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  1. Hysterosalpingography (HSG) is an accepted radiologic diagnostic modality for initial infertility workup, and is generally considered uncomfortable and painful. However, the management of pain related to HSG r...

    Authors: Yi-Ling Wang, Hai-Xiang Gao, Jin-She Wang, Jing-Hui Wang, Lei Bo, Ting-Ting Zhang, Ya-Liang Dai, Lu-Lu Gao, Qiang Liu, Jun-Jun Zhang, Ju-Min Cai, Jian-Qiang Yu and Yu-Xiang Li

    Citation: Trials 2020 21:102

    Content type: Study protocol

    Published on:

  2. Polycystic ovary syndrome (PCOS) affects up to 20% of women and is characterised by higher amounts of visceral fat, obesity, insulin resistance, dyslipidemia and reproductive and cardiometabolic complications....

    Authors: Amie Woodward, David Broom, Caroline Dalton, Mostafa Metwally and Markos Klonizakis

    Citation: Trials 2020 21:101

    Content type: Study protocol

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  3. Multiple sclerosis (MS) is an unpredictable, chronic neurological disease accompanied with high rates of depression and anxiety, particularly in the early stages of diagnosis. There is evidence to suggest that...

    Authors: Litza Kiropoulos, Trevor Kilpatrick, Tomas Kalincek, Leonid Cherulov, Elizabeth McDonald, Tissa Wijeratne, Jennifer Threader, Vanja Rozenblat, Neil Simpson-O’Brien, Anneke Van Der Walt and Lisa Taylor

    Citation: Trials 2020 21:100

    Content type: Study protocol

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    The Correction to this article has been published in Trials 2020 21:284

  4. Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Despite the development of pharmacological and nonpharmacological interve...

    Authors: Chao Hsing Yeh, Cuicui Li, Ronald Glick, Elizabeth A. Schlenk, Kathryn Albers, Lorna Kwai-Ping Suen, Nada Lukkahatai, Nicole Salen, Sonaali Pandiri, Weixia Ma, Nancy Perrin, Natalia E. Morone and Paul J. Christo

    Citation: Trials 2020 21:99

    Content type: Study protocol

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  5. Cognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improve...

    Authors: Marieke Houniet-de Gier, Heleen Beckerman, Kimberley van Vliet, Hans Knoop and Vincent de Groot

    Citation: Trials 2020 21:98

    Content type: Study protocol

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  6. Antimicrobial therapy with appropriate biliary drainage is considered the standard of care for acute cholangitis, but the optimal duration of antimicrobial therapy remains unknown. Seven to 10 days of antimicr...

    Authors: Kentaro Iwata, Asako Doi, Yuichiro Oba, Hiroo Matsuo, Kei Ebisawa, Manabu Nagata, Sho Nishimura, Kenichi Yoshimura, Atsuhiro Masuda, Hideyuki Shiomi and Yuzo Kodama

    Citation: Trials 2020 21:97

    Content type: Study protocol

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  7. Although there have been multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT) and these have been conducted over many years and involved many international cooperative groups, t...

    Authors: Jennifer Anderton, Veronica Moroz, Perrine Marec-Bérard, Nathalie Gaspar, Valerie Laurence, Javier Martín-Broto, Ana Sastre, Hans Gelderblom, Cormac Owens, Sophie Kaiser, Melissa Fernández-Pinto, Nicola Fenwick, Abigail Evans, Sandra Strauss, Jeremy Whelan, Keith Wheatley…

    Citation: Trials 2020 21:96

    Content type: Study protocol

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  8. Fractures of the distal radius are one of the most common osteoporotic fractures in elderly men and women. These fractures are a particular health concern amongst the elderly, who are at risk of fragility frac...

