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  1. Ticagrelor is a reversibly binding, direct-acting, oral, P2Y12 antagonist used for the prevention of atherothrombotic events in patients with coronary artery disease (CAD). Ticagrelor blocks adenosine reuptake th...

    Authors: D. D’Amario, A. Restivo, A. M. Leone, R. Vergallo, S. Migliaro, F. Canonico, M. Galli, C. Trani, F. Burzotta, C. Aurigemma, G. Niccoli, A. Buffon, R. A. Montone, A. Flex, F. Franceschi, G. Tinelli…
    Citation: Trials 2020 21:192
    Content type: Study protocol Published on:

  2. Unhealthy alcohol use is a leading cause of morbidity and mortality among young people, including university students. Delivering secondary prevention interventions against unhealthy alcohol use is challenging...

    Authors: Nicolas Bertholet, Elodie Schmutz, Véronique S. Grazioli, Mohamed Faouzi, Jennifer McNeely, Gerhard Gmel, Jean-Bernard Daeppen and John A. Cunningham
    Citation: Trials 2020 21:191
    Content type: Study protocol Published on:

  3. Approximately one in four pregnant women undergo an induction of labour. The purpose of this study is to investigate the clinical effectiveness, safety, and cost-effectiveness for mothers and babies of two met...

    Authors: Michelle R. Wise, Joy Marriott, Malcolm Battin, John M. D. Thompson, Michael Stitely and Lynn Sadler
    Citation: Trials 2020 21:190
    Content type: Study protocol Published on:

  4. Informal caregivers report substantial burden and depressive symptoms which predict higher rates of patient institutionalization. While caregiver education interventions may reduce caregiver distress and decre...

    Authors: Megan Shepherd-Banigan, Valerie A. Smith, Jennifer H. Lindquist, Michael Paul Cary Jr., Katherine E. M. Miller, Jennifer G. Chapman and Courtney H. Van Houtven
    Citation: Trials 2020 21:189
    Content type: Research Published on:

  5. Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65 years and above. More effective ways to manage dem...

    Authors: Amanda Timler, Caroline Bulsara, Max Bulsara, Alistair Vickery, Jill Smith and Jim Codde
    Citation: Trials 2020 21:188
    Content type: Study protocol Published on:

  6. Earlier, we designed and evaluated an educational mass media intervention for improving people’s ability to think more critically and to assess the trustworthiness of claims (assertions) about the benefits and...

    Authors: Daniel Semakula, Allen Nsangi, Andrew D. Oxman, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Christopher J. Rose and Nelson K. Sewankambo
    Citation: Trials 2020 21:187
    Content type: Research Published on:

  7. Mexico has one of the highest prevalence rates of obesity worldwide. New pharmacological strategies that focus on people with class III obesity are required. Metformin and dapagliflozin are two drugs approved ...

    Authors: Aldo Ferreira-Hermosillo, Mario Antonio Molina-Ayala, Diana Molina-Guerrero, Ana Pamela Garrido-Mendoza, Claudia Ramírez-Rentería, Victoria Mendoza-Zubieta, Etual Espinosa and Moisés Mercado
    Citation: Trials 2020 21:186
    Content type: Study protocol Published on:

  8. Germany hosts a large number of refugees from war-affected countries. The integration of refugees, in particular young refugees from the Middle East, is one of the major current social challenges in Germany. M...

    Authors: Sarah Wilker, Claudia Catani, Jasmin Wittmann, Melissa Preusse, Telja Schmidt, Theodor May, Verena Ertl, Bettina Doering, Rita Rosner, Areej Zindler and Frank Neuner
    Citation: Trials 2020 21:185
    Content type: Study protocol Published on:

    The Update to this article has been published in Trials 2022 23:360

  9. Individuals affected by stroke present with changes in cardiovascular and respiratory functions. Cardiorespiratory training (CRT) is one of the classic intervention guidelines for cardiorespiratory fitness. CR...

