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Zeitschrift

Trials

Trials 1/2018

Ausgabe 1/2018

Inhaltsverzeichnis ( 715 Artikel )

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial

Thijs de Rooij, Jony van Hilst, Koop Bosscha, Marcel G. Dijkgraaf, Michael F. Gerhards, Bas Groot Koerkamp, Jeroen Hagendoorn, Ignace H. de Hingh, Tom M. Karsten, Daan J. Lips, Misha D. Luyer, I. Quintus Molenaar, Hjalmar C. van Santvoort, T. C. Khé Tran, Olivier R. Busch, Sebastiaan Festen, Marc G. Besselink, for the Dutch Pancreatic Cancer Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial

Hong Pan, Yingxia Pei, Bingxue Li, Yi Wang, Jie Liu, Hongsheng Lin

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial

Daren K. Heyland, Judy Davidson, Yoanna Skrobik, Amanda Roze des Ordons, Lauren J. Van Scoy, Andrew G. Day, Virginia Vandall-Walker, Andrea P. Marshall

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness of a psycho-educational intervention to prevent postpartum parental distress and enhance infant well-being: study protocol of a randomized controlled trial

Marjolein Missler, Roseriet Beijers, Jaap Denissen, Annemieke van Straten

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Catherine E. Hanratty, John G. Matthews, Joseph R. Arron, David F. Choy, Ian D. Pavord, P. Bradding, Christopher E. Brightling, Rekha Chaudhuri, Douglas C. Cowan, Ratko Djukanovic, Nicola Gallagher, Stephen J. Fowler, Tim C. Hardman, Tim Harrison, Cécile T. Holweg, Peter H. Howarth, James Lordan, Adel H. Mansur, Andrew Menzies-Gow, Sofia Mosesova, Robert M. Niven, Douglas S. Robinson, Dominick E. Shaw, Samantha Walker, Ashley Woodcock, Liam G. Heaney, on behalf of the RASP-UK (Refractory Asthma Stratification Programme) Consortium

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial): study protocol for a randomised controlled trial

Margaret M. Band, Deepa Sumukadas, Allan D. Struthers, Alison Avenell, Peter T. Donnan, Paul R. Kemp, Karen T. Smith, Cheryl L. Hume, Adrian Hapca, Miles D. Witham

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial

Mindy F. Levin, Melanie C. Baniña, Silvi Frenkel-Toledo, Sigal Berman, Nachum Soroker, John M. Solomon, Dario G. Liebermann

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial

Wing Lok Lam, Wing Fai Yeung, Mei Kuen Wong, Chi Wai Cheung, Karen Kar Loen Chan, Hextan Yuen Sheung Ngan, Carlos King Ho Wong, Hai Yong Chen, Lixing Lao

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section

Patricia Healy, Valerie Smith, Gerard Savage, Mike Clarke, Declan Devane, Mechthild M. Gross, Sandra Morano, Deirdre Daly, Susanne Grylka-Baeschlin, Jane Nicoletti, Marlene Sinclair, Rebekah Maguire, Margaret Carroll, Cecily Begley

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients

Timothy F. Platts-Mills, Allison G. Hollowell, Gary F. Burke, Sheryl Zimmerman, Joseph A. Dayaa, Benjamin R. Quigley, Montika Bush, Morris Weinberger, Mark A. Weaver

01.12.2018 | Editorial | Ausgabe 1/2018 Open Access

Trial management– building the evidence base for decision-making

Shaun Treweek, Roberta Littleford

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect of eicosapentaenoic acid/docosahexaenoic acid on coronary high-intensity plaques detected with non-contrast T1-weighted imaging (the AQUAMARINE EPA/DHA study): study protocol for a randomized controlled trial

Kazuhiro Nakao, Teruo Noguchi, Yasuhide Asaumi, Yoshiaki Morita, Tomoaki Kanaya, Masashi Fujino, Hayato Hosoda, Shuichi Yoneda, Shoji Kawakami, Toshiyuki Nagai, Kensaku Nishihira, Takahiro Nakashima, Reon Kumasaka, Tetsuo Arakawa, Fumiyuki Otsuka, Michio Nakanishi, Yu Kataoka, Yoshio Tahara, Yoichi Goto, Haruko Yamamoto, Toshimitsu Hamasaki, Satoshi Yasuda

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Comparison of outcome measures and complication rates following three different approaches for primary total hip arthroplasty: a pragmatic randomised controlled trial

Adrian J. Talia, Cassandra Coetzee, Oren Tirosh, Phong Tran

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial

Erik Lundström, Eva Isaksson, Per Wester, Ann-Charlotte Laska, Per Näsman

01.12.2018 | Research | Ausgabe 1/2018 Open Access

What are the main inefficiencies in trial conduct: a survey of UKCRC registered clinical trials units in the UK

Lelia Duley, Alexa Gillman, Marian Duggan, Stephanie Belson, Jill Knox, Alison McDonald, Charlotte Rawcliffe, Joanne Simon, Tim Sprosen, Jude Watson, Wendy Wood

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial

Hans M. Nordahl, Joar Øveraas Halvorsen, Odin Hjemdal, Mimoza Rrusta Ternava, Adrian Wells

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol

Guilherme da Cruz Ribeiro Poiani, Ana Luiza Zaninotto, Ana Maria Costa Carneiro, Renato Amaro Zangaro, Afonso Shiguemi Inoue Salgado, Rodolfo Borges Parreira, Almir Ferreira de Andrade, Manoel Jacobsen Teixeira, Wellingson Silva Paiva

01.12.2018 | Commentary | Ausgabe 1/2018 Open Access

Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product

Anna C. Bibby, David J. Torgerson, Samantha Leach, Helen Lewis-White, Nick A. Maskell

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Impact of collaborative pharmaceutical care on in-patients’ medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study)

Géraldine Leguelinel-Blache, Christel Castelli, Clarisse Roux-Marson, Sophie Bouvet, Sandrine Andrieu, Philippe Cestac, Rémy Collomp, Paul Landais, Bertrice Loulière, Christelle Mouchoux, Rémi Varin, Benoit Allenet, Pierrick Bedouch, Jean-Marie Kinowski, MEDREV Working Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Combined Cognitive-Behavioural and Physiotherapeutic Therapy for Patients with Chronic Pelvic Pain Syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial

Christian A. Brünahl, Susanne G. R. Klotz, Christoph Dybowski, Björn Riegel, Sonja Gregorzik, Dean A. Tripp, Gesche Ketels, Bernd Löwe

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Pregabalin versus gabapentin in the treatment of sciatica: study protocol for a randomised, double-blind, cross-over trial (PAGPROS)

Kelvin Robertson, Laurence A. G. Marshman, Maria Hennessy, Linton Harriss, David Plummer

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible: study protocol for a randomised controlled trial

Richard Shaw, Christopher Butterworth, Binyam Tesfaye, Matthew Bickerstaff, Susanna Dodd, Gary Smerdon, Seema Chauhan, Peter Brennan, Keith Webster, James McCaul, Peter Nixon, Anastasios Kanatas, Paul Silcocks

01.12.2018 | Review | Ausgabe 1/2018 Open Access

Application of causal inference methods in the analyses of randomised controlled trials: a systematic review

Ruth E. Farmer, Daphne Kounali, A. Sarah Walker, Jelena Savović, Alison Richards, Margaret T. May, Deborah Ford

01.12.2018 | Research | Ausgabe 1/2018 Open Access

A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area

Jemal Hussein, Martha Zewdie, Lawrence Yamuah, Ahmed Bedru, Markos Abebe, Alemnew F. Dagnew, Menberework Chanyalew, Asfawesen G. Yohannes, Jemal Ahmed, Howard Engers, T. Mark Doherty, Peter Bang, Ingrid Kromann, Søren T. Hoff, Abraham Aseffa

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Data sharing in clinical trials – practical guidance on anonymising trial datasets

Catriona Keerie, Christopher Tuck, Garry Milne, Sandra Eldridge, Neil Wright, Steff C. Lewis

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study

Joerg C. Schefold, Anders Perner, Theis Lange, Jørn Wetterslev, Matt P. Wise, Mark Borthwick, Stepani Bendel, Frederik Keus, Anne Berit Guttormsen, Søren Marker, Mette Krag, Morten Hylander Møller, for the SUP-ICU investigators

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

David Atallah, Malak Moubarak, Nadine El Kassis, Sara Abboud

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Treatment of persistent allergic rhinitis via acupuncture at the sphenopalatine acupoint: a randomized controlled trial

Jiaoping Mi, Xinye Chen, Xiaoyan Lin, Jianling Guo, Hongtao Chen, Liao Wei, Haiyu Hong

01.12.2018 | Review | Ausgabe 1/2018 Open Access

Routinely collected data for randomized trials: promises, barriers, and implications

Kimberly A. Mc Cord, Rustam Al-Shahi Salman, Shaun Treweek, Heidi Gardner, Daniel Strech, William Whiteley, John P. A. Ioannidis, Lars G. Hemkens

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials

Sally Hopewell, Claudia M. Witt, Klaus Linde, Katja Icke, Olubusola Adedire, Shona Kirtley, Douglas G. Altman

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Effects of a peer-led Walking In ScHools intervention (the WISH study) on physical activity levels of adolescent girls: a cluster randomised pilot study

Angela Carlin, Marie H. Murphy, Alan Nevill, Alison M. Gallagher

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

An integrated-delivery-of-care approach to improve patient reported physical function and mental wellbeing after orthopedic trauma: study protocol for a randomized controlled trial

Laura Zdziarski-Horodyski, MaryBeth Horodyski, Kalia K. Sadasivan, Jennifer Hagen, Terrie Vasilopoulos, Matthew Patrick, Robert Guenther, Heather K. Vincent

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial

Tim Baker, Queen Dube, Josephine Langton, Helena Hildenwall

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluating the long-term impact of the Fostering Changes training programme for foster carers in Wales, the Confidence in Care trial: study protocol for a randomised controlled trial

Gwenllian Moody, Lucy Brookes-Howell, Rebecca Cannings-John, Sue Channon, Elinor Coulman, Mandy Lau, Alyson Rees, Jonathan Scourfield, Jeremy Segrott, Michael Robling

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial

Andria R. Morielli, Nawaid Usmani, Normand G. Boulé, Diane Severin, Keith Tankel, Tirath Nijjar, Kurian Joseph, Alysa Fairchild, Kerry S. Courneya

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy and safety of combined treatment of miniscalpel acupuncture and non-steroidal anti-inflammatory drugs: an assessor-blinded randomized controlled pilot study

Seungah Jun, Jung Hee Lee, Han Mi Gong, Yeon-Joong Chung, Ju-Ran Kim, Chung A. Park, Seong Hun Choi, Geon-Mok Lee, Hyun-Jong Lee, Jae Soo Kim

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER): study protocol for a cluster randomised controlled trial

Janet K. Sluggett, Esa Y. H. Chen, Jenni Ilomäki, Megan Corlis, Sarah N. Hilmer, Jan Van Emden, Choon Ean Ooi, Kim-Huong Nguyen, Tracy Comans, Michelle Hogan, Tessa Caporale, Susan Edwards, Lyntara Quirke, Allan Patching, J. Simon Bell

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial

Andy Schmitt, Patrice Crochet, Karine Baumstark, Claire Tourette, Sabine Poizac, Audrey Pivano, Léon Boubli, Ludovic Cravello, Aubert Agostini

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

FIT for FUNCTION: study protocol for a randomized controlled trial

Julie Richardson, Ada Tang, Gordon Guyatt, Lehana Thabane, Feng Xie, Demetrios Sahlas, Robert Hart, Rebecca Fleck, Genevieve Hladysh, Louise Macrae

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial

Crystian B. Oliveira, Márcia R. Franco, Chris G. Maher, Anne Tiedemann, Fernanda G. Silva, Tatiana M. Damato, Michael K. Nicholas, Diego G. D. Christofaro, Rafael Z. Pinto

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, placebo-controlled pilot trial

Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, Ojin Kwon, Joo-Hee Kim, Eun-Ji Park, Seon-Eun Baek, Jeong-Eun Yoo, Jun-Hwan Lee

01.12.2018 | Correction | Ausgabe 1/2018 Open Access

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

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

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The Classroom Communication Resource (CCR) intervention to change peer’s attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial

Rizwana Mallick, Harsha Kathard, Lehana Thabane, Mershen Pillay

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Pregabalin versus placebo in targeting pro-nociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals – a feasibility study for a randomised controlled trial

J. Nikles, G. Keijzers, G. Mitchell, S. Schug, R. Ware, S. A. McLean, L. Connelly, S. Gibson, S. F. Farrell, M. Sterling

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial

Yun Wang, Qian Chen, Jinlin Wang, Xiaoli Wu, Yaqi Duan, Ping Yin, Qiaozhen Guo, Wei Hou, Bin Cheng

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial

Roberta W. Scherer, Lea Drye, Jacobo Mintzer, Krista Lanctôt, Paul Rosenberg, Nathan Herrmann, Prasad Padala, Olga Brawman-Mintzer, William Burke, Suzanne Craft, Alan J. Lerner, Allan Levey, Anton Porsteinsson, Christopher H. van Dyck, the ADMET 2 Research Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy of pre-operative quadriceps strength training on knee-extensor strength before and shortly following total knee arthroplasty: protocol for a randomized, dose-response trial (The QUADX-1 trial)

Rasmus Skov Husted, Anders Troelsen, Kristian Thorborg, Michael Skovdal Rathleff, Henrik Husted, Thomas Bandholm

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Global health trials methodological research agenda: results from a priority setting exercise

Anna Rosala-Hallas, Aneel Bhangu, Jane Blazeby, Louise Bowman, Mike Clarke, Trudie Lang, Mona Nasser, Nandi Siegfried, Karla Soares-Weiser, Matt R. Sydes, Duolao Wang, Junhua Zhang, Paula R. Williamson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial

Simone Birnbaum, Jean-Yves Hogrel, Raphael Porcher, Pierre Portero, Bernard Clair, Bruno Eymard, Sophie Demeret, Guillaume Bassez, Marcela Gargiulo, Estelle Louët, Sonia Berrih-Aknin, Asmaa Jobic, Philippe Aegerter, Philippe Thoumie, Tarek Sharshar, the MGEX Study Group

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework

Caroline Wilson, Leila Rooshenas, Sangeetha Paramasivan, Daisy Elliott, Marcus Jepson, Sean Strong, Alison Birtle, David J. Beard, Alison Halliday, Freddie C. Hamdy, Rebecca Lewis, Chris Metcalfe, Chris A. Rogers, Robert C. Stein, Jane M. Blazeby, Jenny L. Donovan

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Prevention of severe infectious complications after colorectal surgery using preoperative orally administered antibiotic prophylaxis (PreCaution): study protocol for a randomized controlled trial

Tessa Mulder, Marjolein F. Q. Kluytmans-van den Bergh, Anne Marie G. A. de Smet, Nils E. van ‘t Veer, Daphne Roos, Stavros Nikolakopoulos, Marc J. M. Bonten, Jan A. J. W. Kluytmans, PreCaution Study Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy of electrical acupuncture on vascular cognitive impairment with no dementia: study protocol for a randomized controlled trial

Tian Li, Huangan Wu, Franscisca Soto-Aguliar, Li Huang, Wentao Li, Lixing Lao, Shifen Xu

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Successful recruitment to trials: findings from the SCIMITAR+ Trial

Emily Peckham, Catherine Arundel, Della Bailey, Tracy Callen, Christina Cusack, Suzanne Crosland, Penny Foster, Hannah Herlihy, James Hope, Suzy Ker, Tayla McCloud, Crystal-Bella Romain-Hooper, Alison Stribling, Peter Phiri, Ellen Tait, Simon Gilbody, on behalf of the SCIMITAR+ collaborative

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

eRegQual—an electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care: study protocol for a cluster randomized trial

Mahima Venkateswaran, Kjersti Mørkrid, Buthaina Ghanem, Eatimad Abbas, Itimad Abuward, Mohammad Baniode, Ole Frithjof Norheim, J. Frederik Frøen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Overnight auto-adjusting continuous airway pressure + standard care compared with standard care alone in the prevention of morbidity in sickle cell disease phase II (POMS2b): study protocol for a randomised controlled trial

Jo Howard, April E. Slee, Simon Skene, Baba Inusa, Jamie Kawadler, Michelle Downes, Johanna Gavlak, Melanie Koelbel, Hanne Stotesbury, Maria Chorozoglou, Susan Tebbs, Subarna Chakravorty, Moji Awogbade, David C. Rees, Atul Gupta, Patrick B. Murphy, Nicholas Hart, Sati Sahota, Carol Nwosu, Maureen Gwam, Dawn Saunders, Vivek Muthurangu, Nathaniel Barber, Emmanuel Ako, Swee Lay Thein, Melanie Marshall, Isabel C Reading, Man Ying Edith Cheng, Fenella J. Kirkham, Christina Liossi

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: study protocol for two randomised controlled trials

Siobhan A. Loughnan, Jill M. Newby, Hila Haskelberg, Alison Mahoney, Natalie Kladnitski, Jessica Smith, Emma Black, Christopher Holt, Jeannette Milgrom, Marie-Paule Austin, Gavin Andrews

