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  1. Vector control tools, long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS), have significantly contributed to malaria prevention efforts in sub-Saharan Africa. However, insecticide resista...

    Authors: Raphael N’Guessan, Serge-Brice Assi, Alphonsine Koffi, Phamien Ludovic Ahoua Alou, Anatole Mian, Nicole L. Achee, Benedicte Fustec, John P. Grieco, Fang Liu, Santosh Kumar, Matthew Noffsinger, Ashley Hudson, Tim W. R. Möhlmann and Marit Farenhorst
    Citation: Trials 2023 24:704
    Content type: Study protocol Published on:

  2. Supraspinatus tendon reconstruction (STR) was recently introduced as a new treatment option for irreparable posterosuperior massive rotator cuff tears (IPMRCT). STR was thought to be more advantageous than sup...

    Authors: Lin Ma, Xiaoli Gou and Binghua Zhou
    Citation: Trials 2023 24:702
    Content type: Study protocol Published on:

  3. Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus and lack of dorsiflexion after correction of the adductus deformity in clubfoot. Percutaneous tenotomy u...

    Authors: Manon Pigeolet, Jabbar Ghufran Syed, Sadia Ahmed, Muhammad Amin Chinoy and Mansoor Ali Khan
    Citation: Trials 2023 24:701
    Content type: Study protocol Published on:

  4. Cardiovascular diseases are a leading cause of mortality worldwide. A significant contributing factor to this mortality is the lack of engagement in preventive activities. Consequently, strategies for enhancin...

    Authors: Fernanda Laís Loro, Riane Martins, Cintia Laura Pereira de Araújo, Lucio Rene Prade, Denis Lima do Rosário, Marcos César da Rocha Seruffo, Italo Adriano Moraes de Freitas, Jéferson Nobre, Cristiano Bonato Both and Pedro Dal Lago
    Citation: Trials 2023 24:700
    Content type: Study protocol Published on:

  5. Authors: Aleksi Laajala, Paulus Tokola, Timo J. Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä and Olli-Pekka Alho
    Citation: Trials 2023 24:699
    Content type: Correction Published on:

    The original article was published in Trials 2021 22:617

  6. Chronic Obstructive Pulmonary Disease (COPD) is a chronic, noncommunicable disease characterized by hypoxemia, with altered lung function, dyspnea on mild exertion, limited tolerance to physical exertion, and ...

    Authors: Wilder Villamil-Parra, Édgar Cristancho-Mejía, Joan Ramon Torrella and Erica Mabel Mancera-Soto
    Citation: Trials 2023 24:698
    Content type: Study protocol Published on:

  7. Rheumatoid arthritis (RA) considerably impacts patients’ lives. Patients’ confidence in their ability to manage this impact, or self-efficacy, can be supported with self-management interventions. One approach ...

    Authors: Michaël Doumen, Elias De Meyst, Cedric Lefevre, Sofia Pazmino, Johan Joly, Delphine Bertrand, Mieke Devinck, René Westhovens and Patrick Verschueren
    Citation: Trials 2023 24:697
    Content type: Study protocol Published on:

  8. The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to sa...

    Authors: Maria Linander Vestager, Mathias Lühr Hansen, Marie Isabel Rasmussen, Gitte Holst Hahn, Simon Hyttel-Sørensen, Adelina Pellicer, Anne Marie Heuchan, Cornelia Hagmann, Eugene Dempsey, Gabriel Dimitriou, Gerhard Pichler, Gunnar Naulaers, Hans Fuchs, Jakub Tkaczyk, Jonathan Mintzer, Monica Fumagalli…
    Citation: Trials 2023 24:696
    Content type: Study protocol Published on:

  9. Cystic fibrosis (CF) is an autosomal recessive disorder caused by abnormal function of the chloride ion channels and characterized by pancreatic insufficiency and chronic endobronchial airway infection. Pulmon...

