Table of Contents    
SPECIAL ARTICLE
Year : 2010  |  Volume : 1  |  Issue : 2  |  Page : 100-107
 

CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials


1 Family Health International, Research Triangle Park, North Carolina, USA
2 Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, United Kingdom
3 Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada

Date of Web Publication10-Nov-2010

Correspondence Address:
Kenneth F Schulz
Family Health International, Research Triangle Park, North Carolina
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0976-500X.72352

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How to cite this article:
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010;1:100-7

How to cite this URL:
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother [serial online] 2010 [cited 2021 Dec 7];1:100-7. Available from: http://www.jpharmacol.com/text.asp?2010/1/2/100/72352



   Introduction Top


Randomised controlled trials, when appropriately designed, conducted and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour. [1] To assess a trial accurately, readers of a published report need complete, clear and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information. [2],[3],[4]

That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later. [6],[7],[8] While those statements improved the reporting quality for some randomised controlled trials, [9],[10] many trial reports still remain inadequate. [2] Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement. [6],[7],[8] We introduce here the result of that process, CONSORT 2010.


   Intent of CONSORT 2010 Top


The CONSORT 2010 Statement is this paper including the 25 item checklist in the [Table 1] and the flow diagram [Figure 1]. It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type-individually randomised, two group, parallel trials. Other trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information. CONSORT extensions for these designs, [11],[12] and other CONSORT products, can be found through the CONSORT website ( http://www.consort-statement.org ). Along with the CONSORT statement, we have updated the explanation and elaboration article, [13] which explains the inclusion of each checklist item, provides methodological background and gives published examples of transparent reporting.
Table 1: CONSORT 2010 checklist of information to include when reporting a randomised trial (for a downloadable version of this checklist see Text S1 or the CONSORT website)*

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Figure 1: Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up and data analysis).

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Diligent adherence by authors to the checklist items facilitates clarity, completeness and transparency of reporting. Explicit descriptions, not ambiguity or omission, best serve the interests of all readers. Note that the CONSORT 2010 Statement does not include recommendations for designing, conducting and analysing trials. It solely addresses the reporting of what was done and what was found.

Nevertheless, CONSORT does indirectly affect design and conduct. Transparent reporting reveals deficiencies in research if they exist. Thus, investigators who conduct inadequate trials, but who must transparently report, should not be able to pass through the publication process without revelation of their trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work. Moreover, CONSORT can help researchers in designing their trial.


   Background to CONSORT Top


Efforts to improve the reporting of randomised controlled trials accelerated in the mid-1990s, spurred partly by methodological research. Researchers had shown for many years that authors reported such trials poorly and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14] Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CONSORT statement in 1996. [5] Further methodological research on similar topics reinforced earlier findings [15] and fed into the revision of 2001. [6],[7],[8] Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on the CONSORT website), which provides the empirical evidence to underpin the CONSORT initiative.

Indeed, CONSORT Group members continually monitor the literature. Information gleaned from these efforts provides an evidence base on which to update the CONSORT statement. We add, drop, or modify items based on that evidence and the recommendations of the CONSORT Group, an international and eclectic group of clinical trialists, statisticians, epidemiologists and biomedical editors. The CONSORT Executive (KFS, DGA, DM) strives for a balance of established and emerging researchers. The membership of the group is dynamic. As our work expands in response to emerging projects and needed expertise, we invite new members to contribute. As such, CONSORT continually assimilates new ideas and perspectives. That process informs the continually evolving CONSORT statement.

Over time, CONSORT has garnered much support. More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement. Many other healthcare journals support it without our knowledge. Moreover, thousands more have implicitly supported it with the endorsement of the CONSORT statement by the International Committee of Medical Journal Editors ( http://www.icmje.org ). Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORT. That support seems warranted: when used by authors and journals, CONSORT seems to improve reporting. [9]


   Development of CONSORT 2010 Top


Thirty one members of the CONSORT 2010 Group met in Montebello, Canada, in January 2007 to update the 2001 CONSORT statement. In addition to the accumulating evidence relating to existing checklist items, several new issues had come to prominence since 2001. Some participants were given primary responsibility for aggregating and synthesising the relevant evidence on a particular checklist item of interest. Based on that evidence, the group deliberated the value of each item. As in prior CONSORT versions, we kept only those items deemed absolutely fundamental to reporting a randomised controlled trial. Moreover, an item may be fundamental to a trial but not included, such as approval by an institutional ethical review board, because funding bodies strictly enforce ethical review and medical journals usually address reporting ethical review in their instructions for authors. Other items may seem desirable, such as reporting on whether on-site monitoring was done, but a lack of empirical evidence or any consensus on their value cautions against inclusion at this point. The CONSORT 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important.

After the meeting, the CONSORT Executive convened teleconferences and meetings to revise the checklist. After seven major iterations, a revised checklist was distributed to the larger group for feedback. With that feedback, the executive met twice in person to consider all the comments and to produce a penultimate version. That served as the basis for writing the first draft of this paper, which was then distributed to the group for feedback. After consideration of their comments, the executive finalised the statement.

The CONSORT Executive then drafted an updated explanation and elaboration manuscript, with assistance from other members of the larger group. The substance of the 2007 CONSORT meeting provided the material for the update. The updated explanation and elaboration manuscript was distributed to the entire group for additions, deletions and changes. That final iterative process converged to the CONSORT 2010 Explanation and Elaboration. [13]


   Changes in CONSORT 2010 Top


The revision process resulted in evolutionary, not revolutionary, changes to the checklist [Table 1] and the flow diagram was not modified except for one word [Figure 1]. Moreover, because other reporting guidelines augmenting the checklist refer to item numbers, we kept the existing items under their previous item numbers except for some renumbering of items 2 to 5. We added additional items either as a sub-item under an existing item, an entirely new item number at the end of the checklist, or (with item 3) an interjected item into a renumbered segment. We have summarised the noteworthy general changes in [Box 1] [Additional file 1] and specific changes in [Box 2]. [Additional file 2] The CONSORT website contains a side by side comparison of the 2001 and 2010 versions.


   Implications and Limitations Top


We developed CONSORT 2010 to assist authors in writing reports of randomised controlled trials, editors and peer reviewers in reviewing manuscripts for publication and readers in critically appraising published articles. The CONSORT 2010 Explanation and Elaboration provides elucidation and context to the checklist items. We strongly recommend using the explanation and elaboration in conjunction with the checklist to foster complete, clear and transparent reporting and aid appraisal of published trial reports.

CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature. [2] Most of the items from the CONSORT 2010 Statement, however, pertain to all types of randomised trials. Nevertheless, some types of trials or trial situations dictate the need for additional information in the trial report. When in doubt, authors, editors and readers should consult the CONSORT website for any CONSORT extensions, expansions (amplifications), implementations, or other guidance that may be relevant.

The evidence based approach we have used for CONSORT also served as a model for development of other reporting guidelines, such as for reporting systematic reviews and meta-analyses of studies evaluating interventions, [16] diagnostic studies, [17] and observational studies. [18] The explicit goal of all these initiatives is to improve reporting. The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network will facilitate development of reporting guidelines and help disseminate the guidelines: http://www.equator-network.org provides information on all reporting guidelines in health research.

With CONSORT 2010, we again intentionally declined to produce a rigid structure for the reporting of randomised trials. Indeed, SORT [19] tried a rigid format and it failed in a pilot run with an editor and authors. [20] Consequently, the format of articles should abide by journal style, editorial directions, the traditions of the research field addressed and, where possible, author preferences. We do not wish to standardise the structure of reporting. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity. That stated, we think that manuscripts benefit from frequent subheadings within the major sections, especially the methods and results sections.

CONSORT urges completeness, clarity and transparency of reporting, which simply reflects the actual trial design and conduct. However, as a potential drawback, a reporting guideline might encourage some authors to report fictitiously the information suggested by the guidance rather than what was actually done. Authors, peer reviewers and editors should vigilantly guard against that potential drawback and refer, for example, to trial protocols, to information on trial registers and to regulatory agency websites. Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised trials. The items should elicit clear pronouncements of how and what the authors did, but do not contain any judgments on how and what the authors should have done. Thus, CONSORT 2010 is not intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist to construct a "quality score."

