01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): study protocol for a cluster randomised controlled trial of a community-based smoke-free homes intervention, with or without Indoor Air Quality feedback
Noreen Mdege, Caroline Fairhurst, Tarana Ferdous, Catherine Hewitt, Rumana Huque, Cath Jackson, Ian Kellar, Steve Parrott, Sean Semple, Aziz Sheikh, Shilpi Swami, Kamran Siddiqi
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Evaluating Modular Approach to Therapy for Children with Anxiety, Depression, Trauma and Conduct Problems (MATCH-ADCT) in Norwegian child and adolescent outpatient clinics: Study protocol for a randomized controlled trial
Kristine Amlund Hagen, Asgeir Røyrhus Olseth, Hanne Laland, Kristian Rognstad, Anett Apeland, Elisabeth Askeland, Knut Taraldsen, Bernadette Christensen, John Kjøbli, Ana M. Ugueto, Sarah Kate Bearman, John Weisz
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Study protocol: developing, disseminating, and implementing a core outcome set for selective fetal growth restriction in monochorionic twin pregnancies
Asma Khalil, James M. N. Duffy, Helen Perry, Wessel Ganzevoort, Keith Reed, Ahmet A. Baschat, Jan Deprest, Eduardo Gratacos, Kurt Hecher, Liesbeth Lewi, Enrico Lopriore, Dick Oepkes, Aris Papageorghiou, Sanne J. Gordijn, On behalf of the International Collaboration to Harmonise Outcomes for Selective Fetal Growth Restriction (CHOOSE-FGR)
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Clazakizumab in late antibody-mediated rejection: study protocol of a randomized controlled pilot trial
Farsad Eskandary, Michael Dürr, Klemens Budde, Konstantin Doberer, Roman Reindl-Schwaighofer, Johannes Waiser, Markus Wahrmann, Heinz Regele, Andreas Spittler, Nils Lachmann, Christa Firbas, Jakob Mühlbacher, Gregor Bond, Philipp F. Halloran, Edward Chong, Bernd Jilma, Georg A. Böhmig
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
Montse Ballbè, Cristina Martínez, Ariadna Feliu, Núria Torres, Gemma Nieva, Cristina Pinet, Antònia Raich, Sílvia Mondon, Pablo Barrio, Rosa Hernández-Ribas, Jordi Vicens, Sílvia Costa, Jordi Vilaplana, Laura Alaustre, Eva Vilalta, Roser Blanch, Susana Subirà, Eugeni Bruguera, Josep Maria Suelves, Joseph Guydish, Esteve Fernández
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial
Yi Liang, Guanai Bao, Liyan Gong, Jie Zhou, Xiangming Kong, Ran Ran, Xiaomei Shao, Yongliang Jiang, Weiping Zhang, Boyi Liu, Junying Du, Junfan Fang, Na Nie, Conghua Ji, Jianqiao Fang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial
Taoyun Ji, Zhao Yang, Qingzhu Liu, Jianxiang Liao, Fei Yin, Yanhui Chen, Liping Zou, Baomin Li, Yuxing Gao, Xiaomei Shu, Shaoping Huang, Feng Gao, Jianmin Liang, Su Fang Lin, Jing Peng, Shiwei Song, Jing Wang, Chao Che, Wenxiu Sun, Maoqiang Tian, Lin Yang, Yi Hua, Yunpeng Hao, Lixin Cai, Luming Li, Yuwu Jiang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial
Yu Heng Kwan, Warren Fong, Xiang Ling Ang, Chuen Seng Tan, Bee Choo Tai, Youyi Huang, Marcel Bilger, Jie Kie Phang, Hui Chin Tan, Jia Ven Lee, Limin Sun, Choy Tip Tan, Bao Qiang Dong, Hwee Ling Koh, Ying Ying Leung, Nai Lee Lui, Siaw Ing Yeo, Swee Cheng Ng, Kok Yong Fong, Julian Thumboo, Truls Østbye
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
María José Jaén-Moreno, Nuria Feu, Justa Redondo-Écija, Francisco Javier Montiel, Cristina Gómez, Gloria I. del Pozo, Jose Ángel Alcalá, Luis Gutiérrez-Rojas, Vicente Balanzá-Martinez, Geli Marie Chauca, Laura Carrión, Maria Isabel Osuna, María Dolores Sánchez, Inmaculada Caro, Miriam Ayora, Francisca Valdivia, María Soledad López, Jose Manuel Poyato, Fernando Sarramea
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial
David S. Lawrence, Nabila Youssouf, Síle F. Molloy, Alexandre Alanio, Melanie Alufandika, David R. Boulware, Timothée Boyer-Chammard, Tao Chen, Francoise Dromer, Admire Hlupeni, William Hope, Mina C. Hosseinipour, Cecilia Kanyama, Oliver Lortholary, Angela Loyse, David B. Meya, Mosepele Mosepele, Conrad Muzoora, Henry C. Mwandumba, Chiratidzo E. Ndhlovu, Louis Niessen, Charlotte Schutz, Katharine E. Stott, Duolao Wang, David G. Lalloo, Graeme Meintjes, Shabbar Jaffar, Thomas S. Harrison, Joseph N. Jarvis
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial
Thomas G. de Leeuw, Laura Mangiarini, Rebecca Lundin, Florentia Kaguelidou, Tjitske van der Zanden, Oscar Della Pasqua, Dick Tibboel, Adriana Ceci, Saskia N. de Wildt, on behalf of the GAPP consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy and cost-effectiveness of two online interventions for children and adolescents at risk for depression (E.motion trial): study protocol for a randomized controlled trial within the ProHEAD consortium
Sabrina Baldofski, Elisabeth Kohls, Stephanie Bauer, Katja Becker, Sally Bilic, Heike Eschenbeck, Michael Kaess, Markus Moessner, Hans Joachim Salize, Silke Diestelkamp, Elke Voß, Christine Rummel-Kluge, the ProHEAD consortium
01.12.2019 | Update | Ausgabe 1/2019
Open Access
PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial
Anne-Laure Couderc, Emilie Nouguerède, Karine Baumstarck, Sandrine Loubière, Hervé Le Caer, Olivier Guillem, Frédérique Rousseau, Laurent Greillier, Emmanuelle Norguet-Monnereau, Maud Cecile, Rabia Boulahssass, Françoise Le Caer, Sandrine Tournier, Chantal Butaud, Pierre Guillet, Sophie Nahon, Sylvie Kirscher, Nadine Diaz, Claire Morando, Patrick Villani, Pascal Auquier, Aurélie Daumas
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
Koh-Woon Kim, Kyungmo Park, Hi-Joon Park, Geon-Ho Jahng, Dae-Jean Jo, Jae-Heung Cho, Eun-Mo Song, Woo-Chul Shin, Ye-Ji Yoon, Soo-Jeon Kim, Seulgi Eun, Mi-Yeon Song
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial
Myungsun Lee, Jeongha Mok, Deog Kyeom Kim, Tae Sun Shim, Won-Jung Koh, Doosoo Jeon, Taehoon Lee, Seung Heon Lee, Ju Sang Kim, Jae Seuk Park, Ji Yeon Lee, Song Yee Kim, Jae Ho Lee, Kyung-Wook Jo, Byung Woo Jhun, Young Ae Kang, Joong Hyun Ahn, Chang-Ki Kim, Soyoun Shin, Taeksun Song, Sung Jae Shin, Young Ran Kim, Heejung Ahn, Seokyung Hahn, Ho Jeong Won, Ji Yeon Jang, Sang Nae Cho, Jae-Joon Yim
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Cerebral mechanism of celecoxib for treating knee pain: study protocol for a randomized controlled parallel trial
Chenjian Tang, Xiaohui Dong, Wenhua He, Shirui Cheng, Yang Chen, Yong Huang, Bao Yin, Yu Sheng, Jun Zhou, Xiaoli Wu, Fang Zeng, Zhengjie Li, Fanrong Liang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy of tuina in patients with chronic neck pain: study protocol for a randomized controlled trial
Zhiwei Wu, Lingjun Kong, Qingguang Zhu, Pengfei Song, Min Fang, Wuquan Sun, Hao Zhang, Yanbin Cheng, Shanda Xu, Guangxin Guo, Xin Zhou, Zhizhen Lv
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial
Douglas Evans, Deborah Shure, Linda Clark, Gerard J. Criner, Martin Dres, Marcelo Gama de Abreu, Franco Laghi, David McDonagh, Basil Petrof, Teresa Nelson, Thomas Similowski
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial
Elena Gross, Niveditha Putananickal, Anna-Lena Orsini, Simone Schmidt, Deborah R. Vogt, Sven Cichon, Peter Sandor, Dirk Fischer
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial
Carl H. Backes, Jennifer L. Notestine, Jane M. Lamp, Jeanne C. Balough, Allison M. Notestine, Crystal M. Alfred, Juli M. Kern, Michael R. Stenger, Brian K. Rivera, Mohannad Moallem, Randy R. Miller, Apurwa Naik, Jennifer N. Cooper, Christopher R. Howard, Stephen E. Welty, Noah H. Hillman, John A. F. Zupancic, Larissa I. Stanberry, Thomas N. Hansen, Charles V. Smith
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
School-based mental health promotion in children and adolescents with StresSOS using online or face-to-face interventions: study protocol for a randomized controlled trial within the ProHEAD Consortium
Heike Eschenbeck, Laya Lehner, Hanna Hofmann, Stephanie Bauer, Katja Becker, Silke Diestelkamp, Michael Kaess, Markus Moessner, Christine Rummel-Kluge, Hans-Joachim Salize, the ProHEAD Consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial
Ya-Quan Hou, Xin Zhang, Jian-Feng Tu, Yang Zheng, Jing-Wen Yang, Mirim Kim, Hui Hu, Li-Qiong Wang, Jing-Jie Zhao, Wei Zhou, Jun Wang, Xuan Zou, Yu Wang, Guang-Xia Shi, Cun-Zhi Liu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Chinese herbal medicine bi min fang for allergic rhinitis: protocol for a double-blind, double-dummy, randomized controlled trial
Qiulan Luo, Shiqing Zhou, Xiaoshan Li, Qubo Chen, Wenmin Lin, Liming Lu, Hua Li, Caifeng Chen, Wenyong Chen, Yunying Li
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a randomized controlled trial
Francesco Cresi, Elena Maggiora, Silvia Maria Borgione, Elena Spada, Alessandra Coscia, Enrico Bertino, Fabio Meneghin, Luigi Tommaso Corvaglia, Maria Luisa Ventura, Gianluca Lista, ENTARES Study Research Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults—study protocol for a stepped-wedge cluster randomized trial (PAWEL Study)
Alba Sánchez, Christine Thomas, Friederike Deeken, Sören Wagner, Stefan Klöppel, Felix Kentischer, Christine A. F. von Arnim, Michael Denkinger, Lars O. Conzelmann, Janine Biermann-Stallwitz, Stefanie Joos, Heidrun Sturm, Brigitte Metz, Ramona Auer, Yoanna Skrobik, Gerhard W. Eschweiler, Michael A. Rapp, PAWEL Study group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium
Silke Diestelkamp, Lutz Wartberg, Michael Kaess, Stephanie Bauer, Christine Rummel-Kluge, Katja Becker, Heike Eschenbeck, Hans-Joachim Salize, Markus Moessner, Christiane Baldus, Nicolas Arnaud, Rainer Thomasius, the ProHEAD consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial
Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao, Li-Qiong Wang, Zhang-Sheng Yu, Cun-Zhi Liu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial
Jemma Regan, Eric Frison, Fidéline Collin, Piers Dawes, Mark Hann, Ines Himmelsbach, Emma Hooper, David Reeves, Zoe Simkin, Chryssoula Thodi, Fan Yang, Iracema Leroi, for the SENSE-Cog Trial Development Team
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial
Hironori Kitabata, Takashi Kubo, Yasutsugu Shiono, Kunihiro Shimamura, Yasushi Ino, Takashi Tanimoto, Yasushi Hayashi, Kenichi Komukai, Hiromichi Sougawa, Keizo Kimura, Masahiro Gohda, Toshikazu Hashizume, Masahiro Obana, Kazuisa Maeda, Junichi Yamaguchi, Takashi Akasaka
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial)
Lucy C. Chappell, Marcus Green, Neil Marlow, Jane Sandall, Rachael Hunter, Stephen Robson, Ursula Bowler, Virginia Chiocchia, Pollyanna Hardy, Edmund Juszczak, Louise Linsell, Anna Placzek, Peter Brocklehurst, Andrew Shennan
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium
Stephanie Bauer, Sally Bilić, Christina Reetz, Fikret Ozer, Katja Becker, Heike Eschenbeck, Michael Kaess, Christine Rummel-Kluge, Hans-Joachim Salize, Silke Diestelkamp, Markus Moessner, the ProHEAD Consortium
01.12.2019 | Update | Ausgabe 1/2019
Open Access
Update on the General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) trial: statistical analysis plan for a multi-centre randomised controlled trial
Sharmala Thuraisingam, Patty Chondros, Max Catchpool, Kim Dalziel, Jo-Anne Manski-Nankervis, Jane Speight, Elizabeth Holmes-Truscott, Ralph Audehm, Jason Chiang, Irene Blackberry, David O’Neal, Kamlesh Khunti, James Best, John Furler
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Promoting Help-seeking using E-technology for ADolescents with mental health problems: study protocol for a randomized controlled trial within the ProHEAD Consortium
Michael Kaess, Sabrina Ritter, Sophia Lustig, Stephanie Bauer, Katja Becker, Heike Eschenbeck, Markus Moessner, Christine Rummel-Kluge, Hans-Joachim Salize, Rainer Thomasius, Franz Resch, Julian Koenig, the ProHEAD Consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial
Qiuxia Cui, Deguang Kong, Zhihua Li, Kun Wang, Dan Zhang, Jianing Tang, Xing Liao, Qianqian Yuan, Yan Gong, Gaosong Wu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients – the study design of the LIBERAL-Trial
