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  1. Automated peripheral mechanical stimulation (AMPS) has been proposed as a new complementary therapy with potential for improving motor and cardiovascular abnormalities in Parkinson’s disease (PD). However, AMP...

    Authors: Nicolle Zelada-Astudillo, Vinicius Christianini Moreno, Andrea Herrera-Santelices, Fabio Augusto Barbieri and Antonio Roberto Zamunér

    Citation: Trials 2021 22:250

    Content type: Study protocol

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  2. Autism spectrum disorder (ASD) is characterized by impaired social communication and interaction, and stereotyped, repetitive behaviour and sensory interests. To date, there is no effective medication that can...

    Authors: Christina Luckhardt, Magdalena Schütz, Andreas Mühlherr, Hannah Mössinger, Sara Boxhoorn, Astrid Dempfle, Ricardo Salvador, Giulio Ruffini, Helena C. Pereira, Miguel Castelo-Branco, Marianne Latinus, Frédérique Bonnet-Brilhault, Julia Siemann, Michael Siniatchkin, Christine Ecker and Christine M. Freitag

    Citation: Trials 2021 22:248

    Content type: Study protocol

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  3. Transcutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham-co...

    Authors: Lynn Ghijselings, Catherine Renson, Johan Van de Walle, Karel Everaert and Anne-Françoise Spinoit

    Citation: Trials 2021 22:247

    Content type: Study protocol

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  4. This study is conducted to investigate efficacy of pomegranate juice on inflammatory biomarkers, C-reactive protein (CRP), interleukin 6(IL-6), erythrocyte sedimentation rate (ESR) and complete blood count (CB...

    Authors: Mojtaba Yousefi, Mohammadreza Sadriirani, Azizollah PourMahmoudi, Sara Mahmoodi, Bahar Samimi, Mahboobe Hosseinikia, Zaker Saeedinezhad and Seyed Bahman Panahande

    Citation: Trials 2021 22:246

    Content type: Letter

    Published on:

  5. These 2 parallel studies (K031 and K032) aim to evaluate the safety of KB109 in addition to supportive self-care (SSC) compared with SSC alone in outpatients with mild to moderate coronavirus disease 2019 (COV...

    Authors: John P. Haran, Jose C. Pinero, Yan Zheng, Norma Alonzo Palma and Mark Wingertzahn

    Citation: Trials 2021 22:245

    Content type: Letter

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  6. Lifestyle intervention, i.e. diet and physical activity, forms the basis for care of type 2 diabetes (T2D). The current physical activity recommendation for T2D is aerobic training for 150 min/week of moderate...

    Authors: Mark P. P. Lyngbaek, Grit E. Legaard, Sebastian L. Bennetsen, Camilla S. Feineis, Villads Rasmussen, Nana Moegelberg, Cecilie F. Brinkløv, Anette B. Nielsen, Katja S. Kofoed, Carsten A. Lauridsen, Caroline Ewertsen, Henrik E. Poulsen, Robin Christensen, Gerrit Van Hall, Kristian Karstoft, Thomas P. J. Solomon…

    Citation: Trials 2021 22:244

    Content type: Study protocol

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  7. Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is o...

    Authors: Mairead Furlong, Sinead McGilloway, Christine Mulligan, Colm McGuinness and Nuala Whelan

    Citation: Trials 2021 22:243

    Content type: Study protocol

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  8. Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the ...

    Authors: Anju Pradhan Sinha, Subodh S. Gupta, Ramesh Poluru, Abhishek V. Raut, Narendra Kumar Arora, Ravindra Mohan Pandey, Aditya Ranjan Sahu, Adhisivam Bethou, Sunil Sazawal, Sailajanandan Parida, Ashish Bavdekar, Arvind Saili, Rajni Gaind, Arti Kapil, Bishan S. Garg, Chetna Maliye…

    Citation: Trials 2021 22:242

    Content type: Study protocol

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  9. Randomised controlled trials (RCTs) are comparatively rare in UK social work, but can offer distinct advantages. Confidence in Care (CiC) is an RCT with embedded process evaluation evaluating Fostering Changes...

    Authors: Gwenllian Moody, Lucy Brookes-Howell, Rebecca Cannings-John, Sue Channon, Elinor Coulman, Alyson Rees, Jeremy Segrott and Michael Robling

    Citation: Trials 2021 22:241

    Content type: Research

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  10. Restricted and repetitive behaviours vary greatly across the autism spectrum, and although not all are problematic some can cause distress and interfere with learning and social opportunities. We have, alongsi...

