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Call for papers: Big data for randomized trials

Edited by: Dr Lars Hemkens

Trials invites you to submit to our new thematic series, ‘Big data for randomized trials’.

The Editors will consider articles that report on what is currently known about using big data or routinely collected data (such as electronic health records, registries or administrative databases) for randomized trials, the promises and limitations of using such data sources for trials and how we could make best use of them to improve clinical trial research for better patient care. 

We encourage articles on any topic relevant to big data for conducting randomized trials on any level of health care. This includes articles describing the current knowledge about how using this data may make trials more feasible or would allow exploring research questions otherwise not possible to be explored , or which novel designs would be possible. Topics related to ethical implications, costs, or methodological aspects are very welcome. We are highly interested in empirical research on research studies. Commentaries and opinion pieces are welcome, especially those looking explicitly to practical challenges and offering solutions. All articles should make clear the relevance of using big data for randomized trials and current research gaps, and they should describe how the results or opinions in the article can be used to improve trial design and conduct in the future.

Manuscripts should be formatted according to our submission guidelines and submitted via the online submission system. In the submission system please make sure the correct collection title is chosen from the additional information tab. Please also indicate clearly in the covering letter that the manuscript is to be considered in the ‘Big data for randomized trials’ series.

For further information, please use the contact us email on the journal website.

  1. 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:

  2. 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

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  3. 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

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  4. Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascula...

    Authors: Josefin Sundh, Anders Magnuson, Scott Montgomery, Pontus Andell, Gustaf Rindler and Ole Fröbert

    Citation: Trials 2020 21:123

    Content type: Study protocol

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  5. Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupunct...

    Authors: Yin Shou, Li Hu, Cuihong Zhang, Shifen Xu, Qi Jin, Li Huang, Bingrong Li, Long Yuan, Siwei Xu, Kaiyong Zhang, Huiru Jiang and Bimeng Zhang

    Citation: Trials 2020 21:110

    Content type: Study protocol

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  6. Drug resistance in China is becoming a more and more serious issue. Infection by drug-resistant bacteria has become a major disease that seriously threatens the health of Chinese people and affects national me...

    Authors: Dong Deng, Zhenyi Chen, Liyang Jia, Jianhong Bu, Miaoqing Ye, Lihua Sun, Yun Gen, Wen Zhang, Gang Chen and Bangjiang Fang

    Citation: Trials 2019 20:817

    Content type: Study protocol

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  7. Diabetic kidney disease (DKD) is the main cause of end-stage kidney disease and has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patie...

    Authors: De Jin, Wen-Jing Huang, Xiang Meng, Fan Yang, Qi Bao, Mei-zhen Zhang, Ya-nan Yang, Qing Ni, Feng-Mei Lian and Xiao-Lin Tong

    Citation: Trials 2019 20:756

    Content type: Study protocol

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  8. We aimed to test whether a common set of key data items reported across high-impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonata...

    Authors: Sena Jawad, Neena Modi, A. Toby Prevost and Chris Gale

    Citation: Trials 2019 20:731

    Content type: Review

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  9. The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be us...

    Authors: Tomotsugu Seki, Morio Aki, Hirotsugu Kawashima, Tomotaka Miki, Shiro Tanaka, Koji Kawakami and Toshi A. Furukawa

    Citation: Trials 2019 20:706

    Content type: Study protocol

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  10. Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. ...

    Authors: Ying-ping Fei, Yun Zheng, Dan Lai, Ping Zhong, Jing-zhe Lu, Gang Li and Peng Liu

    Citation: Trials 2019 20:666

    Content type: Study protocol

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  11. Denture-related stomatitis (DS) is chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganisms held together by a mucus-like matr...

    Authors: Adriana B. Ribeiro, Camila B. de Araújo, Luiz Eduardo V. Silva, Rubens Fazan-Junior, Helio C. Salgado, Aline B. Ribeiro, Caroline V. Fortes, Frank L. Bueno, Viviane C. de Oliveira, Helena de F. O. Paranhos, Evandro Watanabe and Cláudia H. da Silva-Lovato

    Citation: Trials 2019 20:661

    Content type: Study protocol

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  12. Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affects quality of life. Patients with KOA frequently develop one or more of the following typical symptoms: joint pain, st...

    Authors: Bao-ping Xu, Min Yao, Zi-rui Tian, Long-yun Zhou, Long Yang, Zhen-jun Li, Sen Zhu, Xiao-tao Wang, Jia-hui Lan, Yong-jun Wang and Xue-jun Cui

    Citation: Trials 2019 20:377

    Content type: Study protocol

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  13. Contrast-induced acute kidney injury (CI-AKI) contributes toward unfavorable clinical outcomes. Oral hydration with water is inexpensive and it may be effective in the prevention of CI-AKI, but its efficacy am...

    Authors: Feier Song, Guoli Sun, Jin Liu, Ji-yan Chen, Yibo He, Liwei Liu and Yong Liu

    Citation: Trials 2019 20:290

    Content type: Study protocol

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  14. Sickle cell disease (SCD) is an inherited hematological disorder where the shape of red blood cells is altered, resulting in the destruction of red blood cells, anemia, and other complications. SCD is prevalen...

    Authors: Mohammed S. Alshahrani, Laila Perlas Asonto, Mohamed M. El Tahan, Amal H. Al Sulaibikh, Sukayna Z. Al Faraj, Abdullah A. Al Mulhim, Murad F. Al Abbad, Samar A. Al Nahhash, Moath N. Aldarweesh, Alaa M. Mahmoud, Nisreen Almaghraby, Mohammed A. Al Jumaan, Thamir O. Al Junaid, Faisal M. Al Hawaj, Samar AlKenany, Omaima F. ElSayed…

    Citation: Trials 2019 20:286

    Content type: Study protocol

    Published on: