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Trials

Ausgabe 1/2012

Inhalt (246 Artikel)

Open Access Research

Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial)

Ramon B van Loon, Gerrit Veen, Leo H B Baur, Otto Kamp, Jean G F Bronzwaer, Jos W R Twisk, Freek W A Verheugt, Albert C van Rossum

Open Access Research

Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

Stephanie M Zielinski, Helena Viveiros, Martin J Heetveld, Marc F Swiontkowski, Mohit Bhandari, Peter Patka, Esther MM Van Lieshout

Open Access Study protocol

Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

Kirsten Kortram, Bert van Ramshorst, Thomas L Bollen, Marc G H Besselink, Dirk J Gouma, Tom Karsten, Philip M Kruyt, Grard A P Nieuwenhuijzen, Johannes C Kelder, Ellen Tromp, Djamila Boerma

Open Access Study protocol

A GO intervention program for enhancing elementary school children's cognitive functions and control abilities of emotion and behavior: study protocol for a randomized controlled trial

Yoshiyuki Tachibana, Jiro Yoshida, Masahito Ichinomiya, Rui Nouchi, Carlos Miyauchi, Hikaru Takeuchi, Naoki Tomita, Hiroyuki Arai, Ryuta Kawashima

Open Access Study protocol

MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group

Nicholas C Harvey, Kassim Javaid, Nicholas Bishop, Stephen Kennedy, Aris T Papageorghiou, Robert Fraser, Saurabh V Gandhi, Inez Schoenmakers, Ann Prentice, Cyrus Cooper

Open Access Research

Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial

Carita Savolainen-Kopra, Jaason Haapakoski, Piia A Peltola, Thedi Ziegler, Terttu Korpela, Pirjo Anttila, Ali Amiryousefi, Pentti Huovinen, Markku Huvinen, Heikki Noronen, Pia Riikkala, Merja Roivainen, Petri Ruutu, Juha Teirilä, Erkki Vartiainen, Tapani Hovi

Open Access Study protocol

Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial

Jan Dörr, Stephanie Ohlraun, Horst Skarabis, Friedemann Paul

Open Access Research

Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy

Andrew J Vickers, Caroline Bennette, Karim Touijer, Jonathan Coleman, Vincent Laudone, Brett Carver, James A Eastham, Peter T Scardino

Open Access Study protocol

Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial

Johannes C Lauscher, Peter Martus, Andrea Stroux, Jens Neudecker, Uwe Behrens, Ralf Hammerich, Heinz J Buhr, Jörg-Peter Ritz

Open Access Study protocol

Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial

Lise Bergman Nordgren, Gerhard Andersson, Åsa Kadowaki, Per Carlbring

Open Access Study protocol

Evaluating the effectiveness of GP endorsement on increasing participation in the NHS Bowel Cancer Screening Programme in England: study protocol for a randomized controlled trial

Sarah Damery, Steve Smith, Alison Clements, Roger Holder, Linda Nichols, Heather Draper, Sue Clifford, Laura Parker, Richard Hobbs, Sue Wilson

Open Access Study protocol

Assertive Community Treatment for alcohol dependence (ACTAD): study protocol for a randomised controlled trial

Helen Gilburt, Tom Burns, Alex Copello, Simon Coulton, Michael Crawford, Ed Day, Paolo Deluca, Christine Godfrey, Steve Parrott, Abigail K Rose, Julia M A Sinclair, Christine Wright, Colin Drummond

Open Access Study protocol

A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: a study protocol for a randomized controlled trial

Virginia Wiseman, Lindsay J Mangham, Bonnie Cundill, Olivia A Achonduh, Akindeh Mbuh Nji, Abanda Ngu Njei, Clare Chandler, Wilfred F Mbacham

Open Access Study protocol

Effect of TENS on pain in relation to central sensitization in patients with osteoarthritis of the knee: study protocol of a randomized controlled trial

David Beckwée, Willem De Hertogh, Pierre Lievens, Ivan Bautmans, Peter Vaes

Open Access Study protocol

Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial

Romain Eschalier, Frédéric Jean, Bruno Pereira, Séverine Monzy, Charles Vorilhon, Valérie Mactoux, Bernard Citron, Vincent Sapin, Pascal Motreff, Jean R Lusson

Open Access Methodology

Clustering in surgical trials - database of intracluster correlations

Jonathan A Cook, Thomas Bruckner, Graeme S MacLennan, Christoph M Seiler

Open Access Research

Comparison of embedded and added motor imagery training in patients after stroke: results of a randomised controlled pilot trial

Corina Schuster, Jenny Butler, Brian Andrews, Udo Kischka, Thierry Ettlin

Open Access Erratum

Erratum to: The International Stroke Trial database

Peter A G Sandercock, Maciej Niewada, Anna Członkowska

Open Access Research

Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

Claire L Vale, Lindsay C Thompson, Claire Murphy, Silvia Forcat, Bec Hanley

Open Access Study protocol

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial

Rajiv Bahl, Nita Bhandari, Brinda Dube, Karen Edmond, Wafaie Fawzi, Olivier Fontaine, Jasmine Kaur, Betty R Kirkwood, Jose Martines, Honorati Masanja, Sarmila Mazumder, Salum Msham, Sam Newton, Maureen Oleary, Julia Ruben, Caitlin Shannon, Emily Smith, Sunita Taneja, Sachiyo Yoshida

Open Access Research

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Christian Gluud, Christine Kubiak, Kate Whitfield, Jane Byrne, Karl-Heinz Huemer, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Zsuza Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Fernando de Andres, Nuria Sanz, German Kreis, Charlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Adeeba Asghar, Jean-Marc Husson, Jacques Demotes-Mainard

Open Access Study protocol

The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

Kyung Woo Park, Byoung-Eun Park, Si-Hyuck Kang, Jin-Joo Park, Seung-Pyo Lee, Kwang Soo Cha, Jay Young Rhew, Hui-Kyoung Jeon, Eun Seok Shin, Ju Hyeon Oh, Myung-Ho Jeong, Sanghyun Kim, Kyung-Kuk Hwang, Jung-Han Yoon, Sung Yun Lee, Tae-Ho Park, Keon Woong Moon, Hyuck-Moon Kwon, In-Ho Chae, Hyo-Soo Kim

Open Access Letter

Motivations for participating in a clinical trial on an avian influenza vaccine

Laura Costas, José M Bayas, Beatriz Serrano, Sarah Lafuente, M-Amparo Muñoz

Open Access Research

Surgical treatment of zygomatic bone fracture using two points fixation versus three point fixation-a randomised prospective clinical trial

Majeed Rana, Riaz Warraich, Salman Tahir, Asifa Iqbal, Constantin von See, André M Eckardt, Nils-Claudius Gellrich

Open Access Study protocol

Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

Daniel D L Bernal, Leanne Stafford, Luke R E Bereznicki, Ronald L Castelino, Patricia M Davidson, Gregory M Peterson

Open Access Study protocol

Beneficial effects of reading aloud and solving simple arithmetic calculations (learning therapy) on a wide range of cognitive functions in the healthy elderly: study protocol for a randomized controlled trial

Rui Nouchi, Yasuyuki Taki, Hikaru Takeuchi, Hiroshi Hashizume, Takayuki Nozawa, Atsushi Sekiguchi, Haruka Nouchi, Ryuta Kawashima

Open Access Study protocol

Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial

Anne-Lise Poirier, Fabrice Kwiatkowski, Jean-Marie Commer, Bénédicte D'Aillières, Virginie Berger, Mariette Mercier, Franck Bonnetain

