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  1. Around 10% of school-aged children experience mental health difficulties. Many more are ‘vulnerable’: experiencing emotional and/or behavioural problems reaching clinical levels, and thus at greatest risk of f...

    Authors: S. Jolley, J. Lord, D. Plant, E. Wood, K. Bracegirdle, S. Browning, B. Carter and K. James
    Citation: Trials 2023 24:253
    Content type: Study protocol Published on:

  2. Women experience greater difficulty achieving smoking abstinence compared to men. Recent evidence suggests that hormonal fluctuations during different phases of the menstrual cycle can contribute to lower smok...

    Authors: Laurie Zawertailo, Tina Kabir, Sabrina Voci, Elise Tanzini, Sophia Attwells, Liliana Malat, Scott Veldhuizen, Nadia Minian, Rosa Dragonetti, Osnat C. Melamed, Elad Mei-Dan and Peter Selby
    Citation: Trials 2023 24:251
    Content type: Study protocol Published on:

  3. A key decision in the treatment of atrial fibrillation is choosing between a rhythm control strategy or a rate control strategy as the main strategy. When choosing rate control, the optimal heart rate target i...

    Authors: Isak Mazanti Cold, Joshua Buron Feinberg, Axel Brandes, Ulla Davidsen, Ulrik Dixen, Helena Dominguez, Uffe Jakob Ortved Gang, Christian Gluud, Rakin Hadad, Kit Engedal Kristensen, Doan Tuyet van Le, Emil Eik Nielsen, Michael Hecht Olsen, Ole Dyg Pedersen, Ilan Esra Raymond, Ahmad Sajadieh…
    Citation: Trials 2023 24:250
    Content type: Update Published on:

  4. Repetitive transcranial magnetic stimulation (rTMS), as a non-invasive brain stimulation technique, has shown potentials for consciousness recovery of patients with disorders of consciousness (DoC), as, to a c...

    Authors: Chengwei Xu, Zhaohua Zhu, Wanchun Wu, Xiaochun Zheng, Haili Zhong, Xiyan Huang, Qiuyou Xie and Xinyi Qian
    Citation: Trials 2023 24:249
    Content type: Study protocol Published on:

  5. Nen ŨnkUmbi/EdaHiYedo (“We Are Here Now,” or NE) is an intervention to prevent STIs, HIV, HCV, and teen pregnancy among Assiniboine and Sioux youth of the Fort Peck Reservation in the state of Montana in the USA....

    Authors: Michael Anastario, Elizabeth Rink, Paula Firemoon, Nicole Carnegie, Olivia Johnson, Malory Peterson and Ana Maria Rodriguez
    Citation: Trials 2023 24:248
    Content type: Research Published on:

  6. Progress of cholangitis to cholangiosepsis is a frequent observation in patients with secondary sclerosing cholangitis in critically ill patients (SSC–CIP). Adequate biliary drainage may reduce episodes of cho...

    Authors: Klaus Stahl, Friederike Klein, Torsten Voigtländer, Anika Großhennig, Thorsten Book, Tobias Müller, Alexander Wree, Armin Kuellmer, Jochen Weigt, Alexander Dechene, Edris Wedi, Arne Kandulski, Christian M. Lange, Dennis Holzwart, Dorothee von Witzendorff, Kristina I. Ringe…
    Citation: Trials 2023 24:247
    Content type: Study protocol Published on:

  7. Management of adults with atrial fibrillation (AF) or atrial flutter in the emergency department (ED) includes rate reduction, cardioversion, and stroke prevention. Different approaches to these components of ...

    Authors: David R. Vinson, Adina S. Rauchwerger, Chandu A. Karadi, Judy Shan, E. Margaret Warton, Jennifer Y. Zhang, Dustin W. Ballard, Dustin G. Mark, Erik R. Hofmann, Dale M. Cotton, Edward J. Durant, James S. Lin, Dana R. Sax, Luke S. Poth, Stephen H. Gamboa, Meena S. Ghiya…
    Citation: Trials 2023 24:246
    Content type: Study protocol Published on:

  8. Non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics are used frequently by athletes either prophylactically for the prevention of pain, or to accelerate recovery following an injury. However, these t...

