Articles

The praziquantel in preschoolers (PIP) trial: study protocol for a phase II PK/PD-driven randomised controlled trial of praziquantel in children under 4 years of age

Over 200 million individuals worldwide are infected with Schistosoma species, with over half of infections occurring in children. Many children experience first infections early in life and this impacts their gro...

Authors: Emily L. Webb, Andrew Edielu, Hannah W. Wu, Narcis B. Kabatereine, Edridah M. Tukahebwa, Alfred Mubangizi, Moses Adriko, Alison M. Elliott, William W. Hope, Patrice A. Mawa, Jennifer F. Friedman and Amaya L. Bustinduy

Protocol for a multi-phase, mixed methods study to develop and evaluate culturally adapted CBT to improve community mental health services for Canadians of south Asian origin

Canadians of South Asian (SA) origin comprise the largest racialized group in Canada, representing 25.6% of what Statistics Canada terms “visible minority populations”. South Asian Canadians are disproportiona...

Authors: Farooq Naeem, Andrew Tuck, Baldev Mutta, Puneet Dhillon, Gary Thandi, Azaad Kassam, Nimo Farah, Aamna Ashraf, M. Ishrat Husain, M. Omair Husain, Helen-Maria Vasiliadis, Marcos Sanches, Tariq Munshi, Maureen Abbott, Nicholas Watters, Sean A. Kidd…

Postpartum Early EMDR therapy Intervention (PERCEIVE) study for women after a traumatic birth experience: study protocol for a randomized controlled trial

Up to 33% of women develop symptoms of posttraumatic stress disorder (PTSD) after a traumatic birth experience. Negative and traumatic childbirth experiences can also lead to fear of childbirth, avoiding or ne...

Authors: Y. M. G. A. Hendrix, K. S. M. van Dongen, A. de Jongh and M. G. van Pampus

Power and sample size calculation for stepped-wedge designs with discrete outcomes

Stepped-wedge designs (SWD) are increasingly used to evaluate the impact of changes to the process of care within health care systems. However, to generate definitive evidence, a correct sample size calculatio...

Authors: Fan Xia, James P. Hughes, Emily C. Voldal and Patrick J. Heagerty

Patient perceptions of the challenges of recruitment to a renal randomised trial registry: a pilot questionnaire-based study

Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using reg...

Authors: Ellen Murphy, Aoife O’Keeffe, Niamh O Shea, Eva Long, Joseph A. Eustace and Frances Shiely

Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial

The objective of this study will be to investigate the additional effect of pain neuroscience education program compared to a craniocervical manual therapy and exercises program for pain intensity and disabili...

Authors: Aroldo dos Santos Aguiar, Cesar Bataglion, Lilian Ramiro Felício, Beatriz Azevedo and Thaís Cristina Chaves

Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial)

Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatme...

Authors: Barbara Soria-Juan, Mariano Garcia-Arranz, Lucía Llanos Jiménez, César Aparicio, Alejandro Gonzalez, Ignacio Mahillo Fernandez, Luis Riera del Moral, Lukasz Grochowicz, Enrique J. Andreu, Pedro Marin, Gregorio Castellanos, Jose Maria Moraleda, Ana Maria García-Hernández, Francisco S. Lozano, Fermin Sanchez-Guijo, Eva María Villarón…

Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial

Post-traumatic stress disorder (PTSD) is a significant public health problem, affecting approximately 7% of the general population and 13–18% of the combat Veteran population. The first study using acupuncture...

Authors: Michael Hollifield, An-Fu Hsiao, Kala Carrick, Andrea Gory Munoz, Teresa Calloway, Karen Cocozza, Besa Smith, Tyler Smith, Tanja Jovanovic, Seth Norrholm, Estate Sokhadze and Christopher Reist

The effect of framing and communicating COVID-19 vaccine side-effect risks on vaccine intentions for adults in the UK and the USA: A structured summary of a study protocol for a randomized controlled trial

Vaccine hesitancy is a major hurdle for stopping the COVID-19 pandemic. Recently, fear of vaccine side effects created widespread concern and paused global vaccination efforts. Many studies find that how medic...

Authors: Nikkil Sudharsanan, Caterina Favaretti, Violetta Hachaturyan, Till Bärnighausen and Alain Vandormael

Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial

The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-1...