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

MOVING: Motivation-Oriented interVention study for the elderly IN Greifswald: study protocol for a randomized controlled trial

Fabian Kleinke, Thea Schwaneberg, Franziska Weymar, Peter Penndorf, Sabina Ulbricht, Kristin Lehnert, Marcus Dörr, Wolfgang Hoffmann, Neeltje van den Berg

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Relating process evaluation measures to complex intervention outcomes: findings from the PACE-UP primary care pedometer-based walking trial

Cheryl Furness, Emma Howard, Elizabeth Limb, Derek G. Cook, Sally Kerry, Charlotte Wahlich, Christina Victor, Ulf Ekelund, Steve Iliffe, Michael Ussher, Peter Whincup, Julia Fox-Rushby, Judith Ibison, Stephen DeWilde, Tess Harris

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial

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

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Evaluation of HbA1c screening during outreach events for prediabetes subject recruitment for clinical research

Sabina Paglialunga, Ryan Bond, Sharon H. Jaycox

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway

Vikki Wylde, Nicholas Howells, Wendy Bertram, Andrew J. Moore, Julie Bruce, Candy McCabe, Ashley W. Blom, Jane Dennis, Amanda Burston, Rachael Gooberman-Hill

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effect of a ketogenic diet versus a high-carbohydrate, low-fat diet on sleep, cognition, thyroid function, and cardiovascular health independent of weight loss: study protocol for a randomized controlled trial

Stella Iacovides, Rebecca M. Meiring

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Kevin Cooper, Kirsty McCormack, Suzanne Breeman, Jessica Wood, Neil W. Scott, Justin Clark, Jed Hawe, Robert Hawthorn, Kevin Phillips, Angela Hyde, Alison McDonald, Mark Forrest, Samantha Wileman, Graham Scotland, John Norrie, Siladitya Bhattacharya, for the HEALTH Study Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children’s early self-regulation development: study protocol for a cluster randomized controlled trial

Steven J. Howard, Elena Vasseleu, Cathrine Neilsen-Hewett, Ken Cliff

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial

Byung-Cheul Shin, Jae-Heung Cho, In-Hyuk Ha, In Heo, Jun-Hwan Lee, Koh-Woon Kim, Me-riong Kim, So-Young Jung, Ojin Kwon, Nam-Kwen Kim, Haeng-Mi Son, Dong-Wuk Son, Kyung-Min Shin

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial

Sara T. Brookes, Katy A. Chalmers, Kerry N. L. Avery, Karen Coulman, Jane M. Blazeby, on behalf of the ROMIO study group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial

Linda Hartman, Linda A. Rasch, Thomas Klausch, Hans W. J. Bijlsma, Robin Christensen, Yvo M. Smulders, Stuart H. Ralston, Frank Buttgereit, Maurizio Cutolo, Jose A. P. Da Silva, Daniela Opris, Jozef Rovenský, Szilvia Szamosi, Leonie M. Middelink, Willem F. Lems, Maarten Boers

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa’dom): study protocol for a randomized controlled trial

David Chaparro, Jean-Christophe Daviet, Benoit Borel, Benjamin Kammoun, Jean-Yves Salle, Achille Tchalla, Stéphane Mandigout

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effects of an activity-based lifestyle intervention on moderate sleep complaints among older adults: study protocol for a randomized controlled trial

Doris, S.F. Yu, Shamay S.M. Ng, Diana T.F. Lee, Kai Chow Choi, Parco M.F. Siu, Lisa P.L. Low, Jean Woo

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial

Ralph Maddison, Ralph Stewart, Rob Doughty, Tony Scott, Andrew Kerr, Jocelyne Benatar, Robyn Whittaker, Jonathan C. Rawstorn, Anna Rolleston, Yannan Jiang, Paul Estabrooks, Rachel Karen Sullivan, Hannah Bartley, Leila Pfaeffli Dale

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial

Luciana G. Langella, Paula F. C. Silva, Larissa Costa-Santos, Marcela L. L. Gonçalves, Lara J. Motta, Alessandro M. Deana, Kristianne P. S. Fernandes, Raquel A. Mesquita-Ferrari, Sandra Kalil Bussadori

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial

Jie Ming, Shaoyong Xu, Chun Liu, Xiangyang Liu, Aihua Jia, Qiuhe Ji

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A hybrid type I trial to increase Veterans’ access to insomnia care: study protocol for a randomized controlled trial

Adam D. Bramoweth, Anne Germain, Ada O. Youk, Keri L. Rodriguez, Matthew J. Chinman

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study

Anna M. Johnson, Sara B. Jones, Pamela W. Duncan, Cheryl D. Bushnell, Sylvia W. Coleman, Laurie H. Mettam, Anna M. Kucharska-Newton, Mysha E. Sissine, Wayne D. Rosamond

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effect of targeted exercise on knee-muscle function in patients with persistent hamstring deficiency following ACL reconstruction – study protocol for a randomized controlled trial

Bo Bregenhof, Uffe Jørgensen, Per Aagaard, Nis Nissen, Mark W. Creaby, Jonas Bloch Thorlund, Carsten Jensen, Trine Torfing, Anders Holsgaard-Larsen

01.12.2018 | Research | Ausgabe 1/2018 Open Access

‘Recruitment, recruitment, recruitment’ – the need for more focus on retention: a qualitative study of five trials

Anne Daykin, Clare Clement, Carrol Gamble, Anna Kearney, Jane Blazeby, Mike Clarke, J. Athene Lane, Alison Shaw

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial

Thomas A. Odeny, Maricianah Onono, Kevin Owuor, Anna Helova, Iris Wanga, Elizabeth A. Bukusi, Janet M. Turan, Lisa L. Abuogi

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach

Rieke van der Graaf, Indira S. E. van der Zande, Hester M. den Ruijter, Martijn A. Oudijk, Johannes J. M. van Delden, Katrien Oude Rengerink, Rolf H. H. Groenwold

01.12.2018 | Commentary | Ausgabe 1/2018 Open Access

Are CONSORT checklists submitted by authors adequately reflecting what information is actually reported in published papers?

David Blanco, Alice M. Biggane, Erik Cobo, MiRoR network

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial

Geoffrey Fatti, Nicoletta Ngorima-Mabhena, Frank Chirowa, Benson Chirwa, Kudakwashe Takarinda, Taurayi A. Tafuma, Nyikadzino Mahachi, Rudo Chikodzore, Simon Nyadundu, Charles A. Ajayi, Tsitsi Mutasa-Apollo, Owen Mugurungi, Eula Mothibi, Risa M. Hoffman, Ashraf Grimwood

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial

Yaseen M. Arabi, Adel Alothman, Hanan H. Balkhy, Abdulaziz Al-Dawood, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Abdullah M. Assiri, Fahad Al-Hameed, Asim AlSaedi, Yasser Mandourah, Ghaleb A. Almekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Javed Memon, Yusri Taha, Abdullah Almotairi, Khalid A. Maghrabi, Ismael Qushmaq, Ali Al Bshabshe, Ayman Kharaba, Sarah Shalhoub, Jesna Jose, Robert A. Fowler, Frederick G. Hayden, Mohamed A. Hussein, And the MIRACLE trial group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial

James R. McKay, David H. Gustafson, Megan Ivey, Fiona McTavish, Klaren Pe-Romashko, Brenda Curtis, David A. Oslin, Daniel Polsky, Andrew Quanbeck, Kevin G. Lynch

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial

Jeffrey Pernica, Stuart Harman, April Kam, Jacob Bailey, Redjana Carciumaru, Sarah Khan, Martha Fulford, Lehana Thabane, Robert Slinger, Cheryl Main, Marek Smieja, Mark Loeb

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial

Marjolein A. M. Mulders, Caroline A. Selles, Joost W. Colaris, Rolf W. Peters, Mark van Heijl, Berry I. Cleffken, Niels W. L. Schep

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial

Liyong Zhang, Wei Xiong, Yuming Peng, Wei Zhang, Ruquan Han

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial

Iain Templeman, Dylan Thompson, Javier Gonzalez, Jean-Philippe Walhin, Sue Reeves, Peter J. Rogers, Jeffrey M. Brunstrom, Leonidas G. Karagounis, Kostas Tsintzas, James A. Betts

01.12.2018 | Research | Ausgabe 1/2018 Open Access

National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme research funding and UK burden of disease

Fay Chinnery, Gemma Bashevoy, Amanda Blatch-Jones, Lisa Douet, Sarah Puddicombe, James Raftery

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial

Elizabeth H. Skinner, Melanie Lloyd, Edward Janus, May Lea Ong, Amalia Karahalios, Terry P. Haines, Anne-Maree Kelly, Melina Shackell, Harin Karunajeewa

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary fibrosis with the Addition of Co-trimoxazole (EME-TIPAC): study protocol for a randomised controlled trial

Matthew Hammond, Allan B. Clark, Anthony P. Cahn, Edwin R. Chilvers, William Duncan Fraser, David M. Livermore, Toby M. Maher, Helen Parfrey, Ann Marie Swart, Susan Stirling, David Thickett, Moira Whyte, Andrew Wilson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: study protocol for a randomized controlled trial

Ugo Grossi, Natasha Stevens, Eleanor McAlees, Jon Lacy-Colson, Steven Brown, Anthony Dixon, Gian Luca Di Tanna, S. Mark Scott, Christine Norton, Nadine Marlin, James Mason, Charles H. Knowles, On behalf of the NIHR CapaCiTY working group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial

Melanie Schipfer, Carmen Albrecht, Dominic Ehrmann, Thomas Haak, Bernd Kulzer, Norbert Hermanns

01.12.2018 | Letter | Ausgabe 1/2018 Open Access

A quasi-placebo may have a role in some randomised controlled trials

William P. Whitehouse

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Guanxinning tablet for patients who switch from dual antiplatelet therapy to aspirin alone after percutaneous coronary intervention: study protocol for a cluster randomized controlled trial

Jingen Li, Jianqing Ju, Zhuo Chen, Jing Liu, Fang Lu, Rui Gao, Hao Xu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial

Sikandar Khan, Ashok Biju, Sophia Wang, Sujuan Gao, Omar Irfan, Amanda Harrawood, Stephanie Martinez, Emily Brewer, Anthony Perkins, Frederick W. Unverzagt, Sue Lasiter, Ben Zarzaur, Omar Rahman, Malaz Boustani, Babar Khan

01.12.2018 | Research | Ausgabe 1/2018 Open Access

When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL

Claire L. Vale, William J. Cragg, Ben Cromarty, Bec Hanley, Annabelle South, Richard Stephens, Kate Sturgeon, Mitzy Gafos

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Nursing home care educational intervention for family caregivers of older adults post stroke (SHARE): study protocol for a randomised trial

Carolina Baltar Day, Carla Cristiane Becker Kottwitz Bierhals, Naiana Oliveira dos Santos, Duane Mocellin, Mariane Lurdes Predebon, Fernanda Laís Fengler Dal Pizzol, Lisiane Manganelli Girardi Paskulin

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Twenty weeks of isometric handgrip home training to lower blood pressure in hypertensive older adults: a study protocol for a randomized controlled trial

Martin Grønbech Jørgensen, Jesper Ryg, Mathias Brix Danielsen, Pascal Madeleine, Stig Andersen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect and safety of acupuncture for Hwa-byung, an anger syndrome: a study protocol of a randomized controlled pilot trial

Hye-Yoon Lee, Jung-Eun Kim, Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, O-Jin Kwon, Jung-Hyo Cho, Sun-Yong Chung, Joo-Hee Kim

01.12.2018 | Correction | Ausgabe 1/2018 Open Access

Correction to: Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials

Steven Penegar, Rebecca Lewis, James Catto, Joanne Cresswell, Leyshon Griffiths, Micki Hill, John Kelly, Allen Knight, John McGrath, Laura Wiley, Hugh Mostafid, Emma Hall

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial

Martina Vanova, Eider Irazoki, J. Antonio García-Casal, Fernando Martínez-Abad, Cristina Botella, Kate R. Shiells, Manuel A. Franco-Martín

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Resistant Hypertension On Treatment (ResHypOT): sequential nephron blockade compared to dual blockade of the renin-angiotensin-aldosterone system plus bisoprolol in the treatment of resistant arterial hypertension – study protocol for a randomized controlled trial

Elizabeth do Espirito Santo Cestário, Letícia Aparecida Barufi Fernandes, Luiz Tadeu Giollo-Júnior, Jéssica Rodrigues Roma Uyemura, Camila Suemi Sato Matarucco, Manoel Idelfonso Paz Landim, Luciana Neves Cosenso-Martin, Lúcia Helena Bonalume Tácito, Heitor Moreno Jr., José Fernando Vilela-Martin, Juan Carlos Yugar-Toledo

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect of Mobile-health on maternal health care service utilization in Eastern Ethiopia: study protocol for a randomized controlled trial

Tilayie Feto Gelano, Nega Assefa, Yadeta Dessie Bacha, Afendi Abdi Mahamed, Kedir Teji Roba, Mitiku Teshome Hambisa

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Assessment of clinical effect and treatment quality of immediate-release carvedilol-IR versus SLOW release carvedilol-SR in Heart Failure patients (SLOW-HF): study protocol for a randomized controlled trial

Dong-Ju Choi, Chan Soon Park, Jin Joo Park, Hae-Young Lee, Seok-Min Kang, Byung-Su Yoo, Eun-Seok Jeon, Seok Keun Hong, Joon-Han Shin, Myung-A Kim, Dae-Gyun Park, Eung-Ju Kim, Soon-Jun Hong, Seok Yeon Kim, Jae-Joong Kim

01.12.2018 | Correction | Ausgabe 1/2018 Open Access

Correction to: Adolescent Coordinated Transition (ACT) to improve health outcomes among young people living with HIV in Nigeria: study protocol for a randomized controlled trial

Nadia A. Sam-Agudu, Jennifer R. Pharr, Tamara Bruno, Chad L. Cross, Llewellyn J. Cornelius, Prosper Okonkwo, Bolanle Oyeledun, Hadiza Khamofu, Ayodotun Olutola, Salome Erekaha, William Nii Ayitey Menson, Echezona E. Ezeanolue

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial

Kurinchi Gurusamy, Neil Corrigan, Julie Croft, Maureen Twiddy, Stephen Morris, Nick Woodward, Steve Bandula, Daniel Hochhauser, Vicky Napp, Alison Pullan, Nicholas Jakowiw, Raj Prasad, Steven Olde Damink, C. J. H. M. van Laarhoven, Johannes H. W. de Wilt, Julia Brown, Brian R. Davidson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Physical activity as treatment for alcohol use disorders (FitForChange): study protocol for a randomized controlled trial

Mats Hallgren, Victoria Andersson, Örjan Ekblom, Sven Andréasson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The HYSTER study: the effect of intracervically administered terlipressin versus placebo on the number of gaseous emboli and fluid intravasation during hysteroscopic surgery: study protocol for a randomized controlled clinical trial

Lucilla E. Overdijk, Bart M. P. Rademaker, Paul J. M. van Kesteren, Peter de Haan, Robert K. Riezebos, Oscar C. H. Haude

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial

Firas Al-Kawas, Harry Aslanian, John Baillie, Filip Banovac, Jonathan M. Buscaglia, James Buxbaum, Amitabh Chak, Bradford Chong, Gregory A. Coté, Peter V. Draganov, Kulwinder Dua, Valerie Durkalski, B. Joseph Elmunzer, Lydia D. Foster, Timothy B. Gardner, Brian S. Geller, Priya Jamidar, Laith H. Jamil, Rajesh N. Keswani, Mouen A. Khashab, Gabriel D. Lang, Ryan Law, David Lichtenstein, Simon K. Lo, Sean McCarthy, Silvio Melo, Daniel Mullady, Jose Nieto, J. Bayne Selby, Vikesh K. Singh, Rebecca L. Spitzer, Brian Strife, Paul Tarnaksy, Jason R. Taylor, Jeffrey Tokar, Andrew Y. Wang, April Williams, Field Willingham, Patrick Yachimski, In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS)

C. Verhaeghe, E. Parot-Schinkel, P. E. Bouet, S. Madzou, F. Biquard, P. Gillard, P. Descamps, G. Legendre

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Bridget Candy, Victoria Vickerstaff, Louise Jones, Michael King

01.12.2018 | Research | Ausgabe 1/2018 Open Access

7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial

Nick Daneman, Asgar H. Rishu, Ruxandra Pinto, Pierre Aslanian, Sean M. Bagshaw, Alex Carignan, Emmanuel Charbonney, Bryan Coburn, Deborah J. Cook, Michael E. Detsky, Peter Dodek, Richard Hall, Anand Kumar, Francois Lamontagne, Francois Lauzier, John C. Marshall, Claudio M. Martin, Lauralyn McIntyre, John Muscedere, Steven Reynolds, Wendy Sligl, Henry T. Stelfox, M. Elizabeth Wilcox, Robert A. Fowler, on behalf of the Canadian Critical Care Trials Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial)

Daniel Steffens, Jane Young, Paula R. Beckenkamp, James Ratcliffe, Freya Rubie, Nabila Ansari, Neil Pillinger, Michael Solomon