Nevertheless, we suggest that researchers begin trials with their end publication in mind. Poor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their trials. However, with wide adoption of CONSORT by journals and editorial groups, most authors should have to report transparently all important aspects of their trial. The ensuing scrutiny rewards well conducted trials and penalises poorly conducted trials. Thus, investigators should understand the CONSORT 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards.

CONSORT 2010 supplants the prior version published in 2001. Any support for the earlier version accumulated from journals or editorial groups will automatically extend to this newer version, unless specifically requested otherwise. Journals that do not currently support CONSORT may do so by registering on the CONSORT website. If a journal supports or endorses CONSORT 2010, it should cite one of the original versions of CONSORT 2010, the CONSORT 2010 Explanation and Elaboration and the CONSORT website in their "Instructions to authors." We suggest that authors who wish to cite CONSORT should cite this or another of the original journal versions of CONSORT 2010 Statement and, if appropriate, the CONSORT 2010 Explanation and Elaboration. [13] All CONSORT material can be accessed through the original publishing journals or the CONSORT website. Groups or individuals who desire to translate the CONSORT 2010 Statement into other languages should first consult the CONSORT policy statement on the website.

We emphasise that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, modifications. In the future we will further revise the CONSORT material considering comments, criticisms, experiences and accumulating new evidence. We invite readers to submit recommendations via the CONSORT website.


   Acknowledgments Top


The CONSORT Group contributors to CONSORT 2010: DG Altman, Centre for Statistics in Medicine, University of Oxford; Virginia Barbour, PLoS Medicine; Jesse A Berlin, Johnson and Johnson Pharmaceutical Research and Development, USA; Isabelle Boutron, University Paris 7 Denis Diderot, Assistance Publique des Hτpitaux de Paris, INSERM, France; PJ Devereaux, McMaster University, Canada; Kay Dickersin, Johns Hopkins Bloomberg School of Public Health, USA; Diana Elbourne, London School of Hygiene and Tropical Medicine; Susan Ellenberg, University of Pennsylvania School of Medicine, USA; Val Gebski, University of Sydney, Australia; Steven Goodman, Journal of the Society for Clinical Trials, USA; Peter C Gψtzsche, Nordic Cochrane Centre, Denmark; Trish Groves, BMJ; Steven Grunberg, American Society of Clinical Oncology, USA; Brian Haynes, McMaster University, Canada; Sally Hopewell, Centre for Statistics in Medicine, University of Oxford; Astrid James, Lancet; Peter Juhn, Johnson and Johnson, USA; Philippa Middleton, University of Adelaide, Australia; Don Minckler, University of California Irvine, USA; D Moher, Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Canada; Victor M Montori, Knowledge and Encounter Research Unit, Mayo Clinic College of Medicine, USA; Cynthia Mulrow, Annals of Internal Medicine, USA; Stuart Pocock, London School of Hygiene and Tropical Medicine; Drummond Rennie, JAMA, USA; David L Schriger, Annals of Emergency Medicine, USA; KF Schulz, Family Health International, USA; Iveta Simera, EQUATOR Network; Elizabeth Wager, Sideview.

Contributors to CONSORT 2010 who did not attend the Montebello meeting: Mike Clarke, UK Cochrane Centre; Gordon Guyatt, McMaster University, Canada.[34]

