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Zeitschrift

Trials

Trials 1/2020

Ausgabe 1/2020

Inhaltsverzeichnis ( 984 Artikel )

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study

Aliza Werner-Seidler, Kit Huckvale, Mark E. Larsen, Alison L. Calear, Kate Maston, Lara Johnston, Michelle Torok, Bridianne O’Dea, Philip J. Batterham, Susanne Schweizer, S. Rachel Skinner, Katharine Steinbeck, Julie Ratcliffe, Ju-Lee Oei, George Patton, Iana Wong, Joanne Beames, Quincy J. J. Wong, Raghu Lingam, Katherine Boydell, Allison M. Salmon, Nicole Cockayne, Andrew Mackinnon, Helen Christensen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial)

Henrik Riel, Bill Vicenzino, Jens Lykkegaard Olesen, Martin Bach Jensen, Lars Holger Ehlers, Michael Skovdal Rathleff

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people

K. Khan, C. Hollis, C. L. Hall, E. B. Davies, D. Mataix-Cols, P. Andrén, T. Murphy, B. J. Brown, E. Murray, C. Glazebrook

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Hani A. Aziz Jokhdar, Adel Alothman, Hanan H. Balkhy, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Ziad A. Memish, Sameeh Ghazal, Sarah Al Faraj, Fahad Al-Hameed, Asim AlSaedi, Yasser Mandourah, Ghaleb A. Al Mekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Abdullah Almotairi, Ali Al Bshabshe, Ayman Kharaba, Jesna Jose, Abdulrahman Al Harthy, Mohammed Al Sulaiman, Ahmed Mady, Robert A. Fowler, Frederick G. Hayden, Abdulaziz Al-Dawood, Mohamed Abdelzaher, Wail Bajhmom, Mohamed A. Hussein, and the Saudi Critical Care Trials group

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Estimating dose-response for time to remission with instrumental variable adjustment: the obscuring effects of drug titration in Genome Based Therapeutic Drugs for Depression Trial (GENDEP): clinical trial data

Jennifer Hellier, Richard Emsley, Andrew Pickles

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of sang-qi granules on blood pressure and endothelial dysfunction in stage I or II hypertension: study protocol for a randomized double-blind double-simulation controlled trial

Haoyue Shi, Deshuang Yang, Jiajun Qiao, Rui Sun, Ruihan Li, Chunlin Zhu, Ruiqing Jing, Liping Liu, Li Huang, Lin Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial

Fiona Gaughran, Dominic Stringer, Michael Berk, Shubulade Smith, David Taylor, Eromona Whiskey, Sabine Landau, Robin Murray, Philip McGuire, Poonam Gardner-Sood, Gabriella Wojewodka, Simone Ciufolini, Harriet Jordan, Jessie Clarke, Lauren Allen, Amir Krivoy, Brendon Stubbs, Philippa Lowe, Maurice Arbuthnott, Shanaya Rathod, Andrew Boardman, Mudasir Firdosi, John J. McGrath

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder

J. Santiago, E. Akeman, N. Kirlic, A. N. Clausen, K. T. Cosgrove, T. J. McDermott, B. Mathis, M. Paulus, M. G. Craske, J. Abelson, C. Martell, K. Wolitzky-Taylor, J. Bodurka, W. K. Thompson, Robin L. Aupperle

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial

Ratna Sohanpal, Hilary Pinnock, Liz Steed, Karen Heslop Marshall, Claire Chan, Moira Kelly, Stefan Priebe, C. Michael Roberts, Sally Singh, Melanie Smuk, Sarah Saqi-Waseem, Andy Healey, Martin Underwood, Patrick White, Chris Warburton, Stephanie J. C. Taylor, On behalf of the TANDEM Investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Metta-based group meditation and individual cognitive behavioral therapy (MeCBT) for chronic depression: study protocol for a randomized controlled trial

Artjom Frick, Isabel Thinnes, Ulrich Stangier

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of school-based physical activity and multi-micronutrient supplementation intervention on growth, health and well-being of schoolchildren in three African countries: the KaziAfya cluster randomised controlled trial protocol with a 2 × 2 factorial design

Markus Gerber, Serge A. Ayekoé, Johanna Beckmann, Bassirou Bonfoh, Jean T. Coulibaly, Dao Daouda, Rosa du Randt, Lina Finda, Stefanie Gall, Getrud J. Mollel, Christin Lang, Kurt Z. Long, Sebastian Ludyga, Honorati Masanja, Ivan Müller, Siphesihle Nqweniso, Fredros Okumu, Nicole Probst-Hensch, Uwe Pühse, Peter Steinmann, Sylvain G. Traoré, Cheryl Walter, Jürg Utzinger

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725)

J. Granados, A. Salazar-Ospina, J. P. Botero-Aguirre, A. F. Valencia-Quintero, N. Ortiz, P. Amariles

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, 1-year follow-up: a cluster-randomised trial

Allen Nsangi, Daniel Semakula, Andrew D. Oxman, Astrid Austvoll-Dahlgren, Matt Oxman, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Yunpeng Ding, Nelson K. Sewankambo

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial

Jun Wang, Wei Shi, Dhiaedin Khiati, Bingpei Shi, Xiaojuan Shi, Dandan Luo, Yin Wang, Rencai Deng, Huayu Huang, Jian Li, Weili Yan, Hong Yang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in IgA nephropathy patients with high-risk of end-stage renal disease (TCM-WINE): study protocol for a randomized controlled trial

Shen Li, Jin-pu Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors in adults with central obesity: study protocol for a randomised controlled study

Juan Zhou, Dan Zhao, Ning Wang, Zhiwei Zeng, Changyi Wang, Liping Hao, Xiaolin Peng

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial

Jeevani Maheshika Dahanayake, Pathirage Kamal Perera, Priyadarshani Galappaththy, Dulani Samaranayake

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”

Mohua Maulik, Jyotsna Gupta, Atul Juneja, Tulsi Adhikari, Saurabh Sharma, Yashmin Panchal, Neha Yadav, Mendu Vishnu Vardhana Rao

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

Response to the Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”

Mounika Pillamarapu, Abhilash Mohan, Gayatri Saberwal

01.12.2020 | Research | Ausgabe 1/2020 Open Access

The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial

Bärbel Knäuper, Huma Shireen, Kimberly Carrière, Mallory Frayn, Elena Ivanova, Zhen Xu, Ilka Lowensteyn, Gentiana Sadikaj, Aleksandra Luszczynska, Steven Grover, McGill CHIP Healthy Weight Program Investigators

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Personalising psychotherapies for depression using a novel mixed methods approach: an example from Morita therapy

Holly Victoria Rose Sugg, Julia Frost, David A. Richards

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial

Marie-Hélène Masse, Julie Ménard, Sheila Sprague, Marie-Claude Battista, Deborah J. Cook, Gordon H. Guyatt, Daren K. Heyland, Salmaan Kanji, Ruxandra Pinto, Andrew G. Day, Dian Cohen, Djillali Annane, Shay McGuinness, Rachael Parke, Anitra Carr, Yaseen Arabi, Bharath Kumar Tirupakuzhi Vijayaraghavan, Frédérick D’Aragon, Élaine Carbonneau, David Maslove, Miranda Hunt, Bram Rochwerg, Tina Millen, Michaël Chassé, Martine Lebrasseur, Patrick Archambault, Estel Deblois, Christine Drouin, François Lellouche, Patricia Lizotte, Irene Watpool, Rebecca Porteous, France Clarke, Nicole Marinoff, Émilie Belley-Côté, Brigitte Bolduc, Scott Walker, John Iazzetta, Neill K. J. Adhikari, François Lamontagne, on behalf of the Canadian Critical Care Trials Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial

Birgit Wagner, Laura Hofmann, Ulrike Maaß

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The PROMOTE study (High-protein and resistance-training combination in overweight and obesity) for short-term weight loss and long-term weight maintenance for Chinese people: a protocol for a pilot randomized controlled trial

Shaoyong Xu, Juan Zhang, Yuxiang Dong, Ruikun Chen, Wenlei Xu, Zhijun Tan, Ling Gao, Lei Shang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study

Zhi-peng Xiao, ke Jin, Jie-qing Wan, Yong Lin, Yao-hua Pan, Yi-chao Jin, Xiao-hua Zhang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study protocol for a randomized controlled trial to evaluate a web-based comprehensive sexual health and media literacy education program for high school students

Tracy M. Scull, Christina V. Malik, Abigail Morrison, Elyse M. Keefe

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Is there an interest in repeating the vaginal administration of dinoprostone (Propess®), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial

P. Coste Mazeau, M. Hessas, R. Martin, J.-L. Eyraud, F. Margueritte, Y. Aubard, C. Sallee, F. Sire, T. Gauthier

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India: protocol for a cluster-randomised controlled trial

Suchitra Rath, Audrey Prost, Subhashree Samal, Hemanta Pradhan, Andrew Copas, Sumitra Gagrai, Shibanand Rath, Raj Kumar Gope, Nirmala Nair, Prasanta Tripathy, Komal Bhatia, Kelly Rose-Clarke

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial—the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study

Ximena Cid, David Canty, Alistair Royse, Andrea B. Maier, Douglas Johnson, Doa El-Ansary, Sandy Clarke-Errey, Timothy Fazio, Colin Royse

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials

Felix Waibel, Martin Berli, Sabrina Catanzaro, Kati Sairanen, Madlaina Schöni, Thomas Böni, Jan Burkhard, Dominique Holy, Tanja Huber, Maik Bertram, Karin Läubli, Dario Frustaci, Andrea Rosskopf, Sander Botter, Ilker Uçkay

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Individualised stepwise adaptive treatment for 3–6-year-old preschool children impaired by attention-deficit/hyperactivity disorder (ESCApreschool): study protocol of an adaptive intervention study including two randomised controlled trials within the consortium ESCAlife

Katja Becker, Tobias Banaschewski, Daniel Brandeis, Christina Dose, Christopher Hautmann, Martin Holtmann, Thomas Jans, Lea Jendreizik, Carolin Jenkner, Katja John, Johanna Ketter, Sabina Millenet, Ursula Pauli-Pott, Tobias Renner, Marcel Romanos, Anne-Katrin Treier, Elena von Wirth, Anne-Kathrin Wermter, Manfred Döpfner

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol

Goeran Fiedler, Anita Singh, Xueyi Zhang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A prospective, randomized, single-blind, multicentre, phase III study on organ preservation with Custodiol-N solution compared with Custodiol® solution in organ transplantation (kidney, liver and pancreas)

Daniela Kniepeiss, Philipp Houben, Philipp Stiegler, Andrea Berghold, Regina Riedl, Judith Kahn, Peter Schemmer

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of the Teaching Recovery Techniques community-based intervention for unaccompanied refugee youth experiencing post-traumatic stress symptoms (Swedish UnaccomPanied yOuth Refugee Trial; SUPpORT): study protocol for a randomised controlled trial

Anna Sarkadi, Georgina Warner, Raziye Salari, Karin Fängström, Natalie Durbeej, Elin Lampa, Zaruhi Baghdasaryan, Fatumo Osman, Sandra Gupta Löfving, Anna Perez Aronsson, Inna Feldman, Filipa Sampaio, Richard Ssegonja, Rachel Calam, Anna Bjärtå, Anna Leiler, Elisabet Rondung, Elisabet Wasteson, Brit Oppedal, Brooks Keeshin

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial

Stephanie S. Leone, Suzanne Lokman, Brigitte Boon, Agnes van der Poel, Filip Smit, Moniek Zijlstra-Vlasveld, Odile Smeets

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr., Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel, Jeanette A. Waxmonsky

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial

Zeng-Qiao Zhang, Kun-Peng Li, Jing He, Li-Ming Jiang, Wu Wang, Xiao-Shen Hu, Wei Feng

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Acute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Research Networks (PERN) study

Simon Craig, Franz E. Babl, Stuart R. Dalziel, Charmaine Gray, Colin Powell, Khalid Al Ansari, Mark D. Lyttle, Damian Roland, Javier Benito, Roberto Velasco, Julia Hoeffe, Diana Moldovan, Graham Thompson, Suzanne Schuh, Joseph J. Zorc, Maria Kwok, Prashant Mahajan, Michael D. Johnson, Robert Sapien, Kajal Khanna, Pedro Rino, Javier Prego, Adriana Yock, Ricardo M. Fernandes, Indumathy Santhanam, Baljit Cheema, Gene Ong, Shu-Ling Chong, Andis Graudins, On behalf of the Pediatric Emergency Research Networks (PERN)

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Swiss chocolate and free beverages to increase the motivation for scientific work amongst residents: a prospective interventional study in a non-academic teaching hospital in Switzerland

Annika Rühle, Florian Oehme, Björn-Christian Link, Jürg Metzger, Henning Fischer, Michael Stickel, Dimitri E. Delagrammaticas, Reto Babst, Frank J. P. Beeres

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Guhong injection for treating coronary microvascular disease: study protocol for a randomized controlled trial

Zhuang Jieqin, Liu Shuling, Cai Hairong, Dai Xingzhen, Chen Yanhong, Jin Zilin, Chen Bojun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of compatible acupoints and single acupoint versus sham acupuncture for functional dyspepsia: study protocol for a randomized controlled trial

Le Guo, Xin Huang, Li-Juan Ha, Jing-Zhou Zhang, Jia Mi, Ping-Hui Sun, Xi-Ying Han, Ying Wang, Jing-Lin Hu, Fu-Chun Wang, Tie Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial

Pedro Parreira, Liliana B. Sousa, Inês A. Marques, Paulo Santos-Costa, Luciene M. Braga, Arménio Cruz, Anabela Salgueiro-Oliveira

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial

L. L. Laslett, B. Antony, A. E. Wluka, C. Hill, L. March, H. I. Keen, P. Otahal, F. M. Cicuttini, G. Jones

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study

Frank Tegtmeier, Reinhard Schinzel, Ronny Beer, Diederik Bulters, Jean-Yves LeFrant, Joan Sahuquillo, Andreas Unterberg, Peter Andrews, Antonio Belli, Javier Ibanez, Alfonso Lagares, Michael Mokry, Harald Willschke, Charlotte Flüh, Erich Schmutzhard, on behalf of the NOSTRA Investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial

Niccolò Butti, Emilia Biffi, Chiara Genova, Romina Romaniello, Davide Felice Redaelli, Gianluigi Reni, Renato Borgatti, Cosimo Urgesi

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)

Emma Lidington, Sophie E McGrath, Jillian Noble, Susannah Stanway, Amanda Lucas, Kabir Mohammed, Winette van der Graaf, Olga Husson

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial

Rob Coleman, Janet Brown, Emma Rathbone, Louise Flanagan, Amber Reid, Jessica Kendall, Sacha Howell, Chris Twelves, Carlo Palmieri, Anjana Anand, Iain MacPherson, Sarah Brown

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial

Celia A. J. Michielsens, Nadine Boers, Nathan den Broeder, Mark H. Wenink, Aatke van der Maas, Elien A. M. Mahler, Michelle L. M. Mulder, Désirée van der Heijde, Frank H. J. van den Hoogen, Lise M. Verhoef, Alfons A. den Broeder

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial

Elizabeth A. O’Connor, William M. Vollmer, Amanda F. Petrik, Beverly B. Green, Gloria D. Coronado

01.12.2020 | Research | Ausgabe 1/2020 Open Access

A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

Nick Daneman, Asgar H. Rishu, Ruxandra Pinto, Yaseen Arabi, Emilie P. Belley-Cote, Robert Cirone, Mark Downing, Deborah J. Cook, Richard Hall, Shay McGuinness, Lauralyn McIntyre, John Muscedere, Rachael Parke, Steven Reynolds, Benjamin A. Rogers, Yahya Shehabi, Phillip Shin, Richard Whitlock, Robert A. Fowler, on behalf of the Canadian Critical Care Trials Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trial

Zhiwei Xiao, Leihao Hu, Jietao Lin, Liming Lu, Xuewu Huang, Xiaoshu Zhu, Chiahshean Teo, Lizhu Lin

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A study protocol for a randomized controlled trial evaluating vibration therapy as an intervention for postural training and fall prevention after distal radius fracture in elderly patients

Ronald Man Yeung WONG, Wing-Tung HO, Ning TANG, Chi Yin TSO, Wai Kit Raymond Ng, Simon Kwoon-Ho CHOW, Wing-Hoi CHEUNG

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

International randomised controlled trial for the treatment of newly diagnosed EWING sarcoma family of tumours – EURO EWING 2012 Protocol

Jennifer Anderton, Veronica Moroz, Perrine Marec-Bérard, Nathalie Gaspar, Valerie Laurence, Javier Martín-Broto, Ana Sastre, Hans Gelderblom, Cormac Owens, Sophie Kaiser, Melissa Fernández-Pinto, Nicola Fenwick, Abigail Evans, Sandra Strauss, Jeremy Whelan, Keith Wheatley, Bernadette Brennan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol

Chao Hsing Yeh, Cuicui Li, Ronald Glick, Elizabeth A. Schlenk, Kathryn Albers, Lorna Kwai-Ping Suen, Nada Lukkahatai, Nicole Salen, Sonaali Pandiri, Weixia Ma, Nancy Perrin, Natalia E. Morone, Paul J. Christo

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparison of the effectiveness of a tailored cognitive behavioural therapy with a supportive listening intervention for depression in those newly diagnosed with multiple sclerosis (the ACTION-MS trial): protocol of an assessor-blinded, active comparator, randomised controlled trial

Litza Kiropoulos, Trevor Kilpatrick, Tomas Kalincek, Leonid Cherulov, Elizabeth McDonald, Tissa Wijeratne, Jennifer Threader, Vanja Rozenblat, Neil Simpson-O’Brien, Anneke Van Der Walt, Lisa Taylor

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study

Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M. Poland, Lee Shepstone, David Turner, Arnold Zermansky, David Wright, On behalf of the CHIPPS Team

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

Letter on “Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK”

Sarah Griffiths, Lorna Manger, Rebecca Chapman, Lauren Weston, Ian Sherriff, Cath Quinn, Paul Clarkson, Caroline Sutcliffe, Karen Davies, Richard Byng

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - the CIPIC Rehab Study: study protocol for a randomised controlled trial

Maj Siercke, Lise Pyndt Jørgensen, Malene Missel, Lau Caspar Thygesen, Pernille Peppercorn Blach, Henrik Sillesen, Selina Kikkenborg Berg

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The efficacy and safety of 'antianxiety granule' for anxiety disorder: a multicentre, randomized, double-blind, placebo-controlled, parallel-group trial

Zhongwei Sha, Yiping Hou, Chunchun Xue, Ou Li, Zhimin Li, Huiru Wang, Wenjing Zhang, Jian Xu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Improving risk perception and uptake of voluntary medical male circumcision with peer-education sessions and incentives, in Manicaland, East Zimbabwe: study protocol for a pilot randomised trial

Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett, Simon Gregson

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Point OutWords: protocol for a feasibility randomised controlled trial of a motor skills intervention to promote communicative development in non-verbal children with autism

Ailbhe McKinney, Kathryn L. Hotson, Alicia Rybicki, Emma J. L. Weisblatt, Claudia Días, Juliet Foster, Sofía S. Villar, Suzanne Murphy, Matthew K. Belmonte

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol

Yin Shou, Li Hu, Cuihong Zhang, Shifen Xu, Qi Jin, Li Huang, Bingrong Li, Long Yuan, Siwei Xu, Kaiyong Zhang, Huiru Jiang, Bimeng Zhang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol

Adnan Al-Kaisy, Jonathan Royds, Stefano Palmisani, David Pang, Samuel Wesley, Rod S. Taylor, Andrew Cook, Sam Eldabe, Lance McCracken, Rui Duarte, Jeremy Fairbank

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)

A.J. Kalkdijk-Dijkstra, J.A.G. van der Heijden, H.L. van Westreenen, P.M.A. Broens, M. Trzpis, J.P.E.N. Pierie, B.R. Klarenbeek, FORCE Trial Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Clinical evaluation of ultrasonic subgingival debridement versus ultrasonic subgingival scaling combined with manual root planing in the treatment of periodontitis: study protocol for a randomized controlled trial

Yue Yan, Yalin Zhan, Xian’e Wang, Jianxia Hou

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Does a mindfulness-augmented version of the German Strengthening Families Program reduce substance use in adolescents? Study protocol for a randomized controlled trial

Nicolas Arnaud, Christiane Baldus, Léa Josette Laurenz, Sonja Bröning, Maja Brandt, Sabrina Kunze, Maria Austermann, Linda Zimmermann, Anne Daubmann, Rainer Thomasius, the IMAC-Mind Consortium

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Streamlining and cycle time reduction of the startup phase of clinical trials

Amani Abu-Shaheen, Ahmad Al Badr, Isamme Al Fayyad, Adel Al Qutub, Eissa Ali Faqeih, Mohamad Al-Tannir

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Challenges in the design, planning and implementation of trials evaluating group interventions

Katie Biggs, Daniel Hind, Rebecca Gossage-Worrall, Kirsty Sprange, David White, Jessica Wright, Robin Chatters, Katherine Berry, Diana Papaioannou, Mike Bradburn, Stephen J. Walters, Cindy Cooper

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors

Franziska Holtdirk, Anja Mehnert, Mario Weiss, Björn Meyer, Carsten Watzl

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Ojeok-san plus Saengmaek-san for gastroesophageal reflux-induced chronic cough: protocol for a pilot, randomized, double-blind, placebo-controlled trial

Yeon Hee Bhang, Kwan-Il Kim, Jaehyo Kim, Junmo Ahn, Hwan-Su Jung, Changsop Yang, Seok-Jae Ko, Youngmin Bu, Jae-Woo Park, Kyoung Sun Park, Hee-Jae Jung, Jun-Hwan Lee, Beom-Joon Lee

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study

Dan Schwarz, Santosh Dhungana, Anirudh Kumar, Bibhav Acharya, Pawan Agrawal, Anu Aryal, Aaron Baum, Nandini Choudhury, David Citrin, Binod Dangal, Meghnath Dhimal, Bikash Gauchan, Tula Gupta, Scott Halliday, Biraj Karmacharya, Sandeep Kishore, Bhagawan Koirala, Uday Kshatriya, Erica Levine, Sheela Maru, Pragya Rimal, Sabitri Sapkota, Ryan Schwarz, Archana Shrestha, Aradhana Thapa, Duncan Maru

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): study protocol for a multicenter randomized controlled trial

Jin Ho Choi, Woo Hyun Paik, Min Su You, Kyong Joo Lee, Young Hoon Choi, Bang-sup Shin, Sang Hyub Lee, Ji Kon Ryu, Yong-Tae Kim

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial

Ka Wang Cheung, Mimi Tin Yan Seto, Ernest Hung Yu Ng

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults

Anu Kemppinen, Carol Howell, Victoria Allgar, Matthew Dodd, John Gregson, Charles Knowles, John McLaughlin, Preeti Pandya, Peter Whorwell, Elena Markaryan, Yan Yiannakou

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) – Study protocol from a randomized controlled trial

Josefin Sundh, Anders Magnuson, Scott Montgomery, Pontus Andell, Gustaf Rindler, Ole Fröbert, the BRONCHIOLE investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and cost-utility of the eHealth self-management application 'Oncokompas', helping partners of patients with incurable cancer to identify their unmet supportive care needs and to take actions to meet their needs: a study protocol of a randomized controlled trial

Anouk S. Schuit, Karen Holtmaat, Nienke Hooghiemstra, Femke Jansen, Birgit I. Lissenberg-Witte, Veerle M. H. Coupé, Irma M. Verdonck-de Leeuw

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial)

Xian Wu, Yunqiu Xia, Ou Zhou, Yan Song, Xianhong Zhang, Daiyin Tian, Qubei Li, Chang Shu, Enmei Liu, Xiaoping Yuan, Ling He, Chengjun Liu, Jing Li, Xiaohua Liang, Ke Yang, Zhou Fu, Lin Zou, Lei Bao, Jihong Dai

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda

Melissa M. Medvedev, Victor Tumukunde, Ivan Mambule, Cally J. Tann, Peter Waiswa, Ruth R. Canter, Christian H. Hansen, Elizabeth Ekirapa-Kiracho, Kenneth Katumba, Catherine Pitt, Giulia Greco, Helen Brotherton, Diana Elbourne, Janet Seeley, Moffat Nyirenda, Elizabeth Allen, Joy E. Lawn

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India

Sunita Taneja, Ranadip Chowdhury, Neeta Dhabhai, Sarmila Mazumder, Ravi Prakash Upadhyay, Sitanshi Sharma, Rupali Dewan, Pratima Mittal, Harish Chellani, Rajiv Bahl, Maharaj Kishan Bhan, Nita Bhandari, on behalf of the Women and Infants Integrated Growth Study (WINGS) Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial

Kyungsun Han, Ojin Kwon, Hyo-ju Park, So-Young Jung, Changsop Yang, Chang-Gue Son

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I)

Henrik Fox, Andrea Hetzenecker, Stefan Stadler, Olaf Oldenburg, Okka W. Hamer, Florian Zeman, Leonhard Bruch, Mirko Seidel, Stefan Buchner, Michael Arzt, for the TEAM-ASV I Investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial

Kyeong Tae Kim, Sophie Morton, Sarah Howe, Yeong Shiong Chiew, Jennifer L. Knopp, Paul Docherty, Christopher Pretty, Thomas Desaive, Balazs Benyo, Akos Szlavecz, Knut Moeller, Geoffrey M. Shaw, J. Geoffrey Chase

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease

Andreas Ziegler, Miriam Mann, Bernard Brandewiede, Hermann Dittrich, Sissy Hintz, Katja Krockenberger, Alper Öner, Marcos Oliviera de Sousa, Christian Schmidt

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial

Louise C. Mâsse, Janae Vlaar, Janice Macdonald, Jennifer Bradbury, Tom Warshawski, E. Jean Buckler, Jill Hamilton, Josephine Ho, Annick Buchholz, Katherine M. Morrison, Geoff D. C. Ball

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Doll therapy intervention for women with dementia living in nursing homes: a randomized single-blind controlled trial protocol

Roberta Vaccaro, Roberta Ballabio, Valentina Molteni, Laura Ceppi, Benedetta Ferrari, Marco Cantù, Daniele Zaccaria, Carla Vandoni, Rita Bianca Ardito, Mauro Adenzato, Barbara Poletti, Antonio Guaita, Rita Pezzati

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Financial incentives for hypertension control: rationale and study design

Liqiang Zheng, Yali Wang, Sitong Liu, Rui Zheng, Dongmei Pei, Yingxian Sun, Zhaoqing Sun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial

Weiqiang Yang, Xiaoling Li, Jiatao Zhong, Xueshuang Mei, Hongyu Liu, Le Yang, Liming Lu, Hongyi Hu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study

Hugues Chabriat, Claudio L. Bassetti, Ute Marx, Françoise Picarel-Blanchot, Aurore Sors, Celine Gruget, Barbara Saba, Marine Wattez, Marie-Laure Audoli, Dirk M. Hermann

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Prevention of doxorubicin-induced Cardiotoxicity by pharmacological non-hypoxic myocardial preconditioning based on Docosahexaenoic Acid (DHA) and carvedilol direct antioxidant effects: study protocol for a pilot, randomized, double-blind, controlled trial (CarDHA trial)

Rodrigo Carrasco, María Cristina Ramirez, Kjersti Nes, Andrés Schuster, Rubén Aguayo, Marcelo Morales, Cristobal Ramos, Daniel Hasson, Camilo G. Sotomayor, Pablo Henriquez, Ignacio Cortés, Marcia Erazo, Claudio Salas, Juan G. Gormaz

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Intravenous versus subcutaneous route pharmacokinetics of paracetamol (acetaminophen) in palliative care patients: study protocol for a randomized trial (ParaSCIVPallia)

Marine Vernant, Marie Lepoupet, Christian Creveuil, Antoine Alix, Charlotte Gourio, Laure Peyro-Saint-Paul, Veronique Lelong-Boulouard, Cyril Guillaumé

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand

Ralph Maddison, Elaine Anne Hargreaves, Yannan Jiang, Amanda Jane Calder, Sally Wyke, Cindy M. Gray, Kate Hunt, David Lubans, Helen Eyles, Nick Draper, Ihirangi Heke, Stephen Kara, Gerhard Sundborn, Claire Arandjus, Matthew Jenkins, Samantha Marsh

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial

Sherry Shiqian Gao, Kitty Jieyi Chen, Duangporn Duangthip, May Chun Mei Wong, Edward Chin Man Lo, Chun Hung Chu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Intra-arterial versus standard intravenous administration of lutetium-177-DOTA-octreotate in patients with NET liver metastases: study protocol for a multicenter, randomized controlled trial (LUTIA trial)

Sander C. Ebbers, Arthur J. A. T. Braat, Adriaan Moelker, Marcel P. M. Stokkel, Marnix G. E. H. Lam, Maarten W. Barentsz

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Anterior quadratus lumborum block for postoperative recovery after total hip arthroplasty: a study protocol for a single-center, double-blind, randomized controlled trial

Masaru Kikuchi, Takahiro Mihara, Yusuke Mizuno, Hiroko Fujimoto, Sachiko Arai, Takeshi Nomura, Takahisa Goto

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial

Yunxuan Huang, Jiabi Zhang, Buhui Xiong, Ruina Huang, Wenjing Zhao, Mengxue Zhou, Qi Chen, Danghan Xu, Xinghua Chen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials)

Michael Betz, Ilker Uçkay, Regula Schüpbach, Tanja Gröber, Sander M. Botter, Jan Burkhard, Dominique Holy, Yvonne Achermann, Mazda Farshad

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation

Matteo Quartagno, A. Sarah Walker, Abdel G. Babiker, Rebecca M. Turner, Mahesh K. B. Parmar, Andrew Copas, Ian R. White

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomised controlled trial of a co-produced, complex, health promotion intervention for women with prior gestational diabetes and their families: the Face-it study

Karoline Kragelund Nielsen, Inger Katrine Dahl-Petersen, Dorte Møller Jensen, Per Ovesen, Peter Damm, Nanna Husted Jensen, Maja Thøgersen, Anne Timm, Line Hillersdal, Ulla Kampmann, Christina Anne Vinter, Elisabeth Reinhardt Mathiesen, Helle Terkildsen Maindal, On behalf of the Face-it Study Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

To continue or not to continue? Antipsychotic medication maintenance versus dose-reduction/discontinuation in first episode psychosis: HAMLETT, a pragmatic multicenter single-blind randomized controlled trial

Marieke J. H. Begemann, Ilse A. Thompson, Wim Veling, Shiral S. Gangadin, Chris N. W. Geraets, Erna van ‘t Hag, Sanne J. Müller-Kuperus, Priscilla P. Oomen, Alban E. Voppel, Mark van der Gaag, Martijn J. Kikkert, Jim Van Os, H. Filip E. Smit, Rikus H. Knegtering, Sybren Wiersma, Luyken H. Stouten, Harm J. Gijsman, Lex Wunderink, Anton B. P. Staring, Selene R. T. Veerman, Amrita G. S. Mahabir, Jörg Kurkamp, Gerdina H. M. Pijnenborg, Natalie D. Veen, Machteld Marcelis, Koen P. Grootens, Gunnar Faber, Nico J. van Beveren, Agaath Been, Truus van den Brink, Maarten Bak, Therese A. M. J. van Amelsvoort, Andrea Ruissen, Christine Blanke, Karin Groen, Lieuwe de Haan, Iris E. C. Sommer

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data

Melanie L. Bell, Brooke A. Rabe

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operation during dura opening: study protocol for a randomized controlled trial

Jinlu Li, Xuemei Wu, Hairui Liu, Ying Huang, Yueqin Liu, Hong Xie, Jun Dong

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Online randomized controlled experiments at scale: lessons and extensions to medicine

Ron Kohavi, Diane Tang, Ya Xu, Lars G. Hemkens, John P. A. Ioannidis

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of Checklist-Based Box System Interventions (CBBSI) versus routine care on improving utilization of maternal health services in Northwest Ethiopia: study protocol for a cluster randomized controlled trial

Netsanet Belete Andargie, Mulusew Gerbaba Jebena, Gurmesa Tura Debelew

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial)

Delphine Hoegy, Nathalie Bleyzac, Alexandra Gauthier-Vasserot, Giovanna Cannas, Angélique Denis, Arnaud Hot, Yves Bertrand, Pauline Occelli, Sandrine Touzet, Claude Dussart, Audrey Janoly-Dumenil, DREPADO study group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial

Taaike Debeuf, Sandra Verbeken, Elisa Boelens, Brenda Volkaert, Eva Van Malderen, Nathalie Michels, Caroline Braet

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Sinako, a study on HIV competent households in South Africa: a cluster-randomised controlled trial protocol

Caroline Masquillier, Lucia Knight, Linda Campbell, Neo Sematlane, Anton Delport, Tanyaradzwa Dube, Edwin Wouters

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis: protocol of a randomized, placebo-controlled, double-blind clinical trial (COMPLETE-PsA)

Michelle L. M. Mulder, Johanna E. Vriezekolk, Nathan den Broeder, Elien A. M. Mahler, Philip S. Helliwell, Frank H. J. van den Hoogen, Alfons A. den Broeder, Mark H. Wenink

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Machine learning analysis plans for randomised controlled trials: detecting treatment effect heterogeneity with strict control of type I error

James A. Watson, Chris C. Holmes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A randomised, double-blind, active placebo-controlled, parallel groups, dose-response study of scopolamine hydrobromide (4–6 μg/kg) in patients with major depressive disorder

Joseph C. C. Chen, Rachael L. Sumner, Venkat Krishnamurthy Naga, Nicholas Hoeh, Hafis Adetokunbo Ayeni, Vikrant Singh, Frederick Sundram, Douglas Campbell, Suresh Muthukumaraswamy

01.12.2020 | Update | Ausgabe 1/2020 Open Access

A randomised placebo controlled trial of anakinra for treating pustular psoriasis: statistical analysis plan for stage two of the APRICOT trial

Suzie Cro, Prakash Patel, Jonathan Barker, David A. Burden, Christopher E. M. Griffiths, Helen J. Lachmann, Nick J. Reynolds, Richard B. Warren, Francesca Capon, Catherine Smith, Victoria Cornelius

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial

Chloé Couret, Alexandra Poinas, Christelle Volteau, Valery-Pierre Riche, Marie-Laure Le Lez, Marie-Hélène Errera, Catherine Creuzot-Garcher, Stéphanie Baillif, Laurent Kodjikian, Catherine Ivan, Laurence Mathilde Le Jumeau de Kergaradec, Anne Chiffoleau, Alexandra Jobert, Julie Jaulin, Laetitia Biron, Elisabeth Hervouet, Michel Weber

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral?

Diana L. Dyrberg, Gudjon L. Gunnarsson, Camilla Bille, Jens A. Sørensen, Jørn B. Thomsen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial

Gara Arteaga-Henríquez, Silvia Karina Rosales-Ortiz, Alejandro Arias-Vásquez, Istvan Bitter, Ylva Ginsberg, Pol Ibañez-Jimenez, Tünde Kilencz, Catharina Lavebratt, Silke Matura, Andreas Reif, Janos Rethelyi, Vanesa Richarte, Nanda Rommelse, Anne Siegl, J. Antoni Ramos-Quiroga

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol

Mahsa Malekahmadi, Omid Moradi Moghaddam, Sheikh Mohammed Shariful Islam, Kiarash Tanha, Mohsen Nematy, Naseh Pahlavani, Safieh Firouzi, Mohammad Reza Zali, Abdolreza Norouzy

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

Shanshan Li, Qing Zhang, Xuan Yin, Hongyu Yue, Wei Zhang, Lixing Lao, Zhangjin Zhang, Huangan Wu, Shifen Xu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: study protocol for a randomised placebo-controlled trial

Shanshan Liu, Lezheng Wang, Jian Yang

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

Comments to “PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial.”

Janusz Maciej Strzelczyk

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Different electrode positioning for transcutaneous electrical nerve stimulation in the treatment of urgency in women: a study protocol for a randomized controlled clinical trial

Juliana Falcão Padilha, Mariana Arias Avila, Enio Júnior Seidel, Patricia Driusso

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence

John Marsden, Paul Anders, Helen Clark, Kyriacos Colocassis, Brian Eastwood, Jonathan Knight, Alexandra Melaugh, David Quinn, Virginia Wright, Jez Stannard

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Anticipatory care planning intervention for older adults at risk of functional decline: study protocol for a primary care cluster feasibility randomised trial

Kevin Brazil, David Scott, Emma Wallace, Mike Clarke, Tom Fahey, Patrick Gillespie, Peter O’Halloran, Christopher Cardwell, Gillian Carter, Kieran McGlade, Frank Doyle

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Improving the accuracy and efficacy of diagnosing polycystic ovary syndrome by integrating metabolomics with clinical characteristics: study protocol for a randomized controlled trial

Cheng-Ming Ni, Wen-Long Huang, Yan-Min Jiang, Juan Xu, Ru Duan, Yun-Long Zhu, Xu-Ping Zhu, Xue-Mei Fan, Guo-An Luo, Yi-Ming Wang, Yan-Yu Li, Qing He, Lan Xu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother’s own milk for preterm infants in the NICU

Huiqing Sun, Yun Cao, Shuping Han, Rui Cheng, Ling Liu, Jiangqin Liu, Shiwen Xia, Jiajie Zhang, Zhankui Li, Xiuyong Cheng, Chuanzhong Yang, Xinnian Pan, Long Li, Xin Ding, Rensheng Wang, Mingyuan Wu, Xiaoying Li, Liping Shi, Falin Xu, Fengqin Yu, Jiahua Pan, Xiaolan Zhang, Li Li, Jie Yang, Mingxia Li, Changhong Yan, Qi Zhou, Jiao Lu, Mou Wei, Laishuan Wang, Ling Yang, Xiang Y. Ye, Sharon Unger, Foteini Kakulas, Shoo K. Lee

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study

Ana Jessica Pinto, Tiago Peçanha, Kamila Meireles, Fabiana Braga Benatti, Karina Bonfiglioli, Ana Lúcia de Sá Pinto, Fernanda Rodrigues Lima, Rosa Maria Rodrigues Pereira, Maria Claudia Costa Irigoyen, James Edward Turner, John P. Kirwan, Neville Owen, David W. Dunstan, Hamilton Roschel, Bruno Gualano

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebocontrolled, randomised, double blind, multi-centre study

Frank Tegtmeier, Reinhard Schinzel, Ronny Beer, Diederik Bulters, Jean-Yves LeFrant, Joan Sahuquillo, Andreas Unterberg, Peter Andrews, Antonio Belli, Javier Ibanez, Alfonso Lagares, Michael Mokry, Harald Willschke, Charlotte Flüh, Erich Schmutzhard, on behalf of the NOSTRA Investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial

Jennifer Barsky Reese, Lauren A. Zimmaro, Stephen J. Lepore, Kristen A. Sorice, Elizabeth Handorf, Mary B. Daly, Leslie R. Schover, Deborah Kashy, Kelly Westbrook, Laura S. Porter

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial

Linda C. Gallo, Addie L. Fortmann, Julia I. Bravin, Taylor L. Clark, Kimberly L. Savin, Duvia Lara Ledesma, Johanna Euyoque, Haley Sandoval, Scott C. Roesch, Todd Gilmer, Gregory A. Talavera, Athena Philis-Tsimikas

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection

Achim J. Kaasch, Anna Rommerskirchen, Martin Hellmich, Gerd Fätkenheuer, Reinhild Prinz-Langenohl, Siegbert Rieg, Winfried V. Kern, Harald Seifert, for the SABATO trial group

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Add-on effect of kinesiotape in patients with acute lateral ankle sprain: a randomized controlled trial

Jeong-Cheol Shin, Jae-Hong Kim, Dongwoo Nam, Gwang-Cheon Park, Jeong-Soon Lee

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial

Sang-Hyun Lee, Byung-Jun Kim, In-Hwa Park, Eui-Hyoung Hwang, Eun Ju Park, Insoo Jang, Man-Suk Hwang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial

Roman Trepp, Raphaela Muri, Stephanie Abgottspon, Lenka Bosanska, Michel Hochuli, Johannes Slotboom, Christian Rummel, Roland Kreis, Regula Everts

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

Katherine J. Rennie, James O’Hara, Nikki Rousseau, Deborah Stocken, Denise Howel, Laura Ternent, Mike Drinnan, Alison Bray, Leila Rooshenas, David W. Hamilton, Alison Steel, Tony Fouweather, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Alaa Abouhajar, Janet A. Wilson, Sean Carrie, for the NAIROS Study Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial

E. Q. Silva, E. Y. Suda, D. P. Santos, J. L. Veríssimo, J. S. S. P. Ferreira, R. H. Cruvinel Júnior, R. L. Monteiro, C. D. Sartor, I. C. N. Sacco

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Pharmacokinetics, SAfety/tolerability, and EFficacy of high-dose RIFampicin in tuberculosis-HIV co-infected patients on efavirenz- or dolutegravir-based antiretroviral therapy: study protocol for an open-label, phase II clinical trial (SAEFRIF)

Ruth Nabisere, Joseph Musaazi, Paolo Denti, Florence Aber, Mohammed Lamorde, Kelly E. Dooley, Rob Aarnoutse, Derek J. Sloan, Christine Sekaggya-Wiltshire

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Sustainable, healthy cities: protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach

Kate Zinszer, Andrea Caprara, Antonio Lima, Stéphanie Degroote, Monica Zahreddine, Kellyanne Abreu, Mabel Carabali, Katia Charland, Mayana Azevedo Dantas, José Wellington, Beatriz Parra, Florence Fournet, Emmanuel Bonnet, Denis Pérez, Emilie Robert, Christian Dagenais, Tarik Benmarhnia, Neil Andersson, Valéry Ridde

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial

Lesley Sinclair, Margaret McFadden, Helen Tilbrook, Alex Mitchell, Ada Keding, Judith Watson, Linda Bauld, Frank Kee, David Torgerson, Catherine Hewitt, Jennifer McKell, Pat Hoddinott, Fiona M. Harris, Isabelle Uny, Kathleen Boyd, Nicola McMeekin, Michael Ussher, David M. Tappin, for the CPIT III local research teams

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial

Renata Janaína Pereira de Souza, Daniella Cunha Brandão, José Vicente Martins, Juliana Fernandes, Armele Dornelas de Andrade

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: study protocol for a multi-center randomized controlled trial (YOURTREAT)

Sarah Wilker, Claudia Catani, Jasmin Wittmann, Melissa Preusse, Telja Schmidt, Theodor May, Verena Ertl, Bettina Doering, Rita Rosner, Areej Zindler, Frank Neuner

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial

Aldo Ferreira-Hermosillo, Mario Antonio Molina-Ayala, Diana Molina-Guerrero, Ana Pamela Garrido-Mendoza, Claudia Ramírez-Rentería, Victoria Mendoza-Zubieta, Etual Espinosa, Moisés Mercado

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about treatment effects: one-year follow up of a randomised trial

Daniel Semakula, Allen Nsangi, Andrew D. Oxman, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Christopher J. Rose, Nelson K. Sewankambo

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial

Amanda Timler, Caroline Bulsara, Max Bulsara, Alistair Vickery, Jill Smith, Jim Codde

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial

Megan Shepherd-Banigan, Valerie A. Smith, Jennifer H. Lindquist, Michael Paul Cary Jr., Katherine E. M. Miller, Jennifer G. Chapman, Courtney H. Van Houtven

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial

Michelle R. Wise, Joy Marriott, Malcolm Battin, John M. D. Thompson, Michael Stitely, Lynn Sadler

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Smartphone-based secondary prevention intervention for university students with unhealthy alcohol use identified by screening: study protocol of a parallel group randomized controlled trial

Nicolas Bertholet, Elodie Schmutz, Véronique S. Grazioli, Mohamed Faouzi, Jennifer McNeely, Gerhard Gmel, Jean-Bernard Daeppen, John A. Cunningham

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Ticagrelor and preconditioning in patients with stable coronary artery disease (TAPER-S): a randomized pilot clinical trial

D. D’Amario, A. Restivo, A. M. Leone, R. Vergallo, S. Migliaro, F. Canonico, M. Galli, C. Trani, F. Burzotta, C. Aurigemma, G. Niccoli, A. Buffon, R. A. Montone, A. Flex, F. Franceschi, G. Tinelli, U. Limbruno, F. Francese, I. Ceccarelli, J. A. Borovac, I. Porto, F. Crea

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial

Soobin Jang, Hyun Kyung Sung, Mi Mi Ko, Seon Mi Shin, Ho-Yeon Go, Jeeyoun Jung

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty

Babar Kayani, Sujith Konan, Jenni Tahmassebi, Sam Oussedik, Peter D. Moriarty, Fares S. Haddad

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr, Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel, Jeanette A. Waxmonsky

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study

Benjamin Carrot, Jeanne Duclos, Caroline Barry, Leslie Radon, Anne-Solène Maria, Irène Kaganski, Zorica Jeremic, Vesper Barton-Clegg, Maurice Corcos, Malaïka Lasfar, Priscille Gerardin, Aurélie Harf, Marie-Rose Moro, Corinne Blanchet, Stéphane Bahrami, Nathalie Godart

01.12.2020 | Update | Ausgabe 1/2020 Open Access

A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan

Patrick Muller, Simon S. Skene, Kashfia Chowdhury, Suzie Cro, Andrew J. Goldberg, Caroline J. Doré, on behalf of the TARVA Study Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial

The DESIGNATION–investigators

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan

René Post, Menno R. Germans, Bert A. Coert, Gabriël J. E. Rinkel, W. Peter Vandertop, Dagmar Verbaan

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Evaluating the re-identification risk of a clinical study report anonymized under EMA Policy 0070 and Health Canada Regulations

Janice Branson, Nathan Good, Jung-Wei Chen, Will Monge, Christian Probst, Khaled El Emam

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A randomized controlled trial investigating the effect of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols on the intestinal microbiome and inflammation in patients with ulcerative colitis: study protocol for a randomized controlled trial

Alireza Milajerdi, Omid Sadeghi, Seyed Davar Siadat, Seyed Ali Keshavarz, Alireza Sima, Homayoon Vahedi, Peyman Adibi, Ahmad Esmaillzadeh

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Examining the benefits and harms of Alzheimer’s disease screening for family members of older adults: study protocol for a randomized controlled trial

Nicole R. Fowler, Katharine J. Head, Anthony J. Perkins, Sujuan Gao, Christopher M. Callahan, Tamilyn Bakas, Shelley D. Suarez, Malaz A. Boustani

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of transcranial direct current stimulation and multicomponent training on functional capacity in older adults: protocol for a randomized, controlled, double-blind clinical trial

Glaucio Carneiro Costa, João Carlos Ferrari Corrêa, Soraia Micaela Silva, Simone Dal Corso, Stefany Ferreira da Cruz, Micaelly de Souza Cunha, Paulo Henrique Leite Souza, Marcella Leiva Saldanha, Fernanda Ishida Corrêa

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial

Xiaofeng Wang, Hui Zhang, Zhenwei Xie, Qingfu Zhang, Wei Jiang, Junfeng Zhang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial

Franz Roth, Flavio Cagienard, Björn C. Link, Sandro Hodel, Dirk Lehnick, Reto Babst, Frank J. P. Beeres

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre clinical trial

M. Fernández Lucas, G. Ruíz-Roso, J. L. Merino, R. Sánchez, H. Bouarich, J. A. Herrero, A. Muriel, J. Zamora, A. Collado

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi

Maria H. Kim, Tapiwa A. Tembo, Alick Mazenga, Xiaoying Yu, Landon Myer, Rachael Sabelli, Robert Flick, Miriam Hartig, Elizabeth Wetzel, Katie Simon, Saeed Ahmed, Rose Nyirenda, Peter N. Kazembe, Mtisunge Mphande, Angella Mkandawire, Mike J. Chitani, Christine Markham, Andrea Ciaranello, Elaine J. Abrams

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Can learning about trials be child’s play? A qualitative exploration of the ‘Schools Teaching Awareness of Randomised Trials’ (START) initiative

Linda Biesty, Sandra Galvin, Elaine Finucane, Patricia Healy, Declan Devane, Tom Conway

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial

A. Hamish R. W. Simpson, Colin R. Howie, Elaine Kinsella, David F. Hamilton, Philip G. Conaghan, Catherine Hankey, Sharon Anne Simpson, Anna Bell-Higgs, Peter Craig, Nicholas D. Clement, Catriona Keerie, Sarah R. Kingsbury, Anthony R. Leeds, Hazel M. Ross, Hemant G. Pandit, Chris Tuck, John Norrie

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial

Yi Li, Helen Mohan, Nan Lan, Xiaojian Wu, Wei Zhou, Jianfeng Gong, Bo Shen, Luca Stocchi, J. Calvin Coffey, Weiming Zhu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Jakyakgamcho-tang in the relief of delayed-onset muscle soreness in healthy adults: study protocol for a randomized, double-blind, placebo-controlled, crossover design clinical trial

Kyungsun Han, Ojin Kwon, So-Young Jung, In-hwa Park, Man-Suk Hwang, Sun-Young Park, Eui-Hyoung Hwang, Jun-Hwan Lee

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Atmiyata, a community-led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

Kaustubh Joag, Jasmine Kalha, Deepa Pandit, Susmita Chatterjee, Sadhvi Krishnamoorthy, Laura Shields-Zeeman, Soumitra Pathare

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?

