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  1. Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secon...

    Authors: Ana I. Fernández, Javier Bermejo, Raquel Yotti, Miguel Ángel Martínez-Gonzalez, Alex Mira, Uri Gophna, Roger Karlsson, Reem Al-Daccak, Irene Martín-Demiguel, Enrique Gutiérrez-Ibanes, Dominique Charron and Francisco Fernández-Avilés
    Citation: Trials 2021 22:795
  2. Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strat...

    Authors: Raíza Dias Freitas, Bruna Lorena Pereira Moro, Laura Regina Antunes Pontes, Haline Cunha Medeiros Maia, Ana Laura Passaro, Rodolfo Carvalho Oliveira, Jonathan Rafael Garbim, Maria Eduarda Franco Vigano, Tamara Kerber Tedesco, Christopher Deery, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes and Mariana Minatel Braga
    Citation: Trials 2021 22:794
  3. Alcohol consumption causes a spectrum of liver abnormalities and leads to over 3 million deaths per year. Alcoholic hepatitis (AH) is a florid presentation of alcoholic liver disease characterized by liver fai...

    Authors: N. Vergis, V. Patel, K. Bogdanowicz, J. Czyzewska-Khan, F. Fiorentino, E. Day, M. Cross, N. Foster, E. Lord, R. Goldin, E. Forrest and M. Thursz
    Citation: Trials 2021 22:792
  4. Problems continue to exist with the reporting quality and risk of bias in search methods and strategies in systematic reviews and related review types. Peer reviewers who are not familiar with what is required...

    Authors: Melissa L. Rethlefsen, Sara Schroter, Lex M. Bouter, David Moher, Ana Patricia Ayala, Jamie J. Kirkham and Maurice P. Zeegers
    Citation: Trials 2021 22:791
  5. Raising children in new social and cultural contexts can be challenging for parents. In order to help parents address these challenges, the Norwegian government has instituted a policy of mandatory parent trai...

    Authors: Joshua Patras, Merete Saus, Marcela Douglas, Ragnhild Bjørknes, Siri Gammelsæter, Lene-Mari Potulski Rasmussen, Therese Halvorsen, Ida Mari Haug, Ragnhild Risholm, Tuva Øktedalen, Reidar Jakobsen and Simon Peter Neumer
    Citation: Trials 2021 22:790
  6. Evidence from previous studies is often used relatively informally in the design of clinical trials: for example, a systematic review to indicate whether a gap in the current evidence base justifies a new tria...

    Authors: Gemma L. Clayton, Daisy Elliott, Julian P. T. Higgins and Hayley E. Jones
    Citation: Trials 2021 22:789
  7. There are several challenges in designing clinical trials for the treatment of novel infectious diseases, such as COVID-19. In particular, the definition of endpoints related to the severity, time frame, and c...

    Authors: Kentaro Sakamaki, Yukari Uemura and Yosuke Shimizu
    Citation: Trials 2021 22:788
  8. About 13% of African Americans and 13% of Hispanics have diabetes, compared to 8% of non-Hispanic Whites (NHWs). This is more pronounced in the elderly where about 25–30% of those aged 65 and older have diabet...

    Authors: Leonard E. Egede, Tatiana M. Davidson, Rebecca G. Knapp, Rebekah J. Walker, Joni S. Williams, Clara E. Dismuke and Aprill Z. Dawson
    Citation: Trials 2021 22:787
  9. Electroconvulsive therapy (ECT) is well-established and effective for treatment-resistant depression (TRD), but in Canada and the USA, less than 1% of patients with TRD receive ECT mainly due to its cognitive ...

    Authors: Zafiris J. Daskalakis, Carol Tamminga, Alanah Throop, Lucy Palmer, Julia Dimitrova, Faranak Farzan, Kevin E. Thorpe, Shawn M. McClintock and Daniel M. Blumberger
    Citation: Trials 2021 22:786

    The Update to this article has been published in Trials 2021 22:906

  10. Canada has one of the highest rates of multiple sclerosis (MS) in the world. Treatments and supports for people with MS (PwMS) have become increasingly complex, requiring individualized and adaptive care. Spec...

