and Yi Xiao

    Citation: Trials 2019 20:133

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  45. Content type: Study protocol

    More than 60,000 people have health problems due to chemical weapons exposure during the Iran–Iraq war. Respiratory consequences of mustard gas exposure are common and disabling; medical interventions have lim...

    Authors: Mohamad Reza Sedighi Moghadam, Mostafa Ghanei, Klaus Kenn and Nicholas S. Hopkinson

    Citation: Trials 2019 20:132

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  46. Content type: Research

    Discrepancies between pre-specified and reported outcomes are an important and prevalent source of bias in clinical trials. COMPare (Centre for Evidence-Based Medicine Outcome Monitoring Project) monitored all...

    Authors: Ben Goldacre, Henry Drysdale, Cicely Marston, Kamal R. Mahtani, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley and Carl Heneghan

    Citation: Trials 2019 20:124

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  47. Content type: Research

    Discrepancies between pre-specified and reported outcomes are an important source of bias in trials. Despite legislation, guidelines and public commitments on correct reporting from journals, outcome misreport...

    Authors: Ben Goldacre, Henry Drysdale, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Cicely Marston, Anna Powell-Smith, Carl Heneghan and Kamal R. Mahtani

    Citation: Trials 2019 20:118

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  48. Content type: Study protocol

    The clinical efficacy of effect-site targeted patient-maintained propofol sedation (PMPS) compared to anaesthetist-controlled propofol sedation (ACPS) for patients undergoing awake joint replacement surgery is...

    Authors: David W. Hewson, Frank Worcester, James Sprinks, Murray D. Smith, Heather Buchanan, Philip Breedon, Jonathan G. Hardman and Nigel M. Bedforth

    Citation: Trials 2019 20:129

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  49. Content type: Study protocol

    Ascites is one of the most common complications of cirrhosis. Umbilical therapy with traditional Chinese medicines has been increasingly prescribed to treat cirrhotic ascites. However, high-quality evidence fr...

    Authors: Xianzhao Yang, Shuying Ru, Lin Luo, Xiaoying Lv, Wenjing Bai, Fuwen Zhang and Feng Jiang

    Citation: Trials 2019 20:127

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