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Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs Trials (IF 2.5) Pub Date : 2024-03-16 Emma Bamford, Hannah Berntsson, Suzanne Beale, Lauren Desoysa, Joseph Dias, Sienna Hamer-Kiwacz, Daniel Hind, Nick Johnson, Amanda Loban, Kaye Molloy, Emma Morvan, Ines Rombach, Anna Selby, Praveen Thokala, Chris Turtle, Stephen Walters, Avril Drummond
Without surgical repair, flexor tendon injuries do not heal and patients’ ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint
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Correction: Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III) Trials (IF 2.5) Pub Date : 2024-03-15 Corinna Engel, Mario Rüdiger, Manon J. N. L. Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Ana Vilan, Mari Falck, Isabella Mauro, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht, Roselinda van der Vlught, Axel R. Franz
Correction: Trials 25, 81 (2024) https://doi.org/10.1186/s13063-023-07828-6 Following publication of the original article [1], we have been notified that updates were needed to the Recruiting Hospitals and Local Principal Investigator list of the ALBINO study group in the acknowledgement section. Names originally included, but removed with this correction: Germany: Stefan Winkler, Universitätsklinikum
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Mean Arterial Pressure (MAP) Trial: study protocol for a multicentre, randomized, controlled trial to compare three different strategies of mean arterial pressure management during cardiopulmonary bypass Trials (IF 2.5) Pub Date : 2024-03-15 Alessandra Francica, Gina Mazzeo, Antonella Galeone, Daniele Linardi, Livio San Biagio, Giovanni Battista Luciani, Francesco Onorati
One of the main goals of cardiopulmonary bypass (CPB) is targeting an adequate mean arterial pressure (MAP) during heart surgery, in order to maintain appropriate perfusion pressures in all end-organs. As inheritance of early studies, a value of 50–60 mmHg has been historically accepted as the “gold standard” MAP. However, in the last decades, the CPB management has remarkably changed, thanks to the
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Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults Trials (IF 2.5) Pub Date : 2024-03-15 Kaoru Nashiro, Hyun Joo Yoo, Christine Cho, Andy Jeesu Kim, Padideh Nasseri, Jungwon Min, Martin J. Dahl, Noah Mercer, Jeiran Choupan, Paul Choi, Hye Rynn J. Lee, David Choi, Kalekirstos Alemu, Alexandra Ycaza Herrera, Nicole F. Ng, Julian F. Thayer, Mara Mather
In healthy people, the “fight-or-flight” sympathetic system is counterbalanced by the “rest-and-digest” parasympathetic system. As we grow older, the parasympathetic system declines as the sympathetic system becomes hyperactive. In our prior heart rate variability biofeedback and emotion regulation (HRV-ER) clinical trial, we found that increasing parasympathetic activity through daily practice of
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Trials that turn from retrospectively registered to prospectively registered: a cohort study of “retroactively prospective” clinical trial registration using history data Trials (IF 2.5) Pub Date : 2024-03-14 Martin Holst, Benjamin Gregory Carlisle
Prospective registration of clinical trials is mandated by various regulations. However, clinical trial registries like ClinicalTrials.gov allow registry entries to be updated at any time, and key study elements, including the start date, may change before the first patient is enrolled. If a trial changes its start date after recruiting began, however, it may indicate a reason for concern. This study
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Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): study protocol for a five-arm, cluster-randomized trial Trials (IF 2.5) Pub Date : 2024-03-14
Globally, 144 million children under 5 years are undernourished and 250 million do not meet their developmental potential. Multi-input interventions, such as bundled nutrition and parenting interventions, are designed to mitigate risks for multiple child outcomes. There is limited evidence that bundled interventions have additive benefits to nutrition, growth, or development outcomes. These outcomes
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The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-13 Ericka C. Solis, Ingrid V. E. Carlier, Noëlle G. A. Kamminga, Erik J. Giltay, Albert M. van Hemert
Persistent depressive disorder (PDD) is prevalent and debilitating. For patients with PDD, psychiatric rehabilitation using self-management interventions is advised as the next therapeutic step after multiple unsuccessful treatment attempts. The “Patient and Partner Education Program for All Chronic Diseases” (PPEP4All) is a brief, structured self-management program that focuses on functional recovery
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Correction: Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial Trials (IF 2.5) Pub Date : 2024-03-13 Nick Birk, Laura L. Oakley, Poppy A. C. Mallinson, Deepa R, Giridhara R. Babu, Mofat Nyirenda, Sanjay Kinra