    Authors: Ronald Man Yeung WONG, Wing-Tung HO, Ning TANG, Chi Yin TSO, Wai Kit Raymond Ng, Simon Kwoon-Ho CHOW and Wing-Hoi CHEUNG

    Citation: Trials 2020 21:95

    Content type: Study protocol

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  9. Chemotherapy-related fatigue (CRF) is a common symptom in non-small cell lung cancer (NSCLC) patients. A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in ...

    Authors: Zhiwei Xiao, Leihao Hu, Jietao Lin, Liming Lu, Xuewu Huang, Xiaoshu Zhu, Chiahshean Teo and Lizhu Lin

    Citation: Trials 2020 21:94

    Content type: Study protocol

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  10. This trial addresses the global problem of chronic venous leg ulcers (CVLUs), wounds that cause significant infirmity for an estimated 9.7 million people annually, mainly older adults with comorbidities. Advan...

    Authors: Jodi C. McDaniel, Jamie Rausch and Alai Tan

    Citation: Trials 2020 21:93

    Content type: Study protocol

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  11. The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RC...

    Authors: Nick Daneman, Asgar H. Rishu, Ruxandra Pinto, Yaseen Arabi, Emilie P. Belley-Cote, Robert Cirone, Mark Downing, Deborah J. Cook, Richard Hall, Shay McGuinness, Lauralyn McIntyre, John Muscedere, Rachael Parke, Steven Reynolds, Benjamin A. Rogers, Yahya Shehabi…

    Citation: Trials 2020 21:92

    Content type: Research

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  12. Colorectal cancer (CRC) screening rates remain suboptimal, particularly in low-income and underserved populations. Mailed fecal immunochemical testing (FIT) may overcome common barriers to screening; however, ...

    Authors: Elizabeth A. O’Connor, William M. Vollmer, Amanda F. Petrik, Beverly B. Green and Gloria D. Coronado

    Citation: Trials 2020 21:91

    Content type: Research

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  13. Tumour necrosis factor inhibitors (TNFi) are effective in the treatment of patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). However, these drugs c...

    Authors: Celia A. J. Michielsens, Nadine Boers, Nathan den Broeder, Mark H. Wenink, Aatke van der Maas, Elien A. M. Mahler, Michelle L. M. Mulder, Désirée van der Heijde, Frank H. J. van den Hoogen, Lise M. Verhoef and Alfons A. den Broeder

    Citation: Trials 2020 21:90

    Content type: Study protocol

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  14. A substantial proportion of breast cancer patients develop metastatic disease, with over 450,000 deaths globally per year. Bone is the most common first site of metastatic disease accounting for 40% of all fir...

    Authors: Rob Coleman, Janet Brown, Emma Rathbone, Louise Flanagan, Amber Reid, Jessica Kendall, Sacha Howell, Chris Twelves, Carlo Palmieri, Anjana Anand, Iain MacPherson and Sarah Brown

    Citation: Trials 2020 21:89

    Content type: Study protocol

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  15. Current guidelines recommend that every person with Parkinson’s disease (PD) should have access to Parkinson’s disease nurse specialist (PDNS) care. However, there is little scientific evidence of the cost-eff...

    Authors: Danique L. M. Radder, Herma H. Lennaerts, Hester Vermeulen, Thies van Asseldonk, Cathérine C. S. Delnooz, Rob H. Hagen, Marten Munneke, Bastiaan R. Bloem and Nienke M. de Vries

    Citation: Trials 2020 21:88

    Content type: Study protocol

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  16. Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus...

    Authors: Nagy A. Mekhail, Charles E. Argoff, Rod S. Taylor, Christian Nasr, David L. Caraway, Bradford E. Gliner, Jeyakumar Subbaroyan and Elizabeth S. Brooks

    Citation: Trials 2020 21:87

    Content type: Study protocol

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  17. There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we wi...

    Authors: Emma Lidington, Sophie E McGrath, Jillian Noble, Susannah Stanway, Amanda Lucas, Kabir Mohammed, Winette van der Graaf and Olga Husson

    Citation: Trials 2020 21:86

    Content type: Study protocol

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  18. Youth depression is highly prevalent and is related to impairments in academic, social and behavioural functioning. Evidence-based treatments are available, but many young people do not respond or sufficiently...

