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  1. The primary objectives of this study are to determine efficacy of Siddha medicine, Kabasura kudineer in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 when compared...

    Authors: S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli and P. Balaji

    Citation: Trials 2020 21:892

    Content type: Letter

    Published on:

  2. The SUPPORT-HF2 randomised controlled trial compared telehealth technology alone with the same technology combined with centralised remote support, in which a clinician responds promptly to biomarker changes. ...

    Authors: Chrysanthi Papoutsi, Christine A’Court, Joseph Wherton, Sara Shaw and Trisha Greenhalgh

    Citation: Trials 2020 21:891

    Content type: Research

    Published on:

  3. In this study, we investigate the effect of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19.

    Authors: Helda Tutunchi, Majid Mobasseri, Samira Pourmoradian, Hamid Soleimanzadeh, Behnam Kafil, Neda Akbari, Alireza Monshikarimi and Alireza Ostadrahimi

    Citation: Trials 2020 21:890

    Content type: Letter

    Published on:

  4. Suicide is a serious public health problem. The development and use of effective treatments for people hospitalized for suicide attempts remain a priority. Regarding psychosocial treatment, the evidence for tr...

    Authors: Laurent S. Chaïb, Jorge Lopez-Castroman and Mocrane Abbar

    Citation: Trials 2020 21:889

    Content type: Study protocol

    Published on:

  5. Exercise training is suggested to have a stress-buffering effect on physiological reactions to acute stress. The so-called cross-stressor adaptation hypothesis is one of many theories behind the plausible effe...

    Authors: Elin Arvidson, Anna Sjörs Dahlman, Mats Börjesson, Lennart Gullstrand and Ingibjörg H. Jonsdottir

    Citation: Trials 2020 21:888

    Content type: Research

    Published on:

  6. Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic paediatric ocular inflammatory condition that can result in visual impairment. Adalimumab, a tumour necrosis factor (TNF)-alpha inhibitor, ef...

    Authors: Nisha R. Acharya, Caleb D. Ebert, Nicole K. Kelly, Travis C. Porco, Athimalaipet V. Ramanan and Benjamin F. Arnold

    Citation: Trials 2020 21:887

    Content type: Study protocol

    Published on:

  7. We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill.

    Authors: Mehdi Hassaniazad, Ali Bazram, Soheil Hassanipour and Mohammad Fathalipour

    Citation: Trials 2020 21:886

    Content type: Letter

    Published on:

  8. An amendment to this paper has been published and can be accessed via the original article.

    Authors: Ryan Bradley, Blake O. Langley, Jennifer J. Ryan, John Phipps, Douglas A. Hanes, Emily Stack, Janet K. Jansson, Thomas O. Metz and Jan Frederik Stevens

    Citation: Trials 2020 21:885

    Content type: Correction

    Published on:

    The original article was published in Trials 2020 21:835

  9. Aspiration, infections, and fever are common in the first days after stroke, especially in older patients. The occurrence of these complications has been associated with an increased risk of death or dependency.

    Authors: Jeroen C. de Jonge, Lisa J. Woodhouse, Hendrik Reinink, H. Bart van der Worp and Philip M. Bath

    Citation: Trials 2020 21:884

    Content type: Update

    Published on:

    A Related Article has been published.

  10. General: To assess the safety, efficacy and dose response of convalescent plasma (CP) transfusion in severe COVID-19 patients

    Authors: Fazle Rabbi Chowdhury, Ashraful Hoque, Forhad Uddin Hasan Chowdhury, Md. Ruhul Amin, Abdur Rahim, M. Mujibur Rahman, Rubina Yasmin, Md. Robed Amin, Md. Titu Miah, Md. Abul Kalam and Md. Sayedur Rahman

    Citation: Trials 2020 21:883

    Content type: Letter

    Published on:

  11. We will evaluate the efficacy and safety of Melatonin, compared to the standard therapeutic regimen on clinical symptoms and serum inflammatory parameters in patients with confirmed COVID-19, who are moderatel...

