Articles

Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial

HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization pri...

Authors: Ruanne V. Barnabas, Elizabeth R. Brown, Maricianah Onono, Elizabeth A. Bukusi, Betty Njoroge, Rachel L. Winer, Deborah Donnell, Denise Galloway, Stephen Cherne, Kate Heller, Hannah Leingang, Susan Morrison, Elena Rechkina, R. Scott McClelland, Jared M. Baeten, Connie Celum…

Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial

Randomized trials of assisted reproductive technology (ART) have been designed for outcomes of clinical pregnancy or live birth and have not been powered for obstetric outcomes such as preeclampsia, critical f...

Authors: Sheriza Baksh, Anne Casper, Mindy S. Christianson, Kate Devine, Kevin J. Doody, Stephan Ehrhardt, Karl R. Hansen, Ruth B. Lathi, Fatmata Timbo, Rebecca Usadi, Wendy Vitek, David M. Shade, James Segars and Valerie L. Baker

A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease

Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases ha...

Authors: Uwe Konerding, Marcus Redaèlli, Karolin Ackermann, Sibel Altin, Sebastian Appelbaum, Bianca Biallas, August-Wilhelm Bödecker, Suzan Botzenhardt, Chloé Chermette, Martin Cichocki, Iris Dapper, Katja Dehnen, Christian Funke, Angeli Gawlik, Lisa Giesen, Johannes Goetz…

Women’s experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery: a qualitative study

Information about and invitation to participate in a clinical trial involving an intervention during childbirth may cause fear or worry in pregnant women. The aim of this study was to describe nulliparous wome...

Authors: Jenny Ericson, Cecilia Anagrius, Agnes Rygaard, Lisa Guntram, Sophia Brismar Wendel and Susanne Hesselman

Study protocol: a multi-center, double-blind, randomized, 6-month, placebo-controlled trial to investigate the effect of supplementing hormone therapy FET cycles with Gushen’antai pills on the outcomes of in vitro fertilization

Infertility is a widespread global challenge. Currently, the most effective treatment strategy for infertility is in vitro fertilization (IVF), which is an assisted reproductive technique (ART). The use of IVF...

Authors: Ying-jie Ma, Xian-ling Cao, Ting Ma, Jing-yan Song, Ling-yu Yu, Yang-yang Yu, Jian-Yun Zhao and Zhen-Gao Sun

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling

To achieve higher effectiveness in population-based SARS-CoV-2 surveillance and to reliably predict the course of an outbreak, screening, and monitoring of infected individuals without major symptoms (about 40...

Authors: Andreas Deckert, Simon Anders, Manuela De Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Matthias Meurer, Robin Burk, Matthias Sand, Lisa Koeppel, Lena Maier Hein, Tobias Roß, Tim Adler, Tobias Siems, Lucia Brugnara, Stephan Brenner…

Comparison of effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of primary dysmenorrhea: a randomized clinical trial

Primary dysmenorrhea (PD) is the most common complaint in young women and adolescents. Side effects of non-steroidal anti-inflammatory drugs can limit their use. Therefore, non-pharmacological pain relief meth...

Authors: Masoomeh Vahedi, Seyedeh Batool Hasanpoor-Azghady, Leila Amiri-Farahani and Imaneh Khaki

Use of routinely collected health data in randomised clinical trials: comparison of trial-specific death data in the BOSS trial with NHS Digital data

A promising approach to reduce the increasing costs of clinical trials is the use of routinely collected health data as participant data. However, the quality of this data could limit its usability as trial pa...

Authors: Sharon B. Love, Anna Kilanowski, Victoria Yorke-Edwards, Oliver Old, Hugh Barr, Clive Stokes, Catherine Kendall and Matthew R. Sydes

The PRolaCT studies — a study protocol for a combined randomised clinical trial and observational cohort study design in prolactinoma

First-line treatment for prolactinomas is a medical treatment with dopamine agonists (DAs), which effectively control hyperprolactinaemia in most patients, although post-withdrawal remission rates are approxim...