    Authors: Penelope Smyth, Kaitlyn E. Watson and Ross T. Tsuyuki
    Citation: Trials 2021 22:785
  11. Targeted normoxia (SpO2 90–96% or PaO2 60–100 mmHg) may help to conserve oxygen and improve outcomes in critically ill patients by avoiding potentially harmful hyperoxia. However, the role of normoxia for critica...

    Authors: Layne Dylla, David J. Douin, Erin L. Anderson, John D. Rice, Conner L. Jackson, Vikhyat S. Bebarta, Christopher J. Lindsell, Alex C. Cheng, Steven G. Schauer and Adit A. Ginde
    Citation: Trials 2021 22:784
  12. The majority of older people (> 65 years) in hospital have frailty and are at increased risk of readmission or death following discharge home. In the UK, following acute hospitalisation, around one third of ol...

    Authors: Matthew Prescott, Amanda Lilley-Kelly, Bonnie Cundill, David Clarke, Sian Drake, Amanda J. Farrin, Anne Forster, Madeline Goodwin, Victoria A. Goodwin, Abi J. Hall, Suzanne Hartley, Mike Holland, Claire Hulme, Silviya Nikolova, Catriona Parker, Phil Wright…
    Citation: Trials 2021 22:783
  13. Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates. Patients’ adherence to both treatment...

    Authors: Xavier Pourrat, Elise Berthy, Antoine Dupuis, Louise Barbier, Matthias Buchler, Leslie Grammatico Guillon, Fanny Monmousseau, Eric Ruspini, Ephrem Salamé, Solène Brunet Houdard and Bruno Giraudeau
    Citation: Trials 2021 22:782

    The Correction to this article has been published in Trials 2022 23:438

  14. Polycystic ovary syndrome (PCOS) is a common reproductive endocrine disease in women. Insulin resistance (IR) has emerged as a central contributor to the pathogenesis of this disease. According to traditional ...

    Authors: Haiqing Qian, Wenting Xu, Lijuan Cui, Rong Wang, Jiahui Wang, Mengyu Tang, Minggang Wei and Lihong Wang
    Citation: Trials 2021 22:781
  15. Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly challenging given the complexities of what is both practical and ethical to randomize. We are often faced with t...

    Authors: Noah A. Haber, Sarah E. Wieten, Emily R. Smith and David Nunan
    Citation: Trials 2021 22:780

    The Correction to this article has been published in Trials 2021 22:951

    The original article was published in Trials 2021 22:234

  16. People with physical disabilities need exercise routines that are enjoyable, readily available in the home, adapted to their functional level, and eliminate common barriers to exercise participation related to...

    Authors: Hui-Ju Young, Byron Lai, Tapan Mehta, Mohanraj Thirumalai, Jereme Wilroy, Alex Yates, Brandon Kane and James H. Rimmer
    Citation: Trials 2021 22:779
  17. A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention mo...

    Authors: Maurine D. Miner, Linda-Gail Bekker, Tamara Kredo, Niresh Bhagwandin, Lawrence Corey and Glenda E. Gray
    Citation: Trials 2021 22:778
  18. Strong evidence supports the proximal combined with quadriceps strengthening for patellofemoral pain (PFP) rehabilitation. However, most reported rehabilitation programs do not follow specific exercise prescri...

    Authors: Gabriela Souza de Vasconcelos, Guilherme Silva Nunes, Christian John Barton, Raquel Fantinelli Munhoz, Maria Eduarda Chinotti Batista da Silva, Giulia Keppe Pisani, Bruna Calazans Luz and Fábio Viadanna Serrão
    Citation: Trials 2021 22:777
  19. Despite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We a...

    Authors: Scott L. Weiss, Fran Balamuth, Elliot Long, Graham C. Thompson, Katie L. Hayes, Hannah Katcoff, Marlena Cook, Elena Tsemberis, Christopher P. Hickey, Amanda Williams, Sarah Williamson-Urquhart, Meredith L. Borland, Stuart R. Dalziel, Ben Gelbart, Stephen B. Freedman, Franz E. Babl…
    Citation: Trials 2021 22:776
  20. Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter fun...

