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  1. Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients’ general activity and increases the length of hospital stays and the use of care. It is ...

    Authors: Célia Depaulis, Nadia Steer, Léa Garessus, Dominique Chassard and Frédéric Aubrun

    Citation: Trials 2020 21:55

    Content type: Study protocol

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  2. Few studies have addressed the appropriate duration of antibiotic therapy for diabetic foot infections (DFI) with or without amputation. We will perform two randomized clinical trials (RCTs) to reduce the anti...

    Authors: Felix Waibel, Martin Berli, Sabrina Catanzaro, Kati Sairanen, Madlaina Schöni, Thomas Böni, Jan Burkhard, Dominique Holy, Tanja Huber, Maik Bertram, Karin Läubli, Dario Frustaci, Andrea Rosskopf, Sander Botter and Ilker Uçkay

    Citation: Trials 2020 21:54

    Content type: Study protocol

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  3. Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management. This makes ...

    Authors: Ximena Cid, David Canty, Alistair Royse, Andrea B. Maier, Douglas Johnson, Doa El-Ansary, Sandy Clarke-Errey, Timothy Fazio and Colin Royse

    Citation: Trials 2020 21:53

    Content type: Study protocol

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  4. Improving the health and development of adolescents aged 10–19 years is a global health priority. One in five adolescents globally live in India. The Rashtriya Kishor Swasthya Karyakram (RKSK), India’s national a...

    Authors: Suchitra Rath, Audrey Prost, Subhashree Samal, Hemanta Pradhan, Andrew Copas, Sumitra Gagrai, Shibanand Rath, Raj Kumar Gope, Nirmala Nair, Prasanta Tripathy, Komal Bhatia and Kelly Rose-Clarke

    Citation: Trials 2020 21:52

    Content type: Study protocol

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  5. School-based comprehensive sexual health education can improve adolescent health outcomes, and web-based programs are a promising approach to overcoming challenges associated with teacher-led formats by ensuri...

    Authors: Tracy M. Scull, Christina V. Malik, Abigail Morrison and Elyse M. Keefe

    Citation: Trials 2020 21:50

    Content type: Study protocol

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  6. Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exerc...

    Authors: Lynne Taylor, John Parsons, Denise Taylor, Elizabeth Binns, Sue Lord, Richard Edlin, Lynn Rochester, Silvia Del Din, Jochen Klenk, Christopher Buckley, Alana Cavadino, Simon A. Moyes and Ngaire Kerse

    Citation: Trials 2020 21:46

    Content type: Study protocol

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  7. The death of a significant person through suicide is a very difficult experience and can have long-term impact on an individual’s psychosocial and physical functioning. However, there are only few studies that...

    Authors: Birgit Wagner, Laura Hofmann and Ulrike Maaß

    Citation: Trials 2020 21:45

    Content type: Study protocol

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  8. Current evidence suggests that some of the most effective weight loss approaches are changes in dietary and physical activity behaviors through lifestyle modification programs. The Group Lifestyle Balance (GLB...

    Authors: Bärbel Knäuper, Huma Shireen, Kimberly Carrière, Mallory Frayn, Elena Ivanova, Zhen Xu, Ilka Lowensteyn, Gentiana Sadikaj, Aleksandra Luszczynska and Steven Grover

    Citation: Trials 2020 21:40

    Content type: Research

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  9. An article published in this journal analyses the deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India. We wish to rebut some of the inferences and highlight ...

    Authors: Mohua Maulik, Jyotsna Gupta, Atul Juneja, Tulsi Adhikari, Saurabh Sharma, Yashmin Panchal, Neha Yadav and Mendu Vishnu Vardhana Rao

    Citation: Trials 2020 21:38

    Content type: Letter

    Published on:

    The original article was published in Trials 2019 20:535

    The Letter to this article has been published in Trials 2020 21:39

  10. Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhiniti...

    Authors: Jeevani Maheshika Dahanayake, Pathirage Kamal Perera, Priyadarshani Galappaththy and Dulani Samaranayake

    Citation: Trials 2020 21:37

    Content type: Study protocol

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  11. Non-medical data, such as the amount of time that patients and caregivers spend managing their condition, may be relevant when assessing therapeutic strategies. For chronic pediatric conditions, the time that ...