Eilidh M. Duncan, Tina Bennett, Katie Gillies

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

GERiatric Screening in the treatment of elderly patients with Ovarian Carcinoma (GERSOC): study protocol for a pragmatic, cluster randomised controlled trial

Neeltje J. van Soolingen, Carolina H. Smorenburg, Marije E. Hamaker, Wim G. Groen, Valesca P. Retèl, Christianne A. R. Lok, Lonneke V. van de Poll-Franse, Johannes W. Trum

01.12.2020 | Research | Ausgabe 1/2020 Open Access

What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study

N. Lovell, S. N. Etkind, S. Bajwah, M. Maddocks, I. J. Higginson

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Randomized trial comparing low-pressure versus standard-pressure pneumoperitoneum in laparoscopic colectomy: PAROS trial

S. Celarier, S. Monziols, M. O. Francois, V. Assenat, P. Carles, M. Capdepont, C. Fleming, E. Rullier, G. Napolitano, Q. Denost

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study protocol of the multi-centre, randomised controlled trial of the Frankfurt Early Intervention Programme A-FFIP versus early intervention as usual for toddlers and preschool children with Autism Spectrum Disorder (A-FFIP study)

Janina Kitzerow, Matthes Hackbusch, Katrin Jensen, Meinhard Kieser, Michele Noterdaeme, Ulrike Fröhlich, Regina Taurines, Julia Geißler, Nicole Wolff, Veit Roessner, Nico Bast, Karoline Teufel, Ziyon Kim, Christine M. Freitag

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Neuromuscular exercise and pain neuroscience education compared with pain neuroscience education alone in patients with chronic pain after primary total knee arthroplasty: study protocol for the NEPNEP randomized controlled trial

Jesper Bie Larsen, Søren T. Skou, Lars Arendt-Nielsen, Ole Simonsen, Pascal Madeleine

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparison of the efficacy and safety of tacrolimus monotherapy and cyclophosphamide combined with glucocorticoid in the treatment of adult primary membranous nephropathy: protocol of a multicenter, randomized, controlled, open study

Shasha Chen, Song Ren, Amanda Y. Wang, Hieu Tran, Zheng Li, Xiaoyun Cheng, Manli Liu, Guisen Li, Li Wang, Daqing Hong

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial

Alvin Kuo Jing Teo, Kiesha Prem, Konstantin Evdokimov, Chetra Ork, Sothearith Eng, Sovannary Tuot, Monyrath Chry, Tan Eang Mao, Li Yang Hsu, Siyan Yi

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: study protocol and a review of previous studies

Najmeh Seifi, Mohammad Safarian, Mohsen Nematy, Reza Rezvani, Majid Khadem-Rezaian, Alireza Sedaghat

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial

Celia Clarke, Valerie Pomeroy, Allan Clark, Graham Creelman, Nicola Hancock, Simon Horton, Anne Killett, Charles Mann, Estelle Payerne, Andoni Toms, Gareth Roberts, Toby Smith, Ann Marie Swart, Iain McNamara

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial

Iracema Leroi, Christopher J. Armitage, Fidéline Collin, Eric Frison, Mark Hann, Emma Hooper, David Reeves, Zoe Simkin, Lucas Wolski, on behalf of the SENSE-Cog Work Package 3 Investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of electroacupuncture on acute abdomen emergency care: study protocol for a randomized controlled trial

Yuan Ya Chang, Chih Wen Chiu, Chia Yun Chen, Chin Fu Chang, Tsung Chieh Lee, Lun Chien Lo, Chia Ying Lee, Kai Chang, Po Wei Chen, Chang Ju Hsieh, Yu Jun Chang, Sung Yen Huang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of vitamin D and/or magnesium supplementation on mood, serum levels of BDNF, inflammatory biomarkers, and SIRT1 in obese women: a study protocol for a double-blind, randomized, placebo-controlled trial

Behnaz Abiri, Mohammadreza Vafa

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial

Juan Chen, Jiajie Yu, Abraham Morse, Christian Fünfgeld, Kuanhui Huang, Jian Gong, Guangshi Tao, Binan Wang, Yuling Wang, Xiangyang Jiang, Gulina Ababaikeli, Peishu Liu, Hatiguli Nisier, Xiaowei Zhang, Ping Wang, Xin Sun, Lan Zhu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Promoting smoking abstinence in smokers willing to quit smoking through virtual reality-approach bias retraining: a study protocol for a randomized controlled trial

Alla Machulska, Tanja Joan Eiler, Armin Grünewald, Rainer Brück, Katharina Jahn, Björn Niehaves, Heiko Ullrich, Tim Klucken

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

Jinzhang He, Daniel R. Morales, Bruce Guthrie

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of moving cupping therapy for plaque psoriasis: study protocol for a randomized multicenter clinical trial

Meng Xing, Xiaoning Yan, Suqing Yang, Linge Li, Liping Gong, Hongxia Liu, Rong Xu, Jie Chen, Luo Ying, Yiding Zhao, Yuepeng An, Yang Liu, Gang Huang, Fei Guo, Qingfeng Yin, Ruiping Wang, Bin Li, Xin Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Promoting sport participation during early parenthood: a randomized controlled trial protocol

Stina J. Grant, Mark R. Beauchamp, Chris M. Blanchard, Valerie Carson, Ryan E. Rhodes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Responding to the challenge of Adolescent Perinatal Depression (RAPiD): protocol for a cluster randomized hybrid trial of psychosocial intervention in primary maternal care

Oye Gureje, Lola Kola, Bibilola D. Oladeji, Jibril Abdulmalik, Olatunde Ayinde, Phyllis Zelkowitz, Ian Bennett

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial

Jian Zhou, Chengwu Liu, Shulei Man, Mengyuan Lyu, Hu Liao, Nan Chen, Yuhui Cheng, Lunxu Liu

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden

Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead, Graeme J. Hankey, Maree L. Hackett, Katharina S. Sunnerhagen, For the EFFECTS Trial Collaboration

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Scaling up Quality Improvement for Surgical Teams (QIST) – avoiding surgical site infection and anaemia at the time of surgery: protocol for a cluster randomised controlled trial

Ashley B Scrimshire, Alison Booth, Caroline Fairhurst, Mike Reed, Win Tadd, Annie Laverty, Belen Corbacho, David Torgerson, Catriona McDaid

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect and safety of 4% albumin in the treatment of cardiac surgery patients: study protocol for the randomized, double-blind, clinical ALBICS (ALBumin In Cardiac Surgery) trial

Hanna Vlasov, Tatu Juvonen, Seppo Hiippala, Raili Suojaranta, Markku Peltonen, Alexey Schramko, Kaapo Arvonen, Ulla-Stina Salminen, Ilona Kleine Budde, Tiina Eränen, Maxim Mazanikov, Mihkel Meinberg, Tommi Vähäsilta, Erika Wilkman, Ville Pettilä, Eero Pesonen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Mindfulness-based resilience training for aggression, stress and health in law enforcement officers: study protocol for a multisite, randomized, single-blind clinical feasibility trial

Michael Christopher, Sarah Bowen, Katie Witkiewitz

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)

Margot Baudelet, Leen Van den Steen, Fréderic Duprez, Marc De Bodt, Sarah Deschuymer, Ann Goeleven, Isabel Hutsebaut, Steven Mariën, Sabine Meersschout, Daan Nevens, Sandra Nuyts, Marc Peeters, Pol Specenier, Michiel Van den Brekel, Lisette van der Molen, Caroline Vandenbruaene, Olivier Vanderveken, Joost Van Dinther, Carl Van Laer, Tom Vauterin, Hilde Verstraete, Gwen Van Nuffelen, Member of the Belgian PRESTO Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey

Roulla Katiri, Deborah A. Hall, Nora Buggy, Nicholas Hogan, Adele Horobin, Paul van de Heyning, Jill B. Firszt, Iain A. Bruce, Pádraig T. Kitterick

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome

Shiya Huang, Min Hu, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Yanhua Zheng, Qidan Wen, Cong Wang, Maohua Lai, Juan Li, Xingcheng Gao, Xinhua Wang, Zhenxing Hu, Tian Xia, Rongkui Hu, Jianping Liu, Xiaohui Wen, Shuna Li, Kewei Quan, Xingyan Liang, Hongcai Shang, Hongxia Ma, Jie Qiao

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: a study protocol for a randomized controlled trial

Shuanglan Lin, Lily Dongxia Xiao, Diane Chamberlain

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Verifying participant-reported clinical outcomes: challenges and implications

Suzanne Breeman, Lynda Constable, Anne Duncan, Kath Starr, Alison McDonald, Samantha Wileman, Seonaidh Cotton

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study

Helene Haeberle, Stefanie Prohaska, Peter Martus, Andreas Straub, Alexander Zarbock, Gernot Marx, Manola Zago, Martin Giera, Michael Koeppen, Peter Rosenberger

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients—protocol for a randomized controlled trial

Brian Eichner, Le Ann C. Michaels, Kelsey Branca, Katrina Ramsey, Julie Mitchell, Cynthia D. Morris, Lyle J. Fagnan, Rowena J. Dolor, Nancy Elder, David L. Hahn, Donald E. Nease, Jodi Lapidus, Ricardo Cibotti, Julie Block, Eric L. Simpson

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Amanda Rodrigues Amorim Adegboye, Paula G. Cocate, Camila Benaim, Maria Claudia da Veiga Soares Carvalho, Michael M. Schlüssel, Maria Beatriz T. de Castro, Gilberto Kac, Berit L. Heitmann

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of Transcranial Direct Current Stimulation (tDCS) and Approach Bias Modification (ABM) training on food cravings in people taking antipsychotic medication

Luiza Grycuk, Gemma Gordon, Fiona Gaughran, Iain C. Campbell, Ulrike Schmidt

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial

Anneli Olsson, Camilla Ring, Johan Josefsson, Annika Eriksson, Rebecca Rylance, Ole Fröbert, Stefan James, David Sparv, David Erlinge

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC)

Helen Brotherton, Abdou Gai, Cally J. Tann, Ahmadou Lamin Samateh, Anna C. Seale, Syed M. A. Zaman, Simon Cousens, Anna Roca, Joy E. Lawn

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain

Travis Cleland, Nitin B. Jain, John Chae, Kristine M. Hansen, Terri Z. Hisel, Douglas D. Gunzler, Victoria C. Whitehair, Chong H. Kim, Richard D. Wilson

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A study of capecitabine metronomic chemotherapy is non-inferior to conventional chemotherapy as maintenance strategy in responders after induction therapy in metastatic colorectal cancer

Min Shi, Tao Ma, Wenqi Xi, Jinling Jiang, Junwei Wu, Chenfei Zhou, Chen Yang, Zhenggang Zhu, Jun Zhang

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial

Soobin Jang, Hyun Kyung Sung, Mi Mi Ko, Seon Mi Shin, Ho-Yeon Go, Jeeyoun Jung

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Designs for adding a treatment arm to an ongoing clinical trial

Maxine Bennett, Adrian P. Mander

01.12.2020 | Research | Ausgabe 1/2020 Open Access

How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis

Laura Flight, Steven Julious, Alan Brennan, Susan Todd, Daniel Hind

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial

Frederike Lunkenheimer, Matthias Domhardt, Agnes Geirhos, Reinhold Kilian, Annabel S. Mueller-Stierlin, Reinhard W. Holl, Thomas Meissner, Kirsten Minden, Morten Moshagen, Ramona Ranz, Cedric Sachser, Doris Staab, Petra Warschburger, Harald Baumeister, COACH consortium

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of LiuZiJue Qigong versus traditional core stability training for poststroke patients complicated with abnormal trunk postural control: study protocol for a single-center randomized controlled trial

Chen Wang, Long Yu, Jian Yang, Ren Wei Wang, Ya Nan Zheng, Ying Zhang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effectiveness of a comprehensive corrective exercises program and subsequent detraining on alignment, muscle activation, and movement pattern in men with upper crossed syndrome: protocol for a parallel-group randomized controlled trial

Mohammad Bayattork, Foad Seidi, Hooman Minoonejad, Lars Louis Andersen, Phil Page

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Improved recording of work relatedness during patient consultations in occupational primary health care: a cluster randomized controlled trial using routine data

Salla Atkins, Tiia Reho, Nina Talola, Markku Sumanen, Mervi Viljamaa, Jukka Uitti

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: 3D vs. 4 K Display System - Influence of “State-of-the-art”-Display Technique On Surgical Performance (IDOSP-Study) in minimally invasive surgery: protocol for a randomized cross-over trial

Roger Wahba, Rabi Raj Datta, Andrea Hedergott, Jana Bußhoff, Thomas Bruns, Robert Kleinert, Georg Dieplinger, Hans Fuchs, Caroline Gietzelt, Desdemona Möller, Martin Hellmich, Christiane J. Bruns, Dirk L. Stippel

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa

Kate Clouse, Tamsin K. Phillips, Carol Camlin, Sandisiwe Noholoza, Phepo Mogoba, Julian Naidoo, Richard Langford, Martin Weiss, Christopher J. Seebregts, Landon Myer

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators

Rebecca Sheridan, Jacqueline Martin-Kerry, Joanna Hudson, Adwoa Parker, Peter Bower, Peter Knapp

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial

Pei Wu, Cisong Cheng, Xiaojun Song, Ling Yang, Dandan Deng, Zhenrong Du, Xingyu Chen, Tingting Zou, Ling Qiao, Na Li, Pingping Zhou, Li Du, Yihui Zhu

01.12.2020 | Research | Ausgabe 1/2020 Open Access

A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)

Fiona J. Gifford, Philip D. J. Dunne, Graeme Weir, Hamish Ireland, Catriona Graham, Sharon Tuck, Peter C. Hayes, Jonathan A. Fallowfield

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review

Flora Shan, Sonya MacVicar, Karel Allegaert, Martin Offringa, Lauren M. Jansson, Sarah Simpson, Wendy Moulsdale, Lauren E. Kelly

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Transcranial direct current stimulation (tDCS) as an intervention to improve empathic abilities and reduce violent behavior in forensic offenders: study protocol for a randomized controlled trial

Carmen S. Sergiou, Adam J. Woods, Ingmar H. A. Franken, Josanne D. M. van Dongen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Different kinds of acupuncture treatments for knee osteoarthritis: a multicentre, randomized controlled trial

Qifei Zhang, Jianqiao Fang, Lifang Chen, Jiayao Wu, Jing Ni, Fang Liu, Jing Sun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Treating anxiety in autistic adults: study protocol for the Personalised Anxiety Treatment–Autism (PAT-A©) pilot randomised controlled feasibility trial

Jeremy R. Parr, Samuel Brice, Patrick Welsh, Barry Ingham, Ann Le Couteur, Gemma Evans, Alexander Monaco, Mark Freeston, Jacqui Rodgers

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Shu-gan-qing-re formula for generalized anxiety disorder: study protocol for a multi-center, prospective, double-blind, double-dummy, randomized controlled trial

Pei Chen, Hong Zhu, Yanzhe Ning, Dongqing Yin, Hongxiao Jia

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of Astragalus injection and Salvia Miltiorrhiza injection on serum inflammatory markers in patients with stable coronary heart disease: a randomized controlled trial protocol

Zhihao Luo, Yuntao Liu, Zhen Zhao, Xia Yan, Dawei Wang, Qing Liu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1)

Matthew Mclaughlin, Jed Duff, Rachel Sutherland, Elizabeth Campbell, Luke Wolfenden, John Wiggers

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): protocol for a feasibility cluster-randomised controlled trial

Christopher P. Dwyer, Alberto Alvarez-Iglesias, Robert Joyce, Timothy J. Counihan, Dympna Casey, Sinéad M. Hynes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Positive deviance for dual-method promotion among women in Uganda: study protocol for a cluster randomized controlled trial

Hodaka Kosugi, Akira Shibanuma, Junko Kiriya, Ken Ing Cherng Ong, Stephen Mucunguzi, Conrad Muzoora, Masamine Jimba

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of Tuina in patients with chronic low back pain: study protocol for a randomized controlled trial

Shuaipan Zhang, Lingjun Kong, Qingguang Zhu, Zhiwei Wu, Jianhua Li, Min Fang, Wuquan Sun, Yanbin Cheng, Shanda Xu, Guangxin Guo, Xin Zhou, Zhizhen Lv

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey

Roulla Katiri, Deborah A. Hall, Nora Buggy, Nicholas Hogan, Adele Horobin, Paul van de Heyning, Jill B. Firszt, Iain A. Bruce, Pádraig T. Kitterick

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Protocol and baseline data for a prospective open-label explorative randomized singlecenter comparative study to determine the effects of various intravenous iron preparations on markers of oxidative stress and kidney injury in chronic kidney disease (IRON-CKD)

Ahmed Ziedan, Xenophon Kassianides, Sunil Bhandari

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients

Julien Pottecher, Eric Noll, Marie Borel, Gérard Audibert, Sébastien Gette, Christian Meyer, Elisabeth Gaertner, Vincent Legros, Raphaël Carapito, Béatrice Uring-Lambert, Erik Sauleau, Walter G. Land, Seiamak Bahram, Alain Meyer, Bernard Geny, Pierre Diemunsch

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): study protocol for a cluster randomised controlled trial

Johanna Breilmann, Reinhold Kilian, Steffi G. Riedel-Heller, Uta Gühne, Alkomiet Hasan, Peter Falkai, Andreas Allgöwer, Rainer Muche, Thomas Becker, Klemens Ajayi, Peter Brieger, Karel Frasch, Stephan Heres, Markus Jäger, Andreas Küthmann, Albert Putzhammer, Max Schmauß, Bertram Schneeweiß, Michael Schwarz, Markus Kösters

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Standardized patients in psychotherapy training and clinical supervision: study protocol for a randomized controlled trial

Franziska Kühne, Peter Eric Heinze, Florian Weck

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomized control trial of the caregiver support intervention with Syrian refugees in Lebanon

Kenneth E. Miller, Maguy Arnous, Fadila Tossyeh, Alexandra Chen, Ioannis Bakolis, Gabriela V. Koppenol-Gonzalez, Nayla Nahas, Mark J. D. Jordans

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Ginger in patients with active ulcerative colitis: a study protocol for a randomized controlled trial

Forough Shayesteh, Fatemeh Haidari, Ali Akbar Shayesteh, Javad Mohammadi-Asl, Kambiz Ahmadi-Angali

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial

Yan Li, Yafei Fu, Kai Wang, Zhiming Liu, Xiaoqing Shi, Mingwei Zhao

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of continuous Kangaroo Mother Care initiated immediately after birth (iKMC) on survival of newborns with birth weight between 1.0 to < 1.8 kg: study protocol for a randomized controlled trial

WHO Immediate KMC Study Group

01.12.2020 | Research | Ausgabe 1/2020 Open Access

How pragmatic are the randomised trials used in recommendations for control of glycosylated haemoglobin levels in type 2 diabetic patients in general practice: an application of the PRECIS II tool

Isabelle Ettori-Ajasse, Elise Tatin, Gordon Forbes, Sandra Eldridge, Clarisse Dibao-Dina

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial

Karen M. Benzies, Vibhuti Shah, Khalid Aziz, Wanrudee Isaranuwatchai, Luz Palacio-Derflingher, Jeanne Scotland, Jill Larocque, Kelly Mrklas, Esther Suter, Christopher Naugler, Henry T. Stelfox, Radha Chari, Abhay Lodha, Alberta FICare Level II NICU Study Team

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey

Ersin Uygun, Zeynep Ilkkursun, Marit Sijbrandij, A. Tamer Aker, Richard Bryant, Pim Cuijpers, Daniela C. Fuhr, Anne M. de Graaff, Joop de Jong, David McDaid, Naser Morina, A-La Park, Bayard Roberts, Peter Ventevogel, Taylan Yurtbakan, Ceren Acarturk, On behalf of the STRENGHTS consortium

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Comparison of the effectiveness of a tailored cognitive behavioural therapy with a supportive listening intervention for depression in those newly diagnosed with multiple sclerosis (the ACTION-MS trial): protocol of an assessor-blinded, active comparator, randomised controlled trial

Litza Kiropoulos, Trevor Kilpatrick, Tomas Kalincik, Leonid Churilov, Elizabeth McDonald, Tissa Wijeratne, Jennifer Threader, Vanja Rozenblat, Neil O’Brien-Simpson, Anneke Van Der Walt, Lisa Taylor

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Family conferences and shared prioritisation to improve patient safety in the frail elderly (COFRAIL): study protocol of a cluster randomised intervention trial in primary care

Achim Mortsiefer, Stefan Wilm, Sara Santos, Susanne Löscher, Anja Wollny, Eva Drewelow, Manuela Ritzke, Petra Thürmann, Nina-Kristin Mann, Gabriele Meyer, Jens Abraham, Andrea Icks, Joseph Montalbo, Birgitt Wiese, Attila Altiner, on behalf of the COFRAIL study group

01.12.2020 | Commentary | Ausgabe 1/2020 Open Access

When assessing generalisability, focusing on differences in population or setting alone is insufficient

Helen E. D. Burchett, Dylan Kneale, Laurence Blanchard, James Thomas

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Tongmai Yangxin intervening in myocardial remodeling after PCI for coronary heart disease: study protocol for a double-blind, randomized controlled trial

Yongxia Wang, Xinlu Wang, Jianru Wang, Bin Li, Rui Yu, Yucai Hu, Xingyuan Li, Guangcao Peng, Mengmeng Zhang, Mingjun Zhu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Adjunct low-dose ketamine infusion vs standard of care in mechanically ventilated critically ill patients at a Tertiary Saudi Hospital (ATTAINMENT Trial): study protocol for a randomized, prospective, pilot, feasibility trial

Mohammed Bawazeer, Marwa Amer, Khalid Maghrabi, Kamel Alshaikh, Rashid Amin, Muhammad Rizwan, Mohammad Shaban, Edward De Vol, Mohammed Hijazi

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study

Jennifer F. Bobb, Hongxiang Qiu, Abigail G. Matthews, Jennifer McCormack, Katharine A. Bradley

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial

Katleen Van der Gucht, Michelle Melis, Soumaya Ahmadoun, Anneleen Gebruers, Ann Smeets, Mathieu Vandenbulcke, Hans Wildiers, Patrick Neven, Peter Kuppens, Filip Raes, Stefan Sunaert, Sabine Deprez

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease: protocol of the PERION multicenter, two-arm, open-label, randomized trial

Yohei Kamata, Takaomi Kessoku, Tomoko Shimizu, Takashi Kobayashi, Takeo Kurihashi, Satsuki Sato, Syotaro Kuraji, Norio Aoyama, Tomoyuki Iwasaki, Shogo Takashiba, Nobushiro Hamada, Toshiro Kodama, Toshiyuki Tamura, Satoshi Ino, Takuma Higurashi, Masataka Taguri, Takeharu Yamanaka, Masato Yoneda, Haruki Usuda, Koichiro Wada, Atsushi Nakajima, Masato Minabe

01.12.2020 | Research | Ausgabe 1/2020 Open Access

An international, Delphi consensus study to identify priorities for methodological research in behavioral trials in health research

Molly Byrne, Jenny McSharry, Oonagh Meade, Kim L. Lavoie, Simon L. Bacon

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Postoperative complications and mobilisation following major abdominal surgery with vs. without fitness tracker-based feedback (EXPELLIARMUS): study protocol for a student-led multicentre randomised controlled trial (CHIR-Net SIGMA study group)

Marius Schwab, Niall Brindl, Alexander Studier-Fischer, Thomas Tu, Julia Gsenger, Max Pilgrim, Mirco Friedrich, Pia-Elena Frey, Christina Achilles, Alexander Leuck, Thore Bürgel, Manuel Feisst, Christina Klose, Solveig Tenckhoff, Colette Dörr-Harim, André L. Mihaljevic

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Traumatic brain injury—needs and treatment options in the chronic phase: Study protocol for a randomized controlled community-based intervention

Ida Maria H. Borgen, Marianne Løvstad, Nada Andelic, Solveig Hauger, Solrun Sigurdardottir, Helene L. Søberg, Unni Sveen, Marit V. Forslund, Ingerid Kleffelgård, Marte Ørud Lindstad, Laraine Winter, Cecilie Røe

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Light-enhanced cognitive behavioural therapy for sleep and fatigue: study protocol for a randomised controlled trial during chemotherapy for breast cancer

Helena R. Bean, Lesley Stafford, Ruth Little, Justine Diggens, Maria Ftanou, Marliese Alexander, Prudence A. Francis, Bei Bei, Joshua F. Wiley

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study

Yuqin Chen, Wenjun He, Haiping Ouyang, Chunli Liu, Cheng Hong, Tao Wang, Kai Yang, Wenju Lu, Jian Wang

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial

Ling Zhu, Xiao Shi, Suqing Yin, Jiemin Yin, Ziyu Zhu, Xiong Gao, Yingfu Jiao, Weifeng Yu, Liqun Yang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Phase II, open-label, multicenter trial of crizotinib in Japanese patients with advanced non-small cell lung cancer harboring a MET gene alteration: Co-MET study

Mototsugu Shimokawa, Kaname Nosaki, Takashi Seto, Kadoaki Ohashi, Masahiro Morise, Hidehito Horinouchi, Jun Sakakibara, Haruyasu Murakami, Seiji Yano, Miyako Satouchi, Shingo Matsumoto, Koichi Goto, Kiyotaka Yoh

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine

Xiaoying Sun, Xiaoyong Zhou, Yuegang Wei, Wenxin Yang, Ning Huang, Yangfeng Ding, Rongyi Hu, Shun Guo, Chunyan Yang, Huilan Weng, Ying Zhang, Xi Chen, Xiaojie Ding, Liu Liu, Qingfeng Yin, Ruiping Wang, Xin Li, Bin Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol

Rohan D’Souza, Chelsea Hall, Mathew Sermer, Samuel Siu, Candice Silversides

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Sample size calculation in randomised phase II selection trials using a margin of practical equivalence

Hakim-Moulay Dehbi, Allan Hackshaw

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2)

Mark Hayward, Clio Berry, Ben Cameron, Kate Arnold, Katherine Berry, Stephen Bremner, Kate Cavanagh, David Fowler, Heather Gage, Kathryn Greenwood, Cassie Hazell, Anna-Marie Jones, Sam Robertson, Clara Strauss

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

PALLiON – PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care

Marianne Jensen Hjermstad, Nina Aass, Sigve Andersen, Cinzia Brunelli, Olav Dajani, Herish Garresori, Hanne Hamre, Ellinor C. Haukland, Mats Holmberg, Frode Jordal, Hilde Krogstad, Tonje Lundeby, Erik Torbjørn Løhre, Svein Mjåland, Arve Nordbø, Ørnulf Paulsen, Erik Schistad Staff, Torunn Wester, Stein Kaasa, Jon Håvard Loge

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Using digital tools in the recruitment and retention in randomised controlled trials: survey of UK Clinical Trial Units and a qualitative study

Amanda Blatch-Jones, Jacqueline Nuttall, Abby Bull, Louise Worswick, Mark Mullee, Robert Peveler, Stephen Falk, Neil Tape, Jeremy Hinks, Athene J. Lane, Jeremy C. Wyatt, Gareth Griffiths

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): study protocol for a randomized controlled trial

Helle Nystrup Lund, Inge Nygaard Pedersen, Søren Paaske Johnsen, Agnieszka M. Heymann-Szlachcinska, Maryla Tuszewska, Gustav Bizik, Jens Ivar Larsen, Eszter Kulhay, Anelia Larsen, Bettina Grønbech, Helle Østermark, Heidi Borup, Jan Brink Valentin, Jan Mainz

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Robotic radical antegrade modular pancreatosplenectomy (RAMPS) versus standard retrograde pancreatosplenectomy (SRPS): study protocol for a randomized controlled trial

Gong Zhang, Yuhao Kang, Haifeng Zhang, Fei Wang, Rong Liu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Prospective evaluation of hydroxychloroquine in pediatric interstitial lung diseases: Study protocol for an investigator-initiated, randomized controlled, parallel-group clinical trial

Matthias Griese, Meike Köhler, Sabine Witt, Daniela Sebah, Matthias Kappler, Martin Wetzke, Nicolaus Schwerk, Nagehan Emiralioglu, Nural Kiper, Kai Kronfeld, Christian Ruckes, Hans Rock, Gisela Anthony, Elias Seidl

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Reporting of health equity considerations in cluster and individually randomized trials

Jennifer Petkovic, Janet Jull, Manosila Yoganathan, Omar Dewidar, Sarah Baird, Jeremy M. Grimshaw, Kjell Arne Johansson, Elizabeth Kristjansson, Jessie McGowan, David Moher, Mark Petticrew, Bjarne Robberstad, Beverley Shea, Peter Tugwell, Jimmy Volmink, George A. Wells, Margaret Whitehead, Luis Gabriel Cuervo, Howard White, Monica Taljaard, Vivian Welch

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of comprehensive rehabilitation program plus chemotherapy on quality of life in patients with postoperative non-small-cell lung cancer: study protocol of a multicenter randomized clinical trial

Jialin Yao, Lijing Jiao, Yiqing Yao, Yan Lu, Jun Shi, Jiaqi Li, Peiqi Chen, Ling Xu, Yabin Gong

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial

Sarah Devroe, Lisa Devriese, Frederik Debuck, Steffen Fieuws, Bjorn Cools, Marc Gewillig, Marc Van de Velde, Steffen Rex

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

Maryam Hannah Daud, Anis Safura Ramli, Suraya Abdul-Razak, Mohamad Rodi Isa, Fakhrul Hazman Yusoff, Noorhida Baharudin, Mohamed Syarif Mohamed-Yassin, Siti Fatimah Badlishah-Sham, Azlina Wati Nikmat, Nursuriati Jamil, Hapizah Mohd-Nawawi

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Cost-utility analysis of curative and maintenance repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant unipolar depression: a randomized controlled trial protocol

Samuel Bulteau, Andrew Laurin, Christelle Volteau, Cécile Dert, Lydie Lagalice, Solène Schirr-Bonnans, Nicolas Bukowski, Marie Guitteny, Luc Simons, Clémence Cabelguen, Anne Pichot, Fabienne Tessier, Annabelle Bonnin, Adeline Lepage, Jean-Marie Vanelle, Anne Sauvaget, Valery-Pierre Riche, ACOUSTIM Investigators Group, HUGOPSY Network

