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  1. Depressive disorders are a leading cause of disability, but current behavioural and pharmacological therapies have a slow onset of response, typically taking several weeks before achieving efficacy. Prior stud...

    Authors: Joseph C. C. Chen, Rachael L. Sumner, Venkat Krishnamurthy Naga, Nicholas Hoeh, Hafis Adetokunbo Ayeni, Vikrant Singh, Frederick Sundram, Douglas Campbell and Suresh Muthukumaraswamy

    Citation: Trials 2020 21:157

    Content type: Study protocol

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  2. Maternal mortality is still high in Ethiopia. Antenatal care, the use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in ...

    Authors: Netsanet Belete Andargie, Mulusew Gerbaba Jebena and Gurmesa Tura Debelew

    Citation: Trials 2020 21:151

    Content type: Study protocol

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  3. The objective of this trial is to investigate the effects of protective lung ventilation on regional cerebral oxygen saturation (rSO2) during dura opening, that is from Ta (after dura opening) to Tb (before dura ...

    Authors: Jinlu Li, Xuemei Wu, Hairui Liu, Ying Huang, Yueqin Liu, Hong Xie and Jun Dong

    Citation: Trials 2020 21:149

    Content type: Study protocol

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  4. Cluster randomized trials (CRTs) are a design used to test interventions where individual randomization is not appropriate. The mixed model for repeated measures (MMRM) is a popular choice for individually ran...

    Authors: Melanie L. Bell and Brooke A. Rabe

    Citation: Trials 2020 21:148

    Content type: Methodology

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  5. Antipsychotic medication is effective for symptomatic treatment in schizophrenia-spectrum disorders. After symptom remission, continuation of antipsychotic treatment is associated with lower relapse rates and ...

    Authors: Marieke J. H. Begemann, Ilse A. Thompson, Wim Veling, Shiral S. Gangadin, Chris N. W. Geraets, Erna van ‘t Hag, Sanne J. Müller-Kuperus, Priscilla P. Oomen, Alban E. Voppel, Mark van der Gaag, Martijn J. Kikkert, Jim Van Os, H. Filip E. Smit, Rikus H. Knegtering, Sybren Wiersma, Luyken H. Stouten…

    Citation: Trials 2020 21:147

    Content type: Study protocol

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  6. Gestational diabetes mellitus (GDM) is associated with an increased risk of future diabetes in both mother, father and offspring. More knowledge is needed about how to effectively reduce the risk of diabetes t...

    Authors: Karoline Kragelund Nielsen, Inger Katrine Dahl-Petersen, Dorte Møller Jensen, Per Ovesen, Peter Damm, Nanna Husted Jensen, Maja Thøgersen, Anne Timm, Line Hillersdal, Ulla Kampmann, Christina Anne Vinter, Elisabeth Reinhardt Mathiesen and Helle Terkildsen Maindal

    Citation: Trials 2020 21:146

    Content type: Study protocol

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  7. Non-inferiority trials are increasingly used to evaluate new treatments that are expected to have secondary advantages over standard of care, but similar efficacy on the primary outcome. When designing a non-i...

    Authors: Matteo Quartagno, A. Sarah Walker, Abdel G. Babiker, Rebecca M. Turner, Mahesh K. B. Parmar, Andrew Copas and Ian R. White

    Citation: Trials 2020 21:145

    Content type: Methodology

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  8. There are several open scientific questions regarding the optimal antibiotic treatment of spinal infections (SIs) with or without an implant. The duration of postsurgical antibiotic therapy is debated.

    Authors: Michael Betz, Ilker Uçkay, Regula Schüpbach, Tanja Gröber, Sander M. Botter, Jan Burkhard, Dominique Holy, Yvonne Achermann and Mazda Farshad

    Citation: Trials 2020 21:144

    Content type: Study protocol

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  9. Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder...