Open Access Study protocol

Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial

Jeong-Su Park, Sunju Park, Chun-Hoo Cheon, Ho-Yeon Go, Seung-Ho Sun, Yong-Cheol Shin, Bo-Hyoung Jang, Seong-Gyu Ko

Open Access Study protocol

The Anticoagulation of Calf Thrombosis (ACT) project: study protocol for a randomized controlled trial

Daniel Horner, Kerstin Hogg, Richard Body, Michael J Nash, Kevin Mackway-Jones

Open Access Study protocol

Effect of sequential treatment with syndrome differentiation on acute exacerbation of chronic obstructive pulmonary disease and "AECOPD Risk-Window": study protocol for a randomized placebo-controlled trial

Wang Haifeng, Li Jiansheng, Li Suyun, Yu Xueqing, Zhang Hailong, Wang Zhiwan, Wu Qiyi, Zhang Pankui, Wang Zhongchao, Li Fenglei, Yan Haihong

Open Access Study protocol

A pilot study to evaluate the effect of Taeumjowi-tang on obesity in Korean adults: study protocol for a randomised, double-blind, placebo-controlled, multicentre trial

Sunju Park, Jeong-Su Park, ChunHoo Cheon, Yong Joon Yang, Changsuk An, Bo-Hyoung Jang, Yun-Kyung Song, Hoyeon Go, Ju Ah Lee, Yongcheol Shin, Seong-Gyu Ko

Open Access Research

Forty-five years of schizophrenia trials in Italy: a survey

Marianna Purgato, Clive Adams, Corrado Barbui

Open Access Study protocol

Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial

Stuart J Russell, Christine Tan, Peter O'Keefe, Saeed Ashraf, Afzal Zaidi, Alan G Fraser, Zaheer R Yousef

Open Access Study protocol

The effect of telephone-based interpersonal psychotherapy for the treatment of postpartum depression: study protocol for a randomized controlled trial

Cindy-Lee Dennis, Paula Ravitz, Sophie Grigoriadis, Melissa Jovellanos, Ellen Hodnett, Lori Ross, John Zupancic

Open Access Review

Factors contributing to therapeutic effects evaluated in acupuncture clinical trials

Guang-Xia Shi, Xiao-Min Yang, Cun-Zhi Liu, Lin-Peng Wang

Open Access Methodology

Should we reconsider the routine use of placebo controls in clinical research?

Andrew L Avins, Daniel C Cherkin, Karen J Sherman, Harley Goldberg, Alice Pressman

Open Access Study protocol

A study of the effect of the FertilMate™ scrotum cooling patch on male fertility. SCOP trial (scrotal cooling patch) - study protocol for a randomised controlled trial

M Waseem Osman, llias Nikolopoulos, Zeina Haoula, Jayaprakasan Kannamannadiar, William Atiomo

Open Access Study protocol

INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial

Francesco Burzotta, Marta Francesca Brancati, Carlo Trani, Italo Porto, Antonella Tommasino, Gianluigi De Maria, Giampaolo Niccoli, Antonio Maria Leone, Valentina Coluccia, Giovanni Schiavoni, Filippo Crea

Open Access Study protocol

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

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

Open Access Study protocol

Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD). TECEPOC: study protocol for a partially randomized controlled trial (preference trial)

Francisca Leiva-Fernández, José Leiva-Fernández, Fernando Zubeldia-Santoyo, Antonio García-Ruiz, Daniel Prados-Torres, Pilar Barnestein-Fonseca

Open Access Study protocol

Analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain: study protocol for a randomized controlled trial

Li Yuxiang, Tang Lu, Yu Jianqiang, Dai Xiuying, Zhou Wanfang, Zhang Wannian, Hu Xiaoyan, Xiao Shichu, Ni Wen, Ma Xiuqiang, Wu Yinsheng, Yao Ming, Mu Guoxia, Wang Guangyi, Han Wenjun, Xia Zhaofan, Tang Hongtai, Zhao Jijun

Open Access Study protocol

The effect of ultrapro or prolene mesh on postoperative pain and well-being following endoscopic Totally Extraperitoneal (TEP) hernia repair (TULP): study protocol for a randomized controlled trial

Nelleke Schouten, Thijs van Dalen, Niels Smakman, Sjoerd G Elias, Geert Jan Clevers, Egbert-Jan M M Verleisdonk, Paul H P Davids, Ine PJ Burgmans

Open Access Study protocol

Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II – Trial): study protocol for a randomised controlled trial

Ronald M van Dam, Edgar M Wong-Lun-Hing, Gerard JP van Breukelen, Jan HMB Stoot, Joost R van der Vorst, Marc HA Bemelmans, Steven WM Olde Damink, Kristoffer Lassen, Cornelis HC Dejong

Open Access Research

The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase

Shinji Shimodera, Tadashi Kato, Hirotoshi Sato, Kazuhira Miki, Yoshihiro Shinagawa, Masaki Kondo, Hirokazu Fujita, Ippei Morokuma, Yoshio Ikeda, Tatsuo Akechi, Norio Watanabe, Mitsuhiko Yamada, Masatoshi Inagaki, Naohiro Yonemoto, Toshi A Furukawa

Open Access Study protocol

Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial

Johann Schinzel, Lina Schwarzlose, Holger Dietze, Karolina Bartusch, Susanne Weiss, Stephanie Ohlraun, Friedemann Paul, Jan Dörr

Open Access Study protocol

Stimulation of the autonomic nervous system in colorectal surgery: a study protocol for a randomized controlled trial

Tim MP Berghmans, Karel WE Hulsewé, Wim A Buurman, Misha DP Luyer

Open Access Study protocol

A benefit-finding intervention for family caregivers of persons with Alzheimer disease: study protocol of a randomized controlled trial

Sheung-Tak Cheng, Rosanna WL Lau, Emily PM Mak, Natalie SS Ng, Linda CW Lam, Helene H Fung, Julian CL Lai, Timothy Kwok, Diana TF Lee

Open Access Study protocol

Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: Study protocol for a randomised controlled trial

Michael Joseph Barrett, John Cronin, Adrian Murphy, Siobhan McCoy, John Hayden, SinéadNic an Fhailí, Tim Grant, Abel Wakai, Corrina McMahon, Sean Walsh, Ronan O’Sullivan

Open Access Study protocol

Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

Ying Li, Hui Zheng, Fang Zeng, Si-yuan Zhou, Feng Zhong, Hua-bing Zheng, Min Chen, Xiang-hong Jing, Yu-ying Cai, Bao-hui Jia, Bing Zhu, Zhi-shun Liu

Open Access Study protocol

Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial

Denise Rook, Henk Schierbeek, Anne C van der Eijk, Mariangela Longini, Giuseppe Buonocore, Maximo Vento, Johannes B van Goudoever, Marijn J Vermeulen

Open Access Study protocol

Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial

Amy Streater, Aimee Spector, Elisa Aguirre, Juanita Hoe, Zoe Hoare, Robert Woods, Ian Russell, Martin Orrell

Open Access Study protocol

Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial

Susanne Jäger, Kai W Müller, Christian Ruckes, Tobias Wittig, Anil Batra, Michael Musalek, Karl Mann, Klaus Wölfling, Manfred E Beutel

Open Access Study protocol

Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

Corrine I Voils, Cynthia J Coffman, David Edelman, Matthew L Maciejewski, Janet M Grubber, Azita Sadeghpour, Alex Cho, Jamiyla McKenzie, Francoise Blanpain, Maren Scheuner, Margarete Sandelowski, M Patrick Gallagher, Geoffrey S Ginsburg, William S Yancy Jr

