martes, 24 de diciembre de 2019

Trials | Articles

Trials | Articles

Trials

  1. Following publication of the original article [1], we have been notified that Figure 1 was published with the track changes. In this Correction the incorrect and correct Fig. 1 are shown.
    Authors:Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts and Aemal Akhtar
    Citation:Trials 2019 20:617
    Content type:Correction
    Published on: 
    The original article was published in Trials 2019 20:545
  2. Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs...
    Authors:A. Magnin, V. Cabral Iversen, G. Calvo, B. Čečetková, O. Dale, R. Demlova, Gy. Blasko, F. Keane, G. L. Kovacs, C. Levy-Marchal, E. C. Monteiro, L. Palmisano, D. Pella, A. Portolés Pérez, O. Rascol, C. Schmid…
    Citation:Trials 2019 20:616
    Content type:Research
    Published on: 
  3. The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is ca...
    Authors:Marijke Dieltjens, Marc J. Braem, Sara Op de Beeck, Anneclaire V. M. T. Vroegop, Elahe Kazemeini, Eli Van de Perck, Jolien Beyers, Chloé Kastoer, Kristien Wouters, Marc Willemen, Johan A. Verbraecken and Olivier M. Vanderveken
    Citation:Trials 2019 20:615
    Content type:Study protocol
    Published on: 
  4. Cognitive and mood disorders negatively impact daily life in patients with multiple sclerosis (MS). Pharmacological treatments did not demonstrate any effect on cognition compared with cognitive rehabilitation...
    Authors:Caroline Harand, France Daniel, Audrey Mondou, Damien Chevanne, Christian Creveuil and Gilles Defer
    Citation:Trials 2019 20:614
    Content type:Study protocol
    Published on: 
  5. Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be w...
    Authors:Katie Gillies, Iain Chalmers, Paul Glasziou, Diana Elbourne, Jim Elliott and Shaun Treweek
    Citation:Trials 2019 20:613
    Content type:Commentary
    Published on: 
  6. Wound repair is one of the most complex biological processes of human life. Allogeneic cell-based engineered skin substitutes provide off-the-shelf temporary wound coverage and act as biologically active dress...
    Authors:Alexandra Poinas, Pierre Perrot, Judith Lorant, Olivier Nerrière, Jean-Michel Nguyen, Soraya Saiagh, Cécile Frenard, Audrey Leduc, Olivier Malard, Florent Espitalier, Franck Duteille, Anne Chiffoleau, Florence Vrignaud, Amir Khammari and Brigitte Dréno
    Citation:Trials 2019 20:612
    Content type:Study protocol
    Published on: 
  7. Following publication of the original article [1], we have been notified that one of an error in the Conclusions section of the Abstract.
    Authors:Stephen J. Walters, Richard M. Jacques, Inês Bonacho dos Anjos Henriques-Cadby, Jane Candlish, Nikki Totton and Mica Teo Shu Xian
    Citation:Trials 2019 20:611
    Content type:Correction
    Published on: 
    The original article was published in Trials 2019 20:566
  8. Following publication of the original article [1], we have been notified that the final specification of randomisation implemented in the study is slightly different to that stated in the protocol and needs to...
    Authors:Sam Eldabe, Ashish Gulve, Simon Thomson, Ganesan Baranidharan, Rui Duarte, Susan Jowett, Harbinder Sandhu, Raymond Chadwick, Morag Brookes, Anisah Tariq, Jenny Earle, Jill Bell, Anu Kansal, Shelley Rhodes and Rod S. Taylor
    Citation:Trials 2019 20:610
    Content type:Correction
    Published on: 
    The original article was published in Trials 2018 19:633
  9. Palliative antalgic treatments represent an issue for clinical management and a challenge for scientific research. Radiotherapy (RT) plays a central role. Techniques such as stereotactic body radiotherapy (SBR...
    Authors:Francesco Cellini, Stefania Manfrida, Francesco Deodato, Savino Cilla, Ernesto Maranzano, Stefano Pergolizzi, Fabio Arcidiacono, Rossella Di Franco, Francesco Pastore, Matteo Muto, Valentina Borzillo, Costanza Maria Donati, Giambattista Siepe, Salvatore Parisi, Antonia Salatino, Antonino D’Agostino…
    Citation:Trials 2019 20:609
    Content type:Study protocol
    Published on: 
  10. Treatment of bipolar disorder (BD) usually requires drug combinations. Combinations of lithium plus valproic acid (Li/VPA) and lithium plus carbamazepine (Li/CBZ) are used in clinical practice but were not pre...