    Authors: Renata Janaína Pereira de Souza, Daniella Cunha Brandão, José Vicente Martins, Juliana Fernandes and Armele Dornelas de Andrade
    Citation: Trials 2020 21:184
    Content type: Study protocol Published on:

  10. Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect i...

    Authors: Lesley Sinclair, Margaret McFadden, Helen Tilbrook, Alex Mitchell, Ada Keding, Judith Watson, Linda Bauld, Frank Kee, David Torgerson, Catherine Hewitt, Jennifer McKell, Pat Hoddinott, Fiona M. Harris, Isabelle Uny, Kathleen Boyd, Nicola McMeekin…
    Citation: Trials 2020 21:183
    Content type: Study protocol Published on:

  11. Dengue is increasing in its global presence with an estimated 4 billion people at-risk of infection in at least 128 countries. Despite the promising results of EcoHealth and community mobilization approaches to A...

    Authors: Kate Zinszer, Andrea Caprara, Antonio Lima, Stéphanie Degroote, Monica Zahreddine, Kellyanne Abreu, Mabel Carabali, Katia Charland, Mayana Azevedo Dantas, José Wellington, Beatriz Parra, Florence Fournet, Emmanuel Bonnet, Denis Pérez, Emilie Robert, Christian Dagenais…
    Citation: Trials 2020 21:182
    Content type: Study protocol Published on:

  12. Tuberculosis (TB) is a significant public health problem that causes substantial morbidity and mortality. Current first-line anti-TB chemotherapy, although very effective, has limitations including long-treatm...

    Authors: Ruth Nabisere, Joseph Musaazi, Paolo Denti, Florence Aber, Mohammed Lamorde, Kelly E. Dooley, Rob Aarnoutse, Derek J. Sloan and Christine Sekaggya-Wiltshire
    Citation: Trials 2020 21:181
    Content type: Study protocol Published on:

  13. This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals’ f...

    Authors: E. Q. Silva, E. Y. Suda, D. P. Santos, J. L. Veríssimo, J. S. S. P. Ferreira, R. H. Cruvinel Júnior, R. L. Monteiro, C. D. Sartor and I. C. N. Sacco
    Citation: Trials 2020 21:180
    Content type: Study protocol Published on:

  14. Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasti...

    Authors: Katherine J. Rennie, James O’Hara, Nikki Rousseau, Deborah Stocken, Denise Howel, Laura Ternent, Mike Drinnan, Alison Bray, Leila Rooshenas, David W. Hamilton, Alison Steel, Tony Fouweather, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Alaa Abouhajar…
    Citation: Trials 2020 21:179
    Content type: Study protocol Published on:

  15. The population of adult patients with early-treated phenylketonuria (PKU) following newborn screening is growing substantially. The ideal target range of blood phenylalanine (Phe) levels in adults outside preg...

    Authors: Roman Trepp, Raphaela Muri, Stephanie Abgottspon, Lenka Bosanska, Michel Hochuli, Johannes Slotboom, Christian Rummel, Roland Kreis and Regula Everts
    Citation: Trials 2020 21:178
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2020 21:561

  16. Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with l...

    Authors: Sang-Hyun Lee, Byung-Jun Kim, In-Hwa Park, Eui-Hyoung Hwang, Eun Ju Park, Insoo Jang and Man-Suk Hwang
    Citation: Trials 2020 21:177
    Content type: Study protocol Published on:

  17. Evidence for the add-on effect of kinesiotape (KT) with acupuncture for treating ankle sprains remains insufficient. We assessed the add-on effect of KT on ankle sprains by comparing acupuncture combined with ...

    Authors: Jeong-Cheol Shin, Jae-Hong Kim, Dongwoo Nam, Gwang-Cheon Park and Jeong-Soon Lee
    Citation: Trials 2020 21:176
    Content type: Research Published on:

  18. SABATO (Staphylococcus aureus bacteremia antibiotic treatment options) is a randomized, parallel-group, clinical non-inferiority trial designed to examine the efficacy and safety of early oral switch therapy in l...