    Authors: Yunxuan Huang, Jiabi Zhang, Buhui Xiong, Ruina Huang, Wenjing Zhao, Mengxue Zhou, Qi Chen, Danghan Xu and Xinghua Chen

    Citation: Trials 2020 21:143

    Content type: Study protocol

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  10. Appropriate pain management is essential to improve the postoperative recovery after total hip arthroplasty (THA). Various case reports have indicated that anterior quadratus lumborum block (QLB) provides effe...

    Authors: Masaru Kikuchi, Takahiro Mihara, Yusuke Mizuno, Hiroko Fujimoto, Sachiko Arai, Takeshi Nomura and Takahisa Goto

    Citation: Trials 2020 21:142

    Content type: Study protocol

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  11. Lutetium-177-DOTA-octreotate (177Lu-DOTATATE) significantly increases survival and response rates in patients with grade I and grade II neuroendocrine tumors (NETs). However, survival and response rates are signi...

    Authors: Sander C. Ebbers, Arthur J. A. T. Braat, Adriaan Moelker, Marcel P. M. Stokkel, Marnix G. E. H. Lam and Maarten W. Barentsz

    Citation: Trials 2020 21:141

    Content type: Study protocol

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  12. Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies have suggested that it might exert a preventive effect in managing ECC. However, no well-designed...

    Authors: Sherry Shiqian Gao, Kitty Jieyi Chen, Duangporn Duangthip, May Chun Mei Wong, Edward Chin Man Lo and Chun Hung Chu

    Citation: Trials 2020 21:140

    Content type: Study protocol

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  13. A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Māori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training...

    Authors: Ralph Maddison, Elaine Anne Hargreaves, Yannan Jiang, Amanda Jane Calder, Sally Wyke, Cindy M. Gray, Kate Hunt, David Lubans, Helen Eyles, Nick Draper, Ihirangi Heke, Stephen Kara, Gerhard Sundborn, Claire Arandjus, Matthew Jenkins and Samantha Marsh

    Citation: Trials 2020 21:139

    Content type: Study protocol

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  14. Among palliative care (PC) patients who are administered paracetamol, the subcutaneous (SC) route is often an alternative to the intravenous (IV) route. Yet pharmacological and clinical data on whether these a...

    Authors: Marine Vernant, Marie Lepoupet, Christian Creveuil, Antoine Alix, Charlotte Gourio, Laure Peyro-Saint-Paul, Veronique Lelong-Boulouard and Cyril Guillaumé

    Citation: Trials 2020 21:138

    Content type: Study protocol

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  15. Anthracycline-induced cardiotoxicity (AIC), a condition associated with multiple mechanisms of damage, including oxidative stress, has been associated with poor clinical outcomes. Carvedilol, a β-blocker with ...

    Authors: Rodrigo Carrasco, María Cristina Ramirez, Kjersti Nes, Andrés Schuster, Rubén Aguayo, Marcelo Morales, Cristobal Ramos, Daniel Hasson, Camilo G. Sotomayor, Pablo Henriquez, Ignacio Cortés, Marcia Erazo, Claudio Salas and Juan G. Gormaz

    Citation: Trials 2020 21:137

    Content type: Study protocol

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  16. The GABAA-α5 receptor antagonist S44819 is a promising candidate to enhance functional recovery after acute ischemic stroke (IS). S44819 is currently evaluated in this indication; RESTORE brain study started in D...

    Authors: Hugues Chabriat, Claudio L. Bassetti, Ute Marx, Françoise Picarel-Blanchot, Aurore Sors, Celine Gruget, Barbara Saba, Marine Wattez, Marie-Laure Audoli and Dirk M. Hermann

    Citation: Trials 2020 21:136

    Content type: Study protocol

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  17. Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. T...

    Authors: Weiqiang Yang, Xiaoling Li, Jiatao Zhong, Xueshuang Mei, Hongyu Liu, Le Yang, Liming Lu and Hongyi Hu

    Citation: Trials 2020 21:135

    Content type: Study protocol

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  18. Even though the effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention of hypertension and its complications have been demonstrated in randomized controlled t...