    Authors: Victoria Grahame, Linda Dixon, Sue Fletcher-Watson, Deborah Garland, Magdalena Glod, Jane Goodwin, Zoe Grayson, Saoirse Heron, Emma Honey, Rebecca Iversen, Adetayo S. Kasim, Ashleigh Kernohan, Ehsan Kharatikoopaei, Ann Le Couteur, Leila Mackie, Ayesha Mathias…

    Citation: Trials 2021 22:240

    Content type: Study protocol

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  11. The efficacy of peripheral low add multifocal soft contact lenses (SCLs) for suppressing the progression of myopia is controversial. The aim of the on-going present clinical study is to investigate whether or ...

    Authors: Osamu Hieda, Yo Nakamura, Takahiro Hiraoka, Miho Kojima, Tetsuro Oshika and Chie Sotozono

    Citation: Trials 2021 22:239

    Content type: Study protocol

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  12. Cricopharyngeal dysfunction (CPD) occurs in various neurological disorders, especially stroke. The treatment approaches of CPD include swallowing training, cricopharyngeal dilation, botulinum toxin (BTX) injec...

    Authors: Mengshu Xie, Zulin Dou, Guifang Wan, Peishan Zeng and Hongmei Wen

    Citation: Trials 2021 22:238

    Content type: Study protocol

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  13. Rapid-onset paralytic agents are recommended to achieve muscle relaxation and facilitate tracheal intubation during rapid sequence induction in patients at risk of pulmonary aspiration of gastric contents. How...

    Authors: Nicolas Grillot, Matthias Garot, Sigismond Lasocki, Olivier Huet, Pierre Bouzat, Charlène Le Moal, Mathieu Oudot, Nolwenn Chatel-Josse, Younes El Amine, Marc Danguy des Déserts, Nathalie Bruneau, Raphael Cinotti, Jean-Stéphane David, Olivier Langeron, Vincent Minville, Martine Tching-Sin…

    Citation: Trials 2021 22:237

    Content type: Study protocol

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  14. Data from interventional studies suggest that a peritoneal flap after pelvic lymph node dissection (LND) during laparoscopic, robotic-assisted radical prostatectomy (RARP) may reduce the rate of symptomatic ly...

    Authors: M. Neuberger, K. F. Kowalewski, V. Simon, F. Wessels, F. Siegel, T. S. Worst, N. Westhoff, J. von Hardenberg, M. Kriegmair, M. S. Michel, P. Honeck and P. Nuhn

    Citation: Trials 2021 22:236

    Content type: Study protocol

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  15. An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2...

    Authors: Carina King, Malini Pires, Naveed Ahmed, Kohenour Akter, Abdul Kuddus, Andrew Copas, Hassan Haghparast-Bidgoli, Joanna Morrison, Tasmin Nahar, Sanjit Kumer Shaha, A. K. Azad Khan, Kishwar Azad and Edward Fottrell

    Citation: Trials 2021 22:235

    Content type: Study protocol

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  16. Sjogren’s syndrome (SS) is a chronic autoimmune rheumatic disease with an incidence of 0.03 to 0.3%. In recent years, there are an increasing number of randomized controlled trials of traditional Chinese medic...

    Authors: Ming Liu, Ya Gao, Yuan Yuan, Shuzhen Shi, Kelu Yang, Jiyuan Shi, Jiarui Wu, Junhua Zhang and Jinhui Tian

    Citation: Trials 2021 22:233

    Content type: Study protocol

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  17. The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the ‘implementability’ of trials as they are designed and conducted. Impl...

    Authors: Miranda S. Cumpston, Steven A. Webb, Philippa Middleton, Greg Sharplin and Sally Green

    Citation: Trials 2021 22:232

    Content type: Review

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  18. Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled...

    Authors: Hadi Bazyar, Ahmad Zare Javid, Hossein Bavi Behbahani, Fardin Moradi, Bahman Moradi Poode and Parichehr Amiri

    Citation: Trials 2021 22:231

    Content type: Research

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  19. Novel therapies often fail to reach the bedside due to low trial recruitment rates. Prior to conducting one of the first chimeric antigen receptor (CAR) T cell therapy trials in Canada, we used the Theoretical...

    Authors: Gisell Castillo, Manoj Lalu, Sarah Asad, Madison Foster, Natasha Kekre, Dean Fergusson, Terry Hawrysh, Harold Atkins, Kednapa Thavorn, Joshua Montroy, Stuart Schwartz, Robert Holt, Raewyn Broady and Justin Presseau

    Citation: Trials 2021 22:230

    Content type: Research

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  20. Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease characterized by coughing, the production of excess sputum, and dyspnea. Patients with excessively thick sputum may have freq...