    Authors: Zoya Huschtscha, Jackson J. Fyfe, Simon A. Feros, Andrew C. Betik, Christopher S. Shaw, Luana C. Main, Gavin Abbott, Sze-Yen Tan, Martin C. Refalo, Michael Gerhardy, Emma Grunwald, Anthony May, Jessica Silver, Craig M. Smith, Matthew White and D. Lee Hamilton
    Citation: Trials 2023 24:245
    Content type: Study protocol Published on:

  9. There is increasing interest in the use of electronic health records (EHRs) to improve the efficiency and cost-effectiveness of clinical trials, including the capture of outcome measures.

    Authors: David Dunn, Leanne McCabe, Ellen White, Valerie Delpech, Peter D. Kirwan, Jameel Khawam, Sara Croxford, Denise Ward, Elizabeth Brodnicki, Alison Rodger and Sheena McCormack
    Citation: Trials 2023 24:244
    Content type: Methodology Published on:

  10. Researchers are increasingly seeking to use routinely collected data to support clinical trials. This approach has the potential to transform the way clinical trials are conducted in the future. The availabili...

    Authors: Adam D. N. Williams, Gwyneth Davies, Amanda J. Farrin, Marion Mafham, Michael Robling, Matthew R. Sydes and Fiona V. Lugg-Widger
    Citation: Trials 2023 24:243
    Content type: Research Published on:

  11. Representation of all members of society within research, especially those typically underserved, is needed to ensure that trial evidence applies to the relevant population, and that effective interventions ar...

    Authors: Adam D. N. Williams, Kerenza Hood, Karen Bracken and Gillian W. Shorter
    Citation: Trials 2023 24:242
    Content type: Commentary Published on:

  12. Antenatal depression (AD) is the most common complication of pregnancy in developed countries and increases the risk of preterm birth (PTB). Many pregnant individuals with AD do not obtain treatment due in par...

    Authors: Kathleen H. Chaput, Makayla Freeman, Carly McMorris, Amy Metcalfe, Emily E. Cameron, James Jung, Suzanne Tough, Laurel M. Hicks, Sona Dimidjian and Lianne M. Tomfohr-Madsen
    Citation: Trials 2023 24:240
    Content type: Study protocol Published on:

  13. Pain predominant multisymptom illness (pain-CMI) refers to symptom-based conditions where pain is a primary symptom. There is initial evidence that health coaching may be efficacious in treating pain-CMI becau...

    Authors: Sarah Crosky, Mikhaela McFarlin, Nicole Sullivan, Darren Winograd, David Litke, Robin M. Masheb, Shou-En Lu, Michelle Costanzo, Nicole Anastasides, Christina Gonzalez, Jaineel Doshi, Fiona Graff, Linda Khatib, Scott Thien and Lisa M. McAndrew
    Citation: Trials 2023 24:239
    Content type: Study protocol Published on:

  14. Pain management is a critical component of comprehensive postsurgical care, as it influences patient safety and outcomes, and inadequate control has been associated with the development of chronic pain syndrom...

    Authors: Ian A. Jones, Amit S. Piple, Pui Yuk Yan, Donald B. Longjohn, Paul K. Gilbert, Jay R. Lieberman, Gligor V. Gucev, Daniel A. Oakes, Christina E. Ratto, Alexander B. Christ and Nathanael D. Heckmann
    Citation: Trials 2023 24:238
    Content type: Study protocol Published on:

  15. Buprenorphine-naloxone is a medication shown to improve outcomes for individuals seeking treatment for opioid use disorder (OUD); however, outcomes are limited by low medication adherence rates. This is especi...

    Authors: Samuel C. Peter, James G. Murphy, Katie Witkiewitz, Sarah B. Hand, Fridtjof Thomas, Karen Chandler Johnson, Ronald Cowan, Matt Harris and Karen J. Derefinko
    Citation: Trials 2023 24:237
    Content type: Study protocol Published on:

  16. Melanoma surveillance photography (MSP) is a comprehensive surveillance method that comprises two- or three-dimensional total body photography with tagged digital dermoscopy, performed at prescribed intervals....