    Authors: Anaïs Le Jeannic, Hassani Maoulida, Sophie Guilmin-Crépon, Corinne Alberti, Nadia Tubiana-Rufi and Isabelle Durand-Zaleski

    Citation: Trials 2020 21:36

    Content type: Research

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  12. Breast cancer is a global public health issue. The side effects of the clinical treatment can decrease the quality of life of these women. Therefore, a healthy lifestyle is essential to minimize the physical a...

    Authors: Leonessa Boing, Tatiana do Bem Fretta, Melissa de Carvalho Souza Vieira, Gustavo Soares Pereira, Jéssica Moratelli, Fabiana Flores Sperandio, Anke Bergmann, Fatima Baptista, Mirella Dias and Adriana Coutinho de Azevedo Guimarães

    Citation: Trials 2020 21:35

    Content type: Study protocol

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  13. Randomised controlled trials (RCTs) provide the most reliable information to inform clinical practice and patient care. We aimed to map global clinical research publication activity through RCT-related article...

    Authors: Ferrán Catalá-López, Rafael Aleixandre-Benavent, Lisa Caulley, Brian Hutton, Rafael Tabarés-Seisdedos, David Moher and Adolfo Alonso-Arroyo

    Citation: Trials 2020 21:34

    Content type: Research

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  14. The evidence base available to trialists to support trial process decisions—e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants—is thin. One way ...

    Authors: Shaun Treweek, Simon Bevan, Peter Bower, Matthias Briel, Marion Campbell, Jacquie Christie, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky, Sandra Galvin, Heidi Gardner, Katie Gillies, Kerenza Hood, Jan Jansen, Roberta Littleford…

    Citation: Trials 2020 21:33

    Content type: Methodology

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  15. The prevalence of central obesity is constantly increasing, and visceral fat is associated with increased production of inflammatory factors and metabolic risk factors. Lutein might retard the development of m...

    Authors: Juan Zhou, Dan Zhao, Ning Wang, Zhiwei Zeng, Changyi Wang, Liping Hao and Xiaolin Peng

    Citation: Trials 2020 21:32

    Content type: Study protocol

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  16. IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). For high-risk IgAN, which is clinical...

    Authors: Shen Li and Jin-pu Li

    Citation: Trials 2020 21:31

    Content type: Study protocol

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  17. Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, an...

    Authors: Brittany B. Dennis, Nitika Sanger, Monica Bawor, Leen Naji, Carolyn Plater, Andrew Worster, Julia Woo, Anuja Bhalerao, Natasha Baptist-Mohseni, Alannah Hillmer, Danielle Rice, Kim Corace, Brian Hutton, Peter Tugwell, Lehana Thabane and Zainab Samaan

    Citation: Trials 2020 21:30

    Content type: Research

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  18. Scalp acupuncture has been widely used as treatment for motor dysfunction in children with cerebral palsy in China. Previous studies have failed to provide high-quality evidence to demonstrate the effectivenes...

    Authors: Jun Wang, Wei Shi, Dhiaedin Khiati, Bingpei Shi, Xiaojuan Shi, Dandan Luo, Yin Wang, Rencai Deng, Huayu Huang, Jian Li, Weili Yan and Hong Yang

    Citation: Trials 2020 21:29

    Content type: Study protocol

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  19. Randomised controlled trials (RCTs), while still considered the gold standard approach in medical research, can encounter impediments to their successful conduct and the dissemination of results. Pretrial qual...

    Authors: Emilie Francis-Auton, Chris Warren, Jeffrey Braithwaite and Frances Rapport

    Citation: Trials 2020 21:28

    Content type: Research

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  20. We evaluated an intervention designed to teach 10- to 12-year-old primary school children to assess claims about the effects of treatments (any action intended to maintain or improve health). We report outcome...

    Authors: Allen Nsangi, Daniel Semakula, Andrew D. Oxman, Astrid Austvoll-Dahlgren, Matt Oxman, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Yunpeng Ding and Nelson K. Sewankambo

    Citation: Trials 2020 21:27

    Content type: Research

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  21. According to WHO, medication error (ME) is a subject that requires attention at all levels of care to reduce severe and preventable damage related to medication use. Clinical pharmacy practice standards have b...

