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Zeitschrift

Trials

Trials 1/2017

Ausgabe 1/2017

Inhaltsverzeichnis ( 628 Artikel )

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME): study protocol for a randomised controlled trial

Sophie E. Rowbotham, Doug Cavaye, Rene Jaeggi, Jason S. Jenkins, Corey S. Moran, Joseph V. Moxon, Jenna L. Pinchbeck, Frank Quigley, Christopher M. Reid, Jonathan Golledge

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trial

Irene Lie, Stein Ove Danielsen, Theis Tønnessen, Svein Solheim, Marit Leegaard, Leiv Sandvik, Torbjørn Wisløff, Jonny Vangen, Tor Henning Røsstad, Philip Moons

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial

Shengjun Wang, Hongli Jiang, Qin Yu, Bin She, Bing Mao

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial

Jennifer Fleming, Tamara Ownsworth, Emmah Doig, Lauren Hutton, Janelle Griffin, Melissa Kendall, David H. K. Shum

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

F. Eduardo Martinez, Matthew Anstey, Andrew Ford, Brigit Roberts, Miranda Hardie, Robert Palmer, Lynn Choo, David Hillman, Michael Hensley, Erin Kelty, Kevin Murray, Bhajan Singh, Bradley Wibrow

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Publishing protocols for trials of complex interventions before trial completion – potential pitfalls, solutions and the need for public debate

Anna Purna Basu, Janice Elizabeth Pearse, Tim Rapley

01.12.2017 | Research | Ausgabe 1/2017 Open Access

STICKS study – Short-sTretch Inelastic Compression bandage in Knee Swelling following total knee arthroplasty – a feasibility study

T. M. Brock, A. P. Sprowson, S. Muller, M. R. Reed

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial

Talia Palacios, Luis Vitetta, Samantha Coulson, Claire D. Madigan, Gareth S. Denyer, Ian D. Caterson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial

Kai Zheng, Hong Shen, Jia Jia, Yuelin Lu, Lei Zhu, Lu Zhang, Zhaofeng Shen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Improving Nursing Home Care through Feedback On PerfoRMance Data (INFORM): Protocol for a cluster-randomized trial

Matthias Hoben, Peter G. Norton, Liane R. Ginsburg, Ruth A. Anderson, Greta G. Cummings, Holly J. Lanham, Janet E. Squires, Deanne Taylor, Adrian S. Wagg, Carole A. Estabrooks

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial

Seung-Yeon Cho, Seung-Bo Yang, Hee Sup Shin, Seung Hwan Lee, Jun Seok Koh, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko, Seong-Uk Park

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

PANSAID – PAracetamol and NSAID in combination: study protocol for a randomised trial

Kasper Højgaard Thybo, Daniel Hägi-Pedersen, Jørn Wetterslev, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Ole Mathiesen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials

Paul M. O’Byrne, J. Mark FitzGerald, Nanshan Zhong, Eric Bateman, Peter J. Barnes, Christina Keen, Gun Almqvist, Kristine Pemberton, Carin Jorup, Stefan Ivanov, Helen K. Reddel

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A fixed inhaled nitrous oxide/oxygen mixture as an analgesic for adult cancer patients with breakthrough pain: study protocol for a randomized controlled trial

Qiang Liu, Yu Wang, Xiang-Jiang Luo, Ning-Ju Wang, Ping Chen, Xin Jin, Guo-Xia Mu, Xiao-Min Chai, Yue-Juan Zhang, Yu-Xiang Li, Jian-Qiang Yu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial

Raana Zahid, Omara Dogar, Sonia Mansoor, Amina Khan, Mona Kanaan, Mohammed Jawad, Jasjit S. Ahluwalia, Kamran Siddiqi

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery: study protocol for a randomised controlled trial

Anne G. Vedel

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial

Mikyung Kim, Eun-Ji Choi, Sung-Phil Kim, Jung-Eun Kim, Hyo-Ju Park, Ae-Ran Kim, Bok-Nam Seo, O-Jin Kwon, Jung Hyo Cho, Sun-Yong Chung, Joo-Hee Kim

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial

Samuel Bulteau, Veronique Sébille, Guillemette Fayet, Veronique Thomas-Ollivier, Thibault Deschamps, Annabelle Bonnin-Rivalland, Edouard Laforgue, Anne Pichot, Pierre Valrivière, Elisabeth Auffray-Calvier, June Fortin, Yann Péréon, Jean-Marie Vanelle, Anne Sauvaget

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Physical activity and nutrition behaviour outcomes of a cluster-randomized controlled trial for adults with metabolic syndrome in Vietnam

Van Dinh Tran, Andy H. Lee, Jonine Jancey, Anthony P. James, Peter Howat, Le Thi Phuong Mai

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial

Erin Kobetz, Julia Seay, Anthony Amofah, Larry Pierre, Jordan Baeker Bispo, Dinah Trevil, Martha Gonzalez, Martine Poitevien, Tulay Koru-Sengul, Olveen Carrasquillo

01.12.2017 | Research | Ausgabe 1/2017 Open Access

A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise

Anne Kirstine Eriksen, Rikke Dalgaard Hansen, Michael Borre, Ryan Godsk Larsen, Jeppe Munthe Jensen, Kristian Overgaard, Mette Borre, Cecilie Kyrø, Rikard Landberg, Anja Olsen, Anne Tjønneland

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

An internet-based self-help intervention for older adults after marital bereavement, separation or divorce: study protocol for a randomized controlled trial

Jeannette Brodbeck, Thomas Berger, Hans Joerg Znoj

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

Amy E. Maxwell, Martin Dennis, Anthony Rudd, Christopher J. Weir, Richard A. Parker, Rustam Al-Shahi Salman

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Spinal versus general anaesthesia in surgery for inguinodynia (SPINASIA trial): study protocol for a randomised controlled trial

Willem A. R. Zwaans, Léon H. P. M. le Mair, Marc R. M. Scheltinga, Rudi M. H. Roumen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial

Manuel Rullán, Oana Bulilete, Alfonso Leiva, Aina Soler, Antonia Roca, María José González-Bals, Patricia Lorente, Joan Llobera, PHN group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial – study protocol for a randomized controlled trial

Tomáš Hrbáč, David Netuka, Vladimír Beneš, Vladimír Nosáľ, Petra Kešnerová, Aleš Tomek, Táňa Fadrná, Vladimír Beneš Jr, Jiří Fiedler, Vladimír Přibáň, Miroslav Brozman, Kateřina Langová, Roman Herzig, David Školoudík

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study)

Byung-Cheul Shin, Me-riong Kim, Jae-Heung Cho, Jae-Young Jung, Koh-Woon Kim, Jun-Hwan Lee, Kibong Nam, Min ho Lee, Eui-Hyoung Hwang, Kwang-Ho Heo, Namkwen Kim, In-Hyuk Ha

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Moderated online social therapy for carers of young people recovering from first-episode psychosis: study protocol for a randomised controlled trial

John Gleeson, Reeva Lederman, Helen Herrman, Peter Koval, Dina Eleftheriadis, Sarah Bendall, Sue M. Cotton, Mario Alvarez-Jimenez

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial

Dimitrios A. Koutoukidis, Rebecca J. Beeken, Ranjit Manchanda, Matthew Burnell, M. Tish Knobf, Anne Lanceley

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The (cost-)effectiveness of a patient-tailored intervention programme to enhance adherence to antihypertensive medication in community pharmacies: study protocol of a randomised controlled trial

Danielle M. van der Laan, Petra J. M. Elders, Christel C. L. M. Boons, Judith E. Bosmans, Giel Nijpels, Jacqueline G. Hugtenburg

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial

Malene Nøhr Demant, Ramon Gordon Jensen, Janus Christian Jakobsen, Christian Gluud, Preben Homøe

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Can an educational podcast improve the ability of parents of primary school children to assess the reliability of claims made about the benefits and harms of treatments: study protocol for a randomised controlled trial

Daniel Semakula, Allen Nsangi, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Margaret Kaseje, Laetitia Nyirazinyoye, Atle Fretheim, Iain Chalmers, Andrew D. Oxman, Nelson K. Sewankambo

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Reporting of critical care trial abstracts: a comparison before and after the announcement of CONSORT guideline for abstracts

Akira Kuriyama, Naomi Takahashi, Takeo Nakayama

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features

Michael J. Grayling, James M. S. Wason, Adrian P. Mander

01.12.2017 | Editorial | Ausgabe 1/2017 Open Access

Review and publication of protocol submissions to Trials – what have we learned in 10 years?

Tianjing Li, Isabelle Boutron, Rustam Al-Shahi Salman, Erik Cobo, Ella Flemyng, Jeremy M. Grimshaw, Douglas G. Altman

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial

A. Solari

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The impact of torasemide on haemodynamic and neurohormonal stress, and cardiac remodelling in heart failure – TORNADO: a study protocol for a randomized controlled trial

Paweł Balsam, Krzysztof Ozierański, Agata Tymińska, Renata Główczyńska, Michał Peller, Anna Fojt, Andrzej Cacko, Bartosz Sieradzki, Elwira Bakuła, Maciej Markulis, Robert Kowalik, Zenon Huczek, Krzysztof J. Filipiak, Grzegorz Opolski, Marcin Grabowski

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Impact of the duration of antibiotics on clinical events in patients with Pseudomonas aeruginosa ventilator-associated pneumonia: study protocol for a randomized controlled study

Adrien Bouglé, Arnaud Foucrier, Hervé Dupont, Philippe Montravers, Alexandre Ouattara, Pierre Kalfon, Pierre Squara, Tabassome Simon, Julien Amour, for the iDIAPASON study group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial

Qing Du, Yasser Salem, Hao (Howe) Liu, Xuan Zhou, Sun Chen, Nan Chen, Xiaoyan Yang, Juping Liang, Kun Sun

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Endoscopic sinus surgery in adult patients with chronic rhinosinusitis with nasal polyps (PolypESS): study protocol for a randomised controlled trial

Evelijn S. Lourijsen, Corianne A. J. M. de Borgie, Marleen Vleming, Wytske J. Fokkens

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial

Maria Bryant, Wendy Burton, Bonnie Cundill, Amanda J. Farrin, Jane Nixon, June Stevens, Kim Roberts, Robbie Foy, Harry Rutter, Suzanne Hartley, Sandy Tubeuf, Michelle Collinson, Julia Brown

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial

Friederike Blume, Justin Hudak, Thomas Dresler, Ann-Christine Ehlis, Jan Kühnhausen, Tobias J. Renner, Caterina Gawrilow

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cognitive remediation therapy plus behavioural weight loss compared to behavioural weight loss alone for obesity: study protocol for a randomised controlled trial

Evelyn Smith, Charlotte Whittingham

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial

Ana Stevanovic, Stefan Kurt Beckers, Michael Czaplik, Sebastian Bergrath, Mark Coburn, Jörg Christian Brokmann, Ralf-Dieter Hilgers, Rolf Rossaint, TEMS Collaboration Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+): study protocol for a randomised controlled trial

Emily Peckham, Catherine Arundel, Della Bailey, Stuart Brownings, Caroline Fairhurst, Paul Heron, Jinshuo Li, Steve Parrott, Simon Gilbody

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial

Charlotte Mühlmann, Trine Madsen, Carsten Hjorthøj, Ad Kerkhof, Merete Nordentoft, Annette Erlangsen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial

Enoch Akowuah, Andrew T. Goodwin, W. Andrew Owens, Helen C. Hancock, Rebecca Maier, Adetayo Kasim, Adrian Mellor, Khalid Khan, Gavin Murphy, James Mason

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial

Justin Lambert, Rouzbeh Ghadry-Tavi, Kate Knuff, Marc Jutras, Jodi Siever, Paul Mick, Carolyn Roque, Gareth Jones, Jonathan Little, Harry Miller, Colin Van Bergen, Donna Kurtz, Mary Ann Murphy, Charlotte Ann Jones

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Tranexamic acid in bleeding trauma patients: an exploration of benefits and harms

Ian Roberts, Phil Edwards, David Prieto, Miland Joshi, Abda Mahmood, Katharine Ker, Haleema Shakur

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial)

Felipe Ribeiro Cabral Fagundes, Caique de Melo do Espírito Santo, Francine Mendonça de Luna Teixeira, Thaís Vanelli Tonini, Cristina Maria Nunes Cabral

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial

David A. Drew, Samantha M. Chin, Katherine K. Gilpin, Melanie Parziale, Emily Pond, Madeline M. Schuck, Kathleen Stewart, Meaghan Flagg, Crystal A. Rawlings, Vadim Backman, Peter J. Carolan, Daniel C. Chung, Francis P. Colizzo III, Matthew Freedman, Manish Gala, John J. Garber, Curtis Huttenhower, Dmitriy Kedrin, Hamed Khalili, Douglas S. Kwon, Sanford D. Markowitz, Ginger L. Milne, Norman S. Nishioka, James M. Richter, Hemant K. Roy, Kyle Staller, Molin Wang, Andrew T. Chan

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The pathway to RCTs: how many roads are there? Examining the homogeneity of RCT justification

Jeffrey Tin Yu Chow, Kevin Lam, Abdul Naeem, Zarique Z. Akanda, Francie Fengqin Si, William Hodge

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Optimizing adalimumab treatment in psoriasis with concomitant methotrexate (OPTIMAP): study protocol for a pragmatic, single-blinded, investigator-initiated randomized controlled trial

C. I. Busard, S. P. Menting, J. S. van Bezooijen, J. M. van den Reek, B. A. Hutten, E. P. Prens, E. M. de Jong, M. B. van Doorn, P. I. Spuls

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Investigating the effect of independent, blinded digital image assessment on the STOP GAP trial

Emily Patsko, Peter J. Godolphin, Kim S. Thomas, Trish Hepburn, Eleanor J. Mitchell, Fiona E. Craig, Philip M. Bath, Alan A. Montgomery

01.12.2017 | Letter | Ausgabe 1/2017 Open Access

The COMET Initiative database: progress and activities update (2015)

E. Gargon, P. R. Williamson, D. G. Altman, J. M. Blazeby, S. Tunis, M. Clarke

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial

Maureen Markle-Reid, Jenny Ploeg, Kimberly D. Fraser, Kathryn Ann Fisher, Noori Akhtar-Danesh, Amy Bartholomew, Amiram Gafni, Andrea Gruneir, Sandra P. Hirst, Sharon Kaasalainen, Caralyn Kelly Stradiotto, John Miklavcic, Carlos Rojas-Fernandez, Cheryl A. Sadowski, Lehana Thabane, Jean A. C. Triscott, Ross Upshur

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

App-based serious gaming for training of chest tube insertion: study protocol for a randomized controlled trial

Mirco Friedrich, Christian Bergdolt, Patrick Haubruck, Thomas Bruckner, Karl-Friedrich Kowalewski, Beat Peter Müller-Stich, Michael C. Tanner, Felix Nickel

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial

Aurélien Dupré, David Pérol, Ellen Blanc, Patrice Peyrat, Valéria Basso, Yao Chen, Jérémy Vincenot, Anthony Kocot, David Melodelima, Michel Rivoire