    Authors: M. D. Shen, L. R. Guo, Y. W. Li, R. T. Gao, X. Sui, Z. Du, L. Q. Xu, H. Y. Shi, Y. Y. Ni, X. Zhang, Y. Pang, W. Zhang, T. Z. Yu and F. Li

    Citation: Trials 2021 22:228

    Content type: Study protocol

    Published on:

  21. Pregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psych...

    Authors: Pedro Fonseca Zuccolo, Mariana O. Xavier, Alicia Matijasevich, Guilherme Polanczyk and Daniel Fatori

    Citation: Trials 2021 22:227

    Content type: Study protocol

    Published on:

  22. The Zinc for INflammation and Chronic disease in HIV (ZINC) trial randomized person who live with HIV (PLWH) who engage in heavy drinking to either daily zinc supplementation or placebo. The primary outcome wa...

    Authors: Sara Lodi, Matthew Freiberg, Natalia Gnatienko, Elena Blokhina, Tatiana Yaroslavtseva, Evgeny Krupitsky, Eleanor Murray, Jeffrey H. Samet and Debbie M. Cheng

    Citation: Trials 2021 22:226

    Content type: Research

    Published on:

  23. An amendment to this paper has been published and can be accessed via the original article.

    Authors: Barbara Carey, Arwa M. Farag, Cibele Nasri-Heir, Gary D. Klasser, Anura Ariyawardana, Milda Chmieliauskaite, Andrea Sardella, Charles R. Carlson, Craig S. Miller, Lina Mejia, Francis E. O’Neill and Ruy Albuquerque

    Citation: Trials 2021 22:225

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:711

  24. Post-exposure prophylaxis (PEP) is a well-established strategy for the prevention of infectious diseases, in which recently exposed people take a short course of medication to prevent infection. The primary ob...

    Authors: Darrell H. S. Tan, Adrienne K. Chan, Peter Jüni, George Tomlinson, Nick Daneman, Sharon Walmsley, Matthew Muller, Rob Fowler, Srinivas Murthy, Natasha Press, Curtis Cooper, Todd Lee, Tony Mazzulli and Allison McGeer

    Citation: Trials 2021 22:224

    Content type: Study protocol

    Published on:

  25. Limb salvage with endoprosthetic reconstruction is the current standard practice for the surgical management of lower extremity bone tumors in skeletally mature patients and typically includes tumor resection ...

    Authors: Patricia Schneider, Diane Heels-Ansdell, Lehana Thabane and Michelle Ghert

    Citation: Trials 2021 22:223

    Content type: Update

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  26. Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term ...

    Authors: Zejian Chen, Nan Xia, Chang He, Minghui Gu, Jiang Xu, Xiaohua Han and Xiaolin Huang

    Citation: Trials 2021 22:222

    Content type: Study protocol

    Published on:

  27. Convalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). However, the clinical efficacy of COVID-19 convalescent plasma is unclear.

    Authors: Wesley H. Self, Thomas G. Stewart, Allison P. Wheeler, Wissam El Atrouni, Amanda J. Bistran-Hall, Jonathan D. Casey, Vince D. Cataldo, James D. Chappell, Claudia S. Cohn, Jessica B. Collins, Mark R. Denison, Marjolein de Wit, Sheri L. Dixon, Abhijit Duggal, Terri L. Edwards, Magali J. Fontaine…

    Citation: Trials 2021 22:221

    Content type: Study protocol

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  28. This systematic review aimed to identify, compare and contrast outcome domains and outcome instruments reported in studies investigating interventions that seek to restore bilateral (two-sided) and/or binaural...

    Authors: Roulla Katiri, Deborah A. Hall, Catherine F. Killan, Sandra Smith, Pattarawadee Prayuenyong and Pádraig T. Kitterick

    Citation: Trials 2021 22:220

    Content type: Review

    Published on:

  29. The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) randomized controlled trial (RCT) was the first study to prospectively enroll and randomize orthopedic oncology patients in multiple centers inter...

    Authors: Aaron Gazendam, Anthony Bozzo, Patricia Schneider, Victoria Giglio, David Wilson and Michelle Ghert

    Citation: Trials 2021 22:219

    Content type: Research

    Published on:

  30. Cytomegalovirus retinitis (CMVR) is an important opportunistic infection (OI) occurring mainly in patients with acquired immunodeficiency syndrome (AIDS) and has the potential to cause severe visual impairment...