Patrick Meybohm, Simone Lindau, Sascha Treskatsch, Roland Francis, Claudia Spies, Markus Velten, Maria Wittmann, Erdem Gueresir, Christian Stoppe, Ana Kowark, Mark Coburn, Sixten Selleng, Marcel Baschin, Gregor Jenichen, Melanie Meersch, Thomas Ermert, Alexander Zarbock, Peter Kranke, Markus Kredel, Antonia Helf, Rita Laufenberg-Feldmann, Marion Ferner, Eva Wittenmeier, Karl-Heinz Gürtler, Peter Kienbaum, Marcel Gama de Abreu, Michael Sander, Michael Bauer, Timo Seyfried, Matthias Gruenewald, Suma Choorapoikayil, Markus M. Mueller, Erhard Seifried, Oana Brosteanu, Holger Bogatsch, Dirk Hasenclever, Kai Zacharowski, LIBERAL Collaboration Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Converting habits of antibiotic use for respiratory tract infections in German primary care – study protocol of the cluster-randomized controlled CHANGE-3 trial
Anja Wollny, Attila Altiner, Tonia Brand, Katharina Garbe, Martina Kamradt, Petra Kaufmann-Kolle, Mirko Leyh, Regina Poß-Doering, Joachim Szecsenyi, Lorenz Uhlmann, Arwed Voss, Dorothea Weber, Michel Wensing, Christin Löffler
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial
Marlise Poolman, Jessica Roberts, Anthony Byrne, Paul Perkins, Zoe Hoare, Annmarie Nelson, Julia Hiscock, Dyfrig Hughes, Betty Foster, Julie O’Connor, Liz Reymond, Sue Healy, Rossela Roberts, Bee Wee, Penney Lewis, Rosalynde Johnstone, Sian Roberts, Emily Holmes, Stella Wright, Annie Hendry, Clare Wilkinson
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
Design and implementation of a large and complex trial in emergency medical services
Maria J. Robinson, Jodi Taylor, Stephen J. Brett, Jerry P. Nolan, Matthew Thomas, Barnaby C. Reeves, Chris A. Rogers, Sarah Voss, Madeleine Clout, Jonathan R. Benger, In collaboration with the AIRWAYS-2 study team
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled trial
Elizabeth Randell, Rachel McNamara, Sue Delport, Monica Busse, Richard P. Hastings, David Gillespie, Rhys Williams-Thomas, Lucy Brookes-Howell, Renee Romeo, Janet Boadu, Alka S. Ahuja, Anne Marie McKigney, Martin Knapp, Kathryn Smith, Jacqui Thornton, Gemma Warren
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial
Ana Verdelho, Sofia Madureira, Manuel Correia, José Manuel Ferro, Mário Rodrigues, Manuel Gonçalves-Pereira, Mafalda Gonçalves, Ana Catarina Santos, Pedro Vilela, Helena Bárrios, Mariana Borges, Helena Santa-Clara
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial
Aurélie Maiguy-Foinard, Bertrand Décaudin, Pierre Tourneux, Bernard Guillois, Thierry Blanc, Sophie Galène-Gromez, Morgane Masse, Pascal Odou, Fannette Denies, Benoît Dervaux, Alain Duhamel, Laurent Storme
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences
Joanna C. Crocker, Keira Pratt-Boyden, Jenny Hislop, Sian Rees, Louise Locock, Sophie Olszowski, Alan Chant, Shaun Treweek, Jonathan A. Cook, Kerry Woolfall, Nicola Farrar, Jennifer Bostock, Richard Bulbulia
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The Oxford study of Calcium channel Antagonism, Cognition, Mood instability and Sleep (OxCaMS): study protocol for a randomised controlled, experimental medicine study
Lauren Z. Atkinson, Lucy Colbourne, Alexander Smith, Catherine H. Harmer, Anna C. Nobre, Jennifer Rendell, Helen Jones, Christopher Hinds, Arne Mould, Elizabeth M. Tunbridge, Andrea Cipriani, John R. Geddes, Kate E. A. Saunders, Paul J. Harrison
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial
Christopher I. Price, Lisa Shaw, Peter Dodd, Catherine Exley, Darren Flynn, Richard Francis, Saiful Islam, Mehdi Javanbakht, Rachel Lakey, Joanne Lally, Graham McClelland, Peter McMeekin, Helen Rodgers, Helen Snooks, Louise Sutcliffe, Pippa Tyrell, Luke Vale, Alan Watkins, Gary A. Ford
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial
Noemi Lois, Evie Gardner, Norman Waugh, Augusto Azuara-Blanco, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M. Aslam, Clare Bailey, Victor Chong, Louise Downey, Haralabos Eleftheriadis, Samia Fatum, Sheena George, Faruque Ghanchi, Markus Groppe, Robin Hamilton, Geeta Menon, Ahmed Saad, Sobha Sivaprasad, Marianne Shiew, David H. Steel, James Stephen Talks, Catherine Adams, Christina Campbell, Matthew Mills, Mike Clarke, On behalf of the DIAMONDS Study Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS): study protocol for a prospective, randomized, double-blind, non-inferiority trial
Shangyi Hui, Liyuan Tao, Feroze Mahmood, Derong Xu, Zhinan Ren, Xin Chen, Lin Sheng, Qianyu Zhuang, Shugang Li, Yuguang Huang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The cerebral mechanism of acupuncture for treating knee osteoarthritis: study protocol for a randomized controlled trial
Jing Guo, Yang Chen, Zhengjie Li, Shirui Cheng, Chenjian Tang, Xiaohui Dong, Wenhua He, Yong Huang, Bao Yin, Yu Sheng, Jun Zhou, Aijia Li, Fang Zeng, Lei Lan, Fanrong Liang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial
Lai Xu, Zhi-Yan Tao, Jun-Yang Lu, Guan-Nan Zhang, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Tao Xu, Yi Xiao
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial
Jae-Uk Sul, Myung Kwan Kim, Jungtae Leem, Hee-Geun Jo, Sang-hoon Yoon, Jeeyong Kim, Eun-Jung Lee, Jeong-Eun Yoo, So Jung Park, Young Il Kim, Eunseok Kim, In Chul Jung, Ju-Hyun Jeon, Yang-Chun Park
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy and safety of levothyroxine (L-T4) replacement on the exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism: Study protocol for a multi-center, open label, randomized, parallel group trial (ThyroHeart-CHF)
Xuan Zhang, Wen-yao Wang, Kuo Zhang, Jian Tian, Ji-lin Zheng, Jing Chen, Shi-min An, Si-yuan Wang, Yu-peng Liu, Yan Zhao, Jing-jia Wang, Min Yang, Yi-da Tang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Modulation of frontal EEG alpha oscillations during maintenance and emergence phases of general anaesthesia to improve early neurocognitive recovery in older patients: protocol for a randomised controlled trial
Amy Gaskell, Rebecca Pullon, Darren Hight, Jonathan Termaat, Gay Mans, Logan Voss, Matthias Kreuzer, Sebastian Schmid, Stephan Kratzer, Amy Rodriguez, Gerhard Schneider, Paul Garcia, Jamie Sleigh
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Conditional cash transfers to retain rural Kenyan women in the continuum of care during pregnancy, birth and the postnatal period: protocol for a cluster randomized controlled trial
Caroline A. Ochieng, Hassan Haghparast-Bidgoli, Neha Batura, Aloyce Odhiambo, Geordan Shannon, Andrew Copas, Tom Palmer, Sarah Dickin, Stacey Noel, Matthew Fielding, Sangoro Onyango, Sarah Odera, Alie Eleveld, Alex Mwaki, Fedra Vanhuyse, Jolene Skordis
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial
Matias C. Vieira, Sophie Relph, Andrew Copas, Andrew Healey, Kirstie Coxon, Alessandro Alagna, Annette Briley, Mark Johnson, Deborah A. Lawlor, Christoph Lees, Neil Marlow, Lesley McCowan, Louise Page, Donald Peebles, Andrew Shennan, Baskaran Thilaganathan, Asma Khalil, Jane Sandall, Dharmintra Pasupathy, on behalf of the DESiGN Collaborative Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial
Christina Kalvelage, Kai Zacharowski, Artur Bauhofer, Ulrich Gockel, Michael Adamzik, Axel Nierhaus, Peter Kujath, Christian Eckmann, Mathias W. Pletz, Hendrik Bracht, Tim-Philipp Simon, Michael Winkler, Detlef Kindgen-Milles, Markus Albertsmeier, Markus Weigand, Björn Ellger, Maximilian Ragaller, Roman Ullrich, Gernot Marx
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
Using discrete choice experiments to inform the design of complex interventions
Fern Terris-Prestholt, Nyasule Neke, Jonathan M. Grund, Marya Plotkin, Evodius Kuringe, Haika Osaki, Jason J. Ong, Joseph D. Tucker, Gerry Mshana, Hally Mahler, Helen A. Weiss, Mwita Wambura, The VMMC study team
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial)
Matthieu Legrand, Emmanuel Futier, Marc Leone, Benjamin Deniau, Alexandre Mebazaa, Benoît Plaud, Pierre Coriat, Patrick Rossignol, Eric Vicaut, Etienne Gayat, for the STOP-OR-NOT study investigators
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)
Nancy J. Butcher, Andrea Monsour, Emma J. Mew, Peter Szatmari, Agostino Pierro, Lauren E. Kelly, Mufiza Farid-Kapadia, Alyssandra Chee-a-tow, Leena Saeed, Suneeta Monga, Wendy Ungar, Caroline B. Terwee, Sunita Vohra, Dean Fergusson, Lisa M. Askie, Paula R. Williamson, An-Wen Chan, David Moher, Martin Offringa
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
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
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial
Angelos G. Kolias, Ellie Edlmann, Eric P. Thelin, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z. Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A. Anderson, Oliver Richards, Peter Whitfield, Monica Gherle, Karen Caldwell, Carol Davis-Wilkie, Silvia Tarantino, Garry Barton, Hani J. Marcus, Aswin Chari, Paul Brennan, Antonio Belli, Simon Bond, Carole Turner, Lynne Whitehead, Ian Wilkinson, Peter J. Hutchinson, British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A single-blind, dose-escalation, phase I study of high-fluence light-emitting diode-red light on Caucasian non-Hispanic skin: study protocol for a randomized controlled trial
Erica B. Wang, Ramanjot Kaur, Julie Nguyen, Derek Ho, Evan Austin, Emanual Maverakis, Chin-Shang Li, Samuel T. Hwang, R. Rivkah Isseroff, Jared Jagdeo
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial
Gerhard Pichler, Sigrid Baumgartner, Marlene Biermayr, Eugene Dempsey, Hans Fuchs, Tom G. Goos, Gianluca Lista, Laila Lorenz, Lukasz Karpinski, Souvik Mitra, Lilijana Kornhauser-Cerar, Alexander Avian, Berndt Urlesberger, Georg M. Schmölzer
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
What is the impact of mother’s bed incline on episodes of decreased oxygen saturation in healthy newborns in skin-to-skin contact after delivery: Study protocol for a randomized controlled trial
Jesús Rodríguez López, Nadia Raquel García Lara, María López Maestro, Javier De la Cruz Bértolo, José Carlos Martínez Ávila, Máximo Vento, Ana Parra Llorca, Isabel Izquierdo Macián, Adelina Pellicer, Natalia Marín Huarte, Izaskun Asla Elorriaga, Lourdes Román Echevarría, Cristina Copons Fernández, Ana Martín Ancel, Fernando Cabañas, Óscar García Algar, Carmen Rosa Pallás Alonso
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Enhancing practitioners’ confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training – a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study
Kerry Woolfall, Louise Roper, Amy Humphreys, Mark D. Lyttle, Shrouk Messahel, Elizabeth Lee, Joanne Noblet, Anand Iyer, Carrol Gamble, Helen Hickey, Naomi Rainford, Richard Appleton
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial – the PRADA trial
Catherine Droitcourt, Sébastien Barbarot, Annabel Maruani, Laure Darrieux, Laurent Misery, Emilie Brenaut, Henri Adamski, Cécile Chabbert, Annie Vermersch, Marie Weiborn, Julien Seneschal, Alain Taïeb, Patrice Plantin, Hervé Maillard, Alice Phan, François Skowron, Manuelle Viguier, Delphine Staumont-Salle, Audrey Nosbaum, Angèle Soria, Annick Barbaud, Emmanuel Oger, Alain Dupuy, Groupe de Recherche sur l’Eczéma Atopique de la Société Française de Dermatologie (GREAT)
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial
T. M. Wassenaar, C. M. Wheatley, N. Beale, P. Salvan, A. Meaney, J. B. Possee, K. E. Atherton, J. L. Duda, H. Dawes, H. Johansen-Berg
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study
O. Diaz-Cambronero, G. Mazzinari, C. L. Errando, M. J. Schultz, B. Flor Lorente, N. García-Gregorio, M. Vila Montañés, Daniel Robles-Hernández, L. E. Olmedilla Arnal, A. Martín-De-Pablos, A. Marqués Marí, M. P. Argente Navarro, for the IPPCollapse-II study group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
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, David J. Brooks, Anthony Peter Passmore, Clive Ballard, Paul Edison
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) Protocol: a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial
David N. Hager, Michael H. Hooper, Gordon R. Bernard, Laurence W. Busse, E. Wesley Ely, Alpha A. Fowler, David F. Gaieski, Alex Hall, Jeremiah S. Hinson, James C. Jackson, Gabor D. Kelen, Mark Levine, Christopher J. Lindsell, Richard E. Malone, Anna McGlothlin, Richard E. Rothman, Kert Viele, David W. Wright, Jonathan E. Sevransky, Greg S. Martin
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The iBobbly Aboriginal and Torres Strait Islander app project: Study protocol for a randomised controlled trial