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys

Alice M. Biggane, Lucy Brading, Philippe Ravaud, Bridget Young, Paula R. Williamson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Quality of life, satisfaction and outcomes after ministernotomy versus full sternotomy isolated aortic valve replacement (QUALITY-AVR): study protocol for a randomised controlled trial

Emiliano A. Rodríguez-Caulo, Ana Guijarro-Contreras, Juan Otero-Forero, María José Mataró, Gemma Sánchez-Espín, Arantza Guzón, Carlos Porras, Miguel Such, Antonio Ordóñez, José María Melero-Tejedor, Manuel Jiménez-Navarro

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach

Rossybelle P. Amorrortu, Mariana Arevalo, Sally W. Vernon, Arch G. Mainous III, Vanessa Diaz, M. Diane McKee, Marvella E. Ford, Barbara C. Tilley

01.12.2018 | Commentary | Ausgabe 1/2018 Open Access

Promoting public access to clinical trial protocols: challenges and recommendations

An-Wen Chan, Asbjørn Hróbjartsson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF): study protocol for a randomised controlled trial

Habib Rehman Khan, Ines Kralj-Hans, Shouvik Haldar, Toufan Bahrami, Jonathan Clague, Anthony De Souza, Darrel Francis, Wajid Hussain, Julian Jarman, David Gareth Jones, Neeraj Mediratta, Raad Mohiaddin, Tushar Salukhe, Simon Jones, Joanne Lord, Caroline Murphy, Joanna Kelly, Vias Markides, Dhiraj Gupta, Tom Wong

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness of a transdiagnostic individually tailored Internet-based and mobile-supported intervention for the indicated prevention of depression and anxiety (ICare Prevent) in Dutch college students: study protocol for a randomised controlled trial

Felix Bolinski, Annet Kleiboer, Eirini Karyotaki, Judith E. Bosmans, Anna-Carlotta Zarski, Kiona K. Weisel, David D. Ebert, Corinna Jacobi, Pim Cuijpers, Heleen Riper

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Management of medial humeral epicondyle fractures in children: a structured review protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Sara L. Dorman, James A. Shelton, Robert Allen Stevenson, Kenneth Linkman, Jamie Kirkham, Daniel C. Perry

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV

Christian Schmidt, Alper Öner, Miriam Mann, Katja Krockenberger, Melanie Abbondanzieri, Bernard Brandewiede, Armin Brüge, Gisela Hostenkamp, Axel Kaiser, Henriette Neumeyer, Andreas Ziegler

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Recruitment of older adults to three preventative lifestyle improvement studies

Robin Chatters, Louise Newbould, Kirsty Sprange, Daniel Hind, Gail Mountain, Katy Shortland, Lauren Powell, Rebecca Gossage-Worrall, Tim Chater, Anju Keetharuth, Ellen Lee, Bob Woods

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Assessing dengue transmission risk and a vector control intervention using entomological and immunological indices in Thailand: study protocol for a cluster-randomized controlled trial

Hans J. Overgaard, Chamsai Pientong, Kesorn Thaewnongiew, Michael J. Bangs, Tipaya Ekalaksananan, Sirinart Aromseree, Thipruethai Phanitchat, Supranee Phanthanawiboon, Benedicte Fustec, Vincent Corbel, Dominique Cerqueira, Neal Alexander

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Towards an appropriate framework to facilitate responsible inclusion of pregnant women in drug development programs

Kit C. B. Roes, Indira S. E. van der Zande, Maarten van Smeden, Rieke van der Graaf

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy and safety of Ding-Kun-Dan for female infertility patients with predicted poor ovarian response undergoing in vitro fertilization/intracytoplasmic sperm injection: study protocol for a randomized controlled trial

Saihua Ma, Ruihong Ma, Tian Xia, Masoud Afnan, Xueru Song, Fengqin Xu, Guimin Hao, Fangfang Zhu, Jingpei Han, Zhimei Zhao

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effects of Kinesiotape on acute lateral ankle sprain: study protocol for a randomized controlled trial

Jae-Hong Kim, Myung-Rae Cho, Ju-Hyung Park, Jeong-Cheol Shin, Ji-Hyun Cho, Gwang-Cheon Park, Dongwoo Nam

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Reactive community-based self-administered treatment against residual malaria transmission: study protocol for a randomized controlled trial

Joseph Okebe, Joan Muela Ribera, Julie Balen, Fatou Jaiteh, Yoriko Masunaga, Davis Nwakanma, John Bradley, Shunmay Yeung, Koen Peeters Grietens, Umberto D’Alessandro

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Prophylactic platelet transfusion prior to central venous catheter placement in patients with thrombocytopenia: study protocol for a randomised controlled trial

Emma K. van de Weerdt, Bart J. Biemond, Sacha S. Zeerleder, Krijn P. van Lienden, Jan M. Binnekade, Alexander P. J. Vlaar, Study collaborative

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

A simulation study on estimating biomarker–treatment interaction effects in randomized trials with prognostic variables

Bernhard Haller, Kurt Ulm

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Clinical and radiological effect of medialized cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis: study protocol for a randomized controlled trial (mPACT)

Anja Tschugg, Pujan Kavakebi, Sebastian Hartmann, Sara Lener, Christoph Wipplinger, Wolfgang N. Löscher, Sabrina Neururer, Matthias Wildauer, Claudius Thomé

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Controlling Hypertension After Severe Cerebrovascular Event (CHASE): study protocol for a randomized controlled trial

Fang Yuan, Fang Yang, Changhu Xue, Kangjun Wang, Qiuwu Liu, Jun Zhou, Feng Fu, Xiaocheng Wang, Wei Zhang, Yi Liu, Kang Huo, Hua Lv, Wen Jiang, on behalf of the CHASE Study Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial

Lynda Constable, Nikki Cotterill, David Cooper, Cathryn Glazener, Marcus J. Drake, Mark Forrest, Chris Harding, Mary Kilonzo, Graeme MacLennan, Kirsty McCormack, Alison McDonald, Anthony Mundy, John Norrie, Robert Pickard, Craig Ramsay, Rebecca Smith, Samantha Wileman, Paul Abrams, (Chief Investigator) for the MASTER Study Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial

Vikki Wylde, Wendy Bertram, Andrew D. Beswick, Ashley W. Blom, Julie Bruce, Amanda Burston, Jane Dennis, Kirsty Garfield, Nicholas Howells, Athene Lane, Candy McCabe, Andrew J. Moore, Sian Noble, Tim J. Peters, Andrew Price, Emily Sanderson, Andrew D. Toms, David A. Walsh, Simon White, Rachael Gooberman-Hill

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial

Wei Jiang, Xiangyou Yu, Tongwen Sun, Yanfen Chai, Ping Chang, Zhongqing Chen, Jingye Pan, Zhiyong Peng, Ruilan Wang, Xiaozhi Wang, Yuan Xu, Li Yu, Qingshan Zheng, Bin Du, for the China Critical Care Clinical Trials Group (CCCCTG)

01.12.2018 | Review | Ausgabe 1/2018 Open Access

Quality of reporting of outcomes in phase III studies of pulmonary tuberculosis: a systematic review

Laura Jayne Bonnett, Gie Ken-Dror, Geraint Rhys Davies

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Recovery of muscle function after deep neuromuscular block by means of diaphragm ultrasonography and adductor of pollicis acceleromyography with comparison of neostigmine vs. sugammadex as reversal drugs: study protocol for a randomized controlled trial

Iacopo Cappellini, Fabio Picciafuochi, Daniele Ostento, Ginevra Danti, Angelo Raffaele De Gaudio, Chiara Adembri

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial

Sarah Baos, Amberly Brigden, Emma Anderson, William Hollingworth, Simon Price, Nicola Mills, Lucy Beasant, Daisy Gaunt, Kirsty Garfield, Chris Metcalfe, Roxanne Parslow, Harriet Downing, David Kessler, John Macleod, Paul Stallard, Hans Knoop, Elise Van de Putte, Sanne Nijhof, Gijs Bleijenberg, Esther Crawley

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient’s caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial

Anne-Marie Mendyk, Alain Duhamel, Yannick Bejot, Didier Leys, Laurent Derex, Olivier Dereeper, Olivier Detante, Pierre-Yves Garcia, Olivier Godefroy, Francisco Macian Montoro, Jean-Philippe Neau, Sébastien Richard, Thierry Rosolacci, Igor Sibon, Denis Sablot, Serge Timsit, Mathieu Zuber, Charlotte Cordonnier, Régis Bordet, on the behalf of Strokavenir network

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Phase-based treatment versus immediate trauma-focused treatment in patients with childhood trauma-related posttraumatic stress disorder: study protocol for a randomized controlled trial

Noortje I. van Vliet, Rafaele J. C. Huntjens, Maarten K. van Dijk, Ad de Jongh

01.12.2018 | Letter | Ausgabe 1/2018 Open Access

Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

Shaun Treweek, Simon Bevan, Peter Bower, Marion Campbell, Jacquie Christie, Mike Clarke, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky, Ella Flemyng, Sandra Galvin, Heidi Gardner, Katie Gillies, Jan Jansen, Roberta Littleford, Adwoa Parker, Craig Ramsay, Lynne Restrup, Frank Sullivan, David Torgerson, Liz Tremain, Matthew Westmore, Paula R. Williamson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder: study protocol for a randomized controlled trial

Jutta S. Mayer, Katharina Hees, Juliane Medda, Oliver Grimm, Philip Asherson, Mariano Bellina, Michael Colla, Pol Ibáñez, Elena Koch, Antonio Martinez-Nicolas, Adrià Muntaner-Mas, Anna Rommel, Nanda Rommelse, Saskia de Ruiter, Ulrich W. Ebner-Priemer, Meinhard Kieser, Francisco B. Ortega, Johannes Thome, Jan K. Buitelaar, Jonna Kuntsi, J. Antoni Ramos-Quiroga, Andreas Reif, Christine M. Freitag

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

EEPIC - Enhancing Employability through Positive Interventions for improving Career potential: the impact of a high support career guidance intervention on the wellbeing, hopefulness, self-efficacy and employability of the long-term unemployed - a study protocol for a randomised controlled trial

Nuala Whelan, Sinéad McGilloway, Mary P. Murphy, Colm McGuinness

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe): a phase IV multicenter, randomized, placebo-controlled, double-blind clinical trial of ketamine versus haloperidol for prevention of postoperative delirium

Harriet Riegger, Alexa Hollinger, Burkhardt Seifert, Katharina Toft, Andrea Blum, Tatjana Zehnder, Martin Siegemund

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Antifibrotic and molecular aspects of rifaximin in alcoholic liver disease: study protocol for a randomized controlled trial

Bjørn Stæhr Madsen, Jonel Trebicka, Maja Thiele, Mads Israelsen, Manimozhiyan Arumugan, Troels Havelund, Aleksander Krag

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET)

Jaime Gallo-Villegas, Juan Carlos Aristizabal, Mauricio Estrada, Luis H. Valbuena, Raul Narvaez-Sanchez, Jorge Osorio, Daniel C. Aguirre-Acevedo, Juan C. Calderón

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving pain treatment with a smartphone app: study protocol for a randomized controlled trial

Carlos Suso-Ribera, Ángela Mesas, Javier Medel, Anna Server, Esther Márquez, Diana Castilla, Irene Zaragozá, Azucena García-Palacios

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial

Huachan Gan, Jinxuan Lin, Zhi Jiang, Qicheng Chen, Lixing Cao, Zhiqiang Chen

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – the PRioRiTy (Prioritising Recruitment in Randomised Trials) study

Patricia Healy, Sandra Galvin, Paula R. Williamson, Shaun Treweek, Caroline Whiting, Beccy Maeso, Christopher Bray, Peter Brocklehurst, Mary Clarke Moloney, Abdel Douiri, Carrol Gamble, Heidi R. Gardner, Derick Mitchell, Derek Stewart, Joan Jordan, Martin O’Donnell, Mike Clarke, Sue H. Pavitt, Eleanor Woodford Guegan, Amanda Blatch-Jones, Valerie Smith, Hannah Reay, Declan Devane

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial

Anne-Sophie Bouthors, Benjamin Hennart, Emmanuelle Jeanpierre, Anne-Sophie Baptiste, Imen Saidi, Elodie Simon, Damien Lannoy, Alain Duhamel, Delphine Allorge, Sophie Susen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial

Anne-Sophie Ducloy-Bouthors, Emmanuelle Jeanpierre, Imen Saidi, Anne-Sophie Baptiste, Elodie Simon, Damien Lannoy, Alain Duhamel, Delphine Allorge, Sophie Susen, Benjamin Hennart

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect of an exercise-based cardiac rehabilitation program “Baduanjin Eight-Silken-Movements with self-efficacy building” for heart failure (BESMILE-HF study): study protocol for a randomized controlled trial

Xiankun Chen, Wei Jiang, Xiaoli Lin, Cecilia Stålsby Lundborg, Zehuai Wen, Weihui Lu, Gaetano Marrone

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial

Walkyria Vilas Boas Fernandes, Cleofás Rodríguez Blanco, Fabiano Politti, Fernanda de Cordoba Lanza, Paulo Roberto Garcia Lucareli, João Carlos Ferrari Corrêa

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy and safety of electroacupuncture for post stroke depression: study protocol for a randomized controlled trial

Wa Cai, Wen Ma, Guan-Tao Wang, Wei-Dong Shen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial

Natalie Hutchings, Wendy Wood, Isabel Reading, Erin Walker, Jane M. Blazeby, William van’t Hoff, Bridget Young, Esther M. Crawley, Simon Eaton, Maria Chorozoglou, Frances C. Sherratt, Lucy Beasant, Harriet Corbett, Michael P. Stanton, Simon Grist, Elizabeth Dixon, Nigel J. Hall

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The Strengthening Exercises in Shoulder Impingement trial (The SExSI-trial) investigating the effectiveness of a simple add-on shoulder strengthening exercise programme in patients with long-lasting subacromial impingement syndrome: Study protocol for a pragmatic, assessor blinded, parallel-group, randomised, controlled trial

Mikkel Bek Clausen, Thomas Bandholm, Michael Skovdal Rathleff, Karl Bang Christensen, Mette Kreutzfeldt Zebis, Thomas Graven-Nielsen, Per Hölmich, Kristian Thorborg

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial

Dazhi Fan, Qing Xia, Shuzhen Wu, Shaoxin Ye, Li Liu, Wen Wang, Xiaoling Guo, Zhengping Liu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of combined high-intensity aerobic interval training program and Mediterranean diet recommendations after myocardial infarction (INTERFARCT Project): study protocol for a randomized controlled trial

Sara Maldonado-Martín, Jon Ander Jayo-Montoya, Tatiana Matajira-Chia, Beatriz Villar-Zabala, Juan José Goiriena, G. Rodrigo Aispuru

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

High-flow nasal oxygen vs. standard oxygen therapy in immunocompromised patients with acute respiratory failure: study protocol for a randomized controlled trial

Elie Azoulay, Virginie Lemiale, Djamel Mokart, Saad Nseir, Laurent Argaud, Frédéric Pène, Loay Kontar, Fabrice Bruneel, Kada Klouche, François Barbier, Jean Reignier, Anabelle Stoclin, Guillaume Louis, Jean-Michel Constantin, Julien Mayaux, Florent Wallet, Achille Kouatchet, Vincent Peigne, Pierre Perez, Christophe Girault, Samir Jaber, Johanna Oziel, Martine Nyunga, Nicolas Terzi, Lila Bouadma, Christine Lebert, Alexandre Lautrette, Naike Bigé, Jean-Herlé Raphalen, Laurent Papazian, Antoine Rabbat, Michael Darmon, Sylvie Chevret, Alexandre Demoule

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Improved adherence adjustment in the Coronary Drug Project

Eleanor J. Murray, Miguel A. Hernán

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial

Ha-Ra Kang, Chan-Yung Jung, Seung-Deok Lee, Kyung-Ho Kim, Kap-Sung Kim, Eun-Jung Kim

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial

Chunbo Li, Zhiyuan Dai, Huimin Shu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

BetaMe: impact of a comprehensive digital health programme on HbA1c and weight at 12 months for people with diabetes and pre-diabetes: study protocol for a randomised controlled trial

Diana Sarfati, Melissa McLeod, James Stanley, Virginia Signal, Jeannine Stairmand, Jeremy Krebs, Anthony Dowell, William Leung, Cheryl Davies, Rebecca Grainger

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

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

Rustam Al-Shahi Salman, Martin S. Dennis, Gordon D. Murray, Karen Innes, Jonathan Drever, Lynn Dinsmore, Carol Williams, Philip M. White, William N. Whiteley, Peter A. G. Sandercock, Cathie L. M. Sudlow, David E. Newby, Nikola Sprigg, David J. Werring, the RESTART collaborators

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations

Mary Sawtell, Lorna Sweeney, Meg Wiggins, Cathryn Salisbury, Sandra Eldridge, Lauren Greenberg, Rachael Hunter, Inderjeet Kaur, Christine McCourt, Bethan Hatherall, Gail Findlay, Joanne Morris, Sandra Reading, Adrian Renton, Ruth Adekoya, Belinda Green, Belinda Harvey, Sarah Latham, Kanta Patel, Logan Vanlessen, Angela Harden