    Authors:Giovani Missio, Doris Hupfeld Moreno, Frederico Navas Demetrio, Marcio Gerhardt Soeiro-de-Souza, Fernando dos Santos Fernandes, Vivian Boschesi Barros and Ricardo Alberto Moreno
    Citation:Trials 2019 20:608
    Content type:Research
    Published on: 
  11. Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature sugg...
    Authors:Nadja Kehler Curth, Ursula Brinck-Claussen, Kirstine Bro Jørgensen, Susanne Rosendal, Carsten Hjorthøj, Merete Nordentoft and Lene Falgaard Eplov
    Citation:Trials 2019 20:607
    Content type:Study protocol
    Published on: 
  12. Following publication of the original article [1], we have been notified that one of the authors’ names is spelled incorrectly. In this Correction the incorrect and correct author name are shown.
    Authors:Devin S. McCaskell, Alexander J. Molloy, Laura Childerhose, F. Aileen Costigan, Julie C. Reid, Magda McCaughan, France Clarke, Deborah J. Cook, Jill C. Rudkowski, Christopher Farley, Tim Karachi, Bram Rochwerg, Anastasia Newman, Alison Fox-Robichaud, Margaret S. Herridge, Vincent Lo…
    Citation:Trials 2019 20:606
    Content type:Correction
    Published on: 
    The original article was published in Trials 2019 20:532
  13. Recent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16–20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of...
    Authors:Stephen Benjamin Peckham, Emily Ionson, Marouane Nassim, Kevin Ojha, Lena Palaniyappan, Joe Gati, Jean Thebérge, Andrea Lazosky, Mark Speechley, Imants Barušs, Soham Rej and Akshya Vasudev
    Citation:Trials 2019 20:605
    Content type:Study protocol
    Published on: 
  14. Acute mountain sickness (AMS) is a cluster of symptoms that commonly occur in those ascending to high altitudes. Symptoms can include headaches, nausea, insomnia and fatigue. Exposure to high altitude can also...
    Authors:O. Fisher, R. A. Benson, S. Wayte, P. K. Kimani, C. Hutchinson and C. H. E. Imray
    Citation:Trials 2019 20:604
    Content type:Study protocol
    Published on: 
  15. Routine application of chlorhexidine oral rinse is recommended to reduce risk of ventilator-associated pneumonia (VAP) in mechanically ventilated patients. Recent reappraisal of the evidence from two meta-anal...
    Authors:Craig M. Dale, Louise Rose, Sarah Carbone, Orla M. Smith, Lisa Burry, Eddy Fan, Andre Carlos Kajdacsy-Balla Amaral, Victoria A. McCredie, Ruxandra Pinto, Carlos R. Quiñonez, Susan Sutherland, Damon C. Scales and Brian H. Cuthbertson
    Citation:Trials 2019 20:603
    Content type:Study protocol
    Published on: 
  16. Following publication of the original article [1], we have been notified of a few mistakes:
    Authors:William Sones, Steven A. Julious, Joanne C. Rothwell, Craig Robert Ramsay, Lisa V. Hampson, Richard Emsley, Stephen J. Walters, Catherine Hewitt, Martin Bland, Dean A. Fergusson, Jesse A. Berlin, Doug Altman, Luke David Vale and Jonathan Alistair Cook
    Citation:Trials 2019 20:602
    Content type:Correction
    Published on: 
    The original article was published in Trials 2018 19:542
  17. Fibroblast growth factor 23 (FGF23) is associated with left ventricular hypertrophy (LVH) in patients with chronic kidney disease, and calcimimetic therapy reduces plasma concentrations of FGF23. It remains un...
    Authors:Katharina Dörr, Michael Kammer, Roman Reindl-Schwaighofer, Matthias Lorenz, Christian Loewe, Rodrig Marculescu, Reinhold Erben and Rainer Oberbauer
    Citation:Trials 2019 20:601
    Content type:Study protocol
    Published on: 
  18. There is a growing debate on the relationship between health-related quality of life (HRQoL) and patient survival which has been going on for the last few decades. The greatest wish of clinicians is to extend ...