Fiona Shand, Andrew Mackinnon, Kathleen O’Moore, Rebecca Ridani, Bill Reda, Mel Hoy, Todd Heard, Luke Duffy, Marian Shanahan, Lisa Jackson Pulver, Helen Christensen
01.12.2019 | Update | Ausgabe 1/2019
Open Access
Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis
Carmen Lim, Andrea Baker, Sukanta Saha, Sharon Foley, Anne Gordon, David Ward, Bjorn Burgher, Frances Dark, Martin Beckmann, Stephen Stathis, George Bruxner, Alex Ryan, Drew Richardson, Sean Hatherill, Michael Berk, Olivia Dean, John McGrath, James Scott, Cadence Working Group
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial
Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao, Li-Qiong Wang, Zhang-Sheng Yu, Cun-Zhi Liu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial
Ruinuo Jia, Weijiao Yin, Shuoguo Li, Ruonan Li, Junqiang Yang, Tanyou Shan, Dan Zhou, Wei Wang, Lixin Wan, Fuyou Zhou, Shegan Gao
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: A multicenter, randomized controlled comparison of three renutrition strategies for the management of moderate acute malnutrition among children aged from 6 to 24 months (the MALINEA project)
Muriel Vray, Boris G. Hedible, Pierrick Adam, Laura Tondeur, Alexandre Manirazika, Rindra Randremanana, Halima Mainassara, André Briend, Cecile Artaud, Cassandre von Platen, Mathias Altmann, Ronan Jambou
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial
T. Kiss, J. Wittenstein, C. Becker, K. Birr, G. Cinnella, E. Cohen, M. R. El Tahan, L. F. Falcão, C. Gregoretti, M. Granell, T. Hachenberg, M. W. Hollmann, R. Jankovic, W. Karzai, J. Krassler, T. Loop, M. J. Licker, N. Marczin, G. H. Mills, M. T. Murrell, V. Neskovic, Z. Nisnevitch-Savarese, P. Pelosi, R. Rossaint, M. J. Schultz, A. Serpa Neto, P. Severgnini, L. Szegedi, T. Vegh, G. Voyagis, J. Zhong, M. Gama de Abreu, M. Senturk, for the PROTHOR investigators, the Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA)
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Evaluation of the masticatory muscle function, physiological sleep variables, and salivary parameters after electromechanical therapeutic approaches in adult patients with Down syndrome: a randomized controlled clinical trial
Lilian Chrystiane Giannasi, Marignês T. S. Dutra, Vera L. S. Tenguan, Gabriela P. Mancilha, Gabriela R. C. Silva, Elaine Fillietaz-Bacigalupo, Daniel B. da Silva, Fabiano Politti, Sergio R. Nacif, Ezequiel F. de Oliveira, João C. da Rocha, Carolina T. Rocha, Mateus M. Romero, Claudia S. de Oliveira, Luis V. F. de Oliveira, Sigmar de Mello Rode, Cristiane Yumi Koga-Ito, Jose B. O. Amorim, Miguel A. C. Salgado, Mônica F. Gomes
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Comparative effectiveness of Chuna manual therapy versus conventional usual care for non-acute low back pain: a pilot randomized controlled trial
Kyeong-Tae Lim, Eui-Hyoung Hwang, Jae-Heung Cho, Jae-Young Jung, Koh-Woon Kim, In-Hyuk Ha, Me-riong Kim, Kibong Nam, Min ho Lee A, Jun-Hwan Lee, Namkwen Kim, Byung-Cheul Shin
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial
Youme Ko, Seung-Ho Sun, In-Sik Han, Ho-Yeon Go, Tae-Hun Kim, Jin-Moo Lee, Jun-Bok Jang, Kyoung Sun Park, Yun-Kyung Song, Kyou-Young Lee, Chan-Yong Jeon, Seong-Gyu Ko
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) – study protocol for a randomised placebo-controlled trial in Australia
Roseanne Peel, Alexis Hure, John Wiggers, Mark McEvoy, Elizabeth Holliday, Andrew Searles, Penny Reeves, Priyanga Ranasinghe, Ranil Jayawardena, Samir Samman, Shamasunder Acharya, Judy Luu, Chris Rissel, John Attia
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The effectiveness of high intensity intermittent training on metabolic, reproductive and mental health in women with polycystic ovary syndrome: study protocol for the iHIT- randomised controlled trial
Danielle Hiam, Rhiannon Patten, Melanie Gibson-Helm, Alba Moreno-Asso, Luke McIlvenna, Itamar Levinger, Cheryce Harrison, Lisa J Moran, Anju Joham, Alex Parker, Soulmaz Shorakae, David Simar, Nigel Stepto
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Novel optical spectral transmission (OST)-guided versus conventionally disease activity-guided treatment: study protocol of a randomized clinical trial on guidance of a treat-to-target strategy for early rheumatoid arthritis
N. J. Besselink, A. A. A. Westgeest, R. Klaasen, M. Gamala, J. M. van Woerkom, J. Tekstra, M. M. A. Verhoeven, W. E. Van Spil, F. P. J. G. Lafeber, A. C. A. Marijnissen, J. M. Van Laar, J. W. G. Jacobs
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Structural and functional brain biomarkers of clinical response to rTMS of medication-resistant auditory hallucinations in schizophrenia patients: study protocol for a randomized sham-controlled double-blind clinical trial
Fanny Thomas, Noomane Bouaziz, Cécile Gallea, Palmyre Schenin-King Andrianisaina, Florence Durand, Ombline Bolloré, René Benadhira, Clémence Isaac, Sonia Braha-Zeitoun, Virginie Moulier, Antoni Valero-Cabré, Dominique Januel
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme)
Helen Blackshaw, Jane Vennik, Carl Philpott, Mike Thomas, Caroline Eyles, James Carpenter, Caroline S. Clarke, Steve Morris, Anne Schilder, Valerie Lund, Paul Little, Stephen Durham, Spiros Denaxas, Elizabeth Williamson, David Beard, Jonathan Cook, Steffi Le Conte, Kim Airey, Jim Boardman, Claire Hopkins
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial
Jing Lin, Zhaoxia Tan, Hao Yao, Xiaolin Hu, Dafa Zhang, Yuan Zhao, Jiyue Xiong, Bo Dou, Xueshuang Zhu, Zhong Wu, Yingqiang Guo, Deying Kang, Lei Du
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: study protocol for a multi-centre randomized controlled trial
Daniel-Mihai Rusu, Ianis Siriopol, Ioana Grigoras, Mihaela Blaj, Adi-Ionut Ciumanghel, Dimitrie Siriopol, Ionut Nistor, Mihai Onofriescu, Gigel Sandu, Beatrice Cobzaru, Dragos Viorel Scripcariu, Olguta Diaconu, Adrian Constantin Covic
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial
Janneke van Grinsven, Sven M. van Dijk, Marcel G. Dijkgraaf, Marja A. Boermeester, Thomas L. Bollen, Marco J. Bruno, Sandra van Brunschot, Cornelis H. Dejong, Casper H. van Eijck, Krijn P. van Lienden, Djamila Boerma, Peter van Duijvendijk, Muhammed Hadithi, Jan Willem Haveman, René W. van der Hulst, Jeroen M. Jansen, Daan J. Lips, Eric R. Manusama, I. Quintus Molenaar, Donald L. van der Peet, Alexander C. Poen, Rutger Quispel, Alexander F. Schaapherder, Erik J. Schoon, Matthijs P. Schwartz, Tom C. Seerden, B. W. Marcel Spanier, Jan Willem Straathof, Niels G. Venneman, Wim van de Vrie, Ben J. Witteman, Harry van Goor, Paul Fockens, Hjalmar C. van Santvoort, Marc G. Besselink, for the Dutch Pancreatitis Study Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A double-blind randomized comparative clinical trial to evaluate the safety and efficacy of dendritic cell vaccine loaded with WT1 peptides (TLP0-001) in combination with S-1 in patients with advanced pancreatic cancer refractory to standard chemotherapy
Masahiro Katsuda, Motoki Miyazawa, Toshiyasu Ojima, Akio Katanuma, Kenichi Hakamada, Kentaro Sudo, Shingo Asahara, Itaru Endo, Makoto Ueno, Kazuo Hara, Suguru Yamada, Tsutomu Fujii, Sohei Satoi, Tatsuya Ioka, Masaichi Ohira, Takahiro Akahori, Masayuki Kitano, Hiroaki Nagano, Masayuki Furukawa, Tomohiko Adachi, Hiroki Yamaue
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Clarithromycin and endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps: study protocol for the MACRO randomised controlled trial
Carl Philpott, Steffi le Conte, David Beard, Jonathan Cook, William Sones, Steve Morris, Caroline S. Clarke, Mike Thomas, Paul Little, Jane Vennik, Valerie Lund, Helen Blackshaw, Anne Schilder, Stephen Durham, Spiros Denaxas, James Carpenter, James Boardman, Claire Hopkins, On behalf of the MACRO programme team
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
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, Nathalie Godart
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effects of inclined treadmill training on functional and cardiovascular parameters of stroke patients: study protocol for a randomized controlled trial
Raiff Simplício da Silva, Stephano Tomaz da Silva, Jesimiel Missias de Souza, Marianna Celeste Cordeiro de Figueiredo, Thaís Almeida Silveira Mendes, Maria Clara de Sena Nunes, Samara Katiane Rolim de Oliveira, Daiane Carla Rodrigues Cardoso, Raiza Gabriella da Câmara Silva, Débora Carvalho de Oliveira, Tatiana Souza Ribeiro
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The effects of two early parenting interventions on child aggression and risk for violence in Brazil (The PIÁ Trial): protocol for a randomised controlled trial
Joseph Murray, Iná S. Santos, Andréa D. Bertoldi, Lynne Murray, Adriane Arteche, Luciana Tovo-Rodrigues, Suélen Cruz, Luciana Anselmi, Rafaela Martins, Elisa Altafim, Tâmara Biolo Soares, Maria Gabriela Andriotti, Andrea Gonzalez, Isabel Oliveira, Mariângela Freitas da Silveira, Peter Cooper
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial
T. Kiss, J. Wittenstein, C. Becker, K. Birr, G. Cinnella, E. Cohen, M. R. El Tahan, L. F. Falcão, C. Gregoretti, M. Granell, T. Hachenberg, M. W. Hollmann, R. Jankovic, W. Karzai, J. Krassler, T. Loop, M. J. Licker, N. Marczin, G. H. Mills, M. T. Murrell, V. Neskovic, Z. Nisnevitch-Savarese, P. Pelosi, R. Rossaint, M. J. Schultz, A. Serpa Neto, P. Severgnini, L. Szegedi, T. Vegh, G. Voyagis, J. Zhong, M. Gama de Abreu, M. Senturk, for the PROTHOR investigators and the Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA)
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis
Antonio Uccelli, Alice Laroni, Lou Brundin, Michel Clanet, Oscar Fernandez, Seyed Massood Nabavi, Paolo A. Muraro, Roberto S. Oliveri, Ernst W. Radue, Johann Sellner, Per Soelberg Sorensen, Maria Pia Sormani, Jens Thomas Wuerfel, Mario A. Battaglia, Mark S. Freedman, on behalf of the MESEMS study group
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols
Francesca Schiavone, Riya Bathia, Krishna Letchemanan, Lindsey Masters, Claire Amos, Anna Bara, Louise Brown, Clare Gilson, Cheryl Pugh, Nafisah Atako, Fleur Hudson, Mahesh Parmar, Ruth Langley, Richard S. Kaplan, Chris Parker, Gert Attard, Noel W. Clarke, Silke Gillessen, Nicholas D. James, Tim Maughan, Matthew R. Sydes, On behalf of past and present members of the STAMPEDE and FOCUS4 Trial Management Group
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial
Chuo Yew Ting, Shahren Ahmad Zaidi Adruce, Mohamed Azmi Hassali, Hiram Ting, Chien Joo Lim, Rachel Sing-Kiat Ting, Abu Hassan Alshaari Abd Jabar, Nor Anizah Osman, Izzul Syazwan Shuib, Shing Chyi Loo, Sui Theng Sim, Su Ee Lim
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth
C. Fernandez Turienzo, D. Bick, M. Bollard, L. Brigante, A. Briley, K. Coxon, P. Cross, A. Healey, M. Mehta, A. Melaugh, J. Moulla, P. T. Seed, A. H. Shennan, C. Singh, R. M. Tribe, J. Sandall
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Are stage-based health information messages effective and good value for money in improving maternal newborn and child health outcomes in India? Protocol for an individually randomized controlled trial
Amnesty LeFevre, Smisha Agarwal, Sara Chamberlain, Kerry Scott, Anna Godfrey, Rakesh Chandra, Aditya Singh, Neha Shah, Diva Dhar, Alain Labrique, Aarushi Bhatnagar, Diwakar Mohan
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients’ treatment adherence via electronic monitors and an app versus usual care in Tibet
Xiaolin Wei, Joseph Paul Hicks, Pande Pasang, Zhitong Zhang, Victoria Haldane, Xiaoqiu Liu, Tingting Yin, Lixia Wang, Dachun Shi, Shiliang Ge, John Walley, Ross Upshur, Jun Hu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial
Gabriel Birgand, Thomas Haudebourg, Leslie Grammatico-Guillon, Léa Ferrand, Leila Moret, François Gouin, Nicolas Mauduit, Christophe Leux, Yannick Le Manach, Didier Lepelletier, Elsa Tavernier, Jean-Christophe Lucet, Bruno Giraudeau
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis
Rachel Whitemore, Jo Leonardi-Bee, Felix Naughton, Stephen Sutton, Sue Cooper, Steve Parrott, Catherine Hewitt, Miranda Clark, Michael Ussher, Matthew Jones, David Torgerson, Tim Coleman