 
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    Tables

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22 The relative weak way and the absolute strong way to communicate risk information
Patrick O. Perche, Madison K. Cook, Steven R. Feldman
Journal of Dermatological Treatment. 2021; : 1
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23 Effects of probiotics on gastrointestinal complications and nutritional status of postoperative patients with esophageal cancer
Chao Liu, Jing Yang, Weiwei Dong, Jinyan Yuan
Medicine. 2021; 100(11): e25138
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24 Response to the Comment on “Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial”
R.M Nataraja, M. Pacilli
Annals of Surgery. 2021; 274(6): e869
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25 Time to ventilation and success rate of airway devices in microgravity: A randomized crossover manikin-trial using an underwater setting
Tobias Warnecke, Lisa Dauth, Anton Ahlbäck, James DuCanto, Elisabeth Fleischhammer, Carlos Glatz, Steffen Kerkhoff, Alexander Mathes, Jan Schmitz, Clement Starck, Seamus Thierry, Jochen Hinkelbein
Acta Anaesthesiologica Scandinavica. 2021; 65(5): 681
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26 Higher vs lower doses of dexamethasone in patients with COVID-19 and severe hypoxia (COVID STEROID 2) trial: Protocol and statistical analysis plan
MW Munch, Anders Granholm, SN Myatra, BKT Vijayaraghavan, Maria Cronhjort, RR Wahlin, Stephan M. Jakob, Luca Cioccari, MN Kjær, GK Vesterlund, TS Meyhoff, Marie Helleberg, MH Møller, Thomas Benfield, Balasubramanian Venkatesh, Naomi Hammond, Sharon Micallef, Abhinav Bassi, Oommen John, Vivekanand Jha, KT Kristiansen, CS Ulrik, VL Jørgensen, Margit Smitt, Morten H. Bestle, AS Andreasen, LM Poulsen, BS Rasmussen, AC Brøchner, Thomas Strøm, Anders Møller, MS Khan, Ajay Padmanaban, JV Divatia, Sanjith Saseedharan, Kapil Borawake, Farhad Kapadia, Subhal Dixit, Rajesh Chawla, Urvi Shukla, Pravin Amin, Michelle S. Chew, Christian Gluud, Theis Lange, Anders Perner
Acta Anaesthesiologica Scandinavica. 2021; 65(6): 834
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27 Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia: The COVID STEROID randomised, placebo-controlled trial
Marie Warrer Munch, Tine Sylvest Meyhoff, Marie Helleberg, Maj-Brit Nørregaard Kjær, Anders Granholm, Carl Johan Steensen Hjortsø, Thomas Steen Jensen, Morten Hylander Møller, Peter Buhl Hjortrup, Mik Wetterslev, Gitte Kingo Vesterlund, Lene Russell, Vibeke Lind Jørgensen, Klaus Tjelle Kristiansen, Thomas Benfield, Charlotte Suppli Ulrik, Anne Sofie Andreasen, Morten Heiberg Bestle, Lone Musaeus Poulsen, Thomas Hildebrandt, Lene Surland Knudsen, Anders Møller, Christoffer Grant Sølling, Anne Craveiro Brøchner, Bodil Steen Rasmussen, Henrik Nielsen, Steffen Christensen, Thomas Strøm, Maria Cronhjort, Rebecka Rubenson Wahlin, Stephan M. Jakob, Luca Cioccari, Balasubramanian Venkatesh, Naomi Hammond, Vivekanand Jha, Sheila Nainan Myatra, Marie Qvist Jensen, Jens Wolfgang Leistner, Vibe Sommer Mikkelsen, Jens S. Svenningsen, Signe Bjørn Laursen, Emma Victoria Hatley, Camilla Meno Kristensen, Ali Al-Alak, Esben Clapp, Trine Bak Jonassen, Caroline Løkke Bjerregaard, Niels Christian Haubjerg
Acta Anaesthesiologica Scandinavica. 2021; 65(10): 1421
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28 Effect of family nursing therapeutic conversations on patients with heart failure and their family members: Secondary outcomes of a randomised multicentre trial
Birte Østergaard, Romy Mahrer-Imhof, Mahdi Shamali, Birgitte Nørgaard, Bernard Jeune, Karen Steenvinkel Pedersen, Jørgen Lauridsen
Journal of Clinical Nursing. 2021; 30(5-6): 742
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29 Effects of roflumilast on arterial stiffness in COPD ( ELASTIC ): A randomized trial
Matthias H. Urban, Nicole Kreibich, Andreas Gleiss, Georg-Christian Funk, Sylvia Hartl, Otto C. Burghuber
Respirology. 2021; 26(2): 153
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30 Effect of the oXiris membrane on microcirculation after cardiac surgery under cardiopulmonary bypass: study protocol for a randomised controlled trial (OXICARD Study)
Osama Abou-Arab, Pierre Huette, Guillaume Haye, Mathieu Guilbart, Gilles Touati, Momar Diouf, Christophe Beyls, Herve Dupont, Yazine Mahjoub
BMJ Open. 2021; 11(7): e044424
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31 Web-based early intervention for children with motor difficulties aged 3–8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families
Chantal Camden, Jill G Zwicker, Melanie Morin, Tibor Schuster, Melanie Couture, Thomas G Poder, Desiree B Maltais, Marie-Claude Battista, Jean-Patrice Baillargeon, Mathieu Goyette, Gabrielle Pratte, Karen Hurtubise, Michelle Phoenix, Tram Nguyen, Jade Berbari, Michel Tousignant
BMJ Open. 2021; 11(4): e046561
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32 Arterial stiffness responses to prolonged sitting combined with a high-glycemic-index meal: a double-blind, randomized crossover trial
Elizabeth Kelsch, Jake C. Diana, Kathryn Burnet, Erik D. Hanson, Simon F. Fryer, Daniel P. Credeur, Keeron J. Stone, Lee Stoner
Journal of Applied Physiology. 2021; 131(1): 229
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33 Web-based education of the elderly improves drug utilization literacy: A randomized controlled trial
Maria Qvarfordt, Victoria Throfast, Göran Petersson, Tora Hammar, Lina Hellström
Health Informatics Journal. 2021; 27(1): 1460458220
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34 Effectiveness of a specialised breathlessness service for patients with advanced disease in Germany: a pragmatic fast-track randomised controlled trial (BreathEase)
Michaela Schunk, Lien Le, Zulfiya Syunyaeva, Birgit Haberland, Susanne Tänzler, Ulrich Mansmann, Larissa Schwarzkopf, Hildegard Seidl, Sabine Streitwieser, Miriam Hofmann, Thomas Müller, Tobias Weiß, Philipp Morawietz, Eva Annette Rehfuess, Rudolf Maria Huber, Ursula Berger, Claudia Bausewein
European Respiratory Journal. 2021; 58(2): 2002139
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35 A dementia care training using mobile e-learning with mentoring support for home care workers: a controlled study
Hsin-Feng Su, Malcolm Koo, Wen-Li Lee, Huei-Chuan Sung, Ru-Ping Lee, Wen-I Liu
BMC Geriatrics. 2021; 21(1)
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36 A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit
Catherine Gire, Any Beltran Anzola, Monique Kaminski, Karine Baumstarck, Pierre-Yves Ancel, Julie Berbis, Meriem Zahed, Patricia Garcia, Tristan Desiles, Ludovic Zahed, Mélodie Pache, Gwenaëlle Menard, Nathalie Bednarek Weirauch, Karine Voirin, Virginie Verriere, Gilles Cambonie, Claire Lerat, Maythé Poujol, Olivier Claris, Sophie Rubio Gurung, Eliane Basson, Melanie Rodriguez, Anne Rannaud, Johanna Boulant, Thierry Debillon, Isabelle Pin, Karine Guichardet, Caroline Tournegros, Laurence Foix L’Helias, Delphine Mitanchez, Jennifer Sommer, Hélène Ruys Masson, Michele Granier, Marylène Riou, Dalia Mignot, Bernard Guillois, Valérie Dorriere Datin, Mireille Denaveaut Boulay, Delphine Rots, Jean-Michel Hascot, Hélène Deforge, Sabine Guignon, Pierre Kuhn, Anne de Saint Martin, Claire Zores Koenig, Hélène Musmeaux, Lucille Schneider, Carole Ramousset, Coralie Mangin, Bénédicte Lecomte, Angélique Pannetier, Emmanuelle Rochette, Nelly Goudon-Dubois, Julie Oertel, Sandrine La Planeta, Stéphane M
BMC Pediatrics. 2021; 21(1)
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37 The influence of a cognitive behavioural approach on changing patient expectations for conservative care in shoulder pain treatment: a protocol for a pragmatic randomized controlled trial
Heather Myers, Francis Keefe, Steven Z. George, June Kennedy, Ashley Davis Lake, Corina Martinez, Chad Cook
BMC Musculoskeletal Disorders. 2021; 22(1)
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38 Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional
Suzanne Phelan, Elissa Jelalian, Donald Coustan, Aaron B. Caughey, Kristin Castorino, Todd Hagobian, Karen Muñoz-Christian, Andrew Schaffner, Laurence Shields, Casey Heaney, Angelica McHugh, Rena R. Wing
Trials. 2021; 22(1)
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39 Evaluation of the “Let’s Get Organized” group intervention to improve time management: protocol for a multi-centre randomised controlled trial
