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Zeitschrift

Trials

Trials 1/2019

Ausgabe 1/2019

Inhaltsverzeichnis ( 759 Artikel )

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The bowel preparation for magnetic resonance enterography in patients with Crohn’s disease: study protocol for a randomized controlled trial

Min Dai, Ting Zhang, Qianqian Li, Bota Cui, Liyuan Xiang, Xiao Ding, Rong Rong, Jianling Bai, Jianguo Zhu, Faming Zhang

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program

Marianne Granbom, Lindy Clemson, Laken Roberts, Melissa D. Hladek, Safiyyah M. Okoye, Minhui Liu, Cynthia Felix, David L. Roth, Laura N. Gitlin, Sarah Szanton

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Chinese herbal medicine for the treatment of cough variant asthma: a study protocol for a double-blind randomized controlled trial

Rong-rong Fan, Ze-huai Wen, Da-wei Wang, Rong-yuan Yang, Ai-hua Ou, Lian-shun Jin, Zhong-de Zhang, Yun-tao Liu

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Intramuscular oxytocin versus oxytocin/ergometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: study protocol for a randomised controlled trial (the IMox study)

Helen van der Nelson, Stephen O’Brien, Erik Lenguerrand, Elsa Marques, Mary Alvarez, Michelle Mayer, Sara Burnard, Dimitrios Siassakos, Timothy Draycott

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Effect of chiropractic manipulative therapy on reaction time in special operations forces military personnel: a randomized controlled trial

James W. DeVocht, Robert Vining, Dean L. Smith, Cynthia Long, Thomas Jones, Christine Goertz

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial

Erik Frykholm, Peter Klijn, Didier Saey, Hieronymus W. H. van Hees, Per Stål, Thomas Sandström, Ann Sörlin, François Maltais, André Nyberg

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Effectiveness of a short video-based educational intervention on factors related to clinical trial participation in adolescents and young adults: a pre-test/post-test design

Joan E. Cowdery, James H. Powell, Yolanda A. Fleming, Devin L. Brown

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Local effects of acupuncture on the median and ulnar nerves in patients with carpal tunnel syndrome: a pilot mechanistic study protocol

Alexandra Dimitrova, Charles Murchison, Barry Oken

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Metabolic follow-up at one year and beyond of women with gestational diabetes treated with insulin and/or oral hypoglycaemic agents: study protocol for the identification of a core outcomes set using a Delphi survey

Delia Bogdanet, Aoife Egan, Narjes Fhelelboom, Linda Biesty, Shakila Thangaratinam, Eugene Dempsey, Caroline Crowther, Declan Devane, Fidelma Dunne

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Hysterectomy and opportunistic salpingectomy (HOPPSA): study protocol for a register-based randomized controlled trial

Annika Idahl, Anna Darelius, Karin Sundfeldt, Mathias Pålsson, Annika Strandell

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 | Methodology | Ausgabe 1/2019 Open Access

Involving people living with dementia in research: an accessible modified Delphi survey for core outcome set development

Hazel Morbey, Andrew J. E. Harding, Caroline Swarbrick, Faraz Ahmed, Ruth Elvish, John Keady, Paula R. Williamson, Siobhan T. Reilly

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric thermal burn injuries: study protocol for a randomised controlled trial

Maleea D. Holbert, Bronwyn R. Griffin, Steven M. McPhail, Robert S. Ware, Kelly Foster, Demi C. Bertoni, Roy M. Kimble

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey

Geng Li, Li Zhou, Wenwei Ouyang, Meiling Xuan, Liming Lu, Xiaoyan Li, Zehuai Wen, Xiankun Chen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

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

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

01.12.2019 | 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 | Correction | Ausgabe 1/2019 Open Access

Correction to: Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial

Martha A. Q. Curley, Rainer G. Gedeit, Brenda L. Dodson, June K. Amling, Deborah J. Soetenga, Christiane O. Corriveau, Lisa A. Asaro, David Wypij, For the RESTORE Investigative Team

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training

Nicole Müller, Kathrin M. Gschwendtner, Sarah Dwinger, Corinna Bergelt, Wolfgang Eich, Martin Härter, Christiane Bieber

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Organising Support for Carers of Stroke Survivors (OSCARSS): study protocol for a cluster randomised controlled trial, including health economic analysis

Emma Patchwood, Katy Rothwell, Sarah Rhodes, Evridiki Batistatou, Kate Woodward-Nutt, Yiu-Shing Lau, Gunn Grande, Gail Ewing, Audrey Bowen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial

Tiphaine Petot, Nicolas Bouscaren, Olivier Maillard, Laetitia Huiart, Malik Boukerrou, Danielle Reynaud

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Longitudinal multi-centre brain imaging studies: guidelines and practical tips for accurate and reproducible imaging endpoints and data sharing

Stewart J. Wiseman, Rozanna Meijboom, Maria del C. Valdés Hernández, Cyril Pernet, Eleni Sakka, Dominic Job, Adam D. Waldman, Joanna M. Wardlaw

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect of ultrasound-guided lumbar plexus block on emergence agitation in children undergoing hip surgery: study protocol for a randomized controlled trial

Hui Zhang, Qing Fan, Junfeng Zhang, Bin Wu, Xiaofeng Wang, Yu Zhang, Aizhong Wang

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Single dose of intravenous ferric carboxymaltose infusion versus multiple fractionated doses of intravenous iron sucrose in the treatment of postoperative anaemia in colorectal cancer patients: study protocol for a randomised controlled trial

María Jesús Laso-Morales, Roser Vives, Andrea Vallejo-Tarrat, Novella Caló, Anna Valle-Beltran, Caridad Pontes

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial

Termeh Feinberg, L. Susan Wieland, Larry E. Miller, Kashif Munir, Toni I. Pollin, Alan R. Shuldiner, Steve Amoils, Lisa Gallagher, Mary Bahr-Robertson, Christopher R. D’Adamo

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Evaluation of an intensive education program on the treatment of tobacco-use disorder for pharmacists: a study protocol for a randomized controlled trial

Maguy Saffouh El Hajj, Ahmed Awaisu, Nadir Kheir, Mohamad Haniki Nik Mohamed, Rula Shami Haddad, Rana Ahmed Saleh, Noora Mohammed Alhamad, Ahmad Mohd Almulla, Ziyad R. Mahfoud

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect of cognitive training on episodic memory retrieval in amnestic mild cognitive impairment patients: study protocol for a clinical randomized controlled trial

Kan Zhang, Junyang Wang, Guoping Peng, Ping Liu, Fangping He, Zude Zhu, Benyan Luo

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose—the PP100–01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial

James Dear, The POP Trial Investigators

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Comparison of dexmedetomidine vs. remifentanil combined with sevoflurane during radiofrequency ablation of hepatocellular carcinoma: a randomized controlled trial

Jingru Pan, Xianlong Li, Ye He, Chaojun Jian, Hui-xin Chen, Ziqing Hei, Shaoli Zhou

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial

Mikael Thastum, Daniel Bach Johnsen, Wendy K. Silverman, Pia Jeppesen, David A. Heyne, Johanne Jeppesen Lomholt

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Sciatic nerve block or not for outpatient total knee arthroplasty? Study protocol for a randomized controlled trial

Laurie Tran, Melissa Barthelemy, Pascal Boileau, Marc Raucoules-Aime, Michel Carles, Christophe Trojani

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial

Sung Hye Byun, Soo Jin Kim, Eugene Kim

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial

Tine Luyten, Paul Van de Heyning, Laure Jacquemin, Nancy Van Looveren, Frank Declau, Erik Fransen, Annick Gilles

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Scopolamine augmentation of a newly initiated escitalopram treatment for major depressive disorder: study protocol for a randomized controlled trial

Jingjing Zhou, Weiwei Wang, Jian Yang, Xuequan Zhu, Lei Feng, Le Xiao, Gang Wang

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study

Yiyi Chen, Xiaomin Cao, Wensi Zang, Shanyong Tan, Chun-quan Ou, Xiaoyan Shen, Tianming Gao, Lianxu Zhao

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

The safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: study protocol for a randomised controlled trial

Matthew G. Liptak, Annika Theodoulou, Billingsley Kaambwa, Steve Saunders, Scott W. Hinrichs, Richard J. Woodman, Jeganath Krishnan

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

Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial

Senthil Packiasabapathy, Ammu T. Susheela, Ariel Mueller, Melissa Patxot, Doris-Vanessa Gasangwa, Brian O’Gara, Shahzad Shaefi, Edward R. Marcantonio, Gloria Y. Yeh, Balachundhar Subramaniam

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

Effects of home-based prescribed pulmonary exercise by patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Xiaodan Liu, Peijun Li, Lu Xiao, Yufan Lu, Ning Li, Zhengrong Wang, Hongxia Duan, Jian Li, Weibing Wu

01.12.2019 | Update | Ausgabe 1/2019 Open Access

Detailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restriction

Anouk Pels, Janus C. Jakobsen, Wessel Ganzevoort, Christiana A. Naaktgeboren, Wes Onland, Aleid G. van Wassenaer-Leemhuis, Christian Gluud

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

The correlation between baseline score and post-intervention score, and its implications for statistical analysis

Lei Clifton, David A. Clifton

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 | Research | Ausgabe 1/2019 Open Access

Process evaluation of the context, reach and recruitment of participants and delivery of dementia-specific case conferences (WELCOME-IdA) in nursing homes (FallDem): a mixed-methods study

Daniela Holle, Rene Müller-Widmer, Sven Reuther, Ute Rosier-Segschneider, Rabea Graf, Martina Roes, Margareta Halek

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

Effect of preconceptional DHEA treatment on in vitro fertilization outcome in poor ovarian respond women: study protocol for a randomized controlled trial

Wei Wang, Hong Liu, Jing Li, Daimin Wei, Jiangtao Zhang, Jianfeng Wang, Jinlong Ma, Yuhua Shi, Zi-Jiang Chen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparing the placement of a left-sided double-lumen tube via fiberoptic bronchoscopy guidance versus conventional intubation using a Macintosh laryngoscope, to reduce the incidence of malpositioning: study protocol for a randomized controlled pilot trial

Taeha Ryu, Eugene Kim, Jong Hae Kim, Seong Jun Woo, Woon Seok Roh, Sung Hye Byun

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Nurse-led, telephone-based secondary preventive follow-up benefits stroke/TIA patients with low education: a randomized controlled trial sub-study

Anna-Lotta Irewall, Joachim Ögren, Lisa Bergström, Katarina Laurell, Lars Söderström, Thomas Mooe

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

BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial

C. S. Seefeldt, J. S. Meyer, J. Knievel, A. Rieger, R. Geißen, R. Lefering, M. M. Heiss

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

A phase III wait-listed randomised controlled trial of novel targeted inter-professional clinical education intervention to improve cancer patients’ reported pain outcomes (The Cancer Pain Assessment (CPAS) Trial): study protocol

Jane L. Phillips, Nicole Heneka, Melanie Lovell, Lawrence Lam, Patricia Davidson, Frances Boyle, Nikki McCaffrey, Sally Fielding, Tim Shaw

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 | Commentary | Ausgabe 1/2019 Open Access

Introducing the new CONSORT extension for stepped-wedge cluster randomised trials

Karla Hemming, Monica Taljaard, Jeremy Grimshaw

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Integral movement therapy versus local movement therapy approach in patients with idiopathic chronic low-back pain: study protocol for a randomized controlled trial

Suzana Pustivšek, Nejc Šarabon

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study

Maria Kamenova, Christian Mueller, Michael Coslovsky, Raphael Guzman, Luigi Mariani, Jehuda Soleman

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 | Commentary | Ausgabe 1/2019 Open Access

Editorial Promoting Help-seeking using E-Technology for ADolescents: The ProHEAD consortium

Michael Kaess, Stephanie Bauer

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

A self-guided Internet-based intervention for individuals with gambling problems: study protocol for a randomized controlled trial

Lara Bücker, Stefan Westermann, Simone Kühn, Steffen Moritz

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Rationale and methods of an Evaluation of the Effectiveness of the Community Paramedicine at Home (CP@home) program for frequent users of emergency medical services in multiple Ontario regions: a study protocol for a randomized controlled trial

Gina Agarwal, Melissa Pirrie, Brent McLeod, Ricardo Angeles, Walter Tavares, Francine Marzanek, Lehana Thabane

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect of a lifestyle-focused electronic patient support application for improving risk factor management, self-rated health, and prognosis in post-myocardial infarction patients: study protocol for a multi-center randomized controlled trial

Manuel Gonzalez, Ingela Sjölin, Maria Bäck, Halldora Ögmundsdottir Michelsen, Tina Tanha, Camilla Sandberg, Alexandru Schiopu, Margret Leosdottir

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial

Ingebjørg Irgens, Jana M. Hoff, Hilde Sørli, Hanne Haugland, Johan K. Stanghelle, Tiina Rekand

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial

Anna Niezgoda, Andrzej Winnicki, Tomasz Kosmalski, Bogna Kowaliszyn, Jerzy Krysiński, Rafał Czajkowski

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

Efficacy of motivating short interventions for smokers in primary care (COSMOS trial): study protocol for a cluster-RCT

Thomas Grischott, Oliver Senn, Thomas Rosemann, Anja Frei, Jacques Cornuz, Eva Martin-Diener, Stefan Neuner-Jehle

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing?