    Authors: Mabel K. Yan, Anne E. Cust, H. Peter Soyer, Monika Janda, Katja Loewe, Gabrielle Byars, Paul Fishburn, Paul White, Rashidul Alam Mahumud, Robyn P. M. Saw, Alan Herschtal, Pablo Fernandez-Penas, Pascale Guitera, Rachael L. Morton, John Kelly, Rory Wolfe…
    Citation: Trials 2023 24:236
    Content type: Study protocol Published on:

  17. Australia has one of the highest rates of methamphetamine (MA) use in the world; however, uptake of in-person psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and s...

    Authors: Dan I. Lubman, Victoria Manning, Shalini Arunogiri, Kate Hall, John Reynolds, Peta Stragalinos, Rachel Petukhova, Robyn Gerhard, Jonathan Tyler, Anna Bough, Anthony Harris and Jasmin Grigg
    Citation: Trials 2023 24:235
    Content type: Study protocol Published on:

  18. Many previous studies evaluated a combination of transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) for treating early hepatocellular carcinoma (HCC); however, studies evaluating...

    Authors: Soon Kyu Lee, Hyun Yang, Jung Hyun Kwon, Dong Jae Shim, Doyoung Kim, Soon Woo Nam, Sun Hong Yoo, Si Hyun Bae, Ahlim Lee, Young Joon Lee, Changho Jeon, Jeong Won Jang, Pil Soo Sung, Ho Jong Chun, Su Ho Kim, Joon-Il Choi…
    Citation: Trials 2023 24:234
    Content type: Study protocol Published on:

  19. While randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists ...

    Authors: Pepijn Al, Spencer Hey, Charles Weijer, Katie Gillies, Nicola McCleary, Mei-Lin Yee, Juliette Inglis, Justin Presseau and Jamie Brehaut
    Citation: Trials 2023 24:233
    Content type: Commentary Published on:

    The Letter to this article has been published in Trials 2023 24:525

  20. Proportional assist ventilation with load-adjustable gain factors (PAV+) is a mechanical ventilation mode that delivers assistance to breathe in proportion to the patient’s effort. The proportional assistance,...

    Authors: Karen J. Bosma, Claudio M. Martin, Karen E. A. Burns, Jordi Mancebo Cortes, Juan Carlos Suárez Montero, Yoanna Skrobik, Kevin E. Thorpe, Andre Carlos Kajdacsy-Balla Amaral, Yaseen Arabi, John Basmaji, Gaëtan Beduneau, Francois Beloncle, Guillaume Carteaux, Emmanuel Charbonney, Alexandre Demoule, Martin Dres…
    Citation: Trials 2023 24:232
    Content type: Study protocol Published on:

  21. Patients who are admitted to the intensive care unit (ICU) for severe acute exacerbations of chronic obstructive pulmonary disease (COPD) have poor outcomes. Although international clinical practice guidelines...

    Authors: Alexis Ferré, Arnaud W. Thille, Armand Mekontso-Dessap, Thomas Similowski, Stéphane Legriel, Philippe Aegerter and Alexandre Demoule
    Citation: Trials 2023 24:231
    Content type: Study protocol Published on:

  23. Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are inflammatory diseases that often affect the wrist and, when affected, can lead to impaired wrist function and progressive joint destruction if inadeq...

    Authors: P. N. d’Ailly, C. Deugd, N. W. L. Schep, T. M. Kuijper, M. R. Kok, A. Willemze, J. H. Coert, P. H. P. de Jong, W. K. Lam-Tse, A. H. M. van der Helm-van Mil, I. Tchetverikov, A. E. A. M. Weel-Koenders and R. J. Bisoendial
    Citation: Trials 2023 24:229
    Content type: Study protocol Published on:

  25. There has been an increase in the integration of qualitative studies in randomised controlled trials. The purpose of this article is to reflect on our experience of carrying out a rapid qualitative study durin...

