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  1. Cognitive deficit is a common syndrome of methamphetamine (MA) dependence. It is related to decision-making, control ability, and social functioning. High-intensity interval training (HIIT) is a training techn...

    Authors: Shen Menglu, Yang Suyong, Wang Xiaoyan, Wolfgang I. Schöllhorn and Zhu Dong

    Citation: Trials 2021 22:650

    Content type: Study protocol

    Published on:

  2. Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes.

    Authors: Richard J. Derman, Shivaprasad S. Goudar, Simal Thind, Sudhir Bhandari, Zubair Aghai, Michael Auerbach, Rupsa Boelig, Umesh S. Charantimath, Rosemary Frasso, M. S. Ganachari, Kusum Lata Gaur, Michael K. Georgieff, Frances Jaeger, S Yogeshkumar, Parth Lalakia, Benjamin Leiby…

    Citation: Trials 2021 22:649

    Content type: Study protocol

    Published on:

  3. This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical act...

    Authors: Emma Robson, Steven J. Kamper, Alix Hall, Hopin Lee, Simon Davidson, Priscilla Viana da Silva, Connor Gleadhill and Christopher M. Williams

    Citation: Trials 2021 22:648

    Content type: Study protocol

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  4. Transcranial direct current stimulation (tDCS) has the potential to modulate cortical excitability and enhance the effects of walking training in people with Parkinson’s disease. This study will examine the ef...

    Authors: Lucas Rodrigues Nascimento, Ester Miyuki Nakamura-Palacios, Augusto Boening, Daniel Lyrio Cabral, Alessandra Swarowsky, Guilherme Peixoto Tinoco Arêas, Wellingson Silva Paiva and Fernando Zanela da Silva Arêas

    Citation: Trials 2021 22:647

    Content type: Study protocol

    Published on:

  5. Citation: Trials 2021 22:646

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:506

  6. Hypermobility is a poorly recognised and understood musculoskeletal disorder thought to affect around 20% of the population. Hypermobility is associated with reduced physiological and psychological functioning...

    Authors: Geoff Davies, Jenny L. L. Csecs, Heather Ball, Jess Dare, Stephen Bremner, Robin Hosking, Hugo D. Critchley, Nick Grey and Jessica A. Eccles

    Citation: Trials 2021 22:645

    Content type: Study protocol

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  7. Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation...

    Authors: Mimi M. Y. Tse, Shuk Kwan Tang, Shamay Ng, Yajie Li, Daphne Sze Ki Cheung and Rick Yiu Cho Kwan

    Citation: Trials 2021 22:644

    Content type: Research

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  8. Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar d...

    Authors: Benedikt Schmid, Markus Kredel, Roman Ullrich, Katharina Krenn, Rudolf Lucas, Klaus Markstaller, Bernhard Fischer, Peter Kranke, Patrick Meybohm, Bernhard Zwißler and Sandra Frank

    Citation: Trials 2021 22:643

    Content type: Study protocol

    Published on:

  9. Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of ch...

    Authors: Sheraz Yaqub, Bjørn Atle Bjørnbeth, Jon-Helge Angelsen, Claus Wilki Fristrup, Jon Erik Grønbech, Oskar Hemmingsson, Bengt Isaksson, Ingebjørg Soterud Juel, Peter Nørgaard Larsen, Gert Lindell, Frank Viborg Mortensen, Kim Erlend Mortensen, Magnus Rizell, Per Sandström, Oddvar Mathias Sandvik, Ernesto Sparrelid…

    Citation: Trials 2021 22:642

    Content type: Study protocol

    Published on:

  10. Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling ...