Marie Holmefur, Afsaneh Roshanay, Suzanne White, Gunnel Janeslätt, Elin Vimefall, Kajsa Lidström-Holmqvist
Trials. 2021; 22(1)
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40 Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial
Jenna Smith-Turchyn, Michelle E. McCowan, Erin O’Loughlin, Angela J. Fong, Meghan H. McDonough, Daniel Santa Mina, Kelly P. Arbour-Nicitopoulos, Linda Trinh, Jennifer M. Jones, Jackie L. Bender, S. Nicole Culos-Reed, Jennifer R. Tomasone, Madison F. Vani, Catherine M. Sabiston
BMC Sports Science, Medicine and Rehabilitation. 2021; 13(1)
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41 CanDirect: Effectiveness of a Telephone-Supported Depression Self-Care Intervention for Cancer Survivors
Jane McCusker, Jennifer M. Jones, Madeline Li, Rosana Faria, Mark J. Yaffe, Sylvie D. Lambert, Antonio Ciampi, Eric Belzile, Manon de Raad
Journal of Clinical Oncology. 2021; 39(10): 1150
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42 A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma
Can Yurttas, Philipp Horvath, Imma Fischer, Christoph Meisner, Silvio Nadalin, Ingmar Königsrainer, Alfred Königsrainer, Stefan Beckert, Markus W. Löffler
Annals of Surgical Oncology. 2021;
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43 A feasibility study to assess the design of a multicentre randomized controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery
Toby Smith, Lucy Clark, Reema Khoury, Mei-See Man, Sarah Hanson, Allie Welsh, Allan Clark, Sally Hopewell, Klaus Pfeiffer, Pip Logan, Maria Crotty, Matthew Costa, Sarah E. Lamb
Bone & Joint Open. 2021; 2(11): 909
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44 Quantifying the extent of visit irregularity in longitudinal data
Armend Lokku, Catherine S Birken, Jonathon L Maguire, Eleanor M Pullenayegum
The International Journal of Biostatistics. 2021; 0(0)
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45 Induction of Efficacy Expectancies in an Ambulatory Smartphone-Based Digital Placebo Mental Health Intervention: Randomized Controlled Trial
Esther Stalujanis, Joel Neufeld, Martina Glaus Stalder, Angelo Belardi, Marion Tegethoff, Gunther Meinlschmidt
JMIR mHealth and uHealth. 2021; 9(2): e20329
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46 Supporting Women Undergoing IVF Treatment With Timely Patient Information Through an App: Randomized Controlled Trial
Thomas Timmers, Manouk Keijsers, Jan A M Kremer, Loes Janssen, Jesper Smeenk
JMIR mHealth and uHealth. 2021; 9(8): e28104
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47 Acceptability and feasibility of an app-based just-in-time-adaptive self-management intervention for care partners: Protocol for the CareQOL pilot trial (Preprint)
Noelle Carlozzi, Sung Won Choi, Zhenke Wu, Jennifer A. Miner, Angela K. Lyden, Christopher Graves, Jitao Wang, Srijan Sen
JMIR Research Protocols. 2021;
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48 Occupational Therapy with the Screw Block® Kit for Improving Upper Limb Function in Stroke Patients: A Quasi-randomized Controlled Trial
Naoya Akiyama, Ichiro Fujishima, Satoshi Tanaka, Nobuhiro Matsuura, Hidehiro Hashimoto, Seiji Yamamoto
Progress in Rehabilitation Medicine. 2021; 6(0): n/a
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49 The Safety and Efficacy of Inspiratory Muscle Training for Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Study Protocol for a Randomized Controlled Trial
YuanHui Liu, YiNing Dai, Zhi Liu, HuiMin Zhan, Manyu Zhu, XianYuan Chen, ShengQing Zhang, GuoLin Zhang, Ling Xue, ChongYang Duan, JiYan Chen, Lan Guo, PengCheng He, Ning Tan
Frontiers in Cardiovascular Medicine. 2021; 7
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50 Effects of Dynamic Hyperinflation on Left Ventricular Diastolic Function in Healthy Subjects — A Randomized Controlled Crossover Trial
Matthias Helmut Urban, Anna Katharina Mayr, Ingrid Schmidt, Erwin Grasmuk-Siegl, Otto Chris Burghuber, Georg-Christian Funk
Frontiers in Medicine. 2021; 8
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51 A Randomized Controlled Trial Evaluating the Effectiveness of a Short Video-Based Educational Program for Improving Mental Health Literacy Among Schoolteachers
Junya Ueda, Satoshi Yamaguchi, Yasuhiro Matsuda, Kosuke Okazaki, Tsubasa Morimoto, Seiya Matsukuma, Tsukasa Sasaki, Toshifumi Kishimoto
Frontiers in Psychiatry. 2021; 12
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52 Effectiveness of Ergonomic Training to Decrease Awkward Postures during Dental Scaling Procedures: A Randomized Clinical Trial
Ana Virginia de Santana Sampaio Castilho, Edgard Michel Crosato, Silvia Helena de Carvalho Sales-Peres, Gerson Aparecido Foratori Junior, Adriana Rodrigues de Freitas Aznar, Rogerio Leone Buchaim, Daniela Vieira Buchaim, Dayane Maria Braz Nogueira, Eliana de Souza Bastos Mazuqueli Pereira, Luis Carlos Paschoarelli, Eliel Soares Orenha
International Journal of Environmental Research and Public Health. 2021; 18(21): 11217
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53 Effects of a 2-Week 5000 IU versus 1000 IU Vitamin D3 Supplementation on Recovery of Symptoms in Patients with Mild to Moderate Covid-19: A Randomized Clinical Trial
Shaun Sabico, Mushira A. Enani, Eman Sheshah, Naji J. Aljohani, Dara A. Aldisi, Naif H. Alotaibi, Naemah Alshingetti, Suliman Y. Alomar, Abdullah M. Alnaami, Osama E. Amer, Syed D. Hussain, Nasser M. Al-Daghri
Nutrients. 2021; 13(7): 2170
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54 Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trial
Douglas Rafael da Rosa Pinheiro, Maria Eduarda Parcianello Cabeleira, Luigi Antonio da Campo, Philipe Souza Corrêa, Ariane Haydeé Estrada Gamarra Blauth, Fernanda Cechetti
NeuroRehabilitation. 2021; 48(1): 39
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55 Upper limbs cycle ergometer increases muscle strength, trunk control and independence of acute stroke subjects: A randomized clinical trial
Douglas Rafael da Rosa Pinheiro, Maria Eduarda Parcianello Cabeleira, Luigi Antonio da Campo, Laís Andrielli Ferreira Gattino, Kellen Sábio de Souza, Laura dos Santos Burg, Ariane Haydeé Estrada Gamarra Blauth, Philipe Souza Corrêa, Fernanda Cechetti
NeuroRehabilitation. 2021; 48(4): 533
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56 The critical appraisal of randomized controlled trials published in an Indian journal to assess the quality of reporting: A retrospective, cross-sectional study
SandeepKumar Gupta, RaviKant Tiwari, RajKumar Goel
Perspectives in Clinical Research. 2021; 0(0): 0
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57 A 10-week exercise intervention can improve work posture but not neck/shoulder symptoms in dental health students: A pilot cohort study
Xin Yi Yiu, Andrea Maguire, Marcelle Johnson, Charlotte Wåhlin, Venerina Johnston
Work. 2020; 67(1): 239
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58 Osteopathic Manual Treatment vs Kaltenborn-Evjenth Orthopedic Manual Therapy for Chronic Low Back Pain: A Proposal for a Protocol for Randomized Trials
P Lizis, W Kobza , G Manko , J Jaszczur-Nowicki , J Bukowska , J Perlinski , B Para , D Wisniewski , J Nawara
Journal of Biomedical Research & Environmental Sciences. 2020; 1(8): 383
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59 Heparinized Saline Solution vs. Saline Solution (0.9% Sodium Chloride) for the Maintenance of Dorsal Pedal Arterial Catheter Patency in Dogs Undergoing General Anesthesia: A Pilot Study
Kazumasu Sasaki, Gonzalo Polo Paredes, Takuya Shiga
Frontiers in Veterinary Science. 2020; 7
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60 Unsupervised Isometric Exercise versus Wait-and-See for Lateral Elbow Tendinopathy
VIANA VUVAN, BILL VICENZINO, REBECCA MELLOR, LUKE JAMES HEALES, BROOKE KAYE COOMBES
Medicine & Science in Sports & Exercise. 2020; 52(2): 287
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61 Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy
Sun-Kyung Park, Jinyoung Bae, Seokha Yoo, Won Ho Kim, Young-Jin Lim, Jae-Hyon Bahk, Jin-Tae Kim
Anesthesia & Analgesia. 2020; 130(3): 787
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62 Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial
Yeming Wang, Fei Zhou, Dingyu Zhang, Jianping Zhao, Ronghui Du, Yi Hu, Zhenshun Cheng, Ling Gao, Yang Jin, Guangwei Luo, Shouzhi Fu, Qiaofa Lu, Guanhua Du, Ke Wang, Yang Lu, Guohui Fan, Yi Zhang, Ying Liu, Shunan Ruan, Wen Liu, Thomas Jaki, Frederick G. Hayden, Peter W. Horby, Bin Cao, Chen Wang