    Authors: Kerri M. Winters-Stone, Fuzhong Li, Fay Horak, Nathan Dieckmann, Arthur Hung, Christopher Amling and Tomasz M. Beer
    Citation: Trials 2021 22:775
  21. Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) pl...

    Authors: Chong Guan, Ziji Cheng, Fangfang Xie, Ruiping Wang, Jing Zhang, Fei Yao and Min Fang
    Citation: Trials 2021 22:774
  22. Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementat...

    Authors: Maria Bryant, Wendy Burton, Michelle Collinson, Amanda Farrin, Jane Nixon, June Stevens, Kim Roberts, Robbie Foy, Harry Rutter, Bethan Copsey, Suzanne Hartley, Sandy Tubeuf and Julia Brown
    Citation: Trials 2021 22:773
  23. Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles ...

    Authors: Chunmei Zhao, Zipu Jia, Niti Shrestha and Fang Luo
    Citation: Trials 2021 22:772
  24. Constipation is known as a common adverse effect of antipsychotics. Advice for its management remains inadequate. This study is designed to investigate the efficacy and safety of electro-acupuncture (EA) for a...

    Authors: Fang-Ting Yu, Di-He Long, Guang-Xia Shi, Li-Qiong Wang, Jian-Feng Tu, Li-Li Gang, Fu-Quan Liu, Yang Wang, Xiao Cui, Si Bao, Yu Yu, Wei Wei, Shi-Yan Yan, Jing-Wen Yang and Cun-Zhi Liu
    Citation: Trials 2021 22:771
  25. Insomnia is very common in current society, and patients are often accompanied by a certain degree of anxiety, depression, etc. Recent studies have found that the hypothalamic-pituitary-adrenal (HPA) axis exci...

    Authors: Ying Yuan, Qinghui Zhou, Fanfu Fang, Weihong Li and Yanli You
    Citation: Trials 2021 22:770
  26. Trauma is the leading cause of death and disability in children in the USA. Tranexamic acid (TXA) reduces the blood transfusion requirements in adults and children during surgery. Several studies have evaluate...

    Authors: John M. VanBuren, T. Charles Casper, Daniel K. Nishijima, Nathan Kuppermann, Roger J. Lewis, J. Michael Dean and Anna McGlothlin
    Citation: Trials 2021 22:769
  27. The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if 177Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive prostate cancer (oHSPC) to prolong ...

    Authors: Bastiaan M. Privé, Marcel J. R. Janssen, Inge M. van Oort, Constantijn H. J. Muselaers, Marianne A. Jonker, Willemijn A. van Gemert, Michel de Groot, Harm Westdorp, Niven Mehra, J. Fred Verzijlbergen, Tom W. J. Scheenen, Patrik Zámecnik, Jelle O. Barentsz, Martin Gotthardt, Walter Noordzij, Wouter V. Vogel…
    Citation: Trials 2021 22:768

    The Study protocol to this article has been published in BMC Cancer 2020 20:884

  28. While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiati...

    Authors: T. X. Wong, S. T. Chen, S. H. Ong, S. Shyam, P. Kandasami and W. S. S. Chee
    Citation: Trials 2021 22:767
  29. Targeted deprescribing of anticholinergic and sedative medications in older people may improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescri...

    Authors: Ulrich Bergler, Nagham J. Ailabouni, John W. Pickering, Sarah N. Hilmer, Dee Mangin, Prasad S. Nishtala and Hamish Jamieson
    Citation: Trials 2021 22:766
  30. Overall survival remains poor in older patients with acute myeloid leukemia (AML) with less than 10% being alive after 5 years. In recent studies, a significant improvement in event-free, relapse-free and over...

    Authors: Sonia Jaramillo, Johannes Krisam, Lucian Le Cornet, Markus Kratzmann, Lukas Baumann, Tim Sauer, Martina Crysandt, Andreas Rank, Dirk Behringer, Lino Teichmann, Martin Görner, Ralf-Ulrich Trappe, Christoph Röllig, Stefan Krause, Maher Hanoun, Olaf Hopfer…
    Citation: Trials 2021 22:765
  31. Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with the primary clinical symptoms of joint swelling and pain. Early detection of erosion and synovial inflammation at an active stage res...

