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  1. Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with ph...

    Authors: Anouk S. Schuit, Karen Holtmaat, Nienke Hooghiemstra, Femke Jansen, Birgit I. Lissenberg-Witte, Veerle M. H. Coupé and Irma M. Verdonck-de Leeuw
    Citation: Trials 2020 21:124
    Content type: Study protocol Published on:

  2. Bronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors and one of the most common chronic lung diseases. It has a poor prognosis, especially in preterm infants. Ho...

    Authors: Xian Wu, Yunqiu Xia, Ou Zhou, Yan Song, Xianhong Zhang, Daiyin Tian, Qubei Li, Chang Shu, Enmei Liu, Xiaoping Yuan, Ling He, Chengjun Liu, Jing Li, Xiaohua Liang, Ke Yang, Zhou Fu…
    Citation: Trials 2020 21:125
    Content type: Study protocol Published on:

  3. There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in ...

    Authors: Melissa M. Medvedev, Victor Tumukunde, Ivan Mambule, Cally J. Tann, Peter Waiswa, Ruth R. Canter, Christian H. Hansen, Elizabeth Ekirapa-Kiracho, Kenneth Katumba, Catherine Pitt, Giulia Greco, Helen Brotherton, Diana Elbourne, Janet Seeley, Moffat Nyirenda, Elizabeth Allen…
    Citation: Trials 2020 21:126
    Content type: Study protocol Published on:

  4. The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and dur...

    Authors: Sunita Taneja, Ranadip Chowdhury, Neeta Dhabhai, Sarmila Mazumder, Ravi Prakash Upadhyay, Sitanshi Sharma, Rupali Dewan, Pratima Mittal, Harish Chellani, Rajiv Bahl, Maharaj Kishan Bhan and Nita Bhandari
    Citation: Trials 2020 21:127
    Content type: Study protocol Published on:

  5. The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liv...

    Authors: Kyungsun Han, Ojin Kwon, Hyo-ju Park, So-Young Jung, Changsop Yang and Chang-Gue Son
    Citation: Trials 2020 21:128
    Content type: Study protocol Published on:

  6. In acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sl...

    Authors: Henrik Fox, Andrea Hetzenecker, Stefan Stadler, Olaf Oldenburg, Okka W. Hamer, Florian Zeman, Leonhard Bruch, Mirko Seidel, Stefan Buchner and Michael Arzt
    Citation: Trials 2020 21:129
    Content type: Study protocol Published on:

  7. Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. The...

    Authors: Kyeong Tae Kim, Sophie Morton, Sarah Howe, Yeong Shiong Chiew, Jennifer L. Knopp, Paul Docherty, Christopher Pretty, Thomas Desaive, Balazs Benyo, Akos Szlavecz, Knut Moeller, Geoffrey M. Shaw and J. Geoffrey Chase
    Citation: Trials 2020 21:130
    Content type: Study protocol Published on:

  8. Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. For patients with heart failure, atrial fibrillation or therapy-resistant hypertensio...

    Authors: Andreas Ziegler, Miriam Mann, Bernard Brandewiede, Hermann Dittrich, Sissy Hintz, Katja Krockenberger, Alper Öner, Marcos Oliviera de Sousa and Christian Schmidt
    Citation: Trials 2020 21:131
    Content type: Update Published on:

    The Study protocol to this article has been published in Trials 2018 19:120

  9. The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyl...

    Authors: Louise C. Mâsse, Janae Vlaar, Janice Macdonald, Jennifer Bradbury, Tom Warshawski, E. Jean Buckler, Jill Hamilton, Josephine Ho, Annick Buchholz, Katherine M. Morrison and Geoff D. C. Ball
    Citation: Trials 2020 21:132
    Content type: Study protocol Published on:

  10. Doll therapy is a non-pharmacological intervention for people with dementia aimed to reduce distressing behaviours. Reliable results on the efficacy of Doll therapy for people with dementia are needed. The con...

    Authors: Roberta Vaccaro, Roberta Ballabio, Valentina Molteni, Laura Ceppi, Benedetta Ferrari, Marco Cantù, Daniele Zaccaria, Carla Vandoni, Rita Bianca Ardito, Mauro Adenzato, Barbara Poletti, Antonio Guaita and Rita Pezzati
    Citation: Trials 2020 21:133
    Content type: Study protocol Published on:

  11. Even though the effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention of hypertension and its complications have been demonstrated in randomized controlled t...