Maria Flink, Carina Brandberg, Mirjam Ekstedt

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Triangulating stapling vs functional end-to-end stapling for cervical esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer: study protocol for a randomized controlled trial

Toshiaki Tsuji, Toshiyasu Ojima, Mikihito Nakamori, Masaki Nakamura, Masahiro Katsuda, Keiji Hayata, Junya Kitadani, Shimpei Maruoka, Toshio Shimokawa, Hiroki Yamaue

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

Evaluation of the impact of levothyroxine treatment on the psychomotor developmental status of three-year-old children born to mothers with mild thyroid impairment; Tehran Thyroid and pregnancy study: study protocol for a randomized clinical trial

Sima Nazarpour, Fahimeh Ramezani Tehrani, Firoozeh Sajedi, Razieh Bidhendi Yarandi, Fereidoun Azizi

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Automated psychological therapy using virtual reality (VR) for patients with persecutory delusions: study protocol for a single-blind parallel-group randomised controlled trial (THRIVE)

Daniel Freeman, Rachel Lister, Felicity Waite, Ly-Mee Yu, Mel Slater, Graham Dunn, David Clark

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial

Fabienne Marlats, Leila Djabelkhir-Jemmi, Eric Azabou, Marouane Boubaya, Sjaak Pouwels, Anne-Sophie Rigaud

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Virtual reality gait training versus non-virtual reality gait training for improving participation in subacute stroke survivors: study protocol of the ViRTAS randomized controlled trial

Ilona J. M. de Rooij, Ingrid G. L. van de Port, Johanna M. A. Visser-Meily, Jan-Willem G. Meijer

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Evaluation of a blended-learning training concept to train oncology physicians to advise their patients about complementary and integrative medicine (KOKON-KTO): study protocol for a prospective, multi-center, cluster-randomized trial

Stefanie M. Helmer, Alizé A. Rogge, Felix Fischer, Daniel Pach, Markus Horneber, Stephanie Roll, Claudia M. Witt

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 | Study protocol | Ausgabe 1/2019 Open Access

Handheld ECG Tracking of in-hOspital Atrial Fibrillation The HECTO-AF trial Clinical Study Protocol

Sara Schukraft, Marco Mancinetti, Daniel Hayoz, Yannick Faucherre, Stéphane Cook, Diego Arroyo, Serban Puricel

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

Early and comprehensive care bundle in the elderly for acute heart failure in the emergency department: study protocol of the ELISABETH stepped-wedge cluster randomized trial

Yonathan Freund, Judith Gorlicki, Marine Cachanado, Sarah Salhi, Vanessa Lemaître, Tabassome Simon, Alexandre Mebazaa

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

Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: a study protocol for a cost-effectiveness randomized clinical trial

Allisson Filipe Lopes Martins, Túlio Eduardo Nogueira, Marília Oliveira Morais, Angélica Ferreira Oton-Leite, Marize Campos Valadares, Aline Carvalho Batista, Nilceana Maya Aires Freitas, Cláudio Rodrigues Leles, Elismauro Francisco Mendonça

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Social cognitive theory-based intervention to promote physical activity among prediabetic rural people: a cluster randomized controlled trial

Tahereh Shamizadeh, Leila Jahangiry, Parvin Sarbakhsh, Koen Ponnet

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial

Ingo Stoffels, Ken Herrmann, Jan Rekowski, Philipp Jansen, Dirk Schadendorf, Andreas Stang, Joachim Klode

01.12.2019 | Commentary | Ausgabe 1/2019 Open Access

Commentary: On the levels of patient selection in registry-based randomized controlled trials

Florian Lasch, Kristina Weber, Armin Koch

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

Study protocol for a peer-led web-based intervention to promote safe usage of dating applications among young adults: a cluster randomized controlled trial

Stephanie Tsz Hei Lau, Kitty Wai Ying Choi, Julie Chen, William Pak-hing Mak, Ho Kong Christopher Au Yeung, Joseph Tucker, William Chi-Wai Wong

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

Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial

Qianqian Huang, Wei Wu, Xiaolong Chen, Bo Wu, Longqiang Wu, Xiaoli Huang, Songhe Jiang, Lejian Huang

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 | Study protocol | Ausgabe 1/2019 Open Access

COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults

Sinead Duane, Akke Vellinga, Andrew W. Murphy, Martin Cormican, Andrew Smyth, Patricia Healy, Michael Moore, Paul Little, Declan Devane

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Stroke aetiological classification reliability and effect on trial sample size: systematic review, meta-analysis and statistical modelling

Azmil H. Abdul-Rahim, David Alexander Dickie, Johann R. Selvarajah, Kennedy R. Lees, Terence J. Quinn, On behalf of VISTA Collaborators

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

Physical Activity In Renal Disease (PAIRED) and the effect on hypertension: study protocol for a randomized controlled trial

Stephanie Thompson, Natasha Wiebe, Gabor Gyenes, Rachelle Davies, Jeyasundar Radhakrishnan, Michelle Graham

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery. J-SUPPORT 1605 (ProD Study): study protocol for a randomized controlled trial

Saho Wada, Ryoichi Sadahiro, Yutaka J. Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi, Ken Shimizu

01.12.2019 | Research | Ausgabe 1/2019 Open Access

How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions

Marco J. Haenssgen, Nutcha Charoenboon, Nga T. T. Do, Thomas Althaus, Yuzana Khine Zaw, Heiman F. L. Wertheim, Yoel Lubell

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

VIA Family—a family-based early intervention versus treatment as usual for familial high-risk children: a study protocol for a randomized clinical trial

Anne D. Müller, Ida C. T. Gjøde, Mette S. Eigil, Helle Busck, Merete Bonne, Merete Nordentoft, Anne A. E. Thorup

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

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

Jamie J. Kirkham, Sarah Gorst, Douglas G. Altman, Jane M. Blazeby, Mike Clarke, Sean Tunis, Paula R. Williamson, for the COS-STAP Group

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial

Yueqi Chen, Wenjing Zhang, Huangan Wu, Lixing Lao, Jian Xu, Shifen Xu

01.12.2019 | Research | Ausgabe 1/2019 Open Access

COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time

Ben Goldacre, Henry Drysdale, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Cicely Marston, Anna Powell-Smith, Carl Heneghan, Kamal R. Mahtani

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 | Commentary | Ausgabe 1/2019 Open Access

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

Sanne Marie Thysen, Ane Bærent Fisker

01.12.2019 | Research | Ausgabe 1/2019 Open Access

COMPare: Qualitative analysis of researchers’ responses to critical correspondence on a cohort of 58 misreported trials

Ben Goldacre, Henry Drysdale, Cicely Marston, Kamal R. Mahtani, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Carl Heneghan

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

Efficacy and safety of umbilical therapy with the traditional Chinese medicine formulation Lishui Xiaogu cataplasm for cirrhotic ascites: protocol for a randomized controlled trial

Xianzhao Yang, Shuying Ru, Lin Luo, Xiaoying Lv, Wenjing Bai, Fuwen Zhang, Feng Jiang

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Binge-eating disorder treatment goes online – feasibility, usability, and treatment outcome of an Internet-based treatment for binge-eating disorder: study protocol for a three-arm randomized controlled trial including an immediate treatment, a waitlist, and a placebo control group

Simone Munsch, Andrea Wyssen, Pierre Vanhulst, Denis Lalanne, Sharon T. Steinemann, Alexandre Tuch

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Anaesthetist-controlled versus patient-maintained effect-site targeted propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia (ACCEPTS): study protocol for a parallel-group randomised comparison trial

David W. Hewson, Frank Worcester, James Sprinks, Murray D. Smith, Heather Buchanan, Philip Breedon, Jonathan G. Hardman, Nigel M. Bedforth

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Study of negative pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): protocol for a randomised controlled trial

Cody C. Frear, Bronwyn Griffin, Leila Cuttle, Steven M. McPhail, Roy Kimble

01.12.2019 | Research | Ausgabe 1/2019 Open Access

How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the ‘CLASSIC’ trial)

June S. L. Brown, Caroline Murphy, Joanna Kelly, Kimberley Goldsmith

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Pulmonary rehabilitation in patients with mustard gas lung disease: a study protocol for a randomized controlled trial

Mohamad Reza Sedighi Moghadam, Mostafa Ghanei, Klaus Kenn, Nicholas S. Hopkinson

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

Acceptability and feasibility of a 12-week yoga vs. educational film program for the management of restless legs syndrome (RLS): study protocol for a randomized controlled trial

Terry Kit Selfe, Sijin Wen, Karen Sherman, Maryanna Klatt, Kim E. Innes

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of blood flow restriction exercise with very low load and low volume in patients with knee osteoarthritis: protocol for a randomized trial

Mikhail Santos Cerqueira, Wouber Hérickson de Brito Vieira

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Sheling Xie, Peng Yan, Chen Yao, Xiaoyan Yan, Yuliang Huo, Junhua Zhang, Si Liu, Zhiqiao Feng, Hongcai Shang, Lixin Xie

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A parent-led intervention to promote recovery following pediatric injury: study protocol for a randomized controlled trial

Meghan L. Marsac, Ginny Sprang, Leila Guller, Kristen L. Kohser, John M. Draus Jr, Nancy Kassam-Adams

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial

Francine Monique Ducharme, Megan Jensen, Geneviève Mailhot, Nathalie Alos, John White, Elizabeth Rousseau, Sze Man Tse, Ali Khamessan, Benjamin Vinet

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The SURV1VE trial—sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial

Georg M. Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Caroline Fray, Sylvia van Os, Po-Yin Cheung, on behalf of the SURV1VE trial collaborators

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 | Commentary | Ausgabe 1/2019 Open Access

SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials

Jacqueline Martin-Kerry, Adwoa Parker, Peter Bower, Ian Watt, Shaun Treweek, David Torgerson, Catherine Arundel, Peter Knapp

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial)

Benjamin Speich, Kathrin Bausch, Jan A. Roth, Lars G. Hemkens, Hannah Ewald, Deborah R. Vogt, Nicole Bruni, Stefanie Deuster, Hans-H. Seifert, Andreas F. Widmer