    Authors: Ava Ziaei, Parivash Davoodian, Habib Dadvand, Omid Safa, Soheil Hassanipour, Mahmoud Omidi, Moein Masjedi, Fahime Mahmoudikia, Bahareh Rafiee and Mohammad Fathalipour

    Citation: Trials 2020 21:882

    Content type: Letter

    Published on:

  12. The BCG vaccine, widely used in Brazil in new-borns, induces adjuvant protection for several diseases, including childhood virus infections. BCG activates monocytes and innate memory NK cells which are crucial...

    Authors: Ana Paula Junqueira-Kipnis, Laura Raniere Borges dos Anjos, Lília Cristina de Souza Barbosa, Adeliane Castro da Costa, Kellen Christina Malheiros Borges, Amanda da Rocha Oliveira Cardoso, Kaio Mota Ribeiro, Sarah Brena Aparecida Rosa, Carine de Castro Souza, Rogério Coutinho das Neves, Guylherme Saraiva, Sueli Meira da Silva, Erika Aparecida Silveira, Marcelo Fouad Rabahi, Marcus Barreto Conte and André Kipnis

    Citation: Trials 2020 21:881

    Content type: Letter

    Published on:

    The Correction to this article has been published in Trials 2020 21:967

  13. We will investigate the effectiveness of high dose Interferon Beta 1a, compared to low dose Interferon Beta 1a (the base therapeutic regimen) in COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) wi...

    Authors: Ilad Alavi Darazam, Firouze Hatami, Mohammad Mahdi Rabiei, Mohamad Amin Pourhoseingholi, Omid Moradi, Shervin Shokouhi, Mohammad Reza Hajesmaeili, Minoosh Shabani and Seyed Sina Naghibi Irvani

    Citation: Trials 2020 21:880

    Content type: Letter

    Published on:

  14. Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim ...

    Authors: Haiping Deng, Yu Shu, Peiran Lv, Ling Zhao, Ke Cheng, Tingting Zhang, Yi Song, Hua Yang, Hong Tang, Jian Pei and Xueyong Shen

    Citation: Trials 2020 21:879

    Content type: Study protocol

    Published on:

  15. Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulat...

    Authors: Anne van der Meij, Marianne A. A. van Walderveen, Nyika D. Kruyt, Erik W. van Zwet, Eric J. Liebler, Michel D. Ferrari and Marieke J. H. Wermer

    Citation: Trials 2020 21:878

    Content type: Study protocol

    Published on:

  16. Chronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause of death worldwide by 2020. Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients wi...

    Authors:

    Citation: Trials 2020 21:877

    Content type: Study protocol

    Published on:

    The Correction to this article has been published in Trials 2020 21:961

  17. To investigates the effectiveness of curcumin-containing Nanomicelles as a therapeutic supplement in the treatment of patients with COVID-19 and its effect on immune responses balance changes following treatment.

    Authors: Mehdi Hassaniazad, Behnaz Rahnama Inchehsablagh, Hossein Kamali, Abdolali Tousi, Ebrahim Eftekhar, Mahmoud Reza Jaafari, Mohammad Fathalipour, Sara Nikoofal-Sahlabadi, Hamed Gouklani, Hesam Alizade and Amin Reza Nikpoor

    Citation: Trials 2020 21:876

    Content type: Letter

    Published on:

  18. The primary objective is to demonstrate that COVID-19 convalescent plasma (CCP) prevents progression to severe pneumonia in elderly COVID-19 pneumonia patients with chronic comorbidities.

    Authors: Luciana Teofili, Raffaele Landolfi, Antonella Cingolani, Andrea Antinori, Jacopo Vecchiet, Maurizio Sanguinetti, Antonio Gasbarrini, Tina Pasciuto, Nicoletta Orlando and Silvia Lamonica

    Citation: Trials 2020 21:875

    Content type: Letter

    Published on:

  19. Vital pulp therapy aims at maintaining the pulp tissue injured but vital. Thus, the use of capping materials that induce tissue regeneration is a great current trend. This study aims to evaluate clinically and...

