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  1. This study aimed to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in older patients who were diagnosed with gastrointe...

    Authors: Lijuan Xi, Fang Fang, Haijuan Yuan and Daorong Wang

    Citation: Trials 2021 22:563

    Content type: Research

    Published on:

  2. Cognitive training with components that can further enhance the transferred and long-term effects and slow the progress of dementia is needed for preventing dementia.

    Authors: Feng V. Lin, Kathi Heffner, Richard Gevirtz, Zhengwu Zhang, Duje Tadin and Anton Porsteinsson

    Citation: Trials 2021 22:560

    Content type: Study protocol

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  3. The demand for care during the COVID-19 pandemic has affected the mental health of healthcare workers (HCWs), thus increasing the need for psychosocial support services. Internet-based interventions have previ...

    Authors: Lina Jovarauskaite, Austeja Dumarkaite, Inga Truskauskaite-Kuneviciene, Ieva Jovaisiene, Gerhard Andersson and Evaldas Kazlauskas

    Citation: Trials 2021 22:559

    Content type: Study protocol

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  4. Acute kidney injury (AKI) is a common complication of cardiac surgery. Factors such as cardiopulmonary bypass, aortic cross-clamping and surgical stress may precipitate renal hypoperfusion and ischaemia, infla...

    Authors: Mayurathan Balachandran, Piyusha Banneheke, Adrian Pakavakis, Wisam Al-Bassam, Vineet Sarode, Michael Rowland and Yahya Shehabi

    Citation: Trials 2021 22:558

    Content type: Study protocol

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  5. Recruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge. We evaluated the cost and randomization yields of various recruitment methods used for a ...

    Authors: Michelle Park, Raveendhara R. Bannuru, Lori Lyn Price, William F. Harvey, Jeffrey B. Driban and Chenchen Wang

    Citation: Trials 2021 22:557

    Content type: Research

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  6. Colorectal cancer is a major public concern, being the second deadliest cancer in the world. Whereas survival is high for localized forms, metastatic colorectal cancer has showed poor prognosis, with a 5-year ...

    Authors: Muriel Mathonnet, Mathieu Vanderstraete, Christophe Bounaix Morand du Puch, Stéphanie Giraud, Christophe Lautrette, Mehdi Ouaissi, Nicolas Tabchouri, Abdelkader Taïbi, Renaud Martin, Isabelle Herafa, Achille Tchalla and Niki Christou

    Citation: Trials 2021 22:556

    Content type: Study protocol

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  7. Esophagogastroduodenoscopy is very useful in diagnosing and treating upper gastrointestinal mucosal disorders, but too much foam and water in stomach decrease its diagnostic efficiency. Simethicone administrat...

    Authors: Xiaotian Sun, Yang Xu, Xueting Zhang, Cuiyun Ma, Aitong Li, Haiyan Yu, Weihua Zhang, Hanqing Zhang, Teng Yang, Xinfang Miao, Huiming Zhang, Yan Liu and Zheng Lu

    Citation: Trials 2021 22:555

    Content type: Research

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  8. Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, lead...

    Authors: Edmund Juszczak, Oliver Hewer, Christopher Partlett, Madeleine Hurd, Vasha Bari, Ursula Bowler, Louise Linsell and Jon Dorling

    Citation: Trials 2021 22:554

    Content type: Methodology

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  9. With the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovas...

    Authors: Yuanlong Sun, Chengxin Huang, Li Huo, Ying Li, Jun Chen, Zixiu Zhang, Meijun Jia, Meixian Jiang and Xiaofen Ruan

    Citation: Trials 2021 22:553

    Content type: Study protocol

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  10. SiFAr-Stress investigates the impact of cycling on stress levels in older adults. Uncertainty due to change to motorized bicycle or fear of falling can be perceived as stressors for cyclists. Stress activates ...

    Authors: Sabine Britting, Robert Kob, Cornel Christian Sieber, Nicolas Rohleder, Ellen Freiberger and Linda Becker

    Citation: Trials 2021 22:552

    Content type: Study protocol

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  11. Many people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and funct...

    Authors: Hui-Ju Young, Tapan Mehta, Yumi Kim, Sangeetha Padalabalanarayanan, Chia-Ying Chiu, James H. Rimmer and Mohanraj Thirumalai

    Citation: Trials 2021 22:551

    Content type: Study protocol

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  12. The primary objective is to evaluate the efficacy of camostat to prevent respiratory deterioration in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.