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

Evaluation of the effect of an antenatal pelvic floor muscle exercise programme on female sexual function during pregnancy and the first 3 months following birth: study protocol for a pragmatic randomised controlled trial

Sahar Sadat Sobhgol, Holly Priddis, Caroline A. Smith, Hannah Grace Dahlen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial

Christopher S. Stauffer, Jenna M. Moschetto, Scott M. McKernan, Elaine Hsiang, Brian Borsari, Joshua D. Woolley

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

Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial

Kar-Hai Chu, César G. Escobar-Viera, Sara J. Matheny, Esa M. Davis, Brian A. Primack

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Mixed-methods approach to evaluate an mHealth intervention to increase adherence to triage of human papillomavirus-positive women who have performed self-collection (the ATICA study): study protocol for a hybrid type I cluster randomized effectiveness-implementation trial

Silvina Arrossi, Melisa Paolino, Liliana Orellana, Laura Thouyaret, Racquel E. Kohler, Kasisomayajula Viswanath

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Rationale and design of PASSAT — patients’ satisfaction with local or general anaesthesia in video-assisted thoracoscopic surgery: study protocol for a randomised controlled trial with a non-randomised side arm

Thomas Galetin, Pascal Bretzke, Alberto Lopez-Pastorini, Mark Schieren, Aris Koryllos, Nils Kosse, Jost Schnell, Jerome M. Defosse, Frank Wappler, Erich Stoelben

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam

Mary DeSilva, Cong Nguyen Vu, Rachael Bonawitz, Le Thanh Hai, Nguyen Van Lam, Le Thi Yen, Allen L. Gifford, Jessica Haberer, Dang Thuy Linh, Lora Sabin

01.12.2019 | Review | Ausgabe 1/2019 Open Access

Statistical design and analysis in trials of proportionate interventions: a systematic review

Jane Candlish, M. Dawn Teare, Judith Cohen, Tracey Bywater

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

Effects of vitamin D supplementation on liver fibrogenic factors in non-alcoholic fatty liver patients with steatohepatitis: study protocol for a randomized clinical trial

Soraiya Ebrahimpour-Koujan, Amir Ali Sohrabpour, Farshad Foroughi, Ehsan Alvandi, Ahmad Esmaillzadeh

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

Jin’s three-needle acupuncture technique for chronic fatigue syndrome: a study protocol for a multicentre, randomized, controlled trial

Wenjia Lin, Xin-lin Chen, Qi Chen, Junmao Wen, Xinghua Chen

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

Mental Health Prevention in Preschool Children: study protocol for a feasibility and acceptability randomised controlled trial of a culturally adapted version of the I Can Problem Solve (ICPS) Programme in Chile

Jorge Gaete, Marcelo Sánchez, Lorena Nejaz, Mikele Otegui

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study

Stephen O’Brien, Emily J. Hotton, Erik Lenguerrand, Julia Wade, Cathy Winter, Tim J. Draycott, Joanna F. Crofts, The ASSIST Study Group

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

Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial

Yang Gao, Feng Zhang, Chenguang Li, Yuxiang Dai, Ji’e Yang, Ya’nan Qu, Juying Qian, Junbo Ge, for the OPTIMAL trial investigators

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effect of manual therapy and exercise on age-related lung function: study protocol for a randomised controlled trial

Roger Engel, Sandra Grace, Suzanne Broadbent

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Role of cerebral hypoperfusion in multiple sclerosis (ROCHIMS): study protocol for a proof-of-concept randomized controlled trial with bosentan

Stéphanie Hostenbach, Ayla Pauwels, Veronique Michiels, Hubert Raeymaekers, Anne-Marie Van Binst, Annick Van Merhaeghen-Wieleman, Peter Van Schuerbeek, Jacques De Keyser, Miguel D’Haeseleer

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of transcranial direct current stimulation on the rehabilitation of painful shoulder following a stroke: protocol for a randomized, controlled, double-blind, clinical trial

Janaina Andressa de Souza, João Carlos Ferrari Corrêa, Letizzia Dall’ Agnol, Filipe Ribeiro dos Santos, Márcia Rafaella Pereira Gomes, Fernanda Ishida Corrêa

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Flexible video endoscope versus Macintosh laryngoscope for orotracheal tracheal intubation in the lateral position: a study protocol for a randomized controlled trial

Youguang Gao, Bo Lin, Jinghao Huang, Xianzhong Lin, Caizhu Lin

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effect of repeated remote ischemic postconditioning on infarct size in patients with an ischemic stroke (REPOST): study protocol for a randomized clinical trial

Thijs Landman, Yvonne Schoon, Michiel Warlé, Frank-Erik De Leeuw, Dick Thijssen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial

Susan Högg, Manfred Holzgraefe, Insa Wingendorf, Jan Mehrholz, Christoph Herrmann, Mark Obermann

01.12.2019 | Review | Ausgabe 1/2019 Open Access

Evaluation of repositories for sharing individual-participant data from clinical studies

Rita Banzi, Steve Canham, Wolfgang Kuchinke, Karmela Krleza-Jeric, Jacques Demotes-Mainard, Christian Ohmann

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Application via mechanical dropper alleviates sufentanil-induced cough: a prospective, randomized, single-blinded trial

Minqiang Liu, Zhichao Li, Song Wang, Yong Liu, Xiangpeng Zhong, Renliang He, Fengxian Li

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of Lysulin™ supplementation on pre-diabetes: study protocol for a randomized controlled trial

Priyanga Ranasinghe, Ranil Jayawardena, Lal Chandrasena, Vivianne Noetzel, John Burd

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Combined test versus logrank/Cox test in 50 randomised trials

Patrick Royston, Babak Choodari-Oskooei, Mahesh K. B. Parmar, Jennifer K. Rogers

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial

Hsiang-Lin Tsai, Tsung-Kun Chang, Wei-Chih Su, Yung-Sung Yeh, Ching-Wen Huang, Cheng-Jen Ma, Jaw-Yuan Wang

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

Multimorbidity risk assessment in adolescents and adults with cerebral palsy: a protocol for establishing a core outcome set for clinical research and practice

Patrick G. McPhee, Joyce L. Benner, Astrid C. J. Balemans, Olaf Verschuren, Rita J. G. van den Berg-Emons, Edward A. Hurvitz, Mark D. Peterson, Wilma M. A. van der Slot, Marij E. Roebroeck, Jan Willem Gorter

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 | Study protocol | Ausgabe 1/2019 Open Access

Effect of electro-acupuncture on lateralization of the human swallowing motor cortex excitability in healthy subjects: study protocol for a single-blind, randomized controlled trial

Minying Li, Lin Wang, Nenggui Xu, Xiaorong Tang, Mindong Xu, Jianhua Liu, Jianpeng Huang, Judith M. Schlaeger

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 | Methodology | Ausgabe 1/2019 Open Access

Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation

Clifton O. Bingham III, Carol L. Gaich, Amy M. DeLozier, Kathryn D. Engstrom, April N. Naegeli, Stephanie de Bono, Pixy Banerjee, Peter C. Taylor

01.12.2019 | Update | Ausgabe 1/2019 Open Access

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

Rustam Al-Shahi Salman, Gordon D. Murray, Martin S. Dennis, David E. Newby, Peter A. G. Sandercock, Nikola Sprigg, Cathie L. M. Sudlow, David J. Werring, Philip M. White, William N. Whiteley

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 | Methodology | Ausgabe 1/2019 Open Access

Use of a Geographic Information System to create treatment groups for group-randomized community trials: The Minnesota Heart Health Program

Brittany Krzyzanowski, Steven M. Manson, Milton Mickey Eder, Len Kne, Niki Oldenburg, Kevin Peterson, Alan T. Hirsch, Russell V. Luepker, Sue Duval

01.12.2019 | Update | Ausgabe 1/2019 Open Access

Wound Healing In Surgery for Trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy

Ruth Knight, Louise M. Spoors, Matthew L. Costa, Susan J. Dutton

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Binafuxi granules in the treatment of common cold with heat syndrome based on traditional Uighur medicine: study protocol for a multicenter randomized controlled trial

Jie Min, Bin She, Xin Zhang, Bing Mao, Yan Chen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial

Mike Ralf Langenbach, Dörthe Seidel

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 | Methodology | Ausgabe 1/2019 Open Access

Estimating Site Performance (ESP): can trial managers predict recruitment success at trial sites? An exploratory study

Hanne Bruhn, Shaun Treweek, Anne Duncan, Kirsty Shearer, Sarah Cameron, Karen Campbell, Karen Innes, Dawn McRae, Seonaidh C. Cotton

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Improving primary care Access in Context and Theory (I-ACT trial): a theory-informed randomised cluster feasibility trial using a realist perspective

John A. Ford, Andy P. Jones, Geoff Wong, Garry Barton, Allan Clark, Erika Sims, Ann Marie Swart, Nick Steel

01.12.2019 | Research | Ausgabe 1/2019 Open Access

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

Ahmed Ziedan, Sunil Bhandari

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial

Mui Teng Chua, Faheem Ahmed Khan, Wei Ming Ng, Qingshu Lu, Matthew Jian Wen Low, Ying Wei Yau, Amila Punyadasa, Win Sen Kuan

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial

Sophie Juul, Susanne Lunn, Stig Poulsen, Per Sørensen, Mehrak Salimi, Janus Christian Jakobsen, Anthony Bateman, Sebastian Simonsen

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 | Study protocol | Ausgabe 1/2019 Open Access

Evaluation of the efficacy of transcranial direct current stimulation in the treatment of cognitive symptomatology in the early stages of psychosis: study protocol for a double-blind randomized controlled trial

Thais Rabanea-Souza, Sheila M. C. Cirigola, Cristiano Noto, July S. Gomes, Caroline C. Azevedo, Ary Gadelha, Quirino Cordeiro, Álvaro M. Dias, Acioly L. T. Lacerda

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Photobiomodulation therapy on the palliative care of temporomandibular disorder and orofacial/cervical skull pain: study protocol for a randomized controlled clinical trial

Fernando Rodrigues Carvalho, Rafael Queiroz Barros, Alyne Simões Gonçalves, Patrícia Moreira Freitas

01.12.2019 | Correction | Ausgabe 1/2019 Open Access

Correction to: Effect of action-based cognitive remediation on cognition and neural activity in bipolar disorder: study protocol for a randomized controlled trial

Caroline V. Ott, Maj Vinberg, Christopher R. Bowie, Ellen Margrethe Christensen, Gitte M. Knudsen, Lars V. Kessing, Kamilla W. Miskowiak

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT)

Oral Ospanov, Galymzhan Yeleuov, Irina Kadyrova, Farida Bekmurzinova

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

Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial

Queenie Ho Yan Wong, Man Wa Lui, Sofie Shuk Fei Yung, Jennifer Ka Yee Ko, Raymond Hang Wun Li, Ernest Hung Yu Ng

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 | Methodology | Ausgabe 1/2019 Open Access

Optimising recruitment into trials using an internal pilot

W. Bertram, A. Moore, V. Wylde, R. Gooberman-Hill

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effect of an expanded long-term periodization exercise training on physical fitness in patients with coronary artery disease: study protocol for a randomized controlled trial

Rita Pinto, Vitor Angarten, Vanessa Santos, Xavier Melo, Helena Santa-Clara

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Nebulized versus intravenous morphine titration for the initial treatment of severe acute pain in the emergency department: study protocol for a multicenter, prospective randomized and controlled trial, CLIN-AEROMORPH

Virginie Eve Lvovschi, Justine Joly, Nicolas Lemaire, Maxime Maignan, Pauline Canavaggio, Anne-Marie Leroi, Marie-Pierre Tavolacci, Luc-Marie Joly