Correction: Trials 24, 520 (2023) https://doi.org/10.1186/s13063-023-07508-5 Following publication of the original article [1], we have been notified that the 5th author’s affiliation was incorrect. Corrected affiliation: Giridhara R Babu, Professor of Global Health, Department of Population Medicine, College of Medicine, QU Health, Qatar University. Birk, et al. Statistical analysis plan and protocol
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Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-13 Jiabin Shen, Yan Wang, Susan Quinn, Stacy J. Suskauer, Julia Birch, Tyler Busch, Adrian Svingos, Roger Crawfis, Keith Owen Yeates, H. Gerry Taylor
Traumatic brain injury (TBI) is a leading cause of disability in children. Cognitive rehabilitation for this population is critical for their long-term health outcomes. This trial aims to evaluate the efficacy of a virtual reality-based program (VICT) for training executive functions in children with TBI. A parallel group randomized controlled trial will be conducted among up to 32 children with TBI
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The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-12 Rui Fen Teoh, Siaw Chui Chai, Nor Afifi Razaob Razab, Mohd Iskandar Mohd Amin, Julianne W. Howell
Occupational Therapists use craft-making activities as therapeutic interventions to improve physical and psychological functioning of injured people. Despite the therapeutic effects, craft-making is not routinely used in hand rehabilitation as an intervention for patients with upper limb fractures. These patients often experience physical and psychosocial issues; however, without supportive evidence
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Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs) Trials (IF 2.5) Pub Date : 2024-03-12 C. E. Arundel, L. K. Clark, A. Parker, D. Beard, E. Coleman, C. Cooper, D. Devane, S. Eldridge, S. Galvin, K. Gillies, C. E. Hewitt, C. Sutton, D. J. Torgerson, S. Treweek
Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned
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The scientific rationale and study protocol for the DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) randomized controlled trial: serum biomarkers to predict response to angiotensin II versus standard-of-care vasopressor therapy in the treatment of septic shock Trials (IF 2.5) Pub Date : 2024-03-12 J. Pedro Teixeira, David Perez Ingles, Jordan B. Barton, James T. Dean, Pablo Garcia, Susan J. Kunkel, Preeyaporn Sarangarm, Natalie K. Weiss, Christopher L. Schaich, Laurence W. Busse, Nathan D. Nielsen
Data to support the use of specific vasopressors in septic shock are limited. Since angiotensin II (AT2) was approved by the Food and Drug Administration in 2017, multiple mechanistically distinct vasopressors are available to treat septic shock, but minimal data exist regarding which patients are most likely to benefit from each agent. Renin and dipeptidyl peptidase 3 (DPP3) are components of the
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The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial Trials (IF 2.5) Pub Date : 2024-03-12 Marlene Wijaya, Gayle Fischer, Rebecca Bronwyn Saunderson
Vulvar lichen planus (VLP) is a chronic vulvar dermatosis that is difficult to treat and can severely impair quality of life in the absence of adequate treatment. There is a lack of high-quality evidence to direct therapy for VLP. This randomised controlled trial will be the first double-blinded study comparing systemic treatments in VLP and aims to investigate the safety and efficacy of deucravacitinib
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Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial Trials (IF 2.5) Pub Date : 2024-03-12 Isabelle R. Weir, Suzanne M. Dufault, Patrick P. J. Phillips
Randomized trials for the treatment of tuberculosis (TB) rely on a composite primary outcome to capture unfavorable treatment responses. However, variability between trials in the outcome definition and estimation methods complicates across-trial comparisons and hinders the advancement of treatment guidelines. The International Council for Harmonization (ICH) provides international regulatory standards
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Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial Trials (IF 2.5) Pub Date : 2024-03-11 Camilla Angelsen Kvestad, Ingvild Rønneberg Holte, Solveig Klæbo Reitan, Charlotte S. Chiappa, Gunn Karin Helle, Anne E. Skjervold, Anne Marit A. Rosenlund, Øyvind Watne, Heidi Brattland, Jon Helle, Turid Follestad, Karen Walseth Hara, Katrine Høyer Holgersen
Referrals to specialised mental health care (such as community mental health centres; CMHC) have increased over the last two decades. Patients often have multifaceted problems, which cannot only be solved by such care. Resources are limited, and triaging is challenging. A novel method which approaches patients early and individually upon referral to a CMHC—possibly with a brief intervention—is an Early
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Correction: Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts Trials (IF 2.5) Pub Date : 2024-03-11 Samyra R. Cox, Abhay Kadam, Sachin Atre, Akshay N. Gupte, Hojoon Sohn, Nikhil Gupte, Trupti Sawant, Vishal Mhadeshwar, Ryan Thompson, Emily Kendall, Christopher Hofmann, Nishi Suryavanshi, Deanna Kerrigan, Srikanth Tripathy, Arjunlal Kakrani, Madhusudan S. Barthwal, Vidya Mave, Jonathan E. Golub