Trials. 2020; 21(1)
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63 The effect of yoga on sleep quality and insomnia in women with sleep problems: a systematic review and meta-analysis
Wei-Li Wang, Kuang-Huei Chen, Ying-Chieh Pan, Szu-Nian Yang, Yuan-Yu Chan
BMC Psychiatry. 2020; 20(1)
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64 Summarizing the extent of visit irregularity in longitudinal data
Armend Lokku, Lily S. Lim, Catherine S. Birken, Eleanor M. Pullenayegum
BMC Medical Research Methodology. 2020; 20(1)
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65 Oral language comprehension interventions in 1–8-year-old children with language disorders or difficulties: A systematic scoping review
Sirpa Tarvainen, Suvi Stolt, Kaisa Launonen
Autism & Developmental Language Impairments. 2020; 5: 2396941520
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66 Effectiveness of non-pharmacological interventions to treat orthostatic hypotension in elderly people and people with a neurological condition: a systematic review
Angela Logan, Jennifer Freeman, Jillian Pooler, Bridie Kent, Hilary Gunn, Sarah Billings, Emma Cork, Jonathan Marsden
JBI Evidence Synthesis. 2020; 18(12): 2556
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67 Effect of Foot Reflexology Intervention on Depression, Anxiety, and Sleep Quality in Adults: A Meta-Analysis and Metaregression of Randomized Controlled Trials
Wei-Li Wang, Hao-Yuan Hung, Ying-Ren Chen, Kuang-Huei Chen, Szu-Nian Yang, Chi-Ming Chu, Yuan-Yu Chan
Evidence-Based Complementary and Alternative Medicine. 2020; 2020: 1
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68 Enhancement of Executive Functions but Not Memory by Multidomain Group Cognitive Training in Patients with Parkinson’s Disease and Mild Cognitive Impairment: A Multicenter Randomized Controlled Trial
Elke Kalbe, Ann-Kristin Folkerts, Anja Ophey, Carsten Eggers, Saskia Elben, Karina Dimenshteyn, Patricia Sulzer, Claudia Schulte, Nele Schmidt, Christian Schlenstedt, Daniela Berg, Karsten Witt, Lars Wojtecki, Inga Liepelt-Scarfone, Giovanni Mirabella
Parkinson's Disease. 2020; 2020: 1
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69 Low Reporting of Cointerventions in Recent Cardiovascular Clinical Trials: A Systematic Review
Elisavet Moutzouri, Luise Adam, Martin Feller, Lamprini Syrogiannouli, Bruno R. Da Costa, Cinzia Del Giovane, Douglas C. Bauer, Drahomir Aujesky, Arnaud Chiolero, Nicolas Rodondi
Journal of the American Heart Association. 2020; 9(12)
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70 Group-based music intervention in Parkinson’s disease – findings from a mixed-methods study
Petra Pohl, Ewa Wressle, Fredrik Lundin, Paul Enthoven, Nil Dizdar
Clinical Rehabilitation. 2020; 34(4): 533
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71 Efficacy and safety of iloprost in patients with septic shock-induced endotheliopathy—Protocol for the multicenter randomized, placebo-controlled, blinded, investigator-initiated trial
Morten H. Bestle, Niels E. Clausen, Peter Søe-Jensen, Klaus T. Kristiansen, Theis Lange, Pär I. Johansson, Jakob Stensballe, Anders Perner
Acta Anaesthesiologica Scandinavica. 2020; 64(5): 705
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72 Effect of abdominal massage on bowel evacuation in neurosurgical intensive care patients
Gulay Altun Ugras, Serpil Yüksel, Meryem Turkan Isik, Bahar Tasdelen, Havva Dogan, Ozum Mutluay
Nursing in Critical Care. 2020;
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73 Rapid LLLT protocol for myofascial pain and mouth opening limitation treatment in the clinical practice: An RCT
Vitória De Oliveira Chami, Lucas Machado Maracci, Fernanda Tomazoni, Anna Carolina Teixeira Centeno, André Luiz Porporatti, Vilmar Antônio Ferrazzo, Mariana Marquezan
CRANIO®. 2020; : 1
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74 Treatment of myofascial pain with a rapid laser therapy protocol compared to occlusal splint: A double-blind, randomized clinical trial
Lucas Machado Maracci, Gabriela Stasiak, Vitória de Oliveira Chami, Gisele Jung Franciscatto, Jovana Milanesi, Cláudio Figueiró, Tatiana Bernardon Silva, Magáli Beck Guimarães, Mariana Marquezan
CRANIO®. 2020; : 1
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75 Sound Therapy for Tinnitus: Options for Audiologists
James A. Henry, Candice M. Quinn
Perspectives of the ASHA Special Interest Groups. 2020; 5(3): 669
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76 Patient-reported outcomes in acute graft-versus-host disease: optimizing patient care and clinical trial endpoints
Sagar S. Patel, Brittany Lapin, Navneet S. Majhail, Betty K. Hamilton
Bone Marrow Transplantation. 2020; 55(8): 1533
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77 Heparin-bonded versus standard polytetrafluoroethylene arteriovenous grafts: A Bayesian perspective on a randomized controlled trial for comparative effectiveness
Alexander P. Nissen, Harleen K. Sandhu, Alexa P. Perlick, Virginia L. Wong, Taylor A. Smith, Matthew R. Smeds, Naveed U. Saqib, Gordon H. Martin, Charles C. Miller, Kristofer M. Charlton-Ouw
Surgery. 2020; 168(6): 1066
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78 Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials
Kyle R. Sochacki, Richard C. Mather, Benedict U. Nwachukwu, David Dong, Shane J. Nho, Mark P. Cote, Joshua D. Harris
Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2020; 36(10): 2750
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79 The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial
Nasser Sakran, Ron Dar, Ahmad Assalia, Ziv Neeman, Moaad Farraj, Shiri Sherf-Dagan, Ian M. Gralnek, Rawi Hazzan, Shams Eldin Mokary, Hadar Nevo-Aboody, Tamar Dola, Uri Kaplan, Dan Hershko
Updates in Surgery. 2020; 72(4): 1125
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80 Effect of Group Embryo Culture under Low-Oxygen Tension in Benchtop Incubators on Human Embryo Culture: Prospective, Randomized, Controlled Trial
Myriam Ruíz, Esther Santamaría-López, Víctor Blasco, María José Hernáez, Cinzia Caligara, Antonio Pellicer, Manuel Fernández-Sánchez, Nicolás Prados
Reproductive Sciences. 2020; 27(7): 1522
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81 Common methodological issues and suggested solutions in bone research
Tuan V. Nguyen
Osteoporosis and Sarcopenia. 2020; 6(4): 161
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82 Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pulmonary Function, and Respiratory Muscle Strength After Posterolateral Thoracotomy: A Randomized Controlled Trial
Hermann H. Husch, Guilherme Watte, Matheus Zanon, Gabriel Sartori Pacini, Daniella Birriel, Pauline L. Carvalho, Adriana Kessler, Graciele Sbruzzi
Lung. 2020; 198(2): 345
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83 A single blinded randomized controlled trial comparing semi-mechanical with hand-sewn cervical anastomosis after esophagectomy for cancer (SHARE-study)
Nina Nederlof, Hugo W. Tilanus, Tahnee Vringer, Jan J. B. Lanschot, Sten P. Willemsen, Wim C. J. Hop, Bas P. L. Wijnhoven
Journal of Surgical Oncology. 2020; 122(8): 1616
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84 Mnemonic strategy training modulates functional connectivity at rest in mild cognitive impairment: Results from a randomized controlled trial
Sharon Sanz Simon, Benjamin M. Hampstead, Mariana P. Nucci, Luiz Kobuti Ferreira, Fábio L. S. Duran, Luciana M. Fonseca, Maria da Graça M. Martin, Renata Ávila, Fábio H. G. Porto, Sônia M. D. Brucki, Camila B. Martins, Lyssandra S. Tascone, Edson Amaro Jr., Geraldo F. Busatto, Cássio M. C. Bottino
Alzheimer's & Dementia: Translational Research & Clinical Interventions. 2020; 6(1)
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85 A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities
Sevil Gurgan, Zeynep Bilge Kutuk, Filiz Yalcin Cakir, Esra Ergin
Journal of Dentistry. 2020; 94: 103175
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86 Two-year clinical evaluation of a proanthocyanidins-based primer in non-carious cervical lesions: A double-blind randomized clinical trial
Lidiane Costa de Souza, Nara Sousa Rodrigues, Diana Araújo Cunha, Victor Pinheiro Feitosa, Sérgio Lima Santiago, Alessandra Reis, Alessandro D. Loguercio, Jorge Perdigão, Vicente de Paulo Aragão Saboia