    Authors: D. J. Hallford, A. M. Carmichael, D. W. Austin, K. Takano, F. Raes and M. Fuller-Tyszkiewicz

    Citation: Trials 2020 21:85

    Content type: Study protocol

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  19. Phase III trials often require large sample sizes, leading to high costs and delays in clinical decision-making. Group sequential designs can improve trial efficiency by allowing for early stopping for efficac...

    Authors: Elizabeth G. Ryan, Nigel Stallard, Ranjit Lall, Chen Ji, Gavin D. Perkins and Simon Gates

    Citation: Trials 2020 21:84

    Content type: Methodology

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  21. Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor functio...

    Authors: Niccolò Butti, Emilia Biffi, Chiara Genova, Romina Romaniello, Davide Felice Redaelli, Gianluigi Reni, Renato Borgatti and Cosimo Urgesi

    Citation: Trials 2020 21:82

    Content type: Study protocol

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  22. High-flow nasal cannula (HFNC) oxygen therapy has been widely used in critically ill patients. Despite the effectiveness of HFNC as a treatment, optimal methods to withdraw HFNC after recovery from preexisting...

    Authors: Min Chul Kim, Yeon Joo Lee, Jong Sun Park, Young-Jae Cho, Ho Il Yoon, Choon-Taek Lee, Jae Ho Lee and Eun Sun Kim

    Citation: Trials 2020 21:81

    Content type: Study protocol

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  23. Traumatic brain injury is a leading cause of death and disability worldwide. The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial.

    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 21:80

    Content type: Study protocol

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    The Correction to this article has been published in Trials 2020 21:172

  24. Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, sy...

    Authors: L. L. Laslett, B. Antony, A. E. Wluka, C. Hill, L. March, H. I. Keen, P. Otahal, F. M. Cicuttini and G. Jones

    Citation: Trials 2020 21:79

    Content type: Study protocol

    Published on:

  25. The prevention of catheter-related complications is nowadays an important topic of research. Flushing catheters is considered an important clinical procedure in preventing malfunction and several complications...

    Authors: Pedro Parreira, Liliana B. Sousa, Inês A. Marques, Paulo Santos-Costa, Luciene M. Braga, Arménio Cruz and Anabela Salgueiro-Oliveira

    Citation: Trials 2020 21:78

    Content type: Study protocol

    Published on:

  26. Acupoint selection is a key factor in the treatment of diseases and has not been well studied. The aim of this trial is to explore the differences in efficacy between compatible acupoints and a single acupoint...

    Authors: Le Guo, Xin Huang, Li-Juan Ha, Jing-Zhou Zhang, Jia Mi, Ping-Hui Sun, Xi-Ying Han, Ying Wang, Jing-Lin Hu, Fu-Chun Wang and Tie Li

    Citation: Trials 2020 21:77

    Content type: Study protocol

    Published on:

  27. The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy...

    Authors: Raine Sihvonen, Roope Kalske, Martin Englund, Aleksandra Turkiewicz, Pirjo Toivonen, Simo Taimela and Teppo L. N. Järvinen

    Citation: Trials 2020 21:76

    Content type: Study protocol

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  28. Coronary microvascular disease (CMVD) can be described as one of the cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculatory lesions, often presenting a...

    Authors: Zhuang Jieqin, Liu Shuling, Cai Hairong, Dai Xingzhen, Chen Yanhong, Jin Zilin and Chen Bojun

    Citation: Trials 2020 21:75

    Content type: Study protocol

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  29. The success of a clinical trial depends on its recruitment of eligible patients; therefore, the recruitment period requires special attention. We hypothesized that with a new approach focused on continuous inf...

