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  1. The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ag...

    Authors: Andrey Grin, Ivan Lvov, Aleksandr Talypov, Vladimir Smirnov, Anton Kordonskiy, Valeriy Lebedev, Andrey Zuev, Ilya Senko, Iren Pogonchenkova and Vladimir Krylov
    Citation: Trials 2023 24:451
  2. Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clin...

    Authors: Simon Crabb, Alannah Morgan, Myra S. Hunter, Evgenia Stefanopoulou, Gareth Griffiths, Alison Richardson, Deborah Fenlon, Louisa Fleure, James Raftery, Cherish Boxall, Sam Wilding, Jacqueline Nuttall, Zina Eminton, Emma Tilt, Alice O’Neill, Roger Bacon…
    Citation: Trials 2023 24:450
  3. Muscle cramps are a common and often disabling symptom in amyotrophic lateral sclerosis (ALS), a devastating and incurable neurodegenerative disorder. To date, there are no medications specifically approved fo...

    Authors: Hiroshi Mitsumoto, Ken Cheung, Björn Oskarsson, Howard F. Andrews, Grace E. Jang, Jinsy A. Andrews, Jaimin S. Shah, Joseph Americo Fernandes, Martin McElhiney and Regina M. Santella
    Citation: Trials 2023 24:449
  4. Hypertension is a highly relevant public health challenge. Digital interventions may support improving adherence to anti-hypertensive medications and alter health behavior. Therefore, this protocol describes a...

    Authors: Muhammad Arshed, Rubeena Zakar, Muhammad Farooq Umer, Mehwish Kiran, Najeeb Ullah, Ghazala Iftikhar and Florian Fischer
    Citation: Trials 2023 24:448
  5. Children undergoing anaesthetic induction experience peri-operative anxiety associated with negative outcomes including emergence delirium, short- and long-term maladaptive behaviour and increased postoperativ...

    Authors: Krittika Vongkiatkajorn, Erin A. Brown, Alexandra Donaldson, Vanessa Rich, Rebecca Paterson, Justin Kenardy, Cameron Graydon and Paul Lee-Archer
    Citation: Trials 2023 24:446
  6. Although the number of cancer clinical drug trials is increasing rapidly in China, issues concerning informed consent in this research context are understudied. By performing a narrative literature review, we ...

    Authors: Xing Liu, Xiaoran Lu, Wei Zhou, Jessica Hahne, Kaveh Khoshnood, Xiaoting Shi, Yuqiong Zhong and Xiaomin Wang
    Citation: Trials 2023 24:445
  7. Pain is frequent after cardiac surgery and source of multiple complications that can impair postoperative recovery. Regional anesthesia seems to be an interesting technique to reduce the pain in this context, ...

    Authors: Audrey Jeanneteau, Achille Demarquette, Aymeric Blanchard-Daguet, Olivier Fouquet, Sigismond Lasocki, Jérémie Riou, Emmanuel Rineau and Maxime Léger
    Citation: Trials 2023 24:444
  8. Clinical trials aim to draw conclusions about the effects of treatments, but a trial can address many different potential questions. For example, does the treatment work well for patients who take it as prescr...

    Authors: Suzie Cro, Brennan C Kahan, Akshaykumar Patel, Ania Henley, Joanna C, Paul Hellyer, Manos Kumar, Yasmin Rahman and Beatriz Goulão
    Citation: Trials 2023 24:443
  9. The coronavirus disease 2019 (COVID-19) pandemic has been shown to affect nutritional recommendations. Some functional foods have been demonstrated to be useful in the treatment of people with COVID-19. Howeve...

    Authors: Hadi Esmaeili Gouvarchinghaleh, Fateme Kiany, Karim Parastouei, Gholamhosein Alishiri, Nematollah Jonaidi Jafari, Abbas Ali Imani Fooladi, Afsaneh Pargar, Ali Ghazvini, Reza Mirnejad, Mehdi Raei, Ahmadreza Sharifi Olounabadi, Mansour Babaei, Soleyman Heydari, Hosein Rostami, Alireza Shahriary, Gholamreza Farnoosh…
    Citation: Trials 2023 24:442
  10. Type 2 diabetes mellitus (T2DM) has increased globally; with a disproportionate burden in South and Southeast Asian countries, including Nepal. There is an urgent need for clinically and cost-effective cultura...