Open Access Methodology

The value of the pragmatic-explanatory continuum indicator summary wheel in an ongoing study: the bullous pemphigoid steroids and tetracyclines study

Daniel J Bratton, Andrew J Nunn, Fenella Wojnarowska, Gudula Kirtschig, Anna Sandell, Hywel C Williams

Open Access Study protocol

UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial

Fiona F Craig, Kim S Thomas, Eleanor J Mitchell, Hywel C Williams, John Norrie, James M Mason, Anthony D Ormerod

Open Access Methodology

Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people

Ian P Sinha, Ruairi Gallagher, Paula R Williamson, Rosalind L Smyth

Open Access Study protocol

The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial

Linda Clare, John V Hindle, Ian R Jones, Jeanette M Thom, Sharon M Nelis, Barry Hounsome, Christopher J Whitaker

Open Access Study protocol

The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial

Anne Juul Wikkelsoe, Arash Afshari, Jakob Stensballe, Jens Langhoff-Roos, Charlotte Albrechtsen, Kim Ekelund, Gabriele Hanke, Heidi Fosgrau Sharif, Anja U Mitchell, Jens Svare, Ane Troelstrup, Lars Møller Pedersen, Jeannet Lauenborg, Mette Gøttge Madsen, Birgit Bødker, Ann M Møller

Open Access Research

Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis.

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

Open Access Study protocol

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial

Mirella Ruggeri, Chiara Bonetto, Antonio Lasalvia, Giovanni De Girolamo, Angelo Fioritti, Paola Rucci, Paolo Santonastaso, Giovanni Neri, Francesca Pileggi, Daniela Ghigi, Maurizio Miceli, Silvio Scarone, Angelo Cocchi, Stefano Torresani, Carlo Faravelli, Christa Zimmermann, Anna Meneghelli, Carla Cremonese, Paolo Scocco, Emanuela Leuci, Fausto Mazzi, Massimo Gennarelli, Paolo Brambilla, Sarah Bissoli, Maria Elena Bertani, Sarah Tosato, Katia De Santi, Sara Poli, Doriana Cristofalo, Michele Tansella

Open Access Research

The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results

Gemma Phillips, Adrian Renton, Derek G Moore, Christian Bottomley, Elena Schmidt, Shahana Lais, Ge Yu, Martin Wall, Patrick Tobi, Caroline Frostick, Angela Clow, Karen Lock, Mark Petticrew, Richard Hayes

Open Access Research

What is the role and authority of gatekeepers in cluster randomized trials in health research?

Antonio Gallo, Charles Weijer, Angela White, Jeremy M Grimshaw, Robert Boruch, Jamie C Brehaut, Allan Donner, Martin P Eccles, Andrew D McRae, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard

Open Access Research

Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation

S Swaroop Vedula, Palko S Goldman, Ilyas J Rona, Thomas M Greene, Kay Dickersin

Open Access Research

Long-term dietary intervention trials: critical issues and challenges

Georgina E Crichton, Peter RC Howe, Jonathan D Buckley, Alison M Coates, Karen J Murphy, Janet Bryan

Open Access Study protocol

Nicotine patches and quitline counseling to help hospitalized smokers stay quit: study protocol for a randomized controlled trial

Sharon Cummins, Shu-Hong Zhu, Anthony Gamst, Carrie Kirby, Kendra Brandstein, Hillary Klonoff-Cohen, Edward Chaplin, Timothy Morris, Gregory Seymann, Joshua Lee

Open Access Study protocol

The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

Zhao-Hui Liang, Zhong Di, Shuo Jiang, Shu-Jun Xu, Xiao-Ping Zhu, Wen-Bin Fu, Ai-Ping Lu

Open Access Methodology

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

Matthew R Sydes, Mahesh KB Parmar, Malcolm D Mason, Noel W Clarke, Claire Amos, John Anderson, Johann de Bono, David P Dearnaley, John Dwyer, Charlene Green, Gordana Jovic, Alastair WS Ritchie, J Martin Russell, Karen Sanders, George Thalmann, Nicholas D James

Open Access Commentary

Developing core outcome sets for clinical trials: issues to consider

Paula R Williamson, Douglas G Altman, Jane M Blazeby, Mike Clarke, Declan Devane, Elizabeth Gargon, Peter Tugwell

Open Access Study protocol

HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial

Renske M van Wijk, Magda M Boere-Boonekamp, Catharina GM Groothuis-Oudshoorn, Leo A van Vlimmeren, Maarten J IJzerman

Open Access Study protocol

Pancreatogastrostomy versus pancreatojejunostomy for RECOnstruction after partial PANCreatoduodenectomy (RECOPANC): study protocol of a randomized controlled trial UTN U1111-1117-9588

Ulrich Friedrich Wellner, Sabine Brett, Thomas Bruckner, Ronald Limprecht, Inga Rossion, Christoph Seiler, Olivia Sick, Inga Wegener, Ulrich Theodor Hopt, Tobias Keck

Open Access Study protocol

Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial

Sevim Uzun, Remco S Djamin, JanAJW Kluytmans, Nils E Van’t Veer, Anton A M Ermens, Aline J Pelle, Paul Mulder, Menno M van der Eerden, JoachimGJV Aerts

Open Access Study protocol

The effects of exercise during pregnancy on the newborn’s brain: study protocol for a randomized controlled trial

Elise L LeMoyne, Daniel Curnier, Samuel St-Jacques, Dave Ellemberg

Open Access Study protocol

Self-help materials for the prevention of smoking relapse: study protocol for a randomized controlled trial

Fujian Song, Richard Holland, Garry R Barton, Max Bachmann, Annie Blyth, Viv Maskrey, Paul Aveyard, Stephen Sutton, Jo Leonardi-Bee, Thomas H Brandon

Open Access Study protocol

Psychoanalytic and cognitive-behavior therapy of chronic depression: study protocol for a randomized controlled trial

Manfred E Beutel, Marianne Leuzinger-Bohleber, Bernhard Rüger, Ulrich Bahrke, Alexa Negele, Antje Haselbacher, Georg Fiedler, Wolfram Keller, Martin Hautzinger

Open Access Commentary

Overview of the consortium of hospitals advancing research on tobacco (chart)

William T Riley, Victor J Stevens, Shu-Hong Zhu, Glen Morgan, Debra Grossman

Open Access Study protocol

Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial

Jochen René Thyrian, Thomas Fiß, Adina Dreier, Georgia Böwing, Aniela Angelow, Sven Lueke, Stefan Teipel, Steffen Fleßa, Hans Jörgen Grabe, Harald Jürgen Freyberger, Wolfgang Hoffmann

Open Access Study protocol

CRASH-3 - tranexamic acid for the treatment of significant traumatic brain injury: study protocol for an international randomized, double-blind, placebo-controlled trial

Yashbir Dewan, Edward O Komolafe, Jorge H Mejía-Mantilla, Pablo Perel, Ian Roberts, Haleema Shakur

Open Access Study protocol

The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial

David M Tappin, Linda Bauld, Carol Tannahill, Linda de Caestecker, Andrew Radley, Alex McConnachie, Kathleen Boyd, Andrew Briggs, Liz Grant, Alan Cameron, Susan MacAskill, Lesley Sinclair, Brenda Friel, Tim Coleman