    Authors:Lei Wang, Liang Wang, Xuefei Song, Chang Cui, Chunyue Ma, Bing Guo and Xingjun Qin
    Citation:Trials 2019 20:600
    Content type:Study protocol
    Published on: 
  19. The Mesothelioma and Radical Surgery Trial (MARS 2) aims to evaluate a surgical procedure by comparing chemotherapy and surgery against chemotherapy alone. The pilot study for MARS 2 evaluated the viability of...
    Authors:Clare Warnock, Karen Lord, Bethany Taylor and Angela Tod
    Citation:Trials 2019 20:598
    Content type:Research
    Published on: 
  20. Currently there are campaigns to raise the awareness of the need to practice physical exercise with several objectives, mainly as a preventive measure. The Pilates method is a form of therapeutic exercise for ...
    Authors:Allysiê Priscilla de Souza Cavina, Eduardo Pizzo Junior, Aryane Flauzino Machado, Taíse Mendes Biral, Carlos Marcelo Pastre and Franciele Marques Vanderlei
    Citation:Trials 2019 20:597
    Content type:Study protocol
    Published on: 
  21. Disorders of consciousness (DOC) after traumatic brain injury (TBI) raise the mortality of patients, restrict the rehabilitation of patients with TBI, and increase the physical and economic burden that TBI imp...
    Authors:Shilin Li, Xiangli Dong, Weiming Sun, Na Zhao, Guohua Yu and Lang Shuai
    Citation:Trials 2019 20:596
    Content type:Study protocol
    Published on: 
  22. Following publication of the original article [1], we have been notified of a few mistakes in the “Sample size calculations” section, second paragraph.
    Authors:Rachel B. van Oostveen, Alberto Romero-Palacios, Richard Whitlock, Shun Fu Lee, Stuart Connolly, Alex Carignan, C. David Mazer, Mark Loeb and Dominik Mertz
    Citation:Trials 2019 20:595
    Content type:Correction
    Published on: 
    The original article was published in Trials 2018 19:688
  23. Infections are common in nursing home (NH) residents with advanced dementia but are often managed inappropriately. Antimicrobials are extensively prescribed, but frequently with insufficient evidence to suppor...
    Authors:Andrea J. Loizeau, Erika M. C. D’Agata, Michele L. Shaffer, Laura C. Hanson, Ruth A. Anderson, Timothy Tsai, Daniel A. Habtemariam, Elaine H. Bergman, Ruth P. Carroll, Simon M. Cohen, Erin M. E. Scott, Erin Stevens, Jeremy D. Whyman, Elizabeth H. Bennert and Susan L. Mitchell
    Citation:Trials 2019 20:594
    Content type:Study protocol
    Published on: 
  24. One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is l...
    Authors:Dan Brunsdon, Linda Biesty, Peter Brocklehurst, Valerie Brueton, Declan Devane, Jim Elliott, Sandra Galvin, Carrol Gamble, Heidi Gardner, Patricia Healy, Kerenza Hood, Joan Jordan, Doris Lanz, Beccy Maeso, Amanda Roberts, Imogen Skene…
    Citation:Trials 2019 20:593
    Content type:Methodology
    Published on: 
  25. Patients with haematological malignancies often develop thrombocytopenia as a consequence of either their disease or its treatment. Platelet transfusions are commonly given to raise a low platelet count and re...
    Authors:Lise J. Estcourt, Zoe McQuilten, Gillian Powter, Claire Dyer, Eleanor Curnow, Erica M. Wood and Simon J. Stanworth
    Citation:Trials 2019 20:592
    Content type:Study protocol
    Published on: 
  26. Older people are frequent emergency department (ED) users who present with complex issues that are linked to poorer health outcomes following the index visit, often have increased ED length of stay, and tend t...
    Authors:Marica Cassarino, Katie Robinson, Íde O’Shaughnessy, Eimear Smalle, Stephen White, Collette Devlin, Rosie Quinn, Dominic Trépel, Fiona Boland, Marie E. Ward, Rosa McNamara, Margaret O’Connor, Gerard McCarthy, Damien Ryan and Rose Galvin
    Citation:Trials 2019 20:591
    Content type:Study protocol
    Published on: 
  27. Recent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with per...
    Authors:Anders Galaasen Bakken, Iben Axén, Andreas Eklund and Søren O’Neill
    Citation:Trials 2019 20:590
    Content type:Study protocol
    Published on: 
  28. Actinic keratoses (AK) are common skin lesions that can progress to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demo...