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study

Thibault Lhermusier, Paul Ohayon, Nicolas Boudou, Frederic Bouisset, Francisco Campelo-Parada, Jerome Roncalli, Meyer Elbaz, Didier Carrié

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 | Research | Ausgabe 1/2019 Open Access

Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Yorokpa Joachim Doua, Hanneke Dominicus, Julius Mugwagwa, Suzelle Magalie Gombe, Jude Nwokike

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 | Research | Ausgabe 1/2019 Open Access

Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study

Dhaneshwar Shep, Chitra Khanwelkar, Prakashchandra Gade, Satyanand Karad

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

Songling Xuemaikang capsules for patients with low-to-medium risk hypertension: study protocol for a randomized controlled trial

Yuerong Jiang, Haiyan Guo, Yue Liu, Xin Wang, Jiaqi Liang, Ruixi Xi, Ruina Bai, Dazhuo Shi

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

Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial

Edris Omar, Grégoire Wallon, Christian Bauer, Grégory Axiotis, Cécile Bouix, Jean-Luc Soubirou, Frédéric Aubrun

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

Efficacy and Feasibility of Pain management and Patient Education for Physical Activity in Intermittent claudication (PrEPAID): protocol for a randomised controlled trial

Ukachukwu O. Abaraogu, Philippa M. Dall, Julie Brittenden, Wesley Stuart, Garry A. Tew, Jon Godwin, Christopher A. Seenan

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Uro-Vaxom® versus placebo for the prevention of recurrent symptomatic urinary tract infections in participants with chronic neurogenic bladder dysfunction: a randomised controlled feasibility study

Derick Wade, James Cooper, Fadel Derry, Julian Taylor

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Pre-trial qualitative work with health care professionals to refine the design and delivery of a randomised controlled trial on kidney care

Samantha Husbands, Fergus Caskey, Helen Winton, Andy Gibson, Jenny L. Donovan, Leila Rooshenas

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study

Lucy Bradshaw, Alexandra Sawyer, Eleanor Mitchell, Lindsay Armstrong-Buisseret, Susan Ayers, Lelia Duley

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 | Methodology | Ausgabe 1/2019 Open Access

Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system

Carlos Diaz-Montana, William J. Cragg, Rahela Choudhury, Nicola Joffe, Matthew R. Sydes, Sally P. Stenning

01.12.2019 | Research | Ausgabe 1/2019 Open Access

A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine

Ona L. McCarthy, Hanadi Zghayyer, Amina Stavridis, Samia Adada, Irrfan Ahamed, Baptiste Leurent, Phil Edwards, Melissa Palmer, Caroline Free

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

Effects of different modalities of inspiratory muscle training as an add-on to conventional treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a randomized controlled trial

Catharinne Angélica Carvalho de Farias, Lucien Peroni Gualdi, Selma Bruno da Silva, Verônica Franco Parreira, Dayane Montemezzo, Vanessa R. Resqueti, Guilherme A. F. Fregonezi

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 | Research | Ausgabe 1/2019 Open Access

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

Victoria Shepherd, Fiona Wood, Richard Griffith, Mark Sheehan, Kerenza Hood

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Promoting physical activity among community groups of older women in socio-economically disadvantaged areas: randomised feasibility study

Emma R. Lawlor, Margaret E. Cupples, Michael Donnelly, Mark A. Tully

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Growing Healthy Together: protocol for a randomized clinical trial using parent mentors for early childhood obesity intervention in a Latino community

Byron A. Foster, Kelsey Weinstein, Jackilen Shannon

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

Long-term effects of motherfit group therapy in pre-(MOTHERFIT1) and post-partum women (MOTHERFIT2) with stress urinary incontinence compared to care-as-usual: study protocol of two multi-centred, randomised controlled trials

Heidi F. A. Moossdorff-Steinhauser, Esther M. J. Bols, Marc E. A. Spaanderman, Carmen D. Dirksen, Mirjam Weemhoff, Fred H. M. Nieman, Bary Berghmans

01.12.2019 | Update | Ausgabe 1/2019 Open Access

Community-based interventions to prevent serious complications following spinal cord injury in Bangladesh: the CIVIC trial statistical analysis plan

Robert D. Herbert, Lisa A. Harvey, Mohammad S. Hossain, Md. Shofiqul Islam, Qiang Li, Laurent Billot, The CIVIC Trial Collaboration

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

Protocol for a randomised controlled feasibility study examining the efficacy of brief cognitive therapy for the Treatment of Anxiety Disorders in Adolescents (TAD-A)

Lucy Taylor, Polly Waite, Brynjar Halldorsson, Ray Percy, Mara Violato, Cathy Creswell

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms

William J. Cragg, Fay Cafferty, Carlos Diaz-Montana, Elizabeth C. James, Johnathan Joffe, Monica Mascarenhas, Victoria Yorke-Edwards

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

A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial

Sebastian Probst, Lara Allet, Jocelyne Depeyre, Sophie Colin, Monika Buehrer Skinner

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Enhancing the efficacy of integrative improvisational music therapy in the treatment of depression: study protocol for a randomised controlled trial

Jaakko Erkkilä, Olivier Brabant, Suvi Saarikallio, Esa Ala-Ruona, Martin Hartmann, Nerdinga Letulė, Monika Geretsegger, Christian Gold

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

All-trans-retinoic acid (ATRA) plus oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX) versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controlled trial

Jie Shi, Juxian Sun, Chang Liu, Zongtao Chai, Nanya Wang, Hui Zhang, Shuqun Cheng

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

Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial

Thaddeus W. W. Pace, Sally E. Dodds, Alla Sikorskii, Terry A. Badger, Chris Segrin, Lobsang Tenzin Negi, Timothy Harrison, Tracy E. Crane

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Addition of a new three-dimensional adjustable cervical thoracic orthosis to a multi-modal program in the treatment of nonspecific neck pain: study protocol for a randomised pilot trial

Ahmed S. A. Youssef, Nan Xia, Shimaa T. E. Emara, Ibrahim M. Moustafa, Xiaolin Huang

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

Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia (SAB7): study protocol for a randomized controlled trial

Louise Thorlacius-Ussing, Christian Østergaard Andersen, Niels Frimodt-Møller, Inge Jenny Dahl Knudsen, Jens Lundgren, Thomas Lars Benfield

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind community-based randomized controlled trial

Fakir Md Yunus, Chowdhury Jalal, Kaosar Afsana, Rajib Podder, Albert Vandenberg, Diane M. DellaValle

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 | Study protocol | Ausgabe 1/2019 Open Access

Ventilation strategies with different inhaled Oxygen conceNTration during CardioPulmonary Bypass in cardiac surgery (VONTCPB): study protocol for a randomized controlled trial

Meng-Qiu Zhang, Yu-Qi Liao, Hong Yu, Xue-Fei Li, Liang Feng, Xiao-Yun Yang, Hai Yu

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial

Kamal Maheshwari, Tetsuya Shimada, Jonathan Fang, Ilker Ince, Edward J. Mascha, Alparslan Turan, Andrea Kurz, Daniel I. Sessler

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial

Jason M. Beneciuk, Steven Z. George, Carol M. Greco, Michael J. Schneider, Stephen T. Wegener, Robert B. Saper, Anthony Delitto

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M)

Alice Pressman, Heather Law, Robert Stahl, Alex Scott, Alice Jacobson, Lisa Dean, Sylvia Sudat, Angelica Obillo, Andrew Avins

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Critical inspiratory pressure – a new methodology for evaluating and training the inspiratory musculature for recreational cyclists: study protocol for a randomized controlled trial

Patricia Rehder-Santos, Vinicius Minatel, Juliana Cristina Milan-Mattos, Étore De Favari Signini, Raphael Martins de Abreu, Carla Cristina Dato, Aparecida Maria Catai

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

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

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

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial

Liz Cook, Matthew J. Northgraves, Caroline Fairhurst, Sarah Ronaldson, David J. Torgerson, Jonathan Kent, Mike Reed

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Partner-assisted cognitive behavioural therapy for insomnia versus cognitive behavioural therapy for insomnia: a randomised controlled trial

Alix Mellor, Kellie Hamill, Melissa M. Jenkins, Donald H. Baucom, Peter J. Norton, Sean P. A. Drummond

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 | Study protocol | Ausgabe 1/2019 Open Access

Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial

Hao-Min Cheng, Shih-Hsien Sung, Chen-Huan Chen, Wen-Chung Yu, Shu-Mei Yang, Chao-Yu Guo, Shao-Yuan Chuang, Chern-En Chiang

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Factors associated with recruitment to randomised controlled trials in general practice: protocol for a systematic review

Keith R. Moffat, Paul Cannon, Wen Shi, Frank Sullivan

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

Video feedback intervention to enhance parental reflective functioning in primary caregivers of inpatient psychiatric children: protocol for a randomized feasibility trial

Fanny Leyton, Marcia Olhaberry, Rubén Alvarado, Graciela Rojas, Luis Alberto Dueñas, George Downing, Howard Steele

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy of the In2Care® auto-dissemination device for reducing dengue transmission: study protocol for a parallel, two-armed cluster randomised trial in the Philippines

Ferdinand Salazar, Jason Angeles, Ava Kristy Sy, Marianette T. Inobaya, Ariza Aguila, Tom Toner, Michael J. Bangs, Edward Thomsen, Richard E. Paul

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asian women: study protocol for a cluster randomized wait-list controlled trial

Cho Lee Wong, Winnie Kwok Wei So, Dorothy Ngo Sheung Chan, Kai Chow Choi, Tika Rana

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 | Correction | Ausgabe 1/2019 Open Access

Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial

Mike Ralf Langenbach, Dörthe Seidel

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

Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial

Qing Yuan, Xulei Cui, Yuda Fei, Zhonghuang Xu, Yuguang Huang

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial

Kim Melchior, Ingmar Franken, Mathijs Deen, Colin van der Heiden

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect of home-based transcranial direct current stimulation (tDCS) on cognitive function in patients with mild cognitive impairment: a study protocol for a randomized, double-blind, cross-over study

Jaesub Park, Yoonkyung Oh, Kyungmi Chung, Kwang Joon Kim, Chang Oh Kim, Jin Young Park

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

FortiColos – a multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants: study protocol for a randomised controlled pilot trial

Agnethe M. Ahnfeldt, Nana Hyldig, Yanqi Li, Susanne Soendergaard Kappel, Lise Aunsholdt, Per T. Sangild, Gitte Zachariassen

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

Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial

Martin Cour, Marielle Buisson, Kada Klouche, Radhia Bouzgarrou, Carole Schwebel, Jean-Pierre Quenot, Fabrice Zeni, Pascal Beuret, Michel Ovize, Laurent Argaud

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 | Research | Ausgabe 1/2019 Open Access

Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned

Anastasia K. Kalpakidou, John Cape, Tarun J. Limbachya, Irwin Nazareth, Marta Buszewicz

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 | Review | Ausgabe 1/2019 Open Access

What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry

Kim Madden, Kerry Tai, Patricia Schneider, Nathan Evaniew, Michelle A. Ghert, Mohit Bhandari

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Ambassadors of hope, research pioneers and agents of change—individuals’ expectations and experiences of taking part in a randomised trial of an innovative health technology: longitudinal qualitative study

Julia Lawton, Maxine Blackburn, Jenna P. Breckenridge, Nina Hallowell, Conor Farrington, David Rankin

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy of post-procedural oral hydration volume on risk of contrast-induced acute kidney injury following primary percutaneous coronary intervention: study protocol for a randomized controlled trial

Feier Song, Guoli Sun, Jin Liu, Ji-yan Chen, Yibo He, Liwei Liu, Yong Liu, the RESCIND group