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease-modifying antirheumatic drugs (TOPIRA): study protocol for a pragmatic trial

Matthijs S. van der Leeuw, Paco M. J. Welsing, Maria J. H. de Hair, Johannes W. G. Jacobs, Anne C. A. Marijnissen, Suzanne P. Linn-Rasker, Faouzia Fodili, Reinhard Bos, Janneke Tekstra, Jacob M. van Laar

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

A simulation study comparing the power of nine tests of the treatment effect in randomized controlled trials with a time-to-event outcome

Patrick Royston, Mahesh K. B. Parmar

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study

Gareth Davies, Nicola Mills, Chris Holcombe, Shelley Potter, on behalf of the iBRA Steering Group

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial

Silje Haukenes Stavestrand, Kristine Sirevåg, Inger Hilde Nordhus, Trond Sjøbø, Trygve Bruun Endal, Hans M. Nordahl, Karsten Specht, Åsa Hammar, Anne Halmøy, Egil W. Martinsen, Eva Andersson, Helene Hjelmervik, Jan Mohlman, Julian F. Thayer, Anders Hovland

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Mother And late Preterm Lactation Study (MAPLeS): a randomised controlled trial testing the use of a breastfeeding meditation by mothers of late preterm infants on maternal psychological state, breast milk composition and volume, and infant behaviour and growth

Sarah Dib, Jonathan C. K. Wells, Mary Fewtrell

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation

Abhimanyu Sud, Michelle L. A. Nelson, Darren K. Cheng, Alana Armas, Kirk Foat, Michelle Greiver, Fardous Hosseiny, Joel Katz, Rahim Moineddin, Benoit H. Mulsant, Ronnie I. Newman, Leon Rivlin, Akshya Vasudev, Ross Upshur

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Upfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy for locally advanced rectal cancer (TME-FOLFOX): an open-label, multicenter, phase II randomized controlled trial

Jii Bum Lee, Han Sang Kim, Inkyung Jung, Sang Joon Shin, Seung Hoon Beom, Jee Suk Chang, Woong Sub Koom, Tae Il Kim, Hyuk Hur, Byung Soh Min, Nam Kyu Kim, Sohee Park, Seung-Yong Jeong, Jeong-Heum Baek, Seon Hahn Kim, Joon Seok Lim, Kang Young Lee, Joong Bae Ahn

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH): a randomized controlled trial

Tamas Geczy, Nawin L. Ramdat Misier, Tamas Szili-Torok

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The use of digitally collected patient-reported outcome measures for newly operated patients with total knee and hip replacements to improve post-treatment recovery: study protocol for a randomized controlled trial

David Kuklinski, Laura Oschmann, Christoph Pross, Reinhard Busse, Alexander Geissler

01.12.2020 | Commentary | Ausgabe 1/2020 Open Access

Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events

Alexander C. Fanaroff, Ghazala Haque, Betsy Thomas, Allegra E. Stone, Lynn M. Perkins, Matthew Wilson, W. Schuyler Jones, Chiara Melloni, Kenneth W. Mahaffey, Karen P. Alexander, Renato D. Lopes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial

Fahime Zeinali, Seyed Mohsen Aghaei Zarch, Mohammad Yahya Vahidi Mehrjardi, Seyed Mehdi Kalantar, Alireza Jahan-mihan, Elham Karimi-Nazari, Hossein Fallahzadeh, Mahdieh Hosseinzadeh-Shamsi-Anar, Masoud Rahmanian, Mohammad Reza Fazeli, Hassan Mozaffari-Khosravi

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol

Michael A. Hoyt, Ashley Wei-Ting Wang, Sean J. Ryan, Elizabeth C. Breen, Jennifer S. Cheavens, Christian J. Nelson

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

Response to the letter on “Comments to ‘PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial’ by Janusz Strzelczyk”

T. Auer, D. Kniepeiss, P. Schemmer

16.04.2020 | COVID-19 | Editorial | Ausgabe 1/2020 Open Access

COVID-19 randomised trial protocols: rapid publication without barriers

Shaun Treweek, Peter Jüni, Tianjing Li, Jonathan Collin, Matthias Briel, An-Wen Chan, Karla Hemming, William J. Meurer, Matthew R. Sydes, Jeremy M. Grimshaw

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial

D. Molina-Morant, M. L. Fernández, P. Bosch-Nicolau, E. Sulleiro, M. Bangher, F. Salvador, A. Sanchez-Montalva, A. L. P. Ribeiro, A. M. B. de Paula, S. Eloi, R. Correa-Oliveira, J. C. Villar, S. Sosa-Estani, I. Molina

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Can hypnosis and virtual reality reduce anxiety, pain and fatigue among patients who undergo cardiac surgery: a randomised controlled trial

Floriane Rousseaux, Marie-Elisabeth Faymonville, Anne-Sophie Nyssen, Nadia Dardenne, Didier Ledoux, Paul B. Massion, Audrey Vanhaudenhuyse

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial

Louise F. Hill, Mark A. Turner, Irja Lutsar, Paul T. Heath, Pollyanna Hardy, Louise Linsell, Evelyne Jacqz-Aigrain, Emmanuel Roilides, Mike Sharland, for the NeoVanc Consortium

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Bronchiectasis Information and Education: a randomised, controlled feasibility trial

Katy L. M. Hester, Vicky Ryan, Julia Newton, Tim Rapley, Anthony De Soyza

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a stepped-wedge, cluster randomized controlled trial of the LifeSpan suicide prevention trial in four communities in New South Wales, Australia

Fiona Shand, Michelle Torok, Nicole Cockayne, Philip J. Batterham, Alison L. Calear, Andrew Mackinnon, Dean Martin, Isabel Zbukvic, Katherine Mok, Nicola Chen, Lauren McGillivray, Matthew Phillips, Henry Cutler, Brian Draper, Grant Sara, Helen Christensen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The clinical and cost-effectiveness of a Victim Improvement Package (VIP) for the reduction of chronic symptoms of depression or anxiety in older victims of common crime (the VIP trial): study protocol for a randomised controlled trial

Marc Serfaty, Trefor Aspden, Jessica Satchell, Anthony Kessel, Gloria Laycock, Chris R. Brewin, Marta Buszewicz, Aidan O’Keeffe, Rachael Hunter, Gerard Leavey, Jon Cuming-Higgs, Vari Drennan, Monica Riveros, David Andrew, Martin Blanchard

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial

T. M. Mackay, F. J. Smits, A. E. J. Latenstein, A. Bogte, B. A. Bonsing, H. Bos, K. Bosscha, L. A. A. Brosens, L. Hol, O. R. C. Busch, G. J. Creemers, W. L. Curvers, M. den Dulk, S. van Dieren, L. M. J. W. van Driel, S. Festen, E. J. M. van Geenen, L. G. van der Geest, D. J. A. de Groot, J. W. B. de Groot, N. Haj Mohammad, B. C. M. Haberkorn, J. T. Haver, E. van der Harst, G. J. M. Hemmink, I. H. de Hingh, C. Hoge, M. Y. V. Homs, N. C. van Huijgevoort, M. A. J. M. Jacobs, E. D. Kerver, M. S. L. Liem, M. Los, H. Lubbinge, S. A. C. Luelmo, V. E. de Meijer, L. Mekenkamp, I. Q. Molenaar, M. G. H. van Oijen, G. A. Patijn, R. Quispel, L. B. van Rijssen, T. E. H. Römkens, H. C. van Santvoort, J. M. J. Schreinemakers, H. Schut, T. Seerden, M. W. J. Stommel, A. J. ten Tije, N. G. Venneman, R. C. Verdonk, J. Verheij, F. G. I. van Vilsteren, J. de Vos-Geelen, A. Vulink, C. Wientjes, F. Wit, F. J. Wessels, B. Zonderhuis, C. H. van Werkhoven, J. E. van Hooft, C. H. J. van Eijck, J. W. Wilmink, H. W. M. van Laarhoven, M. G. Besselink, for the Dutch Pancreatic Cancer Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Mechanisms of change in brief treatments for borderline personality disorder: a protocol of a randomized controlled trial

Ueli Kramer, Loris Grandjean, Hélène Beuchat, Stéphane Kolly, Philippe Conus, Yves de Roten, Bogdan Draganski, Jean-Nicolas Despland

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial

Nancy A. Rigotti, Kristina Schnitzer, Esa M. Davis, Susan Regan, Yuchiao Chang, Jennifer H. K. Kelley, Anna E. Notier, Karen Gilliam, Antoine Douaihy, Douglas E. Levy, Daniel E. Singer, Hilary A. Tindle

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF)

Paulo Cury Rezende, Whady Hueb, Edimar Alcides Bocchi, Michael Farkouh, Carlos Vicente Serrano Junior, Eduardo Gomes Lima, Expedito Eustáquio Ribeiro Silva, Luis Alberto Oliveira Dallan, Fabio Antonio Gaiotto, Cibele Larrosa Garzillo, Carlos Eduardo Rochitte, Cesar Higa Nomura, Thiago Luis Scudeler, Paulo Rogério Soares, Fabio Biscegli Jatene, José Antonio Franchini Ramires, Roberto Kalil Filho

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Combined extracorporeal shock wave lithotripsy and endoscopic treatment for pain in chronic pancreatitis (SCHOKE trial): study protocol for a randomized, sham-controlled trial

Søren S. Olesen, Asbjørn M. Drewes, Rajesh Gaud, Manu Tandan, Sundeep Lakhtakia, Mohan Ramchandani, G. V. Rao, D. Nageshwar Reddy, Rupjyoti Talukdar

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial

Marijke Dieltjens, Marc J. Braem, Sara Op de Beeck, Anneclaire V. M. T. Vroegop, Elahe Kazemeini, Eli Van de Perck, Jolien Beyers, Chloé Kastoer, Kristien Wouters, Marc Willemen, Johan A. Verbraecken, Olivier M. Vanderveken

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Supporting caregivers of veterans with Alzheimer’s disease and traumatic brain injury: study protocol for a randomized controlled trial

Jennifer L. Carnahan, Katherine S. Judge, Joanne K. Daggy, James E. Slaven, Nicki Coleman, Emily L. Fortier, Christopher Suelzer, Nicole R. Fowler

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study

Gema Manrique, Laura Butragueño-Laiseca, Rafael González, Corsino Rey, Zuriñe Martínez de Compañon, Javier Gil, Antonio Rodríguez-Núñez, Cecilia Martínez, Silvia Manrique, Jesús López-Herce

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial

Fabrice Bonnet, Antoine Bénard, Pierre Poulizac, Mélanie Afonso, Aline Maillard, Francesco Salvo, Driss Berdaï, Nathalie Salles, Nicolas Rousselot, Sébastien Marchi, Nathalie Hayes, Jean-Philippe Joseph

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises in Nepal: study protocol for a cluster randomized controlled trial

Edith van’t Hof, Manaswi Sangraula, Nagendra P. Luitel, Elizabeth L. Turner, Kedar Marahatta, Mark van Ommeren, Pragya Shrestha, Richard Bryant, Brandon A. Kohrt, Mark J. D. Jordans

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

ATLANTIS: a randomised multi-arm phase II biomarker-directed umbrella screening trial of maintenance targeted therapy after chemotherapy in patients with advanced or metastatic urothelial cancer

Ben Fulton, Robert Jones, Thomas Powles, Simon Crabb, James Paul, Alison Birtle, Simon Chowdhury, Syed Hussain, Anna Morris, Eileen Soulis, Paula Morrison

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial

A. Hamish R. W. Simpson, Colin R. Howie, Elaine Kinsella, David F. Hamilton, Philip G. Conaghan, Catherine Hankey, Sharon Anne Simpson, Anna Bell-Higgs, Peter Craig, Nicholas D. Clement, Catriona Keerie, Sarah R. Kingsbury, Anthony R. Leeds, Hazel M. Ross, Hemant G. Pandit, Chris Tuck, John Norrie

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Lifestyle changes and glycemic control in type 1 diabetes mellitus: a trial protocol with factorial design approach

Sobiya Sawani, Amna Rehana Siddiqui, Syed Iqbal Azam, Khadija Humayun, Asma Ahmed, Aysha Habib, Sabahat Naz, Mayera Tufail, Romaina Iqbal

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial

Laura L. Oakley, Moji Awogbade, Sarah Brien, Annette Briley, Maria Chorozoglou, Emma Drasar, Jemma Johns, Elizabeth Rhodes, Vicky Robinson, Paul Seed, Joseph Sharif, Claire Singh, Paul Telfer, Hilary Thompson, Ingrid Watt-Coote, Jo Howard, Eugene Oteng-Ntim

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

Arabella Scantlebury, Sarah Cockayne, Caroline Fairhurst, Sara Rodgers, David Torgerson, Catherine Hewitt, Joy Adamson, on behalf of the REFORM study

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Design and implementation of an intelligent monitoring system for household added salt consumption in China based on a real-world study: a randomized controlled trial

Jinli Xian, Mao Zeng, Rui Zhu, Zhengjie Cai, Zumin Shi, Abu S. Abdullah, Yong Zhao

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

Letter on Update to the Vitamin C, Thiamine, and Steroids in Sepsis (VICTAS) Protocol

Mark A. Frommelt, Pierre Kory, Micah T. Long

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

In response: Letter on update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol

Christopher J. Lindsell, Anna McGlothlin, Samuel Nwosu, Todd W. Rice, Alex Hall, Gordon R. Bernard, Laurence W. Busse, E. Wesley Ely, Alpha A. Fowler, David F. Gaieski, Jeremiah S. Hinson, Michael H. Hooper, James C. Jackson, Gabor D. Kelen, Mark Levine, Greg S. Martin, Richard E. Rothman, Jonathan E. Sevransky, Kert Viele, David W. Wright, David N. Hager

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial

Jonas Kuon, Adriane Hommertgen, Johannes Krisam, Felix Lasitschka, Albrecht Stenzinger, Miriam Blasi, Farastuk Bozorgmehr, Martin Maenz, Meinhard Kieser, Marc Schneider, Michael Thomas

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study

Taek-Geun Kwon, Albert Youngwoo Jang, Sang Wook Kim, Young Joon Hong, Jang-Ho Bae, Sung Yun Lee, Sang-Hyun Kim, Seung Hwan Han

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A double-blind, randomized, crossover trial protocol of whole hemp seed protein and hemp seed protein hydrolysate consumption for hypertension

Maryam Samsamikor, Dylan Mackay, Rebecca C. Mollard, Rotimi E. Aluko

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A randomised controlled trial of therapist-assisted online psychological therapies for posttraumatic stress disorder (STOP-PTSD): trial protocol

Anke Ehlers, Jennifer Wild, Emma Warnock-Parkes, Nick Grey, Hannah Murray, Alice Kerr, Alexander Rozental, Esther T. Beierl, Apostolos Tsiachristas, Rafael Perera-Salazar, Gerhard Andersson, David M. Clark

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III

Mathias Lühr Hansen, Marie Isabel Rasmussen, Snorre Rubin, Adelina Pellicer, Guoqiang Cheng, Xin Xu, Yin Zhaoqing, Vibeke Zoffmann, Gorm Greisen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of digital cognitive behavioural therapy for symptoms of generalised anxiety disorder: a study protocol for a randomised controlled trial

J. Gu, C. B. Miller, A. L. Henry, C. A. Espie, M. L. Davis, R. Stott, R. Emsley, J. A. J. Smits, M. Craske, K. E. A. Saunders, G. Goodwin, J. R. Carl

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial

Møyfrid Brenne Fehn, Raija Dahlø, Renate Nielsen, Ingebjørg Laache, Eszter Vanky

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Effectiveness of a multi-level intervention to reduce men’s perpetration of intimate partner violence: a cluster randomised controlled trial

Nicola J. Christofides, Abigail M. Hatcher, Dumisani Rebombo, Ruari-Santiago McBride, Shehnaz Munshi, Angelica Pino, Nada Abdelatif, Dean Peacock, Jonathan Levin, Rachel K. Jewkes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Acupressure to improve sleep quality of older people in residential aged care: a randomised controlled trial protocol

Nant Thin Thin Hmwe, Graeme Browne, Lyndall Mollart, Viv Allanson, Sally Wai-Chi Chan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial

Jingyun Wang, Ayesha Malik, Jing Jin, Yi Pang, Kelly Yin, Megan Allen, Adriana Grigorian, Brandy Scombordi, Joann Bailey, Saeed Aljohani, Katharine Funari, Ruth Shoge, Siva Meiyeppen, Jenny Myung, Ajay Soni, Daniel E. Neely

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomized multicenter study for isolated skin vasculitis (ARAMIS) comparing the efficacy of three drugs: azathioprine, colchicine, and dapsone

Robert G. Micheletti, Christian Pagnoux, Roy N. Tamura, Peter C. Grayson, Carol A. McAlear, Renee Borchin, Jeffrey P. Krischer, Peter A. Merkel, for the Vasculitis Clinical Research Consortium

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial

Michiel A. Greidanus, Angela G. E. M. de Boer, Angelique E. de Rijk, Monique H. W. Frings-Dresen, Sietske J. Tamminga

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

Wenwen Wang, Xiangyi Ma, Wei Zhang, Zhiying Li, Yan Wang, Zhiying Yu, Chunlian Zhang, Li Hong, Ruoyu Luo, Hui Xing, Wuliang Wang, Qingfen Yue, Jia Wei, Minli Zhang, Shixuan Wang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial

Tina Munk, Jonas Anias Svendsen, Anne Wilkens Knudsen, Tanja Bak Østergaard, Anne Marie Beck

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial

Melba A. Hernandez-Tejada, Wendy Muzzy, Matthew Price, Stephanie Hamski, Stephanie Hart, Edna Foa, Ron Acierno

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial

Rebecca Rawlinson, Rabeea’h W. Aslam, Girvan Burnside, Anna Chiumento, Malena Eriksson-Lee, Amy Humphreys, Naila Khan, Daniel Lawrence, Rachel McCluskey, Annette Mackinnon, Lois Orton, Atif Rahman, Ewan Roberts, Anna Rosala-Hallas, Rhiannon Tudor Edwards, Philomene Uwamaliya, Ross G. White, Eira Winrow, Christopher Dowrick

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Increasing uptake of evidence-based screening services though a community health worker-delivered multimodality program: study protocol for a randomized pragmatic trial

Olveen Carrasquillo, Julia Seay, Vasanti Jhaveri, Timothy Long, Sonjia Kenya, Emmanuel Thomas, Daniel Sussman, Dinah Trevil, Tulay Koru-Sengul, Erin Kobetz

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial

Yulong Tian, Shougen Cao, Leping Li, Qingsi He, Lijian Xia, Lixin Jiang, Yinlu Ding, Xinjian Wang, Hao Wang, Weizheng Mao, Xizeng Hui, Yiran Shi, Huanhu Zhang, Xianqun Chu, Henrik Kehlet, Yanbing Zhou

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Shengjiang Xiexin decoction in prophylaxis of chemotherapy-related diarrhea in small cell lung cancer patients: study protocol for a multicenter randomized controlled trial

Chao Deng, Yanni Lou, Yu Gao, Bo Deng, Fei Su, Liqun Jia

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic, multicentre, randomised controlled trial (UPSIDES-RCT)

Galia S. Moran, Jasmine Kalha, Annabel S. Mueller-Stierlin, Reinhold Kilian, Silvia Krumm, Mike Slade, Ashleigh Charles, Candelaria Mahlke, Rebecca Nixdorf, David Basangwa, Juliet Nakku, Richard Mpango, Grace Ryan, Donat Shamba, Mary Ramesh, Fileuka Ngakongwa, Alina Grayzman, Soumitra Pathare, Benjamin Mayer, Bernd Puschner

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of a ketogenic diet for improvement of neurological recovery in individuals with acute spinal cord injury: study protocol for a randomized controlled trial

Aynur Demirel, Jia Li, Casey Morrow, Stephen Barnes, Jan Jansen, Barbara Gower, Keneshia Kirksey, David Redden, Ceren Yarar-Fisher

01.12.2020 | Update | Ausgabe 1/2020 Open Access

The HOME Study: Statistical and economic analysis plan for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the  time spent in hospital by older acute hospital inpatients

Nicholas Magill, Ian R. White, Jane Walker, Katy Burke, Mark Toynbee, Maike van Niekerk, Fan Yang, Simon Walker, Mark Sculpher, Michael Sharpe, Chris Frost

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Low-Intensity Guided Help Through Mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression

Clara Strauss, Amy Arbon, Michael Barkham, Sarah Byford, Rebecca Crane, Richard de Visser, Margaret Heslin, Anna-Marie Jones, Fergal Jones, Laura Lea, Glenys Parry, Claire Rosten, Kate Cavanagh

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial

Nancy A. Rigotti, Kristina Schnitzer, Esa M. Davis, Susan Regan, Yuchiao Chang, Jennifer H. K. Kelley, Anna E. Notier, Karen Gilliam, Antoine Douaihy, Douglas E. Levy, Daniel E. Singer, Hilary A. Tindle

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A study protocol for a cluster randomised controlled trial on mindfulness-based stress reduction: studying effects of mindfulness-based stress reduction and an additional organisational health intervention on mental health and work-related perceptions of teachers in Dutch secondary vocational schools

Math Janssen, Yvonne Heerkens, Beatrice Van der Heijden, Hubert Korzilius, Pascale Peters, Josephine Engels

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Implementation of an intervention to improve the adoption of asthma self-management practices in Peru: Asthma Implementation Research (AIRE) randomized trial study protocol

Elisa D. Romani, Trishul Siddharthan, Nair Lovatón, Carol C. Alvítez-Luna, Oscar Flores-Flores, Suzanne L. Pollard

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Does asymmetry in patient recruitment in large critical care trials follow the Pareto principle?

Mahesh Ramanan, Laurent Billot, Dorrilyn Rajbhandari, John Myburgh, Simon Finfer, Rinaldo Bellomo, Balasubramanian Venkatesh

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of luseogliflozin on bone microarchitecture in older patients with type 2 diabetes: study protocol for a randomized controlled pilot trial using second-generation, high-resolution, peripheral quantitative computed tomography (HR-pQCT)

Ai Haraguchi, Riyoko Shigeno, Ichiro Horie, Shimpei Morimoto, Ayako Ito, Ko Chiba, Yurika Kawazoe, Shigeki Tashiro, Junya Miyamoto, Shuntaro Sato, Hiroshi Yamamoto, Makoto Osaki, Atsushi Kawakami, Norio Abiru

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Is natural (6S)-5-methyltetrahydrofolic acid as effective as synthetic folic acid in increasing serum and red blood cell folate concentrations during pregnancy? A proof-of-concept pilot study

Kelsey M. Cochrane, Chantal Mayer, Angela M. Devlin, Rajavel Elango, Jennifer A. Hutcheon, Crystal D. Karakochuk

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial

Niti Shrestha, Liang Wu, Xiaodi Wang, Wenqing Jia, Fang Luo

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers

Martin Jensen, Eva Hüttenrauch, Jennifer Schmidt, Gerhard Andersson, Mira-Lynn Chavanon, Cornelia Weise

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial

Tsegahun Manyazewal, Yimtubezinash Woldeamanuel, David P. Holland, Abebaw Fekadu, Henry M. Blumberg, Vincent C. Marconi

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals

Eleanor Mitchell, Kirsteen Goodman, Suzanne Hartley, Helen Hickey, Alison M. McDonald, Helen M. Meadows, Shelley Rhodes, Jodi Taylor, Natalie Wakefield, Barbara Farrell, on behalf of the UK Trial Managers’ Network Executive Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Opposing needling for analgesia and rehabilitation after unilateral total knee arthroplasty: a randomized, sham-controlled trial protocol

Hai Huang, Xiuling Song, Ling Zhao, Lin Zheng, Lianbo Xiao, Yuelai Chen

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Graphing and reporting heterogeneous treatment effects through reference classes

James A. Watson, Chris C. Holmes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol

María José Maldonado, Sergio Iván Agudelo, Juan David Suarez, Oscar Gamboa

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden

Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead, Graeme J. Hankey, Maree L. Hackett, Katharina S. Sunnerhagen, For the EFFECTS Trial Collaboration

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial

F. Jasmijn Smits, Anne Claire Henry, Casper H. van Eijck, Marc G. Besselink, Olivier R. Busch, Mark Arntz, Thomas L. Bollen, Otto M. van Delden, Daniel van den Heuvel, Christiaan van der Leij, Krijn P. van Lienden, Adriaan Moelker, Bert A. Bonsing, Inne H. M. Borel Rinkes, Koop Bosscha, R. M. van Dam, Sebastiaan Festen, B. Groot Koerkamp, Erwin van der Harst, Ignace H. de Hingh, Geert Kazemier, Mike Liem, B. Marion van der Kolk, Vincent E. de Meijer, Gijs A. Patijn, Daphne Roos, Jennifer M. Schreinemakers, Fennie Wit, C. Henri van Werkhoven, I. Quintus Molenaar, Hjalmar C. van Santvoort, for the Dutch Pancreatic Cancer Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Survive and Thrive in Brazil: The Boa Vista Early Childhood Program: study protocol of a stepped-wedge, randomized controlled trial

Alexandra Brentani, Ana Paula Scolezze Ferrer, Luana Bessa, Susan Chang, Susan Walker, Christine Powell, Jena Hamadani, Sandra Grisi, Günther Fink

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD)

Toshinari Yamashita, Norikazu Masuda, Shigehira Saji, Kazuhiro Araki, Yoshinori Ito, Toshimi Takano, Masato Takahashi, Junji Tsurutani, Kei Koizumi, Masahiro Kitada, Yasuyuki Kojima, Yasuaki Sagara, Hiroshi Tada, Tsutomu Iwasa, Takayuki Kadoya, Tsuguo Iwatani, Hiroki Hasegawa, Satoshi Morita, Shinji Ohno

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM’ study, a multicentric randomised controlled trial

Romain Forestier, Carey Suehs, Alain Françon, Marc Marty, Stéphane Genevay, Jérémie Sellam, Claire Chauveton, Fatma Begüm Erol Forestier, Nicolas Molinari

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Retaining participants in community-based health research: a case example on standardized planning and reporting

Nicole L. A. Catherine, Rosemary Lever, Lenora Marcellus, Corinne Tallon, Debbie Sheehan, Harriet MacMillan, Andrea Gonzalez, Susan M. Jack, Charlotte Waddell