01.12.2018 | Correction | Ausgabe 1/2018 Open Access

Correction to: Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial

Hans M. Nordahl, Joar Øveraas Halvorsen, Odin Hjemdal, Mimoza Rrusta Ternava, Adrian Wells

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial

Beth D. Darnall, Maisa S. Ziadni, Anuradha Roy, Ming-Chih Kao, John A. Sturgeon, Karon F. Cook, Kate Lorig, John W. Burns, Sean C. Mackey

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Restrictive Versus Massive Fluid Resuscitation Strategy (REFILL study), influence on blood loss and hemostatic parameters in obstetric hemorrhage: study protocol for a randomized controlled trial

Natascha de Lange, Pim Schol, Marcus Lancé, Mallory Woiski, Josje Langenveld, Robbert Rijnders, Luc Smits, Martine Wassen, Yvonne Henskens, Hubertina Scheepers

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect of physical exercise on spontaneous physical activity energy expenditure and energy intake in overweight adults (the EFECT study): a study protocol for a randomized controlled trial

Vitor Barreto Paravidino, Mauro Felippe Felix Mediano, Inácio Crochemore M Silva, Andrea Wendt, Fabrício Boscolo Del Vecchio, Fabiana Alves Neves, Bruno de Souza Terra, Erika Alvarenga Corrêa Gomes, Anibal Sanchez Moura, Rosely Sichieri

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial

Tai-Wa Liu, Gabriel Y. F. Ng, Shamay S. M. Ng

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The role of ixazomib as an augmented conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT consolidation and maintenance strategy in patients with relapsed multiple myeloma (ACCoRd [UK-MRA Myeloma XII] trial): study protocol for a Phase III randomised controlled trial

Alina Striha, A. John Ashcroft, Anna Hockaday, David A. Cairns, Karen Boardman, Gwen Jacques, Cathy Williams, John A. Snowden, Mamta Garg, Jamie Cavenagh, Kwee Yong, Mark T. Drayson, Roger Owen, Mark Cook, Gordon Cook

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Cardiac output Optimisation following Liver Transplant (COLT) trial: study protocol for a feasibility  randomised controlled trial

Farid Froghi, Rahul Koti, Kurinchi Gurusamy, Susan Mallett, Douglas Thorburn, Linda Selves, Sarah James, Jeshika Singh, Manuel Pinto, Christine Eastgate, Margaret McNeil, Helder Filipe, Fatima Jichi, Nick Schofield, Daniel Martin, Brian Davidson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial

Yuchi Wu, Lihong Yang, Lingli Li, Xiuqing Wu, Zhicong Zhong, Zhiren He, Hongyan Ma, Lixin Wang, Zhaoyu Lu, Cun Cai, Daixin Zhao, Xiangxin Meng, Airong Qi, Aicheng Yang, Guobin Su, Xinfeng Guo, Xusheng Liu, Chuan Zou, Qizhan Lin

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: The NOTEPAD study Protocol

Heather Burroughs, Bernadette Bartlam, Mo Ray, Tom Kingstone, Tom Shepherd, Reuben Ogollah, Janine Proctor, Waquas Waheed, Peter Bower, Peter Bullock, Karina Lovell, Simon Gilbody, Della Bailey, Stephanie Butler-Whalley, Carolyn Chew-Graham

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Go Play Outside! Effects of a risk-reframing tool on mothers’ tolerance for, and parenting practices associated with, children’s risky play: study protocol for a randomized controlled trial

Mariana Brussoni, Takuro Ishikawa, Christina Han, Ian Pike, Anita Bundy, Guy Faulkner, Louise C. Mâsse

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial

Gilles Defer, Florian Le Caignec, Sophie Fedrizzi, François Montastruc, Damien Chevanne, Jean-Jacques Parienti, Laure Peyro-Saint-Paul

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness and cost-effectiveness of humanistic counselling in schools for young people with emotional distress (ETHOS): study protocol for a randomised controlled trial

Megan Rose Stafford, Mick Cooper, Michael Barkham, Jeni Beecham, Peter Bower, Karen Cromarty, Andrew J. B. Fugard, Charlie Jackson, Peter Pearce, Rebekah Ryder, Cathy Street

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child nutritional outcomes in rural Odisha, India: study protocol for a cluster randomised controlled trial

Suneetha Kadiyala, Audrey Prost, Helen Harris-Fry, Meghan O’Hearn, Ronali Pradhan, Shibananth Pradhan, Naba Kishore Mishra, Suchitra Rath, Nirmala Nair, Shibanand Rath, Prasantha Tripathy, Sneha Krishnan, Peggy Koniz-Booher, Heather Danton, Diana Elbourne, Joanna Sturgess, Emma Beaumont, Hassan Haghparast-Bidgoli, Jolene Skordis-Worrall, Satyanarayan Mohanty, Avinash Upadhay, Elizabeth Allen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial

Yun Dong, Dax Steins, Shanbin Sun, Fei Li, James D. Amor, Christopher J. James, Zhidao Xia, Helen Dawes, Hooshang Izadi, Yi Cao, Derick T. Wade, Smart watch activity feedback trial committee (SWAFT)

01.12.2018 | Update | Ausgabe 1/2018 Open Access

Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan

Wes Onland, Maruschka P. Merkus, Debbie H. Nuytemans, Marijke C. Jansen-van der Weide, Rebecca Holman, Anton H. van Kaam, on behalf of the SToP-BPD study group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Circulating stem cells, HIF-1, and SDF-1 in septic abdominal surgical patients: randomized controlled study protocol

Antonella Cotoia, Lucia Mirabella, Sabrina Altamura, Rachele Villani, Flavia Marchese, Giuseppe Ferrara, Karim Mariano, Tullo Livio, Gilda Cinnella

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: The SingHypertension cluster randomized trial

Tazeen H. Jafar, Ngiap Chuan Tan, John C. Allen, Eric A. Finkelstein, Paul Goh, Peter Moey, Joanne Hui Min Quah, Siew Wai Hwang, Juliana Bahadin, Anandan Gerard Thiagarajah, Jason Chan, Gary Kang, Agnes Koong

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial

Fred Stephen Sarfo, Osei Sarfo-Kantanka, Sheila Adamu, Vida Obese, Jennifer Voeks, Raelle Tagge, Vipin Sethi, Bruce Ovbiagele

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial

Yaseen Arabi, Fahad Al-Hameed, Karen E. A. Burns, Sangeeta Mehta, Sami Alsolamy, Mohammed Almaani, Yasser Mandourah, Ghaleb A. Almekhlafi, Ali Al Bshabshe, Simon Finfer, Mohammed Alshahrani, Imran Khalid, Yatin Mehta, Atul Gaur, Hassan Hawa, Hergen Buscher, Zia Arshad, Hani Lababidi, Abdulsalam Al Aithan, Jesna Jose, Sheryl Ann I. Abdukahil, Lara Y. Afesh, Maamoun Dbsawy, Abdulaziz Al-Dawood, the PREVENT trial Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The CIRCuiTS study (Implementation of cognitive remediation in early intervention services): protocol for a randomised controlled trial

Til Wykes, Eileen Joyce, Tjasa Velikonja, Andrew Watson, Gregory Aarons, Max Birchwood, Matteo Cella, Sue Dopson, David Fowler, Kathy Greenwood, Sonia Johnson, Paul McCrone, Jesus Perez, Andrew Pickles, Clare Reeder, Diana Rose, Swaran Singh, Dominic Stringer, Matthew Taylor, Rumina Taylor, Rachel Upthegrove

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of heart rate variability biofeedback during exposure to fear-provoking stimuli within spider-fearful individuals: study protocol for a randomized controlled trial

Sarah K. Schäfer, Frank R. Ihmig, Karen A. Lara H., Frank Neurohr, Stephan Kiefer, Marlene Staginnus, Johanna Lass-Hennemann, Tanja Michael

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial

Bronwyn Myers, Crick Lund, Carl Lombard, John Joska, Naomi Levitt, Christopher Butler, Susan Cleary, Tracey Naledi, Peter Milligan, Dan J. Stein, Katherine Sorsdahl

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial

Ditte Beck Jepsen, Jesper Ryg, Niklas Rye Jørgensen, Stinus Hansen, Tahir Masud

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial

Tara McCrimmon, Susan Witte, Gaukhar Mergenova, Assel Terlikbayeva, Sholpan Primbetova, Azamat Kuskulov, Scarlett L. Bellamy, Nabila El-Bassel

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial

Qiong Wang, Yi-Ru Wang, Qing-Yun Jia, Li Liu, Chong-Qing Xu, Xiao-Yun Wang, Min Yao, Xue-Jun Cui, Qi Shi, Yong-Jun Wang, Qian-Qian Liang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Cerebral microembolism in the critically ill with acute kidney injury (COMET-AKI trial): study protocol for a randomized controlled clinical trial

Gabor Erdoes, Dominik E. Uehlinger, Beatrice Kobel, Monika P. Stucki, Roland Wiest, Frank Stueber, Niklaus Fankhauser, Stephan M. Jakob, Joerg C. Schefold

01.12.2018 | Commentary | Ausgabe 1/2018 Open Access

Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings

George Mtove, Joshua Kimani, William Kisinza, Geofrey Makenga, Peter Mangesho, Stephan Duparc, Miriam Nakalembe, Kamija S. Phiri, Russell Orrico, Ricardo Rojo, Pol Vandenbroucke

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial

Macarena Gil-Pagés, Javier Solana, Rocío Sánchez-Carrión, Jose M. Tormos, Antonia Enseñat-Cantallops, Alberto García-Molina

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial

Inge Petersen, Arvin Bhana, Naomi Folb, Graham Thornicroft, Babalwa Zani, One Selohilwe, Ruwayda Petrus, Ntokozo Mntambo, Daniella Georgeu-Pepper, Tasneem Kathree, Crick Lund, Carl Lombard, Max Bachmann, Thomas Gaziano, Naomi Levitt, Lara Fairall, on behalf of the PRIME-SA research team

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial

Lara Fairall, Inge Petersen, Babalwa Zani, Naomi Folb, Daniella Georgeu-Pepper, One Selohilwe, Ruwayda Petrus, Ntokozo Mntambo, Arvin Bhana, Carl Lombard, Max Bachmann, Crick Lund, Jill Hanass-Hancock, Daniel Chisholm, Paul McCrone, Sergio Carmona, Thomas Gaziano, Naomi Levitt, Tasneem Kathree, Graham Thornicroft, the CobALT research team

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial

Máire-Bríd Casey, Keith Smart, Ricardo Segurado, Conor Hearty, Hari Gopal, Damien Lowry, Dearbhail Flanagan, Lance McCracken, Catherine Doody

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)

Lauren M. Bullens, Alexandra D. J. Hulsenboom, Suzanne Moors, Rohan Joshi, Pieter J. van Runnard Heimel, M. Beatrijs van der Hout-van der Jagt, Edwin R. van den Heuvel, S. Guid Oei

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial

Sophia Wang, Jessica Hammes, Sikandar Khan, Sujuan Gao, Amanda Harrawood, Stephanie Martinez, Lyndsi Moser, Anthony Perkins, Frederick W. Unverzagt, Daniel O. Clark, Malaz Boustani, Babar Khan

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol

Katie Gillies, Peter Bower, Jim Elliott, Graeme MacLennan, Rumana S. N. Newlands, Margaret Ogden, Shaun P. Treweek, Mary Wells, Miles D. Witham, Bridget Young, Jill J. Francis

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Sample size implications of mortality definitions in sepsis: a retrospective cohort study

Sushant Govindan, Hallie C. Prescott, Vineet Chopra, Theodore J. Iwashyna

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effects of different forms of daily exercise on metabolic function following short-term overfeeding and reduced physical activity in healthy young men: study protocol for a randomised controlled trial

Jean-Philippe Walhin, Yung-Chih Chen, Aaron Hengist, James Bilzon, James A. Betts, Dylan Thompson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial

Xue-min Zhao, Ying Zhang, Xin-hui He, Hong-dong Chen, Zhu-feng Wang, Jing Guo, Xin-miao Wang, Ze-zheng Gao, Ji-ping Wang, Wei Liu, Lin-hua Zhao, Xiao-lin Tong

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial

Magda Feres, Belén Retamal-Valdes, Maria Josefa Mestnik, Luciene Cristina de Figueiredo, Marcelo Faveri, Poliana M. Duarte, Aretuza Fritoli, Elisangela Faustino, Maria Luisa Silveira Souto, Michelle de Franco Rodrigues, Marcela Giudicissi, Bárbara Campos Lara Nogueira, Luciana Saraiva, Giuseppe Alexandre Romito, Cláudio Mendes Pannuti

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial

Jae-Hong Kim, Eun-Yong Lee, Myung-Rae Cho, Cham-Kyul Lee, Ji-Hyun Cho

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Acceptance and Commitment Therapy preceded by an experimental Attention Bias Modification procedure in recurrent depression: study protocol for a randomized controlled trial

Tom Østergaard, Tobias Lundgren, Robert Zettle, Rune Jonassen, Catherine J. Harmer, Tore C. Stiles, Nils Inge Landrø, Vegard Øksendal Haaland

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol

Ayano Kelly, Allison Tong, Kathleen Tymms, Lyn March, Jonathan C. Craig, Mary De Vera, Vicki Evans, Geraldine Hassett, Karine Toupin-April, Bart van den Bemt, Armando Teixeira-Pinto, Rieke Alten, Susan J. Bartlett, Willemina Campbell, Therese Dawson, Michael Gill, Renske Hebing, Alexa Meara, Robby Nieuwlaat, Yomei Shaw, Jasvinder A. Singh, Maria Suarez-Almazor, Daniel Sumpton, Peter Wong, Robin Christensen, Dorcas Beaton, Maarten de Wit, Peter Tugwell, On behalf of the OMERACT-Adherence Group

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Patient-centered recruitment and retention for a randomized controlled study

Sumedha Chhatre, Ashlie Jefferson, Ratna Cook, Caitlin R. Meeker, Ji Hyun Kim, Kayla Marie Hartz, Yu-Ning Wong, Adele Caruso, Diane K. Newman, Knashawn H. Morales, Ravishankar Jayadevappa

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial)

Hannah L. Nathan, Kate Duhig, Nicola Vousden, Elodie Lawley, Paul T. Seed, Jane Sandall, Mrutyunjaya B. Bellad, Adrian C. Brown, Lucy C. Chappell, Shivaprasad S. Goudar, Muchabayiwa F. Gidiri, Andrew H. Shennan, the CRADLE-3 Trial Collaboration Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial

Xavier J. N. M. Smeets, David W. da Costa, Paul Fockens, Chris J. J. Mulder, Robin Timmer, Wietske Kievit, Marieke Zegers, Marco J. Bruno, Marc G. H. Besselink, Frank P. Vleggaar, Rene W. M. van der Hulst, Alexander C. Poen, Gerbrand D. N. Heine, Niels G. Venneman, Jeroen J. Kolkman, Lubbertus C. Baak, Tessa E. H. Römkens, Sven M. van Dijk, Nora D. L. Hallensleben, Wim van de Vrie, Tom C. J. Seerden, Adriaan C. I. T. L. Tan, Annet M. C. J. Voorburg, Jan-Werner Poley, Ben J. Witteman, Abha Bhalla, Muhammed Hadithi, Willem J. Thijs, Matthijs P. Schwartz, Jan Maarten Vrolijk, Robert C. Verdonk, Foke van Delft, Yolande Keulemans, Harry van Goor, Joost P. H. Drenth, Erwin J. M. van Geenen, for the Dutch Pancreatitis Study Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial

Hege Prag Øra, Melanie Kirmess, Marian C. Brady, Ingvild Elisabeth Winsnes, Silje Merethe Hansen, Frank Becker

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials

Clara Strauss, Jenny Gu, Nikki Pitman, Cavita Chapman, Willem Kuyken, Adrian Whittington

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial

Tina R. Kilburn, Merete Juul Sørensen, Mikael Thastum, Ronald M. Rapee, Charlotte Ulrikka Rask, Kristian Bech Arendt, Per Hove Thomsen

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial

Suzanne H. Richards, Chris Dickens, Rob Anderson, David A. Richards, Rod S. Taylor, Obioha C. Ukoumunne, Katrina M. Turner, Manish Gandhi, Willem Kuyken, Andrew Gibson, Antoinette Davey, Fiona Warren, Rachel Winder, John Campbell

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate- or high-risk prostate cancer: a study protocol for a randomized controlled, pilot trial

Yeon Joo Kim, Hanjong Ahn, Choung-Soo Kim, Jae-Lyun Lee, Young Seok Kim

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving outcomes after pediatric cardiac arrest – the ICU-Resuscitation Project: study protocol for a randomized controlled trial

Ron W. Reeder, Alan Girling, Heather Wolfe, Richard Holubkov, Robert A. Berg, Maryam Y. Naim, Kathleen L. Meert, Bradley Tilford, Joseph A. Carcillo, Melinda Hamilton, Matthew Bochkoris, Mark Hall, Tensing Maa, Andrew R. Yates, Anil Sapru, Robert Kelly, Myke Federman, J. Michael Dean, Patrick S. McQuillen, Deborah Franzon, Murray M. Pollack, Ashley Siems, John Diddle, David L. Wessel, Peter M. Mourani, Carleen Zebuhr, Robert Bishop, Stuart Friess, Candice Burns, Shirley Viteri, David A. Hehir, R. Whitney Coleman, Tammara L. Jenkins, Daniel A. Notterman, Robert F. Tamburro, Robert M. Sutton, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN)