Authors: Ingrid M. Zandbergen, Amir H. Zamanipoor Najafabadi, Iris C. M. Pelsma, M. Elske van den Akker-van Marle, Peter H. L. T. Bisschop, H. D. Jeroen Boogaarts, Arianne C. van Bon, Bakhtyar Burhani, Saskia le Cessie, Olaf M. Dekkers, Madeleine L. Drent, Richard A. Feelders, Johan P. de Graaf, J. Hoogmoed, Kitty K. Kapiteijn, Melanie M. van der Klauw…

Acupuncture as adjunctive therapy for acute renal colic caused by urinary calculi: study protocol for a randomized controlled trial

Acute renal colic caused by urinary calculi (ARCUC) has a considerable impact on the quality of life. Acupuncture might be a potential treatment option. However, the evidence is limited. We will conduct this t...

Authors: Ying Cao, Jian-Feng Tu, Guang-Xia Shi, Li-Qiong Wang, Lian-Cheng Jia, Bo Li, Bao-Li Liu, Wei-Hai Yao, Xiao-Lu Pei, Zhi-Cheng Qu and Cun-Zhi Liu

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial

Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not re...

Authors: L. Guglielmetti, E. Ardizzoni, M. Atger, E. Baudin, E. Berikova, M. Bonnet, E. Chang, S. Cloez, J. M. Coit, V. Cox, B. C. de Jong, C. Delifer, J. M. Do, D. Dos Santos Tozzi, V. Ducher, G. Ferlazzo…

Cognitive effectiveness of high-intensity interval training for individuals with methamphetamine dependence: a study protocol for randomised controlled trial

Cognitive deficit is a common syndrome of methamphetamine (MA) dependence. It is related to decision-making, control ability, and social functioning. High-intensity interval training (HIIT) is a training techn...

Authors: Shen Menglu, Yang Suyong, Wang Xiaoyan, Wolfgang I. Schöllhorn and Zhu Dong

RAPIDIRON: Reducing Anaemia in Pregnancy in India—a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries

Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes.

Authors: Richard J. Derman, Shivaprasad S. Goudar, Simal Thind, Sudhir Bhandari, Zubair Aghai, Michael Auerbach, Rupsa Boelig, Umesh S. Charantimath, Rosemary Frasso, M. S. Ganachari, Kusum Lata Gaur, Michael K. Georgieff, Frances Jaeger, S Yogeshkumar, Parth Lalakia, Benjamin Leiby…

Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial

This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical act...

Authors: Emma Robson, Steven J. Kamper, Alix Hall, Hopin Lee, Simon Davidson, Priscilla Viana da Silva, Connor Gleadhill and Christopher M. Williams

Transcranial direct current stimulation (tDCS) in addition to walking training on walking, mobility, and reduction of falls in Parkinson’s disease: study protocol for a randomized clinical trial

Transcranial direct current stimulation (tDCS) has the potential to modulate cortical excitability and enhance the effects of walking training in people with Parkinson’s disease. This study will examine the ef...

Authors: Lucas Rodrigues Nascimento, Ester Miyuki Nakamura-Palacios, Augusto Boening, Daniel Lyrio Cabral, Alessandra Swarowsky, Guilherme Peixoto Tinoco Arêas, Wellingson Silva Paiva and Fernando Zanela da Silva Arêas

Correction to: A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPal^TM): study protocol for a multisite randomized controlled trial

Authors: Jennifer A. Rabbitts, Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray and Tonya M. Palermo

Altering Dynamics of Autonomic Processing Therapy (ADAPT) trial: a novel, targeted treatment for reducing anxiety in joint hypermobility

Hypermobility is a poorly recognised and understood musculoskeletal disorder thought to affect around 20% of the population. Hypermobility is associated with reduced physiological and psychological functioning...

Authors: Geoff Davies, Jenny L. L. Csecs, Heather Ball, Jess Dare, Stephen Bremner, Robin Hosking, Hugo D. Critchley, Nick Grey and Jessica A. Eccles

Assessing the fidelity of a peer-led chronic pain management program (PAP)

Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation...

Authors: Mimi M. Y. Tse, Shuk Kwan Tang, Shamay Ng, Yajie Li, Daphne Sze Ki Cheung and Rick Yiu Cho Kwan

Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial

Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar d...

Authors: Benedikt Schmid, Markus Kredel, Roman Ullrich, Katharina Krenn, Rudolf Lucas, Klaus Markstaller, Bernhard Fischer, Peter Kranke, Patrick Meybohm, Bernhard Zwißler and Sandra Frank

Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of ch...