Correction: Trials 23, 635 (2022) https://doi.org/10.1186/s13063-022-06503-6 Following publication of the original article [1], we have been notified that sputum collection has been done at the TU instead of at home, as originally stated in the paper. This change was made due to logistical constraints. The Interventions and Data collection and management sections have been modified to reflect this
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Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-11 Christoph Heinrich Lindemann, Volker Burst, Linus Alexander Völker, Sebastian Brähler, Dusan Simic, Ingrid Becker, Martin Hellmich, Clarissa Kurscheid, Nadine Scholten, Ruben Krauspe, Kerstin Leibel, Stephanie Stock, Paul Thomas Brinkkoetter
Multimorbid and frail elderly patients often carry a high burden of treatment. Hospitalization due to the onset of an acute illness can disrupt the fragile balance, resulting in further readmissions after hospital discharge. Current models of care in Germany do not meet the needs of this patient group. Rather lack of coordination and integration of care combined with a lack of interdisciplinary approaches
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EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain (“EFFECT-BACK”): study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-11 Rabea Vogt, Julia Haas, Lukas Baumann, Anja Sander, Christina Klose, Jenny Riecke, Winfried Rief, Ulrike Bingel, Dustin Maser, Michael Witthöft, Jens Keßler, Marco Richard Zugaj, Beate Ditzen, Julia Anna Glombiewski
Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfactory treatment offer for those affected is often not possible. Exposure therapy (EXP) promises to be an effective and economical form of treatment and in a previous pilot study showed to be superior
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The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-11 Morten Haugen, Karin Magnussen, Tonje Eiane Aarsland, Lise Sofie Haug Nissen-Meyer, Tor A. Strand
The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-h donation intervals, the potential short- and long-term consequences of high-frequency plasma donations on donor health remain unknown. This study aims to measure the effect of plasma donation
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Suicide prevention for substance using youth experiencing homelessness: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-09 Natasha Slesnick, Brittany Brakenhoff, Laura J. Chavez, Caleb L. Cuthbertson, Ruri Famelia, Xin Feng, Jodi Ford, Eugene Holowacz, Soren Jaderlund, Kelly Kelleher, Ellison Luthy, Allen M. Mallory, Alexis Pizzulo, Tatiana D. Slesnick, Tansel Yilmazer
While research on substance using youth experiencing homelessness (YEH) is increasing, there is a dearth of information regarding effective prevention interventions for these youth. Suicide is the leading cause of death among YEH and most youth do not access services that may be available to them. Therefore, this study seeks to address this gap in the research literature with the goal to identify an
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Behavioral economic and wellness-based approaches for reducing alcohol use and consequences among diverse non-student emerging adults: study protocol for Project BLUE, a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-09 James G. Murphy, Ashley A. Dennhardt, Jacob Tempchin, Hannah E. Colgonis, Meghan E. McDevitt-Murphy, Brian Borsari, Kristoffer S. Berlin
Emerging adults (EAs) who are not 4-year college students nor graduates are at elevated risk for lifetime alcohol use disorder, comorbid drug use, and mental health symptoms, compared to college graduates. There is a need for tailored brief alcohol intervention (BAI) approaches to reduce alcohol risk and to facilitate healthy development in this high-risk population. Most BAIs include a single session
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IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS) Trials (IF 2.5) Pub Date : 2024-03-07 Hannah Preßler, Marie-Luise Machule, Friederike Ufer, Isabel Bünger, Lucie Yuanting Li, Emilie Buchholz, Claudia Werner, Esther Beraha, Frank Wagner, Matthes Metz, Susen Burock, Lisa Bruckert, Christiana Franke, Nicola Wilck, Anne Krüger, Alexander Reshetnik, Kai-Uwe Eckardt, Matthias Endres, Harald Prüss
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severely debilitating condition which markedly restricts activity and function of affected people. Since the beginning of the COVID-19 pandemic ME/CFS related to post-acute COVID-19 syndrome (PACS) can be diagnosed in a subset of patients presenting with persistent fatigue 6 months after a mostly mild SARS-CoV-2 infection by fulfillment
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Statistical analysis plan for the PRO B study: open-label, superiority randomised controlled trial of alarm-based patient-reported outcome monitoring in patients with metastatic breast cancer Trials (IF 2.5) Pub Date : 2024-03-07 Pimrapat Gebert, Maria Margarete Karsten, Anna Maria Hage, Adam David Dordevic, Ulrike Grittner