    Authors: Maud Daemen, Mary Rose Postma, Ramon Lindauer, Iris Hoes-van der Meulen, Dorien Nieman, Philippe Delespaul, Josefien Johanna Froukje Breedvelt, Mark van der Gaag, Wolfgang Viechtbauer, Koen Schruers, David van den Berg, Claudi Bockting, Therese van Amelsvoort and Ulrich Reininghaus

    Citation: Trials 2021 22:641

    Content type: Study protocol

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  11. Time management skills are essential for living in modern society. People with mental or neurodevelopmental disorders typically have cognitive limitations, including affected time management, which might lead ...

    Authors: Marie Holmefur, Afsaneh Roshanay, Suzanne White, Gunnel Janeslätt, Elin Vimefall and Kajsa Lidström-Holmqvist

    Citation: Trials 2021 22:640

    Content type: Study protocol

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  12. Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patie...

    Authors: Arno M. Wiersema, Liliane C. Roosendaal, Mark J. W. Koelemaij, Jan G. P. Tijssen, Susan van Dieren, Jan D. Blankensteijn, E. Sebastian Debus, Saskia Middeldorp, Jan M. M. Heyligers, Ymke S. Fokma, Michel M. P. J. Reijnen and Vincent Jongkind

    Citation: Trials 2021 22:639

    Content type: Study protocol

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  13. Sleep apnea and coronary artery disease are prevalent and relevant diseases. The mechanism by which sleep apnea leads to coronary artery disease remains unclear. Intermittent hypoxia, caused by sleep apnea, le...

    Authors: Leticia Maria Tedesco Silva, Antonio Cortes, Beatriz Rossi, Liliana Boll, Gustavo Waclawosky, Bruna Eibel, Sandro Cadaval Gonçalves, Maria Claudia Irigoyen and Denis Martinez

    Citation: Trials 2021 22:638

    Content type: Study protocol

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  14. Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care u...

    Authors: Liling Li, Li Wang, Conway Niu, Chan Liu, Tianchan Lv, Futing Ji, Ling Yu, Weili Yan, Ya Lan Dou, Yin Wang, Yun Cao, Guoying Huang and Xiaojing Hu

    Citation: Trials 2021 22:637

    Content type: Study protocol

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  15. Financial toxicity, the material and psychological burden of the cost of treatment, affects 30–50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adh...

    Authors: Lauren M. Hamel, David W. Dougherty, Seongho Kim, Elisabeth I. Heath, Lorna Mabunda, Eyouab Tadesse, RaeAnn Hill and Susan Eggly

    Citation: Trials 2021 22:636

    Content type: Study protocol

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  16. Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for palliative care is increasing and with that the rigor...

    Authors: Patrick M. Wilson, Lindsey M. Philpot, Priya Ramar, Curtis B. Storlie, Jacob Strand, Alisha A. Morgan, Shusaku W. Asai, Jon O. Ebbert, Vitaly D. Herasevich, Jalal Soleimani and Brian W. Pickering

    Citation: Trials 2021 22:635

    Content type: Study protocol

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  17. Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four...

    Authors: Pierre Bouzat, Jean-Luc Bosson, Jean-Stéphane David, Bruno Riou, Jacques Duranteau and Jean-François Payen

    Citation: Trials 2021 22:634

    Content type: Study protocol

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  18. Radical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissec...

    Authors: Ken-ichi Okada, Manabu Kawai, Seiko Hirono, Masayuki Sho, Masaji Tani, Ippei Matsumoto, Suguru Yamada, Ryosuke Amano, Hirochika Toyama, Yo-ichi Yamashita, Takeshi Gocho, Kazuto Shibuya, Minako Nagai, Hiromitsu Maehira, Keiko Kamei, Go Ohira…

    Citation: Trials 2021 22:633

    Content type: Study protocol

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  19. We aim to study the effect of epidural morphine as a means to reduce high respiratory drive in COVID 19 patients on non-invasive ventilation (NIV)—primary end point—and to study its effect on respiratory param...