Authors: Sheraz Yaqub, Bjørn Atle Bjørnbeth, Jon-Helge Angelsen, Claus Wilki Fristrup, Jon Erik Grønbech, Oskar Hemmingsson, Bengt Isaksson, Ingebjørg Soterud Juel, Peter Nørgaard Larsen, Gert Lindell, Frank Viborg Mortensen, Kim Erlend Mortensen, Magnus Rizell, Per Sandström, Oddvar Mathias Sandvik, Ernesto Sparrelid…

Efficacy of a transdiagnostic ecological momentary intervention for improving self-esteem (SELFIE) in youth exposed to childhood adversity: study protocol for a multi-center randomized controlled trial

Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling ...

Authors: Maud Daemen, Mary Rose Postma, Ramon Lindauer, Iris Hoes-van der Meulen, Dorien Nieman, Philippe Delespaul, Josefien Johanna Froukje Breedvelt, Mark van der Gaag, Wolfgang Viechtbauer, Koen Schruers, David van den Berg, Claudi Bockting, Therese van Amelsvoort and Ulrich Reininghaus

Evaluation of the “Let’s Get Organized” group intervention to improve time management: protocol for a multi-centre randomised controlled trial

Time management skills are essential for living in modern society. People with mental or neurodevelopmental disorders typically have cognitive limitations, including affected time management, which might lead ...

Authors: Marie Holmefur, Afsaneh Roshanay, Suzanne White, Gunnel Janeslätt, Elin Vimefall and Kajsa Lidström-Holmqvist

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair

Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patie...

Authors: Arno M. Wiersema, Liliane C. Roosendaal, Mark J. W. Koelemaij, Jan G. P. Tijssen, Susan van Dieren, Jan D. Blankensteijn, E. Sebastian Debus, Saskia Middeldorp, Jan M. M. Heyligers, Ymke S. Fokma, Michel M. P. J. Reijnen and Vincent Jongkind

Effects of Hydroxychloroquine on endOthelial function in eLDerly with sleep apnea (HOLD): study protocol for a randomized clinical trial

Sleep apnea and coronary artery disease are prevalent and relevant diseases. The mechanism by which sleep apnea leads to coronary artery disease remains unclear. Intermittent hypoxia, caused by sleep apnea, le...

Authors: Leticia Maria Tedesco Silva, Antonio Cortes, Beatriz Rossi, Liliana Boll, Gustavo Waclawosky, Bruna Eibel, Sandro Cadaval Gonçalves, Maria Claudia Irigoyen and Denis Martinez

Early skin contact combined with mother’s breastfeeding to shorten the process of premature infants ≤ 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial

Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care u...

Authors: Liling Li, Li Wang, Conway Niu, Chan Liu, Tianchan Lv, Futing Ji, Ling Yu, Weili Yan, Ya Lan Dou, Yin Wang, Yun Cao, Guoying Huang and Xiaojing Hu

DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population

Financial toxicity, the material and psychological burden of the cost of treatment, affects 30–50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adh...

Authors: Lauren M. Hamel, David W. Dougherty, Seongho Kim, Elisabeth I. Heath, Lorna Mabunda, Eyouab Tadesse, RaeAnn Hill and Susan Eggly

Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial

Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for palliative care is increasing and with that the rigor...

Authors: Patrick M. Wilson, Lindsey M. Philpot, Priya Ramar, Curtis B. Storlie, Jacob Strand, Alisha A. Morgan, Shusaku W. Asai, Jon O. Ebbert, Vitaly D. Herasevich, Jalal Soleimani and Brian W. Pickering

Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study

Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four...

Authors: Pierre Bouzat, Jean-Luc Bosson, Jean-Stéphane David, Bruno Riou, Jacques Duranteau and Jean-François Payen

ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial

Radical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissec...

Authors: Ken-ichi Okada, Manabu Kawai, Seiko Hirono, Masayuki Sho, Masaji Tani, Ippei Matsumoto, Suguru Yamada, Ryosuke Amano, Hirochika Toyama, Yo-ichi Yamashita, Takeshi Gocho, Kazuto Shibuya, Minako Nagai, Hiromitsu Maehira, Keiko Kamei, Go Ohira…

Epidural morphine in COVID ARDS patients with high respiratory drive: a structured summary of a study protocol for a randomised controlled trial

We aim to study the effect of epidural morphine as a means to reduce high respiratory drive in COVID 19 patients on non-invasive ventilation (NIV)—primary end point—and to study its effect on respiratory param...