    Authors: Achim J. Kaasch, Anna Rommerskirchen, Martin Hellmich, Gerd Fätkenheuer, Reinhild Prinz-Langenohl, Siegbert Rieg, Winfried V. Kern and Harald Seifert
    Citation: Trials 2020 21:175
    Content type: Update Published on:

    The Study protocol to this article has been published in Trials 2015 16:450

  19. Multimorbidity affects four of ten US adults and eight of ten adults ages 65 years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns. Hispanics/Latinos (hereafte...

    Authors: Linda C. Gallo, Addie L. Fortmann, Julia I. Bravin, Taylor L. Clark, Kimberly L. Savin, Duvia Lara Ledesma, Johanna Euyoque, Haley Sandoval, Scott C. Roesch, Todd Gilmer, Gregory A. Talavera and Athena Philis-Tsimikas
    Citation: Trials 2020 21:174
    Content type: Study protocol Published on:

  20. Sexual concerns are distressing for breast cancer survivors and interfere with their intimate relationships. This study evaluates the efficacy of a four-session couple-based intervention delivered via telephon...

    Authors: Jennifer Barsky Reese, Lauren A. Zimmaro, Stephen J. Lepore, Kristen A. Sorice, Elizabeth Handorf, Mary B. Daly, Leslie R. Schover, Deborah Kashy, Kelly Westbrook and Laura S. Porter
    Citation: Trials 2020 21:173
    Content type: Study protocol Published on:

  21. After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.

    Authors: Frank Tegtmeier, Reinhard Schinzel, Ronny Beer, Diederik Bulters, Jean-Yves LeFrant, Joan Sahuquillo, Andreas Unterberg, Peter Andrews, Antonio Belli, Javier Ibanez, Alfonso Lagares, Michael Mokry, Harald Willschke, Charlotte Flüh and Erich Schmutzhard
    Citation: Trials 2020 21:172
    Content type: Correction Published on:

    The original article was published in Trials 2020 21:80

  22. Patients with rheumatoid arthritis spend most of their daily hours in sedentary behavior (sitting), a predisposing factor to poor health-related outcomes and all-cause mortality. Interventions focused on reduc...

    Authors: Ana Jessica Pinto, Tiago Peçanha, Kamila Meireles, Fabiana Braga Benatti, Karina Bonfiglioli, Ana Lúcia de Sá Pinto, Fernanda Rodrigues Lima, Rosa Maria Rodrigues Pereira, Maria Claudia Costa Irigoyen, James Edward Turner, John P. Kirwan, Neville Owen, David W. Dunstan, Hamilton Roschel and Bruno Gualano
    Citation: Trials 2020 21:171
    Content type: Study protocol Published on:

  23. Necrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at < 30 weeks’ gestation. The incidence of NEC is reduced when infants are fed human milk. However, in many neonatal int...

    Authors: Huiqing Sun, Yun Cao, Shuping Han, Rui Cheng, Ling Liu, Jiangqin Liu, Shiwen Xia, Jiajie Zhang, Zhankui Li, Xiuyong Cheng, Chuanzhong Yang, Xinnian Pan, Long Li, Xin Ding, Rensheng Wang, Mingyuan Wu…
    Citation: Trials 2020 21:170
    Content type: Study protocol Published on:

  24. Polycystic ovary syndrome (PCOS) is a complex endocrine syndrome with poorly understood mechanisms. To provide patients with PCOS with individualized therapy, it is critical to precisely diagnose the phenotype...