    Authors: Liqiang Zheng, Yali Wang, Sitong Liu, Rui Zheng, Dongmei Pei, Yingxian Sun and Zhaoqing Sun
    Citation: Trials 2020 21:134
    Content type: Study protocol Published on:

  12. Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. T...

    Authors: Weiqiang Yang, Xiaoling Li, Jiatao Zhong, Xueshuang Mei, Hongyu Liu, Le Yang, Liming Lu and Hongyi Hu
    Citation: Trials 2020 21:135
    Content type: Study protocol Published on:

  13. The GABAA-α5 receptor antagonist S44819 is a promising candidate to enhance functional recovery after acute ischemic stroke (IS). S44819 is currently evaluated in this indication; RESTORE brain study started in D...

    Authors: Hugues Chabriat, Claudio L. Bassetti, Ute Marx, Françoise Picarel-Blanchot, Aurore Sors, Celine Gruget, Barbara Saba, Marine Wattez, Marie-Laure Audoli and Dirk M. Hermann
    Citation: Trials 2020 21:136
    Content type: Study protocol Published on:

  14. Anthracycline-induced cardiotoxicity (AIC), a condition associated with multiple mechanisms of damage, including oxidative stress, has been associated with poor clinical outcomes. Carvedilol, a β-blocker with ...

    Authors: Rodrigo Carrasco, María Cristina Ramirez, Kjersti Nes, Andrés Schuster, Rubén Aguayo, Marcelo Morales, Cristobal Ramos, Daniel Hasson, Camilo G. Sotomayor, Pablo Henriquez, Ignacio Cortés, Marcia Erazo, Claudio Salas and Juan G. Gormaz
    Citation: Trials 2020 21:137
    Content type: Study protocol Published on:

  15. Among palliative care (PC) patients who are administered paracetamol, the subcutaneous (SC) route is often an alternative to the intravenous (IV) route. Yet pharmacological and clinical data on whether these a...

    Authors: Marine Vernant, Marie Lepoupet, Christian Creveuil, Antoine Alix, Charlotte Gourio, Laure Peyro-Saint-Paul, Veronique Lelong-Boulouard and Cyril Guillaumé
    Citation: Trials 2020 21:138
    Content type: Study protocol Published on:

  16. A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Māori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training...

    Authors: Ralph Maddison, Elaine Anne Hargreaves, Yannan Jiang, Amanda Jane Calder, Sally Wyke, Cindy M. Gray, Kate Hunt, David Lubans, Helen Eyles, Nick Draper, Ihirangi Heke, Stephen Kara, Gerhard Sundborn, Claire Arandjus, Matthew Jenkins and Samantha Marsh
    Citation: Trials 2020 21:139
    Content type: Study protocol Published on:

  17. Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies have suggested that it might exert a preventive effect in managing ECC. However, no well-designed...

    Authors: Sherry Shiqian Gao, Kitty Jieyi Chen, Duangporn Duangthip, May Chun Mei Wong, Edward Chin Man Lo and Chun Hung Chu
    Citation: Trials 2020 21:140
    Content type: Study protocol Published on:

  18. Lutetium-177-DOTA-octreotate (177Lu-DOTATATE) significantly increases survival and response rates in patients with grade I and grade II neuroendocrine tumors (NETs). However, survival and response rates are signi...

    Authors: Sander C. Ebbers, Arthur J. A. T. Braat, Adriaan Moelker, Marcel P. M. Stokkel, Marnix G. E. H. Lam and Maarten W. Barentsz
    Citation: Trials 2020 21:141
    Content type: Study protocol Published on:

  19. Appropriate pain management is essential to improve the postoperative recovery after total hip arthroplasty (THA). Various case reports have indicated that anterior quadratus lumborum block (QLB) provides effe...

    Authors: Masaru Kikuchi, Takahiro Mihara, Yusuke Mizuno, Hiroko Fujimoto, Sachiko Arai, Takeshi Nomura and Takahisa Goto
    Citation: Trials 2020 21:142
    Content type: Study protocol Published on:

  20. 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:

  21. 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:

  22. 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:

  23. 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:

  24. 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:

  25. 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:

  26. 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:

  28. 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:

  29. 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:

  30. 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:

  31. 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:

  32. 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:

  33. 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:

  34. 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:

  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. 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:

  37. 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:

  38. 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:

  39. 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:

  40. 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:

  41. 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:

  42. 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

  43. 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:

  44. 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:

  45. 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:

  46. 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:

  47. 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:

  48. 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

  49. 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:

  50. 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

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