    Authors: Liqiang Zheng, Yali Wang, Sitong Liu, Rui Zheng, Dongmei Pei, Yingxian Sun and Zhaoqing Sun

    Citation: Trials 2020 21:134

    Content type: Study protocol

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  19. Doll therapy is a non-pharmacological intervention for people with dementia aimed to reduce distressing behaviours. Reliable results on the efficacy of Doll therapy for people with dementia are needed. The con...

    Authors: Roberta Vaccaro, Roberta Ballabio, Valentina Molteni, Laura Ceppi, Benedetta Ferrari, Marco Cantù, Daniele Zaccaria, Carla Vandoni, Rita Bianca Ardito, Mauro Adenzato, Barbara Poletti, Antonio Guaita and Rita Pezzati

    Citation: Trials 2020 21:133

    Content type: Study protocol

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  20. The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyl...

    Authors: Louise C. Mâsse, Janae Vlaar, Janice Macdonald, Jennifer Bradbury, Tom Warshawski, E. Jean Buckler, Jill Hamilton, Josephine Ho, Annick Buchholz, Katherine M. Morrison and Geoff D. C. Ball

    Citation: Trials 2020 21:132

    Content type: Study protocol

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  21. Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. For patients with heart failure, atrial fibrillation or therapy-resistant hypertensio...

    Authors: Andreas Ziegler, Miriam Mann, Bernard Brandewiede, Hermann Dittrich, Sissy Hintz, Katja Krockenberger, Alper Öner, Marcos Oliviera de Sousa and Christian Schmidt

    Citation: Trials 2020 21:131

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2018 19:120

  22. Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. The...

    Authors: Kyeong Tae Kim, Sophie Morton, Sarah Howe, Yeong Shiong Chiew, Jennifer L. Knopp, Paul Docherty, Christopher Pretty, Thomas Desaive, Balazs Benyo, Akos Szlavecz, Knut Moeller, Geoffrey M. Shaw and J. Geoffrey Chase

    Citation: Trials 2020 21:130

    Content type: Study protocol

    Published on:

  23. In acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sl...

    Authors: Henrik Fox, Andrea Hetzenecker, Stefan Stadler, Olaf Oldenburg, Okka W. Hamer, Florian Zeman, Leonhard Bruch, Mirko Seidel, Stefan Buchner and Michael Arzt

    Citation: Trials 2020 21:129

    Content type: Study protocol

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  24. The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liv...

    Authors: Kyungsun Han, Ojin Kwon, Hyo-ju Park, So-Young Jung, Changsop Yang and Chang-Gue Son

    Citation: Trials 2020 21:128

    Content type: Study protocol

    Published on:

  25. The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and dur...

    Authors: Sunita Taneja, Ranadip Chowdhury, Neeta Dhabhai, Sarmila Mazumder, Ravi Prakash Upadhyay, Sitanshi Sharma, Rupali Dewan, Pratima Mittal, Harish Chellani, Rajiv Bahl, Maharaj Kishan Bhan and Nita Bhandari

    Citation: Trials 2020 21:127

    Content type: Study protocol

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  26. There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in ...

    Authors: Melissa M. Medvedev, Victor Tumukunde, Ivan Mambule, Cally J. Tann, Peter Waiswa, Ruth R. Canter, Christian H. Hansen, Elizabeth Ekirapa-Kiracho, Kenneth Katumba, Catherine Pitt, Giulia Greco, Helen Brotherton, Diana Elbourne, Janet Seeley, Moffat Nyirenda, Elizabeth Allen…

    Citation: Trials 2020 21:126

    Content type: Study protocol

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  27. Bronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors and one of the most common chronic lung diseases. It has a poor prognosis, especially in preterm infants. Ho...

    Authors: Xian Wu, Yunqiu Xia, Ou Zhou, Yan Song, Xianhong Zhang, Daiyin Tian, Qubei Li, Chang Shu, Enmei Liu, Xiaoping Yuan, Ling He, Chengjun Liu, Jing Li, Xiaohua Liang, Ke Yang, Zhou Fu…

    Citation: Trials 2020 21:125

    Content type: Study protocol

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  28. Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with ph...