    Authors: Nadia Hamedi, Mehrnaz Kajbafvala, Shabnam ShahAli, MohammadReza Pourahmadi, Alireza Eshghi and MohammadReza Modaresi Estahbanati
    Citation: Trials 2023 24:695
    Content type: Study protocol Published on:

  10. Multidrug-resistant Gram-negative bacterial (MRGNB) infections represent a major public health threat. Cancer patients and, among them, hematological patients are most vulnerable to these infections. Gut colon...

    Authors: Ainhoa Fernández Moreno, Lucía Lavín-Alconero, Paula López de Ugarriza, Laura Solán Blanco, Sara Cáceres Hernández, Juan Miguel Bergua Burgués, María Izquierdo de Miguel, Ana Julia González Huerta, Marta Polo Zarzuela, Blanca Boluda, Karem Humala, Maria Luisa Calabuig, Maria Luz Amigo, Marián Cuesta Casas, María del Mar García-Saiz, Ana Fernández Verdugo…
    Citation: Trials 2023 24:694
    Content type: Study protocol Published on:

  11. Postoperative anaemia is common in older cardiac surgery patients and often caused by iron deficiency. Anaemia may negatively affect recovery after cardiac surgery. This study aims to determine the efficacy of...

    Authors: R. M. Smoor, T. C. D. Rettig, L. M. Vernooij, E. M. Groenewegen, H. P. A. van Dongen and P. G. Noordzij
    Citation: Trials 2023 24:693
    Content type: Study protocol Published on:

  12. The Government of Cambodia established the village health support groups (VHSGs) in 2003 to facilitate primary healthcare activities, including maternal and child health (MCH) services. However, VHSGs face sev...

    Authors: Chan Hang Saing, Mengieng Ung, Sovanthida Suy, Sreymom Oy, Chhavarath Dary, Esabelle Lo Yan Yam, Sophea Chhorn, Michiko Nagashima-Hayashi, Dyna Khuon, Sovatha Mam, Rattana Kim, Vonthanak Saphonn and Siyan Yi
    Citation: Trials 2023 24:692
    Content type: Study protocol Published on:

  13. The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowere...

    Authors: M. Elfghi, F. Jordan, S. Sultan and W. Tawfick
    Citation: Trials 2023 24:691
    Content type: Methodology Published on:

  14. Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in females characterized by ovulatory dysfunction, hyperandrogenism, and other metabolic disorders. Both intermittent fasting and ...

    Authors: Sepide Talebi, Sakineh Shab-Bidar, Hamed Mohammadi, Ashraf Moini and Kurosh Djafarian
    Citation: Trials 2023 24:690
    Content type: Study protocol Published on:

  15. A significant proportion of Canadian adults is impacted by chronic noncommunicable diseases. These conditions may be improved by peer-led health promotion interventions that target modifiable risk factors; how...

    Authors: Margherita Cameranesi, Rebecca Mollard, Robert Balshaw and Dylan MacKay
    Citation: Trials 2023 24:689
    Content type: Study protocol Published on:

  16. Type 2 diabetes (T2D) poses a growing public health burden, especially in low- and middle-income countries (LMICs). Task-shifting to lay village health workers (VHWs) and the use of digital clinical decision s...

    Authors: Felix Gerber, Ravi Gupta, Thabo Ishmael Lejone, Thesar Tahirsylaj, Tristan Lee, Maurus Kohler, Maria Ines Haldemann, Fabian Räber, Mamakhala Chitja, Molulela Manthabiseng, Makhebe Khomolishoele, Mota Mota, Matumaole Bane, Pauline Mamorontsane Sematle, Retselisitsoe Makabateng, Madavida Mphunyane…
    Citation: Trials 2023 24:688
    Content type: Study protocol Published on:

  17. Authors: Mathieu Pecqueux, Marius Distler, Olga Radulova-Mauersberger, Ulrike Neckmann, Sandra Korn, Christian Praetorius, Johannes Fritzmann, Anna Klimova, Jürgen Weitz and Christoph Kahlert
    Citation: Trials 2023 24:687
    Content type: Correction Published on:

    The original article was published in Trials 2023 24:641

  18. Existing treatments for young people with severe depression have limited effectiveness. The aim of the Study of Ketamine for Youth Depression (SKY-D) trial is to determine whether a 4-week course of low-dose s...