    Authors: Sarah Halford, Susan Wan, Ilaria Dragoni, Julie Silvester, Bobojon Nazarov, Daniel Anthony, Suzie Anthony, Emma Ladds, John Norrie and Kevin Dhaliwal

    Citation: Trials 2021 22:550

    Content type: Letter

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  13. After receiving breast cancer surgery or reconstruction, shoulder dysfunctions including weakness, post-operative pain, shoulder joint instability, and limited range of motion (ROM) often occur. Due to limited...

    Authors: Hae-Yeon Park, Kyung Eun Nam, Jae-Young Lim, Seung Mi Yeo, Jong In Lee and Ji Hye Hwang

    Citation: Trials 2021 22:549

    Content type: Study protocol

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  14. Arterial hypertension has a direct association with endothelial dysfunction and major cardiovascular events. There is evidence showing the benefits of aerobic exercise on flow-mediated dilation (FMD) in hypert...

    Authors: Gustavo Waclawovsky, Liliana Fortini Cavalheiro Boll, Salvador Gomes Neto, Maria Claudia Costa Irigoyen and Alexandre M. Lehnen

    Citation: Trials 2021 22:548

    Content type: Study protocol

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  15. Randomised controlled trials (RCTs) for surgical interventions have often proven difficult with calls for innovative approaches. The Imperial Prostate (IP4) Comparative Health Research Outcomes of Novel Surger...

    Authors: Emily Day, A. Toby Prevost, Matthew R. Sydes, Deepika Reddy, Taimur T. Shah, Mathias Winkler, Tim Dudderidge, John Staffurth, Stuart McCracken, Vincent Khoo, Puja Jadav, Natalia Klimowska-Nassar, Thiagarajah Sasikaran, Hashim U. Ahmed and Francesca Fiorentino

    Citation: Trials 2021 22:547

    Content type: Update

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  16. High-dose intravenous vitamin C directly scavenges and decreases the production of harmful reactive oxygen species (ROS) generated during ischemia/reperfusion after a cardiac arrest. The aim of this study is t...

    Authors: Sander Rozemeijer, Harm-Jan de Grooth, Paul W. G. Elbers, Armand R. J. Girbes, Corstiaan A. den Uil, Eric A. Dubois, Evert-Jan Wils, Thijs C. D. Rettig, Arthur R. H. van Zanten, Roel Vink, Bas van den Bogaard, Rob J. Bosman, Heleen M. Oudemans-van Straaten and Angélique M. E. de Man

    Citation: Trials 2021 22:546

    Content type: Study protocol

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  17. Proton pump inhibitor (PPI) is effective for the treatment of nonerosive gastroesophageal reflux (NERD), but long-term use of PPI is prone to have complications and recurrence after withdrawal. Traditional Chi...

    Authors: Xiaosi Zhang, Yuan Cheng, Xiaohong Li, Xiang Tan, Lei Shi, Xiaojun Shi, Xiancui Zhang, Chun’e Xie and Junxiang Li

    Citation: Trials 2021 22:545

    Content type: Study protocol

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  18. The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and inform...

    Authors: Lydia O’ Sullivan, Laura Feeney, Rachel K. Crowley, Prasanth Sukumar, Eilish McAuliffe and Peter Doran

    Citation: Trials 2021 22:544

    Content type: Research

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  19. One key pathological finding in giant cell arteritis (GCA) is the presence of interferon-gamma and interleukin (IL)-17 producing T helper (Th) 1 and Th17 cells in affected arteries. There is anecdotal evidence...

    Authors: Nils Venhoff, Wolfgang A. Schmidt, Peter Lamprecht, Hans-Peter Tony, Christine App, Christian Sieder, Carolin Legeler, Claudia Jentzsch and Jens Thiel

    Citation: Trials 2021 22:543

    Content type: Study protocol

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  20. The Sustainable Development Goals (SDGs) highlight the importance of investments in early childhood care and education (ECCE) and youth development. Given Pakistan’s large young population, and gender and urba...