Open Access Study protocol

Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

Rahil Sanatinia, Barbara Barrett, Sarah Byford, Madeleine Dean, John Green, Rachel Jones, Baptiste Leurent, Anne Lingford-Hughes, Michael Sweeting, Robin Touquet, Peter Tyrer, Helen Ward, Mike J Crawford

Open Access Study protocol

Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial

Stephen Crawcour, Eric Leibing, Denise Ginzburg, Ulrich Stangier, Jörg Wiltink, Jürgen Hoyer

Open Access Study protocol

The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial

Rune Rasmussen, Jørn Wetterslev, Trine Stavngaard, Jane Skjøth-Rasmussen, Per Olof Grände, Niels Vidiendal Olsen, Bertil Romner

Open Access Research

The management of dental caries in primary teeth - involving service providers and users in the design of a trial

Zoe Marshman, Nicola Innes, Chris Deery, Melanie Hall, Chris Speed, Gail Douglas, Jan Clarkson, Helen Rodd

Open Access Study protocol

Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial

Sandra J Japuntich, Susan Regan, Joseph Viana, Justyna Tymoszczuk, Michele Reyen, Douglas E Levy, Daniel E Singer, Elyse R Park, Yuchiao Chang, Nancy A Rigotti

Open Access Research

Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials

James Raftery, Eleanor Fairbank, Lisa Douet, Louise Dent, Alison Price, Ruairidh Milne, Tom Walley

Open Access Study protocol

Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

Anne B Chang, Keith Grimwood, Colin F Robertson, Andrew C Wilson, Peter P van Asperen, Kerry-Ann F O’Grady, Theo P Sloots, Paul J Torzillo, Emily J Bailey, Gabrielle B McCallum, Ian B Masters, Catherine A Byrnes, Mark D Chatfield, Helen M Buntain, Ian M Mackay, Peter S Morris

Open Access Study protocol

Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

Barbara A Gregson, Elise N Rowan, Patrick M Mitchell, Andy Unterberg, Elaine M McColl, Iain R Chambers, Paul McNamee, A David Mendelow

Open Access Study protocol

Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial

Aleida G Huppelschoten, Noortje TL van Duijnhoven, Rosella PMG Hermens, Chris Verhaak, Jan AM Kremer, Willianne LDM Nelen

Open Access Study protocol

Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial

Andreas Totzeck, Susanne Unverzagt, Maja Bak, Pierre Augst, Hans-Christoph Diener, Charly Gaul

Open Access Review

Nonadherence to treatment protocol in published randomised controlled trials: a review

Susanna Dodd, Ian R White, Paula Williamson

Open Access Study protocol

Psychosocial group intervention to enhance self-management skills of people with dementia and their caregivers: study protocol for a randomized controlled trial

Marja-Liisa Laakkonen, Eeva H Hölttä, Niina Savikko, Timo E Strandberg, Merja Suominen, Kaisu H Pitkälä

Open Access Research

Developing an educational intervention on dementia diagnosis and management in primary care for the EVIDEM-ED trial

Steve Iliffe, Tamar Koch, Priya Jain, Frances Lefford, Geoffrey Wong, Alex Warner, Jane Wilcock

Open Access Study protocol

Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial

Manfred Hecking, Marlies Antlanger, Wolfgang Winnicki, Thomas Reiter, Johannes Werzowa, Michael Haidinger, Thomas Weichhart, Hans-Dietrich Polaschegg, Peter Josten, Isabella Exner, Katharina Lorenz-Turnheim, Manfred Eigner, Gernot Paul, Renate Klauser-Braun, Walter H Hörl, Gere Sunder-Plassmann, Marcus D Säemann

Open Access Study protocol

Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial

John Cronin, Una Kennedy, Siobhan McCoy, Sinéad Nic an Fhailí, Gloria Crispino-O’Connell, John Hayden, Abel Wakai, Sean Walsh, Ronan O’Sullivan

Open Access Study protocol

Transarterial RAdioembolization versus ChemoEmbolization for the treatment of hepatocellular carcinoma (TRACE): study protocol for a randomized controlled trial

Beatrijs A Seinstra, Luc Defreyne, Bieke Lambert, Marnix GEHH Lam, Helena M Verkooijen, Karel J van Erpecum, Bart van Hoek, Arian R van Erkel, Minneke J Coenraad, Imad Al Younis, Hans van Vlierberghe, Maurice AAJ van den Bosch

Open Access Study protocol

Effect of electroacupuncture on opioid consumption in patients with chronic musculoskeletal pain: protocol of a randomised controlled trial

Charlie CL Xue, Robert D Helme, Stephen Gibson, Malcolm Hogg, Carolyn Arnold, Andrew A Somogyi, Cliff Da Costa, Yanyi Wang, Shao-chen Lu, Zhen Zheng

Open Access Study protocol

Cognitive behavioural therapy (CBT) for anxiety in people with dementia: study protocol for a randomised controlled trial

Aimee Spector, Martin Orrell, Miles Lattimer, Juanita Hoe, Michael King, Kate Harwood, Afifa Qazi, Georgina Charlesworth

Open Access Study protocol

Beneficial effects of short-term combination exercise training on diverse cognitive functions in healthy older people: study protocol for a randomized controlled trial

Rui Nouchi, Yasuyuki Taki, Hikaru Takeuchi, Hiroshi Hashizume, Takayuki Nozawa, Atsushi Sekiguchi, Haruka Nouchi, Ryuta Kawashima

Open Access Study protocol

Lovastatin for adult patients with dengue: protocol for a randomised controlled trial

James Whitehorn, Nguyen Van Vinh Chau, Nguyen Thanh Truong, Luong Thi Hue Tai, Nguyen Van Hao, Tran Tinh Hien, Marcel Wolbers, Laura Merson, Nguyen Thi Phuong Dung, Rosanna Peeling, Cameron Simmons, Bridget Wills, Jeremy Farrar

Open Access Study protocol

Using “warm handoffs” to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial

Kimber P Richter, Babalola Faseru, Laura M Mussulman, Edward F Ellerbeck, Theresa I Shireman, Jamie J Hunt, Beatriz H Carlini, Kristopher J Preacher, Candace L Ayars, David J Cook

Open Access Commentary

Diagnostic randomized controlled trials: the final frontier

Marc Rodger, Tim Ramsay, Dean Fergusson

Open Access Study protocol

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial

Lina Gega, Louise Swift, Garry Barton, Gillian Todd, Nesta Reeve, Kelly Bird, Richard Holland, Amanda Howe, Jon Wilson, Jo Molle

Open Access Study protocol

Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial

Madlen Uhlemann, Volker Adams, Karsten Lenk, Axel Linke, Sandra Erbs, Jennifer Adam, Holger Thiele, Thomas Hilberg, Matthias Gutberlet, Martin Grunze, Gerhard C Schuler, Sven Möbius-Winkler

Open Access Methodology

Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

Melissa J Parker, Asmaa Manan, Mark Duffett

Open Access Research

Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients

Augustine N Odili, Birinus Ezeala-Adikaibe, Mouhamadou B Ndiaye, Benedict C Anisiuba, Marius M Kamdem, Chinwuba K Ijoma, Joseph Kaptue, Hilaire J Boombhi, Philip M Kolo, Elvis N Shu, Lutgarde Thijs, Jan A Staessen, Babatunde A Omotoso, Samuel Kingue, Serigne A Ba, Daniel Lemogoum, Jean-René M’Buyamba-Kabangu, Ifeoma I Ulasi

Open Access Study protocol

Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial

Ellie Grossman, Donna Shelley, R Scott Braithwaite, Iryna Lobach, Ana Goffin, Erin Rogers, Scott Sherman