    Authors: Lal Rawal, Padam Dahal, Grish Paudel, Tuhin Biswas, Rabina Shrestha, Deepa Makaju, Abha Shrestha, Uday Yadav, Berhe W Sahle, Hanako Iwashita, Gaku Masuda, Andre Renzaho, Prabin Shakya, Archana Shrestha, Biraj Karmacharya, Haruka Sakamoto…
    Citation: Trials 2023 24:441
  11. Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies. Early intervention programs for people in the first 5 years after the initial psychoti...

    Authors: D. Jäckel, A. Willert, A. Brose, K. Leopold, D. Nischk, S. Senner, O. Pogarell, S. Sachenbacher, M. Lambert, A. Rohenkohl, P. Kling-Lourenco, N. Rüsch, F. Bermpohl, M. Schouler-Ocak, V. Disselhoff, U. Skorupa…
    Citation: Trials 2023 24:440

    The Correction to this article has been published in Trials 2023 24:476

  12. Comprehensive Behavioral Intervention for Tics (CBIT) is a first-line treatment for tic disorders that aims to improve controllability over tics that an individual finds distressing or impairing. However, it i...

    Authors: Christine Conelea, Deanna J. Greene, Jennifer Alexander, Kerry Houlihan, Sarah Hodapp, Brianna Wellen, Sunday Francis, Bryon Mueller, Tim Hendrickson, Angela Tseng, Mo Chen, Mark Fiecas, Kelvin Lim, Alexander Opitz and Suma Jacob
    Citation: Trials 2023 24:439
  13. Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 3...

    Authors: Juliette Vay-Demouy, Alexandre Cinaud, Nathan Malka, Baptiste Mion, Sandrine Kretz, Hélène Lelong and Jacques Blacher
    Citation: Trials 2023 24:438
  14. Pediatric research is crucial for the development of new scientific advancements, treatments, and therapies for adolescents. Yet relatively few pediatric clinical trials are conducted due to barriers to succes...

    Authors: Alison E. Parker, Tracy M. Scull and Kathryn L. Kennedy
    Citation: Trials 2023 24:436
  15. Parkinson’s disease (PD) is associated with changes in gait and posture, which increases the rate of falls and injuries in this population. Tai Chi (TC) training enhances the movement capacity of patients with...

    Authors: Nok-Yeung Law, Jing Xian Li, Qingguang Zhu and Julie Nantel
    Citation: Trials 2023 24:241
  16. The duration and regimen of tuberculosis (TB) treatment is currently based predominantly on whether the M. tuberculosis (Mtb) strain is drug-sensitive (DS) or multidrug-resistant (MDR) with doses adjusted by pati...

    Authors: Lilibeth Arias, Kennedy Otwombe, Ziyaad Waja, Nestani Tukvadze, Tamta Korinteli, Tumelo Moloantoa, Kaori L Fonseca, Natasha Pillay, Thabiso Seiphetlo, Dan Ouchi-Vernet, Adrian Siles, Lidia Carabias, Carles Quiñones, Sergo Vashakidze, Neil Martinson and Cristina Vilaplana
    Citation: Trials 2023 24:435
  17. In 2021, there were 38.4 million people living with HIV (PLHIV) globally, of which 20.6 million (54%) were living in Eastern and Southern Africa. Longitudinal studies, inclusive of community randomized trials ...

    Authors: Nomtha Bell-Mandla, Ethan Wilson, Deeksha Sharma, Rosa Sloot, Justin Bwalya, Ab Schaap, Deborah Donnell, Estelle Piwowar-Manning, Sian Floyd, Nozizwe Makola, Lungiswa Nkonki, Musonda Simwinga, Ayana Moore, Richard Hayes, Sarah Fidler, Helen Ayles…
    Citation: Trials 2023 24:434
  18. Literacy is one of the most important skills a students can achieve, as it provides access to information and communication. Unfortunately, literacy skills are not easily acquired, especially for students with...

    Authors: Line Britt Ulriksen, Marthe Bilet-Mossige, Hugo Cogo Moreira, Kenneth Larsen and Anders Nordahl-Hansen
    Citation: Trials 2023 24:433
  19. Stenosis is one of the most common complications in patients with Crohn’s disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previo...