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial

Siri Merete Brændvik, Karin Roeleveld, Guro Lillemoen Andersen, Anne Elisabeth Ross Raftemo, Kjersti Ramstad, Jasmina Majkic-Tajsic, Torarin Lamvik, Bendik Lund, Turid Follestad, Torstein Vik

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial

Eleonora Volpato, Paolo Banfi, Francesco Pagnini

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial

Daniel Niederer

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study

Julia Lawton, David White, David Rankin, Jackie Elliott, Carolin Taylor, Cindy Cooper, Simon Heller, Nina Hallowell

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned

Penny S. Reynolds, Mary J. Michael, Bruce D. Spiess

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial

Agneta Malmgren Fänge, Steven M. Schmidt, Maria H. Nilsson, Gunilla Carlsson, Anna Liwander, Caroline Dahlgren Bergström, Paolo Olivetti, Per Johansson, Carlos Chiatti, on behalf of the TECH@HOME Research Group

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Transcranial magnetic stimulation for tinnitus: using the Tinnitus Functional Index to predict benefit in a randomized controlled trial

Sarah M. Theodoroff, Susan E. Griest, Robert L. Folmer

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial

Pierre Renaudin, Karine Baumstarck, Aurélie Daumas, Marie-Anne Esteve, Stéphane Gayet, Pascal Auquier, Michel Tsimaratos, Patrick Villani, Stéphane Honore

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial

Christopher R. Sudfeld, Ferdinand Mugusi, Said Aboud, Tumaini J. Nagu, Molin Wang, Wafaie W. Fawzi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial

Barnaby Young, Sapna Sadarangani, Haur Sen Yew, Chee Fu Yung, Yee Sin Leo, Mark I-Cheng Chen, Annelies Wilder-Smith

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial

Ji Yeon Lee, Deog Kyeom Kim, Jung-Kyu Lee, Ho Il Yoon, Ina Jeong, Eunyoung Heo, Young Sik Park, Jae Ho Lee, Sung Soo Park, Sang-Min Lee, Chang-Hoon Lee, Jinwoo Lee, Sun Mi Choi, Jong Sun Park, Joon-Sung Joh, Young-Jae Cho, Yeon Joo Lee, Se Joong Kim, Young Ran Hwang, Hyeonjeong Kim, Jongeun Ki, Hyungsook Choi, Jiyeon Han, Heejung Ahn, Seokyung Hahn, Jae-Joon Yim

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial

Merethe K. Andersen, Line B. Pedersen, Volkert Siersma, Flemming Bro, Susanne Reventlow, Jens Søndergaard, Marius Brostrøm Kousgaard, Frans B. Waldorff

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review

Johanna Taylor, Jan R. Böhnke, Judy Wright, Ian Kellar, Sarah L. Alderson, Tom Hughes, Richard I. G. Holt, Najma Siddiqi

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Challenges to complete and useful data sharing

Lawrence Mbuagbaw, Gary Foster, Ji Cheng, Lehana Thabane

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial

Jodie Wiseman, Megan Simons, Roy Kimble, Robert Ware, Steven McPhail, Zephanie Tyack

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Vascular Impulse Technology versus elevation in the treatment of posttraumatic swelling of extremity fractures: study protocol for a randomized controlled trial

Marc Schnetzke, Benedict Swartman, Isabel Bonnen, Holger Keil, Svenja Schüler, Paul A. Grützner, Jochen Franke

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for A three-year cluster randomized controlled trial

Elizabeth L. Turner, Siham Sikander, Omer Bangash, Ahmed Zaidi, Lisa Bates, John Gallis, Nima Ganga, Karen O’Donnell, Atif Rahman, Joanna Maselko

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The KiVa antibullying program in primary schools in Chile, with and without the digital game component: study protocol for a randomized controlled trial

Jorge Gaete, Daniela Valenzuela, Cristian Rojas-Barahona, Eduardo Valenzuela, Ricardo Araya, Christina Salmivalli

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial

Cristina Barbero, Davide Ricci, Erik Cura Stura, Augusto Pellegrini, Giovanni Marchetto, Suad ElQarra, Massimo Boffini, Roberto Passera, Maria Consuelo Valentini, Mauro Rinaldi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Use of activity tracking in major visceral surgery—the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial

Steffen Wolk, Theresa Meißner, Sebastian Linke, Benjamin Müssle, Ann Wierick, Andreas Bogner, Dorothée Sturm, Nuh N. Rahbari, Marius Distler, Jürgen Weitz, Thilo Welsch

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Sample size considerations for trials using cerebral white matter hyperintensity progression as an intermediate outcome at 1 year after mild stroke: results of a prospective cohort study

Francesca M. Chappell, Maria del Carmen Valdés Hernández, Stephen D. Makin, Kirsten Shuler, Eleni Sakka, Martin S. Dennis, Paul A. Armitage, Susana Muñoz Maniega, Joanna M. Wardlaw

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial

Heleen Westland, Irene D. Bos-Touwen, Jaap C. A. Trappenburg, Carin D. Schröder, Niek J. de Wit, Marieke J. Schuurmans

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial

Chin Kook Rhee, Hye Yun Park, Jeong-Woong Park, Ji-Hyun Lee, Tae-Hyung Kim, Sei Won Lee, Ji Ye Jung, Song Kim, Yong Il Hwang, Ki-Suck Jung

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial

Michael Tvilling Madsen, Anders Isbrand, Ulla Overgaard Andersen, Lars Juel Andersen, Mustafa Taskiran, Erik Simonsen, Ismail Gögenur

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial

Jose-Manuel Pastora-Bernal, Rocío Martín-Valero, Francisco Javier Barón-López, Oscar García-Gómez

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Sample size determination for a binary response in a superiority clinical trial using a hybrid classical and Bayesian procedure

Maria M. Ciarleglio, Christopher D. Arendt

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial

Emma Ghaziani, Christian Couppé, Cecilie Henkel, Volkert Siersma, Mette Søndergaard, Hanne Christensen, S. Peter Magnusson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Thromboelastometry versus standard coagulation tests versus restrictive protocol to guide blood transfusion prior to central venous catheterization in cirrhosis: study protocol for a randomized controlled trial

Leonardo Lima Rocha, Camila Menezes Souza Pessoa, Ary Serpa Neto, Rogerio Ruscitto do Prado, Eliezer Silva, Marcio Dias de Almeida, Thiago Domingos Correa, on behalf of the POCKET Trial Investigators

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Clinical trial registries: more international, converging efforts are needed

Claudia Pansieri, Chiara Pandolfini, Maurizio Bonati

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries

Louise A. A. Gerbens, Aaron E. Boyce, Dmitri Wall, Sebastien Barbarot, Richard J. de Booij, Mette Deleuran, Maritza A. Middelkamp-Hup, Amanda Roberts, Christian Vestergaard, Stephan Weidinger, Christian J. Apfelbacher, Alan D. Irvine, Jochen Schmitt, Paula R. Williamson, Phyllis I. Spuls, Carsten Flohr

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial

Sofia Straudi, Fabio Manfredini, Nicola Lamberti, Paolo Zamboni, Francesco Bernardi, Giovanna Marchetti, Paolo Pinton, Massimo Bonora, Paola Secchiero, Veronica Tisato, Stefano Volpato, Nino Basaglia

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial

Lauren Tingey, Rachel Chambers, Novalene Goklish, Francene Larzelere, Angelita Lee, Rosemarie Suttle, Summer Rosenstock, Kristin Lake, Allison Barlow

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study)

Henrik Eshoj, Sten Rasmussen, Lars Henrik Frich, Inge Hvass, Robin Christensen, Steen Lund Jensen, Jens Søndergaard, Karen Søgaard, Birgit Juul-Kristensen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

Geoffrey C. S. Smith, Ed Bateman, Ben Cass, Maurizio Damiani, Wade Harper, Hugh Jones, David Lieu, Jeff Petchell, Minas Petrelis, Kalman Piper, Doron Sher, Christopher J. Smithers, John Trantalis, Sindy Vrancic, Ian A. Harris

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effectiveness of a skin care program for the prevention of contact dermatitis in health care workers (the Healthy Hands Project): study protocol for a cluster randomized controlled trial

Maryam Soltanipoor, Sanja Kezic, Judith K. Sluiter, Thomas Rustemeyer

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial

David Saxon, Kate Ashley, Lindsey Bishop-Edwards, Janice Connell, Phillippa Harrison, Sally Ohlsen, Gillian E. Hardy, Stephen Kellett, Clara Mukuria, Toni Mank, Peter Bower, Mike Bradburn, John Brazier, Robert Elliott, Lynne Gabriel, Michael King, Stephen Pilling, Sue Shaw, Glenn Waller, Michael Barkham

01.12.2017 | Update | Ausgabe 1/2017 Open Access

Promoting Recruitment using Information Management Efficiently (PRIME): statistical analysis plan for a stepped wedge cluster randomised trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

Richard A. Parker, Christopher J. Weir, Amy E. Maxwell, Rustam Al-Shahi Salman

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a clusterrandomised controlled trial

Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M. Freitag, Robert L. Trestman, Christina Stadler

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial

M. Oliveira-Santos

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial

Katherine L. Downing, Jo Salmon, Trina Hinkley, Jill A. Hnatiuk, Kylie D. Hesketh

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial

Eva Meyerhof, Tanja Sprave, Stefan Ezechiel Welte, Nils H. Nicolay, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Jürgen Debus, Harald Rief

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study

Moira H. D. Bruintjes, Andries E. Braat, Albert Dahan, Gert-Jan Scheffer, Luuk B. Hilbrands, Frank C. H. d’Ancona, Rogier A. R. T. Donders, Cornelis J. H. M. van Laarhoven, Michiel C. Warlé

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial

Bente Storm Mowatt Haugland, Solfrid Raknes, Aashild Tellefsen Haaland, Gro Janne Wergeland, Jon Fauskanger Bjaastad, Valborg Baste, Joe Himle, Ron Rapee, Asle Hoffart

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Analysis of cluster randomised stepped wedge trials with repeated cross-sectional samples

Karla Hemming, Monica Taljaard, Andrew Forbes

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial

Shou-hai Hong, Sha-sha Ding, Fei Wu, Ying Bi, Fu Xu, Yi-jia Wan, Li-hua Xuan

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Mobile Exergaming for Health—Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus—study protocol for a randomized controlled trial

Christoph Höchsmann, Steffen P. Walz, Juliane Schäfer, Jussi Holopainen, Henner Hanssen, Arno Schmidt-Trucksäss

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

Thomas Cayton, Amy E. Harwood, George E. Smith, Joshua P. Totty, Daniel Carradice, Ian C. Chetter

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Marketing trials, marketing tricks — how to spot them and how to stop them

Alastair Matheson

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study

Ellie Shingler, Lucy Hackshaw-McGeagh, Luke Robles, Raj Persad, Anthony Koupparis, Edward Rowe, Constance Shiridzinomwa, Amit Bahl, Richard M. Martin, J. Athene Lane

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review

Turki A. Althunian, Anthonius de Boer, Olaf H. Klungel, Widya N. Insani, Rolf H. H. Groenwold

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial

Christian Grønhøj, David H. Jensen, Peter V. Glovinski, Siri Beier Jensen, Allan Bardow, Roberto S. Oliveri, Lena Specht, Carsten Thomsen, Sune Darkner, Katalin Kiss, Anne Fischer-Nielsen, Christian von Buchwald

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

An imbalance in cluster sizes does not lead to notable loss of power in cross-sectional, stepped-wedge cluster randomised trials with a continuous outcome

Caroline A. Kristunas, Karen L. Smith, Laura J. Gray

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial

Eric Noll, Shivam Shodhan, Maria Cecilia Madariaga, Christopher R. Page, Diane Santangelo, Xiaojun Guo, Ehab Al Bizri, Aurora D. Pryor, Jamie Romeiser, Elliott Bennett-Guerrero

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Amy Cranston, Deborah D. Stocken, Elaine Stamp, David Roblin, Julia Hamlin, James Langtry, Ruth Plummer, Alan Ashworth, John Burn, Neil Rajan

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Rituximab versus azathioprine as therapy for maintenance of remission for anti-neutrophil cytoplasm antibody-associated vasculitis (RITAZAREM): study protocol for a randomized controlled trial

Seerapani Gopaluni, Rona M. Smith, Michelle Lewin, Carol A. McAlear, Kim Mynard, Rachel B. Jones, Ulrich Specks, Peter A. Merkel, David R. W. Jayne, on behalf of the RITAZAREM Investigators

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Optimizing adalimumab treatment in psoriasis with concomitant methotrexate (OPTIMAP): study protocol for a pragmatic, single-blinded, investigator-initiated randomized controlled trial

Celine Busard, Stef Menting, SJ van Bezooijen, Juul van den Reek, Barbara Hutten, Errol Prens, Elke de Jong, Martijn van Doorn, Phyllis Spuls

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Acute effects of foam rolling on passive tissue stiffness and fascial sliding: study protocol for a randomized controlled trial

Frieder Krause, Jan Wilke, Daniel Niederer, Lutz Vogt, Winfried Banzer

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial

Juan Li, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Zhenxing Hu, Xiaoguang Shao, Haiyan Wang, Meifang Li, Maohua Lai, Changcai Xie, Nianjun Su, Chuyi Yu, Jia Liu, Taixiang Wu, Hongxia Ma

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Treatment with L-citrulline in patients with post-polio syndrome: study protocol for a single-center, randomised, placebo-controlled, double-blind trial

Simone Schmidt, Vanya Gocheva, Thomas Zumbrunn, Daniela Rubino-Nacht, Ulrike Bonati, Dirk Fischer, Patricia Hafner

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The use of randomisation-based efficacy estimators in non-inferiority trials

David Gillespie, Daniel Farewell, Peter Barrett-Lee, Angela Casbard, Anthony Barney Hawthorne, Chris Hurt, Nick Murray, Chris Probert, Rachel Stenson, Kerenza Hood

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The Benefits of Early Book Sharing (BEBS) for child cognitive and socio-emotional development in South Africa: study protocol for a randomised controlled trial

Nicholas Dowdall, Peter J. Cooper, Mark Tomlinson, Sarah Skeen, Frances Gardner, Lynne Murray

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Minimum number of clusters and comparison of analysis methods for cross sectional stepped wedge cluster randomised trials with binary outcomes: A simulation study

Daniel Barker, Catherine D’Este, Michael J. Campbell, Patrick McElduff

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial’s conduct and progress: a narrative review

Victoria Borg Debono, Lawrence Mbuagbaw, Lehana Thabane

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment

Lee J. Middleton, Jane P. Daniels, Annalise Weckesser, Siladitya Bhattacharya, on behalf of the PRE-EMPT trial collaborative group

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Why clinical trial outcomes fail to translate into benefits for patients

Carl Heneghan, Ben Goldacre, Kamal R. Mahtani

01.12.2017 | Letter | Ausgabe 1/2017 Open Access

Quality of transurethral resection of bladder tumor procedure influenced a phase III trial comparing the effect of KLH and mitomycin C

Narasimha N. G. Prasad, Shammana N. Muddukrishna

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Addition of Propranolol in Resistant Arterial hypertension Treatment (APROPRIATE study): study protocol for a randomized double-blind placebo-controlled trial