Open Access Study protocol

Interaction between cytokine gene polymorphisms and the effect of physical exercise on clinical and inflammatory parameters in older women: study protocol for a randomized controlled trial

Daniele S Pereira, Bárbara Z Queiroz, Elvis CC Mateo, Alexandra M Assumpção, Diogo C Felício, Aline S Miranda, Daniela MC Anjos, Fabianna Jesus-Moraleida, Rosângela C Dias, Danielle AG Pereira, Antônio L Teixeira, Leani SM Pereira

Open Access Research

Sponsors’ participation in conduct and reporting of industry trials: a descriptive study

Andreas Lundh, Lasse T Krogsbøll, Peter C Gøtzsche

Open Access Study protocol

Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639]

Hrvoje Gasparovic, Mate Petricevic, Tomislav Kopjar, Zeljko Djuric, Lucija Svetina, Bojan Biocina

Open Access Study protocol

Using novel Canadian resources to improve medication reconciliation at discharge: study protocol for a randomized controlled trial

Robyn Tamblyn, Allen R Huang, Ari N Meguerditchian, Nancy E Winslade, Christian Rochefort, Alan Forster, Tewodros Eguale, David Buckeridge, André Jacques, Kiyuri Naicker, Kristen E Reidel

Open Access Research

Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study

Edward D Janus, James D Best, Nathalie Davis-Lameloise, Benjamin Philpot, Andrea Hernan, Catherine M Bennett, Sharleen O’Reilly, Rob Carter, Erkki Vartiainen, James A Dunbar

Open Access Study protocol

Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation -- a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study)

Michal M Farkowski, Aleksander Maciag, Rafal Dabrowski, Mariusz Pytkowski, Ilona Kowalik, Hanna Szwed

Open Access Research

Inadequate description of educational interventions in ongoing randomized controlled trials

Cécile Pino, Isabelle Boutron, Philippe Ravaud

Open Access Research

An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice

Kathrin M Cresswell, Stacey Sadler, Sarah Rodgers, Anthony Avery, Judith Cantrill, Scott A Murray, Aziz Sheikh

Open Access Study protocol

A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

Tanya Abramsky, Karen Devries, Ligia Kiss, Leilani Francisco, Janet Nakuti, Tina Musuya, Nambusi Kyegombe, Elizabeth Starmann, Dan Kaye, Lori Michau, Charlotte Watts

Open Access Review

Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

Noah M Ivers, Ilana J Halperin, Jan Barnsley, Jeremy M Grimshaw, Baiju R Shah, Karen Tu, Ross Upshur, Merrick Zwarenstein

Open Access Study protocol

Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial

Yuelong Cao, Graeme Jones, Flavia Cicuttini, Tania Winzenberg, Anita Wluka, James Sharman, Kay Nguo, Changhai Ding

Open Access Study protocol

Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo)

Desirée CWM Vos-Vromans, Rob JEM Smeets, Leonie JM Rijnders, René RM Gorrissen, Menno Pont, Albère JA Köke, Minou WMGC Hitters, Silvia MAA Evers, André J Knottnerus

Open Access Study protocol

A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

Natalie Armstrong, Darrin Baines, Richard Baker, Richard Crossman, Melanie Davies, Ainsley Hardy, Kamlesh Khunti, Sudhesh Kumar, Joseph Paul O’Hare, Neil Raymond, Ponnusamy Saravanan, Nigel Stallard, Ala Szczepura, Andrew Wilson

Open Access Study protocol

Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial

Jeffrey L Fellows, Richard Mularski, Lisa Waiwaiole, Kim Funkhouser, Julie Mitchell, Kathleen Arnold, Sabrina Luke

Open Access Study protocol

Decreasing adrenergic or sympathetic hyperactivity after severe traumatic brain injury using propranolol and clonidine (DASH After TBI Study): study protocol for a randomized controlled trial

Mayur B Patel, John W McKenna, JoAnn M Alvarez, Ayaka Sugiura, Judith M Jenkins, Oscar D Guillamondegui, Pratik P Pandharipande

Open Access Study protocol

Permissive underfeeding versus target enteral feeding in adult critically ill patients (PermiT Trial): a study protocol of a multicenter randomized controlled trial

Yaseen M Arabi, Samir H Haddad, Abdulaziz S Aldawood, Hasan M Al-Dorzi, Hani M Tamim, Maram Sakkijha, Gwynne Jones, Lauralyn McIntyre, Sangeeta Mehta, Othman Solaiman, Musharaf Sadat, Lara Afesh, Bushra Sami

Open Access Study protocol

Patient directed self management of pain (PaDSMaP) compared to treatment as usual following total knee replacement: study protocol for a randomized controlled trial

Simon Donell, Katherine Deane, Louise Swift, Garry Barton, Paula Balls, Clare Darrah, Richard Gray

Open Access Study protocol

A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria: study protocol for a randomized controlled trial

Virginia Wiseman, Ezeoke Ogochukwu, Nwala Emmanuel, Mangham Lindsay J, Cundill Bonnie, Enemuo Jane, Uchegbu Eloka, Uzochukwu Benjamin, Onwujekwe Obinna

Open Access Study protocol

Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial

Stefan A Bouwense, Marc G Besselink, Sandra van Brunschot, Olaf J Bakker, Hjalmar C van Santvoort, Nicolien J Schepers, Marja A Boermeester, Thomas L Bollen, Koop Bosscha, Menno A Brink, Marco J Bruno, Esther C Consten, Cornelis H Dejong, Peter van Duijvendijk, Casper H van Eijck, Jos J Gerritsen, Harry van Goor, Joos Heisterkamp, Ignace H de Hingh, Philip M Kruyt, I Quintus Molenaar, Vincent B Nieuwenhuijs, Camiel Rosman, Alexander F Schaapherder, Joris J Scheepers, Marcel BW Spanier, Robin Timmer, Bas L Weusten, Ben J Witteman, Bert van Ramshorst, Hein G Gooszen, Djamila Boerma

Open Access Study protocol

Alzheimer’s disease multiple intervention trial (ADMIT): study protocol for a randomized controlled clinical trial

Christopher M Callahan, Malaz A Boustani, Arlene A Schmid, Mary G Austrom, Douglas K Miller, Sujuan Gao, Carrie S Morris, Mickey Vogel, Hugh C Hendrie

Open Access Methodology

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

Ather Ali, Janet Kahn, Lisa Rosenberger, Adam I Perlman

Open Access Study protocol

Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial

Michael Ussher, Paul Aveyard, Isaac Manyonda, Sarah Lewis, Robert West, Beth Lewis, Bess Marcus, Adrian H Taylor, Pelham Barton, Tim Coleman

Open Access Study protocol

Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial

José Côté, Gaston Godin, Yann-Gaël Guéhéneuc, Geneviève Rouleau, Pilar Ramirez-Garcìa, Joanne Otis, Cécile Tremblay, Ghayas Fadel

Open Access Study protocol

The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand

Annelies Wilder-Smith, Peter Byass, Phanthip Olanratmanee, Pongsri Maskhao, Luechai Sringernyuang, James G Logan, Steve W Lindsay, Sarah Banks, Duane Gubler, Valérie R Louis, Yesim Tozan, Pattamaporn Kittayapong

Open Access Study protocol

Collaborative Interventions for Circulation and Depression (COINCIDE): study protocol for a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease

Peter A Coventry, Karina Lovell, Chris Dickens, Peter Bower, Carolyn Chew-Graham, Andrea Cherrington, Charlotte Garrett, Chris J Gibbons, Clare Baguley, Kate Roughley, Isabel Adeyemi, Chris Keyworth, Waquas Waheed, Mark Hann, Linda Davies, Farheen Jeeva, Chris Roberts, Sarah Knowles, Linda Gask

Open Access Review

Adaptive trial designs: a review of barriers and opportunities

John A Kairalla, Christopher S Coffey, Mitchell A Thomann, Keith E Muller

Open Access Study protocol

Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

Jeong-Su Park, Sunju Park, Chun-Hoo Cheon, Bo-Hyoung Jang, Song-Hee Lee, Seung-Hyun Lee, Sun-Yong Chung, Jong-Woo Kim, Chan-Yong Jeon, Jong-Hyeong Park, Yong-Cheol Shin, Seong-Gyu Ko

Open Access Study protocol

Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial

Enza Gucciardi, Mariella Fortugno, Stacey Horodezny, Wendy Lou, Souraya Sidani, Sherry Espin, Fiona Webster, Baiju R Shah

Open Access Study protocol

Surgery versus Active Monitoring in Intermittent Exotropia (SamExo): study protocol for a pilot randomised controlled trial

Deborah Buck, Elaine McColl, Christine J Powell, Jing Shen, John Sloper, Nick Steen, Robert Taylor, Peter Tiffin, Luke Vale, Michael P Clarke

Open Access Methodology

Advancing the evidence base in cancer: psychosocial multicenter trials

Robert Sanson-Fisher, Lisa Mackenzie, Phyllis Butow, Nicole Rankin, Christine Paul

Open Access Study protocol

Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial

Martin Orrell, Lauren A Yates, Alistair Burns, Ian Russell, Robert T Woods, Zoe Hoare, Esme Moniz-Cook, Catherine Henderson, Martin Knapp, Aimee Spector, Vasiliki Orgeta

Open Access Research

Use of randomisation in clinical trials: a survey of UK practice

Gladys C McPherson, Marion K Campbell, Diana R Elbourne

Open Access Study protocol

The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial

Jasper AJ Smits, Michael J Zvolensky, David Rosenfield, Bess H Marcus, Timothy S Church, Georita M Frierson, Mark B Powers, Michael W Otto, Michelle L Davis, Lindsey B DeBoer, Nicole F Briceno

Open Access Research

A qualitative study evaluating experiences of a lifestyle intervention in men with prostate cancer undergoing androgen suppression therapy

Liam Bourke, Ratna Sohanpal, Veronica Nanton, Helen Crank, Derek J Rosario, John M Saxton

Open Access Letter

Information on blinding in registered records of clinical trials

Roderik F Viergever, Davina Ghersi

Open Access Study protocol

DeloRes trial: study protocol for a randomized trial comparing two standardized surgical approaches in rectal prolapse - Delorme’s procedure versus resection rectopexy

Simone Rothenhoefer, Florian Herrle, Alexander Herold, Andreas Joos, Dieter Bussen, Meinhard Kieser, Petra Schiller, Christina Klose, Christoph M Seiler, Peter Kienle, Stefan Post

Open Access Study protocol

Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

Lena Schiffer, Mario Schiffer, Saskia Merkel, Anke Schwarz, Michael Mengel, Christopher Jürgens, Christoph Schroeder, Alexander A Zoerner, Kerstin Püllmann, Verena Bröcker, Jan U Becker, Maximilian E Dämmrich, Jana Träder, Anika Großhennig, Frank Biertz, Hermann Haller, Armin Koch, Wilfried Gwinner

Open Access Methodology

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

Corinne SC Merle, Charalambos Sismanidis, Oumou Bah Sow, Martin Gninafon, John Horton, Olivier Lapujade, Mame Bocar Lo, Denis A Mitchinson, Christian Perronne, Francoise Portaels, Joseph Odhiambo, Piero Olliaro, Roxana Rustomjee, Christian Lienhardt, Katherine Fielding

Open Access Study protocol

Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial

André L Mihaljevic, Christoph W Michalski, Mert Erkan, Carolin Reiser-Erkan, Carsten Jäger, Tibor Schuster, Christoph Schuhmacher, Jörg Kleeff, Helmut Friess

Open Access Study protocol

A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

Pip A Logan, Mat P Leighton, Marion F Walker, Sarah Armstrong, John R F Gladman, Tracey H Sach, Shirley Smith, Ossie Newell, Tony Avery, Hywel Williams, James Scott, Kathleen O’Neil, Annie McCluskey, Simon Leach, David Barer, Claire Ritchie, Ailie Turton, Jane Bisiker, David Smithard, Tess Baird, Paul Guyler, Therese Jackson, Ingrid Watmough, Maggie Webster, Janet Ivey

Open Access Research

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]

Rebecca L Ashby, Jo C Dumville, Marta O Soares, Elizabeth McGinnis, Nikki Stubbs, David J Torgerson, Nicky Cullum

Open Access Study protocol

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial

Kathleen F Harrington, Julie A McDougal, Maria Pisu, Bin Zhang, Rajani S Sadasivam, Thomas K Houston, William C Bailey

Open Access Study protocol

Dissemination of the nurse-administered Tobacco Tactics intervention versus usual care in six Trinity community hospitals: study protocol for a comparative effectiveness trial

Sonia A Duffy, David L Ronis, Marita G Titler, Frederic C Blow, Neil Jordan, Patricia L Thomas, Gay L Landstrom, Lee A Ewing, Andrea H Waltje

Open Access Study protocol

Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial

Myo Nyein Aung, Motoyuki Yuasa, Saiyud Moolphate, Supalert Nedsuwan, Hidehiro Yokokawa, Tsutomu Kitajima, Kazuo Minematsu, Susumu Tanimura, Hiroshi Fukuda, Yoshimune Hiratsuka, Koichi Ono, Sachio Kawai, Eiji Marui

Open Access Research

Developing a guideline for clinical trial protocol content: Delphi consensus survey

Jennifer Marie Tetzlaff, David Moher, An-Wen Chan

Open Access Study protocol

The efficacy of a brief intervention to reduce alcohol misuse in patients with HIV in South Africa: study protocol for a randomized controlled trial

Diana Huis in ’t Veld, Linda Skaal, Karl Peltzer, Robert Colebunders, John V Ndimande, Supa Pengpid

Open Access Study protocol

Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]

Nuh N Rahbari, Phillip Knebel, Meinhard Kieser, Thomas Bruckner, Detlef K Bartsch, Helmut Friess, Andre L Mihaljevic, Josef Stern, Markus K Diener, Sabine Voss, Inga Rossion, Markus W Büchler, Christoph M Seiler

Open Access Research

Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial

Pascale Boissonnat, Ségolène Gaillard, Catherine Mercier, Michel Redonnet, Bernard Lelong, Marie-Françoise Mattei, Annick Mouly-Bandini, Sabine Pattier, Agnès Sirinelli, Eric Epailly, Shaida Varnous, Marc-Alain Billes, Laurent Sebbag, René Ecochard, Catherine Cornu, François Gueyffier

Open Access Study protocol

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

Graeme B Wilson, Ruth McGovern, Grace Antony, Paul Cassidy, Mark Deverill, Erin Graybill, Eilish Gilvarry, Moira Hodgson, Eileen FS Kaner, Kirsty Laing, Elaine McColl, Dorothy Newbury-Birch, Judith Rankin