    Authors: Carme Loras, Pablo Ruiz-Ramirez, Juan Romero, Xavier Andújar, Josep Bargallo, Esther Bernardos, Marta Maia Boscá-Watts, Carlo Brugiotti, Eduard Brunet, David Busquets, Elena Cerrillo, Francisco Javier Cortina, Juan Antonio Díaz-Milanés, Carmen Dueñas, Ramón Farrés, Thomas Golda…
    Citation: Trials 2023 24:432
  20. Excessive exposure to solar ultraviolet (UV) radiation can cause skin cancer. Implementing new technologies and computational algorithms can potentially change the outlook for cancer prevention and facilitate ...

    Authors: Hassan Okati-Aliabad, Esmat Sadat Hosseini, Mohammad Ali Morowati Sharifabad, Mahdi Mohammadi, Mohamad Ebrahimzadeh Ardakani and Amir Hossein Talebrouhi
    Citation: Trials 2023 24:430
  21. Recent studies have demonstrated a correlation between intestinal flora and the severity of myocardial infarction as well as post-myocardial infarction repair. However, few studies have investigated whether pr...

    Authors: Yequn Chen, Rongbing Chen, Xin Wang, Yan Zhou, Liekai Hong, Nianling Xiong, Jinxiu Zhu, Shu Ye and Xuerui Tan
    Citation: Trials 2023 24:429
  22. Uganda’s community health worker (CHW), or village health team (VHT), program faces significant challenges with poor retention and insufficient financial and program investment. Adequate compensation comprisin...

    Authors: Smisha Agarwal, Raymond Tweheyo, Shivani Pandya, Emmanuel Obuya, Arisa Kiyomoto, Paloma Mitra, Meike Schleiff, Tanvi Nagpal, Mario Macis and Elizeus Rutebemberwa
    Citation: Trials 2023 24:428
  23. Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at...

    Authors: Sander L. Osstyn, Ron Handels, Lizzy M. M. Boots, Sanne C. E. Balvert, Silvia M. A. A. Evers and Marjolein E. de Vugt
    Citation: Trials 2023 24:427
  24. Many randomized trials that aim to assess new or commonly used medical or surgical interventions have been so small that the validity of conclusions becomes questionable.

    Authors: Jean Raymond, Tim E. Darsaut, Johanna Eneling and Miguel Chagnon
    Citation: Trials 2023 24:426
  25. Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diag...

    Authors: Scott C. Mackenzie, Jacqueline Stephen, Linda Williams, Jane Daniels, John Norrie, Christian M. Becker, Dominic Byrne, Ying Cheong, T. Justin Clark, Kevin G. Cooper, Emma Cox, Ann M. Doust, Priscilla Fernandez, Jeremy Hawe, Tom Holland, Lone Hummelshoj…
    Citation: Trials 2023 24:425
  26. The COVID-19 pandemic impacted the operationalisation of non-COVID-19 clinical trials globally, particularly site and participant recruitment and trial success/stoppage. Trials which anticipate recruitment cha...

    Authors: Ava Lorenc, Leila Rooshenas, Carmel Conefrey, Julia Wade, Nicola Farrar, Nicola Mills, Sangeetha Paramasivan, Alba Realpe and Marcus Jepson
    Citation: Trials 2023 24:424
  27. As a practice-oriented discipline, strict adherence to reporting guidelines is particularly important in randomized controlled trial (RCT) abstracts of the nursing area. However, whether abstract reports after...

    Authors: Yan He, Rong Zhang, Wenjing Shan, Yuhuan Yin, Xiaoli Zhang, Yiyin Zhang and Xiaoping Wang
    Citation: Trials 2023 24:423
  28. Patients experience considerable postoperative pain after spinal surgery. As the spine is located at the centre of the body and supports body weight, severe postoperative pain hinders upper body elevation and ...

    Authors: Ki-Hoon Park, Nam-Su Chung, Hee-Woong Chung, Tae Young Kim and Han-Dong Lee
    Citation: Trials 2023 24:422
  29. Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the ...