Authors: Swagata Tripathy and P. Bhaskar Rao

Employing a mobile health decision aid to improve decision-making for patients with advanced prostate cancer and their decision partners/proxies: the CHAMPION randomized controlled trial study design

Metastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients w...

Authors: Lourdes R. Carhuapoma, Winter M. Thayer, Catherine E. Elmore, Jane Gildersleeve, Tanmay Singh, Farah Shaukat, Melissa K. Uveges, Tamryn Gray, Crystal Chu, Daniel Song, Patricia J. Hollen, Jennifer Wenzel and Randy A. Jones

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial

Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease—including HIV/AIDS. Additionally, depression is a leading cause of disability in the c...

Authors: Ryan K. McBain, Owen Mwale, Todd Ruderman, Waste Kayira, Emilia Connolly, Mark Chalamanda, Chiyembekezo Kachimanga, Brown David Khongo, Jesse Wilson, Emily Wroe, Giuseppe Raviola, Stephanie Smith, Sarah Coleman, Ksakrad Kelly, Amruta Houde, Mahlet G. Tebeka…

The impact of i-PUSH on maternal and child health care utilization, health outcomes, and financial protection: study protocol for a cluster randomized controlled trial based on financial and health diaries data

Universal Health Coverage ensures access to quality health services for all, with no financial hardship when accessing the needed services. Nevertheless, access to quality health services is marred by substant...

Authors: Amanuel Abajobir, Richard de Groot, Caroline Wainaina, Anne Njeri, Daniel Maina, Silvia Njoki, Nelson Mbaya, Hermann Pythagore Pierre Donfouet, Menno Pradhan, Wendy Janssens and Estelle M. Sidze

Vaccine trials during a pandemic: potential approaches to ethical dilemmas

Ever since the emergence of the coronavirus disease 2019 (COVID-19), global public health infrastructures and systems, along with community-wide collaboration and service, have risen to an unprecedented challe...

Authors: Manaf Alqahtani, Saad I. Mallah, Nigel Stevenson and Sally Doherty

Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan

Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Alt...

Authors: Tim Hundscheid, Rogier Donders, Wes Onland, Elisabeth M. W. Kooi, Daniel C. Vijlbrief, Willem B. de Vries, Debbie H. G. M. Nuytemans, Bart van Overmeire, Antonius L. Mulder and Willem P. de Boode

Simple compared to covariate-constrained randomization methods in balancing baseline characteristics: a case study of randomly allocating 72 hemodialysis centers in a cluster trial

Some parallel-group cluster-randomized trials use covariate-constrained rather than simple randomization. This is done to increase the chance of balancing the groups on cluster- and patient-level baseline char...

Authors: Ahmed A. Al-Jaishi, Stephanie N. Dixon, Eric McArthur, P. J. Devereaux, Lehana Thabane and Amit X. Garg

Optimizing nutrition and oral health for caregivers—intervention protocol

The focus of care has shifted from institutional care to home care. Family caregivers provide the majority of home care that allows an opportunity for their care recipients to live at home and avoid costly ins...

Authors: Irma Nykänen, Tarja Välimäki, Liisa Suominen and Ursula Schwab

Improving the continuity and coordination of ambulatory care through feedback and facilitated dialogue—a study protocol for a cluster-randomised trial to evaluate the ACD study (Accountable Care in Germany)

Patients in Germany are free to seek care from any office-based physician and can always ask for multiple opinions on a diagnosis or treatment. The high density of physicians and the freedom to choose among th...

Authors: Leonie Sundmacher, Ronja Flemming, Verena Leve, Isabel Geiger, Sebastian Franke, Thomas Czihal, Clemens Krause, Birgitt Wiese, Frank Meyer, Matthias Brittner, Johannes Pollmanns, Johannes Martin, Paul Brandenburg, Annemarie Schultz, Emmanuelle Brua, Udo Schneider…

Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India

Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation...

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

Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial

Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehens...