    Authors:Markus V. Heppt, Theresa Steeb, Lutz Schmitz, Claus Garbe, Lars E. French, Ulrike Leiter and Carola Berking
    Citation:Trials 2019 20:589
    Content type:Study protocol
    Published on: 
  29. Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide ...
    Authors:Malin E. Carmland, Melissa Kreutzfeldt, Jakob V. Holbech, Niels T. Andersen, Troels S. Jensen, Flemming W. Bach, Søren H. Sindrup and Nanna B. Finnerup
    Citation:Trials 2019 20:588
    Content type:Study protocol
    Published on: 
  30. In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followe...
    Authors:K. E. A. Burns, Leena Rizvi, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Francois Lamontagne, John W. Devlin, Peter Dodek, Michael Mayette, Maged Tanios, Audrey Gouskos, Phyllis Kay, Susan Mitchell, Kenneth C. Kiedrowski and Nicholas S. Hill
    Citation:Trials 2019 20:587
    Content type:Study protocol
    Published on: 
  31. Patellofemoral pain (PFP) often affects young women, and the etiology is multifactorial and poorly understood. Conservative intervention has been focused on risk factors or aggravating factors and is composed ...
    Authors:Natália Camin Silva, Matheus de Castro Silva, Morisa Garcia Guimarães, Manoela Beatriz de Oliveira Nascimento and Lilian Ramiro Felicio
    Citation:Trials 2019 20:586
    Content type:Study protocol
    Published on: 
  32. Nutritional support is essential in the care of critically ill children since malnutrition in this population is associated with increased morbidity and mortality. Injury in patients admitted to pediatric inte...
    Authors:Reyes Fernández, Javier Urbano, Ángel Carrillo, Ana Vivanco, María José Solana, Corsino Rey and Jesús López-Herce
    Citation:Trials 2019 20:585
    Content type:Study protocol
    Published on: 
  33. High salt intake is a risk factor for hypertension and cardiovascular disease. Reducing salt intake has been shown to reduce blood pressure. Despite population-level interventions, including product reformulat...
    Authors:Sarah Payne Riches, Carmen Piernas, Paul Aveyard, James P. Sheppard, Mike Rayner and Susan A. Jebb
    Citation:Trials 2019 20:584
    Content type:Study protocol
    Published on: 
  34. Depression is a major cause of chronic disability throughout the world and an important cardiovascular risk factor, increasing the relative risk of coronary artery disease as well as rates of cardiovascular mo...
    Authors:Catarina Magalhães Porto, Tatiana de Paula Santana da Silva and Everton Botelho Sougey
    Citation:Trials 2019 20:583
    Content type:Study protocol
    Published on: 
    The Correction to this article has been published in Trials 2019 20:628
  35. Intraoperative hypotension is associated with increased morbidity and mortality. Current treatment is mostly reactive. The Hypotension Prediction Index (HPI) algorithm is able to predict hypotension minutes be...
    Authors:M. Wijnberge, J. Schenk, L. E. Terwindt, M. P. Mulder, M. W. Hollmann, A. P. Vlaar, D. P. Veelo and B. F. Geerts
    Citation:Trials 2019 20:582
    Content type:Study protocol
    Published on: 
  36. The World Health Organization recommended (in 2010) universal testing for suspected malaria, due to some fundamental changes in malaria trends such as the declining incidence of malaria in high-burden countrie...
    Authors:Ugwu I. Omale, Benedict N. Azuogu, Chihurumnanya Alo, Ugochukwu C. Madubueze, Onyinyechukwu U. Oka, Kingsley C. Okeke, Ifeyinwa M. Okafor, Rowland Utulu, Uduak E. Akpan, Chijioke V. Iloke, Anthonia O. Nnubia, Ifeyinwa I. Eze, Ogechukwu C. Anene, Chukwuka R. Nnabu and Deborah C. Ibemesi
    Citation:Trials 2019 20:581
    Content type:Study protocol
    Published on: 
  37. Recently factors in the relationship between gut microbiota, obesity, diabetes and the metabolic syndrome have been suggested in the development and progression of nonalcoholic steatohepatitis (NASH). In this ...