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial

Chao Zhuo, Xiaolin Wei, Zhitong Zhang, Joseph Paul Hicks, Jinkun Zheng, Zhixu Chen, Victoria Haldane, John Walley, Yubao Guan, Hongyan Xu, Nanshan Zhong

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study

Gabriela Spencer-Bonilla, Anjali Thota, Paige Organick, Oscar J. Ponce, Marleen Kunneman, Rachel Giblon, Megan E. Branda, Angela L. Sivly, Emma Behnken, Carl R. May, Victor M. Montori, Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials

Yi-ming Chen, Jie-min Deng, Yi Wen, Bin Chen, Jiang-tao Hou, Bin Peng, Shi-jing Zhang, Hong Mi, Qi-long Jiang, Xia-lin Wu, Feng-bin Liu, Xin-lin Chen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial)

Rafał Dąbrowski, Paweł Syska, Justyna Mączyńska, Michał Farkowski, Stefan Sawicki, Agata Kubaszek-Kornatowska, Piotr Michałek, Ilona Kowalik, Hanna Szwed, Tomasz Hryniewiecki

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Access to routinely collected health data for clinical trials – review of successful data requests to UK registries

Sarah Lensen, Archie Macnair, Sharon B. Love, Victoria Yorke-Edwards, Nurulamin M. Noor, Meredith Martyn, Alexandra Blenkinsop, Carlos Diaz-Montana, Graham Powell, Elizabeth Williamson, James Carpenter, Matthew R. Sydes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial

Maria Swennergren Hansen, Marianne Toft Vestermark, Per Hölmich, Morten Tange Kristensen, Kristoffer Weisskirchner Barfod

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients – a protocol for a prosprective randomized clinical trial

Christian Reiterer, Barbara Kabon, Markus Falkner von Sonnenburg, Patrick Starlinger, Alexander Taschner, Oliver Zotti, Julius Goshin, Gregor Drlicek, Edith Fleischmann

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Propranolol for familial cerebral cavernous malformation (Treat_CCM): study protocol for a randomized controlled pilot trial

Silvia Lanfranconi, Elisa Scola, Giulio Andrea Bertani, Barbara Zarino, Roberto Pallini, Giorgio d’Alessandris, Emanuela Mazzon, Silvia Marino, Maria Rita Carriero, Emma Scelzo, Giuseppe Faragò, Marco Castori, Carmela Fusco, Antonio Petracca, Leonardo d’Agruma, Laura Tassi, Piergiorgio d’Orio, Maria Grazia Lampugnani, Enrico Bjorn Nicolis, Antonella Vasamì, Deborah Novelli, Valter Torri, Jennifer Marie Theresia Anna Meessen, Rustam Al-Shahi Salman, Elisabetta Dejana, Roberto Latini, the Treat-CCM Investigators

14.05.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

An online solution focused brief therapy for adolescent anxiety during the novel coronavirus disease (COVID-19) pandemic: a structured summary of a study protocol for a randomised controlled trial

Shitao Chen

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Reducing sitting at work: process evaluation of the SMArT Work (Stand More At Work) intervention

Stuart J. H. Biddle, Sophie E. O’Connell, Melanie J. Davies, David Dunstan, Charlotte L. Edwardson, Dale W. Esliger, Laura J. Gray, Thomas Yates, Fehmidah Munir

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial

Soledad Ballesteros, Jennifer A. Rieker, Julia Mayas, Antonio Prieto, Pilar Toril, María Pilar Jiménez, José Manuel Reales

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial

Loretta Davies, Jonathan Cook, Jose Leal, Carlos Morgado Areia, Beverly Shirkey, William Jackson, Helen Campbell, Heidi Fletcher, Andrew Carr, Karen Barker, Sarah E. Lamb, Paul Monk, Sean O’Leary, Fares Haddad, Chris Wilson, Andrew Price, David Beard

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial

Siyi Yu, Xiaohui Dong, Ruirui Sun, Zhaoxuan He, Chuantao Zhang, Mei Chen, Xiaojuan Hong, Lei Lan, Fang Zeng

01.12.2020 | Update | Ausgabe 1/2020 Open Access

OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) trial—statistical analysis plan

Maadrika M. N. P. Kanglie, Shandra Bipat, Inge A. H. van den Berk, Tjitske S. R. van Engelen, Marcel G. W. Dijkgraaf, Jan M. Prins, Jaap Stoker, Patrick M. M. Bossuyt

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

Congcong Zeng, Xi Liu, Lufeng Hu, Yuan Feng, Nengzhi Xia, Haihuan Zeng, Lin Luo, Ren Ye, Zhengzhong Yuan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Steps to recovery: body weight-supported treadmill training for critically ill patients: a randomized controlled trial

Robin C. H. Kwakman, Juultje Sommers, Janneke Horn, Frans Nollet, Raoul H. H. Engelbert, Marike van der Schaaf

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

Kyou-Young Lee, In-Sik Han, Ho-Yeon Go, Dong-Nyung Lee, Jun-Sang Yu, Seung-Ho Sun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of an interprofessional care concept on the hospitalization of nursing home residents: study protocol for a cluster-randomized controlled trial

Alexandra Piotrowski, Martha Meyer, Iris Burkholder, Dagmar Renaud, Markus Alexander Müller, Thorsten Lehr, Sonja Laag, Joachim Meiser, Lisa Manderscheid, Juliane Köberlein-Neu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE)

J. Laporte-Amargos, C. Gudiol, M. Arnan, P. Puerta-Alcalde, F. Carmona-Torre, M. Huguet, A. Albasanz-Puig, R. Parody, C. Garcia-Vidal, J. L. del Pozo, M. Batlle, C. Tebé, R. Rigo-Bonnin, C. Muñoz, A. Padullés, F. Tubau, S. Videla, A. Sureda, J. Carratalà

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam

Leanne McCabe, Ian R. White, Nguyen Van Vinh Chau, Eleanor Barnes, Sarah L. Pett, Graham S. Cooke, A. Sarah Walker, on behalf of SEARCH investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial

Esther Fernandes Tinoco Volpe, Vanessa R. Resqueti, Ana Aline Marcelino da Silva, Lucien Peroni Gualdi, Guilherme A. F. Fregonezi

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial

Anna Meta Dyrvig Kristensen, Ann Bovin, Ann Dorthe Zwisler, Charlotte Cerquira, Christian Torp-Pedersen, Hans Erik Bøtker, Ida Gustafsson, Karsten Tange Veien, Kristian Korsgaard Thomsen, Michael Hecht Olsen, Mogens Lytken Larsen, Olav Wendelboe Nielsen, Per Hildebrandt, Sussie Foghmar, Svend Eggert Jensen, Theis Lange, Thomas Sehested, Tomas Jernberg, Dan Atar, Borja Ibanez, Eva Prescott

24.05.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Efficacy of Liu-zi-jue in Patients with 2019 Novel Coronavirus Pneumonia (COVID-19): structured summary of a study protocol for a randomized controlled trial

Shuaipan Zhang, Zhizhen Lv, Qingguang Zhu, Wuquan Sun, Fei Yao, Lei Fang, Yanbin Cheng, Zhiwei Wu, Min Fang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial

Jay Morrison, Michele Hasselblad, Ruth Kleinpell, Reagan Buie, Deborah Ariosto, Erin Hardiman, Stephen W. Osborn, Christopher J. Lindsell, for the Vanderbilt Learning Healthcare System Investigators, Vanderbilt University

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study

Shaoyong Xu, Yuxin Jiang, Aihua Jia, Juan Zhang, Bin Gao, Jing Xu, Xiaorui Jing, Yang Jiao, Jia Wei, Wenlei Xu, Ruikun Chen, Ling Gao, Lei Shang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial

Tony Kendrick, Adam W. A. Geraghty, Hannah Bowers, Beth Stuart, Geraldine Leydon, Carl May, Guiqing Yao, Wendy O’Brien, Marta Glowacka, Simone Holley, Samantha Williams, Shihua Zhu, Rachel Dewar-Haggart, Bryan Palmer, Margaret Bell, Sue Collinson, Imogen Fry, Glyn Lewis, Gareth Griffiths, Simon Gilbody, Joanna Moncrieff, Michael Moore, Una Macleod, Paul Little, Christopher Dowrick

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial

Shuo Wu, Liang Zhang, Huan Li, Junnan Xu, Cui Jiang, Tao Sun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial

Shuk Kwan Tang, Mimi Mun Yee Tse, Sau Fong Leung, Theofanis Fotis

25.05.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial

Yeming Wang, Fei Zhou, Dingyu Zhang, Jianping Zhao, Ronghui Du, Yi Hu, Zhenshun Cheng, Ling Gao, Yang Jin, Guangwei Luo, Shouzhi Fu, Qiaofa Lu, Guanhua Du, Ke Wang, Yang Lu, Guohui Fan, Yi Zhang, Ying Liu, Shunan Ruan, Wen Liu, Thomas Jaki, Frederick G. Hayden, Peter W. Horby, Bin Cao, Chen Wang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial

Hongji Liu, Xiang Li, Zongduan Zhang, Jieping Zeng, Yan Dai, Chao Wang, Zhao Xie, Lin Cheng, Linru Cui

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis

Dirk Rades, Carlos Andres Narvaez, Claudia Doemer, Stefan Janssen, Denise Olbrich, Soeren Tvilsted, Antonio J. Conde-Moreno, Jon Cacicedo

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial

Julia Lühnen, Birte Berger-Höger, Burkhard Haastert, Jana Hinneburg, Jürgen Kasper, Anke Steckelberg

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial

Ivan Buljan, Ružica Tokalić, Marija Roguljić, Irena Zakarija-Grković, Davorka Vrdoljak, Petra Milić, Livia Puljak, Ana Marušić

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Analysis of responder-based endpoints: improving power through utilising continuous components

James Wason, Martina McMenamin, Susanna Dodd

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study Protocol for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a pragmatic, registry-based, multi-center, double-blind, randomized controlled trial evaluating the effect of intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline on delayed graft function in deceased donor kidney transplantation

Michael G. Collins, Magid A. Fahim, Elaine M. Pascoe, Kathryn B. Dansie, Carmel M. Hawley, Philip A. Clayton, Kirsten Howard, David W. Johnson, Colin J. McArthur, Rachael C. McConnochie, Peter F. Mount, Donna Reidlinger, Laura Robison, Julie Varghese, Liza A. Vergara, Laurence Weinberg, Steven J. Chadban, for the BEST-Fluids Investigators and the Australasian Kidney Trials Network

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia

Katherine L. Anders, Citra Indriani, Riris Andono Ahmad, Warsito Tantowijoyo, Eggi Arguni, Bekti Andari, Nicholas P. Jewell, Suzanne M. Dufault, Peter A. Ryan, Stephanie K. Tanamas, Edwige Rancès, Scott L. O’Neill, Cameron P. Simmons, Adi Utarini

01.12.2020 | Letter | Ausgabe 1/2020 Open Access

The COVIRL-001 Trial: A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: A structured summary of a study protocol for a randomised controlled trial

Eoin Feeney, Deborah Wallace, Aoife Cotter, Willard Tinago, Cormac McCarthy, David Keane, Rabia Hussain, Elena Alvarez Barco, Peter Doran, Patrick Mallon

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial

Caroline Forde, Ronan McMullan, Mike Clarke, Richard H. Wilson, Ruth Plummer, Margaret Grayson, Cliona McDowell, Ashley Agus, Annmarie Doran, Danny F. McAuley, Anne L. Thomas, Rosemary A. Barnes, Richard Adams, Ian Chau, Vicky Coyle

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care – a study protocol for a randomized controlled trial

K. H. Holgersen, I. Brønstad, M. Jensen, H. Brattland, S. K. Reitan, A. M. Hassel, M. Arentz, M. Lara-Cabrera, A. E. Skjervold

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice

Elizabeth J. Conroy, Jane M. Blazeby, Girvan Burnside, Jonathan A. Cook, Carrol Gamble

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Glioma patients in outpatient care—optimization of psychosocial care in neuro-oncological patients (GLIOPT): Protocol for a cluster randomized controlled trial

Mirjam Renovanz, Melina Hippler, Martin Voss, Jens Wehinger, Almuth F. Keßler, Jens Gempt, Minou Nadji-Ohl, Carolin Weiß Lucas, Marion Rapp, Martin Misch, Jan Coburger, Marcus Mehlitz, Jürgen Meixensberger, Naureen Keric, Ghazaleh Tabatabai, Maria Blettner, Melanie Schranz, Susanne Singer

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial

Stephen B. Freedman, Sarah Williamson-Urquhart, Anna Heath, Petros Pechlivanoglou, Gareth Hopkin, Serge Gouin, Amy C. Plint, Andrew Dixon, Darcy Beer, Gary Joubert, Christopher McCabe, Yaron Finkelstein, Terry P. Klassen, on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial

C. M. Sackley, C. Rick, P. Au, M. C. Brady, G. Beaton, C. Burton, M. Caulfield, S. Dickson, F. Dowling, M. Hughes, N. Ives, S. Jowett, P. Masterson-Algar, A. Nicoll, S. Patel, C. H. Smith, R. Woolley, C. E. Clarke, on behalf of the PD COMM Collaborative Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

Katharina M. Lang, Kathryn L. Harrison, Paula R. Williamson, Brian J. P. Huntly, Gert Ossenkoppele, Jan Geissler, Tamàs Bereczky, Jesús M. Hernández-Rivas, Hélène Chevrou-Séverac, Rory Goodbody, Renate Schulze-Rath, Lars Bullinger

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Effects of robot-assisted gait training in patients with Parkinson’s disease: study protocol for a randomized controlled trial

Min-Gu Kang, Seo Jung Yun, Hyun Iee Shin, Eunkyung Kim, Hyun Haeng Lee, Byung-Mo Oh, Han Gil Seo

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study

Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Linda Birt, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M. Poland, Lee Shepstone, Arnold Zermansky, David Wright, On behalf of the CHIPPS Team

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial

K. M. Latocha, K. B. Løppenthin, M. Østergaard, P. J. Jennum, R. Christensen, M. Hetland, H. Røgind, T. Lundbak, J. Midtgaard, B. A. Esbensen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial

Tony Kendrick, Michael Moore, Geraldine Leydon, Beth Stuart, Adam W. A. Geraghty, Guiqing Yao, Glyn Lewis, Gareth Griffiths, Carl May, Rachel Dewar-Haggart, Samantha Williams, Shihua Zhu, Christopher Dowrick

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial

Dong ( Roman) Xu, Rubee Dev, Abha Shrestha, Lingling Zhang, Archana Shrestha, Pushpanjali Shakya, James P. Hughes, Prabin Raj Shakya, Jinghua Li, Jing Liao, Biraj Man Karmacharya

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of an intervention to support decisions on disclosure in the employment setting (DECIDES): study protocol of a longitudinal cluster-randomized controlled trial

K. M. E. Janssens, J. van Weeghel, C. Henderson, M. C. W. Joosen, E. P. M. Brouwers

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial

Venkatesan Thiruvenkatarajan, Ashok Dharmalingam, Gilberto Arenas, Medhat Wahba, Reinhard Steiner, Vasanth Rao Kadam, Andre Tran, John Currie, Roelof Van Wijk, Anthony Quail, Guy Ludbrook

01.12.2020 | Commentary | Ausgabe 1/2020 Open Access

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Victoria Shepherd

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial

Sanmy Rocha Nóbrega, Silvana Gama Florencio Chachá, Cleiton Augusto Libardi

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial

Leo Pölzl, Felix Nägele, Michael Graber, Jakob Hirsch, Daniela Lobenwein, Martina Mitrovic, Agnes Mayr, Markus Theurl, Michael Schreinlechner, Matthias Pamminger, Christian Dorfmüller, Michael Grimm, Can Gollmann-Tepeköylü, Johannes Holfeld

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study)

Caroline Gronnier, Cécile Chambrier, Alain Duhamel, Benoît Dervaux, Denis Collet, Delphine Vaudoyer, Jean-Marc Régimbeau, Jacques Jougon, Jérémie Théréaux, Gil Lebreton, Julie Veziant, Alain Valverde, Pablo Ortega-Deballon, François Pattou, Muriel Mathonnet, Julie Perinel, Laura Beyer-Berjot, David Fuks, Philippe Rouanet, Jérémie H. Lefevre, Pierre Cattan, Sophie Deguelte, Bernard Meunier, Jean-Jacques Tuech, Patrick Pessaux, Nicolas Carrere, Ephrem Salame, Eleonor Benaim, Bertrand Dousset, Simon Msika, Christophe Mariette, Guillaume Piessen, on behalf of FRENCH association

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study)

C. Sabbagh, N. Siembida, H. Dupont, M. Diouf, J. L. Schmit, S. Boddaert, J. M. Regimbeau

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Genetic basis for prediction of non-responders to dietary plant sterol intervention (GenePredict-PS): a study protocol for a double-blind, placebo-controlled, randomized two-period crossover study

Maryam Shamloo, Matthew J. Granger, Elke A. Trautwein, James D. House, Dylan MacKay

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population

Jean-François Etter, Yasser Khazaal

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial

Markus Bock, Andreas Eisenschenk, Heiko Lorenzen, Martin Lautenbach

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study

Anna Ozaki, Takaomi Kessoku, Michihiro Iwaki, Takashi Kobayashi, Tsutomu Yoshihara, Takayuki Kato, Yasushi Honda, Yuji Ogawa, Kento Imajo, Takuma Higurashi, Masato Yoneda, Masataka Taguri, Takeharu Yamanaka, Hiroto Ishiki, Noritoshi Kobayashi, Satoru Saito, Yasushi Ichikawa, Atsushi Nakajima

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial

Roxanne C. Keynejad, Tesera Bitew, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Negussie Deyessa, Nick Sevdalis, Wietse A. Tol, Louise Howard, Charlotte Hanlon

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Caroline Trang-Poisson, Elise Kerdreux, Alexandra Poinas, Lucie Planche, Harry Sokol, Pascale Bemer, Karine Cabanas, Eliane Hivernaud, Laetitia Biron, Laurent Flet, Emmanuel Montassier, Ghislaine Le Garcasson, Anne Chiffoleau, Alexandra Jobert, Didier Lepelletier, Jocelyne Caillon, Patrice Le Pape, Berthe-Marie Imbert, Arnaud Bourreille

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial

William J. Meurer, Mackenzie Dinh, Kelley M. Kidwell, Adam Flood, Emily Champoux, Candace Whitfield, Deborah Trimble, Joan Cowdery, Dominic Borgialli, Sacha Montas, Rebecca Cunningham, Lorraine R. Buis, Devin Brown, Lesli Skolarus

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Changes to aspects of ongoing randomised controlled trials with fixed designs

Xanthi Coskinas, John Simes, Manjula Schou, Andrew James Martin

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial

Anne-Laure Philippon, Margaux Dumont, Sonia Jimenez, Sarah Salhi, Marine Cachanado, Isabelle Durand-Zaleski, Tabassome Simon, Yonathan Freund

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan

Alysha M. De Livera, Anne Reutens, Mark Cooper, Merlin Thomas, Karin Jandeleit-Dahm, Jonathan E. Shaw, Agus Salim

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins

Sungsin Cho, Hyung Sub Park, Taeseung Lee, Seung Jae Byun, Woo-Sung Yun, Shin-Seok Yang, Hyangkyoung Kim, Woo-Shik Kim, Jin Hyun Joh, In Mok Jung

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial

Yohan Grandperrin, Sidney Grosprêtre, Magali Nicolier, Philippe Gimenez, Chrystelle Vidal, Emmanuel Haffen, Djamila Bennabi

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial

Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S. Tunnicliffe, Gavin D. Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran, Cliona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams, Gerard Curley, John G. Laffey, Mike Clarke, Cecilia O’Kane, Daniel F. McAuley

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol

Kathryn Curtis, Michael Moore, Christie Cabral, Vasa Curcin, Jeremey Horwood, Richard Morris, Vibhore Prasad, Anne Schilder, Nicholas Turner, Scott Wilkes, Alastair D. Hay, Jodi Taylor

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial

Takashi Matsuura, Megumi Mae, Masayuki Ohira, Yasunori Yamashita, Ayako Nakazono, Kouji Sugimoto, Kajiro Yanagiguchi, Shizuka Yamada

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial

Z. Q. Ren, Y. F. Wang, G. F. Ao, H. X. Chen, M. Huang, M. X. Lai, H. D. Zhao, R. Zhao

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial

Irene García García, Miguel Rodriguez-Rubio, Amelia Rodríguez Mariblanca, Lucía Martínez de Soto, Lucía Díaz García, Jaime Monserrat Villatoro, Javier Queiruga Parada, Enrique Seco Meseguer, María J. Rosales, Juan González, José R. Arribas, Antonio J. Carcas, Pedro de la Oliva, Alberto M. Borobia

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial

Reihaneh Pirjani, Tahereh Soori, Ahmad Reza Dehpour, Mahdi Sepidarkish, Ashraf Moini, Arshia Shizarpour, Razieh Mohammad Jafari

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial

Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart Lambrecht

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial

Alain Vandormael, Maya Adam, Merlin Greuel, Till Bärnighausen

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial

Jonathan Rilinger, Winfried V. Kern, Daniel Duerschmied, Alexander Supady, Christoph Bode, Dawid L. Staudacher, Tobias Wengenmayer

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial

B. Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, Shyam Varadarajulu, John J. Vargo, Field F. Willingham, Todd H. Baron, Gregory A. Coté, Joseph Romagnuolo, April Wood-Williams, Emily K. Depue, Rebecca L. Spitzer, Cathie Spino, Lydia D. Foster, Valerie Durkalski, on behalf of the SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial

Antonio Cuadrado-Lavín, José Manuel Olmos, José Manuel Cifrian, Teresa Gimenez, Marco Antonio Gandarillas, Mar García-Saiz, Maria Henar Rebollo, Victor Martínez-Taboada, Marcos López-Hoyos, María Carmen Fariñas, Javier Crespo

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial

Seyed Sina Naghibi Irvani, Maryam Golmohammadi, Mohamad Amin Pourhoseingholi, Shervin Shokouhi, Ilad Alavi Darazam

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Umbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: a structured summary of a study protocol for a pilot randomised controlled trial

Atul Malhotra, David Ernest, Benjamin A. Rogers, David Haylock, Ashalyn Watt, Guy Moeneclaey, Graham Jenkin

04.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Ruanne V. Barnabas, Elizabeth Brown, Anna Bershteyn, R. Scott Miller, Mark Wener, Connie Celum, Anna Wald, Helen Chu, David Wesche, Jared M. Baeten, for the Hydroxychloroquine COVID-19 PEP Study Team

01.12.2020 | Editorial | Ausgabe 1/2020 Open Access

Digital tools for trial recruitment and retention—plenty of tools but rigorous evaluation is in short supply

Shaun Treweek, Matthias Briel

01.12.2020 | Commentary | Ausgabe 1/2020 Open Access

Cluster randomised trials of prescribing policy: an ethical approach to generating drug safety evidence? A discussion of the ethical application of a new research method

Amy Rogers, Gillian Craig, Angela Flynn, Isla Mackenzie, Thomas MacDonald, Alexander Doney

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map

Geoff K. Frampton, Jonathan Shepherd, Karen Pickett, Gareth Griffiths, Jeremy C. Wyatt

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol

Sam McClinton, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Thomas Lam, Rodolfo Hernandez, Robert Pickard, Ken Anson, Terry Clark, Steven MacLennan, David Thomas, Daron Smith, Ben Turney, Alison McDonald, Sarah Cameron, Oliver Wiseman

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)

Lila J. Finney Rutten, Kathryn J. Ruddy, Linda L. Chlan, Joan M. Griffin, Jeph Herrin, Aaron L. Leppin, Deirdre R. Pachman, Jennifer L. Ridgeway, Parvez A. Rahman, Curtis B. Storlie, Patrick M. Wilson, Andrea L. Cheville

08.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials

Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven, Mihai G. Netea, on behalf of the BCG-CORONA study team#

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

Qing-Juan Wu, Wen-Liang Lv, Juan-Mei Li, Ting-Ting Zhang, Wen-hui Zhou, Qiang Zhang, Jiu-Chong Wang, Qing-Nan Wang, Ruo-Xuan Zhang, Xin Zhao, Si-Tong Chen, Shuang Liu, Gao-Hui Li, Zheng-Min Cao, Lei Xu, Jing Chen

01.12.2020 | Research | Ausgabe 1/2020 Open Access

The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes

Fatemeh Haidari, Mehrnoosh Zakerkish, Fatemeh Borazjani, Kambiz Ahmadi Angali, Golnaz Amoochi Foroushani

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics

Annie S. Anderson, Angela M. Craigie, Stephanie Gallant, Chloe McAdam, E. Jane Macaskill, Jennifer McKell, Nanette Mutrie, Ronan E. O’Carroll, Naveed Sattar, Martine Stead, Shaun Treweek

08.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial

Magnus Nakrem Lyngbakken, Jan-Erik Berdal, Arne Eskesen, Dag Kvale, Inge Christoffer Olsen, Anbjørg Rangberg, Christine Monceyron Jonassen, Torbjørn Omland, Helge Røsjø, Olav Dalgard

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Evidencing the impact of cancer trials: insights from the 2014 UK Research Excellence Framework

Catherine R. Hanna, Lauren P. Gatting, Kathleen Anne Boyd, Kathryn A. Robb, Rob J. Jones

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial

Yan Wang, Ming-Xi Jing, Lei Jiang, Yu-Feng Jia, E. Ying, Hui Cao, Xiang-Yu Guo, Tao Sun

08.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial

Jiawen Li, Chi Zhang, Zhao Wu, Guiqiang Wang, Hong Zhao

08.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial

Nooshin Dalili, Alireza Kashefizadeh, Mohsen Nafar, Fatemeh Poorrezagholi, Ahmad Firouzan, Fariba Samadian, Shiva Samavat, Shadi Ziaie, Somayeh Fatemizadeh

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of Parent-Infant-Psychotherapy with mothers with postpartum mental disorder: study protocol of the randomized controlled trial as part of the SKKIPPI project

J. Mattheß, M. Eckert, K. Richter, G. Koch, T. Reinhold, P. Vienhues, A. Berghöfer, S. Roll, T. Keil, F. Schlensog-Schuster, K. von Klitzing, C. Ludwig-Körner, L. Kuchinke

08.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial

Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart Lambrecht

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Prednisolone versus placebo addition in the treatment of patients with recent-onset psychotic disorder: a trial design