    Authors: Cecilia Vindrola-Padros, Farid Froghi, Vignesh Gopalan, Sachan Maruthan, Helder Filipe, Margaret McNeil, Sara Mingo Garcia and Brian Davidson
    Citation: Trials 2023 24:227
    Content type: Methodology Published on:

  26. Fluid therapy is a common intervention in critically ill patients. It is increasingly recognised that deresuscitation is an essential part of fluid therapy and delayed deresuscitation is associated with longer...

    Authors: Siebe G. Blok, Amne Mousa, Michelle G. Brouwer, Harm-Jan de Grooth, Ary Serpa Neto, Michiel J. Blans, Sylvia den Boer, Tom Dormans, Henrik Endeman, Timo Roeleveld, Harm Scholten, Eline R. van Slobbe-Bijlsma, Erik Scholten, Hugo Touw, Fleur Stefanie L. I. M. van der Ven, Evert-Jan Wils…
    Citation: Trials 2023 24:226
    Content type: Study protocol Published on:

  27. There are significant knowledge gaps regarding the effectiveness of serial prophylactic exchange blood transfusion (SPEBT) for pregnant women with sickle cell disease (SCD). The protocol for the randomised fea...

    Authors: Paul T. Seed, Sarah B. Brien, Laura L. Oakley, Vicky Robinson, Joseph Sharif, Hilary Thompson, Jeannine Joseph and Eugene Oteng-Ntim
    Citation: Trials 2023 24:225
    Content type: Update Published on:

    The Study protocol to this article has been published in Trials 2020 21:347

  28. Anterior cruciate ligament (ACL) reconstruction aims to restore anteroposterior and rotatory stability to the knee following ACL injury. This requires the graft to withstand the forces applied during the proce...

    Authors: Lachlan Huntington, Andrew Griffith, Libby Spiers, Rebecca Pile, Lachlan Batty, Scott Tulloch and Phong Tran
    Citation: Trials 2023 24:224
    Content type: Study protocol Published on:

  29. The Chinese government stipulates all food for special medical purposes (FSMP) designed for specific diseases to be tested in clinical trials before approving it for registration. The process of developing cor...

    Authors: Dongyu Mu, Jie Gong, Yaoyao Wei, Muxi Chen, Jiajie Yu, Liang Du and Wen Hu
    Citation: Trials 2023 24:223
    Content type: Study protocol Published on:

  30. The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epith...

    Authors: Annika Idahl, Per Liv, Anna Darelius, Elin Collins, Karin Sundfeldt, Mathias Pålsson and Annika Strandell
    Citation: Trials 2023 24:222
    Content type: Update Published on:

    The Study protocol to this article has been published in Trials 2019 20:10

  31. Perirenal fat plays a key role in sustaining pathological high blood pressure. We aim to investigate the efficacy of intervention for perirenal fat mediated by focused power ultrasound (FPU) on primary hyperte...

    Authors: Menghuan Li, Jing Shi, Yanhui Sheng, Yuqing Zhang, Tingting Wu, Jiaming Yang, Kerui Zhang, Wei Sun and Xiangqing Kong
    Citation: Trials 2023 24:221
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2023 24:309

  32. There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based universal prevention programmes are thought t...

    Authors: Daniel Hayes, Anna Moore, Emily Stapley, Neil Humphrey, Rosie Mansfield, Joao Santos, Emma Ashworth, Praveetha Patalay, Eva-Maria Bonin, Sara Evans-Lacko, Bettina Moltrecht, Kirsty Nisbet, Emma Thornton, Aurelie Lange, Paul Stallard, Abigail Thompson…
    Citation: Trials 2023 24:220
    Content type: Update Published on:

    A Related Article has been published.

  33. CSF leakage is a major complication after cranial surgery, thus, adequate dural closure must be performed. Commercially available fibrin sealants are currently considered the gold standard for dural closure, b...