Journal of Dentistry. 2020; 96: 103325
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87 What type of exercise is most effective for people with knee osteoarthritis and co-morbid obesity?: The TARGET randomized controlled trial
K.L. Bennell, R.K. Nelligan, A.J. Kimp, S. Schwartz, J. Kasza, T.V. Wrigley, B. Metcalf, P.W. Hodges, R.S. Hinman
Osteoarthritis and Cartilage. 2020; 28(6): 755
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88 Effects of progressive resistance training prior to total HIP arthroplasty – a secondary analysis of a randomized controlled trial
A. Holsgaard-Larsen, A. Hermann, B. Zerahn, S. Mejdahl, S. Overgaard
Osteoarthritis and Cartilage. 2020; 28(8): 1038
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89 A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis
M. Franklin Dolwick, Daili Diaz, Danielle L. Freburg-Hoffmeister, Charles G. Widmer
Journal of Oral and Maxillofacial Surgery. 2020; 78(7): 1088
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90 Does the Low-Intensity Laser Protocol Affect Tissue Healing After Third Molar Removal?
Michelle Bianchi de Moraes, Rúbia Gomes de Oliveira, Fernando Vagner Raldi, Rodrigo Dias Nascimento, Mauro Pedrine Santamaria, Fábio Ricardo Loureiro Sato
Journal of Oral and Maxillofacial Surgery. 2020; 78(11): 1920.e1
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91 Educational intervention versus mindfulness-based intervention for ICU nurses with occupational burnout: A parallel, controlled trial
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Complementary Therapies in Medicine. 2020; 52: 102485
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92 Effects of a nurse-led positive psychology intervention on sexual function, depression and subjective well-being in postoperative patients with early-stage cervical cancer: A randomized controlled trial
Yan Shi, Jun Cai, Zhimin Wu, Lian Jiang, Guiqing Xiong, Xiuni Gan, Xiuying Wang
International Journal of Nursing Studies. 2020; 111: 103768
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93 Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (C
Andrei V Krassioukov, Katharine D Currie, Michèle Hubli, Tom E Nightingale, Abdullah A Alrashidi, Leanne Ramer, Janice J Eng, Kathleen A Martin Ginis, Maureen J MacDonald, Audrey Hicks, Dave Ditor, Paul Oh, Molly C Verrier, Beverly Catharine Craven
BMJ Open. 2019; 9(1): e023540
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94 Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials
Marianna Purgato, Kenneth Carswell, Ceren Acarturk, Teresa Au, Sena Akbai, Minna Anttila, Josef Baumgartner, Della Bailey, Massimo Biondi, Martha Bird, Rachel Churchill, Sevde Eskici, Louise Juul Hansen, Paul Heron, Zeynep Ilkkursun, Reinhold Kilian, Markus Koesters, Tella Lantta, Michela Nosè, Giovanni Ostuzzi, Davide Papola, Mariana Popa, Marit Sijbrandij, Lorenzo Tarsitani, Federico Tedeschi, Giulia Turrini, Ersin Uygun, Maritta Anneli Välimäki, Johannes Wancata, Ross White, Elisa Zanini, Pim Cuijpers, Corrado Barbui, Mark Van Ommeren
BMJ Open. 2019; 9(5): e030259
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95 Improved functional outcome after chronic stroke with delayed anti-Nogo-A therapy: A clinically relevant intention-to-treat analysis
Katherine M Podraza,Yasmin Mehta,Vicki A Husak,Elise Lippmann,Timothy E OæBrien,Gwendolyn L Kartje,Shih-Yen Tsai
Journal of Cerebral Blood Flow & Metabolism. 2018; 38(8): 1327
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96 Effect of low-level laser therapy combined with 5000 parts per million fluoride dentifrice on postbleaching sensitivity: A clinical, randomized, and double-blind study
Cristiane De Melo Alencar,Brennda Lucy Freitas De Paula,Jesuína Lamartine Nogueira Araújo,Eliane Bemerguy Alves,Fernanda Ferreira De Albuquerque Jassé,Cecy Martins Silva
Journal of Esthetic and Restorative Dentistry. 2018;
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97 Accuracy of the match between cone beam computed tomography and model scan data in template-guided implant planning: A prospective controlled clinical study
Sigmar Schnutenhaus,Sebastian Gröller,Ralph G. Luthardt,Heike Rudolph
Clinical Implant Dentistry and Related Research. 2018;
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98 Outcomes of Alveolar Ridge Preservation With Recombinant Human Bone Morphogenetic Protein-2
Neda Moslemi,Vahid Khoshkam,Sahar Chokami Rafiei,Naghmeh Bahrami,Hoori Aslroosta
Implant Dentistry. 2018; 27(3): 351
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99 Non-nutritive sucking, oral breast milk, and facilitated tucking relieve preterm infant pain during heel-stick procedures: A prospective, randomized controlled trial
Hsueh-Fang Peng,Ti Yin,Luke Yang,Chi Wang,Yue-Cune Chang,Mei-Jy Jeng,Jen-Jiuan Liaw
International Journal of Nursing Studies. 2018; 77: 162
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100 Study design and protocol for a culturally adapted cognitive behavioral stress and self-management intervention for localized prostate cancer: The Encuentros de Salud study
Frank J. Penedo,Michael H. Antoni,Patricia I. Moreno,Lara Traeger,Dolores Perdomo,Jason Dahn,Gregory E. Miller,Steve Cole,Julian Orjuela,Edgar Pizarro,Betina Yanez
Contemporary Clinical Trials. 2018; 71: 173
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101 How to support cancer genetics counselees in informing at-risk relatives? Lessons from a randomized controlled trial
Willem Eijzenga,Eveline de Geus,Cora M. Aalfs,Fred H. Menko,Rolf H. Sijmons,Hanneke C.J.M. de Haes,Ellen M.A. Smets
Patient Education and Counseling. 2018;
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102 Screening fathers for postpartum depression can be cost-effective: An example from Sweden
Michaela Modin Asper,Nino Hallén,Lene Lindberg,Anna Månsdotter,Magdalena Carlberg,Michael B. Wells
Journal of Affective Disorders. 2018; 241: 154
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103 Exercise program for children and adolescents with leukemia and lymphoma during treatment: A comprehensive review
Giulia Zucchetti,Francesca Rossi,Carolina Chamorro Vina,Nicoletta Bertorello,Franca Fagioli
Pediatric Blood & Cancer. 2018; : e26924
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104 Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome
T. O. Ugland,G. Haugeberg,S. Svenningsen,S. H. Ugland,Ø. H. Berg,A. H. Pripp,L. Nordsletten
Osteoporosis International. 2018;
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105 Reproducibility of CBCT image analysis: a clinical study on intrapersonal and interpersonal errors in bone structure determination
Sigmar Schnutenhaus,Michael Graf,Isabel Doering,Ralph G. Luthardt,Heike Rudolph
Oral Radiology. 2018;
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106 Standard vs delayed ligature of the dorsal vascular complex during robot-assisted radical prostatectomy: results from a randomized controlled trial
Alessandro Antonelli,Carlotta Palumbo,Alessandro Veccia,Simona Fisogni,Stefania Zamboni,Maria Furlan,Simone Francavilla,Marco Lattarulo,Enrico De Marzo,Giuseppe Mirabella,Angelo Peroni,Claudio Simeone
Journal of Robotic Surgery. 2018;
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107 LapTrain: multi-modality training curriculum for laparoscopic cholecystectomy—results of a randomized controlled trial
K. F. Kowalewski,C. R. Garrow,T. Proctor,A. A. Preukschas,M. Friedrich,P. C. Müller,H. G. Kenngott,L. Fischer,B. P. Müller-Stich,F. Nickel
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108 The effects of an 8-week computerized cognitive training program in older adults: a study protocol for a randomized controlled trial
Lisanne F. ten Brinke,John R. Best,Rachel A. Crockett,Teresa Liu-Ambrose
BMC Geriatrics. 2018; 18(1)
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109 The CHIP-Family study to improve the psychosocial wellbeing of young children with congenital heart disease and their families: design of a randomized controlled trial
Malindi van der Mheen,Ingrid M. van Beynum,Karolijn Dulfer,Jan van der Ende,Eugène van Galen,Jorieke Duvekot,Lisette E. Rots,Tabitha P. L. van den Adel,Ad J. J. C. Bogers,Christopher G. McCusker,Frank A. Casey,Willem A. Helbing,Elisabeth M. W. J. Utens
BMC Pediatrics. 2018; 18(1)
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110 Information-based cues at point of choice to change selection and consumption of food, alcohol and tobacco products: a systematic review