Authors: Shoaib Ashraf, Sohaib Ashraf, Iqra Farooq, Sidra Ashraf, Moneeb Ashraf, Muhammad Ahmad Imran, Larab Kalsoom, Rutaba Akmal, Muhammad Ghufran, Sundas Rafique, Muhammad Kiwan Akram, Zaigham Habib, Uzma Nasim Siddiqui, Ammara Ahmad, Shahroze Arshad, Muhammad Abdul Rehman Virk…

The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study

There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate...

Authors: Elena Bustamante Estebanez, Lucía Lavín Alconero, Beatriz Josa Fernández, Monica Gozalo Marguello, Juan Carlos López Caro, Jonathan Diez Vallejo, Marta Fernandez Sampedro, Pedro Muñoz Cacho, Carlos Richard Espiga and María Mar García Saiz

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbers of participants, ...

Authors: Timia Raven-Gregg and Victoria Shepherd

The effect of in-person and virtual prenatal care education of the spouses of primiparous women on the father and mother’s attachment to infant: a quasi-experimental and controlled study

Considering the important role of education in promoting parents’ attachment to the infant, temporal and spatial limitations, and the need to use new educational methods for spouses’ participation in childbirt...

Authors: Zari Doaltabadi and Leila Amiri-Farahani

Effects of intrinsic-foot-muscle exercise combined with the lower extremity resistance training on postural stability in older adults with fall risk: study protocol for a randomised controlled trial

Falls are one of the most common accidents in older adults, often leading to injury, disability and quality-of-life declines. Foot core function contributes to postural stability in most static postures and dy...

Authors: Zhangqi Lai, Hongbo Pang, Xiaoyue Hu, Kun Dong and Lin Wang

Efficacy of Yijinjing combined with Tuina for patients with non-specific chronic neck pain: study protocol for a randomized controlled trial

Non-specific chronic neck pain (NCNP) is a common musculoskeletal disorder which has caused a huge economic burden due to its expensive health costs and high re-occurrence rate. Yijinjing and Tuina are widely ...

Authors: Ziji Cheng, Ziying Chen, Fangfang Xie, Chong Guan, Yuanjia Gu, Ruiping Wang, Yanli You and Fei Yao

The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials.

Authors: Jingjing Huang, Yimin Yu, Yi Jiang, Wu Chen, Yan Li, Yifeng Shen, Qingshan Zheng and Huafang Li

Antiviral and immunomodulatory interferon-beta in high-risk COVID-19 patients: a structured summary of a study protocol for a randomised controlled trial

The primary objective of the study is to demonstrate the efficacy of low-dose IFN-β in reducing the risk of SARS-CoV-2 recently infected elderly patients to progress towards severe COVID-19 versus control group w...

Authors: Eleonora Aricò, Luciano Castiello, Laura Bracci, Francesca Urbani, Flavia Lombardo, Ilaria Bacigalupo, Antonio Ancidoni, Nicola Vanacore, Alessandro Falcione, Chiara Reggiani, Giovanni Marco Dutti, Maria Grazia Maglie, Ombretta Papa, Pier Luigi Bartoletti, Giuseppina Ozzella, Nazario Bevilacqua…

Correction to: 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

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…

Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial

Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to ev...

Authors: Aline Marcadenti, Bernardete Weber, Angela Cristine Bersch-Ferreira, Rachel Helena Vieira Machado, Camila Ragne Torreglosa, Enilda Maria de Sousa Lara, Lucas Ribeiro da Silva, Renato Hideo Nakagawa Santos, Debora Harumi Kodama Miyada, Erica Regina Ribeiro Sady, Rosana Perim Costa, Leopoldo Piegas, Erlon Oliveira de Abreu-Silva, Alexandre Schaan de Quadros, Camila Weschenfelder, Júlia Lorenzon dos Santos…

The impact of frailty Screening of Older adults with muLtidisciplinary assessment of those At Risk during emergency hospital attendance on the quality, safety and cost-effectiveness of care (SOLAR): a randomised controlled trial.

Older people account for 25% of all Emergency Department (ED) admissions. This is expected to rise with an ageing demographic. Older people often present to the ED with complex medical needs in the setting of ...