    Authors: Birgit Coucke, Anaïs Van Hoylandt, Johannes van Loon, Frank Van Calenbergh, Laura Van Gerven and Tom Theys
    Citation: Trials 2023 24:219
    Content type: Study protocol Published on:

  34. The “Diabetes: Community-led Awareness, Response and Evaluation” (D:Clare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform p...

    Authors: Carina King, Malini Pires, Naveed Ahmed, Kohenour Akter, Abdul Kuddus, Andrew Copas, Hassan Haghparast-Bidgoli, Joanna Morrison, Tasmin Nahar, Sanjit Kumer Shaha, AKAzad Khan, Kishwar Azad and Edward Fottrell
    Citation: Trials 2023 24:218
    Content type: Update Published on:

    The Study protocol to this article has been published in Trials 2021 22:235

  35. Contemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascula...

    Authors: Claudina Rudolph, Beate Rikken Lindberg, Timothy Resch, Kevin Mani, Patrick Björkman, Elín Hanna Laxdal, Henrik Støvring, Henriette Margrethe Beck, Gunnar Eriksson and Jacob Budtz-Lilly
    Citation: Trials 2023 24:217
    Content type: Study protocol Published on:

  36. Many patients do not fully regain motor function after ischemic stroke. Transcranial direct current stimulation (TDCS) targeting the motor cortex may improve motor outcome as an add-on intervention to physical...

    Authors: Mia Kolmos, Mads Just Madsen, Marie Louise Liu, Anke Karabanov, Katrine Lyders Johansen, Axel Thielscher, Karen Gandrup, Henrik Lundell, Søren Fuglsang, Esben Thade, Hanne Christensen, Helle Klingenberg Iversen, Hartwig Roman Siebner and Christina Kruuse
    Citation: Trials 2023 24:216
    Content type: Study protocol Published on:

  37. Adaptive clinical trials may use conditional power (CP) to make decisions at interim analyses, requiring assumptions about the treatment effect for remaining patients. It is critical that these assumptions are...

    Authors: Julia M. Edwards, Stephen J. Walters and Steven A. Julious
    Citation: Trials 2023 24:215
    Content type: Methodology Published on:

  38. Stroke is a leading cause of mortality and disability, and its sequelae are associated with inadequate food intake which can lead to sarcopenia. The aim of this study is to verify the effectiveness of creatine...

    Authors: Juli Thomaz de Souza, Marcos F. Minicucci, Natália C. Ferreira, Bertha F. Polegato, Marina Politi Okoshi, Gabriel P. Modolo, Bethan E. Phillips, Philip J. Atherton, Kenneth Smith, Daniel Wilkinson, Adam Gordon, Suzana E. Tanni, Vladimir Eliodoro Costa, Maria Fernanda P. Fernandes, Silméia G. Zanati Bazan, Leonardo A. M. Zornoff…
    Citation: Trials 2023 24:214
    Content type: Study protocol Published on:

  39. Immunosuppression after kidney transplantation is mainly guided via plasma tacrolimus trough level, which cannot sufficiently predict allograft rejection and infection. The plasma load of the non-pathogenic an...

    Authors: Frederik Haupenthal, Jette Rahn, Fabrizio Maggi, Fanny Gelas, Philippe Bourgeois, Christian Hugo, Bernd Jilma, Georg A. Böhmig, Harald Herkner, Michael Wolzt, Konstantin Doberer, Matthias Vossen, Daniele Focosi, Hannes Neuwirt, Miriam Banas, Bernhard Banas…
    Citation: Trials 2023 24:213
    Content type: Study protocol Published on:

  40. Functional limitation among patients with chronic obstructive pulmonary disorder (COPD) and their dependence on their family caregivers (FCs) can significantly increase caregiver burden (CB) and reduce the qua...

    Authors: Mobina Bahadori, Ramin Sami, Shahla Abolhassani and Vajihe Atashi
    Citation: Trials 2023 24:212
    Content type: Research Published on:

  41. Cystic fibrosis (CF) is a rare, inherited, life-limiting condition predominantly affecting the lungs, for which there is no cure. The disease is characterized by recurrent pulmonary exacerbations (PEx), which ...