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

Mie Gaarskjaer de Wolff, Marianne Johansen, Anne S. Ersbøll, Susanne Rosthøj, Anne Brunsgaard, Julie Midtgaard, Ann Tabor, Hanne Kristine Hegaard

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Single vs. double purse-string anastomosis during laparoscopic low anterior rectal resection (SINGLE–DOUBLE trial): study protocol for a randomized controlled trial

Xiaolan You, Jian Wu, Yuanjie Wang, Qinghong Liu, Dehu Chen, Xiaojun Zhao, Yan Zhou, Xiaoqing Wu, Daorong Wang

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Choosing an imbalance metric for covariate-constrained randomization in multiple-arm cluster-randomized trials

Jody D. Ciolino, Alicia Diebold, Jessica K. Jensen, Gerald W. Rouleau, Kimberly K. Koloms, Darius Tandon

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 | Commentary | Ausgabe 1/2019 Open Access

Mind the gap? The platform trial as a working environment

Liz Morrell, Joshua Hordern, Louise Brown, Matthew R. Sydes, Claire L. Amos, Richard S. Kaplan, Mahesh K. B. Parmar, Timothy S. Maughan

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 | Research | Ausgabe 1/2019 Open Access

Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements

Pia Dellson, Christina Carlsson, Mef Nilbert, Helena Jernström

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial

Jan Kottner, Elisabeth Hahnel, Monira El Genedy, Konrad Neumann, Katrin Balzer

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects on stress reduction of a modified mindfulness-based cognitive therapy for family caregivers of those with dementia: study protocol for a randomized controlled trial

Patrick Pui Kin Kor, Justina Yat-Wa Liu, Wai Tong Chien

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of intraoperative PEEP on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer: study protocol for a randomized controlled trial

Zhen-feng Zhou, Jun-biao Fang, Long Chen, Hong-fa Wang, Yong-jian Yu, Wen-yuan Wang, Jia-bao Chen, Miao-zun Zhang, Shuang-fei Hu

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 | Research | Ausgabe 1/2019 Open Access

Is this study feasible? Facilitating management of pragmatic trial planning milestones under a phased award funding mechanism

Paula Darby Lipman, Leanora Dluzak, Catherine M. Stoney

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial

Shanshan Li, Ping Yin, Xuan Yin, Anna Bogachko, Tingting Liang, Lixing Lao, Shifen Xu

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

Neurocircuitry of acupuncture effect on cognitive improvement in patients with mild cognitive impairment using magnetic resonance imaging: a study protocol for a randomized controlled trial

Hyo-Weon Suh, Jieun Kim, Ojin Kwon, Seung-Hun Cho, Jong Woo Kim, Hui-Yong Kwak, Yunna Kim, Kyung Mi Lee, Sun-Yong Chung, Jun-Hwan Lee

01.12.2019 | Update | Ausgabe 1/2019 Open Access

Cast versus functional brace in the rehabilitation of patients with a rupture of the Achilles tendon: statistical analysis plan for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised controlled trial

Ioana R. Marian, Matthew L. Costa, Susan J. Dutton

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial

Brian O’Gara, Balachundhar Subramaniam, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed, Daniel Talmor

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Who says “no” to participating in stroke clinical trials and why: an observational study from the Vancouver Stroke Program

Zoe R. O’Neill, Halina M. Deptuck, Lauren Quong, Genoveva Maclean, Karina Villaluna, Princess King-Azote, Mukul Sharma, Ken Butcher, Robert G. Hart, Thalia S. Field

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

Evaluation of the effect of oral taurine supplementation on fasting levels of fibroblast growth factors, β-Klotho co-receptor, some biochemical indices and body composition in obese women on a weight-loss diet: a study protocol for a double-blind, randomized controlled trial

Fatemeh Haidari, Maryam Asadi, Javad mohammadi-asl, Kambiz Ahmadi-Angali

01.12.2019 | Commentary | Ausgabe 1/2019 Open Access

RTS,S malaria vaccine pilot studies: addressing the human realities in large-scale clinical trials

Machteld van den Berg, Bernhards Ogutu, Nelson K. Sewankambo, Nikola Biller-Andorno, Marcel Tanner

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Real-time foot clearance biofeedback to assist gait rehabilitation following stroke: a randomized controlled trial protocol

Rezaul Begg, Mary P. Galea, Lisa James, W. A. Tony Sparrow, Pazit Levinger, Fary Khan, Catherine M. Said

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

Evaluating the safety and feasibility of a new surgical treatment for forearm fractures in older children: study protocol for a randomised controlled trial

Chunhui Chen, Linzhen Xie, Wenhao Zheng, Hua Chen, Leyi Cai

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 | Correction | Ausgabe 1/2019 Open Access

Correction to: Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation

Clifton O. Bingham III, Carol L. Gaich, Amy M. DeLozier, Kathryn D. Engstrom, April N. Naegeli, Stephanie de Bono, Pixy Banerjee, Peter C. Taylor

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The CHESS trial: protocol for the process evaluation of a randomised trial of an education and self-management intervention for people with chronic headache

Vivien P. Nichols, David R. Ellard, Frances E. Griffiths, Martin Underwood, Stephanie J. C. Taylor, Shilpa Patel, and on behalf of the CHESS team

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effect of a heel-unloading orthosis in short-term treatment of calcaneus fractures on physical function, quality of life and return to work – study protocol for a randomized controlled trial

Hagen Schmal, Anders Holsgaard Larsen, Lonnie Froberg, Julie Ladeby Erichsen, Carsten Fladmose Madsen, Lasse Pedersen

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

Efficacy and safety of acupuncture for patients with chronic urticaria: study protocol of a randomized, sham-controlled pilot trial

Yunzhou Shi, Hui Zheng, Siyuan Zhou, Qianhua Zheng, Leixiao Zhang, Xianjun Xiao, Wei Cao, Ying Liu, Ying Li

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Pomegranate juice to reduce fecal calprotectin levels in inflammatory bowel disease patients with a high risk of clinical relapse: Study protocol for a randomized controlled trial

Eleonora Scaioli, Andrea Belluzzi, Luigi Ricciardiello, Daniele Del Rio, Enrica Rotondo, Pedro Mena, Eleonora Derlindati, Francesca Danesi

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

Home-based virtual reality training after discharge from hospital-based stroke rehabilitation: a parallel randomized feasibility trial

Lisa Sheehy, Anne Taillon-Hobson, Heidi Sveistrup, Martin Bilodeau, Christine Yang, Vivian Welch, Alomgir Hossain, Hillel Finestone

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Synthesizing existing evidence to design future trials: survey of methodologists from European institutions

Adriani Nikolakopoulou, Sven Trelle, Alex J. Sutton, Matthias Egger, Georgia Salanti

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

Effect of high-flow nasal therapy during exercise training in COPD patients with chronic respiratory failure: study protocol for a randomised controlled trial

Michele Vitacca, Irene Pietta, Marta Lazzeri, Mara Paneroni, on behalf of Associazione Italiana Riabilitatori Insufficienza Respiratoria (ARIR) and Associazione Italiana Pneumologi Ospedalieri (AIPO) rehabilitation group

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

Efficacy of an Internet-based intervention for job stress and burnout among medical professionals: study protocol for a randomized controlled trial

Ewelina Smoktunowicz, Magdalena Lesnierowska, Roman Cieslak, Per Carlbring, Gerhard Andersson

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

RADIATE – Radial Dysplasia Assessment, Treatment and Aetiology: protocol for the development of a core outcome set using a Delphi survey

George R. F. Murphy, Malcolm Logan, Gill Smith, Bran Sivakumar

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A factorial randomised controlled trial to identify efficacious self-regulation techniques in an e- and m-health intervention to target an active lifestyle: study protocol

Helene Schroé, Celien Van der Mispel, Ilse De Bourdeaudhuij, Maïté Verloigne, Louise Poppe, Geert Crombez

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

Design paper of the “Blood pressure targets in post-resuscitation care and bedside monitoring of cerebral energy state: a randomized clinical trial”

Simon Mölström, Troels Halfeld Nielsen, Carl H. Nordström, Christian Hassager, Jacob Eifer Møller, Jesper Kjærgaard, Sören Möller, Henrik Schmidt, Palle Toft

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy of Cognition Support Formula® on cognitive function in older adults with subjective cognitive impairment: a protocol for a 26-week, randomised, double-blind, placebo-controlled trial

Adele E. Cave, Dennis H. Chang, Gerald W. Münch, Genevieve Z. Steiner

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Robotic-assisted Esophagectomy vs Video-Assisted Thoracoscopic Esophagectomy (REVATE): study protocol for a randomized controlled trial

Yin-Kai Chao, Zhi-Gang Li, Yu-Wen Wen, Dae-Joon Kim, Seong-Yong Park, Yu-Ling Chang, Pieter C. van der Sluis, Jelle P. Ruurda, Richard van Hillegersberg

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial

Juliana Teti Mayer, Magali Nicolier, Damien Gabriel, Caroline Masse, Julie Giustiniani, Charline Compagne, Pierre Vandel, Lionel Pazart, Emmanuel Haffen, Djamila Bennabi

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Understanding the impact of a multispecialty electronic consultation service on family physician referral rates to specialists: a randomized controlled trial using health administrative data

Clare Liddy, Isabella Moroz, Erin Keely, Monica Taljaard, Catherine Deri Armstrong, Amir Afkham, Claire E. Kendall

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

Oleogel-S10 Phase 3 study “EASE” for epidermolysis bullosa: study design and rationale

Johannes S. Kern, Agnes Schwieger-Briel, Sandra Löwe, Mark Sumeray, Charles Davis, Anna E. Martinez

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A realist process evaluation of Enhanced Triple P for Baby and Mellow Bumps, within a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE): study protocol for a randomized controlled trial

Rosaleen O’Brien, Katie Buston, Daniel Wight, Elizabeth McGee, Jane White, Marion Henderson

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial

Gavin Brupbacher, Doris Straus, Hildburg Porschke, Thea Zander-Schellenberg, Markus Gerber, Roland von Känel, Arno Schmidt-Trucksäss

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 | Commentary | Ausgabe 1/2019 Open Access

Trial management: we need a cadre of high-class triallists to deliver the answers that patients need

Danielle Beaumont, Monica Arribas, Lauren Frimley, Eni Balogun, Ian Roberts, Haleema Shakur-Still

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

Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial

Bergthor Björnsson, Per Sandström, Anna Lindhoff Larsson, Claes Hjalmarsson, Thomas Gasslander

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

Auricular acupressure as a complementary therapy for psoriasis vulgaris: study protocol for a multicenter randomized controlled trial

Jingwen Deng, Chuanjian Lu, Yu Xiang, Hao Deng, Zehuai Wen, Danni Yao, Meiling Xuan, Yuhong Yan

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparison of two metaphyseal-fitting (short) femoral stems in primary total hip arthroplasty: study protocol for a prospective randomized clinical trial with additional biomechanical testing and finite element analysis

I. Tatani, A. Panagopoulos, I. Diamantakos, G. Sakellaropoulos, Sp Pantelakis, P. Megas

01.12.2019 | Commentary | Ausgabe 1/2019 Open Access

The randomization-induced risk of a trial failing to attain its target power: assessment and mitigation

Hubert Wong, Yongdong Ouyang, Mohammad Ehsanul Karim

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

Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol

Seng Chai Chua, Beata Gidaszewski, Marjan Khajehei

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 | Study protocol | Ausgabe 1/2019 Open Access

Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial

Xiao Song, Di Shi, Qinghong Cui, Shanshan Yu, Jing Yang, Priscilla Song, Joseph Walline, Jun Xu, Huadong Zhu, Xuezhong Yu