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Rationale and protocol of the ENGAGE study: a double-blind randomized controlled preference trial using a comprehensive cohort design to measure the effect of a cognitive and leisure-based intervention in older adults with a memory complaint
S. Belleville, A. Moussard, A. I. Ansaldo, P. Belchior, L. Bherer, N. Bier, V. D. Bohbot, M.-A. Bruneau, L. L. Cuddy, B. Gilbert, R. Jokel, K. Mahalingam, K. McGilton, K. J. Murphy, G. Naglie, E. Rochon, A. K. Troyer, N. D. Anderson
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effect and cerebral mechanism of acupuncture treatment for functional constipation: study protocol for a randomized controlled clinical trial
Tao Yin, Zhaoxuan He, Peihong Ma, Likai Hou, Li Chen, Kunnan Xie, Zilei Tian, Fumin Wang, Jing Xiong, Yi Yang, Ruirui Sun, Fang Zeng
01.12.2019 | Commentary | Ausgabe 1/2019
Open Access
Population health intervention research: the place of theories
Graham Moore, Linda Cambon, Susan Michie, Pierre Arwidson, Grégory Ninot, Christine Ferron, Louise Potvin, Nadir Kellou, Julie Charlesworth, François Alla, Discussion Panel
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
Mohammed S. Alshahrani, Laila Perlas Asonto, Mohamed M. El Tahan, Amal H. Al Sulaibikh, Sukayna Z. Al Faraj, Abdullah A. Al Mulhim, Murad F. Al Abbad, Samar A. Al Nahhash, Moath N. Aldarweesh, Alaa M. Mahmoud, Nisreen Almaghraby, Mohammed A. Al Jumaan, Thamir O. Al Junaid, Faisal M. Al Hawaj, Samar AlKenany, Omaima F. ElSayed, Haitham M. Abdelwahab, Mohamed M. Moussa, Bader K. Alossaimi, Shaikah K. Alotaibi, Talal M. AlMutairi, Duaa A. AlSulaiman, Saad D. Al Shahrani, Donia Alfaraj, Waleed Alhazzani
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Protocol for the cost-consequence and equity impact analyses of a cluster randomised controlled trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child dietary diversity and nutritional status in rural Odisha, India (UPAVAN trial)
Hassan Haghparast-Bidgoli, Jolene Skordis, Helen Harris-Fry, Sneha Krishnan, Meghan O’Hearn, Abhinav Kumar, Ronali Pradhan, Naba Kishore Mishra, Avinash Upadhyay, Shibananth Pradhan, Amit Kumar Ojha, Sarah Cunningham, Shibanand Rath, Tom Palmer, Peggy Koniz-Booher, Suneetha Kadiyala
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons
Dominic Hague, Stephen Townsend, Lindsey Masters, Mary Rauchenberger, Nadine Van Looy, Carlos Diaz-Montana, Melissa Gannon, Nicholas James, Tim Maughan, Mahesh K. B. Parmar, Louise Brown, Matthew R. Sydes, for the STAMPEDE and FOCUS4 investigators
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effects of magnesium citrate, magnesium oxide and magnesium sulfate supplementation on arterial stiffness in healthy overweight individuals: a study protocol for a randomized controlled trial
Joëlle C. Schutten, Peter J. Joris, Ronald P. Mensink, Richard M. Danel, Frans Goorman, M. Rebecca Heiner-Fokkema, Rinse K. Weersma, Charlotte A. Keyzer, Martin H. de Borst, Stephan J. L. Bakker
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium
Zhaohui Cui, Kimberly P. Truesdale, Thomas N. Robinson, Victoria Pemberton, Simone A. French, Juan Escarfuller, Terri L. Casey, Anne M. Hotop, Donna Matheson, Charlotte A. Pratt, Lynn J. Lotas, Eli Po’e, Sharon Andrisin, Dianne S. Ward
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Influence of an exercise program on cardiac remodeling and functional capacity in patients with stroke (CRONuS trial): study protocol for a randomized controlled trial
Josiela Cristina da Silva Rodrigues, Gustavo José Luvizutto, Rafael Dalle Molle da Costa, Robson Aparecido Prudente, Taís Regina da Silva, Juli Thomaz de Souza, Caroline Ferreira da Silva Mazeto Pupo da Silveira, Daniele Andreza Antonelli Rossi, Fernanda Cristina Winckler, Gabriel Pinheiro Modolo, Tainá Fabri Carneiro Valadão, Letícia Cláudia de Oliveira Antunes, Luis Cuadrado Martin, Rodrigo Bazan, Silméia Garcia Zanati Bazan
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
3D vs. 4K 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 Giezelt, Desdemona Möller, Martin Hellmich, Christiane J. Bruns, Dirk L. Stippel
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Intraoperative immunomodulatory effects of sevoflurane versus total intravenous anesthesia with propofol in bariatric surgery (the OBESITA trial): study protocol for a randomized controlled pilot trial
Giselle Carvalho de Sousa, Fernanda Ferreira Cruz, Luciana Boavista Heil, Carlos José Saboya Sobrinho, Felipe Saddy, Frederico Paranhos Knibel, Joana Barreto Pereira, Marcus J. Schultz, Paolo Pelosi, Marcelo Gama de Abreu, Pedro Leme Silva, Patricia Rieken Macedo Rocco
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185]
Natalie Nguyen, Regina Thalhammer, Katrin Beutner, Susanne Saal, Ricarda Servaty, Hanna Klingshirn, Andrea Icks, Kristina Freyberg, Markus Vomhof, Ulrich Mansmann, Lien Le, Martin Müller, Gabriele Meyer
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy of different-frequency TEAS on acute pain after the total knee arthroplasty: a study protocol for a parallel group randomized trial
Yulin Li, Lixi Chu, Xiangming Li, Weitao Zhai, Yinghui Ma, Yong He, Yuelin Xu, Sheng Ding, Huali Gao, Jing Zhang, Bowen Ye, Jingchao Wang, Jie Yao, Chonggui Wu, Lianbo Xiao
01.12.2019 | Commentary | Ausgabe 1/2019
Open Access
Population health intervention research: what is the place for pilot studies?
Lehana Thabane, Linda Cambon, Louise Potvin, Jeanine Pommier, Joëlle Kivits, Laetitia Minary, Kareen Nour, Pierre Blaise, Julie Charlesworth, François Alla, Discussion Panel
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A randomised controlled trial evaluating arrhythmia burden, risk of sudden cardiac death and stroke in patients with Fabry disease: the role of implantable loop recorders (RaILRoAD) compared with current standard practice
Ravi Vijapurapu, Rebecca Kozor, Derralynn A. Hughes, Peter Woolfson, Ana Jovanovic, Patrick Deegan, Rosemary Rusk, Gemma A. Figtree, Michel Tchan, David Whalley, Dipak Kotecha, Francisco Leyva, James Moon, Tarekegn Geberhiwot, Richard P. Steeds
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma
P. Murchie, J. Masthoff, F. M. Walter, K. Rahman, J. L. Allan, N. Burrows, C. Proby, A. J. Lee, M. Johnston, A. Durrani, I. Depasquale, B. Brant, A. Neilson, F. Meredith, S. Treweek, S. Hall, A. McDonald
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A randomised controlled trial assessing the use of citalopram, sertraline, fluoxetine and mirtazapine in preventing relapse in primary care patients who are taking long-term maintenance antidepressants (ANTLER: ANTidepressants to prevent reLapse in dEpRession): study protocol for a randomised controlled trial
Larisa Duffy, Faye Bacon, Caroline S. Clarke, Yvonne Donkor, Nick Freemantle, Simon Gilbody, Rachael Hunter, Tony Kendrick, David Kessler, Michael King, Paul Lanham, Gemma Lewis, Dee Mangin, Louise Marston, Michael Moore, Irwin Nazareth, Nicola Wiles, Glyn Lewis
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
LLIN Evaluation in Uganda Project (LLINEUP) – Impact of long-lasting insecticidal nets with, and without, piperonyl butoxide on malaria indicators in Uganda: study protocol for a cluster-randomised trial
Sarah G. Staedke, Moses R. Kamya, Grant Dorsey, Catherine Maiteki-Sebuguzi, Samuel Gonahasa, Adoke Yeka, Amy Lynd, Jimmy Opigo, Janet Hemingway, Martin J. Donnelly
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A study protocol for the N-ICE trial: A randomised double-blind placebo-controlled study of the safety and efficacy of N-acetyl-cysteine (NAC) as a pharmacotherapy for methamphetamine (“ice”) dependence
Rebecca McKetin, Olivia M. Dean, Alyna Turner, Peter J. Kelly, Brendan Quinn, Dan I. Lubman, Paul Dietze, Gregory Carter, Peter Higgs, Amanda L. Baker, Barbara Sinclair, David Reid, Victoria Manning, Nina te Pas, Wenbin Liang, Tamsin Thomas, Ramez Bathish, Margaret Kent, Dayle Raftery, Shalini Arunogiri, Frank Cordaro, Harry Hill, Michael Berk
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study)
Chris Littlewood, Marcus Bateman, Kendra Cooke, Susie Hennnings, Tina Cookson, Kieran Bromley, Martyn Lewis, Lennard Funk, Jean Denton, Maria Moffatt, Rachel Winstanley, Saurabh Mehta, Gareth Stephens, Lisa Dikomitis, Linda Chesterton, Nadine E. Foster
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions
Katy Davis, Nicole Minckas, Virginia Bond, Cari Jo Clark, Tim Colbourn, Sarah J. Drabble, Therese Hesketh, Zelee Hill, Joanna Morrison, Oliver Mweemba, David Osrin, Audrey Prost, Janet Seeley, Maryam Shahmanesh, Esther J. Spindler, Erin Stern, Katrina M. Turner, Jenevieve Mannell
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Therapeutic drug monitoring-based dose optimisation of piperacillin/tazobactam to improve outcome in patients with sepsis (TARGET): a prospective, multi-centre, randomised controlled trial
Stefan Hagel, Sandra Fiedler, Andreas Hohn, Alexander Brinkmann, Otto R. Frey, Heike Hoyer, Peter Schlattmann, Michael Kiehntopf, Jason A. Roberts, Mathias W. Pletz, on behalf of the TARGET Study Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2)
Belinda Lennox, Ksenija Yeeles, Peter B. Jones, Michael Zandi, Eileen Joyce, Ly-Mee Yu, Giuliano Tomei, Rebecca Pollard, Sally-Anne Vincent, Mio Shimazaki, Iona Cairns, Francis Dowling, Thomas Kabir, Thomas R. E. Barnes, Anne Lingford Hughes, Akram A. Hosseini, Timothy Harrower, Camilla Buckley, Alasdair Coles
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial
Joerg Kaiser, Willem Niesen, Pascal Probst, Thomas Bruckner, Colette Doerr-Harim, Oliver Strobel, Phillip Knebel, Markus K. Diener, André L. Mihaljevic, Markus W. Büchler, Thilo Hackert
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A prospective, multicenter, randomized OCT study of early neointimal condition at first and second months after BuMA Supreme stent versus XIENCE stent implantation in high-bleeding-risk coronary artery disease patients: study protocol for a randomized controlled trial
Bo Li, Qin Hua Jin, Yun Dai Chen, Chang Qian Wang, Bei Shi, Xi Su, Guo Sheng Fu, Yan Qing Wu, Xu Chen Zhou, Zu Yi Yuan
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Evaluating the effectiveness and cost-effectiveness of the Smoking Treatment Optimisation in Pharmacies (STOP) intervention: protocol for a cluster randomised controlled trial
Ratna Sohanpal, Sandra Jumbe, Wai-Yee James, Liz Steed, Tammy Yau, Carol Rivas, Vichithranie Madurasinghe, Colin Houlihan, Vlad Berdunisov, Matthew Taylor, Stephanie J. C. Taylor, Chris Griffiths, Sandra Eldridge, Robert Walton
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Optimal management of HIV- positive adults at risk for kidney disease in Nigeria (Renal Risk Reduction “R3” Trial): protocol and study design
Muktar H. Aliyu, Usman J. Wudil, Donna J. Ingles, Bryan E. Shepherd, Wu Gong, Baba M. Musa, Hamza Muhammad, Mahmoud U. Sani, Aliyu Abdu, Aisha M. Nalado, Akinfenwa Atanda, Aima A. Ahonkhai, Talat A. Ikizler, Cheryl A. Winkler, Jeffrey B. Kopp, Paul L. Kimmel, C. William Wester
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The effect of implementing an aseptic practice bundle for anaesthetists to reduce postoperative infections, the Anaesthetists Be Cleaner (ABC) study: protocol for a stepped wedge, cluster randomised, multi-site trial
Alan F. Merry, Derryn A. Gargiulo, Ian Bissett, David Cumin, Kerry English, Christopher Frampton, Richard Hamblin, Jacqueline Hannam, Matthew Moore, Papaarangi Reid, Sally Roberts, Elsa Taylor, Simon J. Mitchell, the ABC Study Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Xu Zhou, Dong-mei Yan, Wei-feng Zhu, Wen-jun Liu, He-yun Nie, Sheng Xu, Yi-ping Jiang, Kun-he Zhang, Ying Fu, Yi-ye Wan, Xin-yu Yu, Hong Li, Xin Sun, Xiao-fan Chen
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Antithrombin supplementation during extracorporeal membrane oxygenation: study protocol for a pilot randomized clinical trial
Mauro Panigada, Elena Spinelli, Alberto Cucino, Elisa Cipriani, Stefano De Falco, Giovanna Panarello, Giovanna Occhipinti, Antonio Arcadipane, Gabriele Sales, Vito Fanelli, Luca Brazzi, Cristina Novembrino, Dario Consonni, Antonio Pesenti, Giacomo Grasselli
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
CASSETTE—clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial
Ravindra Dotel, Steven Y. C. Tong, Asha Bowen, Jane N. Nelson, Matthew V. N. O’Sullivan, Anita J. Campbell, Brendan J. McMullan, Philip N. Britton, Joshua R. Francis, Damon P. Eisen, Owen Robinson, Laurens Manning, Joshua S. Davis
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial to improve quality of life: a study protocol for a randomized clinical trial
Bridget A. Graney, David H. Au, Anna E. Barón, Andrew Cheng, Sara A. Combs, Thomas J. Glorioso, Grady Paden, Elizabeth C. Parsons, Borsika A. Rabin, Debra P. Ritzwoller, Jessica-Jean Stonecipher, Carolyn Turvey, Carolyn H. Welsh, David B. Bekelman
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial
Carmen A. Pfortmueller, Anna S. Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zuercher, Frederik Stoehr, Gabor Erdoes, Markus M. Luedi, Stephan M. Jakob, Lars Englberger, Joerg C. Schefold
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy
Wesley de Jong, Joeri Aerts, Sabine Allard, Christian Brander, Jozefien Buyze, Eric Florence, Eric van Gorp, Guido Vanham, Lorna Leal, Beatriz Mothe, Kris Thielemans, Montse Plana, Félipe Garcia, Rob Gruters, on behalf of the iHIVARNA consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial
Alvaro Casas-Herrero, Ivan Anton-Rodrigo, Fabricio Zambom-Ferraresi, Mikel L. Sáez de Asteasu, Nicolás Martinez-Velilla, Jaione Elexpuru-Estomba, Itxaso Marin-Epelde, Fernanda Ramon-Espinoza, Roberto Petidier-Torregrosa, Juan L. Sanchez-Sanchez, Berta Ibañez, Mikel Izquierdo
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
Cornelia Straßner, Eckhard Frick, Gabriele Stotz-Ingenlath, Nicola Buhlinger-Göpfarth, Joachim Szecsenyi, Johannes Krisam, Friederike Schalhorn, Jan Valentini, Regina Stolz, Stefanie Joos
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Recruitment of men to a multi-centre diabetes prevention trial: an evaluation of traditional and online promotional strategies
Karen Bracken, Wendy Hague, Anthony Keech, Ann Conway, David J. Handelsman, Mathis Grossmann, David Jesudason, Bronwyn Stuckey, Bu B. Yeap, Warrick Inder, Carolyn Allan, Robert McLachlan, Kristy P. Robledo, Gary Wittert
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial
Markus Gerber, Johannes Beck, Serge Brand, Robyn Cody, Lars Donath, Anne Eckert, Oliver Faude, Xenia Fischer, Martin Hatzinger, Edith Holsboer-Trachsler, Christian Imboden, Undine Lang, Sarah Mans, Thorsten Mikoteit, Anja Oswald, Uwe Pühse, Sofia Rey, Ann-Katrin Schreiner, Nina Schweinfurth, Ursula Spitzer, Lukas Zahner
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial
Thomas G. de Leeuw, Laura Mangiarini, Rebecca Lundin, Florentia Kaguelidou, Tjitske van der Zanden, Oscar Della Pasqua, Dick Tibboel, Adriana Ceci, Saskia N. de Wildt, on behalf of the GAPP consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Impact of acupuncture for allergic rhinitis on the activity of the hypothalamus-pituitary-adrenal axis: study protocol for a randomized controlled trial
Sheng Chen, Shu-Han Qu, Yi Zhang, Zhi-Hong Wen, Sheng-Nan Guo, Wei-Mei Zeng, Xue-Si Hou, Yi-Fan Jia, Yi Xiao, Federico Marmori, Jun Wang, Ji-Ping Zhao
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a cluster randomised trial protocol
April Morrow, Emily Hogden, Yoon-Jung Kang, Julia Steinberg, Karen Canfell, Michael J. Solomon, James G. Kench, Anthony J. Gill, Tim Shaw, Nicholas Pachter, Bonny Parkinson, Luke Wolfenden, Gillian Mitchell, Finlay Macrae, Kathy Tucker, Natalie Taylor
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF)
Jesper Jensen, Massar Omar, Caroline Kistorp, Mikael Kjær Poulsen, Christian Tuxen, Ida Gustafsson, Lars Køber, Finn Gustafsson, Emil Fosbøl, Niels Eske Bruun, Lars Videbæk, Peter Hartmund Frederiksen, Jacob Eifer Møller, Morten Schou
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study
E. Gaiffe, T. Crepin, J. Bamoulid, C. Courivaud, M. Büchler, E. Cassuto, L. Albano, J. M. Chemouny, G. Choukroun, M. Hazzan, L. Kessler, C. Legendre, Y. Le Meur, N. Ouali, A. Thierry, A. Anota, V. Nerich, S. Limat, F. Bonnetain, D. Vernerey, D. Ducloux
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial
Bao-ping Xu, Min Yao, Zi-rui Tian, Long-yun Zhou, Long Yang, Zhen-jun Li, Sen Zhu, Xiao-tao Wang, Jia-hui Lan, Yong-jun Wang, Xue-jun Cui
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch (MR ASAP): study protocol for a randomised controlled trial
Sophie A. van den Berg, Diederik W. J. Dippel, Jeannette Hofmeijer, Puck S. S. Fransen, Klaartje Caminada, Arjen Siegers, Nyika D. Kruyt, Henk Kerkhoff, Frank-Erik de Leeuw, Paul J. Nederkoorn, H. Bart van der Worp, on behalf of the MR ASAP Investigators
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial
Jacqui Rodgers, Jane Goodwin, Jeremy R. Parr, Victoria Grahame, Catharine Wright, John Padget, Deborah Garland, Malcolm Osborne, Marie Labus, Ashleigh Kernohan, Mark Freeston
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial
Min-gu Kang, Kwang-il Kim, Sang Hyun Ihm, Moo-Yong Rhee, Il Suk Sohn, Hae-Young Lee, Sungha Park, Eun-Seok Jeon, Jong-Min Song, Wook Bum Pyun, Ki-Chul Sung, Moo Hyun Kim, Sang-Hyun Kim, Seok-Yeon Kim, Shin-Jae Kim, Eung Ju Kim, Jinho Shin, Sung Yun Lee, Kook-Jin Chun, Jin-Ok Jeong, Shung Chull Chae, Ki Dong Yoo, Young Jin Choi, Yong Hwan Park, Cheol-Ho Kim
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial
Corrado Pedrazzani, Soo Yeun Park, Giovanni Scotton, Jun Seok Park, Hye Jin Kim, Enrico Polati, Alfredo Guglielmi, Gyu Seog Choi
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Study protocol for a randomised controlled trial of CBT vs antipsychotics vs both in 14–18-year-olds: Managing Adolescent first episode Psychosis: a feasibility study (MAPS)
Melissa Pyle, Matthew R. Broome, Emmeline Joyce, Graeme MacLennan, John Norrie, Daniel Freeman, David Fowler, Peter M. Haddad, David Shiers, Chris Hollis, Jo Smith, Ashley Liew, Rory E. Byrne, Paul French, Sarah Peters, Jemma Hudson, Linda Davies, Richard Emsley, Alison Yung, Max Birchwood, Eleanor Longden, Anthony P. Morrison
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial
Heidemarie Haller, Taige Wang, Romy Lauche, Kyung-Eun Choi, Petra Voiß, Sabine Felber, Holger Cramer, Beyhan Ataseven, Sherko Kümmel, Anna Paul, Gustav Dobos
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Analgesia effect of premixed nitrous oxide/oxygen during the rehabilitation after total knee arthroplasty: a study protocol for a randomized controlled trial
Ya-Liang Dai, Xiao-Min Chai, Ning Zhu, Kai-Bin Wang, Wen-Qiang Bao, Xue-Sen Zhang, Lu-Lu Gao, Qiang Liu, Dong-Mei Bao, Li-Ting Wang, Yi-Ling Wang, Jun-Jun Zhang, Yu-Xiang Li, Jian-Qiang Yu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial
Chien-Hung Yeh, Tian Yi Zhao, Mei Dan Zhao, Yue Wu, Yong Ming Guo, Zhan Yu Pan, Ren Wei Dong, Bo Chen, Bin Wang, Jing Rong Wen, Dan Li, Yi Guo, Xing Fang Pan
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial
Holly G. Prigerson, Martin Viola, Chris R. Brewin, Christopher Cox, Daniel Ouyang, Madeline Rogers, Cynthia X. Pan, Shayna Rabin, Jiehui Xu, Susan Vaughan, Janna S. Gordon-Elliot, David Berlin, Lindsay Lief, Wendy G. Lichtenthal
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effects of neuromuscular training on pain intensity and self-reported functionality for patellofemoral pain syndrome in runners: study protocol for a randomized controlled clinical trial
Haoyu Hu, Yili Zheng, Xiaochen Liu, Di Gong, Changcheng Chen, Yizu Wang, Mengsi Peng, Bao Wu, Juan Wang, Ge Song, Juan Zhang, Jiabao Guo, Yulin Dong, Xueqiang Wang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A clinical study to assess the influence of acupuncture at “Wang’s Jiaji” acupoints on limb spasticity in patients in convalescent stage of ischemic stroke: study protocol for a randomized controlled trial
Huanqin Li, Dehuai Long, Bin Li, Huilin Liu, Tingting Ma, Tingying Wu, Martin Eriksson, Yali Wen, Jia Wei, Wei You, Yinxia Liu, Xiaobai Xu, Yajie Zhang, Linpeng Wang, Jingqing Sun
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Combination therapy of vitamin C and thiamine for septic shock in a multicentre, double-blind, randomized, controlled study (ATESS): study protocol for a randomized controlled trial
Sung Yeon Hwang, Jong Eun Park, Ik Joon Jo, Seonwoo Kim, Sung Phil Chung, Taeyoung Kong, Jonghwan Shin, Hui Jai Lee, Kyoung Min You, You Hwan Jo, Doyun Kim, Gil Joon Suh, Taegyun Kim, Won Young Kim, Youn-Jung Kim, Seung Mok Ryoo, Sung-Hyuk Choi, Tae Gun Shin, for the Korean Shock Society (KoSS) Investigators
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial
Ann Sarah Walker, Eric Budgell, Magda Laskawiec-Szkonter, Katy Sivyer, Sarah Wordsworth, Jack Quaddy, Marta Santillo, Adele Krusche, Laurence S. J. Roope, Nicole Bright, Fiona Mowbray, Nicola Jones, Kieran Hand, Najib Rahman, Melissa Dobson, Emma Hedley, Derrick Crook, Mike Sharland, Chris Roseveare, F. D. Richard Hobbs, Chris Butler, Louella Vaughan, Susan Hopkins, Lucy Yardley, Timothy E. A. Peto, Martin J. Llewelyn, on behalf of the ARK trial team
01.12.2019 | Commentary | Ausgabe 1/2019
Open Access
Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context
Edouard Lhomme, Camara Modet, Augustin Augier, Sylvain Faye, Tienhan Sandrine Dabakuyo-Yonli, Claire Levy-Marchal, Eric D’Ortenzio, Yazdan Yazdanpanah, Geneviève Chêne, Abdoul Habib Beavogui, Laura Richert, the PREVAC study team
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Self-injury: Treatment, Assessment, Recovery (STAR): online intervention for adolescent non-suicidal self-injury - study protocol for a randomized controlled trial
Michael Kaess, Julian Koenig, Stephanie Bauer, Markus Moessner, Gloria Fischer-Waldschmidt, Margarete Mattern, Sabine C. Herpertz, Franz Resch, Rebecca Brown, Tina In-Albon, Michael Koelch, Paul L. Plener, Christian Schmahl, Alexandra Edinger, the STAR Consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Implementation and effectiveness of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster randomized controlled trial
Marion Sumari-de Boer, Francis M. Pima, Kennedy M. Ngowi, Geoffrey M. Chelangwa, Benson A. Mtesha, Linda M. Minja, Hadija H. Semvua, Stella Mpagama, Blandina T. Mmbaga, Pythia T. Nieuwkerk, Rob E. Aarnoutse
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double-blind, parallel-group, placebo-controlled clinical trial protocol
Mariam Al-Laith, Marianna Jasenecova, Sonya Abraham, Aisla Bosworth, Ian N. Bruce, Christopher D. Buckley, Coziana Ciurtin, Maria-Antonietta D’Agostino, Paul Emery, Hill Gaston, John D. Isaacs, Andrew Filer, Benjamin A. Fisher, Thomas W. J. Huizinga, Pauline Ho, Clare Jacklin, Heidi Lempp, Iain B. McInnes, Arthur G. Pratt, Andrew Östor, Karim Raza, Peter C. Taylor, Dirkjan van Schaardenburg, Dharshene Shivapatham, Alison J. Wright, Joana C. Vasconcelos, Joanna Kelly, Caroline Murphy, A. Toby Prevost, Andrew P. Cope
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial
Ana Kowark, Rolf Rossaint, András P. Keszei, Petra Bischoff, Michael Czaplik, Berthold Drexler, Peter Kienbaum, Moritz Kretzschmar, Christopher Rex, Thomas Saller, Gerhard Schneider, Martin Soehle, Mark Coburn, I-PROMOTE study group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Safety, effectiveness, and economic evaluation of an herbal medicine, Ukgansangajinpibanha granule, in children with autism spectrum disorder: a study protocol for a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group clinical trial
Sun Haeng Lee, Seungwon Shin, Tae-hun Kim, Sang Min Kim, Tae Yoon Do, Sulgi Park, Boram Lee, Hye Jin Shin, Jihong Lee, Jin Yong Lee, Gyu Tae Chang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Executive function training in chronic traumatic brain injury patients: study protocol
Daniel C. Krawczyk, Kihwan Han, David Martinez, Jelena Rakic, Matthew J. Kmiecik, Zhengsi Chang, Linda Nguyen, Michael Lundie, Richard C. Cole, Marielle Nagele, Nyaz Didehbani
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial
Larissa Jennings Mayo-Wilson, Nancy E. Glass, Fred M. Ssewamala, Sebastian Linnemayr, Jessica Coleman, Fatmata Timbo, Matthew W. Johnson, Melissa Davoust, Alain Labrique, Gayane Yenokyan, Brian Dodge, Carl Latkin
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Prevention of Morbidity in Sickle Cell Disease (POMS2a)—overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children