G. R. Constantine, P. Ranasinghe, P. Weeratunga, C. Weeraratne, P. Galappatthy, S. Rajapakse, U. Senarath, P. Katulanda

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The association of funding source on effect size in randomized controlled trials: 2013–2015 – a cross-sectional survey and meta-analysis

Alberto Falk Delgado, Anna Falk Delgado

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The Ghent Psychotherapy Study (GPS) on the differential efficacy of supportive-expressive and cognitive behavioral interventions in dependent and self-critical depressive patients: study protocol for a randomized controlled trial

Reitske Meganck, Mattias Desmet, Claudi Bockting, Ruth Inslegers, Femke Truijens, Melissa De Smet, Rosa De Geest, Kimberly Van Nieuwenhove, Vicky Hennissen, Goedele Hermans, Tom Loeys, Ufuoma Angelica Norman, Chris Baeken, Stijn Vanheule

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Frailty Related to Anesthesia guided by the Index “bispectraL” (FRAIL) study: study protocol for a randomized controlled trial

Morgan Le Guen, Marie Herr, Antoine Bizard, Caroline Bichon, Nathalie Boichut, Thierry Chazot, Ngai Liu, Joel Ankri, Marc Fischler

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A prospective, randomised, placebo-controlled, double-masked, three-armed, multicentre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma – the STRONG study: study protocol for a randomised controlled trial

Katrin Lorenz, Yvonne Scheller, Katharina Bell, Franz Grus, Katharina A. Ponto, Felix Bock, Claus Cursiefen, Jens Flach, Marta Gehring, Tunde Peto, Rufino Silva, Yossi Tal, Norbert Pfeiffer

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial

Matthew W. Semler, Wesley H. Self, Li Wang, Daniel W. Byrne, Jonathan P. Wanderer, Jesse M. Ehrenfeld, Joanna L. Stollings, Avinash B. Kumar, Antonio Hernandez, Oscar D. Guillamondegui, Addison K. May, Edward D. Siew, Andrew D. Shaw, Gordon R. Bernard, Todd W. Rice, for the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) Investigators, the Pragmatic Critical Care Research Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial

Shida Chen, Jianhua Lv, Sujie Fan, Hong Zhang, Lin Xie, Ling Xu, Bing Jiang, Huipin Yuan, Yuanbo Liang, Shuning Li, Pingyan Chen, Xiulan Zhang, Ningli Wang, for the Multi-mechanism Angle Closure Study (MACs) group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health (“NiPPeR”): study protocol for a randomised controlled trial

Keith M. Godfrey, Wayne Cutfield, Shiao-Yng Chan, Philip N. Baker, Yap-Seng Chong, NiPPeR Study Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study protocol for a randomised controlled trial

Elizabeth McGinnis, Sarah Brown, Howard Collier, Phil Faulks, Rachael Gilberts, Clare Greenwood, Valerie Henderson, Delia Muir, Andrea Nelson, Jane Nixon, Isabelle Smith, Nikki Stubbs, Kay Walker, Lyn Wilson, Susanne Coleman

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

The possibility of critical realist randomised controlled trials

Sam Porter, Tracey McConnell, Joanne Reid

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training? Study protocol for a randomized controlled trial

Javier Rodrigo De La Garza, Karl-Friedrich Kowalewski, Mirco Friedrich, Mona Wanda Schmidt, Thomas Bruckner, Hannes Götz Kenngott, Lars Fischer, Beat-Peter Müller-Stich, Felix Nickel

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial

Jung-Eun Kim, Junghyo Cho, Ojin Kwon, Ae-Ran Kim, Hyo-Ju Park, So-Young Jung, Joo-Hee Kim, Mikyung Kim, Hye-Yoon Lee, Jun-Hwan Lee

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial

Susan Chan, Victoria Cornelius, Tao Chen, Suzana Radulovic, Mandy Wan, Rahi Jahan, Gideon Lack

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Poor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners

Christine L. Paul, Leon Piterman, Jonathan E. Shaw, Catherine Kirby, Kristy L. Forshaw, Jennifer Robinson, Isaraporn Thepwongsa, Robert W. Sanson-Fisher

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Cognitive rehabiliation for Parkinson’s disease dementia: a study protocol for a pilot randomised controlled trial

John V. Hindle, Tamlyn J. Watermeyer, Julie Roberts, Anthony Martyr, Huw Lloyd-Williams, Andrew Brand, Petra Gutting, Zoe Hoare, Rhiannon Tudor Edwards, Linda Clare

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial

Christine Norton, Anton Emmanuel, Natasha Stevens, S. Mark Scott, Ugo Grossi, Sybil Bannister, Sandra Eldridge, James M. Mason, Charles H. Knowles

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Equipoise across the patient population: optimising recruitment to a randomised controlled trial

Paul Whybrow, Robert Pickard, Susan Hrisos, Tim Rapley

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial

Olivia Kérourédan, Léonard Jallon, Paul Perez, Christine Germain, Jean-François Péli, Dominique Oriez, Jean-Christophe Fricain, Elise Arrivé, Raphaël Devillard

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cognitive-behavioral rehabilitation vs. treatment as usual for bipolar patients: study protocol for a randomized controlled trial

Bernardo Carramão Gomes, Cristiana Castanho Rocca, Gabriel Okawa Belizario, Beny Lafer

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Why prudence is needed when interpreting articles reporting clinical trial results in mental health

Rafael Dal-Ré, Julio Bobes, Pim Cuijpers

01.12.2017 | Research | Ausgabe 1/2017 Open Access

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

Sarah Cockayne, Caroline Fairhurst, Joy Adamson, Catherine Hewitt, Robin Hull, Kate Hicks, Anne-Maree Keenan, Sarah E. Lamb, Lorraine Green, Caroline McIntosh, Hylton B. Menz, Anthony C. Redmond, Sara Rodgers, David J. Torgerson, Wesley Vernon, Judith Watson, Peter Knapp, Jo Rick, Peter Bower, Sandra Eldridge, Vichithranie W. Madurasinghe, Jonathan Graffy

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial

Annelies A. J. Verlaet, Berten Ceulemans, Helene Verhelst, Dirk Van West, Tess De Bruyne, Luc Pieters, Huub F. J. Savelkoul, Nina Hermans

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

Amy E. Maxwell, Martin Dennis, Anthony Rudd, Christopher J. Weir, Richard A. Parker, Rustam Al-Shahi Salman

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial)

Anna Lee, You Hwan Jo, Kyuseok Kim, Soyeon Ahn, Yun Kyu Oh, Huijai Lee, Jonghwan Shin, Ho Jun Chin, Ki Young Na, Jung Bok Lee, Seon Ha Baek, Sejoong Kim

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial

Nazila Kassaian, Ashraf Aminorroaya, Awat Feizi, Parvaneh Jafari, Masoud Amini

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial

Catherine Elizabeth Carr, Julian O’Kelly, Stephen Sandford, Stefan Priebe

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER — Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial

Doreen McClurg, Kirsteen Goodman, Suzanne Hagen, Fional Harris, Sean Treweek, Anton Emmanuel, Christine Norton, Maureen Coggrave, Selina Doran, John Norrie, Peter Donnan, Helen Mason, Sarkis Manoukian

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial

Christopher Emmett, Helen Close, James Mason, Shiva Taheri, Natasha Stevens, Sandra Eldridge, Christine Norton, Charles Knowles, Yan Yiannakou

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial

Victoria Nankabirwa, James K. Tumwine, Olive Namugga, Thorkild Tylleskär, Grace Ndeezi, Bjarne Robberstad, Mihai G. Netea, Halvor Sommerfelt

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial

Dennis H. Murphree, Theresa N. Kinard, Nandita Khera, Curtis B. Storlie, Che Ngufor, Sudhindra Upadhyaya, Jyotishman Pathak, Emma Fortune, Eapen K. Jacob, Rickey E. Carter, Karl A. Poterack, Daryl J. Kor

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial

Enrico Marchetti, Simona Tecco, Eleonora Caterini, Fabio Casalena, Vincenzo Quinzi, Antonella Mattei, Giuseppe Marzo

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial

Stefan Ezechiel Welte, Joachim Wiskemann, Friederike Scharhag-Rosenberger, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Eva Meyerhof, Tanja Sprave, Nils H. Nicolay, Jürgen Debus, Harald Rief

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Short message service (SMS)-based intervention targeting alcohol consumption among university students: study protocol of a randomized controlled trial

Kristin Thomas, Marcus Bendtsen, Catharina Linderoth, Nadine Karlsson, Preben Bendtsen, Ulrika Müssener

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial

Hannah Brown Amoakoh, Kerstin Klipstein-Grobusch, Mary Amoakoh-Coleman, Irene Akua Agyepong, Gbenga A. Kayode, Charity Sarpong, Diederick E. Grobbee, Evelyn K. Ansah

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy – the COOP Study: study protocol for a cluster randomised controlled trial

Rita Romskaug, Espen Molden, Jørund Straand, Hege Kersten, Eva Skovlund, Kaisu H Pitkala, Torgeir Bruun Wyller

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial

Amy McAndrew, Will Lawn, Tobias Stevens, Lilla Porffy, Brigitta Brandner, Celia J. A. Morgan

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial

Ana Moreno-Alcázar, Joaquim Radua, Ramon Landín-Romero, Laura Blanco, Mercè Madre, Maria Reinares, Mercè Comes, Esther Jiménez, Jose Manuel Crespo, Eduard Vieta, Victor Pérez, Patricia Novo, Marta Doñate, Romina Cortizo, Alicia Valiente-Gómez, Walter Lupo, Peter J. McKenna, Edith Pomarol-Clotet, Benedikt L. Amann

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

Daniel Glinatsi, Marte S. Heiberg, Anna Rudin, Dan Nordström, Espen A. Haavardsholm, Bjorn Gudbjornsson, Mikkel Østergaard, Till Uhlig, Gerdur Grondal, Kim Hørslev-Petersen, Ronald van Vollenhoven, Merete L. Hetland

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study

Amy E. Maxwell, Mary Joan MacLeod, Anu Joyson, Sharon Johnson, Hawraman Ramadan, Ruth Bellfield, Anthony Byrne, Caroline McGhee, Anthony Rudd, Fiona Price, Evangelos Vasileiadis, Melinda Holden, Jonathan Hewitt, Michael Carpenter, Ann Needle, Stacey Valentine, Farzana Patel, Frances Harrington, Paul Mudd, Hedley Emsley, Bindu Gregary, Ingrid Kane, Keith Muir, Divya Tiwari, Peter Owusu-Agyei, Natalie Temple, Lakshmanan Sekaran, Suzanne Ragab, Timothy England, Amanda Hedstrom, Phil Jones, Sarah Jones, Mandy Doherty, Mark O. McCarron, David L. Cohen, Sharon Tysoe, Rustam Al-Shahi Salman

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The pancreatic surgery registry (StuDoQ|Pancreas) of the German Society for General and Visceral Surgery (DGAV) – presentation and systematic quality evaluation

Ulrich F. Wellner, Carsten Klinger, Kai Lehmann, Heinz Buhr, Edmund Neugebauer, Tobias Keck

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Measurement of HbA1c in multicentre diabetes trials – should blood samples be tested locally or sent to a central laboratory: an agreement analysis

Barbara N. Arch, Joanne Blair, Andrew McKay, John W. Gregory, Paul Newland, Carrol Gamble

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial

Alex Ryan, Andrea Baker, Frances Dark, Sharon Foley, Anne Gordon, Sean Hatherill, Stephen Stathis, Sukanta Saha, George Bruxner, Martin Beckman, Drew Richardson, Michael Berk, Olivia Dean, John McGrath, Cadence Working Group, James Scott

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

Thijs de Rooij, Jony van Hilst, Jantien A. Vogel, Hjalmar C. van Santvoort, Marieke T. de Boer, Djamila Boerma, Peter B. van den Boezem, Bert A. Bonsing, Koop Bosscha, Peter-Paul Coene, Freek Daams, Ronald M. van Dam, Marcel G. Dijkgraaf, Casper H. van Eijck, Sebastiaan Festen, Michael F. Gerhards, Bas Groot Koerkamp, Jeroen Hagendoorn, Erwin van der Harst, Ignace H. de Hingh, Cees H. Dejong, Geert Kazemier, Joost Klaase, Ruben H. de Kleine, Cornelis J. van Laarhoven, Daan J. Lips, Misha D. Luyer, I. Quintus Molenaar, Vincent B. Nieuwenhuijs, Gijs A. Patijn, Daphne Roos, Joris J. Scheepers, George P. van der Schelling, Pascal Steenvoorde, Rutger-Jan Swijnenburg, Jan H. Wijsman, Moh’d Abu Hilal, Olivier R. Busch, Marc G. Besselink, for the Dutch Pancreatic Cancer Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial

Jeffrey T. Kullgren, Bradley Youles, Shaina Shetty, Caroline Richardson, Angela Fagerlin, Michele Heisler

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial

Priya Morjaria, Andrew Bastawrous, Gudlavalleti Venkata Satyanarayana Murthy, Jennifer Evans, Clare Gilbert

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses

Lauralie Richard, Donella Piper, Wayne Weavell, Rosemary Callander, Rick Iedema, John Furler, David Pierce, Kali Godbee, Jane Gunn, Victoria J. Palmer

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Abelmoschus manihot – a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial

Ping Li, Yi-zhi Chen, Hong-li Lin, Zhao-hui Ni, Yong-li Zhan, Rong Wang, Hong-tao Yang, Jing-ai Fang, Nian-song Wang, Wen-ge Li, Xue-feng Sun, Xiang-mei Chen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

MYPLAN –mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial

Kate Andreasson, Jesper Krogh, Per Bech, Hanne Frandsen, Niels Buus, Barbara Stanley, Ad Kerkhof, Merete Nordentoft, Annette Erlangsen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial

Heloisa Sousa Gomes, Analya Rodrigues Miranda, Karolline Alves Viana, Aline Carvalho Batista, Paulo Sucasas Costa, Anelise Daher, Geovanna de Castro Morais Machado, Joji Sado-Filho, Liliani Aires Candido Vieira, Patrícia Corrêa-Faria, Marie Therese Hosey, Luciane Rezende Costa

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Prospective clinical study of rehabilitation interventions with multisensory interactive training in patients with cerebral infarction: study protocol for a randomised controlled trial

Wai Leung Ambrose Lo, Yu Rong Mao, Le Li, Ai Hua Lin, Jiang Li Zhao, Ling Chen, Qiang Lin, Hai Li, Dong Feng Huang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial

Elodie Crétel-Durand, Emilie Nouguerède, Hervé Le Caer, Frédérique Rousseau, Frédérique Retornaz, Olivier Guillem, Anne-Laure Couderc, Laurent Greillier, Emmanuelle Norguet, Maud Cécile, Rabia Boulahssass, Francoise Le Caer, Sandrine Tournier, Chantal Butaud, Pierre Guillet, Sophie Nahon, Laure Poudens, Sylvie Kirscher, Sandrine Loubière, Nadine Diaz, Jean Dhorne, Pascal Auquier, Karine Baumstarck

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Anna N. Millar, Amrit Daffu-O’Reilly, Carmel M. Hughes, David P. Alldred, Garry Barton, Christine M. Bond, James A. Desborough, Phyo K. Myint, Richard Holland, Fiona M. Poland, David Wright, On behalf of the CHIPPS Team, University of East Anglia