Patrice Carter,Giacomo Bignardi,?Gareth J. Hollands,Theresa M. Marteau
BMC Public Health. 2018; 18(1)
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111 Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances
Janneke F. M. Scheerman,Berno van Meijel,Pepijn van Empelen,Gem J. C. Kramer,Gijsbert H. W. Verrips,Amir H. Pakpour,Matheus C. T. Van den Braak,Cor van Loveren
BMC Oral Health. 2018; 18(1)
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112 Facilitating physical activity and reducing symptoms in patients with knee osteoarthritis: study protocol of a randomized controlled trial to test a theory-based PrevOP-psychological adherence program (PrevOP-PAP)
Nina Knoll,Diana Hilda Hohl,Susannah Motter,Jan Keller,Daniela Lange,Dieter Felsenberg,Peter Martus,Wolfgang Ertel,Ralf Schwarzer
BMC Musculoskeletal Disorders. 2018; 19(1)
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113 Effect of fish oil omega-3 fatty acids on reduction of depressive symptoms among HIV-seropositive pregnant women: a randomized, double-blind controlled trial
Rose Okoyo Opiyo, Peter Suwirakwenda Nyasulu, Reuben Kamau Koigi, Anne Obondo, Dorington Ogoyi, Wambui Kogi-Makau
Annals of General Psychiatry. 2018; 17(1)
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114 Introducing the CONSORT extension to pilot trials: enhancing the design, conduct and reporting of pilot or feasibility trials
Luciana P. F. Abbade,Joelcio F. Abbade,Lehana Thabane
Journal of Venomous Animals and Toxins including Tropical Diseases. 2018; 24(1)
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115 Ultrasound-Assisted Versus Fluoroscopic-Guided Lumbar Sympathetic Ganglion Block
Jung-Hee Ryu,Chang Soon Lee,Yong-Chul Kim,Sang Chul Lee,Hariharan Shankar,Jee Youn Moon
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116 Effective professional intraoral tooth brushing instruction using the modified plaque score: a randomized clinical trial
Se-Ho Park,Sung-Hee Cho,Ji-Young Han
Journal of Periodontal & Implant Science. 2018; 48(1): 22
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117 Effects of physical activity on the link between PGC-1a and FNDC5 in muscle, circulating ?risin and UCP1 of white adipocytes in humans: A systematic review
Petros C. Dinas,Ian M. Lahart,James A. Timmons,Per-Arne Svensson,Yiannis Koutedakis,Andreas D. Flouris,George S. Metsios
F1000Research. 2017; 6: 286
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118 Effects of physical activity on the link between PGC-1a and FNDC5 in muscle, circulating ?risin and UCP1 of white adipocytes in humans: A systematic review
Petros C. Dinas,Ian M. Lahart,James A. Timmons,Per-Arne Svensson,Yiannis Koutedakis,Andreas D. Flouris,George S. Metsios
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119 Prevention of postsurgical wound dehiscence after abdominal surgery with NPWT: a multicentre randomised controlled trial protocol
K. Sandy-Hodgetts,G.D. Leslie,R. Parsons,N. Zeps,K. Carville
Journal of Wound Care. 2017; 26(Sup2): S23
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120 A Multifactorial, Criteria-based Progressive Algorithm for Hamstring Injury Treatment
JURDAN MENDIGUCHIA,ENRIQUE MARTINEZ-RUIZ,PASCAL EDOUARD,JEAN-BENOÎT MORIN,FRANCISCO MARTINEZ-MARTINEZ,FERNANDO IDOATE,ALBERTO MENDEZ-VILLANUEVA
Medicine & Science in Sports & Exercise. 2017; 49(7): 1482
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121 Optimising conservative management of chronic low back pain: study protocol for a randomised controlled trial
Katherine J. Simson,Clint T. Miller,Jon Ford,Andrew Hahne,Luana Main,Timo Rantalainen,Wei-Peng Teo,Megan Teychenne,David Connell,Guy Trudel,Guoyan Zheng,Gary Thickbroom,Daniel L. Belavy
Trials. 2017; 18(1)
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122 Weight compensation characteristics of Armeo®Spring exoskeleton: implications for clinical practice and research
Bonnie E. Perry,Emily K. Evans,Dobrivoje S. Stokic
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123 Effectiveness of Web- and Mobile-Based Treatment of Subthreshold Depression With Adherence-Focused Guidance: A Single-Blind Randomized Controlled Trial
David Daniel Ebert,Claudia Buntrock,Dirk Lehr,Filip Smit,Heleen Riper,Harald Baumeister,Pim Cuijpers,Matthias Berking
Behavior Therapy. 2017;
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124 Manuscript Development and Publishing: A 5-Step Approach
Susan M. Downey,Stephen A. Geraci
The American Journal of the Medical Sciences. 2017; 353(2): 132
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125 Acupuncture for acute hordeolum
Ke Cheng,Andrew Law,Menghu Guo,L. Susan Wieland,Xueyong Shen,Lixing Lao
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126 The Use of Ketamine for Acute Treatment of Pain: A Randomized, Double-Blind, Placebo-Controlled Trial
Billy Sin,Tamara Tatunchak,Mohammad Paryavi,Maria Olivo,Usman Mian,Josel Ruiz,Bupendra Shah,Sylvie de Souza
The Journal of Emergency Medicine. 2017;
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127 Less periprosthetic bone loss following the anterolateral approach to the hip compared with the direct lateral approach
Terje O Ugland,Glenn Haugeberg,Svein Svenningsen,Stein H Ugland,Øystein H Berg,Are Hugo Pripp,Lars Nordsletten
Acta Orthopaedica. 2017; : 1
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128 Probiotics administration following sleeve gastrectomy surgery: a randomized double-blind trial
S Sherf-Dagan,S Zelber-Sagi,G Zilberman-Schapira,M Webb,A Buch,A Keidar,A Raziel,N Sakran,D Goitein,N Goldenberg,J A Mahdi,M Pevsner-Fischer,N Zmora,M Dori-Bachash,E Segal,E Elinav,O Shibolet
International Journal of Obesity. 2017;
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129 Whole-body vibration training as a workplace-based sports activity for employees with chronic low-back pain
T. S. Kaeding,A. Karch,R. Schwarz,T. Flor,T.-C. Wittke,M. Kück,G. Böselt,U. Tegtbur,L. Stein
Scandinavian Journal of Medicine & Science in Sports. 2017;
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130 A randomised controlled trial of a web-based multi-modal therapy program to improve executive functioning in children and adolescents with acquired brain injury
Adina Piovesana,Stephanie Ross,Owen Lloyd,Koa Whittingham,Jenny Ziviani,Robert S Ware,Lynne McKinlay,Roslyn N Boyd
Clinical Rehabilitation. 2017; 31(10): 1351
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131 Randomised crossover trial of rate feedback and force during chest compressions for paediatric cardiopulmonary resuscitation
Rachael Kathleen Gregson,Tim James Cole,Sophie Skellett,Emmanouil Bagkeris,Denise Welsby,Mark John Peters
Archives of Disease in Childhood. 2017; 102(5): 403
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132 Efficacy and safety of the Chaihuguizhiganjiang-suanzaoren granule on primary insomnia: study protocol for a randomised controlled trial
Qing-Quan Liu,Jie Zhang,Rong-Juan Guo,Ying-Zhen Xie,Qing-Nan Fu,Tian He,Xue-Qi Zhu,Jie Du,Jing Yang,Jia-Lin Wang,Min-Min Wei,Qian-Qian Li,Guang-Xia Shi,Cun-Zhi Liu
BMJ Open. 2016; 6(2): e008459
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133 Guidelines for Reporting Medical Research: A Critical Appraisal
Mathilde Johansen,Simon Francis Thomsen
International Scholarly Research Notices. 2016; 2016: 1
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134 Trial design and endpoints in clinical transplant research
Simon R. Knight,Peter J. Morris,Stefan Schneeberger,Liset H. M. Pengel
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135 Two new mini-slings compared with transobturator tension-free vaginal tape for treatment of stress urinary incontinence: A 1-year follow-up randomized controlled trial
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Journal of Obstetrics and Gynaecology Research. 2016;
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136 System evaluation and Meta analysis on clinical efficacy of heat-sensitive moxibustion in treatment of cervical spondylotic radiculopathy
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137 Randomized open-label trial of baclofen for relapse prevention in alcohol dependence
Manushree Gupta,Pankaj Verma,Rajesh Rastogi,Sheetal Arora,Deeksha Elwadhi
The American Journal of Drug and Alcohol Abuse. 2016; : 1