Authors: Aoife Leahy, Rachel McNamara, Catriona Reddin, Gillian Corey, Ida Carroll, Aoife O’Neill, Darragh Flannery, Collette Devlin, Louise Barry, Brian MacCarthy, Niamh Cummins, Elaine Shanahan, Denys Shchetkovsky, Damien Ryan, Margaret O’Connor and Rose Galvin

Teriparatide and stress fracture healing in young adults (RETURN – Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty): study protocol for a randomised controlled trial

Stress fractures are a common and potentially debilitating overuse injury to bone and occur frequently among military recruits and athletes. Recovery from a lower body stress fracture typically requires severa...

Authors: Alexander T. Carswell, Katharine G. Eastman, Anna Casey, Matthew Hammond, Lee Shepstone, Estelle Payerne, Andoni P. Toms, James W. MacKay, Ann Marie Swart, Julie P. Greeves and William D. Fraser

Study protocol for the Exercising Together© trial: a randomized, controlled trial of partnered exercise for couples coping with cancer

Most cancer survivors are married, and cancer strains the physical and mental health of each partner and their intimate relationship. We created a partnered strength training program, Exercising Together©, whe...

Authors: Kerri M. Winters-Stone, Karen S. Lyons, Nathan F. Dieckmann, Christopher S. Lee, Zahi Mitri and Tomasz M. Beer

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

The SARS-CoV-2 pandemic has disrupted clinical trials worldwide. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) has tracked clinical trial disruption by surveying its 58 trial sites ac...

Authors: Silke van Koningsbruggen-Rietschel, Fiona Dunlevy, Veerle Bulteel, Kate Hayes, Anne Verbrugge, Hettie M. Janssens, Nadine Dufeu, Nicholas J. Simmonds, Lieven J. Dupont and Damian G. Downey

Randomized controlled trial of neurologic music therapy in Parkinson’s disease: research rehabilitation protocols for mechanistic and clinical investigations

Presently available medications and surgical treatments for Parkinson’s disease have limited effects on fine motor problems and often leave patients with significant fine motor disability. Standard of care occ...

Authors: Isabelle Buard, Lucas Lattanzio, Rebekah Stewart, Sarah Thompson, Kristin Sjoberg, Karen Hookstadt, Meghan Morrow, Samantha K. Holden, Stefan Sillau, Michael Thaut and Benzi Kluger

2-Hydroxybenzylamine (2-HOBA) to prevent early recurrence of atrial fibrillation after catheter ablation: protocol for a randomized controlled trial including detection of AF using a wearable device

Although catheter ablation is an effective therapy for atrial fibrillation (AF), the most common cardiac arrhythmia encountered in clinical practice, AF ablation generates inflammation and oxidative stress in ...

Authors: Matthew J. O’Neill, Zachary T. Yoneda, Diane M. Crawford, Fei Ye, Mingfang Ao, Lisa M. Pitchford, John A. Rathmacher, Katherine T. Murray, Wendell S. Akers, Dan M. Roden, Gregory F. Michaud and M. Benjamin Shoemaker

“More air—better performance—faster recovery”: study protocol for randomised controlled trial of the effect of post-stroke inspiratory muscle training for adults

Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among other...

Authors: Susanne Lillelund Sørensen, Simon Svanborg Kjeldsen, Sine Secher Mortensen, Ulla Torp Hansen, Dorthe Hansen, Asger Roger Pedersen and Hanne Pallesen

Effectiveness of deep cervical fascial manipulation and yoga postures on pain, function, and oculomotor control in patients with mechanical neck pain: study protocol of a pragmatic, parallel-group, randomized, controlled trial

Mechanical neck pain (MNP) is a commonly occurring musculoskeletal condition that is usually managed using electrical modalities, joint mobilization techniques, and therapeutic exercises, but has limited evide...

Authors: Prabu Raja G, Shyamasunder Bhat N, César Fernández-de-las-Peñas, Ranganath Gangavelli, Fiddy Davis, Ravi Shankar and Anupama Prabhu

Protocol for the Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY): a randomised controlled trial

SARS-CoV-2 binds to membrane-bound angiotensin-converting enzyme 2 (ACE2) which may result in downregulation of membrane-bound ACE2. ACE2 is a key regulator of the renin-angiotensin system (RAS) and is respons...