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial

Ryota Niikura, Naoyoshi Nagata, Atsuo Yamada, Hisashi Doyama, Yasutoshi Shiratori, Tsutomu Nishida, Shu Kiyotoki, Tomoyuki Yada, Tomoki Fujita, Tetsuya Sumiyoshi, Kenkei Hasatani, Tatsuya Mikami, Tetsuro Honda, Katsuhiro Mabe, Kazuo Hara, Katsumi Yamamoto, Mariko Takeda, Munenori Takata, Mototsugu Tanaka, Tomohiro Shinozaki, Mitsuhiro Fujishiro, Kazuhiko Koike

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial

Adrian Wells, Kirsten McNicol, David Reeves, Peter Salmon, Linda Davies, Anthony Heagerty, Patrick Doherty, Rebecca McPhillips, Rebecca Anderson, Cintia Faija, Lora Capobianco, Helen Morley, Hannah Gaffney, Gemma Shields, Peter Fisher

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

SPIRE – combining SGI-110 with cisplatin and gemcitabine chemotherapy for solid malignancies including bladder cancer: study protocol for a phase Ib/randomised IIa open label clinical trial

Simon Crabb, Sarah J. Danson, James W. F. Catto, Cathy McDowell, James N. Lowder, Joshua Caddy, Denise Dunkley, Jessica Rajaram, Deborah Ellis, Stephanie Hill, David Hathorn, Amy Whitehead, Mihalis Kalevras, Robert Huddart, Gareth Griffiths

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial

Vu Quoc Dat, Ronald B. Geskus, Marcel Wolbers, Huynh Thi Loan, Lam Minh Yen, Nguyen Thien Binh, Le Thanh Chien, Nguyen Thi Hoang Mai, Nguyen Hoan Phu, Nguyen Phu Huong Lan, Nguyen Van Hao, Hoang Bao Long, Tran Phuong Thuy, Nguyen Van Kinh, Nguyen Vu Trung, Vu Dinh Phu, Nguyen Trung Cap, Dao Tuyet Trinh, James Campbell, Evelyne Kestelyn, Heiman F. L. Wertheim, Duncan Wyncoll, Guy Edward Thwaites, H. Rogier van Doorn, C. Louise Thwaites, Behzad Nadjm

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial

Omar Martinez, M. Isabel Fernandez, Elwin Wu, Alex Carballo-Diéguez, Guillermo Prado, Adam Davey, Ethan Levine, Brian Mattera, Nikki Lopez, Omar Valentin, Ashley Murray, Madeline Sutton

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial

Morten Ellegaard Hell, William R. Miller, Bent Nielsen, Anette Søgaard Nielsen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial

Marco Raaben, Syaiful Redzwan, Robin Augustine, Taco Johan Blokhuis

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Open-label, randomized multicentre phase II study to assess the efficacy and tolerability of sunitinib by dose administration regimen (dose modification or dose interruptions) in patients with advanced or metastatic renal cell carcinoma: study protocol of the SURF trial

Guillaume Mouillet, Marie-Justine Paillard, Tristan Maurina, Dewi Vernerey, Thierry Nguyen Tan Hon, Hamadi Almotlak, Ulrich Stein, Fabien Calcagno, Diane Berthod, Elise Robert, Aurelia Meurisse, Antoine Thiery-Vuillemin

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage

Benjamin Müssle, Leonie Zühlke, Ann Wierick, Dorothée Sturm, Xina Grählert, Marius Distler, Nuh N. Rahbari, Jürgen Weitz, Thilo Welsch

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial

Lahiru Russell, Anna Ugalde, Donna Milne, Meinir Krishnasamy, Eric O (Seung Chul), David W Austin, Richard Chambers, Liliana Orellana, Patricia M Livingston

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial

Haya Alayadi, Wael Sabbah, Eduardo Bernabé

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial

Sungha Kim, Jae Kyoun Kim, Mi Ju Son, Dongwoung Kim, Bongkeun Song, Ilhong Son, Hyung Won Kang, Jongdeok Lee, Sungchul Kim

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty

David F. Hamilton, Nicholas E. Ohly, Paul Gaston

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

ENdometrial cancer SURvivors’ follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial

Nicole P. M. Ezendam, Belle H. de Rooij, Roy F. P. M. Kruitwagen, Carien L. Creutzberg, Ingrid van Loon, Dorry Boll, M. Caroline Vos, Lonneke V. van de Poll-Franse

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial

Afroditi Stathi, Janet Withall, Colin J. Greaves, Janice L. Thompson, Gordon Taylor, Antonieta Medina-Lara, Colin Green, James Bilzon, Selena Gray, Heidi Johansen-Berg, Claire E. Sexton, Max J. Western, Jolanthe L. de Koning, Jessica C. Bollen, Sarah J. Moorlock, Naiara Demnitz, Poppy Seager, Jack M. Guralnik, W. Jack Rejeski, Ken R. Fox

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial

Håkan Carlsson, Birgitta Rosén, Hélène Pessah-Rasmussen, Anders Björkman, Christina Brogårdh

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial

Shahrad Taheri, Muhammad Asim, Hassan al Malki, Omar Fituri, Manikkam Suthanthiran, Phyllis August, IDEAL-2 Study Team

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial

Jean-Christophe Orban, Eric Fontaine, Elisabeth Cassuto, Karine Baumstarck, Marc Leone, Jean-Michel Constantin, Carole Ichai, for the AzuRéa network

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Implementation of telemedicine for knee osteoarthritis: study protocol for a randomized controlled trial

Zhengping Huang, Xia Pan, Weiming Deng, Zhixiang Huang, Yukai Huang, Xuechan Huang, Zhaohua Zhu, Weiyu Han, Shaoling Zheng, Xin Guo, Changhai Ding, Tianwang Li

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial

Dean A. Fennell, Emma Kirkpatrick, Kelly Cozens, Mavis Nye, Jason Lester, Gerard Hanna, Nicola Steele, Peter Szlosarek, Sarah Danson, Joanne Lord, Christian Ottensmeier, Daniel Barnes, Stephanie Hill, Mihalis Kalevras, Tom Maishman, Gareth Griffiths

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Erythropoietin as an add-on treatment for cognitive side effects of electroconvulsive therapy: a study protocol for a randomized controlled trial

Lejla Sjanic Schmidt, Jeff Zarp Petersen, Maj Vinberg, Ida Hageman, Niels Vidiendal Olsen, Lars Vedel Kessing, Martin Balslev Jørgensen, Kamilla Woznica Miskowiak

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial

Carinne Brody, Sovannary Tuot, Pheak Chhoun, Dallas Swendenman, Kathryn C. Kaplan, Siyan Yi

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial

Luwishennadige Madhawee N. Fernando, Wan Hua Sim, Anthony F. Jorm, Ron Rapee, Katherine A. Lawrence, Marie B. H. Yap

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial

Chishala Chabala, Anna Turkova, Margaret J. Thomason, Eric Wobudeya, Syed Hissar, Vidya Mave, Marieke van der Zalm, Megan Palmer, Monica Kapasa, Perumal K. Bhavani, Sarath Balaji, Priyanka A. Raichur, Anne-Marie Demers, Graeme Hoddinott, Ellen Owen-Powell, Aarti Kinikar, Philippa Musoke, Veronica Mulenga, Rob Aarnoutse, Helen McIlleron, Anneke Hesseling, Angela M. Crook, Mark Cotton, Diana M. Gibb, on behalf of the SHINE trial team

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services

Chris Bonell, Graham Moore, Emily Warren, Laurence Moore

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial

Catherine M. Legemate, Harold Goei, Esther Middelkoop, Irma M. M. H. Oen, Tim H. J. Nijhuis, Kelly A. A. Kwa, Paul P. M. van Zuijlen, Gerard I. J. M. Beerthuizen, Marianne K. Nieuwenhuis, Margriet E. van Baar, Cornelis H. van der Vlies

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Stages of behavioural change after direct-to-consumer disease risk profiling: study protocol of two integrated controlled pragmatic trials

Kelly F. J. Stewart, Anke Wesselius, Annemie M. W. J. Schols, Maurice P. Zeegers

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial

Rita Rosner, Eline Rimane, Anna Vogel, Jörn Rau, Maria Hagl

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Does sensorimotor upper limb therapy post stroke alter behavior and brain connectivity differently compared to motor therapy? Protocol of a phase II randomized controlled trial

Nele De Bruyn, Bea Essers, Liselot Thijs, Annick Van Gils, Lisa Tedesco Triccas, Sarah Meyer, Kaat Alaerts, Geert Verheyden

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial

Raphael F. de Souza, Christophe Bedos, Shahrokh Esfandiari, Nicholas M. Makhoul, Didem Dagdeviren, Samer Abi Nader, Areej A. Jabbar, Jocelyne S. Feine

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Chemoprophylaxis of leprosy with rifampicin in contacts of multibacillary patients: study protocol for a randomized controlled trial

Daiane Santos dos Santos, Nádia Cristina Duppre, Euzenir Nunes Sarno, Roberta Olmo Pinheiro, Anna Maria Sales, José Augusto Da Costa Nery, Milton Ozório Moraes, Luiz Antônio Bastos Camacho

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Prophylactic antibiotics to reduce pelvic infection in women having miscarriage surgery – The AIMS (Antibiotics in Miscarriage Surgery) trial: study protocol for a randomized controlled trial

David Lissauer, Amie Wilson, Jane Daniels, Lee Middleton, Jon Bishop, Catherine Hewitt, Abi Merriel, Andrew Weeks, Chisale Mhango, Ronald Mataya, Frank Taulo, Theresa Ngalawesa, Agatha Chirwa, Colleta Mphasa, Tayamika Tambala, Grace Chiudzu, Caroline Mwalwanda, Agnes Mboma, Rahat Qureshi, Iffat Ahmed, Humera Ismail, Metin Gulmezoglu, Olufemi T. Oladapo, Godfrey Mbaruku, Jerome Chibwana, Grace Watts, Beatus Simon, James Ditai, Charles Otim Tom, Jane-Frances Acam, John Ekunait, Helen Uniza, Margaret Iyaku, Margaret Anyango, Javier Zamora, Tracy Roberts, Ilias Goranitis, Nicola Desmond, Arri Coomarasamy

01.12.2018 | Review | Ausgabe 1/2018 Open Access

N-of-1 trials in the clinical care of patients in developing countries: a systematic review

Chalachew Alemayehu, Jane Nikles, Geoffrey Mitchell

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Developing a core outcome set for people living with dementia at home in their neighbourhoods and communities: study protocol for use in the evaluation of non-pharmacological community-based health and social care interventions

Andrew J. E. Harding, Hazel Morbey, Faraz Ahmed, Carol Opdebeeck, Ying-Ying Wang, Paula Williamson, Caroline Swarbrick, Iracema Leroi, David Challis, Linda Davies, David Reeves, Fiona Holland, Mark Hann, Ingrid Hellström, Lars-Christer Hydén, Alistair Burns, John Keady, Siobhan Reilly

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Health consequences for mother and baby of substantial pre-conception weight loss in obese women: study protocol for a randomized controlled trial

Sarah Price, Alison Nankervis, Michael Permezel, Luke Prendergast, Priya Sumithran, Joseph Proietto

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial

João Gustavo Rocha Peixoto dos Santos, Ana Luiza Costa Zaninotto, Renato Amaro Zângaro, Ana Maria Costa Carneiro, Iuri Santana Neville, Almir Ferreira de Andrade, Manoel Jacobsen Teixeira, Wellingson Silva Paiva

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effect of regularly dosed paracetamol versus no paracetamol on renal function in Plasmodium knowlesi malaria (PACKNOW): study protocol for a randomised controlled trial

Daniel J. Cooper, Katherine Plewes, Matthew J. Grigg, Giri S. Rajahram, Kim A. Piera, Timothy William, Mark D. Chatfield, Tsin Wen Yeo, Arjen M. Dondorp, Nicholas M. Anstey, Bridget E. Barber

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial

Jeanette Bailey, Natasha Lelijveld, Bethany Marron, Pamela Onyoo, Lara S. Ho, Mark Manary, André Briend, Charles Opondo, Marko Kerac

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation

Natasha Lelijveld, Jeanette Bailey, Amy Mayberry, Lani Trenouth, Dieynaba S. N’Diaye, Hassan Haghparast-Bidgoli, Chloe Puett

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial

Christa Raak, Wolfram Scharbrodt, Bettina Berger, Arndt Büssing, René Geißen, Thomas Ostermann

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Individualised short-term therapy for adolescents impaired by attention-deficit/hyperactivity disorder despite previous routine care treatment (ESCAadol)—Study protocol of a randomised controlled trial within the consortium ESCAlife

Julia Geissler, Thomas Jans, Tobias Banaschewski, Katja Becker, Tobias Renner, Daniel Brandeis, Manfred Döpfner, Christina Dose, Christopher Hautmann, Martin Holtmann, Carolin Jenkner, Sabina Millenet, Marcel Romanos

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Optimizing a community-engaged multi-level group intervention to reduce substance use: an application of the multiphase optimization strategy

Liliane Cambraia Windsor, Ellen Benoit, Douglas Smith, Rogério M. Pinto, Kari C. Kugler, Newark Community Collaborative Board (NCCB)

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader–Willi syndrome: study protocol for a randomized controlled trial

Zainab Alyousif, Jennifer L. Miller, Mariana Y. Sandoval, Chad W. MacPherson, Varuni Nagulesapillai, Wendy J. Dahl

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Physical activity and nutrition intervention for Singaporean women aged 50 years and above: study protocol for a randomised controlled trial

Elaine Yee-Sing Wong, Andy H. Lee, Anthony P. James, Jonine Jancey

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial

Daniel Berglind, Gisela Nyberg, Mikaela Willmer, Margareta Persson, Michael Wells, Yvonne Forsell

01.12.2018 | Update | Ausgabe 1/2018 Open Access

Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial

Jeffrey Presneill, Dashiell Gantner, Alistair Nichol, Colin McArthur, Andrew Forbes, Jessica Kasza, Tony Trapani, Lynnette Murray, Stephen Bernard, Peter Cameron, Gilles Capellier, Olivier Huet, Lynette Newby, Stephen Rashford, Jeffrey V. Rosenfeld, Tony Smith, Michael Stephenson, Dinesh Varma, Shirley Vallance, Tony Walker, Steve Webb, D. James Cooper, On behalf of the POLAR investigators and the ANZICS Clinical Trials Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial

Clément Le Cornec, Said Lariby, Vivien Brenckmann, Jean Benoit Hardouin, Claude Ecoffey, Marion Le Pottier, Philippe Fradin, Hélène Broch, Amine Kabbaj, Yannick Auffret, Florence Deciron, Céline Longo, François Javaudin, Quentin Le Bastard, Joël Jenvrin, Emmanuel Montassier

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Tranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial

Rodney H. Breau, Luke T. Lavallée, Sonya Cnossen, Kelsey Witiuk, Ilias Cagiannos, Franco Momoli, Gregory Bryson, Salmaan Kanji, Christopher Morash, Alexis Turgeon, Ryan Zarychanski, Ranjeeta Mallick, Greg Knoll, Dean A. Fergusson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial

Imogen H. Bell, Sarah F. Fielding-Smith, Mark Hayward, Susan L. Rossell, Michelle H. Lim, John Farhall, Neil Thomas

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

Anne Loes van den Boom, Elisabeth M. L. de Wijkerslooth, Joost van Rosmalen, Frédérique H. Beverdam, Evert-Jan G. Boerma, Marja A. Boermeester, Joanna W. A. M. Bosmans, Thijs A. Burghgraef, Esther C. J. Consten, Imro Dawson, Jan Willem T. Dekker, Marloes Emous, Anna A. W. van Geloven, Peter M. N. Y. H. Go, Luc A. Heijnen, Sander A. Huisman, Dayanara Jean Pierre, Joske de Jonge, Jurian H. Kloeze, Marc A. Koopmanschap, Hester R. Langeveld, Misha D. P. Luyer, Damian C. Melles, Johan W. Mouton, Augustinus P. T. van der Ploeg, Floris B. Poelmann, Jeroen E. H. Ponten, Charles C. van Rossem, Wilhelmina H. Schreurs, Joël Shapiro, Pascal Steenvoorde, Boudewijn R. Toorenvliet, Joost Verhelst, Hendt P. Versteegh, Rene M. H. Wijnen, Bas P. L. Wijnhoven

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Administration of taurolidine-citrate lock solution for prevention of central venous catheter infection in adult neutropenic haematological patients: a randomised, double-blinded, placebo-controlled trial (TAURCAT)

C. Gudiol, S. Nicolae, C. Royo-Cebrecos, M. Aguilar-Guisado, I. Montero, C. Martín-Gandul, M. Perayre, D. Berbel, M. Encuentra, M. Arnan, J. M. Cisneros-Herreros, J. Carratalà

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Outcome pre-specification requires sufficient detail to guard against outcome switching in clinical trials: a case study