    Authors: Swagata Tripathy and P. Bhaskar Rao

    Citation: Trials 2021 22:632

    Content type: Letter

    Published on:

  20. Metastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients w...

    Authors: Lourdes R. Carhuapoma, Winter M. Thayer, Catherine E. Elmore, Jane Gildersleeve, Tanmay Singh, Farah Shaukat, Melissa K. Uveges, Tamryn Gray, Crystal Chu, Daniel Song, Patricia J. Hollen, Jennifer Wenzel and Randy A. Jones

    Citation: Trials 2021 22:631

    Content type: Study protocol

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  21. Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease—including HIV/AIDS. Additionally, depression is a leading cause of disability in the c...

    Authors: Ryan K. McBain, Owen Mwale, Todd Ruderman, Waste Kayira, Emilia Connolly, Mark Chalamanda, Chiyembekezo Kachimanga, Brown David Khongo, Jesse Wilson, Emily Wroe, Giuseppe Raviola, Stephanie Smith, Sarah Coleman, Ksakrad Kelly, Amruta Houde, Mahlet G. Tebeka…

    Citation: Trials 2021 22:630

    Content type: Study protocol

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  22. Universal Health Coverage ensures access to quality health services for all, with no financial hardship when accessing the needed services. Nevertheless, access to quality health services is marred by substant...

    Authors: Amanuel Abajobir, Richard de Groot, Caroline Wainaina, Anne Njeri, Daniel Maina, Silvia Njoki, Nelson Mbaya, Hermann Pythagore Pierre Donfouet, Menno Pradhan, Wendy Janssens and Estelle M. Sidze

    Citation: Trials 2021 22:629

    Content type: Study protocol

    Published on:

  23. Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Alt...

    Authors: Tim Hundscheid, Rogier Donders, Wes Onland, Elisabeth M. W. Kooi, Daniel C. Vijlbrief, Willem B. de Vries, Debbie H. G. M. Nuytemans, Bart van Overmeire, Antonius L. Mulder and Willem P. de Boode

    Citation: Trials 2021 22:627

    Content type: Update

    Published on:

    The Study protocol to this article has been published in BMC Pediatrics 2018 18:262

  24. Some parallel-group cluster-randomized trials use covariate-constrained rather than simple randomization. This is done to increase the chance of balancing the groups on cluster- and patient-level baseline char...

    Authors: Ahmed A. Al-Jaishi, Stephanie N. Dixon, Eric McArthur, P. J. Devereaux, Lehana Thabane and Amit X. Garg

    Citation: Trials 2021 22:626

    Content type: Research

    Published on:

  25. Patients in Germany are free to seek care from any office-based physician and can always ask for multiple opinions on a diagnosis or treatment. The high density of physicians and the freedom to choose among th...

    Authors: Leonie Sundmacher, Ronja Flemming, Verena Leve, Isabel Geiger, Sebastian Franke, Thomas Czihal, Clemens Krause, Birgitt Wiese, Frank Meyer, Matthias Brittner, Johannes Pollmanns, Johannes Martin, Paul Brandenburg, Annemarie Schultz, Emmanuelle Brua, Udo Schneider…

    Citation: Trials 2021 22:624

    Content type: Study protocol

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  26. Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation...

    Authors: S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli and P. Balaji

    Citation: Trials 2021 22:623

    Content type: Research

    Published on:

  27. Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehens...

    Authors: Marc Dohmen, Andrea Petermann-Meyer, Daniel Blei, Rebecca Bremen, Evamarie Brock-Midding, Manuela Brüne, Franziska Geiser, Burkhard Haastert, Sarah Maria Halbach, Christian Heuser, Steffen Holsteg, Lina Heier, Andrea Icks, Andre Karger, Joseph Montalbo, Hannah Nakata…

    Citation: Trials 2021 22:622

    Content type: Study protocol

    Published on:

  28. Colorectal cancer is associated with secondary sarcopenia (muscle loss) and myosteatosis (fatty infiltration of muscle) and patients who exhibit these host characteristics have poorer outcomes following surger...