    Authors: Aisha K. Yousafzai, Christopher R. Sudfeld, Emily E. Franchett, Saima Siyal, Karima Rehmani, Shelina Bhamani, Quanyi Dai, Chin R. Reyes, Günther Fink and Liliana A. Ponguta

    Citation: Trials 2021 22:542

    Content type: Study protocol

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  21. In 1979, Marvin Zelen proposed a new design for randomized clinical trials intended to facilitate clinicians’ and patients’ participation. The defining innovation of Zelen’s proposal was random assignment of t...

    Authors: Gregory E. Simon, Susan M. Shortreed and Lynn L. DeBar

    Citation: Trials 2021 22:541

    Content type: Review

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  22. To compare the efficacy of chlorhexidine–alcohol and povidone–iodine as preoperative antiseptic skin preparation for prevention of surgical site infection (SSI) after cesarean delivery (CD).

    Authors: Athokpam Lenin Luwang, Pradip Kumar Saha, Minakshi Rohilla, Pooja Sikka, Lekha Saha and Vikas Gautam

    Citation: Trials 2021 22:540

    Content type: Research

    Published on:

  23. Many shift workers suffer from sleep issues, which negatively affect quality of life and performance. Scientifically evaluated, structured programs for prevention and treatment are scarce. We developed an anon...

    Authors: Lukas Retzer, Monika Feil, Richard Reindl, Kneginja Richter, Robert Lehmann, Mark Stemmler and Elmar Graessel

    Citation: Trials 2021 22:539

    Content type: Study protocol

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  24. Authors: Ulrich Reininghaus, Annelie Klippel, Henrietta Steinhart, Thomas Vaessen, Martine van Nierop, Wolfgang Viechtbauer, Tim Batink, Zuzana Kasanova, Evelyne van Aubel, Ruud van Winkel, Machteld Marcelis, Therese van Amelsvoort, Mark van der Gaag, Lieuwe de Haan and Inez Myin-Germeys

    Citation: Trials 2021 22:538

    Content type: Correction

    Published on:

    The original article was published in Trials 2019 20:769

  25. Interest in the application of machine learning (ML) to the design, conduct, and analysis of clinical trials has grown, but the evidence base for such applications has not been surveyed. This manuscript review...

    Authors: E. Hope Weissler, Tristan Naumann, Tomas Andersson, Rajesh Ranganath, Olivier Elemento, Yuan Luo, Daniel F. Freitag, James Benoit, Michael C. Hughes, Faisal Khan, Paul Slater, Khader Shameer, Matthew Roe, Emmette Hutchison, Scott H. Kollins, Uli Broedl…

    Citation: Trials 2021 22:537

    Content type: Commentary

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    The Correction to this article has been published in Trials 2021 22:593

  26. Acupuncture is effective for reducing the symptoms of neck pain (NP). However, the underlying mechanisms are not fully elucidated. Based on evaluating the efficacy of two acupuncture prescriptions for treating...

    Authors: Zhen Gao, Tao Yin, Lei Lan, Dehua Li, Ruirui Sun, Guodong Ha, Caili Jiang, Xin Shao, Zhaoxuan He, Laixi Ji and Fang Zeng

    Citation: Trials 2021 22:536

    Content type: Study protocol

    Published on:

  27. Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the inte...

    Authors: D. Reynaud, N. Bouscaren, V. Lenclume and M. Boukerrou

    Citation: Trials 2021 22:535

    Content type: Research

    Published on:

  28. Recent studies point to a lower number and reduced severity of cases in higher altitude cities with decreased oxygen concentration. Specific literature has shown several benefits of physical training, so, in t...

    Authors: Átila Alexandre Trapé, Marta Camacho-Cardenosa, Alba Camacho-Cardenosa, Eugenio Merellano-Navarro, Jhennyfer Aline Lima Rodrigues, Elisangela Aparecida da Silva Lizzi, Carlos Arterio Sorgi, Marcelo Papoti and Javier Brazo-Sayavera

    Citation: Trials 2021 22:534

    Content type: Study protocol

    Published on:

  29. Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive beh...

    Authors: Anna L. MacKinnon, Joshua W. Madsen, Ashley Dhillon, Elizabeth Keys, Gerald F. Giesbrecht, Tyler Williamson, Amy Metcalfe, Tavis Campbell, Kelly J. Mrklas and Lianne Tomfohr-Madsen

    Citation: Trials 2021 22:532

    Content type: Study protocol

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  30. Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) was a pragmatic, cluster randomized trial assessing the effectiveness of a clinical decision support (CDS) tool in...