    Authors: J. Granados, A. Salazar-Ospina, J. P. Botero-Aguirre, A. F. Valencia-Quintero, N. Ortiz and P. Amariles

    Citation: Trials 2020 21:26

    Content type: Study protocol

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  22. The 2016 World Health Organization Antenatal Guidelines and the 2015 South African Maternal and Child Health Guidelines recommend one early antenatal ultrasound scan to establish gestational age and to detect ...

    Authors: Linda Richter, Wiedaad Slemming, Shane A. Norris, Alan Stein, Lucilla Poston and Dharmintra Pasupathy

    Citation: Trials 2020 21:25

    Content type: Study protocol

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  23. Chronic spontaneous urticaria (CSU) is characterized by the spontaneous appearance of wheals, angioedema, or both for > 6 weeks. Continuous treatment with H1-antihistamines is used as a first-line treatment fo...

    Authors: Atsushi Fukunaga, Yoshiko Oda, Ken Washio, Takashi Omori, Yasumasa Kakei, Michihiro Hide and Chikako Nishigori

    Citation: Trials 2020 21:23

    Content type: Study protocol

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  24. In low- and middle-income countries, infectious diseases remain a key public health issue. Additionally, non-communicable diseases are a rapidly growing public health problem that impose a considerable burden ...

    Authors: Markus Gerber, Serge A. Ayekoé, Johanna Beckmann, Bassirou Bonfoh, Jean T. Coulibaly, Dao Daouda, Rosa du Randt, Lina Finda, Stefanie Gall, Getrud J. Mollel, Christin Lang, Kurt Z. Long, Sebastian Ludyga, Honorati Masanja, Ivan Müller, Siphesihle Nqweniso…

    Citation: Trials 2020 21:22

    Content type: Study protocol

    Published on:

  25. This study aims to compare patient preference for, and subsequent change in, oral health behaviour for three forms of risk information given at dental check-ups (verbal advice compared to verbal advice accompa...

    Authors: R. Harris, V. Lowers, L. Laverty, C. Vernazza, G. Burnside, S. Brown and L. Ternent

    Citation: Trials 2020 21:21

    Content type: Research

    Published on:

  26. Depression is a widespread disorder with severe impacts for individuals and society, especially in its chronic form. Current treatment approaches for persistent depression have focused primarily on reducing ne...

    Authors: Artjom Frick, Isabel Thinnes and Ulrich Stangier

    Citation: Trials 2020 21:20

    Content type: Study protocol

    Published on:

  27. Alzheimer’s disease (AD) is an epidemic with tremendous public health impacts because there are currently no disease-modifying therapeutics. Randomized controlled trials (RCTs) for prevention of AD dementia of...

    Authors: Danni Li, Michelle M. Mielke, W. Robert Bell, Cavan Reilly, Lin Zhang, Feng Vankee Lin and Fang Yu

    Citation: Trials 2020 21:19

    Content type: Study protocol

    Published on:

  28. People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychologi...

    Authors: Ratna Sohanpal, Hilary Pinnock, Liz Steed, Karen Heslop Marshall, Claire Chan, Moira Kelly, Stefan Priebe, C. Michael Roberts, Sally Singh, Melanie Smuk, Sarah Saqi-Waseem, Andy Healey, Martin Underwood, Patrick White, Chris Warburton and Stephanie J. C. Taylor

    Citation: Trials 2020 21:18

    Content type: Study protocol

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  29. Only 40–60% of patients with generalized anxiety disorder experience long-lasting improvement with gold standard psychosocial interventions. Identifying neurobehavioral factors that predict treatment success m...

    Authors: J. Santiago, E. Akeman, N. Kirlic, A. N. Clausen, K. T. Cosgrove, T. J. McDermott, B. Mathis, M. Paulus, M. G. Craske, J. Abelson, C. Martell, K. Wolitzky-Taylor, J. Bodurka, W. K. Thompson and Robin L. Aupperle

    Citation: Trials 2020 21:17

    Content type: Study protocol

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  30. Hospitalized infants undergo multiple painful procedures daily. Despite the significant evidence, procedural pain assessment and management continues to be suboptimal. Repetitive and untreated pain at this vit...

