Articles

Evaluating the effect of immersive virtual reality technology on gait rehabilitation in stroke patients: a study protocol for a randomized controlled trial

The high incidence of cerebral apoplexy makes it one of the most important causes of adult disability. Gait disorder is one of the hallmark symptoms in the sequelae of cerebral apoplexy. The recovery of walkin...

Authors: Huihui Cai, Tao Lin, Lina Chen, Huidan Weng, Ruihan Zhu, Ying Chen and Guoen Cai

Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional r...

Authors: Guillaume Marquis-Gravel, Holly Robertson, W. Schuyler Jones, Danielle Riley, Daniel E. Ford, David Crenshaw, Yvonne A. Joosten, Lindsey Rudov, Adrian F. Hernandez and Rachel Hess

Acetate Ringer’s solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial

Previous study drew different conclusions on significant differences between saline and balanced crystalloid solution infused in critical illness but both showed a statistical difference in the sepsis subgroup...

Authors: Fang Liu, Jing Zhang, Yuan Zhu, Lianjiu Su, Yiming Li, Li He, Li Yu and Zhiyong Peng

Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar

There is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on the completeness and accuracy of national ovarian cancer and death registration in th...

Authors: Jatinderpal K. Kalsi, Andy Ryan, Aleksandra Gentry-Maharaj, Danielle Margolin-Crump, Naveena Singh, Matthew Burnell, Elizabeth Benjamin, Sophia Apostolidou, Mariam Habib, Susan Massingham, Chloe Karpinskyj, Robert Woolas, Martin Widschwendter, Lesley Fallowfield, Stuart Campbell, Steven Skates…

Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial

Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain; however, it is challenging to compare different stimulation modalities in an individual patient, and thus, it is largely unknown ...

Authors: Rezvan Ahmadi, Benito Campos, Mohammad Mehdi Hajiabadi, Colette Doerr-Harim, Solveig Tenckhoff, Dirk Rasche, Andreas Unterberg, Jan Vesper, Tom Bruckner and Volker Tronnier

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preve...

Authors: Moses Badio, Edouard Lhomme, Mark Kieh, Abdoul Habib Beavogui, Stephen B. Kennedy, Seydou Doumbia, Bailah Leigh, Samba O. Sow, Alpha Diallo, Daniela Fusco, Matthew Kirchoff, Monique Termote, Renaud Vatrinet, Deborah Wentworth, Helène Esperou, H. Clifford Lane…

Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial

Dyslipidemia is a major risk factor for atherosclerotic cardiovascular disease and a leading cause of death worldwide. The clinical utility of commonly used lipid-lowering drugs such as statins and fibrates is...

Authors: Ying Zhao, Yuan-Yuan Yang, Bao-Lin Yang, Ya-Wei Du, Da-Wei Ren, Hong-Mei Zhou, Jing Wang, Hui-Min Yang, Yao-Xian Wang, Ying-Ying Zhang and Sheng-Xian Wu

A master protocol to investigate a novel therapy acetyl-l-leucine for three ultra-rare neurodegenerative diseases: Niemann-Pick type C, the GM2 gangliosidoses, and ataxia telangiectasia

The lack of approved treatments for the majority of rare diseases is reflective of the unique challenges of orphan drug development. Novel methodologies, including new functionally relevant endpoints, are need...

Authors: T. Fields, M. Patterson, T. Bremova-Ertl, G. Belcher, I. Billington, G. C. Churchill, W. Davis, W. Evans, S. Flint, A. Galione, U. Granzer, J. Greenfield, R. Karl, R. Kay, D. Lewi, T. Mathieson…

Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke)

Sleep-disordered breathing (SDB) is highly prevalent in acute ischaemic stroke and is associated with worse functional outcome and increased risk of recurrence. Recent meta-analyses suggest the possibility of ...

Authors: Simone B. Duss, Anne-Kathrin Brill, Sébastien Baillieul, Thomas Horvath, Frédéric Zubler, Dominique Flügel, Georg Kägi, Gabriel Benz, Corrado Bernasconi, Sebastian R. Ott, Lyudmila Korostovtseva, Yurii Sviryaev, Farid Salih, Matthias Endres, Renaud Tamisier, Haralampos Gouveris…

Oral melatonin as a new tool for neuroprotection in preterm newborns: study protocol for a randomized controlled trial

Prevention of neurodevelopmental impairment due to preterm birth is a major health challenge. Despite advanced obstetric and neonatal care, to date there are few neuroprotective molecules available. Melatonin ...