    Authors: Annika Rühle, Florian Oehme, Björn-Christian Link, Jürg Metzger, Henning Fischer, Michael Stickel, Dimitri E. Delagrammaticas, Reto Babst and Frank J. P. Beeres

    Citation: Trials 2020 21:74

    Content type: Research

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  30. This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for sel...

    Authors: J. S. S. P. Ferreira, R. H. Cruvinel Junior, E. Q. Silva, J. L. Veríssimo, R. L. Monteiro, D. S. Pereira, E. Y. Suda, C. D. Sartor and I. C. N. Sacco

    Citation: Trials 2020 21:73

    Content type: Study protocol

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  31. Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, lead...

    Authors: Simon Craig, Franz E. Babl, Stuart R. Dalziel, Charmaine Gray, Colin Powell, Khalid Al Ansari, Mark D. Lyttle, Damian Roland, Javier Benito, Roberto Velasco, Julia Hoeffe, Diana Moldovan, Graham Thompson, Suzanne Schuh, Joseph J. Zorc, Maria Kwok…

    Citation: Trials 2020 21:72

    Content type: Study protocol

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  32. Acute diarrhoea is a common cause of illness and death among children in low- to middle-income settings. World Health Organization guidelines for the clinical management of acute watery diarrhoea in children f...

    Authors:

    Citation: Trials 2020 21:71

    Content type: Study protocol

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  33. After publication of our article [1] the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study.

    Authors: O. Diaz-Cambronero, G. Mazzinari, C. L. Errando, M. J. Schultz, B. Flor Lorente, N. García-Gregorio, M. Vila Montañés, Daniel Robles-Hernández, L. E. Olmedilla Arnal, A. Martín-De-Pablos, A. Marqués Marí and M. P. Argente Navarro

    Citation: Trials 2020 21:70

    Content type: Correction

    Published on:

    The original article was published in Trials 2019 20:190

  34. The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands. Hand functional exercise is the premise of alleviating hand dysfunction, and th...

    Authors: Zeng-Qiao Zhang, Kun-Peng Li, Jing He, Li-Ming Jiang, Wu Wang, Xiao-Shen Hu and Wei Feng

    Citation: Trials 2020 21:69

    Content type: Study protocol

    Published on:

  35. Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke r...

    Authors: Kris McGill, Catherine M. Sackley, Jon Godwin, Jodie McGarry and Marian C. Brady

    Citation: Trials 2020 21:68

    Content type: Review

    Published on:

  36. Equipoise and role conflict have been previously identified as important factors in professionals’ engagement with trials, inducing behaviours which can impact on recruitment. We explored these phenomena as po...

    Authors: Ruth I. Hart, Nina Hallowell, Jeni Harden, Angela B. Jesudason and Julia Lawton

    Citation: Trials 2020 21:67

    Content type: Research

    Published on:

  37. Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only sho...

    Authors: Daniela Mercado, Jessica Werthmann, Iain C. Campbell and Ulrike Schmidt

    Citation: Trials 2020 21:66

    Content type: Study protocol

    Published on:

  38. Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known ...

    Authors: Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr., Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel and Jeanette A. Waxmonsky

    Citation: Trials 2020 21:65

    Content type: Study protocol

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    The Correction to this article has been published in Trials 2020 21:195

  39. Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more acces...

    Authors: Stephanie S. Leone, Suzanne Lokman, Brigitte Boon, Agnes van der Poel, Filip Smit, Moniek Zijlstra-Vlasveld and Odile Smeets

    Citation: Trials 2020 21:64

    Content type: Study protocol

    Published on:

  40. In 2015, 162,877 persons sought asylum in Sweden, 35,369 of whom were unaccompanied refugee minors (URMs). Refugee children, especially URMs, have often experienced traumas and are at significant risk of devel...