Jo Howard, Sophie A. Lee, Baba Inusa, Man Ying Edith Cheng, Cheema Bavenjit, Isabel C. Reading, Sally Ann Wakeford, Johanna C. Gavlak, Patrick B. Murphy, Nicholas Hart, Atul Gupta, Sati Sahota, Eufemia Jacob, Maria Chorozoglou, Carol Ossai, Maureen Gwam, Fenella J. Kirkham, Angela M. Wade, Christina Liossi
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial
Nicolas J. Pejovic, Susanna Myrnerts Höök, Josaphat Byamugisha, Tobias Alfvén, Clare Lubulwa, Francesco Cavallin, Jolly Nankunda, Hege Ersdal, Giulia Segafredo, Mats Blennow, Daniele Trevisanuto, Thorkild Tylleskär
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial
Jian Lyu, Yan-ming Xie, Zhan Gao, Jian-wu Shen, Yue-yi Deng, Song-tao Xiang, Wen-xi Gao, Wen-tong Zeng, Chun-he Zhang, Dan-hui Yi, Lian-xin Wang, Zhi-fei Wang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions
Anna Lechner, Jan Kottner, Susanne Coleman, Delia Muir, Heather Bagley, Dimitri Beeckman, Wendy Chaboyer, Janet Cuddigan, Zena Moore, Claudia Rutherford, Jochen Schmitt, Jane Nixon, Katrin Balzer
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial
Andrea Cortegiani, Federico Longhini, Annalisa Carlucci, Raffaele Scala, Paolo Groff, Andrea Bruni, Eugenio Garofalo, Maria Rita Taliani, Uberto Maccari, Luigi Vetrugno, Enrico Lupia, Giovanni Misseri, Vittoria Comellini, Antonino Giarratano, Stefano Nava, Paolo Navalesi, Cesare Gregoretti
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial
Zoe Marshman, Hannah Ainsworth, Ivor Gordon Chestnutt, Peter Day, Donna Dey, Sarab El Yousfi, Caroline Fairhurst, Fiona Gilchrist, Catherine Hewitt, Claire Jones, Ian Kellar, Sue Pavitt, Mark Robertson, Sarwat Shah, Katherine Stevens, David Torgerson, Nicola Innes
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial
Andrew Stephen Moriarty, Goedele Maria Louwagie, Noreen Dadirai Mdege, Neo Morojele, John Tumbo, Olufemi Babatunde Omole, Max Oscar Bachmann, Mona Kanaan, Astrid Turner, Steve Parrott, Kamran Siddiqi, Olalekan Abdulwahab Ayo-Yusuf
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Aspirin versus placebo for the treatment of venous leg ulcers—a phase II, pilot, randomised trial (AVURT)
Tilbrook Helen, Cook Liz, Clark Laura, Sbizzera Illary, Bland Martin, Buckley Hannah, Chetter Ian, Dumville Jo, Fenner Chris, Forsythe Rachael, Gabe Rhian, Harding Keith, Layton Alison, Lindsay Ellie, Mc Daid Catriona, Moffatt Christine, Rolfe Debbie, Stansby Gerard, Torgerson David, Vowden Peter, Williams Laurie, Hinchliffe Robert
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP): study protocol for a randomised controlled trial
Ajith K. Siriwardena, Santhalingam Jegatheeswaran, James M. Mason, Minas Baltatzis, Anthony Chan, Aali J. Sheen, Derek O’Reilly, Saurabh Jamdar, Rahul Deshpande, Nicola de Liguori Carino, Thomas Satyadas, Ahmed Qamruddin, Katharine Hayden, Michael J. Parker, John Butler, Azita Rajai, Ben McIntyre
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and β-glucan to improve glycated haemoglobin, metabolic health, and general well-being in adults with pre-diabetes: study protocol for a 2 × 2 factorial design, parallel group, placebo-controlled randomized controlled trial, with embedded qualitative study and economic analysis
Christine Barthow, Fiona Hood, Eileen McKinlay, Jo Hilder, Christine Cleghorn, Mark Huthwaite, Mark Weatherall, Amber Parry-Strong, Sue Pullon, Ben Gray, Kristin Wickens, Julian Crane, Jeremy Krebs
01.12.2019 | Update | Ausgabe 1/2019
Open Access
Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial
Amy Brenner, Adefemi Afolabi, Syed Masroor Ahmad, Monica Arribas, Rizwana Chaudhri, Timothy Coats, Jack Cuzick, Ian Gilmore, Christopher Hawkey, Vipul Jairath, Kiran Javaid, Aasia Kayani, Muttiullah Mutti, Muhammad Arif Nadeem, Haleema Shakur-Still, Simon Stanworth, Andrew Veitch, Ian Roberts, HALT-IT Trial Collaborators
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial
E. Cardon, V. Van Rompaey, L. Jacquemin, G. Mertens, H. Vermeersch, I. Joossen, J. Beyers, O. M. Vanderveken, P. Van de Heyning, V. Topsakal, A. Gilles
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A pragmatic effectiveness randomized controlled trial of the duration of psychiatric hospitalization in a trans-diagnostic sample of patients with acute mental illness admitted to a ward with either blue-depleted evening lighting or normal lighting conditions
Jan Scott, Knut Langsrud, Daniel Vethe, Kaia Kjørstad, Cecilie L. Vestergaard, Patrick Faaland, Stian Lydersen, Arne Vaaler, Gunnar Morken, Terje Torgersen, Håvard Kallestad
01.12.2019 | Update | Ausgabe 1/2019
Open Access
Update to the study protocol, including statistical analysis plan, for the multicentre, randomised controlled OuTSMART trial: a combined screening/treatment programme to prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies
Dominic Stringer, Leanne M. Gardner, Janet L. Peacock, Irene Rebollo-Mesa, Rachel Hilton, Olivia Shaw, Richard Baker, Brendan Clark, Raj C. Thuraisingham, Matthew Buckland, Michael Picton, Judith Worthington, Richard Borrows, David Briggs, Sapna Shah, Kin Yee Shiu, Keith McCullough, Mysore Phanish, Janet Hegarty, John Stoves, Aimun Ahmed, Waqar Ayub, Robert Horne, Paul McCrone, Joanna Kelly, Caroline Murphy, Anthony Dorling
01.12.2019 | Update | Ausgabe 1/2019
Open Access
Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan
Serigne N. Lo, Angela M. Hong, Lauren E. Haydu, Tasnia Ahmed, Elizabeth J. Paton, Victoria Steel, George Hruby, Anh Tran, Rachael L. Morton, Anna K. Nowak, Janette L. Vardy, Katharine J. Drummond, Haryana M. Dhillon, Catherine Mandel, Richard A. Scolyer, Mark R. Middleton, Bryan H. Burmeister, John F. Thompson, Gerald B. Fogarty
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The HOME Study: study protocol 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
Jane Walker, Katy Burke, Mark Toynbee, Maike van Niekerk, Chris Frost, Nicholas Magill, Simon Walker, Mark Sculpher, Ian R. White, Michael Sharpe
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
High-intensity exercise to promote accelerated improvements in cardiorespiratory fitness (HI-PACE): study protocol for a randomized controlled trial
Joshua E. McGee, Savanna G. Barefoot, Nicole R. Gniewek, Patricia M. Brophy, Angela Clark, Gabriel S. Dubis, Terence E. Ryan, Joseph A. Houmard, Paul Vos, Thomas D. Raedeke, Damon L. Swift
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The efficacy of a cyclin dependent kinase 9 (CDK9) inhibitor, FIT039, on verruca vulgaris: study protocol for a randomized controlled trial
Takashi Nomura, Eriko Sumi, Gyohei Egawa, Saeko Nakajima, Eiko Toichi, Ryuji Uozumi, Harue Tada, Takayuki Nakagawa, Masatoshi Hagiwara, Kenji Kabashima
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea
Kazuto Shibuya, Jin-Young Jang, Sohei Satoi, Masayuki Sho, Suguru Yamada, Manabu Kawai, Hongbeom Kim, Song Cheol Kim, Jin Seok Heo, Yoo-Seok Yoon, Joon Seong Park, Ho Kyoung Hwang, Isaku Yoshioka, Toshio Shimokawa, Hiroki Yamaue, Tsutomu Fujii
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
An online intervention for improving stroke survivors’ health-related quality of life: study protocol for a randomised controlled trial
Ashleigh Guillaumier, Sam McCrabb, Neil J. Spratt, Michael Pollack, Amanda L. Baker, Parker Magin, Alyna Turner, Christopher Oldmeadow, Clare Collins, Robin Callister, Chris Levi, Andrew Searles, Simon Deeming, Olivia Wynne, Alexandra M. J. Denham, Brigid Clancy, Billie Bonevski
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness of a home-based re-injury prevention program on motor control, return to sport and recurrence rates after anterior cruciate ligament reconstruction: study protocol for a multicenter, single-blind, randomized controlled trial (PReP)
Daniel Niederer, Matthias Keller, Andrea Achtnich, Ralph Akoto, Atesch Ateschrang, Winfried Banzer, Alexander Barié, Raymond Best, Andree Ellermann, Andreas Fischer, Daniel Guenther, Mirco Herbort, Jürgen Höher, Maren Janko, Tobias M. Jung, Matthias Krause, Wolf Petersen, Thomas Stoffels, Amelie Stöhr, Frederic Welsch, Thomas Stein
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The HOSENG trial – Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV-testing campaign on testing coverage: protocol of a cluster-randomized clinical trial in rural Lesotho
Alain Amstutz, Thabo Ishmael Lejone, Lefu Khesa, Josephine Muhairwe, Bienvenu Lengo Nsakala, Katleho Tlali, Moniek Bresser, Fiona Vanobberghen, Mathebe Kopo, Mpho Kao, Thomas Klimkait, Manuel Battegay, Niklaus Daniel Labhardt, Tracy Renée Glass
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial
Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee, Daniel Wight, THRIVE Trial Research Team
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Impact of the Umoyo mother-infant pair model on HIV-positive mothers’ social support, perceived stigma and 12-month retention of their HIV-exposed infants in PMTCT care: evidence from a cluster randomized controlled trial in Zambia
Sydney Chauwa Phiri, Sandra Mudhune, Margaret L. Prust, Prudence Haimbe, Hilda Shakwelele, Tina Chisenga, Mwangelwa Mubiana-Mbewe, Maureen Mzumara, Elizabeth McCarthy, Marta R. Prescott
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Managing uncertain recovery for patients nearing the end of life in hospital: a mixed-methods feasibility cluster randomised controlled trial of the AMBER care bundle
J. Koffman, E. Yorganci, D. Yi, W. Gao, F. Murtagh, A. Pickles, S. Barclay, H. Johnson, R. Wilson, L. Sampson, J. Droney, M. Farquhar, T. Prevost, C. J. Evans
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effects of oral Nigella sativa oil on the expression levels and serum concentrations of adiponectin, PPAR-γ, and TNF-α in overweight and obese women: a study protocol for a crossover-designed, double-blind, placebo-controlled randomized clinical trial
Elham Razmpoosh, Sara Safi, Mahta Mazaheri, Amin Salehi-Abargouei, Nooshin Abdollahi, Majid Nazari, Hossein Fallahzadeh, Azadeh Nadjarzadeh
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): study protocol for a parallel group randomised controlled trial
Dan I. Lubman, Jasmin Grigg, Victoria Manning, Kate Hall, Isabelle Volpe, Stephanie Dias, Amanda Baker, Petra K. Staiger, John Reynolds, Anthony Harris, Jonathan Tyler, David Best
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial
David Gunn, Ron Fried, Rabia Lalani, Amanda Farrin, Ivana Holloway, Tom Morris, Catherine Olivier, Rachael Kearns, Maura Corsetti, Mark Scott, Adam Farmer, Anton Emmanuel, Peter Whorwell, Yan Yiannakou, David Sanders, John Mclaughlin, Kapil Kapur, Maria Eugenicos, Ayesha Akbar, Nigel Trudgill, Lesley Houghton, Phil G. Dinning, Alexander C. Ford, Qasim Aziz, Robin Spiller
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness of Yi-Zhi-An-Shen granules on cognition and sleep quality in older adults with amnestic mild cognitive impairment: protocol for a randomized, double-blind, placebo-controlled trial
Shengnan Yue, Ting He, Baiyang Li, Yanqin Qu, Hongmei Peng, Jinxin Chen, Ming Lei, Chongli Chen, Wenbin Wu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
Alain Amstutz, Thabo Ishmael Lejone, Lefu Khesa, Josephine Muhairwe, Bienvenu Lengo Nsakala, Katleho Tlali, Moniek Bresser, Fabrizio Tediosi, Mathebe Kopo, Mpho Kao, Thomas Klimkait, Manuel Battegay, Tracy Renée Glass, Niklaus Daniel Labhardt
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Skeletal muscle hypertrophy and attenuation of cardio-metabolic risk factors (SHARC) using functional electrical stimulation-lower extremity cycling in persons with spinal cord injury: study protocol for a randomized clinical trial
Ashraf S. Gorgey, Refka E. Khalil, John C. Davis, William Carter, Ranjodh Gill, Jeannie Rivers, Rehan Khan, Lance L. Goetz, Teodoro Castillo, Timothy Lavis, Adam P. Sima, Edward J. Lesnefsky, Christopher C. Cardozo, Robert A. Adler
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Regional lymphadenectomy vs. extended lymphadenectomy for hilar cholangiocarcinoma (Relay-HC trial): study protocol for a prospective, multicenter, randomized controlled trial
Min He, Xinsen Xu, Hao Feng, Wei Chen, Houbao Liu, Yongjie Zhang, Jianming Wang, Zhimin Geng, Yudong Qiu, Weidong Duan, Xiangcheng Li, Xuting Zhi, Weihua Zhu, Fuyu Li, Jiangtao Li, Shengping Li, Yu He, Zhiwei Quan, Jian Wang