Lyliana G. Nasib, Iris E. Sommer, Inge Winter - van Rossum, Jacqueline de Vries, Shiral S. Gangadin, Priscilla P. Oomen, Gurmeet Judge, Renske E. Blom, Jurjen J. Luykx, Nico J. M. van Beveren, Natalie D. Veen, Rune A. Kroken, Erik L. Johnsen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study protocol for prognosis and treatment strategy of peripheral persistent avascular retina after intravitreal anti-VEGF therapy in retinopathy of prematurity

Ying Yu, Jianxun Wang, Feng Chen, Wensi Chen, Nan Jiang, Daoman Xiang

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study

Barbara Clyne, Fiona Boland, Norah Murphy, Edel Murphy, Frank Moriarty, Alan Barry, Emma Wallace, Tatyana Devine, Susan M. Smith, Declan Devane, Andrew Murphy, Tom Fahey

09.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial

Chi Zhang, Jiawen Li, Zhao Wu, He Wang, Chengli Que, Hong Zhao, Guiqiang Wang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Beta-adrenergic antagonist for the healing of chronic diabetic foot ulcers: study protocol for a prospective, randomized, double-blinded, controlled and parallel-group study

Ramanjot Kaur, Catherine Tchanque-Fossuo, Kaitlyn West, Yasmin Hadian, Anthony Gallegos, Daniel Yoon, Ligia Ismailyan, Saul Schaefer, Sara E. Dahle, R. Rivkah Isseroff

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial

Ali Al-Hamdani, Jeppe V. Rasmussen, Kenneth Holtz, Bo S. Olsen

09.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial

Carlos Chaccour, Paula Ruiz-Castillo, Mary-Ann Richardson, Gemma Moncunill, Aina Casellas, Francisco Carmona-Torre, Miriam Giráldez, Juana Schwartz Mota, José Ramón Yuste, José Ramón Azanza, Miriam Fernández, Gabriel Reina, Carlota Dobaño, Joe Brew, Belen Sadaba, Felix Hammann, Regina Rabinovich

09.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberger, Eldad A. Hod, Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial

Jean-Baptiste Ducloyer, Juliette Ivan, Alexandra Poinas, Olivier Lebreton, Alexandre Bonissent, Paul Fossum, Christelle Volteau, Ramin Tadayoni, Catherine Creuzot-Garchet, Yannick Le Mer, Julien Perol, June Fortin, Anne Chiffoleau, Fanny Billaud, Catherine Ivan, Michel Weber

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study

A. Isselhard, M. Töpper, B. Berger-Höger, A. Steckelberg, H. Fischer, F. Vitinius, K. Beifus, J. Köberlein-Neu, R. Wiedemann, K. Rhiem, R. Schmutzler, S. Stock

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial (“MoVo-App”)

Jiaxi Lin, Ramona Wurst, Sarah Paganini, Vivien Hohberg, Stephan Kinkel, Wiebke Göhner, Christina Ramsenthaler, Reinhard Fuchs

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD)

Toshinari Yamashita, Norikazu Masuda, Shigehira Saji, Kazuhiro Araki, Yoshinori Ito, Toshimi Takano, Masato Takahashi, Junji Tsurutani, Kei Koizumi, Masahiro Kitada, Yasuyuki Kojima, Yasuaki Sagara, Hiroshi Tada, Tsutomu Iwasa, Takayuki Kadoya, Tsuguo Iwatani, Hiroki Hasegawa, Satoshi Morita, Shinji Ohno

09.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial

José Meneses Calderón, Hugo Mendieta Zerón, Srivatsan Padmanabhan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial

Inés María Comino-Sanz, María Dolores López-Franco, Begoña Castro, Pedro Luis Pancorbo-Hidalgo

09.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol

Fahad Faqihi, Abdulrahman Alharthy, Mohammed Alodat, Daood Asad, Waleed Aletreby, Demetrios J. Kutsogiannis, Peter G. Brindley, Dimitrios Karakitsos

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Methods for assessment of patient adherence to removable orthoses used after surgery or trauma to the appendicular skeleton: a systematic review

Gareth Davies, Daniel Yeomans, Zoe Tolkien, Irene A. Kreis, Shelley Potter, Matthew D. Gardiner, Abhilash Jain, James Henderson, Jane M. Blazeby

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Implementing self-management: a mixed methods study of women’s experiences of a postpartum hypertension intervention (SNAP-HT)

Alexandra E. Cairns, Katherine L. Tucker, Carole Crawford, Richard J. McManus, John Powell

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial

Alejandra Paniagua-Avila, Meredith P. Fort, Russell E. Glasgow, Pablo Gulayin, Diego Hernández-Galdamez, Kristyne Mansilla, Eduardo Palacios, Ana Lucia Peralta, Dina Roche, Adolfo Rubinstein, Jiang He, Manuel Ramirez-Zea, Vilma Irazola

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

LIVE@Home.Path—innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial

Bettina Sandgathe Husebo, Heather Allore, Wilco Achterberg, Renira Corinne Angeles, Clive Ballard, Frøydis Kristine Bruvik, Stein Erik Fæø, Marie Hidle Gedde, Eirin Hillestad, Frode Fadnes Jacobsen, Øyvind Kirkevold, Egil Kjerstad, Reidun Lisbeth Skeide Kjome, Janne Mannseth, Mala Naik, Rui Nouchi, Nathalie Puaschitz, Rune Samdal, Oscar Tranvåg, Charalampos Tzoulis, Ipsit Vihang Vahia, Maarja Vislapuu, Line Iden Berge

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Modulation of gut microbiota through nutritional interventions in Behçet’s syndrome patients (the MAMBA study): study protocol for a randomized controlled trial

Giuditta Pagliai, Monica Dinu, Claudia Fiorillo, Matteo Becatti, Silvia Turroni, Giacomo Emmi, Francesco Sofi

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial

Jingjuan Xu, Ruirui Wang, Shengfu You, Lei Zhang, Peiyong Zheng, Guang Ji, Baocheng Liu

12.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial

Pradeesh Sivapalan, Charlotte Suppli Ulrik, Rasmus Dahlin Bojesen, Therese Sophie Lapperre, Josefin Viktoria Eklöf, Kjell Erik Julius Håkansson, Andrea Browatzki, Casper Tidemansen, Jon Torgny Wilcke, Julie Janner, Vibeke Gottlieb, Howraman Meteran, Celeste Porsbjerg, Birgitte Lindegaard Madsen, Mia Moberg, Lars Pedersen, Thomas Lars Benfield, Jens Dilling Lundgren, Filip Krag Knop, Tor Biering-Sørensen, Muzhda Ghanizada, Tine Peick Sonne, Uffe Christian Steinholtz Bødtger, Sidse Graff Jensen, Daniel Bech Rasmussen, Eva Brøndum, Oliver Djurhuus Tupper, Susanne Wiemann Sørensen, Gitte Alstrup, Christian Borbjerg Laursen, Ulla Weinrich Møller, Asger Sverrild, Jens-Ulrik Stæhr Jensen

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials

E. J. Mitchell, P. J. Godolphin, G. Meakin, K. Sprange

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Achieving blood pressure control targets in hypertensive patients of rural China – a pilot randomized trial

Xiao Huang, Lishun Liu, Yun Song, Lan Gao, Min Zhao, Huihui Bao, Xianhui Qin, Yanqing Wu, Qinghua Wu, Chonglei Bi, Aiping Yue, Chongqian Fang, Hai Ma, Yimin Cui, Genfu Tang, Ping Li, Yan Zhang, Jianping Li, Binyan Wang, Xiping Xu, Hong Wang, Gianfranco Parati, J. David Spence, Xiaobin Wang, Yong Huo, Guangliang Chen, Xiaoshu Cheng, for the investigators of intensive BP control in China

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial

Jiajun Zhu, Yingying Bao, Lizhong Du, Huafei Huang, Qin lv, Yejun Jiang, Yuxuan Dai, Zhijun Chen, Jingyun Shi, Yongyan Shi, Chuangzhong Yang, Hua Mei, Hong Jiang, Yanhui Sun, Xuemei Sun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial

Alex H. Krist, Kristen O’Loughlin, Steven H. Woolf, Roy T. Sabo, Jennifer Hinesley, Anton J. Kuzel, Bruce D. Rybarczyk, Paulette Lail Kashiri, E. Marshall Brooks, Russel E. Glasgow, Amy G. Huebschmann, Winston R. Liaw

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A feasibility study of a WhatsApp-delivered Transtheoretical Model-based intervention to promote healthy eating habits for firefighters in Hong Kong: a cluster randomized controlled trial

Wing Man Ng, Kin Cheung

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial

Jéssica Costa Leite, Daniella Cunha Brandão, Simone Cristina Soares Brandão, Helen Kerlen Bastos Fuzari, Tainá Maria Vidal, Jasiel Frutuoso, Maria Inês Remígio, Bruna Thays Santana de Araújo, Shirley Lima Campos, Armele Dornelas de Andrade

15.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II)

Qingsong Ye, Hua Wang, Xia Xia, Chenliang Zhou, Zhiming Liu, Zun-en Xia, Zhan Zhang, Yang Zhao, Jun Yehenala, Si Wang, Gangqiao Zhou, Ke Hu, Bin Wu, Chu-Tse Wu, Songling Wang, Yan He

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women – the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials

Claire Cardaillac, Stéphane Ploteau, Aurélie Le Thuaut, Vincent Dochez, Norbert Winer, Guillaume Ducarme

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial

Maisa S. Ziadni, Abby L. Chen, Tyler Winslow, Sean C. Mackey, Beth D. Darnall

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Corneal cross-linking versus standard care in children with keratoconus – a randomised, multicentre, observer-masked trial of efficacy and safety (KERALINK): a statistical analysis plan

Kashfia Chowdhury, Caroline J. Doré, Catey Bunce, Daniel F. P. Larkin

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs

H. Midgard, A. K. Finbråten, K. B. Malme, R. M. Berg-Pedersen, L. Tanum, I. C. Olsen, R. Bjørnestad, O. Dalgard

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial

Jongho Kim, Kyoung Sun Park, Yoon Jae Lee, Koh-Woon Kim, Jae-Heung Cho, In-Hyuk Ha

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Effectiveness of a multi-level intervention to reduce men’s perpetration of intimate partner violence: a cluster randomised controlled trial

Nicola J. Christofides, Abigail M. Hatcher, Dumisani Rebombo, Ruari-Santiago McBride, Shehnaz Munshi, Angelica Pino, Nada Abdelatif, Dean Peacock, Jonathan Levin, Rachel K. Jewkes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial

Ariane Mamguem Kamga, Cyril Di Martino, Amelie Anota, Sophie Paget-Bailly, Charles Coutant, Patrick Arveux, Isabelle Desmoulins, Tienhan Sandrine Dabakuyo-Yonli

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A. Julious, Adrian P. Mander, Christopher J. Weir, Franz Koenig, Marc K. Walton, Jon P. Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael A. Proschan, John A. Scott, Yuki Ando, Daniel Hind, Douglas G. Altman, on behalf of the ACE Consensus Group

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial

Lucy E. Bradshaw, Alan A. Montgomery, Hywel C. Williams, Joanne R. Chalmers, Rachel H. Haines

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension

Yi Lin Lee, Yvonne Mei Fong Lim, Kian Boon Law, Sheamini Sivasampu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study protocol for daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial

Keiko Ogawa-Ochiai, Kenichi Yoshimura, Akiko Shirai, Seisho Sakai, Hideki Moriyama, Keishi Nakamura, Toshinori Murayama, Hideki Ishikawa

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

IMPROVEjob – Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises – a study protocol of a cluster-randomised controlled trial

Birgitta M. Weltermann, Christine Kersting, Claudia Pieper, Tanja Seifried-Dübon, Annegret Dreher, Karen Linden, Esther Rind, Claudia Ose, Karl-Heinz Jöckel, Florian Junne, Brigitte Werners, Verena Schroeder, Jean-Marie Bois, Achim Siegel, Anika Thielmann, Monika A. Rieger, Stefanie Kasten, on behalf of the IMPROVEjob consortium

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively among surgical gynaecological cancer patients: study protocol of an open-labelled, randomised controlled trial

Chiou Yi Ho, Zuriati Ibrahim, Zalina Abu Zaid, Zulfitri ‘Azuan Mat Daud, Nor Baizura Md Yusop

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Non-specific effects of rabies vaccine on the incidence of common infectious disease episodes: study protocol for a randomized controlled trial

Darryn Knobel, Christianah Ibironke Odita, Anne Conan, Donna Barry, Marshalette Smith-Anthony, Juliet Battice, Shianne England, Bradford D. Gessner

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project

Evelyn Crowley, Shaun Treweek, Katie Banister, Suzanne Breeman, Lynda Constable, Seonaidh Cotton, Anne Duncan, Adel El Feky, Heidi Gardner, Kirsteen Goodman, Doris Lanz, Alison McDonald, Emma Ogburn, Kath Starr, Natasha Stevens, Marie Valente, Gordon Fernie

17.06.2020 | COVID-19 | Correction | Ausgabe 1/2020 Open Access

Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberger, Eldad A. Hod, Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Using targeting to recruit men and women of color into a behavioral weight loss trial

Melissa M. Crane, Elisabeth M. Seburg, Rona L. Levy, Robert W. Jeffery, Nancy E. Sherwood

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial

Man Han, Jiakang Cui, Yuya Xiao, Donghong Xiao, Juan Jiao, Qiuwei Peng, Feng Tian, Xiaopo Tang, Jianyong Zhang, Quan Jiang

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)

Natalia Elis Giordani, Caroline Cabral Robinson, Glauco Adrieno Westphal, Regis Goulart Rosa, Daniel Sganzerla, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo, Fernando Augusto Bozza, Cassiano Teixeira, Joel de Andrade, Cristiano Augusto Franke, Cátia Moreira Guterres, Itiana Cardoso Madalena, Adriane Isabel Rohden, Sabrina Souza da Silva, Luiza Vitelo Andrighetto, Gabriela Soares Rech, Bruna dos Passos Gimenes, Luciano Serpa Hammes, Daniela Ferreira Salomão Pontes, Maureen O. Meade, Maicon Falavigna

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Stakeholder perspectives on adaptive clinical trials: a scoping review

Tina Madani Kia, John C. Marshall, Srinivas Murthy

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study

Kim I. Albers, Fatih Polat, Ivo F. Panhuizen, Marc M. J. Snoeck, Gert-Jan Scheffer, Hans D. de Boer, Michiel C. Warlé

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial

E. A. Bayliss, S. M. Shetterly, M. L. Drace, J. Norton, A. R. Green, E. Reeve, L. A. Weffald, L. Wright, M. L. Maciejewski, O. C. Sheehan, J. L. Wolff, K. S. Gleason, C. Kraus, M. Maiyani, M. Du Vall, C. M. Boyd

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials

K. D. Coulman, A. Nicholson, A. Shaw, A. Daykin, L. E. Selman, R. Macefield, G. W. Shorter, H. Cramer, M. R. Sydes, C. Gamble, M. E. Pick, G. Taylor, J. A. Lane

22.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial

Gareth Griffiths, Richard Fitzgerald, Thomas Jaki, Andrea Corkhill, Ellice Marwood, Helen Reynolds, Louise Stanton, Sean Ewings, Susannah Condie, Emma Wrixon, Andrea Norton, Mike Radford, Sara Yeats, Jane Robertson, Rachel Darby-Dowman, Lauren Walker, Saye Khoo, on behalf of the UK NIHR community

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial

Mauricio Ceballos, Andrea Salazar-Ospina, Daniel Sabater-Hernández, Pedro Amariles

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial

Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Fares S. Haddad

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Zihua Wenfei granules in treatment of postinfectious cough (wind-cold invading lungs syndrome): study protocol for a randomized controlled trial

Huanan Wang, Bin She, Bing Mao, Hongli Jiang

22.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial

J. P. Desilles, C. Gregoire, C. Le Cossec, J. Lambert, O. Mophawe, M. R. Losser, F. Lambiotte, S. Le Tacon, M. Cantier, N. Engrand, P. Trouiller, J. Pottecher

22.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial

Nafiseh Abdolahi, Effat Kaheh, Roghieh Golsha, Behnaz Khodabakhshi, Alireza Norouzi, Mahmoud Khandashpoor, Sima Besharat, Samane Tavassoli, Somayeh Livani, Sadegh Ali Azimi, Mohammad Hadi Gharib, Babak Peivandi, Abdolreza Fazel, Hesamaddin Shirzad-Aski, Gholamreza Roshandel

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of Dingkun pill for female infertility patients with low prognosis undergoing in vitro fertilization-embryo transfer: study protocol for a multicenter, double-blind, randomized, placebo-controlled trial

Jingyan Song, Ting Ma, Yanlin Liang, Xianling Cao, Zhengao Sun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Timing of antiretroviral therapy for HIV-infected patients with moderate to severe Pneumocystis pneumonia: study protocol for a multi-centre prospective randomised controlled trial

Yuanyuan Qin, Yanqiu Lu, Yihong Zhou, Vijay Harypursat, Feng Sun, Sen Yang, Shengquan Tang, Yao Li, Xiaoqing He, Yanming Zeng, Yaokai Chen

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Defining key design elements of registry-based randomised controlled trials: a scoping review

Bill Karanatsios, Khic-Houy Prang, Ebony Verbunt, Justin M. Yeung, Margaret Kelaher, Peter Gibbs

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France

Coralie Gandré, Anaïs Le Jeannic, Marie-Amélie Vinet, Kathleen Turmaine, Philippe Courtet, Jean-Luc Roelandt, Guillaume Vaiva, Bruno Giraudeau, Corinne Alberti, Karine Chevreul

23.06.2020 | COVID-19 | Correction | Ausgabe 1/2020 Open Access

Correction to: Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial

Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart N. Lambrecht

23.06.2020 | COVID-19 | Correction | Ausgabe 1/2020 Open Access

Correction to: Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials

Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven, Mihai G. Netea, on behalf of the BCG-CORONA study team#

23.06.2020 | COVID-19 | Correction | Ausgabe 1/2020 Open Access

Correction to: Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial

Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart N. Lambrecht

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength

Ebaa Al Ozairi, Dalal Alsaeed, Dennis Taliping, Mohamad Jalali, Abeer El Samad, Anant Mashankar, Etab Taghadom, Nicola Guess, Jason M. R. Gill, Naveed Sattar, Cindy Gray, Paul Welsh, Stuart R. Gray

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial

Zhong-Xue Tian, Cun-Zhi Liu, You-Sheng Qi, Jian-Feng Tu, Ying Lin, Yu Wang, Jing-Wen Yang, Guang-Xia Shi, Jun-Hong Liu, Li-Qiong Wang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Clinical efficacy of ceramic versus resin-based composite endocrowns in Chinese adults: study protocol for a randomized controlled trial

Jilei Wang, Zhiting Ling, Ziting Zheng, Chunqing Zheng, Yawen Gai, Yuting Zeng, Xiaoxia Zhu, Liya Chen, Buling Wu, Wenjuan Yan

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Clinical efficacy evaluation of a traditional Miao technique of crossbow needle therapy in the treatment of knee osteoarthritis: a multi-center randomized controlled trial

Jing Fu, Hong-Cai Shang, Li-Ying Wang, Chen Zhao, Xiao-Fang Yang, Wei-Wei Guo, Chun-Xia Lu, Jin Cui, Yan-Ping Wang

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial

Roman Trepp, Raphaela Muri, Stephanie Abgottspon, Lenka Bosanska, Michel Hochuli, Johannes Slotboom, Christian Rummel, Roland Kreis, Regula Everts

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of a short-term residential smoking cessation therapy versus standard outpatient group therapy (‘START-Study’): study protocol of a randomized controlled trial

Jonas Dickreuter, Claudia Schmoor, Jürgen Bengel, Andreas Jähne, Jens A. Leifert

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: study protocol for a randomized controlled trial

Ruimin Jiao, Man Huang, Weina Zhang, Zhishun Liu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluating hearing performance with cochlear implants within the same patient using daily randomization and imaging-based fitting - The ELEPHANT study

L. J. G. Lambriks, M. van Hoof, J. A. Debruyne, M. Janssen, J. Chalupper, K. A. van der Heijden, J. R. Hof, C. A. Hellingman, E. L. J. George, E. M. J. Devocht

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The cerebral mechanism of the specific and nonspecific effects of acupuncture based on knee osteoarthritis: study protocol for a randomized controlled trial

Na Zhang, Jin-Ling Li, Chao-Qun Yan, Xu Wang, Lu-Lu Lin, Jian-Feng Tu, You-Sheng Qi, Jun-Hong Liu, Cun-Zhi Liu, Li-Qiong Wang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of soy milk consumption on gut microbiota, inflammatory markers, and disease severity in patients with ulcerative colitis: a study protocol for a randomized clinical trial

Omid Sadeghi, Alireza Milajerdi, Seyed Davar Siadat, Seyed Ali Keshavarz, Ali Reza Sima, Homayoon Vahedi, Peyman Adibi, Ahmad Esmaillzadeh

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The relationship between hyperuricemia and contrast-induced acute kidney injury undergoing primary percutaneous coronary intervention: secondary analysis protocol for the ATTEMPT RESCIND-1 study

Wei Guo, Feier Song, Shiqun Chen, Li Zhang, Guoli Sun, Jin Liu, Jiyan Chen, Yong Liu, Ning Tan, the RESCIND group

25.06.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

Bangjiang Fang, Wen Zhang, Xinxin Wu, Tingrong Huang, Huacheng Li, You Zheng, Jinhua Che, Shuting Sun, Chao Jiang, Shuang Zhou, Jun Feng

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2)

Arjun Agarwal, Rukmini Banerji, Peter Boone, Diana Elbourne, Ila Fazzio, Chris Frost, Madan Gopal, Sridevi Karnati, Rakhi Nair, Harshavardhan Reddy, Padmanabh Reddy, Dropti Sharma, Sajjan Singh Shekhawat, Siddharudha Shivalli

01.12.2020 | Commentary | Ausgabe 1/2020 Open Access

Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus

Susanna Dodd, Nicola Harman, Nichole Taske, Mark Minchin, Toni Tan, Paula R. Williamson

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial

Alexandra Poinas, Marie Lemoigne, Sarah Le Naour, Jean-Michel Nguyen, Solène Schirr-Bonnans, Valery-Pierre Riche, Florence Vrignaud, Laurent Machet, Jean-Paul Claudel, Marie-Thérèse Leccia, Ewa Hainaut, Nathalie Beneton, Cécile Dert, Aurélie Boisrobert, Laurent Flet, Anne Chiffoleau, Stéphane Corvec, Amir Khammari, Brigitte Dréno

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of the SPIRIT Integrated Suicide Prevention Programme: study protocol for a cluster-randomised controlled trial in rural Gujarat, India

Soumitra Pathare, Laura Shields-Zeeman, Lakshmi Vijayakumar, Deepa Pandit, Renuka Nardodkar, Susmita Chatterjee, Jasmine Kalha, Sadhvi Krishnamoorthy, Nikhil Jain, Arjun Kapoor, Mohammad Shahjahan, Ajay Chauhan, Filip Smit

30.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial

Constantinos Pantos, Georgia Kostopanagiotou, Apostolos Armaganidis, Athanasios Trikas, Ioulia Tseti, Iordanis Mourouzis

30.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol

Marco Marietta, Paola Vandelli, Pasquale Mighali, Roberto Vicini, Valeria Coluccio, Roberto D’Amico, on behalf of COVID-19 HD Study Group

30.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial

Abolghasem Allahyari, Hossein Rahimi, Majid Khadem-Rezaiyan, Zahra Mozaheb, Mohsen Seddigh-Shamsi, Alireza Bary, Mostafa Kamandi, Sajad Ataei Azimi, Saeed Eslami HasanAbadi, Alireza Noferesti, Somayeh Sadat Shariatmaghani, Houshang Rafatpanah, Shohreh Khatami, Afshin Jabbar Imani, Hassan Mortazi, Mohammad Moeini Nodeh

30.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial”

Carlos Tornero, Ricardo Vallejo, David Cedeño, Jorge Orduña, Ernesto Pastor, Moncef Belaouchi, Benigno Escamilla, Marisa Laredo, María del Mar Garzando

30.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

CytoResc – “CytoSorb” Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial

Helena Stockmann, Theresa Keller, Stefan Büttner, Achim Jörres, Detlef Kindgen-Milles, Julius Valentin Kunz, Josef Leebmann, Claudia Spies, Karl Träger, Sascha Treskatsch, Alexander Uhrig, Carsten Willam, Philipp Enghard, Torsten Slowinski, for the CytoResc Trial Investigators

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

A novel method for interpreting survival analysis data: description and test on three major clinical trials on cardiovascular prevention

Alessandro Mengozzi, Domenico Tricò, Andrea Natali

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer

Alessio Crippa, Bram De Laere, Andrea Discacciati, Berit Larsson, Jason T. Connor, Erin E. Gabriel, Camilla Thellenberg, Elin Jänes, Gunilla Enblad, Anders Ullen, Marie Hjälm-Eriksson, Jan Oldenburg, Piet Ost, Johan Lindberg, Martin Eklund, Henrik Grönberg

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial

Wei Xiong, Lu Li, Di Bao, Yaxin Wang, Yi Liang, Pengwei Lu, Di Zhang, Gaifen Liu, Lanxin Qiao, Na Zheng, Xu Jin

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Transmuscular quadratus lumborum (TQL) block for laparoscopic colorectal surgery: study protocol for a double-blind, prospective randomized placebo-controlled trial

Steve Coppens, Steffen Rex, Steffen Fieuws, Arne Neyrinck, Andre D’Hoore, Geertrui Dewinter

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Study design of the DAS-OLT trial: a randomized controlled trial to evaluate the impact of dexmedetomidine on early allograft dysfunction following liver transplantation

Chenlu Ni, Joe Masters, Ling Zhu, Weifeng Yu, Yingfu Jiao, Yuting Yang, Cui Cui, Suqing Yin, Liqun Yang, Bo Qi, Daqing Ma

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

INdividual Vocational and Educational Support Trial (INVEST) for young people with borderline personality disorder: study protocol for a randomised controlled trial

Andrew M. Chanen, Katie Nicol, Jennifer K. Betts, Gary R. Bond, Cathrine Mihalopoulos, Henry J. Jackson, Katherine N. Thompson, Martina Jovev, Hok Pan Yuen, Gina Chinnery, Judith Ring, Kelly Allott, Louise McCutcheon, Ashleigh P. Salmon, Eoin Killackey

30.06.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Corona Virus Disease-19 (Covid-19): A structured summary of a study protocol for a randomised controlled trial