    Authors: Anna Sarkadi, Georgina Warner, Raziye Salari, Karin Fängström, Natalie Durbeej, Elin Lampa, Zaruhi Baghdasaryan, Fatumo Osman, Sandra Gupta Löfving, Anna Perez Aronsson, Inna Feldman, Filipa Sampaio, Richard Ssegonja, Rachel Calam, Anna Bjärtå, Anna Leiler…

    Citation: Trials 2020 21:63

    Content type: Study protocol

    Published on:

  41. Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider’s histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney...

    Authors: Daniela Kniepeiss, Philipp Houben, Philipp Stiegler, Andrea Berghold, Regina Riedl, Judith Kahn and Peter Schemmer

    Citation: Trials 2020 21:62

    Content type: Study protocol

    Published on:

  42. In people living with limb loss, addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from acci...

    Authors: Goeran Fiedler, Anita Singh and Xueyi Zhang

    Citation: Trials 2020 21:61

    Content type: Study protocol

    Published on:

  43. Ketogenic and low-glycemic-index diets are effective in treating drug-resistant seizures in children with Angelman syndrome. Cognition, mobility, sleep, and gastrointestinal health are intrinsically linked to ...

    Authors: Donna L. Herber, Edwin J. Weeber, Dominic P. D’Agostino and Jessica Duis

    Citation: Trials 2020 21:60

    Content type: Study protocol

    Published on:

  45. Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes ch...

    Authors: Kaiyin Chan, Louisa Lui, Kaling Yu, Kwongwai Lau, Manchi Lai, Waiwai Lau, Bacon Ng, Linda L. D. Zhong and Zhao-Xiang Bian

    Citation: Trials 2020 21:58

    Content type: Study protocol

    Published on:

  46. Asylum seekers and refugees are at great risk for developing mental disorders. Afghan refugees are a particularly vulnerable group with a low average education and mental health literacy level. Traumatic exper...

    Authors: Matthias Knefel, Viktoria Kantor, Andrew A. Nicholson, Jennifer Schiess-Jokanovic, Dina Weindl, Ingo Schäfer and Brigitte Lueger-Schuster

    Citation: Trials 2020 21:57

    Content type: Study protocol

    Published on:

  47. Attention-deficit/hyperactivity disorder (ADHD) is a psychosocially impairing and cost-intensive mental disorder, with first symptoms occurring in early childhood. It can usually be diagnosed reliably at presc...

    Authors: Katja Becker, Tobias Banaschewski, Daniel Brandeis, Christina Dose, Christopher Hautmann, Martin Holtmann, Thomas Jans, Lea Jendreizik, Carolin Jenkner, Katja John, Johanna Ketter, Sabina Millenet, Ursula Pauli-Pott, Tobias Renner, Marcel Romanos, Anne-Katrin Treier…

    Citation: Trials 2020 21:56

    Content type: Study protocol

    Published on:

  48. Labor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 h, there is un...

    Authors: P. Coste Mazeau, M. Hessas, R. Martin, J.-L. Eyraud, F. Margueritte, Y. Aubard, C. Sallee, F. Sire and T. Gauthier

    Citation: Trials 2020 21:51

    Content type: Study protocol

    Published on:

  49. No treatment has convincingly been proven to be beneficial for microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI). Several studies have described the effects of Danhong...

    Authors: Xiaoyu Zhang, Guihua Tian, Zhaofeng Shi, Yang Sun, Jiayuan Hu, Yin Jiang, Rui Zheng, Shiqi Chen, Chengyu Li, Xinyu Yang, Tianmai He, Songjie Han, Chi Zhang, Lijing Zhang, Yan Liu and Hongcai Shang

    Citation: Trials 2020 21:48

    Content type: Study protocol

    Published on:

  50. In current study we assessed the effect of transcutaneous electrical acupoint stimulation (TEAS) on the quality of early recovery in patients undergoing gynecological laparoscopic surgery.

    Authors: Xiangdi Yu, Fangxiang Zhang and Bingning Chen

    Citation: Trials 2020 21:43

    Content type: Research

    Published on:

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