    Authors: Cheng-Ming Ni, Wen-Long Huang, Yan-Min Jiang, Juan Xu, Ru Duan, Yun-Long Zhu, Xu-Ping Zhu, Xue-Mei Fan, Guo-An Luo, Yi-Ming Wang, Yan-Yu Li, Qing He and Lan Xu
    Citation: Trials 2020 21:169
    Content type: Study protocol Published on:

  25. The treatment and management of long-term health conditions is the greatest challenge facing health systems around the world today. Innovative approaches to patient care in the community such as Anticipatory C...

    Authors: Kevin Brazil, David Scott, Emma Wallace, Mike Clarke, Tom Fahey, Patrick Gillespie, Peter O’Halloran, Christopher Cardwell, Gillian Carter, Kieran McGlade and Frank Doyle
    Citation: Trials 2020 21:168
    Content type: Study protocol Published on:

  26. Unemployment is highly prevalent in populations with alcohol and drug dependence and the employment support offered in addiction-treatment programmes is ineffective. Individual Placement and Support (IPS) is a...

    Authors: John Marsden, Paul Anders, Helen Clark, Kyriacos Colocassis, Brian Eastwood, Jonathan Knight, Alexandra Melaugh, David Quinn, Virginia Wright and Jez Stannard
    Citation: Trials 2020 21:167
    Content type: Study protocol Published on:

  27. Urgency is a complaint of sudden, compelling desire to pass urine, which is difficult to defer, caused by involuntary contraction of the detrusor muscle during the bladder-filling stage. To enable detrusor inh...

    Authors: Juliana Falcão Padilha, Mariana Arias Avila, Enio Júnior Seidel and Patricia Driusso
    Citation: Trials 2020 21:166
    Content type: Study protocol Published on:

  28. Prophylactic augmentation of the wound with mesh proposed by Kniepeiss et al is the world's first attempt to significantly reduce the risk of postoperative hernia in liver transplantation. Similar technique ha...

    Authors: Janusz Maciej Strzelczyk
    Citation: Trials 2020 21:165
    Content type: Letter Published on:

    The original article was published in Trials 2019 20:371

  29. Primary dysmenorrhoea (PDM) is defined as a series of pain-dominated symptoms during and after menstruation without organic lesions. Nonsteroidal anti-inflammatory drugs and oral contraceptives are usually rec...

    Authors: Shanshan Liu, Lezheng Wang and Jian Yang
    Citation: Trials 2020 21:164
    Content type: Study protocol Published on:

  30. Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacu...

    Authors: Shanshan Li, Qing Zhang, Xuan Yin, Hongyu Yue, Wei Zhang, Lixing Lao, Zhangjin Zhang, Huangan Wu and Shifen Xu
    Citation: Trials 2020 21:163
    Content type: Study protocol Published on:

  31. Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patients. One of ...

    Authors: Mahsa Malekahmadi, Omid Moradi Moghaddam, Sheikh Mohammed Shariful Islam, Kiarash Tanha, Mohsen Nematy, Naseh Pahlavani, Safieh Firouzi, Mohammad Reza Zali and Abdolreza Norouzy
    Citation: Trials 2020 21:162
    Content type: Study protocol Published on:

  32. Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for...

    Authors: Gara Arteaga-Henríquez, Silvia Karina Rosales-Ortiz, Alejandro Arias-Vásquez, Istvan Bitter, Ylva Ginsberg, Pol Ibañez-Jimenez, Tünde Kilencz, Catharina Lavebratt, Silke Matura, Andreas Reif, Janos Rethelyi, Vanesa Richarte, Nanda Rommelse, Anne Siegl and J. Antoni Ramos-Quiroga
    Citation: Trials 2020 21:161
    Content type: Study protocol Published on:

  33. Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of ...

    Authors: Diana L. Dyrberg, Gudjon L. Gunnarsson, Camilla Bille, Jens A. Sørensen and Jørn B. Thomsen
    Citation: Trials 2020 21:160
    Content type: Study protocol Published on:

  34. Whether they are injected peri- or intraocularly, corticosteroids are still essential tools in the therapeutic arsenal for treating inflammatory macular oedema. A few years ago, however, only triamcinolone ace...