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Si-ni-tang (a Chinese herbal formula) for improving immunofunction in sepsis: study protocol for a pilot randomized controlled trial
Ruifeng Zeng, Yi Zheng, Rongrong Fan, Gengbiao Zhou, Yan Zhang, Shutao Mai, Dongping Xie, Yanna Weng, Jiongdong Du, Yun Han, Fang Lai
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Comparing the effect of STan (cardiotocographic electronic fetal monitoring (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with CTG alone on emergency caesarean section rates: study protocol for the STan Australian Randomised controlled Trial (START)
D. Turnbull, A. Salter, B. Simpson, B. W. Mol, E. Chandraharan, A. McPhee, I. Symonds, M. Benton, S. Kuah, G. Matthews, K. Howard, C. Wilkinson
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A double-blinded, randomized placebo-controlled trial on the effect of traditional Chinese medicine formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters
Mingpeng Zhao, Carol Pui Shan Chan, Cosy Wing Ching Cheung, Odai Alqawasmeh, Ronald Chi Chiu Wang, Justin Che Yuen Wu, Zhi Xiu Lin, Tin Chiu Li, Jacqueline Pui Wah Chung, Jennifer Sze Man Mak, Tracy Sze Man Law, David Yiu Leung Chan
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Interventions to promote healthy environments in family child care homes in Oklahoma—Happy Healthy Homes: study protocol for a randomized controlled trial
Susan B. Sisson, Alicia L. Salvatore, Deana Hildebrand, Tiffany Poe, Cady Merchant, Megan Slawinski, Chelsea L. Kracht, Julie A. Stoner, Naneida Alcala Lazarte, Lu Ann Faulkner Schneider, Jennifer Weber, Felecia Jones, Dianne Ward
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Supporting elderly people with cognitive impairment during and after hospital stays with intersectoral care management: study protocol for a randomized controlled trial
Angela Nikelski, Armin Keller, Fanny Schumacher-Schönert, Terese Dehl, Jessica Laufer, Ulf Sauerbrey, Diana Wucherer, Adina Dreier-Wolfgramm, Bernhard Michalowsky, Ina Zwingmann, Horst Christian Vollmar, Wolfgang Hoffmann, Stefan H. Kreisel, Jochen René Thyrian
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Therapy of nodal Follicular Lymphoma (WHO grade 1/2) in clinical stage I/II using response adapted Involved Site Radiotherapy in combination with Obinutuzumab (Gazyvaro) - GAZAI Trial (GAZyvaro and response adapted Involved-site Radiotherapy): a study protocol for a single-arm, non-randomized, open, national, multi-center phase II trial
Laila König, Martin Dreyling, Jan Dürig, Marianne Engelhard, Karin Hohloch, Andreas Viardot, Mathias Witzens-Harig, Meinhard Kieser, Wolfram Klapper, Christiane Pott, Klaus Herfarth
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan
Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts, Aemal Akhtar, on behalf of the STRENGTHS-consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial
Jessica Frost, J. Athene Lane, Nikki Cotterill, Mandy Fader, Lucy Hackshaw-McGeagh, Hashim Hashim, Margaret Macaulay, Stephanie J. MacNeill, Sian Noble, Jonathan Rees, Matthew J. Ridd, Luke Robles, Gordon Taylor, Jodi Taylor, Marcus J Drake, Jo Worthington
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial
Tim Mercer, Benson Njuguna, Gerald S. Bloomfield, Jonathan Dick, Eric Finkelstein, Jemima Kamano, Ann Mwangi, Violet Naanyu, Sonak D. Pastakia, Thomas W. Valente, Rajesh Vedanthan, Constantine Akwanalo
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial
Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee, Daniel Wight, THRIVE Trial Research Team
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial
Pascal Chiari, Michel Durand, Olivier Desebbe, Marc-Olivier Fischer, Diane Lena-Quintard, Jean-Charles Palao, Catherine Mercier, Géraldine Samson, Yvonne Varillon, Matteo Pozzi, Nathan Mewton, Delphine Maucort-Boulch, Michel Ovize, Jean-Luc Fellahi
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Impact of deep water running in interval training (DWR-IT) on body composition, functional capacity, and quality of life in overweight adults: study protocol for a randomized controlled trial
Bruna Pianna, Bianca Christianini Moreno, Caroline Aquino de Souza, Thais Fernanda Bôscoa, Guilherme Eleutério Alcalde, Silvia Regina Barrile, Camila Gimenes, Bruno Martinelli, Antonio Roberto Zamunér, Bruna Varanda Pessoa-Santos, Eduardo Aguilar Arca
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial
Rachana Parikh, Daniel Michelson, Kanika Malik, Sachin Shinde, Helen A. Weiss, Adriaan Hoogendoorn, Jeroen Ruwaard, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur, Paulomi Sudhir, Michael King, Pim Cuijpers, Bruce F. Chorpita, Christopher G. Fairburn, Vikram Patel
01.12.2019 | Review | Ausgabe 1/2019
Open Access
Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols
Jay J. H Park, Ellie Siden, Michael J. Zoratti, Louis Dron, Ofir Harari, Joel Singer, Richard T. Lester, Kristian Thorlund, Edward J. Mills
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy: a randomised trial (RAACENO)
S. Turner, S. C. Cotton, C. D. Emele, R. Thomas, S. Fielding, E. A. Gaillard, J. C. de Jongste, H. Morgan, A. R. Neilson, J. Norrie, M. Pijnenburg, D. Price, M. Thomas
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial
Karen M. Goldstein, Deborah A. Fisher, R. Ryanne Wu, Lori A. Orlando, Cynthia J. Coffman, Janet M. Grubber, Tejinder Rakhra-Burris, Virginia Wang, Maren T. Scheuner, Nina Sperber, Santanu K. Datta, Richard E. Nelson, Elizabeth Strawbridge, Dawn Provenzale, Elizabeth R. Hauser, Corrine I. Voils
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis
Sravya Kakumanu, Braden J. Manns, Sophia Tran, Terry Saunders-Smith, Brenda R. Hemmelgarn, Marcello Tonelli, Ross Tsuyuki, Noah Ivers, Danielle Southern, Jeff Bakal, David J. T. Campbell
01.12.2019 | Research | Ausgabe 1/2019
Open Access
Development, acceptability, appropriateness and appeal of a cancer clinical trials implementation intervention for rural- and minority-serving urology practices
Shellie Ellis, Mugur Geana, Tomas Griebling, Charles McWilliams, Jessie Gills, Kelly Stratton, Christine Mackay, Ariel Shifter, Andrew Zganjar, Brantley Thrasher
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Social group and health care provider interventions to increase the demand for malaria rapid diagnostic test among community members in Ebonyi state, Nigeria: study protocol for a cluster randomized controlled trial
Ugwu I. Omale, Benedict N. Azuogu, Chihurumnanya Alo, Ugochukwu C. Madubueze, Onyinyechukwu U. Oka, Kingsley C. Okeke, Ifeyinwa M. Okafor, Rowland Utulu, Uduak E. Akpan, Chijioke V. Iloke, Anthonia O. Nnubia, Ifeyinwa I. Eze, Ogechukwu C. Anene, Chukwuka R. Nnabu, Deborah C. Ibemesi
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial
K. E. A. Burns, Leena Rizvi, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Francois Lamontagne, John W. Devlin, Peter Dodek, Michael Mayette, Maged Tanios, Audrey Gouskos, Phyllis Kay, Susan Mitchell, Kenneth C. Kiedrowski, Nicholas S. Hill, For the Canadian Critical Care Trials Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol
Marica Cassarino, Katie Robinson, Íde O’Shaughnessy, Eimear Smalle, Stephen White, Collette Devlin, Rosie Quinn, Dominic Trépel, Fiona Boland, Marie E. Ward, Rosa McNamara, Margaret O’Connor, Gerard McCarthy, Damien Ryan, Rose Galvin
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study
Dan Brunsdon, Linda Biesty, Peter Brocklehurst, Valerie Brueton, Declan Devane, Jim Elliott, Sandra Galvin, Carrol Gamble, Heidi Gardner, Patricia Healy, Kerenza Hood, Joan Jordan, Doris Lanz, Beccy Maeso, Amanda Roberts, Imogen Skene, Irene Soulsby, Derek Stewart, David Torgerson, Shaun Treweek, Caroline Whiting, Sharon Wren, Andrew Worrall, Katie Gillies
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The trial to reduce antimicrobial use in nursing home residents with Alzheimer’s disease and other dementias: study protocol for a cluster randomized controlled trial
Andrea J. Loizeau, Erika M. C. D’Agata, Michele L. Shaffer, Laura C. Hanson, Ruth A. Anderson, Timothy Tsai, Daniel A. Habtemariam, Elaine H. Bergman, Ruth P. Carroll, Simon M. Cohen, Erin M. E. Scott, Erin Stevens, Jeremy D. Whyman, Elizabeth H. Bennert, Susan L. Mitchell
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial – the development of the DELTA2 guidance
William Sones, Steven A. Julious, Joanne C. Rothwell, Craig Robert Ramsay, Lisa V. Hampson, Richard Emsley, Stephen J. Walters, Catherine Hewitt, Martin Bland, Dean A. Fergusson, Jesse A. Berlin, Doug Altman, Luke David Vale, Jonathan Alistair Cook
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Protocol for a multi-centered, stepped wedge, cluster randomized controlled trial of the de-adoption of oral chlorhexidine prophylaxis and implementation of an oral care bundle for mechanically ventilated critically ill patients: the CHORAL study
Craig M. Dale, Louise Rose, Sarah Carbone, Orla M. Smith, Lisa Burry, Eddy Fan, Andre Carlos Kajdacsy-Balla Amaral, Victoria A. McCredie, Ruxandra Pinto, Carlos R. Quiñonez, Susan Sutherland, Damon C. Scales, Brian H. Cuthbertson
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Sahaj Samadhi meditation vs a Health Enhancement Program in improving late-life depression severity and executive function: study protocol for a two-site, randomized controlled trial
Stephen Benjamin Peckham, Emily Ionson, Marouane Nassim, Kevin Ojha, Lena Palaniyappan, Joe Gati, Jean Thebérge, Andrea Lazosky, Mark Speechley, Imants Barušs, Soham Rej, Akshya Vasudev
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
Devin S. McCaskell, Alexander J. Molloy, Laura Childerhose, F. Aileen Costigan, Julie C. Reid, Magda McCaughan, France Clarke, Deborah J. Cook, Jill C. Rudkowski, Christopher Farley, Tim Karachi, Bram Rochwerg, Anastasia Newman, Alison Fox-Robichaud, Margaret S. Herridge, Vincent Lo, Deanna Feltracco, Karen E. A. Burns, Rebecca Porteous, Andrew J. E. Seely, Ian M. Ball, Amy Seczek, Michelle E. Kho
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial
Francesco Cellini, Stefania Manfrida, Francesco Deodato, Savino Cilla, Ernesto Maranzano, Stefano Pergolizzi, Fabio Arcidiacono, Rossella Di Franco, Francesco Pastore, Matteo Muto, Valentina Borzillo, Costanza Maria Donati, Giambattista Siepe, Salvatore Parisi, Antonia Salatino, Antonino D’Agostino, Giampaolo Montesi, Anna Santacaterina, Vincenzo Fusco, Mario Santarelli, Maria Antonietta Gambacorta, Renzo Corvò, Alessio Giuseppe Morganti, Valeria Masiello, Paolo Muto, Vincenzo Valentini
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial
Sam Eldabe, Ashish Gulve, Simon Thomson, Ganesan Baranidharan, Rui Duarte, Susan Jowett, Harbinder Sandhu, Raymond Chadwick, Morag Brookes, Anisah Tariq, Jenny Earle, Jill Bell, Anu Kansal, Shelley Rhodes, Rod S. Taylor
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial
Alexandra Poinas, Pierre Perrot, Judith Lorant, Olivier Nerrière, Jean-Michel Nguyen, Soraya Saiagh, Cécile Frenard, Audrey Leduc, Olivier Malard, Florent Espitalier, Franck Duteille, Anne Chiffoleau, Florence Vrignaud, Amir Khammari, Brigitte Dréno
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
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
01.12.2019 | Research | Ausgabe 1/2019
Open Access
European survey on national training activities in clinical research
A. Magnin, V. Cabral Iversen, G. Calvo, B. Čečetková, O. Dale, R. Demlova, Gy. Blasko, F. Keane, G. L. Kovacs, C. Levy-Marchal, E. C. Monteiro, L. Palmisano, D. Pella, A. Portolés Pérez, O. Rascol, C. Schmid, F. Tay, H. von der Leyen, C. Ohmann
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan
Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts, Aemal Akhtar, on behalf of the STRENGTHS-consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial
Francisco De la Gala, Patricia Piñeiro, Almudena Reyes, Carlos Simón, Elena Vara, Lisa Rancan, Luis Javier Huerta, Guillermo Gonzalez, Carmen Benito, Marta Muñoz, Pilar Grande, Sergio D. Paredes, Pablo Tomas Aznar, Alvaro Perez, David Martinez, Fernando Higuero, David Sanz, Juan Pedro De Miguel, Patricia Cruz, Luis Olmedilla, Elena Lopez Gil, Patricia Duque, Guillermo Sanchez-Pedrosa, Mayte Valle, Ignacio Garutti