Authors: Francesca Garofoli, Stefania Longo, Camilla Pisoni, Patrizia Accorsi, Micol Angelini, Salvatore Aversa, Camilla Caporali, Sara Cociglio, Annalisa De Silvestri, Elisa Fazzi, Vittoria Rizzo, Chryssoula Tzialla, Marco Zecca and Simona Orcesi

Effectiveness of a pathway-driven eHealth-based integrated care model (PEICM) for community-based hypertension management in China: study protocol for a randomized controlled trial

The prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in tradition...

Authors: Zheyu Wang, Chengling Li, Wencai Huang, Yan Chen, Yuqiong Li, Libin Huang, Mei Zhang, Dan Wu, Li Wang, Huilong Duan, Jiye An and Ning Deng

STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a prior...

Authors: Bastiaan C. ter Meulen, Johanna M. van Dongen, Marinus van der Vegt, Henry C. Weinstein and Raymond W. J. G. Ostelo

The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial

Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupo...

Authors: Huiqing Xu, Xu Wei, Ranxing Zhang, Ling Li, Zhijun Zhang, Ruo Jia, Xiaofei Zhang, Xiumei Gao, Xicheng Dong and Junjun Pan

Quantifying the advantages of conducting a prospective meta-analysis (PMA): a case study of early childhood obesity prevention

For prospective meta-analyses (PMAs), eligible studies are identified, and the PMA hypotheses, selection criteria, and analysis methods are pre-specified before the results of any of the studies are known. This r...

Authors: A. L. Seidler, K. E. Hunter, D. Espinoza, S. Mihrshahi and L. M. Askie

The coArtHA trial—identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial

Arterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. Only a few and mostly small randomized trials have studied antihypertensive treatments in people of Afr...

Authors: Herry Mapesi, Ravi Gupta, Herieth Ismael Wilson, Blaise Lukau, Alain Amstutz, Aza Lyimo, Josephine Muhairwe, Elizabeth Senkoro, Theonestina Byakuzana, Madavida Mphunyane, Moniek Bresser, Tracy Renée Glass, Mark Lambiris, Günther Fink, Winfrid Gingo, Manuel Battegay…

Commentary on ‘Exclusion rates in randomized trials of treatments for physical conditions: a systematic review’

Authors: Anna Ugalde, Nicole Kiss, Patricia M. Livingston and Nicole Rankin

Efficacy of silver needle therapy for the treatment of chronic nonspecific low back pain: a prospective, single-center, randomized, parallel-controlled clinical trial

Chronic nonspecific low back pain (CNSLBP) troubles approximately 30% of people worldwide. Silver needle therapy (SNT) is a treatment method to relieve soft tissue pain through heating. Therefore, this study a...

Authors: Xuesong Hu, Shaoxing Dong, Bing Zhang, Xuan Wang, Yanwei Yin, Chuansheng Liu, Junmin Yu, Xing Wu, Fenghu Xu and Chao Meng

Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial

The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. There has been no specific etiological treatment for HT. Even though with normal level of thyroid hormone, the patients...

Authors: Shanze Wang, Jiping Zhao, Weimei Zeng, Wanqing Du, Tenghui Zhong, Hui Gao, Yi Xiao and Chao Yang

Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial

Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could...

Authors: Fangyuan Li, Hua Lu, Xinxin Wang, Qi Zhang, Qianchen Liu and Tong Wang

Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial

In the healthcare system in Germany, different institutions and actors play specific roles in the discharge and transition of patients from hospitals into primary care (Sachverständigenrat zur Begutachtung der...

Authors: Terese Dehl, Ulf Sauerbrey, Adina Dreier-Wolfgramm, Angela Nikelski, Nino Chikhradze, Armin Keller, Jessica Laufer, Fanny Schumacher-Schoenert, Stefan Kreisel, Jochen René Thyrian, Wolfgang Hoffmann and Horst Christian Vollmar

Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in severe COVID-19: study protocol for a three-armed randomized controlled trial

SARS-CoV-2, the virus that causes COVID-19, enters the cells through a mechanism dependent on its binding to angiotensin-converting enzyme 2 (ACE2), a protein highly expressed in the lungs. The putative viral-...