With an increasing collection of patient-reported outcomes (PROs) to measure health-related quality of life (HRQoL) in oncological patients, there is still a lack of standardised strategies on how to interpret and use these data in patient care. Prior research has shown support for the use of digital PRO monitoring together with alarm systems to notify clinicians when the PRO values are deteriorating
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The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT Trials (IF 2.5) Pub Date : 2024-03-06 Desalegn Kuche, Zeweter Abebe, Masresha Tessema, Meron Girma, Alemayehu Hussen, Kaleab Baye, Barbara J. Stoecker
Women of reproductive age (WRA) in developing countries are often at risk of micronutrient deficiencies due to inadequate intakes and excessive losses. The purpose of this trial is to assess the effectiveness of United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) versus iron-folic acid (IFA) among WRA in reducing anemia. Three parallel
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UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-06 Johanna Wiedemann, Deniz Hos, Endrik Limburg, Ulrike Zettelmeyer, Petra Schiller, Jeremy Franklin, Björn Bachmann, Daniel Böhringer, Tina Dietrich-Ntoukas, Thomas A. Fuchsluger, Gerd Geerling, Stefan J. Lang, Wolfgang Johann Mayer, Siegfried Priglinger, Thomas Reinhard, Berthold Seitz, Claus Cursiefen
Good vision highly depends on the transparency of the cornea, which is the “windscreen” of the eye. In fact, corneal blindness due to transparency loss is the second most common cause of blindness worldwide, and corneal transplantation is the main cure. Importantly, the cornea is normally avascular but can secondarily be invaded by pathological (blood and lymphatic) vessels due to severe inflammation
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The effects of intermittent fasting diet on quality of life, clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with rheumatoid arthritis: study protocol of a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-05 Mahsa Ranjbar, Sakineh Shab-Bidar, Abdolrahman Rostamian, Hamed Mohammadi, Kurosh Djafarian
Rheumatoid arthritis (RA) is known as a chronic systemic autoimmune disorder that primarily targets synovial joints, and may cause pain and functional limitations. Studies show diet can have beneficial effects on symptoms and oxidative stress of this disease. Intermittent fasting (IF) is a dietary approach with cycles of fasting and intake. The current study aims to investigate the effect of IF on
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Effect of bottled fluoridated water to prevent dental caries in primary teeth: study protocol for a phase 2 parallel-group 3.5-year randomized controlled clinical trial (waterBEST) Trials (IF 2.5) Pub Date : 2024-03-05 Anne E. Sanders, Kimon Divaris, Tewodros R. Godebo, Gary D. Slade
Fluoridation of public water systems is known as a safe and effective strategy for preventing dental caries based on evidence from non-randomized studies. Yet 110 million Americans do not have access to a fluoridated public water system and many others do not drink tap water. This article describes the study protocol for the first randomized controlled trial (RCT) of fluoridated water that assesses
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Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-04 Li-na Yang, Yi Sun, Yu-zhu Wang, Jing Wang, Yi-sha Qi, Shan-shan Mu, Yun-peng Liu, Zi-qing Zhang, Zi-mo Chen, Xiao-jie Wang, Wu-xiang Xie, Chang-wei Wei, Yang Wang, An-shi Wu
Endovascular thrombectomy (EVT) is a standard treatment for acute ischemic stroke (AIS) with large vessel occlusion. Hypertension and increased blood pressure variability within the first 24 h after successful reperfusion are related to a higher risk of symptomatic intracerebral hemorrhage and higher mortality. AIS patients might suffer from ischemia-reperfusion injury following reperfusion, especially
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Evaluation of a financial incentive intervention on malaria prevalence among the residents in Lake Victoria basin, Kenya: study protocol for a cluster-randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-04 Tomoya Matsumoto, Masaru Nagashima, Wataru Kagaya, James Kongere, Jesse Gitaka, Akira Kaneko
In the Lake Victoria basin of western Kenya, malaria remains highly endemic despite high coverage of interventions such as mass distribution of long-lasting insecticidal nets (LLIN), indoor residual spraying (IRS) programs, and improvement of availability and accessibility of rapid diagnostic tests (RDT) and artemisinin-based combination therapy (ACT) at community healthcare facilities. We hypothesize
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Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-04 Sten P. Willemsen, Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L. J. DeKoninck, Enrico Lopriore, Wes Onland, Willem P. de Boode, Anton H. van Kaam, Debbie H. Nuytemans, Irwin K. M. Reiss, G. Jeroen Hutten, Sandra A. Prins, Estelle E. M. Mulder, Christian V. Hulzebos, Sam J. van Sambeeck, Mayke E. van der Putten, Inge A. Zonnenberg, Arjan B. te Pas, Marijn J. Vermeulen
Mortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor for these complications is hemodynamic instability. Pre-clinical studies suggest that the timing of umbilical cord clamping affects hemodynamic stability during transition. Standard care is time-based cord clamping (TBCC), with clamping irrespective of lung aeration
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Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators Trials (IF 2.5) Pub Date : 2024-03-04 Diana Papaioannou, Kirsty Sprange, Sienna Hamer-Kiwacz, Cara Mooney, Gwenllian Moody, Cindy Cooper
Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); however, limited guidance exists on how to record harms in BCI trials. This qualitative study explored experiences and perspectives from multi-disciplinary trial experts
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A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer’s disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial Trials (IF 2.5) Pub Date : 2024-03-04 Nina Possemis, Frans Verhey, Jos Prickaerts, Arjan Blokland, Inez Ramakers
Research into the neurobiological underpinnings of learning and memory has demonstrated the cognitive-enhancing effects associated with diverse classes of phosphodiesterase (PDE) inhibitors. Specific PDE inhibitors have been identified to improve neuronal communication through selective inhibition of PDE activity. Roflumilast, a PDE4 inhibitor, has demonstrated efficacy in enhancing episodic memory
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Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials Trials (IF 2.5) Pub Date : 2024-03-02 Jonathan A. Cook, Richard A. Parker
We would like to thank Wong for their response to our article on the relevance of clinical importance when determining the target difference in sample size calculations and clarification on their position [1, 2]. It is with the hope of making clearer the differences in our positions that we make this further response, though we note we do agree on a number of practical points such as the challenges
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Coenzyme Q10 supplementation in burn patients: a double-blind placebo-controlled randomized clinical trial Trials (IF 2.5) Pub Date : 2024-03-02 Zahra Kiani, Nadereh Khorsand, Fahimeh Beigi, Gholamreza Askari, Manoj Sharma, Mohammad Bagherniya
Burn injuries are important medical problems that, aside from skin damage, cause a systemic response including inflammation, oxidative stress, endocrine disorders, immune response, and hypermetabolic and catabolic responses which affect all the organs in the body. The aim of this study was to determine the effect of coenzyme Q10 (CoQ10) supplementation on inflammation, oxidative stress, and clinical
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Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10–17-year-olds presenting at police custody: a randomised controlled trial Trials (IF 2.5) Pub Date : 2024-03-02 Gwenllian Moody, Elinor Coulman, Emma Crocker-White, Kylie Gray, Richard P. Hastings, Andrea Longman, Fiona Lugg-Widger, Rebecca Playle, Jeremy Segrott, Paul Thompson, Julia Badger, Peter E. Langdon, Samantha Flynn
Within England, children and young people (CYP) who come into police custody are referred to Liaison and Diversion (L&D) teams. L&D teams have responsibility for liaising with healthcare and other support services while working to divert CYP away from the criminal justice system but have traditionally not provided targeted psychological interventions to CYP. Considering evidence that Solution Focused
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Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-03-01 Anne H. Berman, Naira Topooco, Petra Lindfors, Marcus Bendtsen, Philip Lindner, Olof Molander, Martin Kraepelien, Christopher Sundström, Nooshin Talebizadeh, Karin Engström, George Vlaescu, Gerhard Andersson, Claes Andersson
Emerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory concerning work, intimate relationships, and health. This can interfere with academic performance, as mood and anxiety disorders are key predictors of dropout from higher education. A treatment
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Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients Trials (IF 2.5) Pub Date : 2024-03-01 Wanjun Zhou, Yawen Zhang, Zhiwei Wang, Liang Zhang, Xinqiong Zhang
Outcome assessment in perioperative exercise trials for lung cancer is heterogeneous, often omitting those that are important and patient-relevant. This heterogeneity hinders the synthesis of evidence. To address this issue, a core outcome set, an agreed-upon standardized set of outcomes to be measured and reported, is required to reduce heterogeneity among outcome measurements. This study protocol
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Aspin: neurosurgical aspirin intervention prognostic study — perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial Trials (IF 2.5) Pub Date : 2024-02-29 Ahmed Zian, Gijsbert M. Overdevest, Pieter J. Schutte, Frederikus A. Klok, Ewout W. Steyerberg, Wouter A. Moojen, Niels A. van der Gaag
Aspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events. The aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing low complex lumbar spinal surgery, compared