    Authors: Anouk S. Schuit, Karen Holtmaat, Nienke Hooghiemstra, Femke Jansen, Birgit I. Lissenberg-Witte, Veerle M. H. Coupé and Irma M. Verdonck-de Leeuw

    Citation: Trials 2020 21:124

    Content type: Study protocol

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  29. Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascula...

    Authors: Josefin Sundh, Anders Magnuson, Scott Montgomery, Pontus Andell, Gustaf Rindler and Ole Fröbert

    Citation: Trials 2020 21:123

    Content type: Study protocol

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  30. Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for...

    Authors: Anu Kemppinen, Carol Howell, Victoria Allgar, Matthew Dodd, John Gregson, Charles Knowles, John McLaughlin, Preeti Pandya, Peter Whorwell, Elena Markaryan and Yan Yiannakou

    Citation: Trials 2020 21:122

    Content type: Study protocol

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  31. Preterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. For a singleton pregnancy, progesterone treatment is effective in prevention of preterm birth in wom...

    Authors: Ka Wang Cheung, Mimi Tin Yan Seto and Ernest Hung Yu Ng

    Citation: Trials 2020 21:121

    Content type: Study protocol

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  32. Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in u...

    Authors: Jin Ho Choi, Woo Hyun Paik, Min Su You, Kyong Joo Lee, Young Hoon Choi, Bang-sup Shin, Sang Hyub Lee, Ji Kon Ryu and Yong-Tae Kim

    Citation: Trials 2020 21:120

    Content type: Study protocol

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  33. In Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary ca...

    Authors: Dan Schwarz, Santosh Dhungana, Anirudh Kumar, Bibhav Acharya, Pawan Agrawal, Anu Aryal, Aaron Baum, Nandini Choudhury, David Citrin, Binod Dangal, Meghnath Dhimal, Bikash Gauchan, Tula Gupta, Scott Halliday, Biraj Karmacharya, Sandeep Kishore…

    Citation: Trials 2020 21:119

    Content type: Study protocol

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  34. Gastroesophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms....

    Authors: Yeon Hee Bhang, Kwan-Il Kim, Jaehyo Kim, Junmo Ahn, Hwan-Su Jung, Changsop Yang, Seok-Jae Ko, Youngmin Bu, Jae-Woo Park, Kyoung Sun Park, Hee-Jae Jung, Jun-Hwan Lee and Beom-Joon Lee

    Citation: Trials 2020 21:118

    Content type: Study protocol

    Published on:

  35. Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acut...

    Authors: Franziska Holtdirk, Anja Mehnert, Mario Weiss, Björn Meyer and Carsten Watzl

    Citation: Trials 2020 21:117

    Content type: Study protocol

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  36. Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or heal...

    Authors: Katie Biggs, Daniel Hind, Rebecca Gossage-Worrall, Kirsty Sprange, David White, Jessica Wright, Robin Chatters, Katherine Berry, Diana Papaioannou, Mike Bradburn, Stephen J. Walters and Cindy Cooper

    Citation: Trials 2020 21:116

    Content type: Research

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  37. The startup phase of a clinical trial (CT) plays a vital role in the execution of new drug development. Hence, the aim of this study is to identify the factors responsible for delaying the CT startup phase. Fu...

    Authors: Amani Abu-Shaheen, Ahmad Al Badr, Isamme Al Fayyad, Adel Al Qutub, Eissa Ali Faqeih and Mohamad Al-Tannir

    Citation: Trials 2020 21:115

    Content type: Research

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  38. Mindfulness training (MT) for parents of adolescents has been shown to improve mental health and stress-related outcomes in individuals and their families. Studies of MT among young people are mainly delivered...