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138 Results of the PAS study: A randomized controlled trial evaluating the effectiveness of a web-based multiple tailored smoking cessation program combined with tailored counseling by practice nurses
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139 The effect of chlorzoxazone on acute pain after spine surgery. A randomized, blinded trial
R. V. Nielsen,J. S. Fomsgaard,H. Siegel,R. Martusevicius,O. Mathiesen,J. B. Dahl
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140 Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial
Kelechi R. Okoroha,Jonathan R. Lynch,Robert A. Keller,John Korona,Chad Amato,Brian Rill,Patricia A. Kolowich,Stephanie J. Muh
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141 Video-game based exercises for older people with chronic low back pain: A protocol for a feasibility randomised controlled trial (the GAMEBACK Trial)
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Physiotherapy. 2016;
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142 Doubling diet fat on sugar ratio in children with mitochondrial OXPHOS disorders: Effects on a randomized trial on resting energy expenditure, diet induced thermogenesis and body composition
Laurent Béghin,Stéphanie Coopman,Manuel Schiff,Joseph Vamecq,Karine Mention-Mulliez,Régis Hankard,Jean-Marie Cuisset,Hélène Ogier,Frédéric Gottrand,Dries Dobbelaere
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143 Vitamin D3 supplementation, bone health and quality of life in adults with diabetes and chronic kidney disease: Results of an open label randomized clinical trial
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144 5-HTTLPR and gender differences in affective disorders: A systematic review
F. Gressier,R. Calati,A. Serretti
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145 Can the choice of the local anesthetic have an impact on ambulatory surgery perioperative costs? Chloroprocaine for popliteal block in outpatient foot surgery
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146 The quality of evidence in Chinese meta-analyses needs to be improved
Liang Yao,Rao Sun,Yao-Long Chen,Qi Wang,Dang Wei,Xiaoqin Wang,Kehu Yang
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147 Beta blockers for essential tremor
Jingjing Zhang,Rongbo Liu,Muke Zhou,Lan Shang,Mi Yang,Li He,Zhang Xia,Cairong Zhu
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148 A weight-neutral versus weight-loss approach for health promotion in women with high BMI: A randomized-controlled trial
Janell L. Mensinger,Rachel M. Calogero,Saverio Stranges,Tracy L. Tylka
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149 Calcitonin effects on shoulder adhesive capsulitis
Alireza Rouhani,Mohsen Mardani-Kivi,Mohammadreza Bazavar,Mahmood Barzgar,Ali Tabrizi,Keyvan Hashemi-Motlagh,Khashayar Saheb-Ekhtiari
European Journal of Orthopaedic Surgery & Traumatology. 2016; 26(6): 575
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150 Integrating Mobile health and Physical Activity to reduce the burden of Chronic low back pain Trial (IMPACT): a pilot trial protocol
Anita B. Amorim,Evangelos Pappas,Milena Simic,Manuela L. Ferreira,Anne Tiedemann,Matthew Jennings,Paulo H. Ferreira
BMC Musculoskeletal Disorders. 2016; 17(1)
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151 Clinical trial of modulatory effects of oxytocin treatment on higher-order social cognition in autism spectrum disorder: a randomized, placebo-controlled, double-blind and crossover trial
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BMC Psychiatry. 2016; 16(1)
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152 Healthy Learning Mind - a school-based mindfulness and relaxation program: a study protocol for a cluster randomized controlled trial
Salla-maarit Volanen,Maarit Lassander,Nelli Hankonen,Päivi Santalahti,Mirka Hintsanen,Nina Simonsen,Anu Raevuori,Sari Mullola,Tero Vahlberg,Anna But,Sakari Suominen
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153 Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus: a 52-week, multicenter, parallel-group randomized controlled trial
Yaeko Kondo,Norio Harada,Akihiro Hamasaki,Shizuka Kaneko,Koichiro Yasuda,Eiichi Ogawa,Shin-ichi Harashima,Hiroko Yoneda,Yoshihito Fujita,Norikazu Kitano,Yoshio Nakamura,Fujio Matsuo,Megumi Shinji,Shiro Hinotsu,Takeo Nakayama,Nobuya Inagaki
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154 The Effect of Locally-Delivered Statins on Treating Periodontal Intrabony Defects: A Systematic Review and Meta-analysis
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155 A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial
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156 The Impact of a Customized Tray on In-Office Bleaching Tooth Sensitivity: A Randomized Clinical Trial
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157 Randomized Double-blind Clinical Trial of Bleaching Products in Patients Wearing Orthodontic Devices
A Montenegro-Arana,LA Arana-Gordillo,D Farana,A Davila-Sanchez,E Jadad,U Coelho,OMM Gomes,AD Loguercio
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158 Epinephrine in cardiac arrest: systematic review and meta-analysis
Ignacio Morales-Cané,María Del Rocío Valverde-León,María Aurora Rodríguez-Borrego
Revista Latino-Americana de Enfermagem. 2016; 24(0)
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159 High-Intensity Interval Training for Overweight Adolescents: Program Acceptance of a Media Supported Intervention and Changes in Body Composition
Sabine Herget,Sandra Reichardt,Andrea Grimm,David Petroff,Jakob Käpplinger,Michael Haase,Jana Markert,Susann Blüher
International Journal of Environmental Research and Public Health. 2016; 13(11): 1099
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160 Efficacy of fish intake on vitamin D status: a meta-analysis of randomized controlled trials
Ulrike Lehmann,Hanne Rosendahl Gjessing,Frank Hirche,Andreas Mueller-Belecke,Oddrun Anita Gudbrandsen,Per Magne Ueland,Gunnar Mellgren,Lotte Lauritzen,Helen Lindqvist,Anita Lill Hansen,Arja T Erkkilä,Gerda K Pot,Gabriele I Stangl,Jutta Dierkes
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161 Effectiveness of Laser Application for Periodontal Surgical Therapy: Systematic Review and Meta-Analysis
Shabnam Behdin,Alberto Monje,Guo-Hao Lin,Bruce Edwards,Abdullah Othman,Hom-Lay Wang
Journal of Periodontology. 2015; 86(12): 1352
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162 Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial
Linda Berton,Giulia Bano,Sara Carraro,Nicola Veronese,Simona Pizzato,Francesco Bolzetta,Marina De Rui,Elena Valmorbida,Irene De Ronch,Egle Perissinotto,Alessandra Coin,Enzo Manzato,Giuseppe Sergi,Stephen L Atkin
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163 A Systematic Review of Nonpharmacologic Interventions for Treatment-Related Symptoms in Women With Ovarian Cancer
Lorie Davis,Janet Carpenter
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164 Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial
M. Messaggi-Sartor,A. Guillen-Sola,M. Depolo,E. Duarte,D. A. Rodriguez,M.-C. Barrera,E. Barreiro,F. Escalada,M. Orozco-Levi,E. Marco
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165 Development of the Standards of Reporting of Neurological Disorders (STROND) checklist: A guideline for the reporting of incidence and prevalence studies in neuroepidemiology
D. A. Bennett,C. Brayne,V. L. Feigin,S. Barker-Collo,M. Brainin,D. Davis,V. Gallo,N. Jette,A. Karch,J. F. Kurtzke,P. M. Lavados,G. Logroscino,G. Nagel,P.-M. Preux,P. M. Rothwell,L. W. Svenson
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166 A cost analysis of orthopedic foot surgery: can outpatient continuous regional analgesia provide the same standard of care for postoperative pain control at home without shifting costs?
Andrea Saporito,Stefano Calciolari,Laura Gonzalez Ortiz,Luciano Anselmi,Alain Borgeat,José Aguirre
The European Journal of Health Economics. 2015;
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167 Development of the standards of reporting of neurological disorders (STROND) checklist: a guideline for the reporting of incidence and prevalence studies in neuroepidemiology
Derrick A. Bennett,Carol Brayne,Valery L. Feigin,Suzanne Barker-Collo,Michael Brainin,Daniel Davis,Valentina Gallo,Nathalie Jetté,André Karch,John F. Kurtzke,Pablo M. Lavados,Giancarlo Logroscino,Gabriele Nagel,Pierre-Marie Preux,Peter M. Rothwell,Lawrence W. Svenson
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