Authors: Marc Dohmen, Andrea Petermann-Meyer, Daniel Blei, Rebecca Bremen, Evamarie Brock-Midding, Manuela Brüne, Franziska Geiser, Burkhard Haastert, Sarah Maria Halbach, Christian Heuser, Steffen Holsteg, Lina Heier, Andrea Icks, Andre Karger, Joseph Montalbo, Hannah Nakata…

BiCyCLE NMES—neuromuscular electrical stimulation in the perioperative treatment of sarcopenia and myosteatosis in advanced rectal cancer patients: design and methodology of a phase II randomised controlled trial

Colorectal cancer is associated with secondary sarcopenia (muscle loss) and myosteatosis (fatty infiltration of muscle) and patients who exhibit these host characteristics have poorer outcomes following surger...

Authors: Edward T. Pring, Laura E. Gould, George Malietzis, Philip Lung, Mina Bharal, Tutu Fadodun, Paul Bassett, Mani Naghibi, Claire Taylor, Ioanna Drami, Deeptika Chauhan, Tamsyn Street, Nader K. Francis, Thanos Athanasiou, John M. Saxton and John T. Jenkins

Normalising comparative effectiveness trials as clinical practice

There is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical ...

Authors: Tom Briffa, Tanya Symons, Nikolajs Zeps, Nicola Straiton, William Odita Tarnow-Mordi, John Simes, Ian A. Harris, Melinda Cruz, Steven A. Webb, Edward Litton, Alistair Nichol and Christopher M. Williams

Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial

Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis is based on symptoms defined by abdominal pain or discomfort associated with d...

Authors: Linda L. D. Zhong, Tsz Fung Lam, Wei Yang, Ya Zheng, Zipan Lyu and Zhaoxiang Bian

Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial

Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.

Authors: Sohaib Ashraf, Shoaib Ashraf, Rutaba Akmal, Moneeb Ashraf, Larab Kalsoom, Aadil Maqsood, Muhammad Ahmad Imran, Iqra Farooq, Sidra Ashraf, Uzma Nasim Siddiqui, Muhammad Ghufran, Muhammad Kiwan Akram, Nighat Majeed, Sundas Rafique, Zaigham Habib, Muhammad Sarmad Shahab…

Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial

Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired qual...

Authors: Aleksi Laajala, Paulus Tokola, Timo J. Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä and Olli-Pekka Alho

Optimization of Nutrition And Medication (OptiNAM) for acutely admitted older patients: protocol for a randomized single-blinded controlled trial

Internationally, older patients (≥65 years) account for more than 40% of acute admissions. Older patients admitted to the emergency department (ED) are frequently malnourished and exposed to inappropriate medi...

Authors: Aino L. Andersen, Morten B. Houlind, Rikke L. Nielsen, Lillian M. Jørgensen, Charlotte Treldal, Morten Damgaard, Anne Kathrine Bengaard, Helle Gybel Juul-Larsen, Louise Bolvig Laursen, Esben Iversen, Marie Kruse, Anne M. L. Pedersen, Mads Hornum, Anne M. Beck, Mette M. Pedersen, Mikkel Z. Ankarfeldt…

Correction to: Making large-scale surgical trials possible: collaboration and the role of surgical trainees

Authors: Marcus Jepson, Michelle Lazaroo, Samir Pathak, Natalie Blencowe, Jane Collingwood, Madeleine Clout, Giles Toogood and Jane Blazeby

The novel effectiveness of Tai Chi on cardiopulmonary fitness among stroke patients in the recovery phase: a study protocol for a randomized controlled trial

Stroke is the leading cause of death worldwide. China faces a similar risk of stroke as developed countries because of considerable changes in lifestyle, such as overeating and smoking. Tai Chi is a traditiona...

Authors: Tianyang Tan, Yanyan Meng, Xinyu Li, Ruina Bai, Chengchao Wang, Jiaxuan Lyu, Kang Yan, Meng Liu, Chaoyang Zhang and Yulong Wei

Analysis of contamination in cluster randomized trials of malaria interventions

In cluster randomized trials (CRTs) of interventions against malaria, mosquito movement between households ultimately leads to contamination between intervention and control arms, unless they are separated by ...

Authors: Lea Multerer, Tracy R. Glass, Fiona Vanobberghen and Thomas Smith

Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes

Authors: Jennifer L. Bell, Samir Gupta, Edmund Juszczak, Pollyanna Hardy and Louise Linsell