    Authors: Andre Schultz, Charlie McLeod, Scott Berry, Julie Marsh, Anne McKenzie, Mitch Messer, Jamie Wood, Ben Saville, Adam Jaffe, Sarath Ranganathan, Steve Stick, Peter Wark, Steve Webb and Tom Snelling
    Citation: Trials 2023 24:211
    Content type: Study protocol Published on:

  42. Diabetes and hypertension are increasingly important population health challenges in Eswatini. Prior to this project, healthcare for these conditions was primarily provided through physician-led teams at terti...

    Authors: Michaela Theilmann, Ntombifuthi Ginindza, John Myeni, Sijabulile Dlamini, Bongekile Thobekile Cindzi, Dumezweni Dlamini, Thobile L. Dlamini, Maike Greve, Harsh Vivek Harkare, Mbuso Hleta, Philile Khumalo, Lutz M. Kolbe, Simon Lewin, Lisa-Rufaro Marowa, Sakhile Masuku, Dumsile Mavuso…
    Citation: Trials 2023 24:210
    Content type: Study protocol Published on:

  43. Reporting of intervention research has been inadequate for many years. The development and promotion of freely available checklists aims to address this problem by providing researchers with a list of items th...

    Authors: Mairead Ryan, Tammy Hoffmann, Riikka Hofmann and Esther van Sluijs
    Citation: Trials 2023 24:176
    Content type: Commentary Published on:

  44. Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI) to antithrombosis, meanwhile, ...

    Authors: Tienan Zhou, Yinghui Gong, Jingyuan Li, Yasong Wang and Xiaozeng Wang
    Citation: Trials 2023 24:209
    Content type: Study protocol Published on:

  46. Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of su...

    Authors: Liang Wu, Yunwei Ou, Bingcheng Zhu, Xufei Guo, Xiaofan Yu, Long Xu, Jinping Li, Enshan Feng, Huaqing Li, Xiaodong Wang, Huaqun Chen, Zhaosheng Sun, Zaofu Liu, Dawei Yang, Hongbing Zhang, Zhigang Liu…
    Citation: Trials 2023 24:207
    Content type: Study protocol Published on:

  47. Major depressive disorder (MDD) is one of the most common mental disorders in adolescence carrying a serious risk of adverse development later in life. Extant treatments are limited in effectiveness and have h...

    Authors: C. C. Paauw, C. de Roos, M. G. T. Koornneef, B. M. Elzinga, T. M. Boorsma, M. A. Verheij and A. E. Dingemans
    Citation: Trials 2023 24:206
    Content type: Study protocol Published on:

  48. Dreaming reported after anesthesia remains a poorly understood phenomenon. At present, there is a hypothesis that dreaming occurs intraoperatively and is related to light or inadequate anesthesia; thus, in ord...

    Authors: Yufei Zhang, Bijia Song and Junchao Zhu
    Citation: Trials 2023 24:205
    Content type: Study protocol Published on:

  49. Patients receiving total hip arthroplasty (THA) due to metastatic bone disease of the hip (MBD) are at an increased risk of post-operative joint dislocation compared to other populations. Different joint solut...

    Authors: Afrim Iljazi, Michala Skovlund Sørensen, Kolja Sebastian Weber, Allan Villadsen, Frank Eriksson and Michael Mørk Petersen
    Citation: Trials 2023 24:204
    Content type: Study protocol Published on:

  50. The need for coronavirus 2019 (COVID-19) vaccination in different age groups and populations is a subject of great uncertainty and an ongoing global debate. Critical knowledge gaps regarding COVID-19 vaccinati...

    Authors: C. McLeod, J Ramsay, K. L. Flanagan, M. Plebanski, H. Marshall, M. Dymock, J. Marsh, M. J. Estcourt, U. Wadia, P. C. M. Williams, M. C. Tjiam, C. Blyth, K. Subbarao, S. Nicholson, S. Faust, R. B. Thornton…
    Citation: Trials 2023 24:202
    Content type: Study protocol Published on:
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