Authors: Eli Mansour, Flávia F. Bueno, José C. de Lima-Júnior, Andre Palma, Milena Monfort-Pires, Bruna Bombassaro, Eliana P. Araujo, Ana Flavia Bernardes, Raisa G. Ulaf, Thyago A. Nunes, Luciana C. Ribeiro, Antônio Luís E. Falcão, Thiago Martins Santos, Plinio Trabasso, Rachel P. Dertkigil, Sergio S. Dertkigil…

Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or ther...

Authors: Elena Diago-Sempere, José Luis Bueno, Aránzazu Sancho-López, Elena Múñez Rubio, Ferrán Torres, Rosa Malo de Molina, Ana Fernández-Cruz, Isabel Salcedo de Diego, Ana Velasco-Iglesias, Concepción Payares-Herrera, Inmaculada Casas Flecha, Cristina Avendaño-Solà, Rafael Duarte Palomino, Antonio Ramos-Martínez and Belén Ruiz-Antorán

Mingjing granule, a traditional Chinese medicine in the treatment of neovascular age-related macular degeneration: study protocol for a randomized controlled trial

Neovascular age-related macular degeneration (nAMD) is the most common cause of irreversible vision loss and blindness among the older people aged 50 and over. Although anti-vascular endothelial growth factor ...

Authors: Yamin Li, Lina Liang, Torkel Snellingen, Kai Xu, Yun Gao, Fengmei Zhang, Chengwei Guo, Tao Zuo, Fengming Liang, Xiaoping Yao and Xueyan Yang

Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project

Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elem...

Authors: Nikki Totton, Steven Julious, Dyfrig Hughes, Jonathan Cook, Katie Biggs, Lizzie Coates, Andrew Cook, Catherine Hewitt and Simon Day

The Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a study protocol for a double-blinded randomized controlled trial

Atopic dermatitis (AD) is a complex, common inflammatory skin disease. The Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been a common dermatosis treatment in China for many years, but there is no high-le...

Authors: Meiling Xuan, Xiaohui Guo, Hongyi Li, Ting Xie, Xiumei Mo and Zehuai Wen

Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial

Cardiovascular disease remains the leading cause of death in Singapore. Uncontrolled hypertension confers the highest attributable risk of CVD and remains a significant public health issue with sub-optimal blo...

Authors: John C. Allen Jr, Benjamin Halaand, Rupesh M. Shirore and Tazeen H. Jafar

Mentoring upcoming researchers for non-communicable diseases’ research and practice in Malawi

The Malawi College of Medicine and its partners are building non-communicable diseases’ (NCDs’) research capacity through a grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Insti...

Authors: Adamson S. Muula, Mina C. Hosseinipour, Martha Makwero, Johnstone Kumwenda, Prosper Lutala, Mary Mbeba, Sarah Rylance, Collins Mitambo and Moffat Nyirenda

In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Imaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availabilit...

Authors: Aldo Badano

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleedin...

Authors: Ayla S. Turan, Leon M. G. Moons, Ramon-Michel Schreuder, Erik J. Schoon, Jochim S. Terhaar sive Droste, Ruud W. M. Schrauwen, Jan Willem Straathof, Barbara A. J. Bastiaansen, Matthijs P. Schwartz, Wouter L. Hazen, Alaa Alkhalaf, Daud Allajar, Muhammed Hadithi, Bas W. van der Spek, Dimitri G. D. N. Heine, Adriaan C. I. T. L. Tan…

Managing clinical trials during COVID-19: experience from a clinical research facility

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the co...

Authors: Frances Shiely, Jean Foley, Amy Stone, Emma Cobbe, Shaunagh Browne, Ellen Murphy, Maeve Kelsey, Joanne Walsh-Crowley and Joseph A. Eustace

Diabetes management intervention studies: lessons learned from two studies

Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. ...