    Authors: Orli S. Schwartz, Paul Amminger, Bernard T. Baune, Gillinder Bedi, Michael Berk, Sue M. Cotton, Rothanthi Daglas-Georgiou, Nick Glozier, Ben Harrison, Daniel F. Hermens, Emma Jennings, Jim Lagopoulos, Colleen Loo, Sumudu Mallawaarachchi, Donel Martin, Bethany Phelan…
    Citation: Trials 2023 24:686
    Content type: Study protocol Published on:

  19. Diabetic macular edema (DME) is the main cause of vision loss in diabetic patients. Currently, anti-vascular endothelial growth factor (VEGF) intravitreal injection stands as the first-line therapy for DME. Ho...

    Authors: Haoxin Guo, Wenbo Li, Zetong Nie, Xiang Zhang, Mingfei Jiao, Siqiong Bai, Naxin Duan, Xiaorong Li and Bojie Hu
    Citation: Trials 2023 24:685
    Content type: Study protocol Published on:

  20. With regard to the esthetics and comfort of orthodontic treatment, the requirement for removable clear aligners (CAs) is increasing. Unlike conventional fixed orthodontic appliances, CAs were made of thermopla...

    Authors: Chuangchuang Mu, Bingjing Sun, Zhicheng Gong, Yuanyuan Wei, Li Chen, Wei Zhang, Haimiao Wu and Bingjiao Zhao
    Citation: Trials 2023 24:684
    Content type: Study protocol Published on:

  21. The autonomic nervous system can be responsible for the initiation and maintenance of arrhythmias. Low-level tragus stimulation (LLTS), a noninvasive form of autonomic neuromodulation, has been shown to be eff...

    Authors: Cheng Cai, Nan Wu, Gang Yang, Shu Yang, Wenjie Liu, Minglong Chen and Sunny S. Po
    Citation: Trials 2023 24:683
    Content type: Study protocol Published on:

  22. Hundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder...

    Authors: Abby Bailin, Evelyn Cho, Ariel Sternberg, Spencer C. Evans, Nathan L. Hollinsaid, Sarah Kate Bearman and John R. Weisz
    Citation: Trials 2023 24:682
    Content type: Study protocol Published on:

  23. CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers (“caregivers”) at the point of healthcare to address health-related social risks (HRSRs). Two CommunityRx ran...

    Authors: Emily M. Abramsohn, MariaDelSol De Ornelas, Soo Borson, Cristianne R. M. Frazier, Charles M. Fuller, Mellissa Grana, Elbert S. Huang, Jyotsna S. Jagai, Jennifer A. Makelarski, Doriane Miller, Dena Schulman-Green, Eva Shiu, Katherine Thompson, Victoria Winslow, Kristen Wroblewski and Stacy Tessler Lindau
    Citation: Trials 2023 24:681
    Content type: Study protocol Published on:

  24. In this commentary, we discuss a recent article in Trials that raised concerns about the number of poorly performed randomised trials in the medical literature and discuss the trials literature more widely. Altho...

    Authors: Fergus Hamilton, David Arnold and Richard Lilford
    Citation: Trials 2023 24:680
    Content type: Commentary Published on:

  25. Type 2 diabetes mellitus (T2D) is a serious global health problem, and exercise is considered an essential non-pharmacological tool in T2D prevention and treatment. During periods of social isolation experienc...