    Authors: Chloé Couret, Alexandra Poinas, Christelle Volteau, Valery-Pierre Riche, Marie-Laure Le Lez, Marie-Hélène Errera, Catherine Creuzot-Garcher, Stéphanie Baillif, Laurent Kodjikian, Catherine Ivan, Laurence Mathilde Le Jumeau de Kergaradec, Anne Chiffoleau, Alexandra Jobert, Julie Jaulin, Laetitia Biron, Elisabeth Hervouet…
    Citation: Trials 2020 21:159
    Content type: Study protocol Published on:

  35. Current treatment options for Palmoplantar Pustulosis (PPP), a debilitating chronic skin disease which affects the hands and feet, are limited. The Anakinra for Pustular psoriasis: Response in a Controlled Tri...

    Authors: Suzie Cro, Prakash Patel, Jonathan Barker, David A. Burden, Christopher E. M. Griffiths, Helen J. Lachmann, Nick J. Reynolds, Richard B. Warren, Francesca Capon, Catherine Smith and Victoria Cornelius
    Citation: Trials 2020 21:158
    Content type: Update Published on:

    The Study protocol to this article has been published in Trials 2018 19:465

  36. Depressive disorders are a leading cause of disability, but current behavioural and pharmacological therapies have a slow onset of response, typically taking several weeks before achieving efficacy. Prior stud...

    Authors: Joseph C. C. Chen, Rachael L. Sumner, Venkat Krishnamurthy Naga, Nicholas Hoeh, Hafis Adetokunbo Ayeni, Vikrant Singh, Frederick Sundram, Douglas Campbell and Suresh Muthukumaraswamy
    Citation: Trials 2020 21:157
    Content type: Study protocol Published on:

  37. Retrospective exploratory analyses of randomised controlled trials (RCTs) seeking to identify treatment effect heterogeneity (TEH) are prone to bias and false positives. Yet the desire to learn all we can from...

    Authors: James A. Watson and Chris C. Holmes
    Citation: Trials 2020 21:156
    Content type: Methodology Published on:

  38. Both methotrexate (MTX) and leflunomide (LEF) are registered and regularly prescribed as first-line treatments for the use in patients with psoriatic arthritis (PsA) and they are occasionally used in combinati...

    Authors: Michelle L. M. Mulder, Johanna E. Vriezekolk, Nathan den Broeder, Elien A. M. Mahler, Philip S. Helliwell, Frank H. J. van den Hoogen, Alfons A. den Broeder and Mark H. Wenink
    Citation: Trials 2020 21:155
    Content type: Study protocol Published on:

  39. With 7.7 million South Africans currently infected with human immunodeficiency virus (HIV) and 4.8 million currently receiving antiretroviral treatment (ART), the epidemic represents a considerable burden for ...

    Authors: Caroline Masquillier, Lucia Knight, Linda Campbell, Neo Sematlane, Anton Delport, Tanyaradzwa Dube and Edwin Wouters
    Citation: Trials 2020 21:154
    Content type: Study protocol Published on:

  40. The prevalence rates of childhood obesity are increasing. The current multidisciplinary treatments for (childhood) obesity are effective but only moderately and in the short term. A possible explanation for th...

    Authors: Taaike Debeuf, Sandra Verbeken, Elisa Boelens, Brenda Volkaert, Eva Van Malderen, Nathalie Michels and Caroline Braet
    Citation: Trials 2020 21:153
    Content type: Study protocol Published on:

  41. Thanks to advancements in medical care, a majority of patients with sickle cell disease (SCD) worldwide live beyond 18 years of age, and therefore, patients initially followed in paediatric departments are the...