    Authors: Joanna M. Nemis-White, Laura M. Hamilton, Sarah Shaw, James H. MacKillop, Ratika Parkash, Shurjeel H. Choudhri, Antonio Ciaccia, Feng Xie, Lehana Thabane and Jafna L. Cox

    Citation: Trials 2021 22:531

    Content type: Commentary

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  31. Systemic lupus erythematosus (SLE) is an autoimmune disease that can involve multiple organs or systems. Lupus nephritis (LN) is associated with high mortality and morbidity. However, plenty of patients do not...

    Authors: Qingran Yan, Fang Du, Yuening Kang, Ping Ye, Xiaodong Wang, Jianhua Xu, Jianping Tang, Niansong Wang, Gengru Jiang, Zhijun Li, Xuan Wang, Qin Xue, Xinfang Huang, Xiaoyan Zhang, Ying Zhou, Min Dai…

    Citation: Trials 2021 22:530

    Content type: Study protocol

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  32. Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and ...

    Authors: Victoria Hodgetts-Morton, Catherine A. Hewitt, Laura Jones, Lisa Leighton, Nicole Pilarski, Eleanor Molloy, Kim Hinshaw, Jane Norman, Jason Waugh, Sarah Stock, Jim Thornton, Philip Toozs-Hobson, Tracey Johnston, Arri Coomarasamy, Shakila Thangaratinam, Ben Mol…

    Citation: Trials 2021 22:529

    Content type: Study protocol

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  33. Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and d...

    Authors: Russell E. Glasgow, Christopher E. Knoepke, David Magid, Gary K. Grunwald, Thomas J. Glorioso, Joy Waughtal, Joel C. Marrs, Sheana Bull and P. Michael Ho

    Citation: Trials 2021 22:528

    Content type: Study protocol

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  34. Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to the resorption of alveolar bone. The initial strategy for treating periodontal diseas...

    Authors: Carly A. R. Zanatta, Peter C. Fritz, Elena M. Comelli and Wendy E. Ward

    Citation: Trials 2021 22:527

    Content type: Study protocol

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  35. A healthy lifestyle can help prevent diseases that impair quality of life and lead to premature death. The Techniker health insurance fund offers a comprehensive online health program to support users in achievin...

    Authors: Iris Tinsel, Gloria Metzner, Christian Schlett, Matthias Sehlbrede, Martina Bischoff, Robin Anger, Judith Brame, Daniel König, Ramona Wurst, Reinhard Fuchs, Peter Lindinger, Rainer Bredenkamp and Erik Farin-Glattacker

    Citation: Trials 2021 22:526

    Content type: Study protocol

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  36. Atrial fibrillation is a cardiac arrhythmia commonly encountered in a primary care setting. Current screening is limited to pulse palpation and ECG confirmation when an irregular pulse is found. Paroxysmal atr...

    Authors: Simon Gabriël Beerten, Tine Proesmans and Bert Vaes

    Citation: Trials 2021 22:525

    Content type: Study protocol

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  37. Lumbar spinal stenosis (LSS) is a common degenerative condition associated with old age. Its incidence continues to increase with the rapidly aging population in China. Treatment for LSS usually begins with co...

    Authors: Akram Osman, Wei Hu, Jianhua-Sun, Jing Li, Xiao Luo, Nianrong Han, Ehsan Abduhani and Zhenqiang Liu

    Citation: Trials 2021 22:524

    Content type: Study protocol

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  38. A drive to improve functional outcomes for patients undergoing total knee arthroplasty (TKA) has led to alternative alignment being used. Functional alignment (FA) uses intraoperative soft tissue tension to de...

    Authors: Richard Steer, Beth Tippett, R. Nazim Khan, Dermot Collopy and Gavin Clark

    Citation: Trials 2021 22:523

    Content type: Study protocol

    Published on:

  39. Community-based diabetes prevention programs varied widely in effectiveness, and the intervention strategy consisting of lifestyle interventions, stepwise addition of metformin, and financial incentives has no...