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Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv) Trials (IF 2.5) Pub Date : 2024-02-29 Einar Furulund, Tesfaye Madebo, Karl Trygve Druckrey-Fiskaaen, Jørn Henrik Vold, Mette Hegland Nordbotn, Eivin Dahl, Sindre M. Dyrstad, Torgeir Gilje Lid, Lars T. Fadnes
Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have high morbidity and reduced quality of life. Physical activity is recommended as an adjunctive treatment for people with substance use disorder, but there is minimal evidence from randomized controlled
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A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India Trials (IF 2.5) Pub Date : 2024-02-29 Sundus Shafat Ahmad, Reena Verma, Robert J. Commons, Nitika, Sauman Singh-Phulgenda, Rutuja Chhajed, Praveen K. Bharti, Beauty Behera, Syed Mohammad Naser, Salil Kumar Pal, Parinita Halder Ranjit, Rajendra Kumar Baharia, Bhavin Solanki, K. J. Upadhyay, Philippe J. Guerin, Amit Sharma, Ric N. Price, Manju Rahi, Kamala Thriemer
Plasmodium vivax remains a major challenge for malaria control and elimination due to its ability to cause relapsing illness. To prevent relapses the Indian National Center for Vector Borne Diseases Control (NCVBDC) recommends treatment with primaquine at a dose of 0.25 mg/kg/day provided over 14 days. Shorter treatment courses may improve adherence and treatment effectiveness. This is a hospital-based
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Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial Trials (IF 2.5) Pub Date : 2024-02-29 Helena Smartt, Gianni D. Angelini, Ben Gibbison, Chris A. Rogers
The ProMPT-2 trial (Propofol for Myocardial Protection Trial #2) aims to compare the safety and efficacy of low- and high-dose propofol supplementation of the cardioplegia solution during adult cardiac surgery versus sham supplementation. This update presents the statistical analysis plan, detailing how the trial data will be analysed and presented. Outlined analyses are in line with the Consolidated
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Effects of a chronotype-adapted diet on weight loss, cardiometabolic health, and gut microbiota: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-02-28 Monica Dinu, Sofia Lotti, Giuditta Pagliai, Antonia Napoletano, Marta Tristan Asensi, Ilaria Giangrandi, Rossella Marcucci, Amedeo Amedei, Barbara Colombini, Francesco Sofi
Obesity and its associated health complications have become a global public health concern, necessitating innovative approaches to weight management. One emerging area of research focuses on the influence of chronotype, an individual’s preferred timing for daily activities, on eating habits, weight regulation, and metabolic health. Recent observational studies suggest that the misalignment between
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Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Côte d’Ivoire: a three group, cluster randomised trial Trials (IF 2.5) Pub Date : 2024-02-28 Colette Sih, Natacha Protopopoff, Alphonsine A. Koffi, Ludovic P. Ahoua Alou, Edouard Dangbenon, Louisa A. Messenger, Manisha A. Kulkarni, Marius G. Zoh, Soromane Camara, Serge B. Assi, Raphael N’Guessan, Jackie Cook
The massive scale-up of long-lasting insecticidal nets (LLIN) has led to a major reduction in malaria burden in many sub-Saharan African (SSA) countries. The World Health Organization (WHO) has recently issued a strong recommendation for the use of chlorfenapyr-pyrethroid LLINs compared to standard pyrethroid-only LLINs in areas of high insecticide resistance intensity. However, there is still a lack
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Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III) Trials (IF 2.5) Pub Date : 2024-02-28 Brad J. Kolls, Keith W. Muir, Sean I. Savitz, Lawrence R. Wechsler, Julie G. Pilitsis, Scott Rahimi, Richard L. Beckman, Vincent Holmes, Peng R. Chen, David S. Albers, Daniel T. Laskowitz
Recruitment of participants is the greatest risk to completion of most clinical trials, with 20–40% of trials failing to reach the targeted enrollment. This is particularly true of trials of central nervous system (CNS) therapies such as intervention for chronic stroke. The PISCES III trial was an invasive trial of stereotactically guided intracerebral injection of CTX0E03, a fetal derived neural stem
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An e-mental health intervention to reduce depression symptoms in individuals with obesity: study protocol for the randomized, controlled, two-armed, confirmatory LightMood trial Trials (IF 2.5) Pub Date : 2024-02-28 Dilara Kocol, Sheila Geiger, Adam Schweda, Jil Beckord, Theresa Schadendorf, Christoph Jansen, Anita Robitzsch, Eva-Maria Skoda, Martin Teufel, Alexander Bäuerle
Patients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical apps, can provide a suitable approach to support affected people. In the envisaged prospective randomized controlled trial, we aim to examine the efficacy of the LightMood intervention. The LightMood