    Authors: Samara Nickel Rodrigues, Rodrigo Sudatti Delevatti, Mauricio Tatsch Ximenes Carvalho, Valentina Bullo, Marco Bergamin and Cristine Lima Alberton
    Citation: Trials 2023 24:679
    Content type: Study protocol Published on:

  26. The Unified Protocol (UP) is a transdiagnostic intervention based on emotional regulation for the treatment of emotional disorders. Its application in individual and group formats has been studied worldwide, o...

    Authors: Milagros Celleri, Camila F. Cremades, Martin J. Etchevers and Cristian J. Garay
    Citation: Trials 2023 24:678
    Content type: Study protocol Published on:

  27. Patients with stroke frequently experience walking dysfunction. Core training can help improve balance and walking function in patients with stroke. However, core training movements in clinical practice are nu...

    Authors: Jianqing Su, Yunrong Ding, Yanjun Cao, Zengqiao Zhang, Mengxue Sun, Yajuan Zhang, Kunpeng Li and Wu Wang
    Citation: Trials 2023 24:677
    Content type: Study protocol Published on:

  28. Approximately ten percent of US military veterans suffer from posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) is a highly effective, evidence-based, first-line treatment for PTSD that ...

    Authors: Rebecca K. Sripada, Cassaundra L. Peterson, John J. Dziak, Inbal Nahum-Shani, Erika M. Roberge, Amber A. Martinson, Katherine Porter, Peter Grau, Diana Curtis, Sydney McElroy, Sarah Bryant, Isabel Gracy, Cosette Pryor, Heather M. Walters, Karen Austin, Carolina Ehlinger…
    Citation: Trials 2023 24:676
    Content type: Study protocol Published on:

  29. Chronic prostatitis/chronic pelvic pain syndrome is a highly prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve the quality of life i...

    Authors: Ningqing Huang, Zhi Qin, Wudong Sun, Kaiming Bao, Jingxian Zha, Peng Zhang, Panpan Feng, Xiaojun Zhao, Mengqian Liu, Jinjun Shi and Ming Ma
    Citation: Trials 2023 24:675
    Content type: Study protocol Published on:

  30. Myopia prevalence has been increasing in the last decades, and its pathological consequences, including myopic maculopathy and high myopia-associated optic neuropathy, are now one of the most common causes of ...

    Authors: Cristina Alvarez-Peregrina, Miguel Angel Sanchez-Tena, Clara Martinez-Perez, Cesar Villa-Collar and Arne Ohlendorf
    Citation: Trials 2023 24:674
    Content type: Study protocol Published on:

  31. Diabetes self-management education (DSME) helps patients self-manage their condition and improve outcomes/quality of life. However, access to DSME is limited, particularly in low-income areas. This study aims ...

    Authors: Jitender Nagpal, Swapnil Rawat, Lovely Gupta, Avantika Negi and Divya Shashi Oraon
    Citation: Trials 2023 24:673
    Content type: Study protocol Published on:

  32. Running is the most common cardiovascular exercise in the military. However, there is a high incidence of running-related overuse injuries that reduces military readiness. Gait retraining is a common intervent...

    Authors: Michael S. Crowell, Richard A. Brindle, Erin M. Miller, Nicholas Reilly, Kevin R. Ford and Donald L. Goss
    Citation: Trials 2023 24:672
    Content type: Study protocol Published on:

  33. Older patients often experience safety issues when transitioning from hospital to home. The ‘Your Care Needs You’ (YCNY) intervention aims to support older people to ‘know more’ and ‘do more’ whilst in hospita...