    Authors: Debbie Tallon, Laura Thomas, Sally Brabyn, Brian Chi Fung Ching, Jane Sungmin Hahn, Berry Jude, Mekeda X Logan, Alex Burrage, Fiona Fox, Simon Gilbody, Paul Lanham, Glyn Lewis, Jinshuo Li, Stephanie J. MacNeill, Irwin Nazareth, Steve Parrott…
    Citation: Trials 2023 24:421
  30. Anxiety is commonly experienced by people living with mild cognitive impairment (MCI) and dementia. Whilst there is strong evidence for late-life anxiety treatment using cognitive behavioural therapy (CBT) and...

    Authors: Nadeeka Dissanayaka, Deborah Brooks, Peter Worthy, Leander Mitchell, Nancy A. Pachana, Gerard Byrne, Syed Afroz Keramat, Tracy Comans, Sally Bennett, Jacki Liddle, Mark D. Chatfield, Annette Broome, Joanne Oram, Kanaganayagam Appadurai, Elizabeth Beattie, Tiffany Au…
    Citation: Trials 2023 24:420
  31. Abdominal aortic aneurysm (AAA) is a fatal disease due to the tendency to rupture. The drug treatment for small AAA without surgical indications has been controversial. Previous studies showed that high-sensit...

    Authors: Jingyuan Li, Sicong Ma, Xiu Jia, Yingzhen Bu, Tienan Zhou, Lei Zhang, Miaohan Qiu and Xiaozeng Wang
    Citation: Trials 2023 24:419
  32. The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the recommended treatments for neuropathic pain, namely antidepressants and/or gabapentinoids, requires t...

    Authors: Julien Todeschi, Guillaume Dannhoff, Andres Hugo Coca, Daniel Ionut Timbolschi, François Proust, François Lefebvre, Vincent Lelievre, Pierrick Poisbeau, Laurent Vallat, Eric Salvat and Yohann Bohren
    Citation: Trials 2023 24:418
  33. Aneurysmal subarachnoid hemorrhage (aSAH) is a neurological emergency, affecting a younger population than individuals experiencing an ischemic stroke; aSAH is associated with a high risk of mortality and perm...

    Authors: Mikael Laaksonen, Jaakko Rinne, Melissa Rahi, Jussi P. Posti, Ruut Laitio, Juri Kivelev, Ilkka Saarenpää, Dan Laukka, Juhana Frösen, Antti Ronkainen, Stepani Bendel, Jaakko Långsjö, Marika Ala-Peijari, Jani Saunavaara, Riitta Parkkola, Mikko Nyman…
    Citation: Trials 2023 24:417
  34. Critically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. I...

    Authors: Rob J. J. van Gassel, Julia L. M. Bels, Katrien Tartaglia, Bas C. T. van Bussel, Sander M. J. van Kuijk, Adam M. Deane, Zudin Puthucheary, Peter J. M. Weijs, Lilian Vloet, Bert Beishuizen, Ashley De Bie Dekker, Vincent Fraipont, Stoffel Lamote, Didier Ledoux, Clarissa Scheeren, Elisabeth De Waele…
    Citation: Trials 2023 24:416
  35. Different dietary protein sources are supposed to have various effects on metabolic responses and arterial stiffness in the postprandial period. This study aims to assess the postprandial effects of dietary pr...

    Authors: Zahra Dehnavi, Ali Jafarzadeh Esfehani, Omolbanin Hajhoseini, Hanieh Barghchi, Aliyeh Ghannadzadeh Yazdi, Zahra Khorasanchi, Mahdi Shadnoush, Reza Rezvani, Habibollah Esmaily and Mohammad Safarian
    Citation: Trials 2023 24:415
  36. Age-related macular degeneration (AMD) is an irreversible blinding eye condition with complex genetic and environmental etiologies. Genetic testing for AMD for previously identified multiple-risk single nucleo...

    Authors: Emmanuel K. Addo, M. Elizabeth Hartnett and Paul S. Bernstein
    Citation: Trials 2023 24:414
  37. New treatment strategies are required against infections caused by Helicobacter pylori, which grows increasingly resistant to antibiotics. Polymerase chain reaction-based methods for antibiotic susceptibility tes...

    Authors: Kemei Lu, Cuicui Lang, Xuefei Zou, Lina Zang, WeiWei Sang, Qian Feng, Ying Mu, Lifeng Liu, Chunhong Xu and Jingrun Zhao
    Citation: Trials 2023 24:413
  38. After esophagectomy for esophageal and esophagogastric cancer, more than half of patients have lost > 10% of their body weight at 12 months. In most cases, the gastric remnant is used for reconstruction after ...