    Authors: Nicolas Arnaud, Christiane Baldus, Léa Josette Laurenz, Sonja Bröning, Maja Brandt, Sabrina Kunze, Maria Austermann, Linda Zimmermann, Anne Daubmann and Rainer Thomasius

    Citation: Trials 2020 21:114

    Content type: Study protocol

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  39. Periodontal diseases are regarded as the most common diseases of mankind. The prevalence rate of periodontal disease assumes a clear growth tendency, increasing by 57.3% from 1990 to 2010. Thereby, effective p...

    Authors: Yue Yan, Yalin Zhan, Xian’e Wang and Jianxia Hou

    Citation: Trials 2020 21:113

    Content type: Study protocol

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  40. After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of th...

    Authors: A.J. Kalkdijk-Dijkstra, J.A.G. van der Heijden, H.L. van Westreenen, P.M.A. Broens, M. Trzpis, J.P.E.N. Pierie and B.R. Klarenbeek

    Citation: Trials 2020 21:112

    Content type: Study protocol

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  41. Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation...

    Authors: Adnan Al-Kaisy, Jonathan Royds, Stefano Palmisani, David Pang, Samuel Wesley, Rod S. Taylor, Andrew Cook, Sam Eldabe, Lance McCracken, Rui Duarte and Jeremy Fairbank

    Citation: Trials 2020 21:111

    Content type: Study protocol

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  42. Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupunct...

    Authors: Yin Shou, Li Hu, Cuihong Zhang, Shifen Xu, Qi Jin, Li Huang, Bingrong Li, Long Yuan, Siwei Xu, Kaiyong Zhang, Huiru Jiang and Bimeng Zhang

    Citation: Trials 2020 21:110

    Content type: Study protocol

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  43. Point OutWords is a caregiver-delivered, iPad-assisted intervention for non-verbal or minimally verbal children with autism. It aims to develop prerequisite skills for communication such as manual and oral motor ...

    Authors: Ailbhe McKinney, Kathryn L. Hotson, Alicia Rybicki, Emma J. L. Weisblatt, Claudia Días, Juliet Foster, Sofía S. Villar, Suzanne Murphy and Matthew K. Belmonte

    Citation: Trials 2020 21:109

    Content type: Study protocol

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  44. Voluntary medical male circumcision (VMMC) is a key component of combination HIV-prevention programmes. Several high-HIV-prevalence countries in sub-Saharan Africa, including Zimbabwe, are looking to scale up ...

    Authors: Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett and Simon Gregson

    Citation: Trials 2020 21:108

    Content type: Study protocol

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  45. Anxiety disorders are the most prevalent class of lifetime disorders in China, and generalized anxiety disorder (GAD) is one of the most common but frequently overlooked anxiety disorders. Conventional pharmac...

    Authors: Zhongwei Sha, Yiping Hou, Chunchun Xue, Ou Li, Zhimin Li, Huiru Wang, Wenjing Zhang and Jian Xu

    Citation: Trials 2020 21:107

    Content type: Study protocol

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  46. Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy ...

    Authors: Daniel Jost, Sabine Lemoine, Frederic Lemoine, Vincent Lanoe, Olga Maurin, Clément Derkenne, Marilyn Franchin Frattini, Maëlle Delacote, Edouard Seguineau, Anne Godefroy, Nicolas Hervault, Ludovic Delhaye, Nicolas Pouliquen, Emilie Louis-Delauriere, Julie Trichereau, Florian Roquet…

    Citation: Trials 2020 21:106

    Content type: Study protocol

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  47. Intermittent claudication (IC) caused by peripheral artery disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced...

    Authors: Maj Siercke, Lise Pyndt Jørgensen, Malene Missel, Lau Caspar Thygesen, Pernille Peppercorn Blach, Henrik Sillesen and Selina Kikkenborg Berg

    Citation: Trials 2020 21:105

    Content type: Study protocol

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  48. Prescribing, monitoring and administration of medicines in care homes could be improved. Research has identified the need for one person to assume overall responsibility for the management of medicines within ...

    Authors: Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M. Poland…

    Citation: Trials 2020 21:103

    Content type: Study protocol

    Published on:

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