    Authors: Kar-Fu Yeung, Mihir Gandhi, Amanda Yun Rui Lam, Selly Julianty, Alvin Yeow Meng Chia, Gilbert Choon Seng Tan, Su-Yen Goh, Emily Tse Lin Ho, Angela Fang Yung Koh, Gavin Siew Wei Tan, Eugene Jin Wen Shum, Eric A. Finkelstein, Tazeen H. Jafar, Yee Leong Teoh, Rob M. van Dam, Clare Whitton…

    Citation: Trials 2021 22:522

    Content type: Study protocol

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  40. Adverse drug events (ADE) represent one of the main causes of admission to emergency department (ED). Their detection, documentation, and reporting are essential to avoid readmission.

    Authors: Cyril Breuker, Marie Faucanié, Marion Laureau, Damien Perier, Véronique Pinzani, Grégory Marin, Mustapha Sebbane and M. Villiet

    Citation: Trials 2021 22:521

    Content type: Study protocol

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  41. Randomised controlled trials in reproductive medicine are often subject to outcome truncation, where the study outcomes are only defined in a subset of the randomised cohort. Examples include birthweight (meas...

    Authors: Jack Wilkinson, Jonathan Y. Huang, Antonia Marsden, Michael O. Harhay, Andy Vail and Stephen A. Roberts

    Citation: Trials 2021 22:520

    Content type: Methodology

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  42. Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF ...

    Authors: Sherry Shiqian Gao, Faith Miaomiao Zheng, Kitty Jieyi Chen, Duangporn Duangthip, Edward Chin Man Lo and Chun Hung Chu

    Citation: Trials 2021 22:519

    Content type: Study protocol

    Published on:

  43. Sarcopenia is accompanied by a decline in muscle mass, muscle strength, and muscle function. Resistance training is the most potential training method for the prevention and treatment of sarcopenia. However, t...

    Authors: Nan Chen, Xiangfeng He, Guoyun Zhao, Linqian Lu, Barbara E. Ainsworth, Yu Liu and Xie Wu

    Citation: Trials 2021 22:518

    Content type: Study protocol

    Published on:

  44. Diabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on per...

    Authors: Meryl Cinzía Tila Tamara Gramberg, Rimke Sabine Lagrand, Louise Willy Elizabeth Sabelis, Martin den Heijer, Vincent de Groot, Max Nieuwdorp, Willemijn Kortmann, Elske Sieswerda and Edgar Josephus Gerardus Peters

    Citation: Trials 2021 22:517

    Content type: Study protocol

    Published on:

  45. Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to te...

    Authors: Christine Norton, Jonathan Syred, Sally Kerry, Micol Artom, Louise Sweeney, Ailsa Hart, Wladyslawa Czuber-Dochan, Stephanie J. C. Taylor, Borislava Mihaylova, Chris Roukas, Qasim Aziz, Laura Miller, Richard Pollok, Sonia Saxena, Imogen Stagg, Helen Terry…

    Citation: Trials 2021 22:516

    Content type: Study protocol

    Published on:

  46. Safe, more efficacious treatments are needed to address the considerable morbidity and mortality associated with pulmonary tuberculosis (TB). However, the current practice in TB therapeutics trials is to use c...

    Authors: N. K. Hills, J. Lyimo, P. Nahid, R. M. Savic, C. Lienhardt and P. P. J. Phillips

    Citation: Trials 2021 22:515

    Content type: Review

    Published on:

  47. The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentat...

    Authors: Sara Mahmoodi, Mojtaba Yousefi, Omid Sadeghi, Ali Mahmoodabadi, Mohammadreza Sadriirani, Zahra Hosseinzade, Abdolhossein Jahanbakhsh, Seyed Bahman Panahande, Zaker Saeedinejad, Jan Mohamad Malekzadeh, Mohsen Naghmachi and Azizollah Pourmahmoudi

    Citation: Trials 2021 22:514

    Content type: Letter

    Published on:

  48. Financial incentives are an effective way of helping women to stop smoking during pregnancy. Unfortunately, most women who stop smoking at this time return to smoking within 12 months of the infant’s birth. Th...

    Authors: M. Ussher, C. Best, S. Lewis, J. McKell, T. Coleman, S. Cooper, S. Orton and L. Bauld

    Citation: Trials 2021 22:512

    Content type: Study protocol

    Published on:

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