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Topical application of Jaungo in atopic dermatitis patients: study protocol for a randomized, controlled trial

Younghee Yun, Youme Ko, Jin-Hyang Ahn, Bo-Hyoung Jang, Kyuseok Kim, Seong-Gyu Ko, Inhwa Choi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial

Sung-Phil Kim, Joo-Hee Kim, Bo-Kyung Kim, Hyeong-Jun Kim, In Chul Jung, Jung Hyo Cho, Jung-Eun Kim, Mi-Kyung Kim, O-Jin Kwon, Ae-Ran Kim, Hyo-Ju Park, Bok-Nam Seo

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial

Wesley H. Self, Matthew W. Semler, Jonathan P. Wanderer, Jesse M. Ehrenfeld, Daniel W. Byrne, Li Wang, Leanne Atchison, Matthew Felbinger, Ian D. Jones, Stephan Russ, Andrew D. Shaw, Gordon R. Bernard, Todd W. Rice

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) – the UNBLOCS trial: a study protocol for a randomised controlled trial

Jo Worthington, Hilary Taylor, Paul Abrams, Sara T. Brookes, Nikki Cotterill, Sian M. Noble, Tobias Page, K. Satchi Swami, J. Athene Lane, Hashim Hashim

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Do images of a personalised future body shape help with weight loss? A randomised controlled study

Gemma Ossolinski, Moyez Jiwa, Alexandra McManus, Richard Parsons

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Optimizing veteran-centered prostate cancer survivorship care: study protocol for a randomized controlled trial

Ted A. Skolarus, Tabitha Metreger, Soohyun Hwang, Hyungjin Myra Kim, Robert L. Grubb III, Jeffrey R. Gingrich, Sarah T. Hawley

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Research Exploring Physical Activity in Care Homes (REACH): study protocol for a randomised controlled trial

Anne Forster, Jennifer Airlie, Karen Birch, Robert Cicero, Bonnie Cundill, Alison Ellwood, Mary Godfrey, Liz Graham, John Green, Claire Hulme, Rebecca Lawton, Vicki McLellan, Nicola McMaster, Amanda Farrin, on behalf of the REACH Programme Team

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A multicenter randomized controlled trial of surgery alone or surgery with atrial natriuretic peptide in lung cancer surgery: study protocol for a randomized controlled trial

Takashi Nojiri, Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Kikuko Ohshima, Yasushi Shintani, Meinoshin Okumura, Kenji Kangawa, on behalf of the Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP Study) Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

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

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial

Qi-wei Li, Ming-wei Yu, Guo-wang Yang, Xiao-min Wang, Huan Wang, Chen-xi Zhang, Na Xue, Wei-ru Xu, Qi Fu, Zhong Yang, Lin Yang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial

Eldré W. Beukes, David M. Baguley, Peter M. Allen, Vinaya Manchaiah, Gerhard Andersson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial

Tor A. Strand, Manjeswori Ulak, Ram K. Chandyo, Ingrid Kvestad, Mari Hysing, Merina Shrestha, Sudha Basnet, Suman Ranjitkar, Laxman Shrestha, Prakash S. Shrestha

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial

Lin-lin Zhu, Jian-ying Zhou, Ling Luo, Xiang Wang, Jia-xi Peng, Sha-sha Chen, Hai-Yan Yin, Qiao-Feng Wu, Cheng-shun Zhang, Peng Lv, Yong Tang, Shu-guang Yu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial

Rasmus E. Berthelsen, Theis Itenov, Anders Perner, Jens-Ulrik Jensen, Michael Ibsen, Andreas Emil Kryger Jensen, Morten Bestle

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial

Anna Chiumento, Syed Usman Hamdani, Muhammad Naseem Khan, Katie Dawson, Richard A. Bryant, Marit Sijbrandij, Huma Nazir, Parveen Akhtar, Aqsa Masood, Duolao Wang, Mark van Ommeren, Atif Rahman

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial

Yung-Sung Yeh, Hsiang-Lin Tsai, Ching-Wen Huang, Po-Li Wei, Yung-Chuan Sung, Hsiu-Chih Tang, Jaw-Yuan Wang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Metformin to Augment Strength Training Effective Response in Seniors (MASTERS): study protocol for a randomized controlled trial

Doug E. Long, Bailey D. Peck, Jenny L. Martz, S. Craig Tuggle, Heather M. Bush, Gerald McGwin, Philip A. Kern, Marcas M. Bamman, Charlotte A. Peterson

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial

U. Teichgräber, R. Aschenbach, D. Scheinert, T. Zeller, K. Brechtel, M. Thieme, E. Blessing, M. Treitl, M. Lichtenberg, P. von Flotow, B. Vogel, M. Werk, V. Riambau, A. Wienke, T. Lehmann, S. Sixt

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Willem Kuyken, Elizabeth Nuthall, Sarah Byford, Catherine Crane, Tim Dalgleish, Tamsin Ford, Mark T. Greenberg, Obioha C. Ukoumunne, Russell M. Viner, J. Mark G. Williams, the MYRIAD team

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Ketogenic diet in the treatment of epilepsy in children under the age of 2 years: study protocol for a randomised controlled trial

Siobhan Titre-Johnson, Natasha Schoeler, Christin Eltze, Ruth Williams, Katharina Vezyroglou, Helen McCullagh, Nick Freemantle, Simon Heales, Rachel Kneen, Louise Marston, Tim Martland, Irwin Nazareth, Elizabeth Neal, Andrew Lux, Alasdair Parker, Shakti Agrawal, Penny Fallon, J. Helen Cross

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Clinicians’ views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Celine Y. Chhoa, Alexandra Sawyer, Susan Ayers, Angela Pushpa-Rajah, Lelia Duley

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial

Hanna Sandelowsky, Ingvar Krakau, Sonja Modin, Björn Ställberg, Anna Nager

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial

Shannon E. Munteanu, Karl B. Landorf, Jodie A. McClelland, Edward Roddy, Flavia M. Cicuttini, Alan Shiell, Maria Auhl, Jamie J. Allan, Andrew K. Buldt, Hylton B. Menz

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Lymphoma InterVEntion (LIVE) – patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial

Lindy P. J. Arts, Lonneke V. van de Poll-Franse, Sanne W. van den Berg, Judith B. Prins, Olga Husson, Floortje Mols, Angelique V. M. Brands-Nijenhuis, Lidwine Tick, Simone Oerlemans

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial

Dina Visca, Vicky Tsipouri, Letizia Mori, Ashi Firouzi, Sharon Fleming, Morag Farquhar, Elizabeth Leung, Toby M. Maher, Paul Cullinan, Nick Hopkinson, Athol U. Wells, Winston Banya, Jennifer A. Whitty, Huzaifa Adamali, Lisa G. Spencer, Piersante Sestini, Elisabetta A. Renzoni

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

T. Bluth, R. Teichmann, T. Kiss, I. Bobek, J. Canet, G. Cinnella, L. De Baerdemaeker, C. Gregoretti, G. Hedenstierna, S. N. Hemmes, M. Hiesmayr, M. W. Hollmann, S. Jaber, J. G. Laffey, M. J. Licker, K. Markstaller, I. Matot, G. Müller, G. H. Mills, J. P. Mulier, C. Putensen, R. Rossaint, J. Schmitt, M. Senturk, A. Serpa Neto, P. Severgnini, J. Sprung, M. F. Vidal Melo, H. Wrigge, M. J. Schultz, P. Pelosi, M. Gama de Abreu, for the PROBESE investigators, and the PROtective VEntilation Network (PROVEnet), on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Comparative costs and activity from a sample of UK clinical trials units

Daniel Hind, Barnaby C. Reeves, Sarah Bathers, Christopher Bray, Andrea Corkhill, Christopher Hayward, Lynda Harper, Vicky Napp, John Norrie, Chris Speed, Liz Tremain, Nicola Keat, Mike Bradburn

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Subversion of allocation concealment in a randomised controlled trial: a historical case study

Andrew D. M. Kennedy, David J. Torgerson, Marion K. Campbell, Adrian M. Grant

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

Young-Nim You, Myung-Rae Cho, Ju-Hyung Park, Gwang-Cheon Park, Min-Yeong Song, Jin-Bong Choi, Chang-Su Na, Jae-Young Han, Jeong-cheol Shin, Jae-Hong Kim

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial

Kate Sitnikova, Stephanie S. Leone, Lyonne N. L. Zonneveld, Harm W. J. van Marwijk, Judith E. Bosmans, Johannes C. van der Wouden, Henriëtte E. van der Horst

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Sequence balance minimisation: minimising with unequal treatment allocations

Vichithranie W. Madurasinghe

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial

Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Paredes, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H. Hamdan, Maurizio Lunati, Angel Moya, Alessio Gargaro, BIOSync Study Steering Committee

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial

Jill Murphy, Charles H. Goldsmith, Wayne Jones, Pham Thi Oanh, Vu Cong Nguyen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of supervised exercise in groups on psychological well-being among pregnant women at risk of depression (the EWE Study): study protocol for a randomized controlled trial

Lotte Broberg, Mette Backhausen, Peter Damm, Per Bech, Ann Tabor, Hanne Kristine Hegaard

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial

Raphael F. de Souza, Muhammad Faheem Khiyani, Carolina A. L. Chaves, Jocelyne Feine, Jean Barbeau, Ramón Fuentes, Eduardo Borie, Luciana C. Crizostomo, Claudia H. Silva-Lovato, Pierre Rompre, Elham Emami

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial

Aron Onerup, Eva Angenete, David Bock, Mats Börjesson, Monika Fagevik Olsén, Elin Grybäck Gillheimer, Stefan Skullman, Sven-Egron Thörn, Eva Haglind, Hanna Nilsson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element: study protocol for a randomised controlled trial

Micol Artom, Wladyslawa Czuber-Dochan, Jackie Sturt, Christine Norton

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction – a randomised placebo-controlled trial (KARE): study protocol

Laurence J. M. Cross, Cecilia M. O’Kane, Cliona McDowell, Jospeh J. Elborn, Michael A. Matthay, Daniel F. McAuley

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial

Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentagotai, Vlad Mureşan, Rareș Boian

01.12.2017 | Research | Ausgabe 1/2017 Open Access

A feasibility randomised controlled trial of extended brief intervention for alcohol misuse in adults with mild to moderate intellectual disabilities living in the community; The EBI-LD study

Christos Kouimtsidis, Alessandro Bosco, Katrina Scior, Gianluca Baio, Rachael Hunter, Vittoria Pezzoni, Eileen Mcnamara, Angela Hassiotis

01.12.2017 | Letter | Ausgabe 1/2017 Open Access

Centralised versus local measurement of glycated haemoglobin in clinical trial settings: a comment on Arch et al., Trials. 2016

Sudip Chatterjee, Richeek Pradhan

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial

Hants Williams, Susan Silva, Leigh Ann Simmons, Paula Tanabe

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials

Gemma L. Clayton, Isabelle L. Smith, Julian P. T. Higgins, Borislava Mihaylova, Benjamin Thorpe, Robert Cicero, Kusal Lokuge, Julia R. Forman, Jayne F. Tierney, Ian R. White, Linda D. Sharples, Hayley E. Jones

01.12.2017 | Research | Ausgabe 1/2017 Open Access

HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

Noor Heim, Henk F. van Stel, Roelof G. Ettema, Roos C. van der Mast, Sharon K. Inouye, Marieke J. Schuurmans

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The SITLESS project: exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: study protocol for a randomised controlled trial

Maria Giné-Garriga, Laura Coll-Planas, Míriam Guerra, Àlex Domingo, Marta Roqué, Paolo Caserotti, Michael Denkinger, Dietrich Rothenbacher, Mark A. Tully, Frank Kee, Emma McIntosh, Carme Martín-Borràs, Guillermo R. Oviedo, Javier Jerez-Roig, Marta Santiago, Oriol Sansano, Guillermo Varela, Mathias Skjødt, Katharina Wirth, Dhayana Dallmeier, Jochen Klenk, Jason J. Wilson, Nicole E. Blackburn, Manuela Deidda, Guillaume Lefebvre, Denise González, Antoni Salvà

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial

Ana Marina Moreira, Roberta Marobin, Dimitris Varvaki Rados, Camila Bergonsi de Farias, Sabrina Coelli, Bárbara Luiza Bernardi, Lívia de Almeida Faller, Laura Ferraz dos Santos, Ana Maria Matzenbacher, Natan Katz, Erno Harzheim, Sandra Pinho Silveiro, TelessaudeRS

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Does the use of the Informed Healthcare Choices (IHC) primary school resources improve the ability of grade-5 children in Uganda to assess the trustworthiness of claims about the effects of treatments: protocol for a cluster-randomised trial

Allen Nsangi, Daniel Semakula, Andrew D. Oxman, Matthew Oxman, Sarah Rosenbaum, Astrid Austvoll-Dahlgren, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Nelson K. Sewankambo

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial

Benjamin D. Hunt, Matthew A. Popplewell, Huw Davies, Lewis Meecham, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Catherine Hewitt, Lazaros Andronis, Jonathan J. Deeks, Andrew Bradbury, on behalf of the BASIL-3 Collaborative Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A multimodal day treatment program for multi-problem young adults: study protocol for a randomized controlled trial

Marie-Jolette A. Luijks, Floor Bevaart, Josjan Zijlmans, Laura van Duin, Reshmi Marhe, Theo A. H. Doreleijers, Henning Tiemeier, Jessica J. Asscher, Arne Popma

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial

Marko Kraljević, Tarik Delko, Thomas Köstler, Elena Osto, Thomas Lutz, Sarah Thommen, Raoul A. Droeser, Lincoln Rothwell, Daniel Oertli, Urs Zingg

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis

Justin Presseau, Brittany Mutsaers, Ahmed A. Al-Jaishi, Janet Squires, Christopher W. McIntyre, Amit X. Garg, Manish M. Sood, Jeremy M. Grimshaw, on behalf of the Major outcomes with personalized dialysate TEMPerature (MyTEMP) investigators

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial

Anja van der Hout, Cornelia F. van Uden-Kraan, Birgit I. Witte, Veerle M. H. Coupé, Femke Jansen, C. René Leemans, Pim Cuijpers, Lonneke V. van de Poll-Franse, Irma M. Verdonck-de Leeuw

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS): study protocol for a randomised controlled trial

Mathilde M. H. Pauls, Natasha Clarke, Sarah Trippier, Shai Betteridge, Franklyn A. Howe, Usman Khan, Christina Kruuse, Jeremy B. Madigan, Barry Moynihan, Anthony C. Pereira, Debbie Rolfe, Egill Rostrup, Caroline E. Haig, Thomas R. Barrick, Jeremy D. Isaacs, Atticus H. Hainsworth

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial

Ruth Bolier, Elsemieke S. de Vries, Albert Parés, Jeltje Helder, E. Marleen Kemper, Koos Zwinderman, Ronald P. Oude Elferink, Ulrich Beuers, the Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group

01.12.2017 | Update | Ausgabe 1/2017 Open Access

The role of anti-IgE (omalizumab/Xolair) in the management of severe recalcitrant paediatric atopic eczema (ADAPT): statistical analysis plan