    Authors: Edward T. Pring, Laura E. Gould, George Malietzis, Philip Lung, Mina Bharal, Tutu Fadodun, Paul Bassett, Mani Naghibi, Claire Taylor, Ioanna Drami, Deeptika Chauhan, Tamsyn Street, Nader K. Francis, Thanos Athanasiou, John M. Saxton and John T. Jenkins

    Citation: Trials 2021 22:621

    Content type: Study protocol

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  29. There is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical ...

    Authors: Tom Briffa, Tanya Symons, Nikolajs Zeps, Nicola Straiton, William Odita Tarnow-Mordi, John Simes, Ian A. Harris, Melinda Cruz, Steven A. Webb, Edward Litton, Alistair Nichol and Christopher M. Williams

    Citation: Trials 2021 22:620

    Content type: Commentary

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  30. Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis is based on symptoms defined by abdominal pain or discomfort associated with d...

    Authors: Linda L. D. Zhong, Tsz Fung Lam, Wei Yang, Ya Zheng, Zipan Lyu and Zhaoxiang Bian

    Citation: Trials 2021 22:619

    Content type: Study protocol

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  31. Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.

    Authors: Sohaib Ashraf, Shoaib Ashraf, Rutaba Akmal, Moneeb Ashraf, Larab Kalsoom, Aadil Maqsood, Muhammad Ahmad Imran, Iqra Farooq, Sidra Ashraf, Uzma Nasim Siddiqui, Muhammad Ghufran, Muhammad Kiwan Akram, Nighat Majeed, Sundas Rafique, Zaigham Habib, Muhammad Sarmad Shahab…

    Citation: Trials 2021 22:618

    Content type: Letter

    Published on:

  32. Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired qual...

    Authors: Aleksi Laajala, Paulus Tokola, Timo J. Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä and Olli-Pekka Alho

    Citation: Trials 2021 22:617

    Content type: Study protocol

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  33. Internationally, older patients (≥65 years) account for more than 40% of acute admissions. Older patients admitted to the emergency department (ED) are frequently malnourished and exposed to inappropriate medi...

    Authors: Aino L. Andersen, Morten B. Houlind, Rikke L. Nielsen, Lillian M. Jørgensen, Charlotte Treldal, Morten Damgaard, Anne Kathrine Bengaard, Helle Gybel Juul-Larsen, Louise Bolvig Laursen, Esben Iversen, Marie Kruse, Anne M. L. Pedersen, Mads Hornum, Anne M. Beck, Mette M. Pedersen, Mikkel Z. Ankarfeldt…

    Citation: Trials 2021 22:616

    Content type: Study protocol

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  34. Stroke is the leading cause of death worldwide. China faces a similar risk of stroke as developed countries because of considerable changes in lifestyle, such as overeating and smoking. Tai Chi is a traditiona...

    Authors: Tianyang Tan, Yanyan Meng, Xinyu Li, Ruina Bai, Chengchao Wang, Jiaxuan Lyu, Kang Yan, Meng Liu, Chaoyang Zhang and Yulong Wei

    Citation: Trials 2021 22:614

    Content type: Study protocol

    Published on:

  35. Globally, over 1.2 million people die from chronic kidney disease (CKD) every year. Patients with CKD are up to 10 times more likely to die prematurely than progress to kidney failure requiring kidney replacem...

    Authors: Nicole Evangelidis, Benedicte Sautenet, Magdalena Madero, Allison Tong, Gloria Ashuntantang, Laura Cortes Sanabria, Ian H. de Boer, Samuel Fung, Daniel Gallego, Andrew S. Levey, Adeera Levin, Eduardo Lorca, Ikechi G. Okpechi, Patrick Rossignol, Laura Sola, Tim Usherwood…

    Citation: Trials 2021 22:612

    Content type: Study protocol

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  36. Increasingly, it is argued that clinical trials struggle to recruit participants because they do not respond to key questions or study treatments that patients will be willing or able to use. This study explor...