    Authors: Maria Aparecida Andrade Moreira Machado, Tássia Carina Stafuzza, Luciana Lourenço Ribeiro Vitor, Silgia Aparecida da Costa, Sirlene Maria da Costa, Natalino Lourenço Neto and Thais Marchini Oliveira

    Citation: Trials 2020 21:874

    Content type: Study protocol

    Published on:

  20. When planning a multicentre clinical trial, it can be difficult to predict the time needed to open individual sites, and this in turn impacts on the total number of sites needed, the budget and the time frame ...

    Authors: Rosemary Greenwood, Julie Pell, Paula Foscarini-Craggs, Katharine Wale, Ian Thomas and Charlotte Bradbury

    Citation: Trials 2020 21:873

    Content type: Letter

    Published on:

  21. Almost 20% of U.S. women remain at risk for cervical cancer due to their inability or unwillingness to participate in periodic clinic-based screening. Self-sampling has been shown to be an effective strategy f...

    Authors: Jane R. Montealegre, Matthew L. Anderson, Susan G. Hilsenbeck, Elizabeth Y. Chiao, Scott B. Cantor, Susan L. Parker, Maria Daheri, Shaun Bulsara, Betsy Escobar, Ashish A. Deshmukh, Maria L. Jibaja-Weiss, Mohammed Zare and Michael E. Scheurer

    Citation: Trials 2020 21:872

    Content type: Study protocol

    Published on:

  22. Suicide risk among individuals with schizophrenia (SZ) is intractably high, with over 40% of individuals attempting to take their own lives during their lifetime and an estimated 5–10% completing suicide. At p...

    Authors: Katie Beck-Felts, Marianne Goodman, Luz H. Ospina, Melanie Wall, Joseph McEvoy, Lars F. Jarskog, Jacob S. Ballon, Matthew N. Bartels, Richard Buchsbaum, Richard P. Sloan, T. Scott Stroup and David Kimhy

    Citation: Trials 2020 21:871

    Content type: Study protocol

    Published on:

  23. The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression...

    Authors: Luisa Weiner, Fabrice Berna, Nathalie Nourry, François Severac, Pierre Vidailhet and Amaury C. Mengin

    Citation: Trials 2020 21:870

    Content type: Study protocol

    Published on:

  24. Tenosynovitis of the long head of the biceps (LHB) brachii is a common disease in patients over 40 years old. It can always result in chronic anterior shoulder pain and limited function. Acupuncture is one of ...

    Authors: Rongrong Li, Yongliang Jiang, Renjie Hu, Xiaofen He and Jianqiao Fang

    Citation: Trials 2020 21:869

    Content type: Methodology

    Published on:

  25. Resuscitated out-of-hospital cardiac arrest (OHCA) patients who remain comatose at admission are at high risk of morbidity and mortality. This has been attributed to the post-cardiac arrest syndrome (PCAS) whi...

    Authors: Martin A. S. Meyer, Sebastian Wiberg, Johannes Grand, Jesper Kjaergaard and Christian Hassager

    Citation: Trials 2020 21:868

    Content type: Study protocol

    Published on:

  26. There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination...

    Authors: Pradeesh Sivapalan, Charlotte Suppli Ulrik, Therese Sophie Lappere, Josefin Viktoria Eklöf, Saher Burhan Shaker, Uffe Christian Steinholtz Bødtger, Andrea Browatzki, Christian Niels Meyer, Ulla Møller Weinreich, Christian B. Laursen, Tor Biering-Sørensen, Filip Krag Knop, Jens D. Lundgren and Jens-Ulrik Stæhr Jensen

    Citation: Trials 2020 21:867

    Content type: Update

    Published on:

    The Letter to this article has been published in Trials 2020 21:513

  27. 1. To compare the safety and efficacy of Hydroxychloroquine with Ribavirin and standard treatment in patients with non-severe COVID-19 infection

    Authors: Prasan Kumar Panda, Arkapal Bandyopadhyay, Budha Charan Singh, Bikram Moirangthem, Gaurav Chikara, Sarama Saha and Yogesh Arvind Bahurupi

    Citation: Trials 2020 21:866

    Content type: Letter

    Published on:

  28. Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson’s disease, Alzheimer’s disease, and major depression. De...