Brennan C. Kahan, Vipul Jairath

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The role of exercise combined with tocilizumab in visceral and epicardial adipose tissue and gastric emptying rate in abdominally obese participants: protocol for a randomised controlled trial

Regitse Højgaard Christensen, Anne-Sophie Wedell-Neergaard, Louise Lang Lehrskov, Grit Elster Legård, Emma Berndt Dorph, Stine Nymand, Maria Korf Ball, Morten Zacho, Robin Christensen, Helga Ellingsgaard, Jaya Birgitte Rosenmeier, Rikke Krogh-Madsen, Bente Klarlund Pedersen, Kristian Karstoft

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Financial management of large, multi-center trials in a challenging funding milieu

Olivia Lovegreen, Danielle Riggs, Myrlene A. Staten, Patricia Sheehan, Anastassios G. Pittas

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Synthetic versus autologous reconstruction (Syn-VAR) of the medial patellofemoral ligament: a study protocol for a randomised controlled trial

Adam Tucker, Sam McMahon, Bronwyn McArdle, Bridgeen Rutherford, Danny Acton

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Patient consent to publication and data sharing in industry and NIH-funded clinical trials

O’Mareen Spence, Richie Onwuchekwa Uba, Seongbin Shin, Peter Doshi

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A cluster randomised controlled trial of the Wellbeing in Secondary Education (WISE) Project – an intervention to improve the mental health support and training available to secondary school teachers: protocol for an integrated process evaluation

Rhiannon Evans, Rowan Brockman, Jillian Grey, Sarah Bell, Sarah Harding, David Gunnell, Rona Campbell, Simon Murphy, Tamsin Ford, William Hollingworth, Kate Tilling, Richard Morris, Bryar Kadir, Ricardo Araya, Judi Kidger

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

iSupport, an online training and support program for caregivers of people with dementia: study protocol for a randomized controlled trial in India

Kala M. Mehta, Dolores Gallagher-Thompson, Mathew Varghese, Santosh Loganathan, Upasana Baruah, Katrin Seeher, Diana Zandi, Tarun Dua, Anne Margriet Pot

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

RELAx – REstricted versus Liberal positive end-expiratory pressure in patients without ARDS: protocol for a randomized controlled trial

Anna Geke Algera, Luigi Pisani, Dennis C. J. Bergmans, Sylvia den Boer, Corianne A. J. de Borgie, Frank H. Bosch, Karina Bruin, Thomas G. Cherpanath, Rogier M. Determann, Arjen M. Dondorp, Dave A. Dongelmans, Henrik Endeman, Jasper J. Haringman, Janneke Horn, Nicole P. Juffermans, David M. van Meenen, Nardo J. van der Meer, Maruschka P. Merkus, Hazra S. Moeniralam, Ilse Purmer, Pieter Roel Tuinman, Mathilde Slabbekoorn, Peter E. Spronk, Alexander P. J. Vlaar, Marcelo Gama de Abreu, Paolo Pelosi, Ary Serpa Neto, Marcus J. Schultz, Frederique Paulus, for the RELAx Investigators and the PROVE Network Investigators

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial

Sandra Funcke, Bernd Saugel, Christian Koch, Dagmar Schulte, Thomas Zajonz, Michael Sander, Angelo Gratarola, Lorenzo Ball, Paolo Pelosi, Savino Spadaro, Riccardo Ragazzi, Carlo Alberto Volta, Thomas Mencke, Amelie Zitzmann, Benedikt Neukirch, Gonzalo Azparren, Marta Giné, Vicky Moral, Hans Otto Pinnschmidt, Oscar Díaz-Cambronero, Maria Jose Alberola Estelles, Marisol Echeverri Velez, Maria Vila Montañes, Javier Belda, Marina Soro, Jaume Puig, Daniel Arnulf Reuter, Sebastian Alois Haas

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Progressive mobility program and technology to increase the level of physical activity and its benefits in respiratory, muscular system, and functionality of ICU patients: study protocol for a randomized controlled trial

Debora Stripari Schujmann, Adriana Claudia Lunardi, Carolina Fu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

Ai-mei Zhao, Wen-ran Qiu, Li-jun Mao, Jun-guo Ren, Li Xu, Ming-jiang Yao, Kellie Bilinksi, Dennis Chang, Jian-xun Liu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness of the KENKOJISEICHI local revitalization system on cognitive function change in older adults with mild cognitive impairment: study protocol for a randomized controlled trial

Songee Jung, Sungchul Lee, Seongryu Bae, Sangyoon Lee, Keitaro Makino, Yohei Shinkai, Hiroyuki Shimada

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial

Vera Salvo, Jean Kristeller, Jesus Montero Marin, Adriana Sanudo, Bárbara Hatzlhoffer Lourenço, Mariana Cabral Schveitzer, Vania D’Almeida, Héctor Morillo, Suely Godoy Agostinho Gimeno, Javier Garcia-Campayo, Marcelo Demarzo

01.12.2018 | Letter | Ausgabe 1/2018 Open Access

Pragmatic randomised clinical trials using electronic health records: general practitioner views on a model of a priori consent

Thomas Hills, Alex Semprini, Richard Beasley

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial

Dong Kee Jang, Chan Yung Jung, Kyung Ho Kim, Jun Kyu Lee

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial

Toivo Zinnow, Tobias Banaschewski, Andreas J. Fallgatter, Carolin Jenkner, Florence Philipp-Wiegmann, Alexandra Philipsen, Wolfgang Retz, Esther Sobanski, Johannes Thome, Michael Rösler

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Survey of professional views on sharing interim results by the Data Safety Monitoring Board (DSMB): what to share, with whom and why

Victoria Borg Debono, Lawrence Mbuagbaw, James Paul, Norman Buckley, Lehana Thabane

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

GoActive: a protocol for the mixed methods process evaluation of a school-based physical activity promotion programme for 13–14year old adolescents

Stephanie T. Jong, Helen Elizabeth Brown, Caroline H. D. Croxson, Paul Wilkinson, Kirsten L. Corder, Esther M. F. van Sluijs

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Contributions of a survey and retrospective cohort study to the planning of a randomised controlled trial of corticosteroids in the treatment of paediatric septic shock

Anna Liu, Kusum Menon

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial

Shahrad Taheri, Odette Chagoury, Hadeel Zaghloul, Sara Elhadad, Salma Hayder Ahmed, Omar Omar, Sherryl Payra, Salma Ahmed, Neda El Khatib, Rasha Abou Amona, Katie El Nahas, Matthew Bolton, Henem Chaar, Noor Suleiman, Amin Jayyousi, Mahmoud Zirie, Ibrahim Janahi, Wahiba Elhag, Abdulla Alnaama, Abduljaleel Zainel, Dahlia Hassan, Tim Cable, Mary Charlson, Martin Wells, Abdulla Al-Hamaq, Samya Al-Abdulla, Abdul Badi Abou-Samra

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial

Sasha-Denise Grünzig, Harald Baumeister, Jürgen Bengel, David Ebert, Lena Krämer

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial

Samuel McClinton, Sarah Cameron, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Alison McDonald, Thomas Lam, James N’Dow, Mary Kilonzo, Robert Pickard, Ken Anson, Frank Keeley, Neil Burgess, Charles Terry Clark, Sara MacLennan, John Norrie, for the TISU Study Group

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Exposure to a multi-level multi-component childhood obesity prevention community-randomized controlled trial: patterns, determinants, and implications

Angela Cristina Bizzotto Trude, Anna Yevgenyevna Kharmats, Jessica C. Jones-Smith, Joel Gittelsohn

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial

Ulla Klaiber, Lisa M. Stephan-Paulsen, Thomas Bruckner, Gisela Müller, Silke Auer, Ingrid Farrenkopf, Christine Fink, Colette Dörr-Harim, Markus K. Diener, Markus W. Büchler, Phillip Knebel

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A dose-response study of aerobic training for oxygen uptake, oxidative stress and cardiac autonomic function in type 2 diabetes mellitus: study protocol for a randomized controlled trial

Shalini Verma, Jamal Ali Moiz, Shahnawaz Anwer, Ahmad H. Alghadir, Mohammed Ejaz Hussain

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

World Health Organization “School Mental Health Manual”-based training for school teachers in Urban Lahore, Pakistan: study protocol for a randomized controlled trial

Nazish Imran, Atif Rahman, Nakhshab Chaudhry, Aftab Asif

01.12.2018 | Review | Ausgabe 1/2018 Open Access

A checklist for clinical trials in rare disease: obstacles and anticipatory actions—lessons learned from the FOR-DMD trial

Rebecca A. Crow, Kimberly A. Hart, Michael P. McDermott, Rabi Tawil, William B. Martens, Barbara E. Herr, Elaine McColl, Jennifer Wilkinson, Janbernd Kirschner, Wendy M. King, Michele Eagle, Mary W. Brown, Deborah Hirtz, Hanns Lochmuller, Volker Straub, Emma Ciafaloni, Perry B. Shieh, Stefan Spinty, Anne-Marie Childs, Adnan Y. Manzur, Lucia Morandi, Russell J. Butterfield, Iain Horrocks, Helen Roper, Kevin M. Flanigan, Nancy L. Kuntz, Jean K. Mah, Leslie Morrison, Basil T. Darras, Maja von der Hagen, Ulrike Schara, Ekkehard Wilichowski, Tiziana Mongini, Craig M. McDonald, Giuseppe Vita, Richard J. Barohn, Richard S. Finkel, Matthew Wicklund, Hugh J. McMillan Jr, Imelda Hughes, Elena Pegoraro, W. Bryan Burnette, James F. Howard, Mathula Thangarajh, Craig Campbell, Robert C. Griggs, Kate Bushby, Michela Guglieri

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial

Dhong Eun Jung, Hyung-Chul Lee, Hyun-Kyu Yoon, Hee-Pyoung Park

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

A randomized controlled phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy of newly diagnosed glioblastoma (GlioVax): study protocol for a randomized controlled trial

Marion Rapp, Oliver M. Grauer, Marcel Kamp, Natalie Sevens, Nikola Zotz, Michael Sabel, Rüdiger V. Sorg

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set

Bronwen Connolly, Linda Denehy, Nicholas Hart, Natalie Pattison, Paula Williamson, Bronagh Blackwood

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Online interventions for problem gamblers with and without co-occurring problem drinking: study protocol of a randomized controlled trial

John A. Cunningham, David C. Hodgins, Matthew Keough, Christian S. Hendershot, Kylie Bennett, Anthony Bennett, Alexandra Godinho

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial

Jie Liu, Xinsheng Xue, Ying Wu, Chaohua Yang, Ning Li, Huiping Li

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial

Matthew P. Cheng, Alexander Lawandi, Guillaume Butler-Laporte, Katryn Paquette, Todd C. Lee

01.12.2018 | Review | Ausgabe 1/2018 Open Access

Post-trial follow-up methodology in large randomised controlled trials: a systematic review

Rebecca Llewellyn-Bennett, Danielle Edwards, Nia Roberts, Atticus H. Hainsworth, Richard Bulbulia, Louise Bowman

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial

Michael C. Tanner, Raban Heller, Fabian Westhauser, Matthias Miska, Thomas Ferbert, Christian Fischer, Simone Gantz, Gerhard Schmidmaier, Patrick Haubruck

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Sex and cardiovascular disease status differences in attitudes and willingness to participate in clinical research studies/clinical trials

Thomas S. Gruca, Wesley J. Hottel, Janine Comstock, Anna Olson, Gary E. Rosenthal

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial

Bolette Daniels Beck, Steen Teis Lund, Ulf Søgaard, Erik Simonsen, Thomas Christian Tellier, Torben Oluf Cordtz, Gunnar Hellmund Laier, Torben Moe

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial

Katherine L. Anders, Citra Indriani, Riris Andono Ahmad, Warsito Tantowijoyo, Eggi Arguni, Bekti Andari, Nicholas P. Jewell, Edwige Rances, Scott L. O’Neill, Cameron P. Simmons, Adi Utarini

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial

Ying Xu, Shufang Lin, Cai Jiang, Xiaoqian Ye, Jing Tao, Schupp Wilfried, Alex W. K. Wong, Lidian Chen, Shanli Yang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial

Paul A. Matthews, Brigitte E. Scammell, Arfan Ali, Timothy Coughlin, Jessica Nightingale, Tanvir Khan, Ben J. Ollivere

01.12.2018 | Research | Ausgabe 1/2018 Open Access

A randomized phase 2B trial of vancomycin versus daptomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteremia due to isolates with high vancomycin minimum inhibitory concentrations – results of a prematurely terminated study

Shirin Kalimuddin, Yvonne F. Z. Chan, Rachel Phillips, Siew Pei Ong, Sophia Archuleta, David Chien Lye, Thuan Tong Tan, Jenny G. H. Low

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial

Julie M. Fritz, Jason A. Sharpe, Elizabeth Lane, Doug Santillo, Tom Greene, Gregory Kawchuk

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial

Clémence Louis, Thomas Godet, Gérald Chanques, Nathalie Bourguignon, Dominique Morand, Bruno Pereira, Jean-Michel Constantin, for the AZUREA network

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Comparing isolated soy protein with flaxseed oil vs isolated soy protein with corn oil and wheat flour with corn oil consumption on muscle catabolism, liver function, blood lipid, and sugar in burn patients: a randomized clinical trial

Siavash Babajafari, Abdollah Hojhabrimanesh, Zahra Sohrabi, Mehdi Ayaz, Ali Noorafshan, Atefeh Akrami

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial

Terry Wahls, Maria O. Scott, Zaidoon Alshare, Linda Rubenstein, Warren Darling, Lucas Carr, Karen Smith, Catherine A. Chenard, Nicholas LaRocca, Linda Snetselaar

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

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, Donald E. Morisky

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

‘Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial

Sarah Kerry-Barnard, Charlotte Fleming, Fiona Reid, Rachel Phillips, Vari M. Drennan, Elisabeth J. Adams, Wendy Majewska, Anjella Balendra, Emma Harding-Esch, Emma Cousins, S. Tariq Sadiq, Pippa Oakeshott

01.12.2018 | Update | Ausgabe 1/2018 Open Access

‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan

Rachel Phillips, Pippa Oakeshott, Sarah Kerry-Barnard, Fiona Reid

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial

Phelgona Otieno, Peter Waiswa, Elizabeth Butrick, Gertrude Namazzi, Kevin Achola, Nicole Santos, Ryan Keating, Felicia Lester, Dilys Walker

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial

Ruining Liang, Peishuang Li, Xuemei Peng, Ling Xu, Pei Fan, Jiahua Peng, Xu Zhou, Chunlin Xiao, Miao Jiang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial

Lars Morso, Berit Schiøttz-Christensen, Jens Søndergaard, Nils-Bo de Vos Andersen, Flemming Pedersen, Kim Rose Olsen, Morten Sall Jensen, Jonathan Hill, David Høyrup Christiansen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Augmentation effect of acupuncture on Bi’nao for hypophasis in patients with Bell’s palsy: study protocol for a randomized controlled trial

Xiaoyan Li, Chunlan Chen, Chuang Zhao, Zunyuan Li, Wei Liang, Zhidan Liu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

Anne Forster, Suzanne Hartley, Lorna Barnard, Seline Ozer, Natasha Hardicre, Tom Crocker, Marie Fletcher, Lauren Moreau, Ross Atkinson, Claire Hulme, Ivana Holloway, Laetitia Schmitt, Allan House, Jenny Hewison, Gillian Richardson, Amanda Farrin, on behalf of the LoTS2Care Programme Management Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol for a randomized controlled trial

Gerdien A. Zeilmaker-Roest, Joost van Rosmalen, Monique van Dijk, Erik Koomen, Nicolaas J. G. Jansen, Martin C. J. Kneyber, Sofie Maebe, Greet van den Berghe, Dirk Vlasselaers, Ad J. J. C. Bogers, Dick Tibboel, Enno D. Wildschut

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: Study protocol for a multi-center prospective randomized controlled trial

Xing-Wang Zhu, Yuan Shi, Li-Ping Shi, Ling Liu, Jiang Xue, Rangasamy Ramanathan, for the NHFOV Study Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Protecting Adolescents in Low- And Middle-Income Countries from Interpersonal Violence (PRO YOUTH TRIAL): Study Protocol for a Cluster Randomized Controlled Trial of the Strengthening Families Programme 10-14 (“Familias Fuertes”) in Panama

Anilena Mejia, Richard Emsley, Eleonora Fichera, Wadih Maalouf, Jeremy Segrott, Rachel Calam

01.12.2018 | Research | Ausgabe 1/2018 Open Access

A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma

Veronica Swystun, Francis H. Y. Green, John H. Dennis, Emmanouil Rampakakis, Gurkeet Lalli, Morenike Fadayomi, Andrea Chiu, Grishma Shrestha, Sharif Galal El Shahat, David Evan Nelson, Tamer Y. El Mays, Cora A. Pieron, Richard Leigh

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial

Marleen M. Roos, Egbert-Jan M. M. Verleisdonk, Floris B. M. Sanders, Arno W. Hoes, Rebecca K. Stellato, Geert W. J. Frederix, Rogier K. J. Simmermacher, Josephina P. J. Burgmans, EFFECT study group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Follow-up study regarding the medium-term effectiveness of the home-visiting program “Pro Kind” at age 7 years: study protocol for a randomized controlled trial