    Authors: Naoya Okada, Yoshihiro Kinoshita, Shoji Nishihara, Takuma Kurotaki, Aya Sato, Kotaro Kimura, Hiroki Kushiya, Kazufumi Umemoto, Shotaro Furukawa, Takumi Yamabuki, Minoru Takada, Kentaro Kato, Yoshiyasu Ambo and Fumitaka Nakamura
    Citation: Trials 2023 24:412
  39. Low-carbohydrate diet (LCD) is an emerging therapy for type 2 diabetes mellitus (T2DM). Although its effect on glucose control has been confirmed in previous clinical trials, most of those studies have focused...

    Authors: Xinyi Xia, Miao Xu, Yunjie Gu, Yangxue Li, Li Li and Jun Yin
    Citation: Trials 2023 24:411
  40. First-line rehabilitative strategies to improve motor deficits are based on functional training (physical or occupational therapy), which has been demonstrated to facilitate neural reorganisation. Accumulating...

    Authors: Zhao-hui Jin, Yi-xuan Wang, De-tao Meng, Yi Qin, Yi-nan Duan, Jin-ping Fang, Rui-dan Wang, Yan-jun Liu, Cui Liu, Ping Wang, Hong-jiao Yan, Yi Zhen, Xia An, Ke-ke Chen, Xin Yu, Diyang Lyu…
    Citation: Trials 2023 24:410
  41. Cervical hybrid surgery (HS) combines anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) to establish an individualized surgical plan for patients with multiple cervical disc d...

    Authors: Junbo He, Qingyu Liu, Zijiao Yang, Hao Liu, Tingkui Wu, Chen Ding, Kangkang Huang and Beiyu Wang
    Citation: Trials 2023 24:409
  42. Platform trials gained popularity during the last few years as they increase flexibility compared to multi-arm trials by allowing new experimental arms entering when the trial already started. Using a shared c...

    Authors: Marta Bofill Roig, Cora Burgwinkel, Ursula Garczarek, Franz Koenig, Martin Posch, Quynh Nguyen and Katharina Hees
    Citation: Trials 2023 24:408
  43. Patients with active nonvariceal upper gastrointestinal bleeding (NVUGIB) usually require urgent endoscopic treatment. Standard therapy (ST) using haemoclip + / − epinephrine injection is not always successful...

    Authors: Daniel Schmitz, Lucas Thielemann and Felix Grassmann
    Citation: Trials 2023 24:407

    The Correction to this article has been published in Trials 2023 24:718

  44. The rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low- and low-middle-income countries. These injuries are orthopedic emer...

    Authors: Billy T. Haonga, Jamieson M. O’Marr, Patrick Ngunyale, Joshua Ngahyoma, Justin Kessey, Ibrahim Sasillo, Patricia Rodarte, Tigist Belaye, Eleni Berhaneselase, Edmund Eliezer, Travis C. Porco, Saam Morshed and David W. Shearer
    Citation: Trials 2023 24:406
  45. Because of high demand on hospital beds, hospitals seek to reduce patients’ length of stay (LOS) while preserving the quality of care. In addition to usual intermittent vital sign monitoring, continuous monito...

    Authors: Sjoerd H. Garssen, Niels Kant, Carlijn A. Vernooij, Gert-Jan Mauritz, Mark V. Koning, Frank H. Bosch and Carine J. M. Doggen
    Citation: Trials 2023 24:405
  46. Ventilated infants frequently require supplemental oxygen, but its use should be monitored carefully due to associated complications. The achievement of oxygen saturation (SpO2) targets can be challenging as neon...

    Authors: Ourania Kaltsogianni, Theodore Dassios, Allan Jenkinson and Anne Greenough
    Citation: Trials 2023 24:404
  47. The factors which influence participant retention in paediatric randomised controlled trials are under-researched. Retention may be more challenging due to child developmental stages, involving additional part...

    Authors: Daisy M. Gaunt, Cat Papastavrou Brooks, Hugo Pedder, Esther Crawley, Jeremy Horwood and Chris Metcalfe
    Citation: Trials 2023 24:403

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