    Authors: Lanlan Pu, Nauman Khalid Qureshi, Joanne Ly, Bingwei Zhang, Fengyu Cong, William C. Tang and Zhanhua Liang

    Citation: Trials 2020 21:864

    Content type: Study protocol

    Published on:

  29. Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experie...

    Authors: Susan N. Hastings, Karen M. Stechuchak, Ashley Choate, Elizabeth P. Mahanna, Courtney Van Houtven, Kelli D. Allen, Virginia Wang, Nina Sperber, Leah Zullig, Hayden B. Bosworth and Cynthia J. Coffman

    Citation: Trials 2020 21:863

    Content type: Methodology

    Published on:

  30. We present a study protocol for a randomized, double-blind, placebo-controlled trial that investigates the hypothesis if intervention in the symptomatic phase preceding clinical arthritis (clinically suspect a...

    Authors: Ellis Niemantsverdriet, Yousra J. Dakkak, Leonie E. Burgers, Femke Bonte-Mineur, Gerda M. Steup-Beekman, Sjoerd M. van der Kooij, Hido D. Boom, Cornelia F. Allaart, Pascal H. P. de Jong and Annette H. M. van der Helm-van Mil

    Citation: Trials 2020 21:862

    Content type: Study protocol

    Published on:

  31. Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related pro...

    Authors: Marthe E. Ford, Gert J. Geurtsen, Erny Groet, Coen A. M. Van Bennekom and Eus J. W. Van Someren

    Citation: Trials 2020 21:861

    Content type: Study protocol

    Published on:

  32. Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive ...

    Authors: Simon Provoost, Annet Kleiboer, José Ornelas, Tibor Bosse, Jeroen Ruwaard, Artur Rocha, Pim Cuijpers and Heleen Riper

    Citation: Trials 2020 21:860

    Content type: Study protocol

    Published on:

  33. Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to interve...

    Authors: Sofia Strömmer, Millie Barrett, Kathryn Woods-Townsend, Janis Baird, David Farrell, Joanne Lord, Leanne Morrison, Sarah Shaw, Christina Vogel, Wendy Lawrence, Donna Lovelock, Lisa Bagust, Judit Varkonyi-Sepp, Patsy Coakley, Lyall Campbell, Ross Anderson…

    Citation: Trials 2020 21:859

    Content type: Study protocol

    Published on:

  34. The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), l...

    Authors: Claire L. Chan, Melanie Smuk, Ratna Sohanpal, Hilary Pinnock and Stephanie J. C. Taylor

    Citation: Trials 2020 21:858

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2020 21:18

  35. Equine-assisted therapy is more often practiced with children and adolescents than with the elderly, although individuals in the second half of life could also profit from it. This group, from the age of 50, i...

    Authors: Julia Schmidt, Andrea Wartenberg-Demand and Simon Forstmeier

    Citation: Trials 2020 21:857

    Content type: Study protocol

    Published on:

  36. Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recru...

    Authors: Holly C. Mattock, Rachael Ryan, Christine O’Farrelly, Daphne Babalis and Paul G. Ramchandani

    Citation: Trials 2020 21:856

    Content type: Research

    Published on:

  37. Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivors...