    Authors: Xiao-Qing He, Yin-Qiu Huang, Yan-Ming Zeng, Yuan-Yuan Qin, Sheng-Quan Tang, Xiao-Lei Xu, Vijay Harypursat, Yan-Qiu Lu, Min Liu, Jing Yuan and Yao-Kai Chen

    Citation: Trials 2021 22:218

    Content type: Study protocol

    Published on:

  31. Subcortical ischemic vascular cognitive impairment (SIVCI) is the most common form of vascular cognitive impairment. Importantly, SIVCI is considered the most treatable form of cognitive impairment in older ad...

    Authors: Teresa Liu-Ambrose, Elizabeth Dao, Rachel A. Crockett, Cindy K. Barha, Ryan S. Falck, John R. Best, Ging-Yeuk R. Hsiung, Thalia S. Field, Kenneth M. Madden, Walid A. Alkeridy, Narlon C. Boa Sorte Silva, Jennifer C. Davis, Lisanne F. ten Brinke, Stephanie Doherty and Roger C. Tam

    Citation: Trials 2021 22:217

    Content type: Study protocol

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  32. Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However...

    Authors: Yan-ning Ma, Cheng-liang Zhong, Si-yuan Hu, Qiu-han Cai and Sheng-xuan Guo

    Citation: Trials 2021 22:216

    Content type: Study protocol

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  33. Hemiplegia is a common sequela after stroke, and acupuncture is one of the most common physical therapies used to treat hemiplegia during the recovery stage after ischaemic stroke. ‘Hand and foot acupuncture w...

    Authors: Wei-Hao Fang, Gui-Ling Wang, Qiang Liu, Xiao Ding, Zhen-Yao Wang, Xin-Wei Wang, Xiao-Wei Yang, Yang Yang, Da-Wei Zhang, Qing Wei and Hu Zhang

    Citation: Trials 2021 22:215

    Content type: Study protocol

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  34. Non-small-cell lung cancer (NSCLC) is usually diagnosed at an advanced stage, and chemotherapy is the main treatment for this disease. Kanglaite injections (KLTi) have been widely used for the treatment of can...

    Authors: Ruike Gao, Ying Zhang, Wei Hou, Jie Li, Guanghui Zhu, Xiaoxiao Zhang, Bowen Xu, Zhe Wu and Heping Wang

    Citation: Trials 2021 22:214

    Content type: Study protocol

    Published on:

  35. COPD is a leading cause of death globally, with the majority of morbidity and mortality occurring in low- and middle-income country (LMIC) settings. While tobacco-smoke exposure is the most important risk fact...

    Authors: Trishul Siddharthan, Suzanne L. Pollard, Peter Jackson, Nicole M. Robertson, Adaeze C. Wosu, Nihaal Rahman, Roma Padalkar, Isaac Sekitoleko, Esther Namazzi, Patricia Alupo, John R. Hurst, Robert Kalyesubula, David Dowdy, Robert Wise, Peter J. Barnes, William Checkley…

    Citation: Trials 2021 22:213

    Content type: Study protocol

    Published on:

  36. There is an emerging body of evidence that links exposure to shift work to cardiovascular disease (CVD). The risk of coronary events, such as myocardial infarction, is greater among night shift workers compare...

    Authors: P. Daniel Patterson, Leonard S. Weiss, Matthew D. Weaver, David D. Salcido, Samantha E. Opitz, Tiffany S. Okerman, Tanner T. Smida, Sarah E. Martin, Francis X. Guyette, Christian Martin-Gill and Clifton W. Callaway

    Citation: Trials 2021 22:212

    Content type: Study protocol

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  37. UK FASHIoN was a multicentre randomised controlled trial comparing hip arthroscopic surgery (HA) with personalised hip therapy (PHT, physiotherapist-led conservative care), for patients with hip pain attribute...

    Authors: A. X. Realpe, N. E. Foster, E. J. Dickenson, M. Jepson, D. R. Griffin and J. L. Donovan

    Citation: Trials 2021 22:211

    Content type: Research

    Published on:

  38. Disease-related malnutrition is highly prevalent in hospitalized medical and geriatric inpatients. It is associated with negative outcomes such as muscle wasting, decline of functional status, and increased mo...