    Authors: Rebecca Lawton, Jenni Murray, Ruth Baxter, Gerry Richardson, Sarah Cockayne, Kalpita Baird, Laura Mandefield, Stephen Brealey, Jane O’Hara, Robbie Foy, Laura Sheard, Alison Cracknell, Edmund Breckin and Catherine Hewitt
    Citation: Trials 2023 24:671
    Content type: Study protocol Published on:

  34. The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is kno...

    Authors: Sally Wheelwright, Lucy Matthews, Valerie Jenkins, Shirley May, Daniel Rea, Pat Fairbrother, Claire Gaunt, Jennie Young, Sarah Pirrie, Matthew G. Wallis and Lesley Fallowfield
    Citation: Trials 2023 24:670
    Content type: Research Published on:

  35. For patients with varicose veins, the goal is to relieve pain and swelling, reduce the severity of edema, improve skin changes, and heal ulcers associated with venous disease. Compression therapy is the corner...

    Authors: Mingjun Tang, Weihua Jiang, Jin Hong, Lubing Li, Dan Shang, Yue Zhao, Zhenjie Liu, Ming Qi, Mingjuan Jin and Yuefeng Zhu
    Citation: Trials 2023 24:669
    Content type: Study protocol Published on:

  36. Nonadherence to medication is a major issue in patients with chronic disorders such as Parkinson’s disease (PD). Many interventions for increasing adherence have been tested, and these have shown weak-to-moder...

    Authors: Sarah Mendorf, Ulrike Teschner, Thomas Lehmann, Tino Prell and Hannah Maria Mühlhammer
    Citation: Trials 2023 24:668
    Content type: Study protocol Published on:

  37. Autism Spectrum Disorder (ASD) is a neurodevelopmental disability affecting at least 5 million children in South Asia. Majority of these children are without access to evidence-based care. The UK Pre-school Au...

    Authors: Reetabrata Roy, Kathy Leadbitter, Gemma Shields, Carol Taylor, Catherine Aldred, Monica Juneja, Sheffali Gulati, Vivek Vajaratkar, Linda Davies, Richard Emsley, Vikram Patel, Gauri Divan and Jonathan Green
    Citation: Trials 2023 24:667
    Content type: Study protocol Published on:

  39. Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected...

    Authors: Nine de Graaf, Anouk M. L. H. Emmen, Marco Ramera, Bergthor Björnsson, Ugo Boggi, Caro L. Bruna, Olivier R. Busch, Freek Daams, Giovanni Ferrari, Sebastiaan Festen, Jony van Hilst, Mathieu D’Hondt, Benedetto Ielpo, Tobias Keck, Igor E. Khatkov, Bas Groot Koerkamp…
    Citation: Trials 2023 24:665
    Content type: Study protocol Published on:

  40. Hormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ...

    Authors: Joannie Ivory, Stephanie B. Wheeler, Sarah Drier, Heather Gunn, David Zahrieh, Electra Paskett, Michelle Naughton, Rachel Wills, Kayla Swetel, Selina Chow and Katherine Reeder-Hayes
    Citation: Trials 2023 24:664
    Content type: Study protocol Published on:

  41. Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothes...

    Authors: Lisa E. Vossen, Jaap J. van Netten, Chantal D. Bakker, Heleen A. Berendsen, Tessa E. Busch-Westbroek, Edgar J. G. Peters, Louise W. E. Sabelis, Marcel G. W. Dijkgraaf and Sicco A. Bus
    Citation: Trials 2023 24:663
    Content type: Study protocol Published on:

  42. The negative impacts of the COVID-19 pandemic on public health have affected people socially, psychologically, and physically. Young people particularly are having to adjust many aspects of their personal live...

    Authors: Winnie Lai-Sheung Cheng, Anson Chui-Yan Tang, Mark Cheuk-Man Tsang, Lokki Lok-Ki Wong and Dag Körlin
    Citation: Trials 2023 24:662
    Content type: Study protocol Published on:

  43. The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment...

    Authors: Cherish Boxall, Susanne Renz, Zina Eminton, Jacqueline Nuttall, Alan Saji, Charlotte Cluff, Christopher Wilcox, Ingrid Muller, Alison M. Layton, Irene Soulsby and Miriam Santer
    Citation: Trials 2023 24:661
    Content type: Research Published on:

  44. As a result of increased life expectancy and improved care for patients suffering from chronic disease, the number of patients with multimorbidity requiring surgical intervention is increasing. For complex sur...