    Authors: Magda Aguiar, Tracey-Lea Laba, Sarah Munro, Tiasha Burch, Jennifer Beckett, K. Julia Kaal, Nick Bansback, Marie Hudson and Mark Harrison

    Citation: Trials 2021 22:611

    Content type: Research

    Published on:

  37. Postoperative ileus (POI) occurs in almost all patients after abdominal laparoscopic surgery, resulting in complications and increasing the length of hospitalization. Electroacupuncture has been used as an alt...

    Authors: Jia-Kai Shao, Qian Liu, Wei Pei, Yu Wang, Na-Na Yang, Ling-Yu Qi, Jin Huang, Jing-Wen Yang and Cun-zhi Liu

    Citation: Trials 2021 22:610

    Content type: Study protocol

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  38. Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to...

    Authors: Jony van Hilst, Maarten Korrel, Sanne Lof, Thijs de Rooij, Frederique Vissers, Bilal Al-Sarireh, Adnan Alseidi, Adrian C. Bateman, Bergthor Björnsson, Ugo Boggi, Svein Olav Bratlie, Olivier Busch, Giovanni Butturini, Riccardo Casadei, Frederike Dijk, Safi Dokmak…

    Citation: Trials 2021 22:608

    Content type: Study protocol

    Published on:

  39. Cervical radiculopathy is the most common disease in the cervical spine, affecting patients around 50–55 year of age. An operative treatment is common clinical praxis when non-operative treatment fails. The co...

    Authors: Marek Holy, Anna MacDowall, Freyr Gauti Sigmundsson and Class Olerud

    Citation: Trials 2021 22:607

    Content type: Study protocol

    Published on:

  40. Endoscopic sinus surgery (ESS) has been used for decades to treat recurrent acute rhinosinusitis episodes (RARS) in adults. RARS results in infectious symptoms, antibiotic courses, sick leaves, and impaired qu...

    Authors: Heidi M. Kaski, Antti Alakärppä, Ulla Lantto, Aleksi Laajala, Paulus Tokola, Tomi Penna, Pasi Ohtonen and Olli-Pekka Alho

    Citation: Trials 2021 22:606

    Content type: Study protocol

    Published on:

  41. Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a r...

    Authors: Shakira Milton, Jennifer McIntosh, Lucy Boyd, Napin Karnchanachari, Finlay Macrae and Jon David Emery

    Citation: Trials 2021 22:605

    Content type: Commentary

    Published on:

  42. The sequence of establishing a proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study pl...

    Authors: Yi-chen Lee, Yi-chun Li, Keh-chung Lin, Chia-ling Chen, Yi-hsuan Wu, Chihchieh Kuo, Yi-ping Yeh and Ting-xuan Liu

    Citation: Trials 2021 22:604

    Content type: Study protocol

    Published on:

  43. The World Health Organization declared the outbreak of SARS-CoV-2 a pandemic on February 11, 2020. This organism causes COVID-19 disease and the rapid rise in cases and geographic spread strained healthcare sy...

    Authors: Hans H. Liu, Michael D. Ezekowitz, Michele Columbo, Oneib Khan, Jack Martin, Judith Spahr, David Yaron, Lisa Cushinotto and Luciano Kapelusznik

    Citation: Trials 2021 22:603

    Content type: Commentary

    Published on:

  44. Authors: E. Hope Weissler, Tristan Naumann, Tomas Andersson, Rajesh Ranganath, Olivier Elemento, Yuan Luo, Daniel F. Freitag, James Benoit, Michael C. Hughes, Faisal Khan, Paul Slater, Khader Shameer, Matthew Roe, Emmette Hutchison, Scott H. Kollins, Uli Broedl…

    Citation: Trials 2021 22:593

    Content type: Correction

    Published on:

    The original article was published in Trials 2021 22:537

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