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
The best from East and West? Acupuncture and medical training therapy as monotherapies or in combination for adult patients with episodic and chronic tension-type headache: study protocol for a randomized controlled trial
J. Schiller, T. Kellner, J. Briest, K. Hoepner, A. Woyciechowski, A. Ostermann, C. Korallus, C. Sturm, T. Weiberlenn, L. Jiang, C. Egen, F. Beissner, M. Stiesch, M. Karst, C. Gutenbrunner, M. G. Fink
01.12.2019 | Review | Ausgabe 1/2019
Open Access
Designing and using incentives to support recruitment and retention in clinical trials: a scoping review and a checklist for design
Beth Parkinson, Rachel Meacock, Matt Sutton, Eleonora Fichera, Nicola Mills, Gillian W. Shorter, Shaun Treweek, Nicola L Harman, Rebecca C. H. Brown, Katie Gillies, Peter Bower
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial
Zhaoqin Wang, Shanshan Li, Luyi Wu, Qin Qi, Huirong Liu, Xiaoming Jin, Jianhui Tian, Ming Zhang, Xiaopeng Ma, Deli Sun, Shifen Xu, Huangan Wu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial
Clara Sanches, Richard Levy, Sarah Benisty, Lisette Volpe-Gillot, Marie-Odile Habert, Aurelie Kas, Sébastian Ströer, Nadya Pyatigorskaya, Anna Kaglik, Angelina Bourbon, Bruno Dubois, Raffaella Migliaccio, Antoni Valero-Cabré, Marc Teichmann
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Liraglutide and the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis: protocol for a pilot trial
Clare Alexandra Whicher, Hermione Clare Price, Peter Phiri, Shanaya Rathod, Katharine Barnard-Kelly, Claire Reidy, Kerensa Thorne, Carolyn Asher, Robert Peveler, Joanne McCarthy, Richard Ian Gregory Holt
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A mobile device app to reduce prehospital medication errors and time to drug preparation and delivery by emergency medical services during simulated pediatric cardiopulmonary resuscitation: study protocol of a multicenter, prospective, randomized controlled trial
Johan N. Siebert, Laurie Bloudeau, Frédéric Ehrler, Christophe Combescure, Kevin Haddad, Florence Hugon, Laurent Suppan, Frédérique Rodieux, Christian Lovis, Alain Gervaix, Sergio Manzano
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol
Margo S. Harrison, Saskia Bunge-Montes, Claudia Rivera, Andrea Jimenez-Zambrano, Gretchen Heinrichs, Sharon Scarbro, Elizabeth Juarez-Colunga, Antonio Bolanos, Edwin Asturias, Stephen Berman, Jeanelle Sheeder
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)
Daniel Hayes, Anna Moore, Emily Stapley, Neil Humphrey, Rosie Mansfield, Joao Santos, Emma Ashworth, Praveetha Patalay, Eva-Maria Bonin, Bettina Moltrecht, Jan R. Boehnke, Jessica Deighton
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis
Lindsay Armstrong-Buisseret, Clare Brittain, Miruna David, Gillian Dean, Frances Griffiths, Trish Hepburn, Louise Jackson, Joe Kai, Alan Montgomery, Tracy Roberts, Sukhwinder Thandi, Jonathan D. C. Ross
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives
Robyn Su May Lim, Daphne Su Lyn Gardner, Yong Mong Bee, Yin Bun Cheung, Joann Bairavi, Mihir Gandhi, Su-Yen Goh, Emily Tse Lin Ho, Xinyi Lin, Ngiap Chuan Tan, Tunn Lin Tay, Eric Andrew Finkelstein
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial
Yong Chul Kim, Jae Yoon Park, Sohee Oh, Jang-Hee Cho, Jae Hyun Chang, Dae Eun Choi, Jung Tak Park, Jung Pyo Lee, Sejoong Kim, Dong Ki Kim, Dong-Ryeol Ryu, Chun Soo Lim
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
ENACT: a protocol for a randomised placebo-controlled trial investigating the efficacy and mechanisms of action of adjunctive N-acetylcysteine for first-episode psychosis
S. M. Cotton, M. Berk, A. Watson, S. Wood, K. Allott, C. F. Bartholomeusz, C. C. Bortolasci, K. Walder, B. O’Donoghue, O. M. Dean, A. Chanen, G. P. Amminger, P. D. McGorry, A. Burnside, J. Uren, A. Ratheesh, S. Dodd
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial
Rachna Begh, Tim Coleman, Lucy Yardley, Rebecca Barnes, Felix Naughton, Hazel Gilbert, Anne Ferrey, Claire Madigan, Nicola Williams, Louisa Hamilton, Yolanda Warren, Jenna Grabey, Miranda Clark, Anne Dickinson, Paul Aveyard
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial
Marc Kowalkowski, Shih-Hsiung Chou, Andrew McWilliams, Cathryn Lashley, Stephanie Murphy, Whitney Rossman, Alfred Papali, Alan Heffner, Mark Russo, Larry Burke, Michael Gibbs, Stephanie P. Taylor, On behalf of Atrium Health ACORN Investigators
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Hygiene protocols for the treatment of denture-related stomatitis: local and systemic parameters analysis - a randomized, double-blind trial protocol
Adriana B. Ribeiro, Camila B. de Araújo, Luiz Eduardo V. Silva, Rubens Fazan-Junior, Helio C. Salgado, Aline B. Ribeiro, Caroline V. Fortes, Frank L. Bueno, Viviane C. de Oliveira, Helena de F. O. Paranhos, Evandro Watanabe, Cláudia H. da Silva-Lovato
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
eHealth-supported case management for patients with panic disorder or depression in primary care: Study protocol for a cRCT (PREMA)
Karoline Lukaschek, Karola Mergenthal, Dirk Heider, Alexander Hanke, Kathrein Munski, Anne Moschner, Michelle Emig, Marjan van den Akker, Antonia Zapf, Karl Wegscheider, Hans-Helmut König, Jochen Gensichen, for the PREMA-study group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)
Philip Asherson, Lena Johansson, Rachel Holland, Tom Fahy, Andrew Forester, Sheila Howitt, Stephen Lawrie, John Strang, Susan Young, Sabine Landau, Lindsay Thomson
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Improving risk perception and uptake of pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement in young women in Manicaland, East Zimbabwe: study protocol for a pilot randomized trial
Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett, Simon Gregson
01.12.2019 | Update | Ausgabe 1/2019
Open Access
Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial
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
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial
Jaameeta Kurji, Manisha A. Kulkarni, Lakew Abebe Gebretsadik, Muluemebet Abera Wordofa, Sudhakar Morankar, Kunuz Haji Bedru, Gebeyehu Bulcha, Kednapa Thavorn, Ronald Labonte, Monica Taljaard
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial
Yuan-Bo Fu, Bin Li, San-Feng Sun, Hui-Lin Liu, Xin Wang, Shao-Song Wang, Fan Zhang, Xin Du, Du-Juan Ge, Lei Shang, Rui-Li Liang, Li-Na Wang, Fang Yuan, Jing-Qing Sun, Jun-Wei Chen
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Fire needle acupuncture or moxibustion for chronic plaque psoriasis: study protocol for a randomized controlled trial
Zhaoxia Chen, Dongmei Zhou, Yan Wang, Haibing Lan, Xingwu Duan, Bohua Li, Jingxia Zhao, Wei Li, Zhengrong Liu, Tingting Di, Xinwei Guo, Jinchao Zhang, Bo Li, Shuo Feng, Ping Li
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol
Ali Sié, Mamadou Ouattara, Mamadou Bountogo, Cheik Bagagnan, Boubacar Coulibaly, Valentin Boudo, Elodie Lebas, Jessica M. Brogdon, Ying Lin, Till Bärnighausen, Travis C. Porco, Thuy Doan, Thomas M. Lietman, Catherine E. Oldenburg, for the Étude CHAT Study Group
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
Devin S. McCaskell, Alexander J. Molloy, Laura Childerhose, F. Aileen Costigan, Julie C. Reid, Magda McCaughan, France Clarke, Deborah J. Cook, Jill C. Rudkowski, Christopher Farley, Tim Karachi, Bram Rochwerg, Anastasia Newman, Alison Fox-Robichaud, Margaret S. Herridge, Vincent Lo, Deanna Feltracco, Karen EA Burns, Rebecca Porteous, Andrew J. E. Seely, Ian M. Ball, Amy Seczek, Michelle E. Kho
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY)
Laura Green, Neil Roberts, Jackie Cooper, Jane Field, Ravi Gill, Andrew Klein, Seema Agarwal, Simon Stanworth, Atholl Johnston, Vivienne Monk, Ben O’Brien
01.12.2019 | Methodology | Ausgabe 1/2019
Open Access
Overcoming challenges to data quality in the ASPREE clinical trial
Jessica E. Lockery, Taya A. Collyer, Christopher M. Reid, Michael E. Ernst, David Gilbertson, Nino Hay, Brenda Kirpach, John J. McNeil, Mark R. Nelson, Suzanne G. Orchard, Kunnapoj Pruksawongsin, Raj C. Shah, Rory Wolfe, Robyn L. Woods, on behalf of the ASPREE Investigator Group
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
KONTAKT© for Australian adolescents on the autism spectrum: protocol of a randomized control trial
Bahareh Afsharnejad, Marita Falkmer, Melissa H. Black, Tasha Alach, Fabian Lenhard, Anna Fridell, Christina Coco, Kelly Milne, Nigel T. M. Chen, Sven Bölte, Sonya Girdler
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Fecal microbiome as determinant of the effect of diet on colorectal cancer risk: comparison of meat-based versus pesco-vegetarian diets (the MeaTIc study)
Francesco Sofi, Monica Dinu, Giuditta Pagliai, Fabrice Pierre, Francoise Gueraud, Jildau Bowman, Philippe Gerard, Vincenzo Longo, Lisa Giovannelli, Giovanna Caderni, Carlotta de Filippo
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial
Taoying Lu, Huiyan Zhang, Lingjia Yin, Jianxiong Cai, Meiling Li, Lin Dai, Conghao Zhu, Yongping Zhang, Feng Xiang, Li Wang, Lu Li, Lixin Wang, Darong Wu
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction
Yen-I Chen, Kashi Callichurn, Avijit Chatterjee, Etienne Desilets, Donnellan Fergal, Nauzer Forbes, Ian Gan, Sana Kenshil, Mouen A. Khashab, Rastislav Kunda, Eric Lam, Gary May, Rachid Mohamed, Jeff Mosko, Sarto C. Paquin, Anand Sahai, Gurpal Sandha, Christopher Teshima, Alan Barkun, Jeffrey Barkun, Ali Bessissow, Kristina Candido, Myriam Martel, Corey Miller, Kevin Waschke, George Zogopoulos, Clarence Wong, for the ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC)
01.12.2019 | Update | Ausgabe 1/2019
Open Access
Statistical analysis plan for the Dex-CSDH trial: a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma
Annabel Allison, Ellie Edlmann, Angelos G. Kolias, Carol Davis-Wilkie, Harry Mee, Eric P. Thelin, Carole Turner, Peter J. Hutchinson, Simon Bond
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial
Aisha Shafayat, Emese Csipke, Lucy Bradshaw, Georgina Charlesworth, Florence Day, Phuong Leung, Esme Moniz-Cook, Alan A. Montgomery, Steve Morris, Gail Mountain, Reuben Ogollah, Kirsty Sprange, Lauren Yates, Martin Orrell
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Efficacy and safety of dexmedetomidine for prevention of withdrawal syndrome in the pediatric intensive care unit: protocol for an adaptive, multicenter, randomized, double-blind, placebo-controlled, non-profit clinical trial
Maria Cristina Mondardini, Francesca Sperotto, Marco Daverio, Fabio Caramelli, Dario Gregori, Maria Francesca Caligiuri, Francesca Vitale, Maria Teresa Cecini, Marco Piastra, Aldo Mancino, Andrea Pettenazzo, Giorgio Conti, Angela Amigoni
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Effectiveness of an online self-management tool, OPERAS (an On-demand Program to EmpoweR Active Self-management), for people with rheumatoid arthritis: a research protocol
Johnathan Tam, Diane Lacaille, Teresa Liu-Ambrose, Chris Shaw, Hui Xie, Catherine L. Backman, John M. Esdaile, Kimberly Miller, Robert Petrella, Linda C. Li
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial
Myrick C. Shinall Jr, Aimee Hoskins, Alexander T. Hawkins, Christina Bailey, Alaina Brown, Rajiv Agarwal, Maria C. Duggan, Laura M. Beskow, Vyjeyanthi S. Periyakoil, David F. Penson, Ryan T. Jarrett, Rameela Chandrasekhar, E. Wesley Ely
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
Landiolol, an ultra-short acting beta-1 blocker, for preventing postoperative lung cancer recurrence: study protocol for a phase III, multicenter randomized trial with two parallel groups of patients
Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Takashi Nojiri, Masato Aragaki, Nao Horie, Norihiro Sato, Yasuhiro Hida
01.12.2019 | Correction | Ausgabe 1/2019
Open Access
Correction to: iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy
Wesley de Jong, Joeri Aerts, Sabine Allard, Christian Brander, Jozefien Buyze, Eric Florence, Eric van Gorp, Guido Vanham, Lorna Leal, Beatriz Mothe, Kris Thielemans, Montse Plana, Félipe Garcia, Rob Gruters, on behalf of the iHIVARNA consortium
01.12.2019 | Study protocol | Ausgabe 1/2019
Open Access