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

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial

Cho Lee Wong, Miranda Mei Wa Lui, Kai Chow Choi

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial

Mindy Vroomen, Mark La Meir, Bart Maesen, Justin G. L. Luermans, Kevin Vernooy, Brigitte Essers, Bianca T. A. de Greef, Jos G. Maessen, Harry J. Crijns, Laurent Pison

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial

Daniela Kniepeiss, James Elvis Waha, Thomas Auer, Andrea Berghold, Peter Schemmer

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

Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial

Susan Atuhairwe, Josaphat Byamugisha, Marie Klingberg-Allvin, Amanda Cleeve, Claudia Hanson, Nazarius Mbona Tumwesigye, Othman Kakaire, Kristina Gemzell Danielsson

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 | Research | Ausgabe 1/2019 Open Access

Some data quality issues at ClinicalTrials.gov

Neha Chaturvedi, Bagish Mehrotra, Sangeeta Kumari, Saurabh Gupta, H. S. Subramanya, Gayatri Saberwal

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effects of probiotic Saccharomyces boulardii on the mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in patients with multiple sclerosis: study protocol for a double-blind randomized controlled clinical trial

Dawood Aghamohammadi, Hormoz Ayromlou, Neda Dolatkhah, Fatemeh Jahanjoo, Seyed Kazem Shakouri

01.12.2019 | Letter | Ausgabe 1/2019 Open Access

Letter in response to: “Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N acetylcysteine for paracetamol overdose—the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial”

Jan Olof G. Karlsson, Per Jynge, Ingemar Lundström, Louis J. Ignarro

01.12.2019 | Review | Ausgabe 1/2019 Open Access

Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials

Claire Planner, Peter Bower, Ailsa Donnelly, K. Gillies, Katrina Turner, Bridget Young

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Self-administered acupressure for allergic rhinitis: study protocol for a randomized, single-blind, non-specific controlled, parallel trial

Yaqun Liang, George Binh Lenon, Angela Wei Hong Yang

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

Safety of early oral feeding after total laparoscopic radical gastrectomy for gastric cancer (SOFTLY): Study protocol for a randomized controlled trial

Quan Wang, Bo-Yang Guo, Qing-Chuan Zhao, Zun-Dong Yan, Li-Feng Shang, Juan Yu, Gang Ji

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

Piloting and evaluating feasibility of a training program to improve patient safety for inter-professional inpatient care teams – study protocol of a cluster randomized controlled trial

Julia Dinius, Antje Hammer, Tanja Manser, Corinna Bergelt, Levente Kriston, Mirjam Körner

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

José Ramón Lamas, Carlos García-Fernández, Pilar Tornero-Esteban, Yaiza Lópiz, Luis Rodriguez-Rodriguez, Luis Ortega, Benjamín Fernández-Gutiérrez, Fernando Marco

01.12.2019 | Research | Ausgabe 1/2019 Open Access

PULSE-I - Is rePetitive Upper Limb SEnsory stimulation early after stroke feasible and acceptable? A stratified single-blinded randomised controlled feasibility study

Kausik Chatterjee, Rachel C. Stockley, Steven Lane, Caroline Watkins, Katy Cottrell, Brenda Ankers, Sioned Davies, Mary Fisher Morris, Nick Fallon, Turo Nurmikko

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

Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial

Daniel Matz, Saskia Teuteberg, Andrea Wiencierz, Savas Deniz Soysal, Oleg Heizmann

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

Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial

Amjad Belramman, Roshan Bootun, Tristan R. A. Lane, Alun H. Davies

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Inhaled methoxyflurane (Penthrox®) versus placebo for injury-associated analgesia in children—the MAGPIE trial (MEOF-002): study protocol for a randomised controlled trial

Stuart Hartshorn, Michael J. Barrett, Mark D. Lyttle, Sue Anne Yee, Alan T. Irvine, in collaboration with Paediatric Emergency Research in the UK and Ireland (PERUKI)

01.12.2019 | Update | Ausgabe 1/2019 Open Access

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang, Yang Wang, Jin-ling Li, Na Zhang, Lu-Lu Lin, Zhang-Sheng Yu, Cun-Zhi Liu

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

HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya

Katrina F. Ortblad, John E. Kearney, Kenneth Mugwanya, Elizabeth M. Irungu, Jessica E. Haberer, Ruanne V. Barnabas, Deborah Donnell, Nelly Rwamba Mugo, Jared M. Baeten, Kenneth Ngure

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial

Jan Ostermann, Lavanya Vasudevan, Joy Noel Baumgartner, Esther Ngadaya, Sayoki Godfrey Mfinanga

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

Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial

Yin-Kai Chao, Kuang-Tse Pan, Chih-Tsung Wen, Hsin-Yueh Fang, Ming-Ju Hsieh

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework

Katie Gillies, Marion K. Campbell

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder

Raphaela M. Tschuemperlin, Maria Stein, Hallie M. Batschelet, Franz Moggi, Leila M. Soravia

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

Investigating the effect of Eye Movement Desensitization and Reprocessing on pain intensity in patients with primary dysmenorrhea: a protocol for a randomized controlled trial

Sahar Valedi, Zainab Alimoradi, Mohammad MoradiBaglooei, Amir H. Pakpour, Mehdi Ranjbaran, Venus Chegini

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Collaborative care for child and youth mental health problems in a middle-income country: study protocol for a randomized controlled trial training general practitioners

Vandad Sharifi, Zahra Shahrivar, Hadi Zarafshan, Sheida Beiky Ashkezary, Elizabeth Stuart, Ramin Mojtabai, Lawrence Wissow

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A novel mindful-compassion art therapy (MCAT) for reducing burnout and promoting resilience for end-of-life care professionals: a waitlist RCT protocol

Andy Hau Yan Ho, Geraldine Tan-Ho, Thuy Anh Ngo, Grace Ong, Poh Heng Chong, Dennis Dignadice, Jordan Potash

01.12.2019 | Research | Ausgabe 1/2019 Open Access

The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka

Mahesh Karra, Erin Pearson, Elina Pradhan, Ranjith de Silva, Arnjali Samarasekera, David Canning, Iqbal Shah, Deepal Weerasekera, Hemantha Senanayake

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

Ovarian function after the use of various hemostatic techniques during treatment for endometrioma: protocol for a randomized clinical trial

Raquel Silveira da Cunha Araujo, Sabina Bastos Maia, Clara Micalli Ferruzzi Baracat, Moisés Diogo Lima, Eduardo Sérgio Sousa Soares, Helizabet Salomão Abdalla Ayroza Ribeiro, Paulo Augusto Ayroza Galvão Ribeiro

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial

Susanne Saal, Hanna Klingshirn, Katrin Beutner, Ralf Strobl, Eva Grill, Martin Müller, Gabriele Meyer

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial

Justin P. Turner, Patricia Caetano, Cara Tannenbaum

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Glibenclamide in aneurysmatic subarachnoid hemorrhage (GASH): study protocol for a randomized controlled trial

Bruno Braga Sisnando da Costa, Isabela Costola Windlin, Edwin Koterba, Vitor Nagai Yamaki, Nícollas Nunes Rabelo, Davi Jorge Fontoura Solla, Manoel Jacobsen Teixeira, Eberval Gadelha Figueiredo

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect of motivational interviewing in hypertensive patients (MIdNIgHT): study protocol for a randomized controlled trial

Luana Claudia Jacoby Silveira, Graziella Badin Aliti, Elisabeth Meyer Da Silva, Ravi Pereira Pimentel, Miguel Gus, Eneida Rejane Rabelo-Silva

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

To evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes: study protocol for a randomized controlled trial

Su-Ji Choi, Dong-Il Kim

01.12.2019 | Commentary | Ausgabe 1/2019 Open Access

Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality

Joanna Kelly, Barry Hounsome, Gill Lambert, Caroline Murphy

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effect of visual support strategies on the quality of life of children with cerebral palsy and cerebral visual impairment/perceptual visual dysfunction in Nigeria: study protocol for a randomized controlled trial

Roseline Duke, Komomo Eyong, Kathryn Burton, David MacLeod, Gordon N. Dutton, Clare Gilbert, Richard Bowman

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Cervicogenic headache treated by acupuncture based on jin theory: study protocol for a randomized controlled trial

Youkang Dong, Taipin Guo, Lei Xu, Chunlin Wang, Guanfen Wen, Zhiyong Zhao, Lianhai Duan, Mei Zou, Yong Xiang, Shu 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

Acupuncture of different treatment frequency in knee osteoarthritis: a protocol for a pilot randomized clinical trial

Lu-Lu Lin, Jian-Feng Tu, Jia-Kai Shao, Xuan Zou, Tian-Qi Wang, Li-Qiong Wang, Jing-Wen Yang, Ning Sun, Cun-Zhi Liu

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Depression in the nursing home: a cluster-randomized stepped-wedge study to probe the effectiveness of a novel case management approach to improve treatment (the DAVOS project)

Valentina A. Tesky, Arthur Schall, Ulrike Schulze, Ulrich Stangier, Frank Oswald, Monika Knopf, Jochem König, Maria Blettner, Elisabeth Arens, Johannes Pantel

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

Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial

Zaid Issa, Jeppe Vejlgaard Rasmussen, John Kloth Petersen, Kim Schantz, Stig Brorson

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial

Shi Chen, Dong-Wen Chen, Xi-Jie Chen, Yi-Jia Lin, Jun Xiang, Jun Sheng Peng

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

Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial

Juan Carlos Villar, Víctor Mauricio Herrera, Juan Guillermo Pérez Carreño, Eliana Váquiro Herrera, Yeny Zulay Castellanos Domínguez, Skarlet Marcell Vásquez, Zulma Milena Cucunubá, Nilda Graciela Prado, Yolanda Hernández

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A dose-ranging, parallel group, split-face, single-blind phase II study of light emitting diode-red light (LED-RL) for skin scarring prevention: study protocol for a randomized controlled trial

Julie K. Nguyen, Jeremy Weedon, Jeannette Jakus, Edward Heilman, R. Rivkah Isseroff, Daniel M. Siegel, Jared R. Jagdeo

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Impact of exercise training on cardiotoxicity and cardiac health outcomes in women with breast cancer anthracycline chemotherapy: a study protocol for a randomized controlled trial

Pedro Antunes, Dulce Esteves, Célia Nunes, Francisco Sampaio, António Ascensão, Eduardo Vilela, Madalena Teixeira, Anabela Leal Amarelo, Ana Joaquim

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

A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial

Natalia Araujo Mazzini, Murilo Groschitz Ruas Almeida, José Eduardo Pompeu, Janaine Cunha Polese, Camila Torriani-Pasin

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5–12 years: a randomised controlled trial

Rebecca Brown, Peter Blanchfield, Apostolos Fakis, Paul McGraw, Alexander J. E. Foss, And on behalf of the I-BiT Study Group

01.12.2019 | Correction | Ausgabe 1/2019 Open Access

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

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

01.12.2019 | 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 | Study protocol | Ausgabe 1/2019 Open Access

Probiotics in pregnancy: protocol of a double-blind randomized controlled pilot trial for pregnant women with depression and anxiety (PIP pilot trial)

Pamela D. Browne, Antoinette Bolte, Eric Claassen, Carolina de Weerth

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery

M. B. Breebaart, D. Van Aken, O. De Fré, L. Sermeus, N. Kamerling, L. de Jong, J. Michielsen, E. Roelant, V. Saldien, B. Versyck

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

Protocol for a randomized clinical trial exploring the effect of antimicrobial agents on the penile microbiota, immunology and HIV susceptibility of Ugandan men