Open Access Methodology

Continuous controllable balloon dilation: a novel approach for cervix dilation

Slobodan Arsenijevic, Gordana Vukcevic-Globarevic, Vladislav Volarevic, Ivan Macuzic, Petar Todorovic, Irena Tanaskovic, Milan Mijailovic, Sasa Raicevic, Branislav Jeremic

Open Access Methodology

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

Cathy Lodewijckx, Marc Decramer, Walter Sermeus, Massimiliano Panella, Svin Deneckere, Kris Vanhaecht

Open Access Study protocol

Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial

Boadie W Dunlop, Elisabeth B Binder, Joseph F Cubells, Mark M Goodman, Mary E Kelley, Becky Kinkead, Michael Kutner, Charles B Nemeroff, D Jeffrey Newport, Michael J Owens, Thaddeus W W Pace, James C Ritchie, Vivianne Aponte Rivera, Drew Westen, W Edward Craighead, Helen S Mayberg

Open Access Study protocol

Augmented visual feedback of movement performance to enhance walking recovery after stroke: study protocol for a pilot randomised controlled trial

Heather Thikey, Madeleine Grealy, Frederike van Wijck, Mark Barber, Philip Rowe

Open Access Study protocol

Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial: study protocol for a randomized controlled trial

Daniel F McAuley, John G Laffey, Cecilia M O’Kane, Mark Cross, Gavin D Perkins, Lynn Murphy, Christine McNally, Grainne Crealey, Michael Stevenson

Open Access Research

DiAlert: a prevention program for overweight first degree relatives of type 2 diabetes patients: results of a pilot study to test feasibility and acceptability

Wieke H Heideman, Maartje de Wit, Barend JC Middelkoop, Vera Nierkens, Karien Stronks, Arnoud P Verhoeff, Frank J Snoek

Open Access Research

Open-access clinical trial registries: the Italian scenario

Paola Mosconi, Anna Roberto

Open Access Study protocol

Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

Bogdan Tudor Tulbure, Kristoffer NT Månsson, Gerhard Andersson

Open Access Research

General practice-based clinical trials in Germany - a problem analysis

Eva Hummers-Pradier, Jutta Bleidorn, Guido Schmiemann, Stefanie Joos, Annette Becker, Attila Altiner, Jean-François Chenot, Martin Scherer

Open Access Research

Treatment-emergent adverse events after infusion of adherent stem cells: the MiSOT-I score for solid organ transplantation

Johannes Dillmann, Felix C Popp, Barbara Fillenberg, Florian Zeman, Elke Eggenhofer, Stefan Farkas, Marcus N Scherer, Michael Koller, Edward K Geissler, Robert Deans, Deborah Ladenheim, Martin Loss, Hans J Schlitt, Marc H Dahlke

Open Access Research

Practice effects in a longitudinal, multi-center Alzheimer’s disease prevention clinical trial

Erin L Abner, Brandon C Dennis, Melissa J Mathews, Marta S Mendiondo, Allison Caban-Holt, Richard J Kryscio, Frederick A Schmitt, John J Crowley

Open Access Update

Update on the Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II): statistical analysis plan

Barbara A Gregson, Gordon D Murray, Patrick M Mitchell, Elise N Rowan, Anil R Gholkar, A David Mendelow

Open Access Study protocol

School-based intervention to reduce anxiety in children: study protocol for a randomized controlled trial (PACES)

Paul Stallard, Gordon Taylor, Rob Anderson, Harry Daniels, Neil Simpson, Rhiannon Phillips, Elena Skryabina

Open Access Study protocol

Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

Nicola Saywell, Alain C Vandal, Paul Brown, H Carl Hanger, Leigh Hale, Suzie Mudge, Stephan Milosavljevic, Valery Feigin, Denise Taylor

Open Access Study protocol

Efficiency and effectiveness of the use of an acenocoumarol pharmacogenetic dosing algorithm versus usual care in patients with venous thromboembolic disease initiating oral anticoagulation: study protocol for a randomized controlled trial

Antonio J Carcas, Alberto M Borobia, Marta Velasco, Francisco Abad-Santos, Manuel Quintana Díaz, Carmen Fernández-Capitán, Nuria Ruiz-Giménez, Olga Madridano, Pilar Llamas Sillero

Open Access Study protocol

A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

Koen Teeuwen, Tom Adriaenssens, Ben JL Van den Branden, José PS Henriques, Rene J Van der Schaaf, Jacques J Koolen, Paul HMJ Vermeersch, Mike AR Bosschaert, Jan GP Tijssen, Maarten J Suttorp

Open Access Study protocol

Immigrant family skills-building to prevent tobacco use in Latino youth: study protocol for a community-based participatory randomized controlled trial

Michele L Allen, Diego Garcia-Huidobro, G Ali Hurtado, Rose Allen, Cynthia S Davey, Jean L Forster, Monica Hurtado, Katia Lopez-Petrovich, Mary Marczak, Ursula Reynoso, Laura Trebs, María Veronica Svetaz

Open Access Study protocol

Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial

Gilberto M Sperandio da Silva, Mayara C Chambela, Andrea S Sousa, Luiz Henrique C Sangenis, Sergio S Xavier, Andréa R Costa, Pedro Emmanuel AA Brasil, Alejandro M Hasslocher-Moreno, Roberto M Saraiva

Open Access Study protocol

Reducing inappropriate, anticholinergic and psychotropic drugs among older residents in assisted living facilities: study protocol for a randomized controlled trial

Kaisu H Pitkala, Anna-Liisa Juola, Helena Soini, Marja-Liisa Laakkonen, Hannu Kautiainen, Mariko Teramura-Gronblad, Harriet Finne-Soveri, Mikko Bjorkman

Open Access Study protocol

Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy - a randomised controlled trial

Momin Malik, Kirsty McCormack, Zygmunt H Krukowski, Alison McDonald, Gladys McPherson, Jonathan A Cook, Irfan Ahmed

Open Access Study protocol

Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial

Paulo de Tarso Camillo de Carvalho, Ernesto Cesar Pinto Leal-Junior, Ana Carolina Araruna Alves, Caroline Sobral de Melo Rambo, Luciana Maria Malosa Sampaio, Claudia Santos Oliveira, Regiane Albertini, Luis Vicente Franco de Oliveira

Open Access Study protocol

Individual differences in the efficacy of a short theory of mind intervention for children with autism spectrum disorder: a randomized controlled trial

Elske Hoddenbach, Hans M Koot, Pamela Clifford, Carolien Gevers, Cassandra Clauser, Frits Boer, Sander Begeer

Open Access Study protocol

The effects of reducing worry in patients with persecutory delusions: study protocol for a randomized controlled trial

Daniel Freeman, Graham Dunn, Helen Startup, David Kingdon

Open Access Research

Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study

Norma F Kanarek, Marty S Kanarek, Dare Olatoye, Michael A Carducci

Open Access Commentary

Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact

Sue Ross, Laura Magee, Mark Walker, Stephen Wood

Open Access Research

Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension

Petra Schiller, Nicole Burchardi, Michael Niestroj, Meinhard Kieser

Open Access Study protocol

Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial

Christian Riise Hauge, Peter Jensa E Bonde, Alice Rasmussen, Sine Skovbjerg

Open Access Study protocol

The efficacy of a health-related quality-of-life intervention during 48 weeks of biologic treatment of patients with moderate to severe psoriasis: study protocol for a multicenter randomized controlled trial

Cecilia AC Prinsen, Phyllis I Spuls, Mirjam AG Sprangers, Menno A de Rie, Catharina M Legierse, John de Korte

Open Access Study protocol

Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemia (ARREST): study protocol for a randomised controlled trial