    Authors: Mariana Bueno, Bonnie Stevens, Melanie A. Barwick, Shirine Riahi, Shelly-Anne Li, Alexa Lanese, Andrew R. Willan, Anne Synnes, Carole A. Estabrooks, Christine T. Chambers, Denise Harrison, Janet Yamada, Jennifer Stinson, Marsha Campbell-Yeo, Melanie Noel, Sharyn Gibbins…

    Citation: Trials 2020 21:16

    Content type: Study protocol

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  31. In pharmacological conditioning associations are formed between the effects of medication and contextual factors related to the medication. Pharmacological conditioning with placebo medication can result in co...

    Authors: Meriem Manaï, Henriët van Middendorp, Dieuwke S. Veldhuijzen, Joy A. van der Pol, Tom W. J. Huizinga and Andrea W. M. Evers

    Citation: Trials 2020 21:15

    Content type: Study protocol

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  32. People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outco...

    Authors: Fiona Gaughran, Dominic Stringer, Michael Berk, Shubulade Smith, David Taylor, Eromona Whiskey, Sabine Landau, Robin Murray, Philip McGuire, Poonam Gardner-Sood, Gabriella Wojewodka, Simone Ciufolini, Harriet Jordan, Jessie Clarke, Lauren Allen, Amir Krivoy…

    Citation: Trials 2020 21:14

    Content type: Study protocol

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  33. Infliximab (INX) and other tumour necrosis factor inhibitors (TNFi) have revolutionised the treatment of several immune mediated inflammatory diseases. Still, many patients do not respond sufficiently to thera...

    Authors: Silje W Syversen, Guro L Goll, Kristin K Jørgensen, Inge C Olsen, Øystein Sandanger, Johanna E Gehin, David J Warren, Joseph Sexton, Cato Mørk, Jørgen Jahnsen, Tore K Kvien, Nils Bolstad and Espen A Haavardsholm

    Citation: Trials 2020 21:13

    Content type: Study protocol

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  34. Worldwide, hypertension is an important public health challenge because of its high prevalence and the concomitant risks of cardiovascular disease. It induces half of the coronary heart disease and approximate...

    Authors: Haoyue Shi, Deshuang Yang, Jiajun Qiao, Rui Sun, Ruihan Li, Chunlin Zhu, Ruiqing Jing, Liping Liu, Li Huang and Lin Li

    Citation: Trials 2020 21:12

    Content type: Study protocol

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  35. To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardiovascular disease is a complex and individualised ta...

    Authors: Anders Elkær Jensen, Jens Søndergaard, Niels Kristian Kjær, Rod Jackson and Jesper Bo Nielsen

    Citation: Trials 2020 21:11

    Content type: Study protocol

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  36. Threshold regression, in which time to remission is modelled as a stochastic drift towards a boundary, is an alternative to the proportional hazards survival model and has a clear conceptual mechanism for exam...

    Authors: Jennifer Hellier, Richard Emsley and Andrew Pickles

    Citation: Trials 2020 21:10

    Content type: Methodology

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  37. Many HIV-positive patients do not appropriately adhere to their antiretroviral medication (ART). This leads to higher viral loads and greater probability of HIV transmission. Present bias—a tendency to give in...

    Authors: Sebastian Linnemayr, Chad Stecher, Uzaib Saya, Sarah MacCarthy, Zachary Wagner, Larissa Jennings and Barbara Mukasa

    Citation: Trials 2020 21:9

    Content type: Study protocol

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  38. The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-...

    Authors: Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Hani A. Aziz Jokhdar, Adel Alothman, Hanan H. Balkhy, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Ziad A. Memish, Sameeh Ghazal, Sarah Al Faraj, Fahad Al-Hameed, Asim AlSaedi…

    Citation: Trials 2020 21:8

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2018 19:81

  39. Acute promyelocytic leukemia (APL) is a highly curable disease when treated with all-trans retinoid acid (ATRA) and arsenic trioxide (ATO). The combination of ATO and ATRA has become the standard therapeutic p...