Ronald M. Galiwango, Bernard Bagaya, Juliet Mpendo, Vineet Joag, Brenda Okech, Annet Nanvubya, Ali Ssetaala, Moses Muwanga, Rupert Kaul

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

Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial

Chan-Yung Jung, Min-Jin Cho, Ha-Ra Kang, Seung-Ug Hong, Won-Suk Sung, Eun-Jung Kim

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 | Research | Ausgabe 1/2019 Open Access

Development of the IRIS-AR strategy: an intervention to improve rates of accrual and retention for the VTE-PRO randomized controlled trial

Christine Fahim, Danielle Hylton, Marko Simunovic, John Agzarian, Christian Finley, Wael C. Hanna, Yaron Shargall

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effectiveness and safety of Kami Guibi-tang for mild cognitive impairment: study protocol of a pilot, randomized, placebo-controlled, double-blind trial

Hee-Yeon Shin, Jeong-Hwa Kim, Geon-Ho Jahng, Woo-Sang Jung, Seong-Uk Park, Chang-Nam Ko, Jung-Mi Park

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

Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe’s voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial

Caryl Feldacker, Vernon Murenje, Scott Barnhart, Sinokuthemba Xaba, Batsirai Makunike-Chikwinya, Isaac Holeman, Mufuta Tshimanga

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 | Research | Ausgabe 1/2019 Open Access

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled ‘study within a trial’ (SWAT) of a multimedia information resource

Kate Jolly, Manbinder Sidhu, Peter Bower, Vichithranie Madurasinghe, on behalf of the PSM COPD Group, MRC START Group

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial

Jieli Sun, Wenhao Ruan, Jiahui He, Xiaoyu Lin, Bowen Ci, Siye Yin, Wenjuan Yan

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effect of a single 4CMenB vaccine booster in young people more than ten years after infant immunisation: protocol of an exploratory immunogenicity study

Kimberly Davis, Karen Ford, Rachel Craik, Ushma Galal, Christine S. Rollier, Andrew J. Pollard

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial

Ismita Chhetri, Julie E. A. Hunt, Jeewaka R. Mendis, Stephen D. Patterson, Zudin A. Puthucheary, Hugh E. Montgomery, Benedict C. Creagh-Brown

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

Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial

Barbara Prediger, Esther Meyer, Roland Büchter, Tim Mathes

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

Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia

Dibyadyuti Datta, Ruth Namazzi, Andrea L. Conroy, Sarah E. Cusick, Heather A. Hume, Abner Tagoola, Russell E. Ware, Robert O. Opoka, Chandy C. John

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial

L. Nibali, V. Koidou, S. Salomone, T. Hamborg, R. Allaker, R. Ezra, L. Zou, G. Tsakos, N. Gkranias, N. Donos

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The use and protective effects of transcutaneous electrical acupoint stimulation during abdominal surgery: study protocol for a multicenter randomized parallel controlled trial

Yuantao Hou, Qi Yan, Haiyan An, Junlu Wang, Ming Tian, Wensheng Zhao, Anshi Wu, Yi Feng

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 | Study protocol | Ausgabe 1/2019 Open Access

Extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial

Nicholas A. Barrett, Eirini Kostakou, Nicholas Hart, Abdel Douiri, Luigi Camporota

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Utilizing a low-carbohydrate/high-protein diet to improve metabolic health in individuals with spinal cord injury (DISH): study protocol for a randomized controlled trial

Ceren Yarar-Fisher, Jia Li, Amie McLain, Barbara Gower, Robert Oster, Casey Morrow

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 | Research | Ausgabe 1/2019 Open Access

A randomized clinical trial on the effects of bupropion and buprenorphine on the reduction of methamphetamine craving

Jamshid Ahmadi, Ali Sahraian, Mehdi Biuseh

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The redox-dependent regulation of satellite cells following aseptic muscle trauma (SpEED): study protocol for a randomized controlled trial

Konstantinos Papanikolaou, Dimitrios Draganidis, Athanasios Chatzinikolaou, Vassiliki C. Laschou, Kalliopi Georgakouli, Panagiotis Tsimeas, Alexios Batrakoulis, Chariklia K. Deli, Athanasios Z. Jamurtas, Ioannis G. Fatouros

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Evaluation of clinical efficacy of silver-needle warm acupuncture in treating adults with acute low back pain due to lumbosacral disc herniation: study protocol for a randomized controlled trial

Tian Li, Siyao Wang, Shen Zhang, Xueyong Shen, Yanwen Song, Zhen Yang, Zouqin Huang

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 | Study protocol | Ausgabe 1/2019 Open Access

Condom use to enhance regression of cervical intraepithelial neoplasia: study protocol for a randomized controlled trial

Malene Skorstengaard, Julie Suhr, Elsebeth Lynge

01.12.2019 | Commentary | Ausgabe 1/2019 Open Access

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

Victoria Shepherd, Fiona Wood, Richard Griffith, Mark Sheehan, Kerenza Hood

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol

William M. Oliver, Thomas H. Carter, Catriona Graham, Timothy O. White, Nicholas D. Clement, Andrew D. Duckworth, Samuel G. Molyneux

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

Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial

Jae-Hong Kim, Jae-Young Han, Gwang-Cheon Park, Jeong-Soon Lee

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial

Thomas H. Dierikx, Daniel J. C. Berkhout, Laura Visser, Marc A. Benninga, Guus Roeselers, Nanne K. H. de Boer, Johanna I. P. de Vries, Tim G. J. de Meij

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial

Lai Fun Ho, Yuanqi Guo, Jessica Yuet-Ling Ching, Kam Leung Chan, Ping Him Tsang, Man Hin Wong, Liyi Chen, Bacon Fung-Leung Ng, Zhi-Xiu Lin

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Yinang formulation versus placebo granules as a treatment for chronic kidney disease stages III–IV in patients with autosomal dominant polycystic kidney disease: study protocol for a double-blind placebo-controlled randomized clinical trial

Jing Gan, Yansheng Wu, Xuezhong Gong, Yiyi Ma, Shengqiang Yu, Jiandong Gao

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

NA-CONTROL: a study protocol for a randomised controlled trial to compare specific outpatient rehabilitation that targets cerebral mechanisms through relearning motor control and uses self-management strategies to improve functional capability of the upper extremity, to usual care in patients with neuralgic amyotrophy

Renee Lustenhouwer, Nens van Alfen, Ian G. M. Cameron, Ivan Toni, Alexander C. H. Geurts, Rick C. Helmich, Baziel G. M. van Engelen, Jan T. Groothuis

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 | Methodology | Ausgabe 1/2019 Open Access

Limitations of the incidence density ratio as approximation of the hazard ratio

Ralf Bender, Lars Beckmann

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A booklet self-help intervention to reduce depressive symptoms among people living with HIV in Botswana: study protocol for a randomized controlled trial

Boitumelo Vavani, Vivian Kraaij, Phillip Spinhoven, Nadia Garnefski

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial

Carlos Bernal-Utrera, Juan José González-Gerez, Manuel Saavedra-Hernandez, Miguel Ángel Lérida-Ortega, Cleofás Rodríguez-Blanco

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Impact of pharmacist educational intervention on disease knowledge, rehabilitation and medication adherence, treatment-induced direct cost, health-related quality of life and satisfaction in patients with rheumatoid arthritis: study protocol for a randomized controlled trial

Atta Abbas Naqvi, Mohamed Azmi Hassali, Syed Baqir Shyum Naqvi, Muhammad Tariq Aftab

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 | Research | Ausgabe 1/2019 Open Access

Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial

Emma Elizabeth Phelps, Elizabeth Tutton, Xavier Griffin, Janis Baird, On behalf of the TrAFFix study co-applicants

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Progression criteria in trials with an internal pilot: an audit of publicly funded randomised controlled trials

Esther Herbert, Steven A. Julious, Steve Goodacre

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparative study of the inhibitory effect on bone erosion progression with denosumab treatment and conventional treatment in rheumatoid arthritis patients: study protocol for an open-label randomized controlled trial by HR-pQCT

Naoki Iwamoto, Shuntaro Sato, Remi Sumiyoshi, Ko Chiba, Nanami Miyamoto, Kumiko Arinaga, Makiko Kobayashi, Hiroshi Yamamoto, Makoto Osaki, Atsushi Kawakami

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

Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial

David W. McMillan, Jennifer L. Maher, Kevin A. Jacobs, Armando J. Mendez, Mark S. Nash, James L. J. Bilzon

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial

Enrique Lluch-Girbés, Lirios Dueñas, Silvia Mena-del Horno, Alejandro Luque-Suarez, Santiago Navarro-Ledesma, Adriaan Louw

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 | Study protocol | Ausgabe 1/2019 Open Access

Effectiveness of the serious game ‘You & I’ in changing mentalizing abilities of adults with mild to borderline intellectual disabilities: a parallel superiority randomized controlled trial

Suzanne Derks, Suze van Wijngaarden, Mirjam Wouda, Carlo Schuengel, Paula S. Sterkenburg

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A phase 1/2 trial to evaluate the pharmacokinetics, safety, and efficacy of NI-03 in patients with chronic pancreatitis: study protocol for a randomized controlled trial on the assessment of camostat treatment in chronic pancreatitis (TACTIC)

Mitchell L. Ramsey, Janet Nuttall, Phil A. Hart, on behalf of the TACTIC Investigative Team

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial

Hillary Rono, Andrew Bastawrous, David Macleod, Emmanuel Wanjala, Stephen Gichuhi, Matthew Burton

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of prophylactic swallowing exercises on dysphagia and quality of life in patients with head and neck cancer receiving (chemo) radiotherapy: the Redyor study, a protocol for a randomized clinical trial

Anna Guillen-Sola, Neus Bofill Soler, Ester Marco, Oscar Pera-Cegarra, Palmira Foro

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Regional cerebral oxygen saturation and postoperative delirium in endovascular surgery: a prospective cohort study

Xiaohua Wang, Kunpeng Feng, Haixia Liu, Yanhui Liu, Ming Ye, Guoguang Zhao, Tianlong Wang

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

The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: a multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries

WHO ACTION Trials Collaborators

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Non-concealed placebo treatment for menopausal hot flushes: Study protocol of a randomized-controlled trial

Yiqi Pan, Ramona Meister, Bernd Löwe, Anne Winkelmann, Ted J. Kaptchuk, Kai J. Buhling, Yvonne Nestoriuc

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A randomized controlled trial of an Internet-based intervention for eating disorders and the added value of expert-patient support: study protocol

Pieter J. Rohrbach, Alexandra E. Dingemans, Philip Spinhoven, Elske Van den Akker-Van Marle, Joost R. Van Ginkel, Marjolein Fokkema, Markus Moessner, Stephanie Bauer, Eric F. Van Furth

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy of acetaminophen with and without oxycodone for analgesia in non-operative treatment of extremity fractures in adults: protocol for a double-blind randomized clinical trial

Tao Gao, Hongyi Zhu, Changqing Zhang, Yimin Chai, Cheng Guo, Xiaozhong Zhu, Bingbo Bao, Xingwei Li, Junqing Lin, Xianyou Zheng

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Development of a Core Outcome Set and Minimum Reporting Set for intervention studies in growth restriction in the NEwbOrN (COSNEON): study protocol for a Delphi study

Martine Knol, Helena Wang, Frank Bloomfield, Tabitha Piet, Stefanie Damhuis, Asma Khalil, Wessel Ganzevoort, Sanne Gordijn

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 | Commentary | Ausgabe 1/2019 Open Access

Clinical trial data reuse – overcoming complexities in trial design and data sharing

Toby Wilkinson, Siddharth Sinha, Niels Peek, Nophar Geifman

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

A study protocol for a randomised controlled trial evaluating the effects of intraoperative computed tomography on the outcomes of zygomatic fractures

Andrew Higgins, Michael Hurrell, Richard Harris, Geoffrey Findlay, Michael David, Martin Batstone

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 | Correction | Ausgabe 1/2019 Open Access

Correction to: Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial

Juan Carlos Villar, Víctor Mauricio Herrera, Juan Guillermo Pérez Carreño, Eliana Váquiro Herrera, Yeny Zulay Castellanos Domínguez, Skarlet Marcell Vásquez, Zulma Milena Cucunubá, Nilda Graciela Prado, Yolanda Hernández

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

Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial

Louisa J. D. van Dijk, Jihan Harki, Desirée van Noord, Hence J. M. Verhagen, Jeroen J. Kolkman, Robert H. Geelkerken, Marco J. Bruno, Adriaan Moelker, on behalf of the Dutch Mesenteric Ischemia Study group (DMIS)

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The efficacy and safety of Shenzhu Guanxin Recipe Granules for the treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial

Xiao Jin, Biqi Pan, Huanlin Wu, Bingxin Wu, Yukai Li, Xia Wang, Guoqing Liu, Xiaojing Dang, Danping Xu

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation

Antao Ming, Isabell Walter, Ahmad Alhajjar, Martin Leuckert, Peter R. Mertens

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

Efficacy of DiaLife, an education program for relatives of adult patients with diabetes – study protocol of a cluster randomized controlled trial

M. Bernard, N. Müller, L. Hecht, G. Fabisch, A. Harder, C. Luck-Sikorski

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Investigating causal mechanisms in randomised controlled trials

Hopin Lee, Robert D. Herbert, Sarah E. Lamb, Anne M. Moseley, James H. McAuley

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial

Meriel Norris, Leon Poltawski, Raff Calitri, Anthony I. Shepherd, Sarah G. Dean, on behalf of the ReTrain Team

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 | Research | Ausgabe 1/2019 Open Access

Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival

Erinn M. Hade, Gregory S. Young, Richard R. Love

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

Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial

Edith M. Williams, Leonard Egede, Jim C. Oates, Clara L. Dismuke, Viswanathan Ramakrishnan, Trevor D. Faith, Hetlena Johnson, Jillian Rose

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial

Serena Lopez-Cazaux, Elody Aiem, Ana Miriam Velly, Michèle Muller-Bolla

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Treatment of carpal tunnel syndrome with wrist splinting: study protocol for a randomized placebo-controlled trial

Isam Atroshi, Kamelia Tadjerbashi, Steven J. McCabe, Jonas Ranstam

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of C8 nerve root block during interscalene brachial plexus block on anesthesia of the posterior shoulder in patients undergoing arthroscopic shoulder surgery: study protocol for a prospective randomized parallel-group controlled trial

Eugene Kim, Chang Hyuk Choi, Jong Hae Kim

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation

Sébastien Rimbert, Denis Schmartz, Laurent Bougrain, Claude Meistelman, Cédric Baumann, Philippe Guerci

01.12.2019 | Research | Ausgabe 1/2019 Open Access

An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India

Mounika Pillamarapu, Abhilash Mohan, Gayatri Saberwal

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: protocol for a cluster randomized controlled trial in Georgia

Ivdity Chikovani, Karin Diaconu, Predrag Duric, Lela Sulaberidze, Maia Uchaneishvili, Nuredin Ibrahim Mohammed, Akaki Zoidze, Sophie Witter

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

Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial

Ying Ding, Xia Zhang, Xianqing Ren, Wensheng Zhai, Liyun He, Jianping Liu, Chen Yao, Shanshan Han, Long Wang

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

The effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in overweight or obese nursing women: a study protocol for a randomized placebo-controlled clinical trial

Zohre Gerveieeha, Fereydoun Siassi, Mostafa Qorbani, Farzaneh Ziaeian, Gity Sotoudeh

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 | Research | Ausgabe 1/2019 Open Access

Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study

Aleksandra Herbec, Jamie Brown, Lion Shahab, Robert West, Tobias Raupach

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Using peer education to improve diabetes management and outcomes in a low-income setting: a randomized controlled trial

Till Seuring, Marthoenis, Sabrina Rhode, Lisa Rogge, Holger Rau, Stéphane Besançon, Hendra Zufry, Hizir Sofyan, Sebastian Vollmer

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study – the Integrated Diabetes Education, Awareness and Lifestyle modification in Singapore (IDEALS) Program

Eberta Tan, Joan Khoo, Linsey Utami Gani, Roy Debajyoti Malakar, Tunn Lin Tay, Prasanna Sivanath Tirukonda, Jia Wen Kam, Aung Soe Tin, Tjun Yip Tang

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Smoking cessation Through Optimisation of clinical care in Pregnancy: the STOP randomised controlled trial

Brendan P. McDonnell, Patrick Dicker, Sheila Keogan, Luke Clancy, Carmen Regan

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial

Jae-Hong Kim, Myoung-Rae Cho, Gwang-Cheon Park, Jeong-Soon Lee

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Interval-cohort designs and bias in the estimation of per-protocol effects: a simulation study

Jessica G. Young, Rajet Vatsa, Eleanor J. Murray, Miguel A. Hernán

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events

Evan Mayo-Wilson, Nicole Fusco, Hwanhee Hong, Tianjing Li, Joseph K. Canner, Kay Dickersin

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 | Study protocol | Ausgabe 1/2019 Open Access

N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial

Lauren Arancini, Chiara C. Bortolasci, Seetal Dodd, Olivia M. Dean, Michael Berk

01.12.2019 | Research | Ausgabe 1/2019 Open Access

An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Daniel Beever, Lizzie Swaby

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

Is dangling of the lower leg after a free flap reconstruction necessary? Study protocol for a large multicenter randomized controlled study

David D. Krijgh, Teun Teunis, Pascal P. A. Schellekens, Marc A. M. Mureau, Antonius J. M. Luijsterburg, Tallechien M. T. Tempelman, Eva S. J. van der Beek, Wiesje Maarse, J. Henk Coert

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Virtual training leads to real acute physical, cognitive, and neural benefits on healthy adults: study protocol for a randomized controlled trial

Dalila Burin, Noriki Yamaya, Rie Ogitsu, Ryuta Kawashima

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 | Research | Ausgabe 1/2019 Open Access

Leucine-enriched essential amino acid supplementation in mechanically ventilated trauma patients: a feasibility study

L. Wandrag, S. J. Brett, G. S. Frost, M. To, E. Alves Loubo, N. C. Jackson, A. M. Umpleby, V. Bountziouka, M. Hickson

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 clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial

Christian Jons, Peter Sogaard, Steffen Behrens, Jürgen Schrader, Sascha Mrosk, Poul Erik Bloch Thomsen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham-controlled trial

Qiao Wang, Haiping Deng, Ke Cheng, Zouqin Huang, Xiuqi Yin, Yichen Zhou, Yiqin Yang, Weidong Shen, Ling Zhao, Xueyong Shen

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle

Thomas H. Carter, William M. Oliver, Catriona Graham, Andrew D. Duckworth, Timothy O. White

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Stephen J. Walters, Richard M. Jacques, Inês Bonacho dos Anjos Henriques-Cadby, Jane Candlish, Nikki Totton, Mica Teo Shu Xian

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial

Carolyn A. McCarty, Douglas Zatzick, Teah Hoopes, Katelyn Payne, Rebecca Parrish, Frederick P. Rivara

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 | Study protocol | Ausgabe 1/2019 Open Access

The effect of Baduanjin exercise on health-related physical fitness of college students: study protocol for a randomized controlled trial

Fang Zhao, Shanshan Sun, Jian Xiong, Guohua Zheng

01.12.2019 | Research | Ausgabe 1/2019 Open Access

The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial

Ada Keding, Helen Handoll, Stephen Brealey, Laura Jefferson, Catherine Hewitt, Belen Corbacho, David Torgerson, Amar Rangan

01.12.2019 | Methodology | Ausgabe 1/2019 Open Access

A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

Anna Rosala-Hallas, Carrol Gamble, Jane Blazeby, Paula R. Williamson

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

Online Social anxiety Cognitive therapy for Adolescents (OSCA): protocol for a randomised controlled trial

Eleanor Leigh, David M. Clark

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial

Lene Kristiansen, L. H. Magnussen, K. T. Wilhelmsen, S. Mæland, S. H. G. Nordahl, R. Clendaniel, A. Hovland, B. Juul-Kristensen

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

Effect of probiotic supplementation in nonalcoholic steatohepatitis patients: PROBILIVER TRIAL protocol

Amanda Souza Silva-Sperb, Helena Abadie Moraes, Bruna Concheski de Moura, Bruna Cherubini Alves, Juliana Paula Bruch-Bertani, Vittoria Zambon Azevedo, Valesca Dall’Alba

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

The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial

M. Wijnberge, J. Schenk, L. E. Terwindt, M. P. Mulder, M. W. Hollmann, A. P. Vlaar, D. P. Veelo, B. F. Geerts

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Contributions of vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial

Catarina Magalhães Porto, Tatiana de Paula Santana da Silva, Everton Botelho Sougey

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial

Sarah Payne Riches, Carmen Piernas, Paul Aveyard, James P. Sheppard, Mike Rayner, Susan A. Jebb

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance, and energy expenditure in critically ill infants: study protocol for a randomized controlled trial

Reyes Fernández, Javier Urbano, Ángel Carrillo, Ana Vivanco, María José Solana, Corsino Rey, Jesús López-Herce

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of neuromuscular training and strengthening of trunk and lower limbs muscles in women with Patellofemoral Pain: A protocol of randomized controlled clinical trial, blinded

Natália Camin Silva, Matheus de Castro Silva, Morisa Garcia Guimarães, Manoela Beatriz de Oliveira Nascimento, Lilian Ramiro Felicio

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

Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial

Malin E. Carmland, Melissa Kreutzfeldt, Jakob V. Holbech, Niels T. Andersen, Troels S. Jensen, Flemming W. Bach, Søren H. Sindrup, Nanna B. Finnerup

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set

Markus V. Heppt, Theresa Steeb, Lutz Schmitz, Claus Garbe, Lars E. French, Ulrike Leiter, Carola Berking

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial

Anders Galaasen Bakken, Iben Axén, Andreas Eklund, Søren O’Neill

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 | Study protocol | Ausgabe 1/2019 Open Access

The TREATT Trial (TRial to EvaluAte Tranexamic acid therapy in Thrombocytopenia): safety and efficacy of tranexamic acid in patients with haematological malignancies with severe thrombocytopenia: study protocol for a double-blind randomised controlled trial

Lise J. Estcourt, Zoe McQuilten, Gillian Powter, Claire Dyer, Eleanor Curnow, Erica M. Wood, Simon J. Stanworth, on behalf of the TREATT Trial Collaboration (provisional)

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: Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial

Rachel B. van Oostveen, Alberto Romero-Palacios, Richard Whitlock, Shun Fu Lee, Stuart Connolly, Alex Carignan, C. David Mazer, Mark Loeb, Dominik Mertz

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial

Shilin Li, Xiangli Dong, Weiming Sun, Na Zhao, Guohua Yu, Lang Shuai

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Load monitoring on Pilates training: a study protocol for a randomized clinical trial

Allysiê Priscilla de Souza Cavina, Eduardo Pizzo Junior, Aryane Flauzino Machado, Taíse Mendes Biral, Carlos Marcelo Pastre, Franciele Marques Vanderlei

01.12.2019 | Research | Ausgabe 1/2019 Open Access

Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)

Clare Warnock, Karen Lord, Bethany Taylor, Angela Tod

01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial

Jingyi Li, Haibei Zhu, Ren Liao