Authors: Bettina Petersen, Iris Vesper, Bernhild Pachwald, Nicole Dagenbach, Sina Buck, Delia Waldenmaier and Lutz Heinemann

Evaluation of the efficacy and safety of inhaled magnesium sulphate in combination with standard treatment in patients with moderate or severe COVID-19: A structured summary of a study protocol for a randomised controlled trial

Basic and clinical studies have shown that magnesium sulphate ameliorates lung injury and controls asthma attacks by anti-inflammatory and bronchodilatory effects. Both intravenous and inhaled magnesium sulpha...

Authors: Guitti Pourdowlat, Seyed Ruhollah Mousavinasab, Behrooz Farzanegan, Alireza Kashefizadeh, Zohreh Akhoundi Meybodi, Maedeh Jafarzadeh and Shadi Baniasadi

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs

Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosag...

Authors: Florence Rodgers, Toby Pepperrell, Sarai Keestra and Victoria Pilkington

Physiotherapeutic scoliosis-specific exercises performed immediately after spinal manipulative therapy for the treatment of mild adolescent idiopathic scoliosis: study protocol for a randomized controlled pilot trial

Spinal manipulative therapy is commonly used in the treatment of adolescent idiopathic scoliosis. Some therapists also rely on physiotherapeutic scoliosis-specific exercise (PSSE). Combining these two modaliti...

Authors: Li Wang, Chun Wang, Ahmed S. A. Youssef, Jiang Xu, Xiaolin Huang and Nan Xia

The reality of informed consent: empirical studies on patient comprehension—systematic review

Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which pati...

Authors: Tomasz Pietrzykowski and Katarzyna Smilowska

The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children

Increasingly, genomics is informing clinical practice, but challenges remain for medical professionals lacking genetics expertise, and in access to and clinical utility of genomic testing for minority and unde...

Authors: Jacqueline A. Odgis, Katie M. Gallagher, Sabrina A. Suckiel, Katherine E. Donohue, Michelle A. Ramos, Nicole R. Kelly, Gabrielle Bertier, Christina Blackburn, Kaitlyn Brown, Lena Fielding, Jessenia Lopez, Karla Lopez Aguiniga, Estefany Maria, Jessica E. Rodriguez, Monisha Sebastin, Nehama Teitelman…

Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial

Ulcerative colitis (UC) is an intestinal inflammatory disease characterized by inflammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients wi...

Authors: Zhaofeng Shen, Kai Zheng, Jiandong Zou, Peiqing Gu, Jing Xing, Lu Zhang, Lei Zhu and Hong Shen

Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study

Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addres...

Authors: Clare McDermott, Jane Vennik, Carl Philpott, Steffi le Conte, Mike Thomas, Caroline Eyles, Paul Little, Helen Blackshaw, Anne Schilder and Claire Hopkins

Using brain functional magnetic resonance imaging to evaluate the effectiveness of acupuncture combined with mirror therapy on upper limb function in patients with cerebral ischemic stroke: a study protocol for a randomized, controlled trial

Upper limb and hand motor dysfunction is one of the challenges in rehabilitation after cerebral ischemic stroke (CIS), and the clinical efficacy of rehabilitation needs to be improved. This study aims to combi...

Authors: Mingzhu Xu, Run Lin, Jing Luo, Chunzhi Tang, Shuhui Wang, John Wong, Meng Wu, Jianting Huang, Peng Shi, Ang Gao, Yuqian Bai, Ying Xie, Jun Luo, Yunqiu Yang and Shaoyang Cui

A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study

Following the World Health Organization’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-S...

Authors: Mohammed Limbada, Chiti Bwalya, David Macleod, Sian Floyd, Ab Schaap, Vasty Situmbeko, Richard Hayes, Sarah Fidler and Helen Ayles

The impact of computer-based cognitive training intervention on the quality of life among elderly people: a randomized clinical trial

Through the process of normal aging, cognitive decline would cause a lower level of functioning in real life. This flow might interfere with health-related quality of life (QoL). The purpose of this study is t...

Authors: Leila kazazi, Mohsen Shati, Seyede Salehe Mortazavi, Vahid Nejati and Mahshid Foroughan

Absolute vs. relative effects—implications for subgroup analyses

Authors: Lars W. Andersen

Navigate: a study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners

Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We ...