    Authors: Jiaying Shen, Qianwen Chen, Guanghui Yang and Yikun He
    Citation: Trials 2021 22:764
  32. Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications...

    Authors: Marc-Eric Nadeau, Justine L. Henry, Todd C. Lee, Émilie Bortolussi-Courval, Carole Goodine and Emily G. McDonald
    Citation: Trials 2021 22:763
  33. It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continu...

    Authors: Oliver Ristow, Christof Hofele, Philipp Münch, Sylvia Danner, Anja Dietzel, Johannes Krisam, Christina Klose, Maximilian Pilz, Jürgen Hoffmann and Christian Freudlsperger
    Citation: Trials 2021 22:762
  34. Sleep deprivation (SD) among young adults is a major public health concern. In humans, it has adverse effects on mood and results in serious health problems. Faced with SD, persons may take precautionary measu...

    Authors: Bing Yan, Fu-chun Wang, Tian-shu Ma, Yan-ze Liu, Wu Liu, Lei Cheng, Zi-yuan Wang, Zhong-ke Wang and Cheng-yu Liu
    Citation: Trials 2021 22:761
  35. Amblyopia, as a neurodevelopmental preventable visual disorder, affects approximately 1.1 % in Asia. A binocular approach to treating amblyopia has been recently proposed. Whether the binocular playing game tr...

    Authors: Mohammad Etezad Razavi, Marzieh Najjaran, Jaber Mohseni and Shokoufeh Aalaei
    Citation: Trials 2021 22:760
  36. There has been immense interest and debate regarding the effectiveness of antibiotic treatment for chronic low back pain. Two randomised controlled trials have examined the efficacy of antibiotics for chronic ...

    Authors: Donna M. Urquhart, Jeffrey V. Rosenfeld, Maurits van Tulder, Anita E. Wluka, Karin Leder, Allen C. Cheng, Andrew B. Forbes, Patrick Chan, Richard O’Sullivan, Susan Liew and Flavia M. Cicuttini
    Citation: Trials 2021 22:759
  37. Lipedema is a chronic disorder of the adipose tissue that affects mainly women, characterised by symmetrical, excessive fatty tissue on the legs and pain. Standard conservative treatment is long-term comprehen...

    Authors: Maurizio Podda, Maximilian Kovacs, Martin Hellmich, Rebecca Roth, Marouan Zarrouk, Daria Kraus, Reinhild Prinz-Langenohl and Oliver A. Cornely
    Citation: Trials 2021 22:758
  38. Patients with substance use disorders are overrepresented among general hospital inpatients, and their admissions are associated with longer lengths of stay and increased readmission rates. Amid the national o...

    Authors: David E. Marcovitz, Katie D. White, William Sullivan, Heather M. Limper, Mary Lynn Dear, Reagan Buie, David A. Edwards, Cody Chastain, Kristopher A. Kast and Christopher J. Lindsell
    Citation: Trials 2021 22:757
  39. Non-alcoholic steatohepatitis (NASH) is frequently associated with obesity, and its standard treatment is weight loss with diet and exercise; a dy% weight reduction has been associated with improvement in live...

    Authors: Lucía Lavín-Alconero, Tatiana Fernández-Lanas, Paula Iruzubieta-Coz, Maria Teresa Arias-Loste, Juan Carlos Rodriguez-Duque, Coral Rivas, Maria Luisa Cagigal, Coral Montalbán, Antonio Lopez Useros, Ana Álvarez-Cancelo, Mar García-Saiz and Javier Crespo-García
    Citation: Trials 2021 22:756
  40. Facial expression muscles atrophy is one kind of sequelae after peripheral facial paralysis. It causes critical problems in facial appearance of patient as well as social and psychological problems. This study...

    Authors: Binyan Yu, Lihua Xuan, Yutong Jin, Shan Chen, Shan Liu and Yijia Wan
    Citation: Trials 2021 22:755
  41. During child psychiatry hospitalization, working with the families or attachment figures is a challenge, most of the children who are admitted to these units come from multi-problem families, with limited rese...