Felicitas Stoll, Antje Blank, Gerd Mikus, David Czock, Kathrin I. Foerster, Simon Hermann, Katja Häußler, Amin Muhareb, Simone Hummler, Johanna Weiss, Jürgen Burhenne, Walter E. Haefeli

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 × 2 factorial randomized controlled trial

Xiaohan Xu, Yahong Gong, Yuelun Zhang, Jiaxin Lang, Yuguang Huang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial

Jiang-ming Chen, Xi-yang Yan, Tao Zhu, Zi-xiang Chen, Yi-jun Zhao, Kun Xie, Fu-bao Liu, Xiao-ping Geng

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)

Jakob Mechler, Karin Lindqvist, Per Carlbring, Peter Lilliengren, Fredrik Falkenström, Gerhard Andersson, Naira Topooco, Robert Johansson, Nick Midgley, Julian Edbrooke-Childs, Hanne-Sofie J. Dahl, Rolf Sandell, Agneta Thorén, Randi Ulberg, Katja Lindert Bergsten, Björn Philips

30.06.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial

Juan Jose Gonzalez-Gerez, Carlos Bernal-Utrera, Ernesto Anarte-Lazo, Jose Antonio Garcia-Vidal, Jose Martin Botella-Rico, Cleofas Rodriguez-Blanco

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial

Marte Heide, Marianne Mørk, Cecilie Røe, Jens Ivar Brox, Aasne Fenne Hoksrud

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Stress ulcer prophylaxis versus placebo—a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD)

Kimberly I. Mills, Ben D. Albert, Lori J. Bechard, Christopher P. Duggan, Aditya Kaza, Seth Rakoff-Nahoum, Hera Vlamakis, Lynn A. Sleeper, Jane W. Newburger, Gregory P. Priebe, Nilesh M. Mehta

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial

Katline Metzger-Peter, Laurent Daniel Kremer, Gilles Edan, Paulo Loureiro De Sousa, Julien Lamy, Dominique Bagnard, Ayikoe-Guy Mensah-Nyagan, Thibault Tricard, Guillaume Mathey, Marc Debouverie, Eric Berger, Anne Kerbrat, Nicolas Meyer, Jérôme De Seze, Nicolas Collongues

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial

Laurie Zawertailo, Christian S. Hendershot, Rachel F. Tyndale, Bernard Le Foll, Andriy V. Samokhvalov, Kevin E. Thorpe, Andrew Pipe, Robert D. Reid, Peter Selby

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Folic acid supplementation in children with sickle cell disease: study protocol for a double-blind randomized cross-over trial

Brock A. Williams, Heather McCartney, Erin Adams, Angela M. Devlin, Joel Singer, Suzanne Vercauteren, John K. Wu, Crystal D. Karakochuk

01.12.2020 | Update | Ausgabe 1/2020 Open Access

The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan

Serigne N. Lo, Amelia K. Smit, David Espinoza, Anne E. Cust, on behalf of the Managing Your Risk Study Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular retrognathia: study protocol for a multicenter randomized controlled trial

Yuanyuan Li, Jiali Wu, Jinghan Guo, Liming Yu, Jing Wang, Xiaoyan Li, Shuhua Xu, Min Zhu, Jinqiu Feng, Yuehua Liu

01.12.2020 | Update | Ausgabe 1/2020 Open Access

E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan

Jennifer L. Bell, Pollyanna Hardy, Melanie Greenland, Edmund Juszczak, Christina Cole, Abha Maheshwari, Siladitya Bhattacharya, Louise Linsell

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial

Tao Bai, Haoyu Zeng, Yanqin Long, Xiaoqing Li, Xiaohong Sun, Yu Lan, Lingling Gao, Lu Zhang, Zenghui Feng, Xiaohua Hou

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial

Annabel Sandra Mueller-Stierlin, Friedrich Meixner, Anne Kohlmann, Mara Schumacher, Anke Hänsel, Melanie Pouwels, Nicole Bias, Sabrina Hartl, Jessica Reichstein, Elke Prestin, Nils Greve, Thomas Becker, Reinhold Kilian

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol

Sinead Watson, Julie McMullan, Paul Brocklehurst, Georgios Tsakos, Richard G. Watt, Rebecca R. Wassall, Andrea Sherriff, Sheena E. Ramsay, Anup J. Karki, Sayaka Tada, Caroline Lappin, Michael Donaldson, Gerald McKenna

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

TILT: Time-Lapse Imaging Trial—a pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time-lapse imaging in in vitro fertilisation treatment

Priya Bhide, Arasaratnam Srikantharajah, Doris Lanz, Julie Dodds, Bonnie Collins, Javier Zamora, David Chan, Shakila Thangaratinam, Khalid S. Khan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial—study protocol for a randomized controlled trial

Matthieu Legrand, Hafid Ait Oufella, Daniel De Backer, Jacques Duranteau, Marc Leone, Bruno Levy, Patrick Rossignol, Eric Vicaut, François Dépret, for the I-MICRO trial investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of voluntary breathing exercises on stable coronary artery disease in heart rate variability and rate-pressure product: a study protocol for a single-blind, prospective, randomized controlled trial

Qing Wu, Lin Liu, Xin Jiang, Yao-Yao Hu, Qiu-Shi Liang, Zhi-Song He, Yuan Xue, Wei Zhu, Zai-Xiang Tang, Yun-Ying Hou, Qi Zhao, Xiao-Hua Wang

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial)

Yang Yang, Yuchen Su, Xiaobin Zhang, Jun Liu, Hong Zhang, Bin Li, Rong Hua, Lijie Tan, Hezhong Chen, Zhigang Li

03.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial

Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Annette Hubsch, Jane Smith, Ian B. Wilkinson, Joseph Cheriyan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial

Daniela Francescato Veiga, Edgard da Silva Garcia, José Wilson Moreira-Filho, Evelyne Borges de Mattos Andrade, Yara Juliano, Joel Veiga-Filho, Lydia Masako Ferreira

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study

Julian Doll, Stefan Waizenegger, Thomas Bruckner, Gerhard Schmidmaier, Sebastian I. Wolf, Christian Fischer

03.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial

Raquel González, Laura García-Otero, Clara Pons-Duran, Elena Marbán-Castro, Anna Goncé, Elisa Llurba, Maria del Mar Gil, Miguel Ángel Rodríguez-Zambrano, Haily Chen, Máximo Ramírez, Azucena Bardají, Clara Menendez

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial

Mohamad Hadi El Charif, Zeina Hassan, Jamal Hoballah, Mohamad Khalife, Eman Sbaity

06.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial

Mohammad Nasb, Zulfiqar Ali Sayed Shah, Liangjiang Huang, Qian Li, Hong Chen

06.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial

Atsushi Kawaguchi, Gabrielle Bernier, Jacques Lacroix, Saly El Salti, Matthew P. Cheng, Todd C. Lee, Kosar Khwaja, Philippe Jouvet

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

Janet Hardy, Alison Haywood, Gauri Gogna, Jennifer Martin, Patsy Yates, Ristan Greer, Phillip Good

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial

Delphine Meier-Girard, Karin Ribi, Gisa Gerstenberg, Thomas Ruhstaller, Ursula Wolf

07.07.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Impact of vitamins A, B, C, D, and E supplementation on improvement and mortality rate in ICU patients with coronavirus-19: a structured summary of a study protocol for a randomized controlled trial

Mohammad Taghi Beigmohammadi, Sama Bitarafan, Azin Hoseindokht, Alireza Abdollahi, Laya Amoozadeh, Maedeh Mahmoodi Ali Abadi, Morteza Foroumandi

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Registration of phase 3 crossover trials on ClinicalTrials.gov

Lijuan Zeng, Riaz Qureshi, Shilpa Viswanathan, Lea Drye, Tianjing Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Brief educational video plus telecare to enhance recovery for older emergency department patients with acute musculoskeletal pain: study protocol for the BETTER randomized controlled trial

Timothy F. Platts-Mills, Samuel A. McLean, Morris Weinberger, Sally C. Stearns, Montika Bush, Brittni B. Teresi, Karen Hurka-Richardson, Kurt Kroenke, Robert D. Kerns, Mark A. Weaver, Francis J. Keefe

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of a novel nutraceutical combination (BruMeChol™) in subjects with mild hypercholesterolemia: study protocol of a randomized, double-blind, controlled trial

Anna Rita Bonfigli, Olga Protic, Fabiola Olivieri, Alberto Montesanto, Gelsomina Malatesta, Raffaele Di Pillo, Roberto Antonicelli

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Transcutaneous electrical acupuncture stimulation (TEAS) for gastrointestinal dysfunction in adults undergoing abdominal surgery: study protocol for a prospective randomized controlled trial

Ya-Fan Bai, Chao Gao, Wen-Jing Li, Yi Du, Li-Xin An

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of intraoperative individualized PEEP on postoperative atelectasis in obese patients: study protocol for a prospective randomized controlled trial

Chen Zhu, Jing-Wen Yao, Li-Xin An, Ya-Fan Bai, Wen-Jing Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Stepped-wedge cluster randomised trial of a smoking cessation counselling training programme for midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE): a study protocol

Jeroen Bommelé, Linda Springvloet, Naïma Abouri, Karianne Djoyoadhiningrat-Hol, Margriet van Laar, Matthijs Blankers

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Outcome reporting recommendations for clinical trial protocols and reports: a scoping review

Nancy J. Butcher, Emma J. Mew, Andrea Monsour, An-Wen Chan, David Moher, Martin Offringa

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Association between recipient survival and blood donor age after blood transfusion in a surgery intensive care unit: a multicenter randomized controlled trial study protocol

Xianfei Zeng, Yan Liao, Xiaoshuang Wu, Jinmei Xu, Chenxing Da, Zhijun Tan, Fan Feng, Wen Yin, Dongjian Wang, Xingbin Hu

09.07.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study

Xi Liu, Huili Chen, Yuqi Shang, Hongqiong Zhu, Gongqi Chen, Yuanli Chen, Shaoxuan Liu, Yaoyong Zhou, Mingxing Huang, Zhongsi Hong, Jinyu Xia

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial

Olajoju Temidayo Soniran, Benjamin Abuaku, Collins Stephen Ahorlu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial

A. Lacorre, F. Vidal, S. Campagne-Loiseau, B. Marin, Y. Aubard, F. Siegerth, C. Mesnard, E. Chantalat, C. Hocke, T. Gauthier

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis

Jonathan Wickel, Ha-Yeun Chung, Stephanie Platzer, Thomas Lehmann, Harald Prüss, Frank Leypoldt, Albrecht Günther, André Scherag, Christian Geis, on behalf of the GENERATE Study Group

09.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial

Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Simon Bond, Elena Hernan-Sancho, Sam Norton, Joseph Cheriyan, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial

Clément Buléon, Jean-Jacques Parienti, Elodie Morilland-Lecoq, Laurent Halbout, Eric Cesaréo, Pierre-Yves Dubien, Benoit Jardel, Christophe Boyer, Kévin Husson, Florian Andriamirado, Xavier Benet, Emmanuel Morel-Marechal, Antoine Aubrion, Catalin Muntean, Erwan Dupire, Eric Roupie, Hervé Hubert, Christian Vilhelm, Pierre-Yves Gueugniaud, on behalf of the CILICA-HS study group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of preoperative immunonutrition on outcomes of colon cancer surgery: study protocol for a randomized controlled trial

Soo Young Lee, Seung-Seop Yeom, Chang Hyun Kim, Hyeong Rok Kim

01.12.2020 | Research | Ausgabe 1/2020 Open Access

The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial

Rebecca Lewis, Rachel Todd, Michelle Newton, Robert J. Jones, Caroline Wilson, Jenny L. Donovan, Richard T. Bryan, Alison Birtle, Emma Hall, on behalf of the POUT Trial Management Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of the extracorporeal shockwave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial

Lu Chen, Ruihao Zhou, Fuguo Sun, Yan Weng, Ling Ye, Pingliang Yang

09.07.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)—protocol of randomised controlled trial AZIQUINE-ICU

František Duška, Petr Waldauf, Milada Halačová, Václav Zvoníček, Jakub Bala, Martin Balík, Jan Beneš, Olga Klementová, Irena Kozáková, Viktor Kubricht, Anne Le Roy, Tomáš Vymazal, Veronika Řehořová, Vladimír Černý, on behalf of Czech Anaesthesia Clinical Trials and Audit Network

10.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Outpatient treatment of COVID-19 with steroids in the phase of mild pneumonia without the need for admission as an opportunity to modify the course of the disease: A structured summary of a randomised controlled trial

Miriam Saiz-Rodríguez, Teresa Peña, Lourdes Lázaro, Ángel González, Andrés Martínez, José A. Cordero, Juan T. Vicente, Fernando Richard, María Jesús Coma, Martín de Frutos, Jorge Labrador, Ana Pueyo

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial

George Asimakopoulos, Vasilios Pergialiotis, Eleni Anastasiou, Panagiotis Antsaklis, Mariana Theodora, Evangelia Vogiatzi, Aggela Kallergi, Michael Sindos, Dimitrios Loutradis, George Daskalakis

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial

Juncang Wu, Yuanchang Dai, Edward C. M. Lo, Yinliang Qi, Ya Zhang, Quan-li Li, Ruoxi Dai

13.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Test and treat COVID 65 plus - Hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of older patients with COVID19: A structured summary of a study protocol for a randomised controlled trial

Siri Göpel, Wolfgang Bethge, Peter Martus, Florian Kreth, Thomas Iftner, Stefanie Joos, Stefanie Döbele, Benjamin Mordmüller, Peter Kremsner, Thomas Ettrich, Thomas Seufferlein, Michael Bitzer, Nisar Malek

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of a smartphone application (KAIA COPD app) in combination with Activity Monitoring as a maintenance prOgram following PUlmonary Rehabilitation in COPD: the protocol for the AMOPUR Study, an international, multicenter, parallel group, randomized, controlled study

Marc Spielmanns, Tobias Boeselt, Stephan Huber, Pawandeep Kaur Bollinger, Bernhard Ulm, Anna-Maria Peckaka-Egli, Inga Jarosch, Tessa Schneeberger, Sabine Schoendorf, Rainer Gloeckl, A. Rembert Koczulla

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of high-protein diet combined with exercise to counteract frailty in pre-frail and frail community-dwelling older adults: study protocol for a three-arm randomized controlled trial

Sussi F. Buhl, Anne Marie Beck, Britt Christensen, Paolo Caserotti

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of a pre- and post-operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial

Roisin Tully, Lisa Loughney, Jarlath Bolger, Jan Sorensen, Oliver McAnena, Chris G. Collins, Paul A. Carroll, Mayilone Arumugasamy, Tomas J. Murphy, William B. Robb, on behalf of the PERIOP OG Working Group

14.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial

Keisha Smith, Amy Pace, Stephan Ortiz, Shamsah Kazani, Scott Rottinghaus

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

Junhao Zhu, Chao Tang, Zixiang Cong, Jin Yang, Xiangming Cai, Yuxiu Liu, Chiyuan Ma

15.07.2020 | COVID-19 | Correction | Ausgabe 1/2020 Open Access

Correction to: ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial

Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Annette Hubsch, Jane Smith, Ian B. Wilkinson, Joseph Cheriyan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Where is an emotion? Using targeted visceroception as a method of improving emotion regulation in healthy participants to inform suicide prevention initiatives: a randomised controlled trial

Steven Davey, Elliot Bell, Jamin Halberstadt, Sunny Collings

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients

Verena Scheper, Melanie Schmidtheisler, Florian Lasch, Heiko von der Leyen, Armin Koch, Jana Schwieger, Andreas Büchner, Anke Lesinski-Schiedat, Thomas Lenarz

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design

Vicky Chalos, Rob A. van de Graaf, Bob Roozenbeek, Adriaan C. G. M. van Es, Heleen M. den Hertog, Julie Staals, Lukas van Dijk, Sjoerd F.M. Jenniskens, Robert J. van Oostenbrugge, Wim H. van Zwam, Yvo B.W.E.M. Roos, Charles B.L.M. Majoie, Hester F. Lingsma, Aad van der Lugt, Diederik W.J. Dippel, on behalf of the MR CLEAN-MED investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study

Hong-Bai Wang, Liang Zhang, Zhe Zhang, Su Yuan, Fu-Xia Yan, Qi-Peng Luo

15.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial

Justin T. Denholm, Joshua Davis, David Paterson, Jason Roberts, Susan Morpeth, Thomas Snelling, Dominica Zentner, Megan Rees, Matthew O’Sullivan, David Price, Asha Bowen, Steven Y. C. Tong, for the ASCOT Investigator Group

15.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada

Julie K. Wright, Darrell H. S. Tan, Sharon L. Walmsley, Jennifer Hulme, Erin O’Connor, Carolyn Snider, Ivy Cheng, Adrienne K. Chan, Bjug Borgundvaag, Shelley McLeod, Michael H. Gollob, Rosemarie J. Clarke, Linda Dresser, Fatima Haji, Tony Mazzulli, Samira Mubareka, Peter Jüni, Dominic Lee, George Tomlinson, Kevin C. Kain, Megan Landes

15.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial

Ka Sing Paris Lai, Christine Watt, Emily Ionson, Imants Baruss, Cheryl Forchuk, Javeed Sukhera, Amer M. Burhan, Akshya Vasudev

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (the SEcReT study): protocol for a randomised controlled pilot study

Jacqueline M. S. Pengelly, Alistair G. Royse, Adam L. Bryant, Gavin P. Williams, Lynda J. Tivendale, Timothy J. Dettmann, David J. Canty, Colin F. Royse, Doa A. El-Ansary

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength

Ebaa Al Ozairi, Dalal Alsaeed, Dennis Taliping, Mohamad Jalali, Abeer El Samad, Anant Mashankar, Etab Taghadom, Nicola Guess, Jason M. R. Gill, Naveed Sattar, Cindy Gray, Paul Welsh, Stuart R. Gray

01.12.2020 | Update | Ausgabe 1/2020 Open Access

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan

Andrew Lawson, Justine Naylor, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Jai Sungaran, Kim Latendresse, James Wong, Sameer Viswanathan, Keith Landale, Herwig Drobetz, Phong Tran, Richard Page, Raphael Hau, Jonathan Mulford, Ian Incoll, Michael Kale, Bernard Schick, Andrew Higgs, Andrew Oppy, Diana Perriman, Ian Harris

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial: statistical analysis plan

Patrick Muller, Kashfia Chowdhury, Caroline Gordon, Michael R. Ehrenstein, Caroline J. Doré

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Process evaluation of a complex intervention to promote advance care planning in community-dwelling older persons (the STADPLAN study)—study protocol

Katharina Silies, Rieke Schnakenberg, Almuth Berg, Änne Kirchner, Henriette Langner, Juliane Köberlein-Neu, Gabriele Meyer, Falk Hoffmann, Sascha Köpke

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men

Tyler B. Wray, Philip A. Chan, Jeffrey D. Klausner, Leandro A. Mena, James B. Brock, Erik M. Simpanen, Lori M. Ward, Stafylis Chrysovalantis

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial

Damaris Ortiz, Ashley D. Meagher, Heidi Lindroth, Emma Holler, Sujuan Gao, Babar Khan, Sue Lasiter, Malaz Boustani, Ben Zarzaur

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Report of a Delphi exercise to inform the design of a research programme on screening for thoracic aortic disease

R. G. Abbasciano, J. Barwell, R. Sayers, M. Bown, D. Milewicz, G. Cooper, G. Mariscalco, N. Wheeldon, C. Fowler, G. Owens, G. J. Murphy, on behalf of the Aortic Dissection Awareness Day UK 2019 Working Group

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Whey protein supplementation reducing fasting levels of anandamide and 2-AG without weight loss in pre-menopausal women with obesity on a weight-loss diet

Fatemeh Haidari, Vahideh Aghamohammadi, Majid Mohammadshahi, Kambiz Ahmadi-Angali, Mohammad Asghari-Jafarabadi

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials

Nigel Kirby, Victoria Shepherd, Jeremey Howick, Sophie Betteridge, Kerenza Hood

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention—MACUSTAR

Jan H. Terheyden, Frank G. Holz, Steffen Schmitz-Valckenberg, Anna Lüning, Matthias Schmid, Gary S. Rubin, Hannah Dunbar, Adnan Tufail, David P. Crabb, Alison Binns, Clara I. Sánchez, Carel Hoyng, Philippe Margaron, Nadia Zakaria, Mary Durbin, Ulrich Luhmann, Parisa Zamiri, José Cunha-Vaz, Cecília Martinho, Sergio Leal, Robert P. Finger, on behalf of the MACUSTAR consortium

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer’s disease: study protocol for a randomised controlled trial (ELAD study)

Grazia Daniela Femminella, Eleni Frangou, Sharon B. Love, Gail Busza, Clive Holmes, Craig Ritchie, Robert Lawrence, Brady McFarlane, George Tadros, Basil H. Ridha, Carol Bannister, Zuzana Walker, Hilary Archer, Elizabeth Coulthard, Ben R. Underwood, Aparna Prasanna, Paul Koranteng, Salman Karim, Kehinde Junaid, Bernadette McGuinness, Ramin Nilforooshan, Ajay Macharouthu, Andrew Donaldson, Simon Thacker, Gregor Russell, Naghma Malik, Vandana Mate, Lucy Knight, Sajeev Kshemendran, John Harrison, Christian Hölscher, David J. Brooks, Anthony Peter Passmore, Clive Ballard, Paul Edison

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis, people experiencing other mental health problems and for informal carers: Narrative Experiences Online (NEON) study protocol for three randomised controlled trials

Stefan Rennick-Egglestone, Rachel Elliott, Melanie Smuk, Clare Robinson, Sylvia Bailey, Roger Smith, Jeroen Keppens, Hannah Hussain, Kristian Pollock, Pim Cuijpers, Joy Llewellyn-Beardsley, Fiona Ng, Caroline Yeo, James Roe, Ada Hui, Lian van der Krieke, Rianna Walcott, Mike Slade

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Use of olanzapine to treat agitation in traumatic brain injury: study protocol for a randomised controlled trial

Ruby K Phyland, Adam McKay, John Olver, Mark Walterfang, Malcolm Hopwood, Amelia J Hicks, Duncan Mortimer, Jennie L Ponsford

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effectiveness of the level of personal relevance of visual autobiographical stimuli in the induction of positive emotions in young and older adults: pilot study protocol for a randomized controlled trial

Dolores Fernández, Laura Ros, Roberto Sánchez-Reolid, Jorge Javier Ricarte, José Miguel Latorre

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial

Kete M. Klaver, Saskia F. A. Duijts, Chantal A. V. Geusgens, Maureen J. B. Aarts, Rudolf W. H. M. Ponds, Allard J. van der Beek, Sanne B. Schagen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Adaptive interventions for optimizing malaria control: an implementation study protocol for a block-cluster randomized, sequential multiple assignment trial

Guofa Zhou, Ming-chieh Lee, Harrysone E. Atieli, John I. Githure, Andrew K. Githeko, James W. Kazura, Guiyun Yan

21.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial

Mary Daval, Alain Corré, Clement Palpacuer, Juliette Housset, Guillaume Poillon, Michael Eliezer, Benjamin Verillaud, Dorsaf Slama, Denis Ayache, Philippe Herman, Clement Jourdaine, Camille Hervé, Wissame El Bakkouri, Dominique Salmon, Charlotte Hautefort

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication

Ioana R. Marian, Esther Williamson, Angela Garrett, Sarah E. Lamb, Susan J. Dutton

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Overrunning in clinical trials: some thoughts from a methodological review

Ileana Baldi, Danila Azzolina, Nicola Soriani, Beatrice Barbetta, Paola Vaghi, Giampaolo Giacovelli, Paola Berchialla, Dario Gregori

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial

Weiming Hao, Liping Zhao, Huiqian Yu, Huawei Li

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Treatment fidelity in the Tinnitus Retraining Therapy Trial

Roberta W. Scherer, Sue Ann Erdman, Susan Gold, Craig Formby, for the TRTT Research Group

01.12.2020 | Review | Ausgabe 1/2020 Open Access

A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?