    Authors: Jacqueline E. M. Vernooij, Romijn M. Boerlage, Carine J. M. Doggen, Benedikt Preckel, Carmen D. Dirksen, Barbara L. van Leeuwen, Rutger J. Spruit, Suzanne Festen, Hanneke van der Wal-Huisman, Jean P. van Basten, Cor J. Kalkman and Nick J. Koning
    Citation: Trials 2023 24:660
    Content type: Study protocol Published on:

  45. Fluid loading-based goal-directed therapy is a cornerstone of anaesthesia management in major surgery. Its widespread application has contributed to a significant improvement in perioperative morbidity and mor...

    Authors: Bruno Pastene, Matthieu Bernat, Karine Baumstark, Karine Bezulier, Yann Gricourt, Jean-Manuel De Guibert, Aude Charvet, Manon Colin, Marc Leone and Laurent Zieleskiewicz
    Citation: Trials 2023 24:659
    Content type: Study protocol Published on:

  46. Short sleep duration, defined as < 7 h sleep on weeknights, affects 40% of the US adult population, contributing to the increased risk for cardiometabolic diseases, decreased safety, and poorer mental health. ...

    Authors: Kelly Glazer Baron, Jennifer Duffecy, Sara Simonsen, Adam Bress, Molly B. Conroy, Tom Greene, Chelsea Allen and Sofia Vallejo
    Citation: Trials 2023 24:658
    Content type: Study protocol Published on:

  47. During the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote methods for conducting clinical trials, including e-Consent. Although so...

    Authors: E. J. Mitchell, D. Appelbe, A. Bravery, L. Culliford, H. Evans, A. J. Farrin, K. Gillies, K. Hood, S. B. Love, M. R. Sydes, P. R. Williamson and N. Wakefield
    Citation: Trials 2023 24:657
    Content type: Research Published on:

  48. Apnoea of prematurity (AOP) is one of the most common diagnoses among preterm infants. AOP often leads to hypoxemia and bradycardia which are associated with an increased risk of death or disability. In additi...

    Authors: Jarinda A. Poppe, Robert B. Flint, Anne Smits, Sten P. Willemsen, Kelly K. Storm, Debbie H. Nuytemans, Wes Onland, Marten J. Poley, Willem P. de Boode, Katherine Carkeek, Vincent Cassart, Luc Cornette, Peter H. Dijk, Marieke A. C. Hemels, Isabelle Hermans, Matthias C. Hütten…
    Citation: Trials 2023 24:656
    Content type: Study protocol Published on:

  49. Health education is one of the main items to enable health promotion to patients with fibromyalgia. The objective of the study “Amigos de Fibro (Fibro Friends)” is to evaluate the impact of an educational inte...

    Authors: Mateus Dias Antunes, Felipe Cayres Nogueira da Rocha Loures, Ingred Merllin Batista de Souza, Ariela Torres Cruz, Priscila de Oliveira Januário, Mara Maria Lisboa Santana Pinheiro, Ana Carolina Basso Schmitt, Elisa Frutos-Bernal, Ana María Martín-Nogueras and Amélia Pasqual Marques
    Citation: Trials 2023 24:655
    Content type: Study protocol Published on:

  50. Authors: Emily Pettersen, Paolo Sassu, Carina Reinholdt, Peter Dahm, Ola Rolfson, Anders Björkman, Marco Innocenti, Francesca Alice Pedrini, Juan Manuel Breyer, Aidan Roche, Andrew Hart, Lorraine Harrington, Adil Ladak, Hollie Power, Jacqueline Hebert and Max Ortiz-Catalan
    Citation: Trials 2023 24:654
    Content type: Correction Published on:

    The original article was published in Trials 2023 24:304

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