    Authors: Fanny Leyton, Marcia Olhaberry, Javier Morán, Cecilia De la Cerda, María José León, Catalina Sieverson, Ángela Alfaro, Camila Hernández, Rubén Alvardo and Howard Steele
    Citation: Trials 2021 22:754
  42. Survival benefit of adjuvant radiotherapy for locally advanced gastric cancer following gastrectomy plus D2 lymphadenectomy has always been controversial. Esophagogastric junction (EGJ) adenocarcinoma, which i...

    Authors: Jinwen Shen, Xiu Zhu, Yian Du, Yuan Zhu, Pengfei Yu, Litao Yang, Zhiyuan Xu, Ling Huang, Yunli Zhang, Yanqiang Zhang, Luying Liu and Xiangdong Cheng
    Citation: Trials 2021 22:753
  43. Problems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poo...

    Authors: Aida Bikic, Søren Dalsgaard, Kristoffer Dalsgaard Olsen and Denis G. Sukhodolsky
    Citation: Trials 2021 22:752
  44. Family caregivers of dying cancer patients are affected by grief experiences and bereavement complications. Several approaches such as psycho-emotional care and an increase in spirituality have been suggested ...

    Authors: Naima Seyedfatemi, Tahereh Najafi Ghezeljeh, Jafar Bolhari and Masoud Rezaei
    Citation: Trials 2021 22:751
  45. Diabetic foot ulcers have a high impact on mobility and daily functioning and lead to high treatment costs, for example, by hospitalization and amputation. To prevent (re)ulcerations, custom-made orthopedic sh...

    Authors: M. Jongebloed-Westra, C. Bode, J. J. van Netten, P. M. ten Klooster, S. H. Exterkate, H. Koffijberg and J. E. W. C. van Gemert-Pijnen
    Citation: Trials 2021 22:750
  46. Parents’ mental illness (MI) and parental history of early life maltreatment (ELM) are known to be significant risk factors for poor parenting while poor parenting is a crucial mediator of the intergenerationa...

    Authors: C. Neukel, F. Bermpohl, M. Kaess, S. Taubner, K. Boedeker, K. Williams, A. Dempfle and S. C. Herpertz
    Citation: Trials 2021 22:749
  47. Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological ch...

    Authors: Rasmus Kramer Mikkelsen, Lars Blønd, Lisbeth Rosenkrantz Hölmich, Cecilie Mølgaard, Anders Troelsen, Per Hölmich and Kristoffer Weisskirchner Barfod
    Citation: Trials 2021 22:748
  48. After a stroke, 80% of the chronic patients have difficulties to use their paretic upper limb (UL) in activities of daily life (ADL) even after rehabilitation. Virtual reality therapy (VRT) and anodal transcra...

    Authors: Camille O. Muller, Makii Muthalib, Denis Mottet, Stéphane Perrey, Gérard Dray, Marion Delorme, Claire Duflos, Jérôme Froger, Binbin Xu, Germain Faity, Simon Pla, Pierre Jean, Isabelle Laffont and Karima K. A. Bakhti
    Citation: Trials 2021 22:747
  49. Overactive bladder (OAB) syndrome is a symptom complex affecting 12–14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary freq...

    Authors: M. Abdel-fattah, C. Chapple, K. Guerrero, S. Dixon, N. Cotterill, K. Ward, H. Hashim, A. Monga, K. Brown, M. J. Drake, A. Gammie, A. Mostafa, U. K. Bladder Health, S. Breeman, D. Cooper, G. MacLennan…
    Citation: Trials 2021 22:745
  50. The prevalence of renal calculi in patients with gout is high. Alkalized urine has been recommended by the 2020 European Association of Urology (EAU) guidelines to promote calculus dissolution. However, random...

    Authors: Ertao Jia, Haiqiong Zhu, Hongling Geng, Yadong Wang, Li Zhong, Shangwen Liu, Feng Lin and Jianyong Zhang
    Citation: Trials 2021 22:743

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