    Authors: Delphine Hoegy, Nathalie Bleyzac, Alexandra Gauthier-Vasserot, Giovanna Cannas, Angélique Denis, Arnaud Hot, Yves Bertrand, Pauline Occelli, Sandrine Touzet, Claude Dussart and Audrey Janoly-Dumenil
    Citation: Trials 2020 21:152
    Content type: Study protocol Published on:

  42. Maternal mortality is still high in Ethiopia. Antenatal care, the use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in ...

    Authors: Netsanet Belete Andargie, Mulusew Gerbaba Jebena and Gurmesa Tura Debelew
    Citation: Trials 2020 21:151
    Content type: Study protocol Published on:

  44. The objective of this trial is to investigate the effects of protective lung ventilation on regional cerebral oxygen saturation (rSO2) during dura opening, that is from Ta (after dura opening) to Tb (before dura ...

    Authors: Jinlu Li, Xuemei Wu, Hairui Liu, Ying Huang, Yueqin Liu, Hong Xie and Jun Dong
    Citation: Trials 2020 21:149
    Content type: Study protocol Published on:

  45. Cluster randomized trials (CRTs) are a design used to test interventions where individual randomization is not appropriate. The mixed model for repeated measures (MMRM) is a popular choice for individually ran...

    Authors: Melanie L. Bell and Brooke A. Rabe
    Citation: Trials 2020 21:148
    Content type: Methodology Published on:

  46. Antipsychotic medication is effective for symptomatic treatment in schizophrenia-spectrum disorders. After symptom remission, continuation of antipsychotic treatment is associated with lower relapse rates and ...

    Authors: Marieke J. H. Begemann, Ilse A. Thompson, Wim Veling, Shiral S. Gangadin, Chris N. W. Geraets, Erna van ‘t Hag, Sanne J. Müller-Kuperus, Priscilla P. Oomen, Alban E. Voppel, Mark van der Gaag, Martijn J. Kikkert, Jim Van Os, H. Filip E. Smit, Rikus H. Knegtering, Sybren Wiersma, Luyken H. Stouten…
    Citation: Trials 2020 21:147
    Content type: Study protocol Published on:

  47. Gestational diabetes mellitus (GDM) is associated with an increased risk of future diabetes in both mother, father and offspring. More knowledge is needed about how to effectively reduce the risk of diabetes t...

    Authors: Karoline Kragelund Nielsen, Inger Katrine Dahl-Petersen, Dorte Møller Jensen, Per Ovesen, Peter Damm, Nanna Husted Jensen, Maja Thøgersen, Anne Timm, Line Hillersdal, Ulla Kampmann, Christina Anne Vinter, Elisabeth Reinhardt Mathiesen and Helle Terkildsen Maindal
    Citation: Trials 2020 21:146
    Content type: Study protocol Published on:

  48. Non-inferiority trials are increasingly used to evaluate new treatments that are expected to have secondary advantages over standard of care, but similar efficacy on the primary outcome. When designing a non-i...

    Authors: Matteo Quartagno, A. Sarah Walker, Abdel G. Babiker, Rebecca M. Turner, Mahesh K. B. Parmar, Andrew Copas and Ian R. White
    Citation: Trials 2020 21:145
    Content type: Methodology Published on:

  49. There are several open scientific questions regarding the optimal antibiotic treatment of spinal infections (SIs) with or without an implant. The duration of postsurgical antibiotic therapy is debated.

    Authors: Michael Betz, Ilker Uçkay, Regula Schüpbach, Tanja Gröber, Sander M. Botter, Jan Burkhard, Dominique Holy, Yvonne Achermann and Mazda Farshad
    Citation: Trials 2020 21:144
    Content type: Study protocol Published on:

  50. Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder...

    Authors: Yunxuan Huang, Jiabi Zhang, Buhui Xiong, Ruina Huang, Wenjing Zhao, Mengxue Zhou, Qi Chen, Danghan Xu and Xinghua Chen
    Citation: Trials 2020 21:143
    Content type: Study protocol Published on:
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