    Authors: Silvia Kurmann, Emilie Reber, Maria F. Vasiloglou, Philipp Schuetz, Andreas W. Schoenenberger, Katja Uhlmann, Anna-Barbara Sterchi and Zeno Stanga

    Citation: Trials 2021 22:210

    Content type: Study protocol

    Published on:

  39. The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observ...

    Authors: Karin Welén, Anna K Överby, Clas Ahlm, Eva Freyhult, David Robinsson, Anna Jonsson Henningsson, Johan Stranne, Daniel Bremell, Martin Angelin, Elisabeth Lindquist, Robert Buckland, Camilla Thellenberg Carlsson, Karlis Pauksens, Anna Bill-Axelsson, Olof Akre, Cecilia Ryden…

    Citation: Trials 2021 22:209

    Content type: Letter

    Published on:

  40. Arterial hypotension induced by general anesthesia is commonly identified as a risk factor of morbidity, especially neurological, after cardiac or noncardiac surgery in adults and children. Intraoperative hypo...

    Authors: A. S. Szostek, P. Boucher, F. Subtil, O. Zerzaihi, C. Saunier, M. de Queiroz Siqueira, F. Merquiol, P. Martin, M. Granier, A. Gerst, A. Lambert, T. Storme, D. Chassard, P. Nony, B. Kassai and S. Gaillard

    Citation: Trials 2021 22:208

    Content type: Study protocol

    Published on:

  41. Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OF...

    Authors: Jae Yen Song, Hoon Choi, Minsuk Chae, Jemin Ko and Young Eun Moon

    Citation: Trials 2021 22:207

    Content type: Study protocol

    Published on:

  42. Patients and their families often have preferences for medical care that relate to wider considerations beyond the clinical effectiveness of the proposed interventions. Traditionally, these preferences have no...

    Authors: Samina Ali, Gareth Hopkin, Naveen Poonai, Lawrence Richer, Maryna Yaskina, Anna Heath, Terry Paul Klassen and Chris McCabe

    Citation: Trials 2021 22:206

    Content type: Methodology

    Published on:

  43. The burnout phenomenon has been extensively investigated among health care professionals, particularly focusing on physicians and nurses. However, literature concerning burnout in clinical research is poor and...

    Authors: Celeste Cagnazzo, Roberto Filippi, Giulia Zucchetti, Rosita Cenna, Cristiana Taverniti, Agata Sue Ellen Guarrera, Stefano Stabile, Irene Federici, Manuela Monti, Sara Pirondi, Sara Testoni and Franca Fagioli

    Citation: Trials 2021 22:205

    Content type: Research

    Published on:

  44. Incomplete clinical trials for pediatric drug development result in a lack of adequate scientific evidence for providing appropriate medication to pediatric populations; this is especially true for Japan. Thus...

    Authors: Nanae Tanemura, Tsuyoshi Sasaki, Junko Sato and Hisashi Urushihara

    Citation: Trials 2021 22:204

    Content type: Methodology

    Published on:

  45. Platform trials improve the efficiency of the drug development process through flexible features such as adding and dropping arms as evidence emerges. The benefits and practical challenges of implementing nove...

    Authors: Kim May Lee, Louise C. Brown, Thomas Jaki, Nigel Stallard and James Wason

    Citation: Trials 2021 22:203

    Content type: Commentary

    Published on:

  46. To determine the effect of therapeutic anticoagulation, with low molecular weight heparin (LMWH) or unfractionated heparin (UFH, high dose nomogram), compared to standard care in hospitalized patients admitted...

    Authors: Michelle Sholzberg, Grace H. Tang, Elnara Negri, Hassan Rahhal, Lisa Baumann Kreuziger, Carlos E. Pompilio, Paula James, Michael Fralick, Musaad AlHamzah, Faris Alomran, Eric Tseng, Gloria Lim, David Lillicrap, Marc Carrier, Fionnuala Ní Áinle, Andrew Beckett…

    Citation: Trials 2021 22:202

    Content type: Letter

    Published on:

  47. Approximately 2 million patients present to emergency departments in the USA annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and C...

    Authors: Elizabeth M. Schoenfeld, Kye E. Poronsky, Lauren M. Westafer, Brianna M. DiFronzo, Paul Visintainer, Charles D. Scales, Erik P. Hess and Peter K. Lindenauer

    Citation: Trials 2021 22:201

    Content type: Study protocol

    Published on:

  48. Chronic diseases that drive morbidity, mortality, and health care costs are largely influenced by human behavior. Behavioral health conditions such as anxiety, depression, and substance use disorders can often...

    Authors: Abigail M. Crocker, Rodger Kessler, Constance van Eeghen, Levi N. Bonnell, Ryan E. Breshears, Peter Callas, Jessica Clifton, William Elder, Chet Fox, Sylvie Frisbie, Juvena Hitt, Jennifer Jewiss, Roger Kathol, Kelly Clark/Keefe, Jennifer O’Rourke-Lavoie, George S. Leibowitz…

    Citation: Trials 2021 22:200

    Content type: Study protocol

    Published on:

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