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Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda Trials (IF 2.5) Pub Date : 2024-02-27 Catharina F. van der Boor, Dalili Taban, Wietse A. Tol, Josephine Akellot, Melissa Neuman, Helen A. Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts, Daniela C. Fuhr
The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological
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Does somatosensory discrimination therapy alter sensorimotor upper limb function differently compared to motor therapy in children and adolescents with unilateral cerebral palsy: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-02-26 Lize Kleeren, Lisa Mailleux, Belinda McLean, Catherine Elliott, Griet Dequeker, Anja Van Campenhout, Jean-Jacques Orban de Xivry, Geert Verheyden, Els Ortibus, Katrijn Klingels, Hilde Feys
Besides motor impairments, up to 90% of the children and adolescents with unilateral cerebral palsy (uCP) present with somatosensory impairments in the upper limb. As somatosensory information is of utmost importance for coordinated movements and motor learning, somatosensory impairments can further compromise the effective use of the impaired upper limb in daily life activities. Yet, intervention
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Comparing the effects of pulsed and radiofrequency catheter ablation on quality of life, anxiety, and depression of patients with paroxysmal supraventricular tachycardia: a single-center, randomized, single-blind, standard-controlled trial Trials (IF 2.5) Pub Date : 2024-02-24 Ying Du, Shanshan Ma, Pan Yue, Ying Xu, Ya Wen, Mingzhu Ji, Lingxiao He, Dengbin Liao
Radiofrequency catheter ablation (RFCA) may lead to decreased quality of life (QOL) and increased anxiety and depression in patients with paroxysmal supraventricular tachycardia (PSVT), possibly due to the lack of selectivity of the ablation tissue and the long ablation time. In recent years, pulsed field ablation (PFA) has been used for the first time in China to treat PSVT patients because of its
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PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany Trials (IF 2.5) Pub Date : 2024-02-23 Sandra Meyer-Moock, Daniel Szczotkowski, Leonie Schouten, Frank Petzke, Lena Milch, Beatrice Metz-Oster, Louise Zinndorf, Christian Geber, Greta Hoffmann, Anke Preißler, Ursula Marschall, Felix Rottke, Anja Waidner, André Möller, Thomas Isenberg, Gabriele Lindena, Anne Gärtner, Ulrike Kaiser, Thomas Kohlmann
Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The aim of this nationwide, multicentre, randomised controlled trial is to evaluate the efficacy of a 10-week ambulatory (outpatient) interdisciplinary multimodal pain therapy (A-IMPT) for patients
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The effect of a cognitive training therapy based on stimulation of brain oscillations in patients with mild cognitive impairment in a Chilean sample: study protocol for a phase IIb, 2 × 3 mixed factorial, double-blind randomised controlled trial Trials (IF 2.5) Pub Date : 2024-02-23 Alejandra Figueroa-Vargas, Begoña Góngora, María Francisca Alonso, Alonso Ortega, Patricio Soto-Fernández, Lucía Z-Rivera, Sebastián Ramírez, Francisca González, Paula Muñoz Venturelli, Pablo Billeke
The ageing population has increased the prevalence of disabling and high-cost diseases, such as dementia and mild cognitive impairment (MCI). The latter can be considered a prodromal phase of some dementias and a critical stage for interventions to postpone the impairment of functionality. Working memory (WM) is a pivotal cognitive function, representing the fundamental element of executive functions
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Trial protocol for the Building Resilience through Socio-Emotional Training (ReSET) programme: a cluster randomised controlled trial of a new transdiagnostic preventative intervention for adolescents Trials (IF 2.5) Pub Date : 2024-02-23 Essi Viding, Alex Lloyd, Roslyn Law, Peter Martin, Laura Lucas, Tom Chin-Han Wu, Nikolaus Steinbeis, Nick Midgley, René Veenstra, Jaime Smith, Lili Ly, Geoffrey Bird, Jennifer Murphy, David Plans, Marcus Munafo, Ian Penton-Voak, Jessica Deighton, Kathleen Richards, Mya Richards, Pasco Fearon
Adolescence is a period of heightened vulnerability to developing mental health problems, and rates of mental health disorder in this age group have increased in the last decade. Preventing mental health problems developing before they become entrenched, particularly in adolescents who are at high risk, is an important research and clinical target. Here, we report the protocol for the trial of the
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Seroma control in axillary lymphadenectomy with Glubran 2® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain) Trials (IF 2.5) Pub Date : 2024-02-22 Sandra López Gordo, Neus Ruiz-Edo, Maria Teresa Fernández-Planas, Sara Viscaya-Martín, Cristina Serra-Serra
Seroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being tested with aspirative drains. Symptomatic seroma represents the 19% after axillary lymphadenectomy without drains. The aim of this study is to analyze the effect of a sealant in the seroma control