Guy Thwaites, Cressida Auckland, Gavin Barlow, Richard Cunningham, Gerry Davies, Jonathan Edgeworth, Julia Greig, Susan Hopkins, Dakshika Jeyaratnam, Neil Jenkins, Martin Llewelyn, Sarah Meisner, Emmanuel Nsutebu, Tim Planche, Robert C Read, Matthew Scarborough, Marta Soares, Robert Tilley, M Estée Török, John Williams, Peter Wilson, Sarah Wyllie, A Sarah Walker

Open Access Study protocol

Efficacy of moxibustion for pre- or stage I hypertension: study protocol for a pilot randomized controlled trial

Kyung-Min Shin, Ji-Eun Park, Yan Liu, Hee-Jung Jung, So-Young Jung, Min-Hee Lee, Kyung-Won Kang, Tae-Han Yook, Sun-Mi Choi

Open Access Research

Developing novel evidence-based interventions to promote asthma action plan use: a cross-study synthesis of evidence from randomised controlled trials and qualitative studies

Nicola Ring, Ruth Jepson, Hilary Pinnock, Caroline Wilson, Gaylor Hoskins, Sally Wyke, Aziz Sheikh

Open Access Methodology

Developing a survey of barriers and facilitators to recruitment in randomized controlled trials

Geetinder Kaur, Rosalind L Smyth, Paula Williamson

Open Access Study protocol

Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial)

Pieter C van der Sluis, Jelle P Ruurda, Sylvia van der Horst, Roy JJ Verhage, Marc GH Besselink, Margriet JD Prins, Leonie Haverkamp, Carlo Schippers, Inne HM Borel Rinkes, Hans CA Joore, Fiebo JW ten Kate, Hendrik Koffijberg, Christiaan C Kroese, Maarten S van Leeuwen, Martijn PJK Lolkema, Onne Reerink, Marguerite EI Schipper, Elles Steenhagen, Frank P Vleggaar, Emile E Voest, Peter D Siersema, Richard van Hillegersberg

Open Access Study protocol

Efficacy and safety of venous angioplasty of the extracranial veins for multiple sclerosis. Brave dreams study (brain venous drainage exploited against multiple sclerosis): study protocol for a randomized controlled trial

Paolo Zamboni, Antonio Bertolotto, Paolo Boldrini, Patrizia Cenni, Roberto D’Alessandro, Roberto D’Amico, Massimo Del Sette, Roberto Galeotti, Stefania Galimberti, Alessandro Liberati, Luca Massacesi, Donato Papini, Fabrizio Salvi, Silvana Simi, Andrea Stella, Luigi Tesio, Maria Grazia Valsecchi, Graziella Filippini

Open Access Study protocol

Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study): study protocol for a randomized controlled trial

Alex Dregan, Tjeerd van Staa, Lisa Mcdermott, Gerard McCann, Mark Ashworth, Judith Charlton, Charles Wolfe, Anthony Rudd, Lucy Yardley, Martin Gulliford

Open Access Methodology

INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial

Martina de Zwaan, Stephan Herpertz, Stephan Zipfel, Brunna Tuschen-Caffier, Hans-Christoph Friederich, Frauke Schmidt, Olaf Gefeller, Andreas Mayr, Tony Lam, Carmen Schade-Brittinger, Anja Hilbert

Open Access Study protocol

Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

Susanne F Meisel, Rebecca J Beeken, Cornelia HM van Jaarsveld, Jane Wardle

Open Access Study protocol

PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial

Henk-Thijs Brandsma, Birgitta ME Hansson, Hilde V-Haaren-de Haan, Theo J Aufenacker, Camiel Rosman, Rob P Bleichrodt

Open Access Study protocol

Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial

Guang-Xia Shi, Li-Li Han, Li-Ying Liu, Qian-Qian Li, Cun-Zhi Liu, Lin-Peng Wang

Open Access Study protocol

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

Hans J Overgaard, Neal Alexander, Maria Ines Mátiz, Juan Felipe Jaramillo, Victor Alberto Olano, Sandra Vargas, Diana Sarmiento, Audrey Lenhart, Razak Seidu, Thor Axel Stenström

Open Access Study protocol

Acupuncture, Counseling, and Usual care for Depression (ACUDep): study protocol for a randomized controlled trial

Hugh MacPherson, Stewart Richmond, J Martin Bland, Harriet Lansdown, Ann Hopton, Arthur Kang’ombe, Stephen Morley, Sara Perren, Eldon Spackman, Karen Spilsbury, David Torgerson, Ian Watt

Open Access Study protocol

The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities - study protocol for a cluster randomized controlled trial

Peter Waiswa, Stefan S Peterson, Gertrude Namazzi, Elizabeth Kiracho Ekirapa, Sarah Naikoba, Romano Byaruhanga, Juliet Kiguli, Karin Kallander, Abner Tagoola, Margaret Nakakeeto, George Pariyo

Open Access Study protocol

Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial

David E Newby, Michelle C Williams, Andrew D Flapan, John F Forbes, Allister D Hargreaves, Stephen J Leslie, Steff C Lewis, Graham McKillop, Scott McLean, John H Reid, James C Sprat, Neal G Uren, Edwin J van Beek, Nicholas A Boon, Liz Clark, Peter Craig, Marcus D Flather, Chiara McCormack, Giles Roditi, Adam D Timmis, Ashma Krishan, Gillian Donaldson, Marlene Fotheringham, Fiona J Hall, Paul Neary, Louisa Cram, Sarah Perkins, Fiona Taylor, Hany Eteiba, Alan P Rae, Kate Robb, Dawn Barrie, Kim Bissett, Adelle Dawson, Scot Dundas, Yvonne Fogarty, Prasad Guntur Ramkumar, Graeme J Houston, Deborah Letham, Linda O’Neill, Stuart D Pringle, Valerie Ritchie, Thiru Sudarshan, Jonathan Weir-McCall, Alistair Cormack, Iain N Findlay, Stuart Hood, Clare Murphy, Eileen Peat, Barbara Allen, Andrew Baird, Danielle Bertram, David Brian, Amy Cowan, Nicholas L Cruden, Marc R Dweck, Laura Flint, Samantha Fyfe, Collette Keanie, Tom J MacGillivray, David S Maclachlan, Margaret MacLeod, Saeed Mirsadraee, Avril Morrison, Nicholas L Mills, Fiona C Minns, Alyson Phillips, Laura J Queripel, Nicholas W Weir, Fiona Bett, Frances Divers, Katie Fairley, Ashok J Jacob, Edith Keegan, Tricia White, John Gemmill, Margo Henry, James McGowan, Lorraine Dinnel, C Mark Francis, Dennis Sandeman, Ajay Yerramasu, Colin Berry, Heather Boylan, Ammani Brown, Karen Duffy, Alison Frood, Janet Johnstone, Kirsten Lanaghan, Ross MacDuff, Martin MacLeod, Deborah McGlynn, Nigel McMillan, Laura Murdoch, Colin Noble, Victoria Paterson, Tracey Steedman, Nikolaos Tzemos

Open Access Study protocol

Brief intervention to prevent hazardous drinking in young people aged 14–15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized controlled trial

Stephanie O’Neil, Simon Coulton, Paolo Deluca, Mark Deverill, Colin Drummond, Eilish Gilvarry, Erin Graybill, Christine Harle, Denise Howel, Eileen Kaner, Paul McArdle, Elaine McColl, Ruth McGovern, Chris Speed, Elaine Stamp, Les Tate, Dorothy Newbury-Birch