Tao Chen, Susan Chan, Gideon Lack, Suzie Cro, Victoria R. Cornelius

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial

Sang-Don Park, Chang-Hwan Yoon, Il-Young Oh, Jung-Won Suh, Young-Suk Cho, Tae-Jin Youn, Dong-Ju Choi, In-Ho Chae

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of a mindfulness-based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high-risk mental state in a Chilean sample: study protocol for a randomized controlled trial

Álvaro I. Langer, Carlos Schmidt, Rocío Mayol, Marcela Díaz, Javiera Lecaros, Edwin Krogh, Aída Pardow, Carolina Vergara, Guillermo Vergara, Bernardita Pérez-Herrera, María José Villar, Alejandro Maturana, Pablo A. Gaspar

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial

Sarah Ballou, Ted J. Kaptchuk, William Hirsch, Judy Nee, Johanna Iturrino, Kathryn T. Hall, John M. Kelley, Vivian Cheng, Irving Kirsch, Eric Jacobson, Lisa Conboy, Anthony Lembo, Roger B. Davis

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial

W. Ben Mortenson, Sharon Jang, Charlie H. Goldsmith, Laura Hurd Clarke, Sandra Hobson, Richelle Emery

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China’s community hypertension care: study protocol for a randomized controlled trial

Lei Xu, Wei-Yi Fang, Fu Zhu, Hong-Guang Zhang, Kai Liu

01.12.2017 | Research | Ausgabe 1/2017 Open Access

A focused ethnography of a Child and Adolescent Mental Health Service: factors relevant to the implementation of a depression trial

C. E. W. Kitchen, S. Lewis, P. A. Tiffin, P. R. Welsh, L. Howey, D. Ekers

01.12.2017 | Update | Ausgabe 1/2017 Open Access

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol

Chris Bonell, Anne Mathiot, Elizabeth Allen, Leonardo Bevilacqua, Deborah Christie, Diana Elbourne, Adam Fletcher, Richard Grieve, Rosa Legood, Stephen Scott, Emily Warren, Meg Wiggins, Russell M. Viner

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial

Michele Heisler, Jennifer Burgess, Jeffrey Cass, John F. Chardos, Alexander B. Guirguis, Sean M. Jeffery, Lorrie A. Strohecker, Adam S. Tremblay, Wen-Chih Wu, Donna M. Zulman

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial

Qinjun Chu, Dan Shen, Long He, Hongwei Wang, Xianlan Zhao, Zhimin Chen, Yanli Wang, Wei Zhang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial

James Winearls, Martin Wullschleger, Elizabeth Wake, Catherine Hurn, Jeremy Furyk, Glenn Ryan, Melita Trout, James Walsham, Anthony Holley, Jeremy Cohen, Megan Shuttleworth, Wayne Dyer, Gerben Keijzers, John F Fraser, Jeffrey Presneill, Don Campbell

01.12.2017 | Letter | Ausgabe 1/2017 Open Access

Response to letter to editor: ‘Comment on Arch et al., Trials. 2016;17:517’

B. N. Arch, J. Blair, A. McKay, J. W. Gregory, P. Newland, C. Gamble

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial

Lemmy Schakel, Dieuwke S. Veldhuijzen, Henriët van Middendorp, Corine Prins, Simone A. Joosten, Tom H. M. Ottenhoff, Leo G. Visser, Andrea W. M. Evers

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial

Nanna Rolving, Barbara C. Brocki, Hanne R. Mikkelsen, Pernille Ravn, Jannie Rhod Bloch-Nielsen, Lars Frost

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

T. Bluth, R. Teichmann, T. Kiss, I. Bobek, J. Canet, G. Cinnella, L. De Baerdemaeker, C. Gregoretti, G. Hedenstierna, S. N. Hemmes, M. Hiesmayr, M. W. Hollmann, S. Jaber, J. G. Laffey, M. J. Licker, K. Markstaller, I. Matot, G. Müller, G. H. Mills, J. P. Mulier, C. Putensen, R. Rossaint, J. Schmitt, M. Senturk, A. Serpa Neto, P. Severgnini, J. Sprung, M. F. Vidal Melo, H. Wrigge, M. J. Schultz, P. Pelosi, Marcelo Gama de Abreu, for the PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial

Caroline A. Smith, Sheryl de Lacey, Michael Chapman, Julie Ratcliffe, Robert J. Norman, Neil Johnson, Gavin Sacks, Jane Lyttleton, Clare Boothroyd

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial

Tamaya Van Criekinge, Wim Saeys, Ann Hallemans, Luc Vereeck, Willem De Hertogh, Patricia Van de Walle, Nathalie Vaes, Christophe Lafosse, Steven Truijen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial

LS Nascimento, AC Santos, JMS Lucena, LGO Silva, AEM Almeida, MS Brasileiro-Santos

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Influences of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis: study protocol for a randomized controlled trial

Min Li, Hongwen Yuan, Pei Wang, Siyuan Xin, Jie Hao, Miaomiao Liu, Jinfeng Li, Man Yu, Xinrui Zhang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial

Pierre-Louis Henaux, Pierre-Jean Le Reste, Bruno Laviolle, Xavier Morandi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Live birth after fresh versus frozen single blastocyst transfer (Frefro-blastocyst): study protocol for a randomized controlled trial

Daimin Wei, Yun Sun, Jiayin Liu, Xiaoyan Liang, Yimin Zhu, Yuhua Shi, Zi-Jiang Chen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial

P. Daniel Patterson, Charity G. Moore, Frank X. Guyette, Jack M. Doman, Denisse Sequeira, Howard A. Werman, Doug Swanson, David Hostler, Joshua Lynch, Lindsey Russo, Linda Hines, Karen Swecker, Michael S. Runyon, Daniel J. Buysse

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A double-blind randomised controlled investigation into the efficacy of Mirococept (APT070) for preventing ischaemia reperfusion injury in the kidney allograft (EMPIRIKAL): study protocol for a randomised controlled trial

Theodoros Kassimatis, Anass Qasem, Abdel Douiri, Elizabeth G. Ryan, Irene Rebollo-Mesa, Laura L. Nichols, Roseanna Greenlaw, Jonathon Olsburgh, Richard A. Smith, Steven H. Sacks, Martin Drage

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial

Jessica C. Levenson, Bruce L. Rollman, Lee M. Ritterband, Patrick J. Strollo, Kenneth J. Smith, Jonathan G. Yabes, Charity G. Moore, Allison G. Harvey, Daniel J. Buysse

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Comparing counselling models for the hazardous use of alcohol at the Swedish National Alcohol Helpline: study protocol for a randomised controlled trial

Eleonor Säfsten, Yvonne Forsell, Mats Ramstedt, Maria Rosaria Galanti

01.12.2017 | Update | Ausgabe 1/2017 Open Access

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial

Emily J. Robinson, Laura H. Goldstein, Paul McCrone, Iain Perdue, Trudie Chalder, John D. C. Mellers, Mark P. Richardson, Joanna Murray, Markus Reuber, Nick Medford, Jon Stone, Alan Carson, Sabine Landau

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Comparing the effect of buprenorphine and methadone in the reduction of methamphetamine craving: a randomized clinical trial

Jamshid Ahmadi, Leila Razeghian Jahromi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effects of green cardamom on blood glucose indices, lipids, inflammatory factors, paraxonase-1, sirtuin-1, and irisin in patients with nonalcoholic fatty liver disease and obesity: study protocol for a randomized controlled trial

Milad Daneshi-Maskooni, Seyed Ali Keshavarz, Siavash Mansouri, Mostafa Qorbani, Seyed Moayed Alavian, Mahtab Badri-Fariman, Seyed Ali Jazayeri-Tehrani, Gity Sotoudeh

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Simulating therapeutic drug monitoring results for dose individualisation to maintain investigator blinding in a randomised controlled trial

Maia Lesosky, John Joska, Eric Decloedt

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial

Sarmila Mazumder, Sunita Taneja, Suresh Kumar Dalpath, Rakesh Gupta, Brinda Dube, Bireshwar Sinha, Kiran Bhatia, Sachiyo Yoshida, Ole Frithjof Norheim, Rajiv Bahl, Halvor Sommerfelt, Nita Bhandari, Jose Martines

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study)

Cathy Gaillard, Laure Allain, Hélène Legros, Sylvie Brucato, Yohann Desgue, Christophe Rouillon, Laure Peyro-Saint-Paul, Anne Dompmartin

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial

Elena Bignami, Marcello Guarnieri, Francesco Saglietti, Enivarco Massimo Maglioni, Sabino Scolletta, Stefano Romagnoli, Stefano De Paulis, Gianluca Paternoster, Cinzia Trumello, Roberta Meroni, Antonio Scognamiglio, Alessandro Maria Budillon, Vincenzo Pota, Alberto Zangrillo, Ottavio Alfieri

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials

Jacqueline Martin-Kerry, Peter Bower, Bridget Young, Jonathan Graffy, Rebecca Sheridan, Ian Watt, Paul Baines, Catherine Stones, Jennifer Preston, Steven Higgins, Carrol Gamble, Peter Knapp

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

A comparison of approaches for adjudicating outcomes in clinical trials

Brennan C. Kahan, Brian Feagan, Vipul Jairath

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A multicentre, randomised intervention study of the Paediatric Early Warning Score: study protocol for a randomised controlled trial

Claus Sixtus Jensen, Hanne Aagaard, Hanne Vebert Olesen, Hans Kirkegaard

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial

Youme Ko, Ho-Yeon Go, Yoon-Young Cho, Ji-Hye Shin, Tae-Hoon Kim, Dong-Jun Choi, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seong-Gyu Ko, Seung-Ho Sun, Chan-Yong Jeon

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial

Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Paredes, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H. Hamdan, Maurizio Lunati, Angel Moya, Alessio Gargaro, BIOSync Study Steering Committee

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cluster randomized trial of a mHealth intervention “ImTeCHO” to improve delivery of proven maternal, neonatal, and child care interventions through community-based Accredited Social Health Activists (ASHAs) by enhancing their motivation and strengthening supervision in tribal areas of Gujarat, India: study protocol for a randomized controlled trial

Dhiren Modi, Shrey Desai, Kapilkumar Dave, Shobha Shah, Gayatri Desai, Nishith Dholakia, Ravi Gopalan, Pankaj Shah

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Choosing the target difference (‘effect size’) for a randomised controlled trial - DELTA2 guidance protocol

Jonathan A. Cook, Steven A. Julious, William Sones, Joanne C. Rothwell, Craig R. Ramsay, Lisa V. Hampson, Richard Emsley, Stephen J. Walters, Catherine Hewitt, Martin Bland, Dean A. Fergusson, Jesse A. Berlin, Doug Altman, Luke D. Vale

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial

Tazeen H. Jafar, Imtiaz Jehan, H. Asita de Silva, Aliya Naheed, Mihir Gandhi, Pryseley Assam, Eric A. Finkelstein, Helena Legido Quigley, Marcel Bilger, Aamir Hameed Khan, John David Clemens, Shah Ebrahim, Elizabeth L. Turner, Anuradhani Kasturiratne, for COBRA-BPS Study Group

01.12.2017 | Research | Ausgabe 1/2017 Open Access

BADERI: an online database to coordinate handsearching activities of controlled clinical trials for their potential inclusion in systematic reviews

Hector Pardo-Hernandez, Gerard Urrútia, Leticia A. Barajas-Nava, Diana Buitrago-Garcia, Julieth Vanessa Garzón, María José Martínez-Zapata, Xavier Bonfill, on behalf of the Iberoamerican Cochrane Network

01.12.2017 | Update | Ausgabe 1/2017 Open Access

Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial

Lauren Bell, Richard Hooper, Catey Bunce, Saruban Pasu, James Bainbridge

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial

Peter Saunders, Vicky Tsipouri, Gregory J. Keir, Deborah Ashby, Marcus D. Flather, Helen Parfrey, Daphne Babalis, Elisabetta A. Renzoni, Christopher P. Denton, Athol U. Wells, Toby M. Maher

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients: study protocol for a randomised controlled trial

Caitlin Fehily, Kate Bartlem, John Wiggers, Paula Wye, Richard Clancy, David Castle, Sonia Wutzke, Chris Rissel, Andrew Wilson, Paul McCombie, Fionna Murphy, Jenny Bowman

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment – the RADMIS trials: study protocol for two randomized controlled trials

Maria Faurholt-Jepsen, Mads Frost, Klaus Martiny, Nanna Tuxen, Nicole Rosenberg, Jonas Busk, Ole Winther, Jakob Eyvind Bardram, Lars Vedel Kessing

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Non-inferiority versus superiority drug claims: the (not so) subtle distinction

Jitendra Ganju, Dror Rom

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Exploring patients’ treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets

Katrina M. Turner, John Percival, David Kessler, Jenny Donovan

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effects of digital Cognitive Behavioural Therapy for Insomnia on cognitive function: study protocol for a randomised controlled trial

Simon D. Kyle, Madeleine E. D. Hurry, Richard Emsley, Annemarie I. Luik, Ximena Omlin, Kai Spiegelhalder, Colin A. Espie, Claire E. Sexton

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial

Roger M. Engel, Jaxson Wearing, Peter Gonski, Subramanyam Vemulpad

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial

Mark D. Lyttle, Carrol Gamble, Shrouk Messahel, Helen Hickey, Anand Iyer, Kerry Woolfall, Amy Humphreys, Naomi E. A. Bacon, Louise Roper, Franz E. Babl, Stuart R. Dalziel, Mary Ryan, Richard E. Appleton, supported by Paediatric Emergency Research in the United Kingdom & Ireland (PERUKI)

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Improving child nutrition and development through community-based childcare centres in Malawi – The NEEP-IE study: study protocol for a randomised controlled trial

Aulo Gelli, Amy Margolies, Marco Santacroce, Katie Sproule, Sophie Theis, Natalie Roschnik, Aisha Twalibu, George Chidalengwa, Amrik Cooper, Tyler Moorhead, Melissa Gladstone, Patricia Kariger, Mangani Kutundu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Transcranial direct current stimulation for depression in Alzheimer’s disease: study protocol for a randomized controlled trial

Zui Narita, Yuma Yokoi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Bracelet- and self-directed observational therapy for control of tuberculosis: study protocol for a cluster randomized controlled trial

Ruixue Huang, Guofeng Ren, Jianan Hu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

Jun Wang, Jian Pei, Dhiaedin Khiati, Qinhui Fu, Xiao Cui, Yi Song, Minghang Yan, Lijun Shi, Yiwen Cai, Yuhong Ma

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013

Sohyun Jeong, Minji Sohn, Jae Hyun Kim, Minoh Ko, Hee-won Seo, Yun-Kyoung Song, Boyoon Choi, Nayoung Han, Han-Sung Na, Jong Gu Lee, In-Wha Kim, Jung Mi Oh, Euni Lee

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial

Chunhoo Cheon, Soobin Jang, Jeong-Su Park, Youme Ko, Doh Sun Kim, Byung Hoon Lee, Hyun Jong Song, Yun-Kyung Song, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) – standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial

Md Ali Katijjahbe, Linda Denehy, Catherine L. Granger, Alistair Royse, Colin Royse, Rebecca Bates, Sarah Logie, Sandy Clarke, Doa El-Ansary