    Authors: Xinxin Zhang, Li Liu, Yazhou Yao, Sha Gong, Mengchang Wang, Jieying Xi, Limei Chen, Suhua Wei, Huiyun Zhang, Chenyang Zhao and Huaiyu Wang

    Citation: Trials 2020 21:7

    Content type: Study protocol

    Published on:

  40. Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The Online Remote Behavioural Intervention for Tics (ORBIT) study is a randomized controlled trial ...

    Authors: K. Khan, C. Hollis, C. L. Hall, E. B. Davies, D. Mataix-Cols, P. Andrén, T. Murphy, B. J. Brown, E. Murray and C. Glazebrook

    Citation: Trials 2020 21:6

    Content type: Study protocol

    Published on:

  41. Plantar fasciopathy has a lifetime prevalence of 10%. Patients experience sharp pain under the heel, often for several months or years. Multiple treatments are available, but no single treatment appears superi...

    Authors: Henrik Riel, Bill Vicenzino, Jens Lykkegaard Olesen, Martin Bach Jensen, Lars Holger Ehlers and Michael Skovdal Rathleff

    Citation: Trials 2020 21:5

    Content type: Study protocol

    Published on:

  42. Despite the existing national and international plans of action to end violent discipline strategies used by teachers in schools, they still prevail in Tanzanian schools. This underlines the need to implement ...

    Authors: Faustine Bwire Masath, Katharin Hermenau, Mabula Nkuba and Tobias Hecker

    Citation: Trials 2020 21:4

    Content type: Study protocol

    Published on:

  43. Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. Since pharmacological treatments may have substantial side...

    Authors: Lina Samira Bahr, Markus Bock, Daniela Liebscher, Judith Bellmann-Strobl, Liane Franz, Alexandra Prüß, Dania Schumann, Sophie K. Piper, Christian S. Kessler, Nico Steckhan, Andreas Michalsen, Friedemann Paul and Anja Mähler

    Citation: Trials 2020 21:3

    Content type: Study protocol

    Published on:

  44. Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progr...

    Authors: Aliza Werner-Seidler, Kit Huckvale, Mark E. Larsen, Alison L. Calear, Kate Maston, Lara Johnston, Michelle Torok, Bridianne O’Dea, Philip J. Batterham, Susanne Schweizer, S. Rachel Skinner, Katharine Steinbeck, Julie Ratcliffe, Ju-Lee Oei, George Patton, Iana Wong…

    Citation: Trials 2020 21:2

    Content type: Study protocol

    Published on:

  45. Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, ...

    Authors: Esther Aleo Luján, Amanda Lopez-Picado, Ana Rivas, Belén Joyanes Abancens, Marina Laura Rodríguez Rojo, Patricia Fernández García, Carmen Soto Beauregard, Jaime Rodríguez Alarcón, Carlos González Perrino, Borja San Pedro de Urquiza, Eva Arias, Diamelis Rodriguez, Carmen Esteban Polonio and Maria José Torrejón

    Citation: Trials 2020 21:1

    Content type: Study protocol

    Published on:

  46. Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are f...

    Authors: Jingyi Zhao, Xinyu Yan, Jianqing Gai, Jinshuai Han, Hong Zhang, Hui Luo, Shaoting Huang and Junge Wang

    Citation: Trials 2019 20:802

    Content type: Research

    Published on:

  47. In Germany, the care of patients with inflammatory arthritis could be improved. Although specialized rheumatology nurses could take over substantial aspects of patient care, this hardly occurs in Germany. Thus...

    Authors: Anna Mai, Jürgen Braun, Jens-Peter Reese, Benjamin Westerhoff, Ulrike Trampisch, Renate Klaassen-Mielke, Nina Timmesfeld, Hans J. Trampisch and Dietmar Krause

    Citation: Trials 2019 20:793

    Content type: Study protocol

    Published on:

  48. Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol-dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment-seeking in ...

    Authors: Karin Hyland, Anders Hammarberg, Erik Hedman-Lagerlöf, Magnus Johansson and Sven Andreasson

    Citation: Trials 2019 20:790

    Content type: Study protocol

    Published on:

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