Sören Kliem, Malte Sandner, Anna Lohmann, Susan Sierau, Verena Dähne, Annette M. Klein, Tanja Jungmann

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial

Sang-Ho Jo, Sung-Ji Park, Eung Ju Kim, Soo-Joong Kim, Hyun-Jae Cho, Jong-Min Song, Jinho Shin, Jin Joo Park, Joon-Han Shin, Kyoo-Rok Han, Dong-Ju Choi

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Aggression Following Traumatic brain injury: Effectiveness of Risperidone (AFTER): study protocol for a feasibility randomised controlled trial

Shoumitro Deb, Verity Leeson, Lina Aimola, Mayur Bodani, Lucia Li, Tim Weaver, David Sharp, Mike Crawford

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial

Puja Shankar, Ariel Mueller, Senthil Packiasabapathy, Doris Gasangwa, Melissa Patxot, Brian O’Gara, Shahzad Shaefi, Edward R. Marcantonio, Balachundhar Subramaniam

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Qualitative analysis of feasibility of recruitment and retention in a planned randomised controlled trial of a psychosocial cancer intervention within the NHS

M. Duncan, A. Korszun, P. White, G. Eva, on behalf of the SURECAN investigators

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Participation in a trial in the emergency situation: a qualitative study of patient experience in the UK WOLLF trial

Elizabeth Tutton, Juul Achten, Sarah E. Lamb, Keith Willett, Matthew L. Costa, on behalf of the UK WOLLF Research Collaborators

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial

Simona Silvetti, Tommaso Aloisio, Anna Cazzaniga, Marco Ranucci

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of an exercise program on hepatic metabolism, hepatic fat, and cardiovascular health in overweight/obese adolescents from Bogotá, Colombia (the HEPAFIT study): study protocol for a randomized controlled trial

Katherine González-Ruíz, Jorge Enrique Correa-Bautista, Mikel Izquierdo, Antonio García-Hermoso, María Andrea Dominguez-Sanchez, Rosa Helena Bustos-Cruz, Jorge Cañete García-Prieto, Vicente Martínez-Vizcaíno, Felipe Lobelo, Emilio González-Jiménez, Daniel Humberto Prieto-Benavides, Alejandra Tordecilla-Sanders, Jacqueline Schmidt-RioValle, Guillermo Perez, Robinson Ramírez-Vélez

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Protocol, and practical challenges, for a randomised controlled trial comparing the impact of high intensity interval training against standard care before major abdominal surgery: study protocol for a randomised controlled trial

John Woodfield, Matthew Zacharias, Genevieve Wilson, Fran Munro, Kate Thomas, Andrew Gray, James Baldi

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Tailoring and evaluating an intervention to improve shared decision-making among seniors with dementia, their caregivers, and healthcare providers: study protocol for a randomized controlled trial

Anik M. C. Giguere, Moulikatou Adouni Lawani, Émilie Fortier-Brochu, Pierre-Hugues Carmichael, France Légaré, Edeltraut Kröger, Holly O. Witteman, Philippe Voyer, Danielle Caron, Charo Rodríguez

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Speech-guided breathing retraining in asthma: a randomised controlled crossover trial in real-life outpatient settings

Dietrich von Bonin, Sabine D. Klein, Jana Würker, Eva Streit, Oliver Avianus, Christian Grah, Jörg Salomon, Ursula Wolf

01.12.2018 | Commentary | Ausgabe 1/2018 Open Access

Accommodating quality and service improvement research within existing ethical principles

Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Marion Campbell, Dean A. Fergusson, Jeremy M. Grimshaw, Karla Hemming, Austin R. Horn, Monica Taljaard

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Liuzijue Qigong vs traditional breathing training for patients with post-stroke dysarthria complicated with abnormal respiratory control: study protocol of a single center randomized controlled trial

Hongli Li, Gaiyan Li, Gongliang Liu, Ying Zhang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy and mechanism of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence: study protocol for a randomised controlled trial

Eleanor McAlees, Paul F. Vollebregt, Natasha Stevens, Tom C. Dudding, Anton V. Emmanuel, Paul L. Furlong, Shaheen Hamdy, Richard L. Hooper, James F. X. Jones, Christine Norton, P. Ronan O’Connell, S. Mark Scott, Charles H. Knowles

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mechanisms and modulators of cognitive training gain transfer in cognitively healthy aging: study protocol of the AgeGain study

Dominik Wolf, Oliver Tüscher, Stefan Teipel, Andreas Mierau, Heiko Strüder, Alexander Drzezga, Bernhard Baier, Harald Binder, Andreas Fellgiebel, the German AgeGain study group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial

Jing Fu, Hong-cai Shang, Li-ying Wang, Chen Zhao, Jin Cui, Yan-ping Wang

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Exploring and adjusting for potential learning effects in ROLARR: a randomised controlled trial comparing robotic-assisted vs. standard laparoscopic surgery for rectal cancer resection

Neil Corrigan, Helen Marshall, Julie Croft, Joanne Copeland, David Jayne, Julia Brown

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Treatment of voluminous and complicated superficial slow-flow vascular malformations with sirolimus (PERFORMUS): protocol for a multicenter phase 2 trial with a randomized observational-phase design

Annabel Maruani, Olivia Boccara, Didier Bessis, Laurent Guibaud, Pierre Vabres, Juliette Mazereeuw-Hautier, Sébastien Barbarot, Christine Chiaverini, Sophie Blaise, Catherine Droitcourt, Stéphanie Mallet, Ludovic Martin, Gérard Lorette, Jean-Baptiste Woillard, Annie-Pierre Jonville-Bera, Jérome Rollin, Yves Gruel, Denis Herbreteau, Dominique Goga, Anne le Touze, Sophie Leducq, Valérie Gissot, Baptiste Morel, Elsa Tavernier, Bruno Giraudeau, Groupe de Recherche de la Societé Française de Dermatologie Pédiatrique

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Automated recruitment and randomisation for an efficient randomised controlled trial in primary care

Victoria R. Cornelius, Lisa McDermott, Alice S. Forster, Mark Ashworth, Alison J. Wright, Martin C. Gulliford

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Comparison of the effectiveness between transcutaneous electrical nerve stimulation, manual acupuncture, and electroacupuncture on tinnitus: study protocol for a randomized controlled trial

Young-Kyun Moon, Min Hee Kim, Hae Jeong Nam

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Psychological distress following a motor vehicle crash: preliminary results of a randomised controlled trial investigating brief psychological interventions

Rebecca Guest, Yvonne Tran, Bamini Gopinath, Ian D. Cameron, Ashley Craig

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluating parents’ decisions about next-generation sequencing for their child in the NC NEXUS (North Carolina Newborn Exome Sequencing for Universal Screening) study: a randomized controlled trial protocol

Laura V. Milko, Christine Rini, Megan A. Lewis, Rita M. Butterfield, Feng-Chang Lin, Ryan S. Paquin, Bradford C. Powell, Myra I. Roche, Katherine J. Souris, Donald B. Bailey Jr, Jonathan S. Berg, Cynthia M. Powell

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of pre-transplant azithromycin administration on kidney graft function: study protocol for a double-blind randomized clinical trial

Gholamreza Mokhtari, Mojtaba Teimoori

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition: study protocol for a randomized multicenter trial

Michelle Gompelman, Yannick Wouters, Wietske Kievit, Joost Hopman, Heiman F. Wertheim, Chantal P. Bleeker-Rovers, Geert J. A. Wanten

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of a 6-week, whole-body vibration strength-training on depression symptoms, endocrinological and neurobiological parameters in adolescent inpatients experiencing a major depressive episode (the “Balancing Vibrations Study”): study protocol for a randomized placebo-controlled trial

Max Oberste, Nicola Großheinrich, Heidrun-Lioba Wunram, Johannes Levin Graf, Alischa Ziemendorff, Axel Meinhardt, Oliver Fricke, Esther Mahabir, Stephan Bender

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial

Siyi Yu, Yueqiang Wen, Wanting Xia, Mingxiao Yang, Zhengtao Lv, Xiaoji Li, Wenyao Li, Sha Yang, Youping Hu, Fanrong Liang, Jie Yang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol

Alexander Smith, Anna Pennington, Ben Carter, Stephanie Gething, Michelle Price, James White, Richard Dewar, Jonathan Hewitt

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial

Seung Hyun Lee, Jae-Kwang Shim, Sarah Soh, Jong Wook Song, Byung Chul Chang, Sak Lee, Young-Lan Kwak

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Towards a health-enabling working environment - developing and testing interventions to decrease HIV and TB stigma among healthcare workers in the Free State, South Africa: study protocol for a randomised controlled trial

Asta Rau, Edwin Wouters, Michelle Engelbrecht, Caroline Masquillier, Kerry Uebel, Gladys Kigozi, Nina Sommerland, André Janse van Rensburg

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial

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

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Healthy Campus Trial: a multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: study protocol for a randomized controlled trial

Teruhisa Uwatoko, Yan Luo, Masatsugu Sakata, Daisuke Kobayashi, Yu Sakagami, Kazumi Takemoto, Linda M. Collins, Ed Watkins, Steven D. Hollon, James Wason, Hisashi Noma, Masaru Horikoshi, Takashi Kawamura, Taku Iwami, Toshi A. Furukawa

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Safe Birth and Cultural Safety in southern Mexico: study protocol for a randomised controlled trial

Iván Sarmiento, Sergio Paredes-Solís, Neil Andersson, Anne Cockcroft

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy of Jia Wei Yang He formula as an adjunctive therapy for asthma: study protocol for a randomized, double blinded, controlled trial

Wenhan Jiang, Zifeng Ma, Huiyong Zhang, Henry S. Lynn, Beiqi Xu, Xiao Zhang, Rongrong Bi, Jiyou Fu, Yue Chen, Zhen Xiao, Zhijie Zhang, Zhenhui Lu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Acupuncture as an early treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) patients with flat or high-frequency drop audiograms: study protocol for a randomized controlled trial

Kai Shang, Xin Ma, Hui-Lin Liu, Yuan-Yuan Jing, Lin Zeng, Nan Li, De-An Zhou, Jia Wei, Chen Zhang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial

Maria López-Parra, Dolors Gil-Rey, Esmeralda López-González, Eva-Maria González-Rodríguez, Isabel Simó-Sánchez, Francisco Zamora-Carmona, Lidia Roqueta-Andreu, Marta Arizu-Puigvert, Dolors Abril-Sabater, Àngels Moreno-Álvarez, Àngels López-Bonet, Gisela López-Hidalgo, Helena Costa-Ventura, Laura García-Pardo, Mireia Rico-Liberato, Miriam García-Borràs, Maria Teresa Arnal-Leris, Mònica Sianes-Gallén, Roser Vives

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Achieving optimal technology and behavioral uptake of single and combined interventions of water, sanitation hygiene and nutrition, in an efficacy trial (WASH benefits) in rural Bangladesh

Sarker Masud Parvez, Rashidul Azad, Mahbubur Rahman, Leanne Unicomb, Pavani K. Ram, Abu Mohd Naser, Christine P. Stewart, Kaniz Jannat, Musarrat Jabeen Rahman, Elli Leontsini, Peter J. Winch, Stephen P. Luby

01.12.2018 | Research | Ausgabe 1/2018 Open Access

WASH Benefits Bangladesh trial: management structure for achieving high coverage in an efficacy trial

Leanne Unicomb, Farzana Begum, Elli Leontsini, Mahbubur Rahman, Sania Ashraf, Abu Mohd Naser, Fosiul A. Nizame, Kaniz Jannat, Faruqe Hussain, Sarker Masud Parvez, Shaila Arman, Moshammot Mobashara, Stephen P. Luby, Peter J. Winch

01.12.2018 | Research | Ausgabe 1/2018 Open Access

WASH Benefits Bangladesh trial: system for monitoring coverage and quality in an efficacy trial

Mahbubur Rahman, Sania Ashraf, Leanne Unicomb, A. K. M. Mainuddin, Sarker Masud Parvez, Farzana Begum, Kishor Kumar Das, Abu Mohd. Naser, Faruqe Hussain, Thomas Clasen, Stephen P. Luby, Elli Leontsini, Peter J. Winch

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial

Yen-Nien Chen, Li-Chun Chang, Chi-Yang Chang, Peng-Jen Chen, Chi-Yi Chen, Cheng-Hao Tseng, Han-Mo Chiu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of hemodynamic monitoring using a single-use transesophageal echocardiography probe in critically ill patients – study protocol for a randomized controlled trial

Luca Cioccari, Bjoern Zante, Andreas Bloch, David Berger, Andreas Limacher, Stephan M. Jakob, Jukka Takala, Tobias M. Merz

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial

Richard Y. Cao, Hongchao Zheng, Qiongyao Mi, Qing Li, Wenchao Yuan, Yueyou Ding, Jian Yang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial

Henning Budde, Davin P. Akko, Herbert E. Ainamani, Eric Murillo-Rodríguez, Roland Weierstall

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Planning a future randomized clinical trial based on a network of relevant past trials

Georgia Salanti, Adriani Nikolakopoulou, Alex J. Sutton, Stephan Reichenbach, Sven Trelle, Huseyin Naci, Matthias Egger

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a randomised controlled trial

Malcolm Battersby, Michael R. Kidd, Julio Licinio, Philip Aylward, Amanda Baker, Julie Ratcliffe, Stephen Quinn, David J. Castle, Sara Zabeen, A. Kate Fairweather-Schmidt, Sharon Lawn

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Efficacy and indication optimization of Chinese medicine (Tiao-Chang Ke-Min granules) for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial

Qian Li, Bei-ping Zhang, Shao-gang Huang, Wen-wei Ouyang, Jian-hui Xie, Ze-huai Wen, Xiao-bo Yang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial

Natasha K. Hardicre, Thomas F Crocker, Alan Wright, Louisa-Jane Burton, Seline Ozer, Ross Atkinson, Allan House, Jenny Hewison, Christopher McKevitt, Anne Forster, Amanda J. Farrin, on behalf of the LoTS2Care Programme Management Group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial

Suguru Yamada, Tsutomu Fujii, Manabu Kawai, Toshio Shimokawa, Masafumi Nakamura, Yoshiaki Murakami, Sohei Satoi, Hidetoshi Eguchi, Yuichi Nagakawa, Yasuhiro Kodera, Hiroki Yamaue

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial

Ruchir Trivedi, George Fares, Victoria Barany Nunez, Ryan Campbell, Megyn Clement, Joseph Burleson, Jonathan Himmelfarb, Effie Ioannidou

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: study protocol for a randomised controlled trial

Claire L. Macnamara, Erin Cvejic, Gordon B. Parker, Andrew R. Lloyd, Gina Lee, Jessica E. Beilharz, Ute Vollmer-Conna

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial

Taline Bavaresco, Ananda Ughini Bertoldo Pires, Vítor Monteiro Moraes, Viviane Maria Osmarin, Denise Tolfo Silveira, Amália de Fátima Lucena

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The central mechanism of acupuncture treatment with a long-lasting effect for functional dyspepsia: study protocol for a randomized controlled trial

Ruirui Sun, Xiaojuan Hong, Jing Guo, Shuai Yin, Peiming Feng, Lei Lan, Du Lei, Xiaoyan Liu, Xueling Suo, Tao Yin, Tingting Zhang, Liuyang Huang, Feifei Gao, Qiyong Gong, Fanrong Liang, Fang Zeng

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The outcomes of Perthes’ disease of the hip: a study protocol for the development of a core outcome set

Donato Giuseppe Leo, Wei Yee Leong, Tina Gambling, Andrew Long, Rebecca Murphy, Helen Jones, Daniel Christopher Perry

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial

Ji Man Hong, Mun Hee Choi, Sung-Il Sohn, Yang-Ha Hwang, Seong Hwan Ahn, Yeong-Bae Lee, Dong-Ick Shin, Ángel Chamorro, Dennis W. Choi, on the behalf of the SONIC investigators

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial

Yu Tat Chan, Hong Wei Zhang, Yuan Qi Guo, Tony Ngai Ho Chan, Yiu-Keung Kwan, Chun-Kam Lee, Kit Ngan, Zhi-Xiu Lin

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial

Yakup Kulu, Beat P. Müller-Stich, Omid Ghamarnejad, Elias Khajeh, Georgios Polychronidis, Mohammad Golriz, Felix Nickel, Laura Benner, Philipp Knebel, Markus Diener, Christian Morath, Martin Zeier, Markus W. Büchler, Arianeb Mehrabi

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Learning from OCTET – exploring the acceptability of clinical trials management methods

Catherine Arundel, Judith Gellatly

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Use of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes mellitus and microalbuminuria (FLAVA trial): study protocol for a randomized controlled trial

Mardin Rashid, Adrie J. M. Verhoeven, Monique T. Mulder, Reinier Timman, Yvonne van Beek-Nieuwland, Athumani A. Athumani, Adrienne A. M. Zandbergen, Hans E. van der Wiel, Eric J. G. Sijbrands, Kirsten A. Berk

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial

Philipp Houben, Elias Khajeh, Ulf Hinz, Phillip Knebel, Markus K. Diener, Arianeb Mehrabi

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial

Meili Yu, Siming Li, Siwei Li, Jingen Li, Hao Xu, Keji Chen

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Preventing false discovery of heterogeneous treatment effect subgroups in randomized trials

Joseph Rigdon, Michael Baiocchi, Sanjay Basu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial

A. J. Wade, J. S. Doyle, E. Gane, C. Stedman, B. Draper, D. Iser, S. K. Roberts, W. Kemp, D. Petrie, N. Scott, P. Higgs, P. A. Agius, J. Roney, L. Stothers, A. J. Thompson, M. E. Hellard

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Prophylactic intravitreal 5-fluorouracil and heparin to prevent proliferative vitreoretinopathy in high-risk patients with retinal detachment: study protocol for a randomized controlled trial

Friederike Schaub, Robert Hoerster, Petra Schiller, Moritz Felsch, Daria Kraus, Marouan Zarrouk, Bernd Kirchhof, Sascha Fauser

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial

Qiang Tu, Lily Dongxia Xiao, Shahid Ullah, Jeffrey Fuller, Huiyun Du

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect of transcranial direct current stimulation associated with hypocaloric diet on weight loss and metabolic profile in overweight or obesity: study protocol for a double-blind, randomized controlled clinical trial

Carina de Araujo, Raquel Crespo Fitz, Daniela Albugeri Nogara, Pedro Schestatsky, Fernando Gerchman

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Concurrent exergaming and transcranial direct current stimulation to improve balance in people with Parkinson’s disease: study protocol for a randomised controlled trial

Dale M. Harris, Timo Rantalainen, Makii Muthalib, Liam Johnson, Rachel L. Duckham, Stuart T. Smith, Robin M. Daly, Wei-Peng Teo

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Whole brain radiation therapy alone versus radiosurgery for patients with 1–10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial

Denise Bernhardt, Adriane Hommertgen, Daniela Schmitt, Rami El Shafie, Angela Paul, Laila König, Johanna Mair-Walther, Johannes Krisam, Christina Klose, Thomas Welzel, Juliane Hörner-Rieber, Jutta Kappes, Michael Thomas, Claus Peter Heußel, Martin Steins, Meinhard Kieser, Jürgen Debus, Stefan Rieken

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of traditional Chinese herbal medicine in patients with diabetic kidney disease: study protocol for a randomized controlled trial

Mengdi Wang, Zhen Wang, Jingwei Zhou, Weiwei Sun, Ying Wang, Mei Han, Hanwen Yang, Wei Jing Liu, Yaoxian Wang

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial

James X. Chen, E. Paul Wileyto, Michael C. Soulen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial

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

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Effects of small-dose remifentanil combined with index of consciousness monitoring on gastroscopic polypectomy: a prospective, randomized, single-blinded trial

Minqiang Liu, Hongyan Wu, Danling Yang, Fengxian Li, Zhichao Li, Song Wang, Renliang He

01.12.2018 | Correction | Ausgabe 1/2018 Open Access

Correction to: Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial

Sasha-Denise Grünzig, Harald Baumeister, Jürgen Bengel, David Ebert, Lena Krämer

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial

Ann-Marie Rosland, John D. Piette, Ranak Trivedi, Eve A. Kerr, Shelley Stoll, Adam Tremblay, Michele Heisler

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Prophylactic antibiotics for the prevention of infection following operative vaginal delivery (ANODE): study protocol for a randomised controlled trial

Marian Knight, Linda Mottram, Shan Gray, Christopher Partlett, Ed Juszczak, the ANODE collaborative group

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial

Omar Sued, Isabel Cassetti, Diego Cecchini, Pedro Cahn, Lina Bofill de Murillo, Stephen M. Weiss, Lissa N. Mandell, Manasi Soni, Deborah L. Jones

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial

Jennifer G. Walker, Finlay Macrae, Ingrid Winship, Jasmeen Oberoi, Sibel Saya, Shakira Milton, Adrian Bickerstaffe, James G. Dowty, Richard De Abreu Lourenço, Malcolm Clark, Louise Galloway, George Fishman, Fiona M. Walter, Louisa Flander, Patty Chondros, Driss Ait Ouakrim, Marie Pirotta, Lyndal Trevena, Mark A. Jenkins, Jon D. Emery

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial

James J. Lewis, Xiaoqiu Liu, Zhiying Zhang, Bruce V. Thomas, Anna Vassall, Sedona Sweeney, Xu Caihong, Hu Dongmei, Li Xue, Gao Yongxin, Shitong Huan, Jiang Shiwen, Katherine L. Fielding

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial)

Allan Riis, Jan Hartvigsen, Michael Skovdal Rathleff, Tamana Afzali, Martin Bach Jensen

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving empathy and self-efficacy in caregivers of persons with intellectual disabilities, using m-learning (HiSense APP-ID): study protocol for a randomized controlled trial

Evelien van Wingerden, Paula S. Sterkenburg, Mirjam Wouda

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: study protocol for a feasibility randomised controlled trial

Lucia Macken, Louise Mason, Catherine Evans, Heather Gage, Jake Jordan, Mark Austin, Nick Parnell, Max Cooper, Shani Steer, Justine Boles, Stephen Bremner, Debbie Lambert, David Crook, Gemma Earl, Jean Timeyin, Sumita Verma

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

High flow nasal oxygen after bariatric surgery (OXYBAR), prophylactic post-operative high flow nasal oxygen versus conventional oxygen therapy in obese patients undergoing bariatric surgery: study protocol for a randomised controlled pilot trial

Rachel Fulton, Jonathan E. Millar, Megan Merza, Helen Johnston, Amanda Corley, Daniel Faulke, Ivan Rapchuk, Joe Tarpey, Philip Lockie, Shirley Lockie, John F. Fraser

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial

Huanfang Xu, Hong Zhao, Liping Kang, Shixi Huang, Yin Shi, Wei Su, Mingjuan Han, Wenyan Wang, Chunyan Wang, Yuan Zhang, Lanping Guo

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial

Marisa Tucci, Jacques Lacroix, Dean Fergusson, Allan Doctor, Paul Hébert, Robert A. Berg, Jaime Caro, Cassandra D. Josephson, Stéphane Leteurtre, Kusum Menon, Kenneth Schechtman, Marie E. Steiner, Alexis F. Turgeon, Lucy Clayton, Tina Bockelmann, Philip C. Spinella, for the Canadian Critical Care Trials Group, the Pediatric Critical Care Blood Research Network (BloodNet), the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Yoga and breathing technique training in patients with heart failure and preserved ejection fraction: study protocol for a randomized clinical trial

Carla Pinheiro Lopes, Luiz Claudio Danzmann, Ruy Silveira Moraes, Paulo José Cardoso Vieira, Francisco França Meurer, Douglas Santos Soares, Gaspar Chiappa, Luciano Santos Pinto Guimarâes, Santiago Alonso Tobar Leitão, Jorge Pinto Ribeiro, Andreia Biolo

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

Sean Grant, Evan Mayo-Wilson, Paul Montgomery, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, , on behalf of the CONSORT-SPI Group

01.12.2018 | Methodology | Ausgabe 1/2018 Open Access

Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

Paul Montgomery, Sean Grant, Evan Mayo-Wilson, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, on behalf of the CONSORT-SPI Group

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)

Nefyn H. Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A. Hughes, Eifiona Wood, Nadine E. Foster, David Walsh, Dawn Carnes, Valerie Sparkes, Elaine M. Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay, Clare Wilkinson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Robotic versus laparoscopic gastrectomy with lymph node dissection for gastric cancer: study protocol for a randomized controlled trial

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

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Comparison of registered and published intervention fidelity assessment in cluster randomised trials of public health interventions in low- and middle-income countries: systematic review

Myriam Cielo Pérez, Nanor Minoyan, Valéry Ridde, Marie-Pierre Sylvestre, Mira Johri

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving work for the body – a participatory ergonomic intervention aiming at reducing physical exertion and musculoskeletal pain among childcare workers (the TOY-project): study protocol for a wait-list cluster-randomized controlled trial

Charlotte Diana Nørregaard Rasmussen, Peter Rasmus Hendriksen, Malene Jagd Svendsen, Dorte Ekner, Klaus Hansen, Ole Henning Sørensen, Susanne Wulff Svendsen, Allard J. van der Beek, Andreas Holtermann

01.12.2018 | Research | Ausgabe 1/2018 Open Access

The effect of SODIS water treatment intervention at the household level in reducing diarrheal incidence among children under 5 years of age: a cluster randomized controlled trial in Dabat district, northwest Ethiopia

Bikes Destaw Bitew, Yigzaw Kebede Gete, Gashaw Andargie Biks, Takele Tadesse Adafrie

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Assessment of the effect of addition of 24 hours of oral tranexamic acid post-operatively to a single intraoperative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty (TRAC-24): a study protocol for a randomised controlled trial

Janet Hill, Paul Magill, Alastair Dorman, Rosemary Hogg, Andrew Eggleton, Gary Benson, Margaret McFarland, Lynn Murphy, Evie Gardner, Leeann Bryce, Una Martin, Catherine Adams, Jennifer Bell, Christina Campbell, Ashley Agus, Glenn Phair, Dennis Molloy, Brian Mockford, Seamus O’Hagan, David Beverland

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Cognitive behavioral intervention via a smartphone app for non-professional caregivers with depressive symptoms: study protocol for a randomized controlled trial

Fernando L. Vázquez, Ángela Torres, Olga Díaz, Mario Páramo, Patricia Otero, Vanessa Blanco, Lara López

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial

Ashleigh Guillaumier, Victoria Manning, Olivia Wynne, Coral Gartner, Ron Borland, Amanda L. Baker, Catherine J. Segan, Eliza Skelton, Lyndell Moore, Ramez Bathish, Dan I. Lubman, Billie Bonevski

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Combined pretreatment with 18F-FDG PET/CT and Comet assay guides the concurrent chemoradiotherapy of locally advanced cervical cancer: study protocol for a randomized controlled trial

Shengjun Ji, Qunchao Hu, Jiahao Zhu, Jie Chen, Qingqing Chen, Zhengcao Liu, Chen Shen, Ru Yang, Haoyao Sun, Jinchang Wu, Ke Gu

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Gender-specific HIV and substance abuse prevention strategies for South African men: study protocol for a randomized controlled trial

Mary Jane Rotheram-Borus, Mark Tomlinson, Andile Mayekiso, Jason Bantjes, Danielle M. Harris, Jacqueline Stewart, Robert E. Weiss

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: a study protocol for a randomized controlled trial

Laura K. Murray, Emily E. Haroz, S. Benjamin Doty, Namrita S. Singh, Sergey Bogdanov, Judith Bass, Shannon Dorsey, Paul Bolton

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study

Hayley C. Prout, Allan Barham, Emily Bongard, Rhiannon Tudor-Edwards, Gareth Griffiths, Willie Hamilton, Emily Harrop, Kerry Hood, Chris N. Hurt, Rosie Nelson, Catherine Porter, Kirsty Roberts, Trevor Rogers, Emma Thomas-Jones, Angela Tod, Seow Tien Yeo, Richard D. Neal, Annmarie Nelson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Evaluating the impact of Marie Stopes International’s digital family planning counselling application on the uptake of long-acting and permanent methods of contraception in Vietnam and Ethiopia: a study protocol for a multi-country cluster randomised controlled trial

Laura A. Bates, Joseph P. Hicks, John Walley, Emily Robinson

01.12.2018 | Update | Ausgabe 1/2018 Open Access

Statistical analysis plan for the Healthy Hands Project; single centre cluster-randomised clinical trial of a skin care program for the prevention of contact dermatitis in health care workers

Maryam Soltanipoor, Sanja Kezic, Judith Sluiter, Rebecca Holman

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial

Rachel Wells, Macy L. Stockdill, J. Nicholas Dionne-Odom, Deborah Ejem, Kathryn L. Burgio, Raegan W. Durant, Sally Engler, Andres Azuero, Salpy V. Pamboukian, Jose Tallaj, Keith M. Swetz, Elizabeth Kvale, Rodney O. Tucker, Marie Bakitas

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Strengthening mental health and research training in Sub-Saharan Africa (SMART Africa): Uganda study protocol

Fred M. Ssewamala, Ozge Sensoy Bahar, Mary M. McKay, Kimberly Hoagwood, Keng-Yen Huang, Beverly Pringle

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Dose-response relationship of core-specific sensorimotor interventions in healthy, well-trained participants: study protocol for a (MiSpEx) randomized controlled trial

Juliane Mueller, Josefine Stoll, Steffen Mueller, Frank Mayer

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Improving physical activity, pain and function in patients waiting for hip and knee arthroplasty by combining targeted exercise training with behaviour change counselling: study protocol for a randomised controlled trial

Jane O’Brien, Kyra Hamilton, Andrew Williams, James Fell, Jonathan Mulford, Michael Cheney, Sam Wu, Marie-Louise Bird

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Effects of ultrasound-guided stellate ganglion block on cervical vascular blood flow: study protocol for a randomized controlled trial

Shaofeng Pu, Jie Chen, Xing Gu, Yongming Xu, Junzhen Wu, Yingying Lv, Dongping Du

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set

Nicola L. Harman, John Wilding, Dave Curry, James Harris, Jennifer Logue, R. John Pemberton, Leigh Perreault, Gareth Thompson, Sean Tunis, Paula R. Williamson, on behalf of the SCORE-IT study team

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial

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

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial

Nikhil Srinivasapura Venkateshmurthy, Vamadevan S Ajay, Sailesh Mohan, Devraj Jindal, Shuchi Anand, Dimple Kondal, Nikhil Tandon, Malipeddi Bhaskara Rao, Dorairaj Prabhakaran

01.12.2018 | Correction | Ausgabe 1/2018 Open Access

Correction to: Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys

Alice M. Biggane, Lucy Brading, Philippe Ravaud, Bridget Young, Paula R. Williamson

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Whey protein supplementation for the preservation of mass and muscular strength of patients with heart failure: study protocol for a randomized controlled trial

Elisa Maia dos Santos, Roger de Moraes, Eduardo Vera Tibiriça, Grazielle Vilas Bôas Huguenin, Annie Seixas Belo Moreira, Andrea Rocha De Lorenzo

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Prospective randomized controlled trial to compare laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision, D2 + CME) with conventional D2 lymphadenectomy for locally advanced gastric adenocarcinoma: study protocol for a randomized controlled trial

Jie Shen, Beibei Cao, Yatao Wang, Aitang Xiao, Jichao Qin, Jianhong Wu, Qun Yan, Yuanlong Hu, Chuanyong Yang, Zhixin Cao, Junbo Hu, Ping Yin, Daxing Xie, Jianping Gong

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

0Phobia – towards a virtual cure for acrophobia: study protocol for a randomized controlled trial

T. Donker, S. Van Esveld, N. Fischer, A. Van Straten

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Using acute tryptophan depletion to investigate predictors of treatment response in adolescents with major depressive disorder: study protocol for a randomised controlled trial

Richard M. Stewart, Sean D. Hood, Pradeep Rao, Julia K. Moore, Kevin C. Runions, Susannah E. Murphy, Janice W. Y. Wong, Florian D. Zepf

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Reducing violence against children by implementing the preventative intervention Interaction Competencies with Children for Teachers (ICC-T): study protocol for a cluster randomized controlled trial in Southwestern Uganda

Joseph Ssenyonga, Katharin Hermenau, Mabula Nkuba, Tobias Hecker

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder: study protocol for pilot randomised controlled trial

Emma O’Donoghue, Abigail Clark, Matthew Richardson, John Hodsoll, Sunil Nandha, Eric Morris, Fergus Kane, Deirdre O’Keeffe, Lucy Butler, Suzanne Jolley

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The EKSPECT study: the influence of Expectation modification in Knee arthroplasty on Satisfaction of PatiEnts: study protocol for a randomized Controlled Trial

Jaap J. Tolk, Rob P. A. Janssen, Tsjitske M. Haanstra, Sita M. A. Bierma-Zeinstra, Max Reijman

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial

Anja Siegle, Matthias Villalobos, Jasmin Bossert, Katja Krug, Laura Hagelskamp, Johannes Krisam, Violet Handtke, Nicole Deis, Jana Jünger, Michel Wensing, Michael Thomas

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

The “Wholesome Contact” non-pharmacological, volunteer-delivered multidisciplinary programme to prevent hospital delirium in elderly patients: study protocol for a randomised controlled trial

Karolina Piotrowicz, Krzysztof Rewiuk, Stanisław Górski, Weronika Kałwak, Barbara Wizner, Agnieszka Pac, Michał Nowakowski, Tomasz Grodzicki

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Heterogeneous perception of the ethical legitimacy of unbalanced randomization by institutional review board members: a clinical vignette-based survey

Clarisse Dibao-Dina, Agnès Caille, Bruno Giraudeau

01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial

Mads Gustaf Jørgensen, Navid Mohamadpour Toyserkani, Nana Hyldig, Annette Hougaard Chakera, Lisbet Rosenkrantz Hölmich, Jørn Bo Thomsen, Jens Ahm Sørensen

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Partial factorial trials: comparing methods for statistical analysis and economic evaluation

Helen A. Dakin, Alastair M. Gray, Graeme S. MacLennan, Richard W. Morris, David W. Murray