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan Africa

Lee Aymar Ndounga Diakou, Francine Ntoumi, Philippe Ravaud, Isabelle Boutron

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of acupuncture on cerebrovascular reserve in patients with acute cerebral infarction: protocol for a randomized controlled pilot study

Shaosong Wang, Tingting Ma, Linpeng Wang, Lu Liu, Huilin Liu, Bin Li, Yuanbo Fu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial

Michael H. Livingston, Sanjay Mahant, Felix Ratjen, Bairbre L. Connolly, Kevin Thorpe, Muhammad Mamdani, Ian Maclusky, Sophie Laberge, Lucy Giglia, J. Mark Walton, Connie L. Yang, Ashley Roberts, Anna C. Shawyer, Mary Brindle, Simon J. Parsons, Cristina A. Stoian, Eyal Cohen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Ciprofloxacin for contacts of cases of meningococcal meningitis as an epidemic response: study protocol for a cluster-randomized trial

Matthew E. Coldiron, Gabriel Alcoba, Iza Ciglenecki, Matt Hitchings, Ali Djibo, Anne-Laure Page, Celine Langendorf, Rebecca F. Grais

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial

Marcos G. Lopez, Mias Pretorius, Matthew S. Shotwell, Robert Deegan, Susan S. Eagle, Jeremy M. Bennett, Bantayehu Sileshi, Yafen Liang, Brian J. Gelfand, Adam J. Kingeter, Kara K. Siegrist, Frederick W. Lombard, Tiffany M. Richburg, Dane A. Fornero, Andrew D. Shaw, Antonio Hernandez, Frederic T. Billings IV

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial

Xinghua Xu, Yi Zheng, Xiaolei Chen, Fangye Li, Huaping Zhang, Xin Ge

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial

Xinger Li, Haiyan Liu, Huiping Feng, Zhongren Xian, Yanhong Chen, Jianping Chen, Chunzhi Tang, Xinsheng Lai, Xiaoling Lan, Huanzhen Huang, Dongdong Yu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial

Jenny Yiend, Antonella Trotta, Christopher Meek, Ilvana Dzafic, Nora Baldus, Bryony Crane, Thomas Kabir, Daniel Stahl, Margaret Heslin, Sukhwinder Shergill, Philip McGuire, Emmanuelle Peters

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Depressed patients treated by homeopaths: a randomised controlled trial using the “cohort multiple randomised controlled trial” (cmRCT) design

Petter Viksveen, Clare Relton, Jon Nicholl

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Nicolle M. Krebs, Sophia I. Allen, Susan Veldheer, Diane J. Martinez, Kimberly Horn, Craig Livelsberger, Jennifer Modesto, Robin Kuprewicz, Ashley Wilhelm, Shari Hrabovsky, Abid Kazi, Alyse Fazzi, Jason Liao, Junjia Zhu, Emily Wasserman, Samantha M. Reilly, Lisa Reinhart, Neil Trushin, Robinn E. Moyer, Rebecca Bascom, Jonathan Foulds, John P. Richie Jr., Joshua E. Muscat

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of electroacupuncture combined with donepezil on cognitive function in Alzheimer’s disease patients: study protocol for a randomized controlled trial

Weina Peng, Jing Zhou, Min Xu, Qing Feng, Lulu Bin, Zhishun Liu

01.12.2017 | Research | Ausgabe 1/2017 Open Access

A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA2, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial

Nina Hermans, Anastasia Van der Auwera, Annelies Breynaert, Annelies Verlaet, Tess De Bruyne, Luc Van Gaal, Luc Pieters, Veronique Verhoeven

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

Florence Leclercq, Pierre Robert, Jessica Labour, Benoit Lattuca, Mariama Akodad, Jean-Christophe Macia, Richard Gervasoni, Francois Roubille, Thomas Gandet, Laurent Schmutz, Erika Nogue, Nicolas Nagot, Bernard Albat, Guillaume Cayla

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial

Michèle Aubin, Lucie Vézina, René Verreault, Sébastien Simard, Jean-François Desbiens, Lise Tremblay, Serge Dumont, Lise Fillion, Maman Joyce Dogba, Pierre Gagnon

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned

Olamide Ojo-Fati, Anne M. Joseph, Jed Ig-Izevbekhai, Janet L. Thomas, Susan A. Everson-Rose, Rebekah Pratt, Nancy Raymond, Ned L. Cooney, Xianghua Luo, Kolawole S. Okuyemi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial

RC. Rouchy, A. Moreau-Gaudry, E. Chipon, S. Aubry, L. Pazart, B. Lapuyade, M. Durand, M. Hajjam, S. Pottier, B. Renard, R. Logier, X. Orry, A. Cherifi, E. Quehen, G. Kervio, O. Favelle, F. Patat, E. De Kerviler, C. Hughes, M. Medici, J. Ghelfi, A. Mounier, I. Bricault

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial

Claudia Hanson, Andrea B. Pembe, Fadhlun Alwy, Susan Atuhairwe, Sebalda Leshabari, Jessica Morris, Frank Kaharuza, Gaetano Marrone, the HMS BAB study team

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression

Petter Viksveen, Clare Relton, Jon Nicholl

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial

Priya Morjaria, Andrew Bastawrous, Gudlavalleti Venkata Satyanarayana Murthy, Jennifer Evans, Clare Gilbert

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial

Mailan Liu, Qian Zhang, Shan Jiang, Mi Liu, Guoshan Zhang, Zenghui Yue, Qin Chen, Jie Zhou, Yifan Zou, Dan Li, Mingzhu Ma, Guobin Dai, Huan Zhong, Zhihong Wang, Xiaorong Chang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Right median nerve electrical stimulation for acute traumatic coma (the Asia Coma Electrical Stimulation trial): study protocol for a randomised controlled trial

Xiang Wu, Chao Zhang, Junfeng Feng, Qing Mao, Guoyi Gao, Jiyao Jiang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The efficacy of traditional acupuncture on patients with chronic neck pain: study protocol of a randomized controlled trial

Yiling Yang, Xiaoxia Yan, Hongmei Deng, Dian Zeng, Jianpeng Huang, Wenbin Fu, Nenggui Xu, Jianhua Liu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The impact of phosphate-balanced crystalloid infusion on acid-base homeostasis (PALANCE study): study protocol for a randomized controlled trial

Judith-Irina Pagel, Nikolai Hulde, Tobias Kammerer, Michaela Schwarz, Daniel Chappell, Alexander Burges, Klaus Hofmann-Kiefer, Markus Rehm

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effects of the “plate model” as part of dietary intervention on modification of selected cardiometabolic risk factors in post-myocardial infarction patients: study protocol for a randomized controlled trial

Ranil Jayawardena, Pasindu Fernando, Niroshan Lokunarangoda, Anidu Keerthi Pathirana

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial

David Fowler, Paul French, Robin Banerjee, Garry Barton, Clio Berry, Rory Byrne, Timothy Clarke, Rick Fraser, Brioney Gee, Kathryn Greenwood, Caitlin Notley, Sophie Parker, Lee Shepstone, Jon Wilson, Alison R. Yung, Joanne Hodgekins

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The impact of the time of drug administration on the effectiveness of combined treatment of hypercholesterolemia with Rosuvastatin and Ezetimibe (RosEze): study protocol for a randomized controlled trial

Karolina Obońska, Michał Kasprzak, Joanna Sikora, Ewa Obońska, Krzysztof Racki, Natalia Goździkiewicz, Magdalena Krintus, Jacek Kubica

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of aquatic physical therapy on pain perception, functional capacity and quality of life in older people with knee osteoarthritis: study protocol for a randomized controlled trial

Guilherme Eleutério Alcalde, Ana Carolina Fonseca, Thais Fernanda Bôscoa, Mirella Regina Gonçalves, Gabriele Candido Bernardo, Bruna Pianna, Bianca Ferdin Carnavale, Camila Gimenes, Silvia Regina Barrile, Eduardo Aguilar Arca

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial

Victoria Vickerstaff, Gareth Ambler, Catey Bunce, Wen Xing, Gus Gazzard, on behalf of the LiGHT Trial Study Group

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Resource implications of preparing individual participant data from a clinical trial to share with external researchers

Catrin Tudur Smith, Sarah Nevitt, Duncan Appelbe, Richard Appleton, Pete Dixon, Janet Harrison, Anthony Marson, Paula Williamson, Elizabeth Tremain

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature

Archana Soni-Jaiswal, Raj Lakhani, Claire Hopkins

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Daniel I. Schlessinger, Sanjana Iyengar, Arianna F. Yanes, Sarah G. Chiren, Victoria Godinez-Puig, Brian R. Chen, Anastasia O. Kurta, Jochen Schmitt, Stefanie Deckert, Karina C. Furlan, Emily Poon, Todd V. Cartee, Ian A. Maher, Murad Alam, Joseph F. Sobanko

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial

Victoria Nankabirwa, Thorkild Tylleskär, Josephine Tumuhamye, James K. Tumwine, Grace Ndeezi, José C. Martines, Halvor Sommerfelt

01.12.2017 | Update | Ausgabe 1/2017 Open Access

A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update

Karolina A. Wartolowska, Stephen Gerry, Benjamin G. Feakins, Gary S. Collins, Jonathan Cook, Andrew Judge, Andrew J. Carr

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial

Rathi Mahendran, Iris Rawtaer, Johnson Fam, Jonathan Wong, Alan Prem Kumar, Mihir Gandhi, Kenny Xu Jing, Lei Feng, Ee Heok Kua

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Twin–Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set

Asma Khalil, Helen Perry, James Duffy, Keith Reed, Ahmet Baschat, Jan Deprest, Kurt Hecher, Liesbeth Lewi, Enrico Lopriore, Dick Oepkes, On behalf of the International Collaboration to Harmonise Outcomes for Twin–Twin Transfusion Syndrome (CHOOSE)

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial

Martine W. F. T. Verhees, Eva Ceulemans, Marian J. Bakermans-Kranenburg, Marinus H. van IJzendoorn, Simon de Winter, Guy Bosmans

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)

Julia Wade, Daisy Elliott, Kerry N. L. Avery, Daisy Gaunt, Grace J. Young, Rebecca Barnes, Sangeetha Paramasivan, W Bruce Campbell, Jane M. Blazeby, Alison J Birtle, Rob C. Stein, David J Beard, Alison W Halliday, Jenny L. Donovan, On behalf of the ProtecT study group, CLASS study group, Chemorad study group, POUT study group, OPTIMA prelim study group, CSAW study group and ACST-2 study group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial

Christoph Schnelle, Steffen Messerschmidt, Eunice J. Minford, Kate Greenaway-Twist, Maxine Szramka, Marianna Masiorski, Michelle Sheldrake, Mark Jones

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial

Susanne Vahr Lauridsen, Thordis Thomsen, Peter Thind, Hanne Tønnesen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS])

Abda Mahmood, Ian Roberts, Haleema Shakur

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial

Moleen Zunza, Mark F. Cotton, Lawrence Mbuagbaw, Richard Lester, Lehana Thabane

01.12.2017 | Letter | Ausgabe 1/2017 Open Access

Short-term impact of celebrating the international clinical trial day: experience from Ethiopia

Abebaw Fekadu, Asrat Hailu, Eyasu Makonnen, Anteneh Belete, Getnet Yimer

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Association of the FDA Amendment Act with trial registration, publication, and outcome reporting

Adam T. Phillips, Nihar R. Desai, Harlan M. Krumholz, Constance X. Zou, Jennifer E. Miller, Joseph S. Ross

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients’ adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial

Zuzana Haramiova, Michal Stasko, Martin Hulin, Tomas Tesar, Magdalena Kuzelova, Donald M. Morisky

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Blockchain technology for improving clinical research quality

Mehdi Benchoufi, Philippe Ravaud

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol

Joel J. Gagnier, Matthew J. Page, Hsiaomin Huang, Arianne P. Verhagen, Rachelle Buchbinder

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Birth weight differences between those offered financial voucher incentives for verified smoking cessation and control participants enrolled in the Cessation in Pregnancy Incentives Trial (CPIT), employing an intuitive approach and a Complier Average Causal Effects (CACE) analysis

Alex McConnachie, Caroline Haig, Lesley Sinclair, Linda Bauld, David M. Tappin

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of insulin therapy and dietary adjustments on safety and performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized controlled trial

Javier Calvo-Marín, Gabriel Torrealba-Acosta, Matthew Campbell, Jesse Gaboury, Ajmol Ali, Chih Hao Chen-Ku

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial

Kelly L. Hayward, Jennifer H. Martin, W. Neil Cottrell, Antara Karmakar, Leigh U. Horsfall, Preya J. Patel, David D. Smith, Katharine M. Irvine, Elizabeth E. Powell, Patricia C. Valery

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Helen Rodgers, Lisa Shaw, Helen Bosomworth, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L. Cohen, Jesse Dawson, Janet Eyre, Tracy Finch, Gary A. Ford, Jennifer Hislop, Steven Hogg, Denise Howel, Niall Hughes, Hermano Igo Krebs, Christopher Price, Lynn Rochester, Elaine Stamp, Laura Ternent, Duncan Turner, Luke Vale, Elizabeth Warburton, Frederike van Wijck, Scott Wilkes

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The effect of using social pressure in cover letters to improve retention in a longitudinal health study: an embedded randomised controlled retention trial

Sarah Cotterill, Kelly Howells, Sarah Rhodes, Peter Bower

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial

Jane Gunn, Caroline Wachtler, Susan Fletcher, Sandra Davidson, Cathrine Mihalopoulos, Victoria Palmer, Kelsey Hegarty, Amy Coe, Elizabeth Murray, Christopher Dowrick, Gavin Andrews, Patty Chondros

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness and cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children (The BEEP trial): protocol for a randomised controlled trial

Joanne R. Chalmers, Rachel H. Haines, Eleanor J. Mitchell, Kim S. Thomas, Sara J. Brown, Matthew Ridd, Sandra Lawton, Eric L. Simpson, Michael J. Cork, Tracey H. Sach, Lucy E. Bradshaw, Alan A. Montgomery, Robert J. Boyle, Hywel C. Williams

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Collaborative care for depression in general practice: study protocol for a randomised controlled trial

Ursula Ødum Brinck-Claussen, Nadja Kehler Curth, Annette Sofie Davidsen, John Hagel Mikkelsen, Marianne Engelbrecht Lau, Merete Lundsteen, Claudio Csillag, Kaj Sparle Christensen, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial

Marcela Perdomo Rodrigues, Luciana Kaercher John dos Santos, Flavio Danni Fuchs, Sandra Costa Fuchs, Leila Beltrami Moreira

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs

S. Raymond Golish

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial

Augustine T. Choko, Katherine Fielding, Nigel Stallard, Hendramoorthy Maheswaran, Aurelia Lepine, Nicola Desmond, Moses K. Kumwenda, Elizabeth L. Corbett

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair – Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial

Iain Keith Moppett, Stuart White, Richard Griffiths, Donal Buggy

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Behavioral weight-loss treatment plus motivational interviewing versus attention control: lessons learned from a randomized controlled trial

Erin L. Moss, Leah N. Tobin, Tavis S. Campbell, Kristin M. von Ranson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial

Salla Atkins, Ulla Ojajärvi, Nina Talola, Mervi Viljamaa, Jaakko Nevalainen, Jukka Uitti

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial: study protocol for a phase II/III randomised controlled trial

Jamie B. Oughton, Laura Collett, Dena R. Howard, Anna Hockaday, Talha Munir, Kathryn McMahon, Lucy McParland, Claire Dimbleby, David Phillips, Andy C. Rawstron, Peter Hillmen

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Self-declared stock ownership and association with positive trial outcome in randomized controlled trials with binary outcomes published in general medical journals: a cross-sectional study

Alberto Falk Delgado, Anna Falk Delgado

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial

Xuyang Yang, Qingbin Wu, Chengwu Jin, Wanbin He, Meng Wang, Tinghan Yang, Mingtian Wei, Xiangbing Deng, Wenjian Meng, Ziqiang Wang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation

I. van de Glind, C. Bunn, C. M. Gray, K. Hunt, E. Andersen, J. Jelsma, H. Morgan, H. Pereira, G. Roberts, J. Rooksby, Ø. Røynesdal, M. Silva, M. Sorensen, S. Treweek, T. van Achterberg, H. van der Ploeg, F. van Nassau, M. Nijhuis-van der Sanden, S. Wyke

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Evaluation of a bespoke training to increase uptake by midwifery teams of NICE Guidance for membrane sweeping to reduce induction of labour: a stepped wedge cluster randomised design

Sara Kenyon, Sophie Dann, Lucy Hope, Paula Clarke, Amanda Hogan, David Jenkinson, Karla Hemming

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial

Dominik Buckert, Simon Witzel, Maciej Cieslik, Raid Tibi, Wolfgang Rottbauer, Peter Bernhardt

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Daniel I. Schlessinger, Sanjana Iyengar, Arianna F. Yanes, Jill K. Henley, Hovik J. Ashchyan, Anastasia O. Kurta, Payal M. Patel, Umar A. Sheikh, Matthew J. Franklin, Courtney C. Hanna, Brian R. Chen, Sarah G. Chiren, Jochen Schmitt, Stefanie Deckert, Karina C. Furlan, Emily Poon, Ian A. Maher, Todd V. Cartee, Joseph F. Sobanko, Murad Alam

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Barriers to the conduct of randomised clinical trials within all disease areas

Snezana Djurisic, Ana Rath, Sabrina Gaber, Silvio Garattini, Vittorio Bertele, Sandra-Nadia Ngwabyt, Virginie Hivert, Edmund A. M. Neugebauer, Martine Laville, Michael Hiesmayr, Jacques Demotes-Mainard, Christine Kubiak, Janus C. Jakobsen, Christian Gluud

01.12.2017 | Research | Ausgabe 1/2017 Open Access

‘We knew it was a totally at random thing’: parents’ experiences of being part of a neonatal trial

Merryl Harvey, Phumza Nongena, David Edwards, Maggie Redshaw

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Pulsed radiofrequency or anterior neurectomy for anterior cutaneous nerve entrapment syndrome (ACNES) (the PULSE trial): study protocol of a randomized controlled trial

Robbert C. Maatman, Monique A. H. Steegers, Oliver B. A. Boelens, Toine C. Lim, Hans J. van den Berg, Sandra A. S. van den Heuvel, Marc R. M. Scheltinga, Rudi M. H. Roumen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Measurement, Education and Tracking in Integrated Care (METRIC): use of a culturally adapted education tool versus standard education to increase engagement in depression treatment among Hispanic patients: study protocol for a randomized control trial

Katherine Sanchez, Brittany H. Eghaneyan, Michael O. Killian, Leopoldo Cabassa, Madhukar H. Trivedi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Measuring the effect of nurse practitioner (NP)-led care on health-related quality of life in adult patients with atrial fibrillation: study protocol for a randomized controlled trial

Marcie J. Smigorowsky, Colleen M. Norris, Micheal Sean McMurtry, Ross T. Tsuyuki

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial

Richard A. Van Dorn, Sarah L. Desmarais, Candalyn B. Rade, Elizabeth N. Burris, Gary S. Cuddeback, Kiersten L. Johnson, Stephen J. Tueller, Megan L. Comfort, Kim T. Mueser

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study

Aliki Tsichlaki, Kevin O’Brien, Ama Johal, Zoe Marshman, Philip Benson, Fiorella B. Colonio Salazar, Padhraig S. Fleming

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial

John Hustedt, Dyna Doum, Vanney Keo, Sokha Ly, BunLeng Sam, Vibol Chan, Neal Alexander, John Bradley, Didot Budi Prasetyo, Agus Rachmat, Shafique Muhammad, Sergio Lopes, Rithea Leang, Jeffrey Hii

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

To evaluate if increased supervision and support of South African Government health workers’ home visits improves maternal and child outcomes: study protocol for a randomized control trial

Mary Jane Rotheram-Borus, Karl Le Roux, Ingrid M. Le Roux, Joan Christodoulou, Christina Laurenzi, Nokwanele Mbewu, Mark Tomlinson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of a low-fructose and/or low-sucrose diet in decreasing insulin resistance (DISFRUTE study): study protocol for a randomized controlled trial

Santiago Domínguez Coello, Lourdes Carrillo Fernández, Jesús Gobierno Hernández, Manuel Méndez Abad, Carlos Borges Álamo, José Antonio García Dopico, Armando Aguirre Jaime, Antonio Cabrera de León, the DISFRUTE Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study)

Bilal Alkhaffaf, Anne-Marie Glenny, Jane M. Blazeby, Paula Williamson, Iain A. Bruce

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

Louise K. Hoeffding, Maria Haahr Nielsen, Morten A. Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K. Kjær, Kristoffer Sølvsten Burgdorf, Kirsten Jensen Quas, Trine Schow

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial

Lide Arenaza, María Medrano, María Amasene, Beatriz Rodríguez-Vigil, Ignacio Díez, Manuel Graña, Ignacio Tobalina, Edurne Maiz, Edurne Arteche, Eider Larrarte, Inge Huybrechts, Catherine L. Davis, Jonatan R. Ruiz, Francisco B. Ortega, Javier Margareto, Idoia Labayen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study

Florent Besnier, Jean-Michel Sénard, Vincent Grémeaux, Mélanie Riédel, Damien Garrigues, Thibaut Guiraud, Marc Labrunée

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Using smartphones to decrease substance use via self-monitoring and recovery support: study protocol for a randomized control trial

Christy K Scott, Michael L. Dennis, David H. Gustafson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial

Zoltán Ruszkai, Erika Kiss, Ildikó László, Fanni Gyura, Erika Surány, Péter Töhötöm Bartha, Gergely Péter Bokrétás, Edit Rácz, István Buzogány, Zoltán Bajory, Erzsébet Hajdú, Zsolt Molnár

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The influence of 3 months of physical exercises and verbal stimulation on functional efficiency and use of free time in an older population under institutional care: study protocol for a randomized controlled trial

Agnieszka Wiśniowska-Szurlej, Agnieszka Ćwirlej-Sozańska, Anna Wilmowska-Pietruszyńska, Natalia Milewska, Bernard Sozański

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of acupuncture and its influence on cerebral activity in perimenopausal insomniacs: study protocol for a randomized controlled trial

Xiao Wu, Wei Zhang, Yuanyuan Qin, Xuguang Liu, Zhengyan Wang

01.12.2017 | Research | Ausgabe 1/2017 Open Access

The impact of active stakeholder involvement on recruitment, retention and engagement of schools, children and their families in the cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP): a school-based intervention to prevent obesity

J. Lloyd, C. McHugh, J. Minton, H. Eke, K. Wyatt

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial

Babalola Faseru, Edward F. Ellerbeck, Delwyn Catley, Byron J. Gajewski, Taneisha S. Scheuermann, Theresa I. Shireman, Laura M. Mussulman, Niaman Nazir, Terry Bush, Kimber P. Richter

01.12.2017 | Research | Ausgabe 1/2017 Open Access

A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) – one-year results of a pre-maturely terminated study

Thomas Zeller, Hans Krankenberg, Andrejs Erglis, Erwin Blessing, Torsten Fuss, Dierk Scheinert, Ralf Weser, Beatrix B. Doerr, Wilfrid D. Yollo, Joerg Radermacher, for the RADAR Investigators

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Understanding the cluster randomised crossover design: a graphical illustration of the components of variation and a sample size tutorial

Sarah J. Arnup, Joanne E. McKenzie, Karla Hemming, David Pilcher, Andrew B. Forbes

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials

Nadja Kehler Curth, Ursula Ødum Brinck-Claussen, Annette Sofie Davidsen, Marianne Engelbrecht Lau, Merete Lundsteen, John Hagel Mikkelsen, Claudio Csillag, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland’s public sector health system: study protocol for a stepped-wedge randomized trial

Fiona J. Walsh, Till Bärnighausen, Wim Delva, Yvette Fleming, Gavin Khumalo, Charlotte L. Lejeune, Sikhathele Mazibuko, Charmaine Khudzie Mlambo, Ria Reis, Donna Spiegelman, Mandisa Zwane, Velephi Okello

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial

Pazit Levinger, Jeremy Dunn, Nancy Bifera, Michael Butson, George Elias, Keith D. Hill

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Oral hygiene in intensive care unit patients with photodynamic therapy: study protocol for randomised controlled trial

Gabriela Alves Da Collina, Anna Carolina Ratto Tempestini-Horliana, Daniela de Fátima Teixeira da Silva, Priscila Larcher Longo, Maria Luisa Faria Makabe, Christiane Pavani

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial

Wei Hao, Sheng Liu, Yuenong Qin, Chenping Sun, Liying Chen, Chunyu Wu, Yijia Bao

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Assessment of ibrutinib plus rituximab in front-line CLL (FLAIR trial): study protocol for a phase III randomised controlled trial

Laura Collett, Dena R. Howard, Talha Munir, Lucy McParland, Jamie B. Oughton, Andy C. Rawstron, Anna Hockaday, Claire Dimbleby, David Phillips, Kathryn McMahon, Claire Hulme, David Allsup, Adrian Bloor, Peter Hillmen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT’ID study protocol for using a Delphi process and face-to-face meetings to establish consensus

Kathryn Fackrell, Harriet Smith, Veronica Colley, Brian Thacker, Adele Horobin, Haúla F. Haider, Alain Londero, Birgit Mazurek, Deborah A. Hall

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access

G. A. Powell, L. J. Bonnett, C. Tudur-Smith, D. A. Hughes, P. R. Williamson, A. G. Marson

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial

Charlotte S. Loozen, Hjalmar C. van Santvoort, Antoinette A. W. van Geloven, Grard A. P. Nieuwenhuijzen, Philip R. de Reuver, Mark H. G. Besselink, Bart Vlaminckx, Johannes C. Kelder, Catherijne A. J. Knibbe, Djamila Boerma

01.12.2017 | Update | Ausgabe 1/2017 Open Access

The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP)

Fiona Boland, Michael Quirke, Brenda Gannon, Sinead Plunkett, John Hayden, John McCourt, Ronan O’Sullivan, Joseph Eustace, Conor Deasy, Abel Wakai

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (HAND-1): study protocol for a randomised controlled trial

Eleanor Harrison, Wei Tan, Nicola Mills, Alexia Karantana, Kirsty Sprange, Lelia Duley, Daisy Elliott, Jane Blazeby, William Hollingworth, Alan A. Montgomery, Tim Davis

01.12.2017 | Research | Ausgabe 1/2017 Open Access

A large cluster randomized trial of outcome-based pathways to improve home-based wound care

Merrick Zwarenstein, Salimah Shariff, Nicole Mittmann, Anita Stern, Katie N. Dainty

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial

Nick J. Battersby, Mit Dattani, Sheela Rao, David Cunningham, Diana Tait, Richard Adams, Brendan J. Moran, Shelize Khakoo, Paris Tekkis, Shahnawaz Rasheed, Alex Mirnezami, Philip Quirke, Nicholas P. West, Iris Nagtegaal, Irene Chong, Anguraj Sadanandam, Nicola Valeri, Karen Thomas, Michelle Frost, Gina Brown

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial

Alieske E. H. Dam, Marjolein E. de Vugt, Martin P. J. van Boxtel, Frans R. J. Verhey

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial

Wolfgang Geidl, Jana Semrau, René Streber, Nicola Lehbert, Silke Wingart, Alexander Tallner, Michael Wittmann, Rupert Wagner, Konrad Schultz, Klaus Pfeifer

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson’s disease

Patricia Masterson-Algar, Christopher R. Burton, Marian C. Brady, Avril Nicoll, Carl E. Clarke, Caroline Rick, Max Hughes, Pui Au, Christina H. Smith, Catherine M. Sackley

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial

Rebecca Asadpour, Kerstin A. Kessel, Tom Bruckner, Serkan Sertel, Stephanie E. Combs

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH): study protocol for a pilot randomised controlled trial

Stephen P. J. Macdonald, David McD Taylor, Gerben Keijzers, Glenn Arendts, Daniel M. Fatovich, Frances B. Kinnear, Simon G. A. Brown, Rinaldo Bellomo, Sally Burrows, John F. Fraser, Edward Litton, Juan Carlos Ascencio-Lane, Matthew Anstey, David McCutcheon, Lisa Smart, Ioana Vlad, James Winearls, Bradley Wibrow

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Influence of motor skills training on children’s development evaluated in the Motor skills in PreSchool (MiPS) study-DK: study protocol for a randomized controlled trial, nested in a cohort study

Lise Hestbaek, Sarah Thurøe Andersen, Thomas Skovgaard, Line Groenholt Olesen, Mette Elmose, Dorthe Bleses, Simon Calmar Andersen, Henrik Hein Lauridsen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial

Barnaby C. Reeves, Lazaros Andronis, Jane M. Blazeby, Natalie S. Blencowe, Melanie Calvert, Joanna Coast, Tim Draycott, Jenny L. Donovan, Rachael Gooberman-Hill, Robert J. Longman, Laura Magill, Jonathan M. Mathers, Thomas D. Pinkney, Chris A. Rogers, Leila Rooshenas, Andrew Torrance, Nicky J. Welton, Mark Woodward, Kate Ashton, Katarzyna D. Bera, Gemma L. Clayton, Lucy A. Culliford, Jo C. Dumville, Daisy Elliott, Lucy Ellis, Hannah Gould-Brown, Rhiannon C. Macefield, Christel McMullan, Caroline Pope, Dimitrios Siassakos, Sean Strong, Helen Talbot, The Bluebelle Study Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial

Roderick W. Treskes, Willem Gielen, Marieke J. Wermer, Robert W. Grauss, Anouk P. van Alem, Reza Alizadeh Dehnavi, Charles J. Kirchhof, Enno T. van der Velde, Arie C. Maan, Ron Wolterbeek, Onno M. Overbeek, Martin J. Schalij, Serge A. Trines

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Ultra-low dose of rituximab in rheumatoid arthritis: study protocol for a randomised controlled trial

Alfons A. den Broeder, Lise M. Verhoef, Jaap Fransen, Rogier Thurlings, Bart J. F. van den Bemt, Steven Teerenstra, Nadine Boers, Nathan den Broeder, Frank H. J. van den Hoogen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Targeted anti-staphylococcal therapy with endolysins in atopic dermatitis and the effect on steroid use, disease severity and the microbiome: study protocol for a randomized controlled trial (MAAS trial)