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Evaluation of intensive community care services for young people with psychiatric emergencies: study protocol for a multi-centre parallel-group, single-blinded randomized controlled trial with an internal pilot phase Trials (IF 2.5) Pub Date : 2024-02-22 Thilipan Thaventhiran, Ben Hoi-Ching Wong, Izabela Pilecka, Saba Masood, Opeyemi Atanda, Joe Clacey, Jovanka Tolmac, Leon Wehncke, Liana Romaniuk, Margaret Heslin, Emma Tassie, Petrina Chu, Rhys Bevan-Jones, Ruth Woolhouse, Tauseef Mahdi, Veronika Beatrice Dobler, Mandy Wait, Paula Reavey, Sabine Landau, Sarah Byford, Toby Zundel, Dennis Ougrin
Over 3000 young people under the age of 18 are admitted to Tier 4 Child and Adolescent Mental Health Services (CAMHS) inpatient units across the UK each year. The average length of hospital stay for young people across all psychiatric units in the UK is 120 days. Research is needed to identify the most effective and efficient ways to care for young people (YP) with psychiatric emergencies. This study
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Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial Trials (IF 2.5) Pub Date : 2024-02-22 Tibor A. Zwimpfer, Nadja Stiegeler, Philip C. Müller, Andreas Schötzau, Bernhard Fellmann-Fischer, Viola Heinzelmann-Schwarz, Ralph Peterli, Marko Kraljević
Vision is an important and defining element of laparoscopy and significantly affects the outcome of surgery in terms of time, error, and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD) and two-dimensional (2D) ultra-high-resolution (4K) monitors. 3D HD systems offer a number of potential benefits to surgeons
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Understanding implementation of findings from trial method research: a mixed methods study applying implementation frameworks and behaviour change models Trials (IF 2.5) Pub Date : 2024-02-22 Taylor Coffey, Paula R. Williamson, Katie Gillies
Trial method research produces recommendations on how to best conduct trials. However, findings are not routinely implemented into practice. To better understand why, we conducted a mixed method study on the challenges of implementing trial method research findings into UK-based clinical trial units. Three stages of research were conducted. Firstly, case studies of completed projects that provided
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Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial Trials (IF 2.5) Pub Date : 2024-02-22 Soujanya Kaup, Dimple Kondal, Siddharudha Shivalli, John Buchan
Cornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip
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Total laparoscopic partial hepatectomy versus open partial hepatectomy for primary left-sided hepatolithiasis: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-02-22 Shu-bo Pan, Chun-li Wu, Da-chen Zhou, Qi-ru Xiong, Xiao-ping Geng, Hui Hou
The advantages of laparoscopic left-sided hepatectomy (LLH) for treating hepatolithiasis in terms of the time to postoperative length of hospital stay (LOS), morbidity, long-term abdominal wall hernias, hospital costs, residual stone rate, and recurrence of calculus have not been confirmed by a randomized controlled trial. The aim of this trial is to compare the safety and effectiveness of LLH with
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Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA)—protocol for a randomized factorial optimization trial Trials (IF 2.5) Pub Date : 2024-02-21 Christopher Sundström, Ekaterina Ivanova, Philip Lindner, Magnus Johansson, Martin Kraepelien
The continual development and implementation of effective digital interventions is one important strategy that may serve to bridge the well-known treatment gap related to problematic alcohol use. Research suggests that clinician guidance, provided in different ways during the digital intervention (i.e., written weekly messages, phone calls etc.), can boost intervention engagement and effects. Digital
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To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial) Trials (IF 2.5) Pub Date : 2024-02-21 Birgitte Hougs Kjær, Ann M. Cools, Finn E. Johannsen, Jeanette Trøstrup, Theresa Bieler, Volkert Siersma, Peter S. Magnusson
Rotator cuff (RC) tendinopathy is the most reported shoulder disorder in the general population with highest prevalence in overhead athletes and adult working-age population. A growing body of evidence support exercise therapy as an effective intervention, but to date there are no prospective randomized controlled trials addressing pain as an intervention variable. A single-site, prospective, pragmatic
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Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial Trials (IF 2.5) Pub Date : 2024-02-21 Yuyu Zhang, Nailong Tang, Lei Lei, Runxin Lv, Yaochi Zhang, Nian Liu, Haixia Chen, Min Cai, Huaning Wang
Emotional blunting is a symptom that has always been present in depressed patients. Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective supplementary therapy for treating depression. However, the effectiveness and brain imaging processes of functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) in the treatment of depression with emotional blunting have not