M. Mitroiu, K. Oude Rengerink, S. Teerenstra, F. Pétavy, K. C. B. Roes

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Community Tele-pal: A community-developed, culturally based palliative care tele-consult randomized controlled trial for African American and White Rural southern elders with a life-limiting illness

Kristen Allen Watts, Shena Gazaway, Emily Malone, Ronit Elk, Rodney Tucker, Susan McCammon, Michele Goldhagen, Jacob Graham, Veronica Tassin, Joshua Hauser, Sidney Rhoades, Marjorie Kagawa-Singer, Eric Wallace, James McElligott, Richard Kennedy, Marie Bakitas

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of brief dynamic interpersonal therapy in patients with major depressive disorder: a prospective, multicenter randomized controlled trial protocol

Lanlan Wang, Qian Wang, Wenhui Jiang, Jianfeng Luo, Jun Tong, Xiaosi Li, Fang Fang, Hongyan Wang, Wenqing Zhao, Diana Koszycki, Jianyin Qiu

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Communities for Healthy Living (CHL) A Community-based Intervention to Prevent Obesity in Low-Income Preschool Children: Process Evaluation Protocol

Jacob P. Beckerman-Hsu, Alyssa Aftosmes-Tobio, Adam Gavarkovs, Nicole Kitos, Roger Figueroa, Z. Begum Kalyoncu, Kindra Lansburg, Xinting Yu, Crystal Kazik, Adrienne Vigilante, Jessie Leonard, Merieka Torrico, Janine M. Jurkowski, Kirsten K. Davison

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA

Ramtin Talebi, Rita F. Redberg, Joseph S. Ross

01.12.2020 | Update | Ausgabe 1/2020 Open Access

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)

Sylke Haal, Maimoena S. S. Guman, L. Maurits de Brauw, Ruben N. van Veen, Ruben Schouten, Paul Fockens, Victor E. A. Gerdes, Marcel G. W. Dijkgraaf, Rogier P. Voermans

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Rationale and design of individualized quality improvement based on the Computer Analysing system to improve Stroke management quality Evaluation (CASE): a multicenter historically controlled study

Yi Chen, Wansi Zhong, Xiaoxian Gong, Haitao Hu, Shenqiang Yan, Xuting Zhang, Zhicai Chen, Ying Zhou, Min Lou

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088)

Igor Monsellato, Elisabetta Garibaldi, Elisa Cassinotti, Ludovica Baldari, Luigi Boni, Ugo Elmore, Roberto Delpini, Riccardo Rosati, Roberto Perinotti, Filippo Alongi, Elisa Bertocchi, Stefania Gori, Giacomo Ruffo, Graziano Pernazza, Fabio Pulighe, Carlo De Nisco, Emilio Morpurgo, Tania Contardo, Enzo Mammano, Federico Perna, Benedetta Menegatti, Andrea Coratti, Piero Buccianti, Riccardo Balestri, Cristina Ceccarelli, Davide Cavaliere, Leonardo Solaini, Giorgio Ercolani, Elena Traverso, Vittorio Fusco, Valter Torri, Sara Orecchia

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of acupuncture for treatment of intermittent claudication in patients with degenerative lumbar spinal stenosis: protocol for a randomized controlled trial

Jing Zhou, Sixing Liu, Yuanjie Sun, Weiming Wang, Zhishun Liu

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study

Neema Toto, Elaine Douglas, Markus Gmeiner, Lynn K. Barrett, Robert Lindblad, Lumbani Makhaza, Wilfred Nedi, Jacob Phulusa, Gerald V. Quinnan, Leigh A. Sawyer, Herbert Thole, Wesley C. Van Voorhis, Pui-Ying Iroh Tam

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Accuracy of time to treatment estimates in the CRASH-3 clinical trial: impact on the trial results

Raoul Mansukhani, Lauren Frimley, Haleema Shakur-Still, Linda Sharples, Ian Roberts

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial

Carlos Bernal-Utrera, Juan Jose Gonzalez-Gerez, Ernesto Anarte-Lazo, Cleofas Rodriguez-Blanco

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Intermittent theta burst stimulation (iTBS) combined with working memory training to improve cognitive function in schizophrenia: study protocol for a randomized controlled trial

Jiaqi Song, Dan Liu, Meng Zhang, Huiqiu Wang, Shuping Tan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial

Xiaoyan Xie, Danghan Xu, Lixing Zhuang, Hui Liu, Sui Tan, Yanqing Lu, Meiyi Su, Jie Chen, Haihua Pan, Lu Lu, Yiming Xu, Muxi Liao, Zhanqiong Xu, Jun He

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of high-dose versus low-dose vitamin D supplementation on serum levels of inflammatory factors and mortality rate in severe traumatic brain injury patients: study protocol for a randomized placebo-controlled trial

Seyed Mostafa Arabi, Alireza Sedaghat, Mohammad Reza Ehsaei, Mohammad Safarian, Golnaz Ranjbar, Hamid Rezaee, Reza Rezvani, Hamed Tabesh, Abdolreza Norouzy

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Research on allergic rhinitis improvement in asthmatic children after dust mite exposure reduction: a randomized, double-blind, cross-placebo study protocol

Ming Chen, YuFen Wu, Shuhua Yuan, Jiande Chen, Luanluan Li, Jinhong Wu, Jing Zhang, Yong Yin

30.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

RECOVERY- Respiratory Support: Respiratory Strategies for patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow Nasal Oxygen, and standard care: A structured summary of a study protocol for a randomised controlled trial

Gavin D. Perkins, Keith Couper, Bronwen Connolly, J. Kenneth Baillie, Judy M. Bradley, Paul Dark, Anthony De Soyza, Ellen Gorman, Alasdair Gray, Louisa Hamilton, Nicholas Hart, Chen Ji, Ranjit Lall, Nicola McGowan, Scott Regan, Anita K. Simonds, Emma Skilton, Nigel Stallard, Emily Stimpson, Joyce Yeung, Daniel F. McAuley

30.07.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial

Berta Grau-Pujol, Daniel Camprubí, Helena Marti-Soler, Marc Fernández-Pardos, Caterina Guinovart, Jose Muñoz

03.08.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial

Oriana Nanni, Pierluigi Viale, Bernadette Vertogen, Claudia Lilli, Chiara Zingaretti, Caterina Donati, Carla Masini, Manuela Monti, Patrizia Serra, Roberto Vespignani, Veruska Grossi, Annibale Biggeri, Emanuela Scarpi, Francesca Galardi, Lucia Bertoni, Americo Colamartini, Fabio Falcini, Mattia Altini, Ilaria Massa, Raffaella Gaggeri, Giovanni Martinelli

03.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial

Ing Ni Lu, Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Sonakshi Kadyan, Simon Bond, Sam Norton, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson, Joseph Cheriyan

03.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trial

Tom Wilkinson, Rupert Dixon, Clive Page, Miles Carroll, Gareth Griffiths, Ling-Pei Ho, Anthony De Soyza, Timothy Felton, Keir E. Lewis, Karen Phekoo, James D. Chalmers, Anthony Gordon, Lorcan McGarvey, Jillian Doherty, Robert C. Read, Manu Shankar-Hari, Nuria Martinez-Alier, Michael O’Kelly, Graeme Duncan, Roelize Walles, James Sykes, Charlotte Summers, Dave Singh, on behalf of the ACCORD Collaborators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Brief motivational therapy versus enhanced usual care for alcohol use disorders in primary care in Chile: study protocol for an exploratory randomized trial

Nicolas A. Barticevic, Fernando Poblete, Soledad M. Zuzulich, Victoria Rodriguez, Laura Bradshaw

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial

Letícia de Azevedo Ferreira, Fátima Faní Fitz, Márcia Maria Gimenez, Mayanni Magda Pereira Matias, Maria Augusta Tezelli Bortolini, Rodrigo Aquino Castro

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process

Miles D. Witham, Eleanor Anderson, Camille Carroll, Paul M. Dark, Kim Down, Alistair S. Hall, Joanna Knee, Rebecca H. Maier, Gail A. Mountain, Gary Nestor, Laurie Oliva, Sarah R. Prowse, Amanda Tortice, James Wason, Lynn Rochester, On behalf of the INCLUDE writing group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial

Giovanni Ostuzzi, Chiara Gastaldon, Angelo Barbato, Barbara D’Avanzo, Mauro Tettamanti, Igor Monti, Andrea Aguglia, Eugenio Aguglia, Maria Chiara Alessi, Mario Amore, Francesco Bartoli, Massimo Biondi, Paola Bortolaso, Camilla Callegari, Giuseppe Carrà, Rosangela Caruso, Simone Cavallotti, Cristina Crocamo, Armando D’Agostino, Pasquale De Fazio, Chiara Di Natale, Laura Giusti, Luigi Grassi, Giovanni Martinotti, Michela Nosé, Davide Papola, Marianna Purgato, Alessandro Rodolico, Rita Roncone, Lorenzo Tarsitani, Giulia Turrini, Elisa Zanini, Francesco Amaddeo, Mirella Ruggeri, Corrado Barbui

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study)

Maxime Billot, Nicolas Naiditch, Claire Brandet, Bertille Lorgeoux, Sandrine Baron, Amine Ounajim, Manuel Roulaud, Aline Roy-Moreau, Géraldine de Montgazon, Elodie Charrier, Lorraine Misbert, Benjamin Maillard, Tanguy Vendeuvre, Philippe Rigoard

01.12.2020 | Commentary | Ausgabe 1/2020 Open Access

Who knew? The misleading specificity of “double-blind” and what to do about it

Thomas A. Lang, Donna F. Stroup

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Does propolis affect the quality of life and complications in subjects with irritable bowel syndrome (diagnosed with Rome IV criteria)? A study protocol of the randomized, double-blinded, placebo-controlled clinical trial

Mahsa Miryan, Pezhman Alavinejad, Mohammadreza Abbaspour, Davood Soleimani, Alireza Ostadrahimi

06.08.2020 | SARS-CoV-2 | Letter | Ausgabe 1/2020 Open Access

A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial

Miguel Rodríguez-Rubio, Juan Carlos Figueira, Darío Acuña-Castroviejo, Alberto M. Borobia, Germaine Escames, Pedro de la Oliva

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: A nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: a study protocol for a randomized controlled trial

Shuanglan Lin, Lily Dongxia Xiao, Diane Chamberlain

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial

Ying Zhang, Zuohui Liang, Shihua Li, Ling Yang, Taipin Guo, Yan Xu, Juanjuan Yang, Qiannan Xu, Qing Zhang, Jian Zhao, Cailian Li, Xiuhong Liu

10.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial

Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan

10.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial

Abdulrahman E. Koshak, Emad A. Koshak, Abdullah F. Mobeireek, Mazen A. Badawi, Siraj O. Wali, Husam M. Malibary, Ali F. Atwah, Meshari M. Alhamdan, Reem A. Almalki, Tariq A. Madani

10.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19): structured summary of a study protocol for a randomised controlled trial

Greg J. Elder, Pamela Alfonso-Miller, William C. M. Atkinson, Nayantara Santhi, Jason G. Ellis

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Using electroacupuncture to recover muscle strength in patients with knee osteoarthritis after total knee arthroplasty: a study protocol for a double-blinded, randomized, and placebo-controlled trial

Hui Xu, Bingxin Kang, Yulin Li, Jun Xie, Songtao Sun, Sheng Zhong, Chenxin Gao, Xirui Xu, Chi Zhao, Guowei Qiu, Lianbo Xiao

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Recruitment and retention of mothers of preschoolers and school-aged children in a social media-delivered healthy eating intervention: lessons learned from a randomized controlled trial

Audrée-Anne Dumas, Simone Lemieux, Annie Lapointe, Véronique Provencher, Julie Robitaille, Sophie Desroches

01.12.2020 | Correction | Ausgabe 1/2020 Open Access

Correction to: Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial

Sarah Prentice, Emily L. Webb, Hazel M. Dockrell, Pontiano Kaleebu, Alison M. Elliott, Stephen Cose

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multi-center, double-blind, randomized controlled trial in China

Xiaoke Li, Ludan Zhang, Mei Qiu, Yi Huang, Huanming Xiao, Bingjiu Lu, Yuyong Jiang, Fuli Long, Hui Lin, Jinyu He, Qikai Wu, Mingxiang Zhang, Li Wang, Xiaoning Zhu, Man Gong, Xuehua Sun, Jianguang Sun, Fengxia Sun, Wei Lu, Weihua Xu, Guang Chen, Zhiguo Li, Danan Gan, Xianzhao Yang, Hongbo Du, Yong’an Ye

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effects of “Thursdays at the Museum” at the Montreal Museum of Fine Arts on the mental and physical health of older community dwellers: the art-health randomized clinical trial protocol

Olivier Beauchet, Liam Cooper-Brown, Yoko Hayashi, Kevin Galery, Christine Vilcocq, Thomas Bastien

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial

Jeanne A. Teresi, Stephanie Silver, Mildred Ramirez, Jian Kong, Joseph P. Eimicke, Gabriel D. Boratgis, Rhoda Meador, Leslie Schultz, Mark S. Lachs, Karl A. Pillemer

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

IMMPACT-recommended outcome measures and tools of assessment in burning mouth syndrome RCTs: an international Delphi survey protocol

B. Carey, A. M. Farag, C. Nasri-Heir, G. D. Klasser, A. Ariyawardana, M. Chmieliauskaite, A. Sardella, C. R. Carlson, C. S. Miller, L. Mejia, F. E. O’Neill, R. Albuquerque

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials

Sheila Sprague, Taryn Scott, Shannon Dodds, David Pogorzelski, Paula McKay, Anthony D. Harris, Amber Wood, Lehana Thabane, Mohit Bhandari, Samir Mehta, Greg Gaski, Christina Boulton, Francesc Marcano-Fernández, Ernesto Guerra-Farfán, Joan Hebden, Lyndsay M. O’Hara, Gerard P. Slobogean, on behalf of the PREP-IT Investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial

Alon Kalron, Anat Achiron, Massimiliano Pau, Eleonora Cocco

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation

Dee Mangin, Larkin Lamarche, Doug Oliver, Sivan Bomze, Sayem Borhan, Tracy Browne, Tracey Carr, Julie Datta, Lisa Dolovich, Michelle Howard, Sarah Marentette-Brown, Cathy Risdon, Samina Talat, Jean-Eric Tarride, Lehana Thabane, Ruta Valaitis, David Price

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of Mental Health First Aid from the Perspective Of Workplace End UseRs—EMPOWER: protocol of cluster randomised trial phase

Opeyemi Atanda, Patrick Callaghan, Tim Carter, Graham Durcan, Nick O’Shea, Steve D. Brown, Paula Reavey, Eleni Vangeli, Sarah White, Kerry V. Wood

01.12.2020 | Methodology | Ausgabe 1/2020 Open Access

Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population

Kiley B. Vander Wyst, Micah L. Olson, Elva Hooker, Erica G. Soltero, Yolando P. Konopken, Colleen S. Keller, Felipe G. Castro, Allison N. Williams, Arlene D. R. Fernández, Donald L. Patrick, Stephanie L. Ayers, Houchun H. Hu, Armando Peña, Janiel Pimentel, William C. Knowler, Gabriel Q. Shaibi

17.08.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial

Jesús Villar, José M. Añón, Carlos Ferrando, Gerardo Aguilar, Tomás Muñoz, José Ferreres, Alfonso Ambrós, César Aldecoa, Fernando Suárez-Sipmann, Kevin E. Thorpe, Peter Jüni, Arthur S. Slutsky, the DEXA-COVID19 Network

18.08.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial

Timothy S. C. Hinks, Vicki S. Barber, Joanna Black, Susan J. Dutton, Maisha Jabeen, James Melhorn, Najib M Rahman, Duncan Richards, Daniel Lasserson, Ian D. Pavord, Mona Bafadhel

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Prednisone for patients with recurrent implantation failure: study protocol for a double-blind, multicenter, randomized, placebo-controlled trial

Yao Lu, Junhao Yan, Jiayin Liu, Jichun Tan, Yan Hong, Daimin Wei, Zi-jiang Chen, Yun Sun

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial

Sanne Toft Kristiansen, Poul Videbech, Merete Bender Bjerrum, Erik Roj Larsen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial

Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Peter D. Moriarty, Fares S. Haddad

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial

Rindra Vatosoa Randremanana, Mihaja Raberahona, Mamy Jean de Dieu Randria, Minoarisoa Rajerison, Voahangy Andrianaivoarimanana, Agathe Legrand, Tsinjo Fehizoro Rasoanaivo, Ravaka Randriamparany, Théodora Mayouya-Gamana, Reziky Mangahasimbola, Josie Bourner, Alex Salam, Annelies Gillesen, Tansy Edwards, Matthieu Schoenhals, Laurence Baril, Peter Horby, Piero Olliaro

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Integrative medicine rehabilitation for children with cerebral palsy: a study protocol for a multicenter pragmatic randomized controlled trial

Mi-Joo Lee, Young-Ju Yun, Sun-ae Yu, Yong-Beom Shin, Soo-Yeon Kim, Jun-hee Han

18.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Multi-centre, three arm, randomized controlled trial on the use of methylprednisolone and unfractionated heparin in critically ill ventilated patients with pneumonia from SARS-CoV-2 infection: A structured summary of a study protocol for a randomised controlled trial

Stefano Busani, Martina Tosi, Pasquale Mighali, Paola Vandelli, Roberto D’Amico, Marco Marietta, Francesco Forfori, Abele Donati, Gilda Cinnella, Amato De Monte, Daniela Pasero, Giacomo Bellani, Carlo Tascini, Giuseppe Foti, Marco Ranieri, Massimo Girardis

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial

Geoffrey P. Wilkin, Stéphane Poitras, John Clohisy, Etienne Belzile, Ira Zaltz, George Grammatopoulos, Gerd Melkus, Kawan Rakhra, Tim Ramsay, Kednapa Thavorn, Paul E. Beaulé

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial

Stefan J. Schaller, Kristina Fuest, Bernhard Ulm, Sebastian Schmid, Catherina Bubb, Rüdiger von Eisenhart-Rothe, Helmut Friess, Chlodwig Kirchhoff, Thomas Stadlbauer, Peter Luppa, Manfred Blobner, Bettina Jungwirth

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial—a trial protocol

Alexander Rombauts, Gabriela Abelenda-Alonso, Antonella Francesca Simonetti, Guillermo Verdejo, Yolanda Meije, Lucia Ortega, Mercedes Clemente, Jordi Niubó, Yolanda Ruiz, Carlota Gudiol, Cristian Tebé, Sebastian Videla, Jordi Carratalà

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design

Junjie Yang, Dongkai Shan, Mei Dong, Zhiqiang Wang, Xiang Ma, Xinyang Hu, Hesong Zeng, Yundai Chen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial

Sanaz Barghamadi, Zainab Alimoardi, Terry Oleson, Nasim Bahrami

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol—a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of “high-intensity” vs. “low-intensity” smoking cessation intervention in active smokers with chronic obstructive pulmonary disease

Mohamad Isam Saeed, Pradeesh Sivapalan, Josefin Eklöf, Charlotte Suppli Ulrik, Charlotta Pisinger, Therese Lapperre, Philip Tønnesen, Nils Hoyer, Julie Janner, Marie Lavesen Karlsson, Charlotte Sandau Bech, Kristoffer Marså, Nina Godtfredsen, Eva Brøndum, Birgit Munk, Merete Raaschou, Andrea Browatzski, Pernille Lütken, Jens-Ulrik Stæhr Jensen

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)—rationale and design for an international collaborative study

Benjamin Kasenda, Junhao Liu, Yu Jiang, Byron Gajewski, Cen Wu, Erik von Elm, Stefan Schandelmaier, Giusi Moffa, Sven Trelle, Andreas Michael Schmitt, Amanda K. Herbrand, Viktoria Gloy, Benjamin Speich, Sally Hopewell, Lars G. Hemkens, Constantin Sluka, Kris McGill, Maureen Meade, Deborah Cook, Francois Lamontagne, Jean-Marc Tréluyer, Anna-Bettina Haidich, John P. A. Ioannidis, Shaun Treweek, Matthias Briel

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Development of a Core outcome set for fetal Myelomeningocele (COSMiC): study protocol

Samar Altoukhi, Clare L. Whitehead, Greg Ryan, Jan Deprest, Luc Joyeux, Katie Gallagher, James Drake, Paige Church, Daphne Horn, Yenge Diambomba, Jose C. A. Carvalho, Tim Van Mieghem

24.08.2020 | COVID-19 | Correction | Ausgabe 1/2020 Open Access

Correction to: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection: A structured summary of a study protocol for a randomized controlled trial

Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan

25.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials

Jonathan A. C. Sterne, Janet Diaz, Jesús Villar, Srinivas Murthy, Arthur S. Slutsky, Anders Perner, Peter Jüni, Derek C. Angus, Djillali Annane, Luciano Cesar Pontes Azevedo, Bin Du, Pierre-Francois Dequin, Anthony C. Gordon, Cameron Green, Julian P. T. Higgins, Peter Horby, Martin J. Landray, Giuseppe Lapadula, Amelie Le Gouge, Marie Leclerc, Jelena Savović, Bruno Tomazini, Balasubramanian Venkatesh, Steve Webb, John C. Marshall, for the WHO COVID-19 Clinical Management and Characterization Working Group

01.12.2020 | Update | Ausgabe 1/2020 Open Access

A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan

Anna Heath, Juan David Rios, Sarah Williamson-Urquhart, Petros Pechlivanoglou, Martin Offringa, Christopher McCabe, Gareth Hopkin, Amy C. Plint, Andrew Dixon, Darcy Beer, Serge Gouin, Gary Joubert, Terry P. Klassen, Stephen B. Freedman, on behalf of the PERC-KIDSCAN DOSE-AGE Study Group

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial

Lilisbeth Perestelo-Pérez, Yolanda Álvarez-Pérez, Amado Rivero-Santana, Vanesa Ramos-García, Andrea Duarte-Díaz, Alezandra Torres-Castaño, Ana Toledo-Chávarri, Mario Herrera-Perez, José Luis País-Brito, José Carlos del Castillo, José Ramón Vázquez, Carola Orrego, Pedro Serrano-Aguilar

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Impact of the Maternal and Child Health handbook in Angola for improving continuum of care and other maternal and child health indicators: study protocol for a cluster randomised controlled trial

Olukunmi Omobolanle Balogun, Caroline Kaori Tomo, Keiji Mochida, Masashi Mikami, Henda da Rosa Vasconcelos, Isilda Neves, Hisakazu Hiraoka, Hirotsugu Aiga, Rintaro Mori, Kenji Takehara

25.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Impact of Shenfu injection on a composite of organ dysfunction development in critically ill patients with coronavirus disease 2019 (COVID-19): A structured summary of a study protocol for a randomized controlled trial

Zong-Yu Wang, Shou-Zhi Fu, Liang Xu, Shu-Sheng Li, Ke-Jian Qian, Xian-Di He, Guo-Chao Zhu, Liang-Hai Li, Jun Zhang, Wen-Fang Li, Bing-Yu Qin, Chen-Liang Zhou, Peng-Lin Ma

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial

Liu Liu, Yi Lu, Xiao-ning Yan, Su-qing Yang, Li-ping Gong, Ling-e Li, Yi-ding Zhao, Qing-feng Yin, Rui-ping Wang, Yue-peng An, Gang Huang, Jin-fang Zhang, Xiao-ying Sun, Xin Li, Bin Li

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients—a protocol for the prospective randomized controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study

Simona Reinhold, Desirée Yeginsoy, Alexa Hollinger, Atanas Todorov, Lionel Tintignac, Michael Sinnreich, Caroline Kiss, Caroline E. Gebhard, Balázs Kovács, Bianca Gysi, Lara Imwinkelried, Martin Siegemund

01.12.2020 | Update | Ausgabe 1/2020 Open Access

The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan

Mark A Jones, Todd Graves, Bianca Middleton, James Totterdell, Thomas L Snelling, Julie A Marsh

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial

Veronika Markova, Rebecka Hansen, Lars Lykke Thomsen, Anja Pinborg, Torben Moos, Charlotte Holm

27.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial

Luis Patricio Maskin, Gabriel Leonardo Olarte, Fernando Palizas Jr, Agostina E. Velo, María Fernanda Lurbet, Ignacio Bonelli, Natalio D. Baredes, Pablo Oscar Rodríguez

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

“Protocol for a phase 2, randomized, double-blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction”: study protocol for a randomized controlled trial

Dirk von Lewinski, Joseph B. Selvanayagam, Richard A. Schatz, Bernd Jilma, Jacek Kubica, Thomas J. Povsic, Darrell Nix, Stephan Henauer, Markus Wallner, on behalf of the REC-DUT-002 study group

01.12.2020 | Research | Ausgabe 1/2020 Open Access

Delivery of a Mental Health First Aid training package and staff peer support service in secondary schools: a process evaluation of uptake and fidelity of the WISE intervention

Harriet Fisher, Sarah Harding, Sarah Bell, Lauren Copeland, Rhiannon Evans, Jillian Powell, Ricardo Araya, Rona Campbell, Tamsin Ford, David Gunnell, Simon Murphy, Judi Kidger

27.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Pär Ingemar Johansson, Morten Bestle, Peter Søe-Jensen, Klaus Tjelle Kristiansen, Jakob Stensballe, Niels Erikstrup Clausen, Anders Perner

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

The effect of psychoeducational intervention, based on a self-regulation model on menstrual distress in adolescents: a protocol of a randomized controlled trial

Somayeh Asgari, Zainab Alimoardi, Mohammad Ali Soleimani, Kelly-Ann Allen, Nasim Bahrami

28.08.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial

Madunil A. Niriella, Dileepa S. Ediriweera, Arjuna P. De Silva, Ranjan Premarathne, Priyantha Balasooriya, Kaluthanthri D. Duminda, Neelika G. Malavige, Kamani Wanigasuriya, Sarath Lekamwasam, Senanayake A. Kularathne, Sisira Siribaddana, Hithanadura J. de Silva, Saroj Jayasinghe

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Rivaroxaban compared to no treatment in ER-negative stage I–III early breast cancer patients (the TIP Trial): study protocol for a phase II preoperative window-of-opportunity study design randomised controlled trial

John Castle, Emma Blower, Nigel J. Bundred, James R. Harvey, Jecko Thachil, Andrea Marshall, Karina Cox, Silvia Cicconi, Chris Holcombe, Carlos Palmieri, Cliona C. Kirwan

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy of Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to) for patients with hyperlipidemia: a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial

Boram Lee, Kyungsun Han, Hyo-Ju Park, Ae-Ran Kim, O-Jin Kwon, Changsop Yang, Chung-Sik Cho

28.08.2020 | COVID-19 | Study protocol | Ausgabe 1/2020 Open Access

Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial

Shuaipan Zhang, Qingguang Zhu, Chao Zhan, Wei Cheng, Xiao Mingfang, Min Fang, Lei Fang

01.12.2020 | Review | Ausgabe 1/2020 Open Access

Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review

Ahmed A. Al-Jaishi, Kelly Carroll, Cory E. Goldstein, Stephanie N. Dixon, Amit X. Garg, Stuart G. Nicholls, Jeremy M. Grimshaw, Charles Weijer, Jamie Brehaut, Lehana Thabane, P. J. Devereaux, Monica Taljaard

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Evaluation of the efficacy and safety of the use of acupuncture for the adjuvant treatment of patients with post-stroke cognitive impairment: protocol for a randomized controlled trial

Ruijia Liu, Xudong Yu, Jisheng Wang, Ye Liu, Bowen Liu, Xinwei Li, Yue Wang, Tianyu Cao, Hongwei Yuan

31.08.2020 | COVID-19 | Letter | Ausgabe 1/2020 Open Access

Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial

Bharath Kumar Tirupakuzhi Vijayaraghavan, Vivekanand Jha, Dorrilyn Rajbhandari, Sheila Nainan Myatra, Oommen John, Arpita Ghosh, Abhinav Bassi, Sumaiya Arfin, Mallikarjuna Kunigari, Rohina Joshi, Lachlan Donaldson, Naomi Hammond, Balasubramanian Venkatesh, the HOPE investigators

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Efficacy, safety and cost-effectiveness of a web-based platform delivering the results of a biomarker-based predictive model of biotherapy response for rheumatoid arthritis patients: a protocol for a randomized multicenter single-blind active controlled clinical trial (PREDIRA)

Dalifer Freites-Núñez, Athan Baillet, Luis Rodriguez-Rodriguez, Minh Vu Chuong Nguyen, Isidoro Gonzalez, Jose Luis Pablos, Alejandro Balsa, Monica Vazquez, Philippe Gaudin, Benjamín Fernandez-Gutierrez

01.12.2020 | Study protocol | Ausgabe 1/2020 Open Access

Nutritional support for lactating women with or without azithromycin for infants compared to breastfeeding counseling alone in improving the 6-month growth outcomes among infants of peri-urban slums in Karachi, Pakistan—the protocol for a multiarm assessor-blinded randomized controlled trial (Mumta LW trial)

Ameer Muhammad, Yasir Shafiq, Muhammad Imran Nisar, Benazir Baloch, Amna Tanweer Yazdani, Nida Yazdani, Fyezah Jehan