Joan Totté, Jill de Wit, Luba Pardo, Frank Schuren, Martijn van Doorn, Suzanne Pasmans

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Synergistic effects of aerobic exercise and cognitive training on cognition, physiological markers, daily function, and quality of life in stroke survivors with cognitive decline: study protocol for a randomized controlled trial

Ting-ting Yeh, Ching-yi Wu, Yu-wei Hsieh, Ku-chou Chang, Lin-chien Lee, Jen-wen Hung, Keh-chung Lin, Ching-hung Teng, Yi-han Liao

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Identifying research priorities for effective retention strategies in clinical trials

Anna Kearney, Anne Daykin, Alison R. G. Shaw, Athene J. Lane, Jane M. Blazeby, Mike Clarke, Paula Williamson, Carrol Gamble

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study

Aliki Tsichlaki, Kevin O’Brien, Ama Johal, Zoe Z. Marshman, Philip P. Benson, Fiorella B. Colonio Salazar, Padhraig S. Fleming

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis

Liliana López, Martha Robayo, Margarita Vargas, Iván D. Vélez

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial

Zhibao Mi, Kousick Biswas, J. Kaci Fairchild, Anne Davis-Karim, Ciaran S. Phibbs, Steven D. Forman, Michael Thase, Gerald Georgette, Tamara Beale, David Pittman, Margaret Windy McNerney, Allyson Rosen, Grant D. Huang, Mark George, Art Noda, Jerome A. Yesavage

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Intraoperative wound irrigation to prevent surgical site infection after laparotomy (IOWISI): study protocol for a randomized controlled trial

Tara C. Mueller, Ulrich Nitsche, Victoria Kehl, Rebekka Schirren, Beate Schossow, Ruediger Goess, Helmut Friess, Daniel Reim, on behalf of the IOWISI Study Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of maternal vitamin D3 supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial

Christopher R. Sudfeld, Karim P. Manji, Christopher P. Duggan, Said Aboud, Alfa Muhihi, David M. Sando, Fadhlun M. Alwy Al-beity, Molin Wang, Wafaie W. Fawzi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial

Aulo Gelli, Elodie Becquey, Rasmane Ganaba, Derek Headey, Melissa Hidrobo, Lieven Huybregts, Hans Verhoef, Romain Kenfack, Sita Zongouri, Hannah Guedenet

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial

Elis Forcellini Pedrollo, Bruna Bellincanta Nicoletto, Larissa Salomoni Carpes, Júlia de Melo Cardoso de Freitas, Julia Roberta Buboltz, Cristina Carra Forte, Andrea Carla Bauer, Roberto Ceratti Manfro, Gabriela Corrêa Souza, Cristiane Bauermann Leitão

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

Louise K. Hoeffding, Maria Haahr Nielsen, Morten A. Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K. Kjær, Kristoffer Sølvsten Burgdorf, Kirsten Jensen Quas, Trine Schow

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Jigsaw Puzzles As Cognitive Enrichment (PACE) - the effect of solving jigsaw puzzles on global visuospatial cognition in adults 50 years of age and older: study protocol for a randomized controlled trial

Patrick Fissler, Olivia C. Küster, Laura S. Loy, Daria Laptinskaya, Martin J. Rosenfelder, Christine A. F. von Arnim, Iris-Tatjana Kolassa

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial

Philip Ayieko, Grace Irimu, Mike English

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

General Anesthesia versus Local Anesthesia in StereotaXY (GALAXY) for Parkinson’s disease: study protocol for a randomized controlled trial

R. A. Holewijn, D. Verbaan, R. M. A. de Bie, P. R. Schuurman

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India

Jonathon D. Gass Jr., Anamika Misra, Mahendra Nath Singh Yadav, Fatima Sana, Chetna Singh, Anup Mankar, Brandon J. Neal, Jennifer Fisher-Bowman, Jenny Maisonneuve, Megan Marx Delaney, Krishan Kumar, Vinay Pratap Singh, Narender Sharma, Atul Gawande, Katherine Semrau, Lisa R. Hirschhorn

01.12.2017 | Erratum | Ausgabe 1/2017 Open Access

Erratum to: Attention training for infants at familial risk of ADHD (INTERSTAARS): study protocol for a randomised controlled trial

Amy Goodwin, Simona Salomone, Patrick Bolton, Tony Charman, Emily J.H. Jones, Luke Mason, Andrew Pickles, Emily Robinson, Tim Smith, Edmund J.S. Sonuga-Barke, Sam Wass, Mark H. Johnson

01.12.2017 | Methodology | Ausgabe 1/2017 Open Access

Bayesian dose selection design for a binary outcome using restricted response adaptive randomization

Caitlyn Meinzer, Renee Martin, Jose I. Suarez

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial

Jeanne Trill, Catherine Simpson, Frances Webley, Mike Radford, Louise Stanton, Tom Maishman, Angeliki Galanopoulou, Andrew Flower, Caroline Eyles, Merlin Willcox, Alastair Hay, Gareth Griffiths, Paul Little, George Lewith, Michael Moore

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Alexandra Sawyer, Celine Chhoa, Susan Ayers, Angela Pushpa-Rajah, Lelia Duley

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Caroline Hurley, Carol Sinnott, Mike Clarke, Patricia Kearney, Emmy Racine, Joseph Eustace, Frances Shiely

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial

Alicja Kołodziejczyk, Maria K. Borszewska-Kornacka, Joanna Seliga-Siwecka

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

Martine Laville, Berenice Segrestin, Maud Alligier, Cristina Ruano-Rodríguez, Lluis Serra-Majem, Michael Hiesmayr, Annemie Schols, Carlo La Vecchia, Yves Boirie, Ana Rath, Edmund A. M. Neugebauer, Silvio Garattini, Vittorio Bertele, Christine Kubiak, Jacques Demotes-Mainard, Janus C. Jakobsen, Snezana Djurisic, Christian Gluud

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial

Misericòrdia Carles, Montserrat Martínez-Alonso, Anna Pons, Maria José Pérez-Lacasta, Lilisbeth Perestelo-Pérez, Maria Sala, Carmen Vidal, Montse Garcia, Ana Toledo-Chávarri, Núria Codern, Maria Feijoo-Cid, Anabel Romero, Roger Pla, Jorge Soler-González, Xavier Castells, Montserrat Rué, on behalf of the InforMa Group

01.12.2017 | Review | Ausgabe 1/2017 Open Access

Specific barriers to the conduct of randomised clinical trials on medical devices

Edmund A. M. Neugebauer, Ana Rath, Sunya-Lee Antoine, Michaela Eikermann, Doerthe Seidel, Carsten Koenen, Esther Jacobs, Dawid Pieper, Martine Laville, Séverine Pitel, Cecilia Martinho, Snezana Djurisic, Jacques Demotes-Mainard, Christine Kubiak, Vittorio Bertele, Janus C. Jakobsen, Silvio Garattini, Christian Gluud

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial

Yu-zheng Du, Xin-xin Gao, Cheng-Ting Wang, Hai-zhen Zheng, Yun Lei, Meng-han Wu, Xue-min Shi, Hai-peng Ban, Wen-long Gu, Xiang-gang Meng, Mao-ti Wei, Chun-xiao Hu

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A randomized phase II study to assess the effect of adjuvant immunotherapy using α-GalCer-pulsed dendritic cells in the patients with completely resected stage II–IIIA non-small cell lung cancer: study protocol for a randomized controlled trial

Hideo Saka, Chiyoe Kitagawa, Yukito Ichinose, Mitsuhiro Takenoyama, Hidenori Ibata, Tatsuo Kato, Koji Takami, Motohiro Yamashita, Tadashi Maeda, Sadanori Takeo, Hitoshi Ueda, Kan Okabayashi, Seiji Nagashima, Tadayuki Oka, Hidenori Kouso, Seiichi Fukuyama, Kentaro Yoshimoto, Mototsugu Shimokawa, Akiko M. Saito, Suminobu Ito

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effect of a mother’s recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial

Seok Young Song, Sang Gyu Kwak, Eugene Kim

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

TIGA-CUB – manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5–11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial

Elizabeth Edginton, Rebecca Walwyn, Kayleigh Burton, Robert Cicero, Liz Graham, Sadie Reed, Sandy Tubeuf, Maureen Twiddy, Alex Wright-Hughes, Lynda Ellis, Dot Evans, Tom Hughes, Nick Midgley, Paul Wallis, David Cottrell

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial

Sudhin Thayyil, Vania Oliveira, Peter J. Lally, Ravi Swamy, Paul Bassett, Mani Chandrasekaran, Jayashree Mondkar, Sundaram Mangalabharathi, Naveen Benkappa, Arasar Seeralar, Mohammod Shahidullah, Paolo Montaldo, Jethro Herberg, Swati Manerkar, Kumutha Kumaraswami, Chinnathambi Kamalaratnam, Vinayagam Prakash, Rema Chandramohan, Prathik Bandya, Mohammod Abdul Mannan, Ranmali Rodrigo, Mohandas Nair, Siddarth Ramji, Seetha Shankaran, for the HELIX Trial group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A primary school active break programme (ACTI-BREAK): study protocol for a pilot cluster randomised controlled trial

Amanda Watson, Anna Timperio, Helen Brown, Kylie D. Hesketh

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial

N. Chaillet, E. Bujold, B. Masse, W. A. Grobman, P. Rozenberg, J. C. Pasquier, A. Shorten, M. Johri, F. Beaudoin, H. Abenhaim, S. Demers, W. Fraser, M. Dugas, S. Blouin, E. Dubé, R. Gauthier, PRISMA Trial Research Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Topiramate’s effectiveness on weight reduction in overweight/obese persons with schizophrenia: study protocol for a randomized controlled trial

Miyuru Chandradasa, Layani Champika, Silumini de Silva, K. A. L. A. Kuruppuarachchi

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Core outcomes in periodontal trials: study protocol for core outcome set development

Thomas J. Lamont, Jan E. Clarkson, David N. J. Ricketts, Peter A. Heasman, Craig R. Ramsay

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial

Zhangqi Lai, Xueqiang Wang, Seullee Lee, Xihe Hou, Lin Wang

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial

Sarah Eichler, Sophie Rabe, Annett Salzwedel, Steffen Müller, Josefine Stoll, Nina Tilgner, Michael John, Karl Wegscheider, Frank Mayer, Heinz Völler, on behalf of the ReMove-It study group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial

Sanghyun Ahn, Joongyub Lee, Seung-Kee Min, Jongwon Ha, Sang-il Min, Song-Yi Kim, Min-Ji Cho, Sungsin Cho, SAFE study investigators

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Conducting non-commercial international clinical trials: the ICR-CTSU experience

Lisa Fox, Christy Toms, Sarah Kernaghan, Claire Snowdon, Judith M. Bliss

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

An education intervention to improve health literacy and decision making about supporting self-care among older Australians: a study protocol for a randomised controlled trial

Caroline A. Smith, Esther Chang, Gisselle Gallego, Lynda G. Balneaves

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial

Janine Bates, Nick A. Francis, Patrick White, David Gillespie, Emma Thomas-Jones, Rachel Breen, Nigel Kirby, Kerry Hood, Micaela Gal, Rhiannon Phillips, Gurudutt Naik, Jochen Cals, Carl Llor, Hasse Melbye, Mandy Wootton, Evgenia Riga, Ann Cochrane, Robin Howe, Deborah Fitzsimmons, Bernadette Sewell, Mohammed Fasihul Alam, Christopher C. Butler

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial

Marleen Kunneman, Megan E. Branda, Peter A. Noseworthy, Mark Linzer, Bruce Burnett, Sara Dick, Gabriela Spencer-Bonilla, Cara A. Fernandez, Haeshik Gorr, Mike Wambua, Shelly Keune, Claudia Zeballos-Palacios, Ian Hargraves, Nilay D. Shah, Victor M. Montori

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Clinical features of Parkinson’s disease patients are associated with therapeutic misconception and willingness to participate in clinical trials

Emmi Reijula, Anna-Maija Pietilä, Arja Halkoaho, Tuomas Selander, Kirsti Martikainen, Reetta Kälviäinen, Tapani Keränen

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

TAILOR – tapered discontinuation versus maintenance therapy of antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder in remission of psychotic symptoms: study protocol for a randomized clinical trial

Anne Emilie Stürup, Heidi Dorthe Jensen, Signe Dolmer, Merete Birk, Nikolai Albert, Mai Nielsen, Carsten Hjorthøj, Lene Eplov, Bjørn H. Ebdrup, Ole Mors, Merete Nordentoft

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial

Priyanga Ranasinghe, Priyadarshani Galappaththy, Godwin Roger Constantine, Ranil Jayawardena, Hasitha Dhananjaya Weeratunga, Sirimal Premakumara, Prasad Katulanda

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial

Joseph D. Tucker, SESH Study Group

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial

Dziedzom K. de Souza, Collins S. Ahorlu, Susan Adu-Amankwah, Joseph Otchere, Sedzro K. Mensah, Irene A. Larbi, George E. Mensah, Nana-Kwadwo Biritwum, Daniel A. Boakye

01.12.2017 | Commentary | Ausgabe 1/2017 Open Access

Health research participants are not receiving research results: a collaborative solution is needed

Christopher R. Long, M. Kathryn Stewart, Pearl A. McElfish

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Co-trimoxazole versus azithromycin for the treatment of undifferentiated febrile illness in Nepal: study protocol for a randomized controlled trial

Sunil Pokharel, Buddha Basnyat, Amit Arjyal, Saruna Pathak Mahat, Raj Kumar KC, Abhusani Bhuju, Buddhi Poudyal, Evelyne Kestelyn, Ritu Shrestha, Dung Nguyen Thi Phuong, Rajkumar Thapa, Manan Karki, Sabina Dongol, Abhilasha Karkey, Marcel Wolbers, Stephen Baker, Guy Thwaites

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Efficacy of a multi-component exercise programme and nutritional supplementation on musculoskeletal health in men treated with androgen deprivation therapy for prostate cancer (IMPACT): study protocol of a randomised controlled trial

Patrick J. Owen, Robin M. Daly, Patricia M. Livingston, Niamh L. Mundell, Jack Dalla Via, Jeremy L. Millar, Steve F. Fraser

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Effectiveness of two web-based cognitive bias modification interventions targeting approach and attentional bias in gambling problems: study protocol for a pilot randomised controlled trial

Marilisa Boffo, Ronny Willemen, Thomas Pronk, Reinout W. Wiers, Geert Dom

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial

Lingyun Lu, Hui Zheng, Qianhua Zheng, Xinyu Hao, Siyuan Zhou, Shusen Zhang, Tao Wei, Tao Gao, Duoxi Duan, Ling Zhao, Ning Li, Ying Li

01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

An intervention delivered by text message to increase the acceptability of effective contraception among young women in Palestine: study protocol for a randomised controlled trial

Ona L McCarthy, Ola Wazwaz, Iman Jado, Baptiste Leurent, Phil Edwards, Samia Adada, Amina Stavridis, Caroline Free

01.12.2017 | Update | Ausgabe 1/2017 Open Access

Statistical analysis plan for the Urodynamics for