    Authors: Raymond Javan Chan, Jon Emery, Katharine Cuff, Laisa Teleni, Camilla Simonsen, Jane Turner, Monika Janda, Daniel Mckavanagh, Lee Jones, Emma McKinnell, Melissa Gosper, Juanita Ryan, Ria Joseph, Bethany Crowe, Jennifer Harvey, Marissa Ryan…

    Citation: Trials 2020 21:855

    Content type: Study protocol

    Published on:

  38. A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the ef...

    Authors: Daniela Koppold-Liebscher, Christian S. Kessler, Nico Steckhan, Vanessa Bähr, Cornelia Kempter, Manfred Wischnewsky, Marisa Hübner, Barbara Kunz, Marion Paul, Stefanie Zorn, Sophia Sari, Michael Jeitler, Rainer Stange and Andreas Michalsen

    Citation: Trials 2020 21:854

    Content type: Study protocol

    Published on:

  39. To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of...

    Authors: Ricardo Palacios, Elizabeth González Patiño, Roberta de Oliveira Piorelli, Monica Tilli Reis Pessoa Conde, Ana Paula Batista, Gang Zeng, Qianqian Xin, Esper G. Kallas, Jorge Flores, Christian F. Ockenhouse and Christopher Gast

    Citation: Trials 2020 21:853

    Content type: Letter

    Published on:

  40. The demand for total hip arthroplasty (THA) is quickly rising given the escalating global incidence of hip osteoarthritis, and it is widely accepted that the post-surgery rehabilitation is key to optimize outc...

    Authors: Chiara Busso, Gabriele Castorina, Marco Di Monaco, Daniel Rodriguez, Hadis Mahdavi, Simone Balocco, Marco Trucco, Marco Conti, Alessandro Castagna and Marco Alessandro Minetto

    Citation: Trials 2020 21:852

    Content type: Study protocol

    Published on:

  41. Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly descr...

    Authors: Krister W. Fjermestad, Wendy K. Silverman and Torun M. Vatne

    Citation: Trials 2020 21:851

    Content type: Study protocol

    Published on:

  42. Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial...

    Authors: Yongcan Wu, Caixia Pei, Xiaomin Wang, Mingjie Wang, Demei Huang, Fei Wang, Wei Xiao and Zhenxing Wang

    Citation: Trials 2020 21:850

    Content type: Study protocol

    Published on:

  43. In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported ou...

    Authors: Lisa M. Wintner, Johannes M. Giesinger, Monika Sztankay, Andrew Bottomley and Bernhard Holzner

    Citation: Trials 2020 21:849

    Content type: Study protocol

    Published on:

  44. Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation

    Authors: James H. McMahon, Jillian S. Y. Lau, Janine Roney, Benjamin A. Rogers, Jason Trubiano, Joseph Sasadeusz, James S. Molton, Bradley Gardiner, Sue J. Lee, Jennifer F. Hoy, Allen Cheng and Anton Y. Peleg

    Citation: Trials 2020 21:847

    Content type: Letter

    Published on:

  45. To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation.

    Authors: Alexandre Duvignaud, Edouard Lhomme, Thierry Pistone, Racha Onaisi, Rémi Sitta, Valérie Journot, Duc Nguyen, Nathan Peiffer-Smadja, Antoine Crémer, Stéphane Bouchet, Thomas Darnaud, Delphine Poitrenaud, Lionel Piroth, Christine Binquet, Jean-François Michel, Benjamin Lefèvre…

    Citation: Trials 2020 21:846

    Content type: Letter

    Published on:

  46. Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant person...

    Authors: Thomas J. Stamm, Julia C. Zwick, Grace O’Malley, Lene-Marie Sondergeld and Martin Hautzinger

    Citation: Trials 2020 21:845

    Content type: Study protocol

    Published on:

  47. Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic eff...

    Authors: Yajie Ji, Siyu Li, Xinyue Zhang, Yu Liu, Qing Lu, Qiong Li, Weili Chen, Jiayu Sheng, Ke Jiang, Hongli Liang, Shanyan Sha, Mengting Li, Zongxin Chen, Peiyi Zheng, Minhong Wang, Yuanyuan Feng…

    Citation: Trials 2020 21:844

    Content type: Study protocol

    Published on:

  48. We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill.

    Authors: Omid Safa, Mehdi Hassaniazad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour and Mohammad Fathalipour

    Citation: Trials 2020 21:841

    Content type: Letter

    Published on:

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