    Authors:Amanda Souza Silva-Sperb, Helena Abadie Moraes, Bruna Concheski de Moura, Bruna Cherubini Alves, Juliana Paula Bruch-Bertani, Vittoria Zambon Azevedo and Valesca Dall’Alba
    Citation:Trials 2019 20:580
    Content type:Study protocol
    Published on: 
  38. Few community urologists offer cancer patients the opportunity to participate in cancer clinical trials, despite national guidelines that recommend it, depriving an estimated 260,000 urological cancer patients...
    Authors:Shellie Ellis, Mugur Geana, Tomas Griebling, Charles McWilliams, Jessie Gills, Kelly Stratton, Christine Mackay, Ariel Shifter, Andrew Zganjar and Brantley Thrasher
    Citation:Trials 2019 20:578
    Content type:Research
    Published on: 
  39. One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups.
    Authors:Sravya Kakumanu, Braden J. Manns, Sophia Tran, Terry Saunders-Smith, Brenda R. Hemmelgarn, Marcello Tonelli, Ross Tsuyuki, Noah Ivers, Danielle Southern, Jeff Bakal and David J. T. Campbell
    Citation:Trials 2019 20:577
    Content type:Research
    Published on: 
  40. Colorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3–10% of the population has an increased risk for colorectal cancer due to family history and warrants more fr...
    Authors:Karen M. Goldstein, Deborah A. Fisher, R. Ryanne Wu, Lori A. Orlando, Cynthia J. Coffman, Janet M. Grubber, Tejinder Rakhra-Burris, Virginia Wang, Maren T. Scheuner, Nina Sperber, Santanu K. Datta, Richard E. Nelson, Elizabeth Strawbridge, Dawn Provenzale, Elizabeth R. Hauser and Corrine I. Voils
    Citation:Trials 2019 20:576
    Content type:Study protocol
    Published on: 
  41. Dizziness is a common complaint, and the symptom often persists, together with additional complaints. A treatment combining Vestibular Rehabilitation (VR) and Cognitive Behaviour Therapy (CBT) is suggested. Ho...
    Authors:Lene Kristiansen, L. H. Magnussen, K. T. Wilhelmsen, S. Mæland, S. H. G. Nordahl, R. Clendaniel, A. Hovland and B. Juul-Kristensen
    Citation:Trials 2019 20:575
    Content type:Study protocol
    Published on: 
  42. Childhood asthma is a common condition. Currently there is no validated objective test which can be used to guide asthma treatment in children. This study tests the hypothesis that the addition of fractional e...
    Authors:S. Turner, S. C. Cotton, C. D. Emele, R. Thomas, S. Fielding, E. A. Gaillard, J. C. de Jongste, H. Morgan, A. R. Neilson, J. Norrie, M. Pijnenburg, D. Price and M. Thomas
    Citation:Trials 2019 20:573
    Content type:Study protocol
    Published on: 
  43. Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populati...
    Authors:Jay J. H Park, Ellie Siden, Michael J. Zoratti, Louis Dron, Ofir Harari, Joel Singer, Richard T. Lester, Kristian Thorlund and Edward J. Mills
    Citation:Trials 2019 20:572
    Content type:Review
    Published on: 
  44. Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known abo...
    Authors:Anna Rosala-Hallas, Carrol Gamble, Jane Blazeby and Paula R. Williamson
    Citation:Trials 2019 20:571
    Content type:Methodology
    Published on: 
  45. Low health-related physical fitness in college students is a risk factor for future development of cardiovascular diseases at later stages in life, but appropriate exercise is one of the main determinant facto...
    Authors:Fang Zhao, Shanshan Sun, Jian Xiong and Guohua Zheng
    Citation:Trials 2019 20:569
    Content type:Study protocol
    Published on: 
  46. Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going ado...
    Authors:Rachana Parikh, Daniel Michelson, Kanika Malik, Sachin Shinde, Helen A. Weiss, Adriaan Hoogendoorn, Jeroen Ruwaard, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur, Paulomi Sudhir, Michael King, Pim Cuijpers, Bruce F. Chorpita…
    Citation:Trials 2019 20:568
    Content type:Study protocol
    Published on: 
  47. Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown...
    Authors:Carolyn A. McCarty, Douglas Zatzick, Teah Hoopes, Katelyn Payne, Rebecca Parrish and Frederick P. Rivara
    Citation:Trials 2019 20:567
    Content type:Study protocol
    Published on: 

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