Authors: Penelope Schofield, Karla Gough, Amelia Hyatt, Alan White, Mark Frydenberg, Suzanne Chambers, Louisa G. Gordon, Robert Gardiner, Declan G. Murphy, Lawrence Cavedon, Natalie Richards, Barbara Murphy, Stephen Quinn and Ilona Juraskova

Viral load-guided immunosuppression after lung transplantation (VIGILung)—study protocol for a randomized controlled trial

Immunosuppression including high-dose calcineurin inhibitors (CNI) is essential after lung transplantation. Dosing is usually guided by therapeutic drug monitoring adjusted to target trough levels of CNIs to k...

Authors: Jens Gottlieb, Alexander Reuss, Konstantin Mayer, Karin Weide, Carmen Schade-Brittinger, Susanne Hoyer and Peter Jaksch

Enhancing behavioral sleep care with digital technology: study protocol for a hybrid type 3 implementation-effectiveness randomized trial

Insomnia affects almost one in four military service members and veterans. The first-line recommended treatment for insomnia is cognitive-behavioral therapy for insomnia (CBTI). CBTI is typically delivered in-...

Authors: Anne Germain, Rachel R. Markwald, Erika King, Adam D. Bramoweth, Megan Wolfson, Gilbert Seda, Tony Han, Erin Miggantz, Brian O’Reilly, Lars Hungerford, Traci Sitzer, Vincent Mysliwiec, Joseph J. Hout and Meredith L. Wallace

Efficacy of a joint didactic intervention using the Junta De Andalucía School for Patients method to control prothrombin time in patients taking anticoagulants: protocol for a randomized controlled trial

Oral anticoagulant drugs represent an essential tool in the prevention of thromboembolic events. The ones in widespread use are vitamin K antagonists, whose plasma level is monitored by measuring prothrombin t...

Authors: Leovigildo Ginel-Mendoza, Alfonso Hidalgo-Natera, Rocío Reina-Gonzalez, Rafael Poyato-Ramos, Juana Morales-Naranjo, Inmaculada Lupiañez-Pérez, Antonio Baca-Osorio, Miguel Gutiérrez-Jansen, María Paz Fernández-Lara, Diego Lozano-Noriega, Ulises Salgado-Carvallo, Cristina Bandera-García and Francisco Javier Navarro-Moya

Hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting (LIBERTY): A structured summary of a study protocol for a randomised controlled trial

The primary objective of this study is to evaluate the therapeutic potential of hydroxychloroquine (HCQ) in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting,...

Authors: Petri J. Vainio, Pauliina Hietasalo, Anna-Liisa Koivisto, Susanna Kääriäinen, Jari Turunen, Mika Virtala, Jouni Vuorinen and Mika Scheinin

Treatment of COVID-19 pneumonia with glucocorticoids (CORTIVID): a structured summary of a study protocol for a randomised controlled trial

The aim of this study is to assess the effectiveness and safety of glucocorticoid infusion pulse therapy to improve the clinical outcomes of patients with COVID-19 pneumonia with elevated inflammatory biomarkers.

Authors: Iñigo Les Bujanda, Jose Loureiro-Amigo, Ferran Capdevila Bastons, Iñaki Elejalde Guerra, Javier Anniccherico Sánchez, Anna Murgadella-Sancho, Ruth García Rey, Julián Librero López and Julio Sánchez Álvarez

Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial

As of December, 1^st, 2020, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, resulted in more than 1 472 917 deaths worldwide and death toll is still increasing exponentially. Many COVID-19 infected peopl...

Authors: W. Dioh, M. Chabane, C. Tourette, A. Azbekyan, C. Morelot-Panzini, L. A. Hajjar, M. Lins, G. B. Nair, T. Whitehouse, J. Mariani, M. Latil, S. Camelo, R. Lafont, P. J. Dilda, S. Veillet and S. Agus

Minimally Invasive Versus open AbdominoThoracic Esophagectomy for esophageal carcinoma (MIVATE) — study protocol for a randomized controlled trial DRKS00016773

The only curative treatment for most esophageal cancers is radical esophagectomy. Minimally invasive esophagectomy (MIE) aims to reduce postoperative morbidity, but is not yet widely established. Linear staple...

Authors: Felix Nickel, Pascal Probst, Alexander Studier-Fischer, Henrik Nienhüser, Jana Pauly, Karl-Friedrich Kowalewski, Sebastian Weiterer, Philipp Knebel, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Thomas Schmidt and Beat P. Müller-Stich