Authors: Carinna Hockham, Sradha Kotwal, Arlen Wilcox, Abhinav Bassi, James McGree, Carol Pollock, Louise M. Burrell, Nikita Bathla, Mallikarjuna Kunigari, Vinay Rathore, Michael John, Enmoore Lin, Christine Jenkins, Angus Ritchie, Andrew McLachlan, Thomas Snelling…

Reducing the burden of orthodontic care for children with clefts: evaluating the effectiveness of pre-alveolar bone graft orthodontics in unilateral non-syndromic cleft patients (PABO study)— A study protocol for a multicentric randomised controlled trial

An alveolar cleft commonly affects 75% of cleft lip and palate patients. While it is common practice to provide a course of orthodontic treatment before alveolar bone grafting, there are no previous high-quali...

Authors: Badri Thiruvenkatachari, Syed Altaf Hussain, Puneet Batra, Charanya Vijayakumar and Manoj Prathap. C

The impact of physical training on length of hospital stay and physical function in patients hospitalized with community-acquired pneumonia: protocol for a randomized controlled trial

Community-acquired pneumonia (CAP) is a leading cause of hospitalization worldwide. Bed rest with low levels of physical activity is common during periods of hospitalization and leads to functional decline as ...

Authors: Camilla Koch Ryrsø, Daniel Faurholt-Jepsen, Christian Ritz, Bente Klarlund Pedersen, Maria Hein Hegelund, Arnold Matovu Dungu, Adin Sejdic, Birgitte Lindegaard and Rikke Krogh-Madsen

Efficacy of two siddha polyherbal decoctions, Nilavembu Kudineer and Kaba Sura Kudineer, along with standard allopathy treatment in the management of mild to moderate symptomatic COVID-19 patients—a double-blind, placebo-controlled, clinical trial

Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medici...

Authors: Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayanan, Vivek Gupta, Rashmi Upadhayay, Jitender Kumar, Sathiyarajeswaran Parameswaran, KanakavalliKadarkarai and AarthiVelmurugan

Clinical and healthcare improvement through My Health Record usage and education in general practice (CHIME-GP): a study protocol for a cluster-randomised controlled trial

There is an international interest in whether improved primary care can lead to a more rational use of health resources. There is evidence that educational interventions can lead to improvements in the quality...

Authors: Andrew Bonney, Christine Metusela, Judy Mullan, Stephen Barnett, Joel Rhee, Conrad Kobel and Marijka Batterham

Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma (PDAC-GS/GA-rP2, CSGO-HBP-015)

Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease, and multimodal strategies, such as surgery plus neoadjuvant chemotherapy (NAC)/adjuvant chemotherapy, have been attempted to improve survival in pat...

Authors: Daisaku Yamada, Shogo Kobayashi, Hidenori Takahashi, Hirofumi Akita, Terumasa Yamada, Tadafumi Asaoka, Junzo Shimizu, Yutaka Takeda, Shigekazu Yokoyama, Masanori Tsujie, Akira Tomokuni, Masahiro Tanemura, Osakuni Morimoto, Masahiro Murakami, Yongkook Kim, Shin Nakahira…

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

Recruitment to surgical randomised controlled trials (RCTs) can be challenging. The Sunflower study is a large-scale multi-centre RCT that seeks to establish the clinical and cost effectiveness of pre-operativ...

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

Effect of Lycium barbarum polysaccharide supplementation in non-alcoholic fatty liver disease patients: study protocol for a randomized controlled trial

Non-alcohol fatty liver disease (NAFLD) is the most common chronic liver disease in the world, with a high incidence and no effective treatment. At present, the targeted therapy of intestinal microbes for NAFL...

Authors: Lu-Lu Gao, Yu-Xiang Li, Jia-Min Ma, Yi-Qiong Guo, Lin Li, Qing-Han Gao, Yan-Na Fan, Meng-Wei Zhang, Xiu-Juan Tao, Jian-Qiang Yu and Jian-Jun Yang

The SHINE trial (a multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation): statistical analysis plan

Authors: Kate Hodgson, Brett Manley, Omar Kamlin, Louise Owen, Calum Roberts, Kate Francis, Peter Davis and Susan Donath

CRISTAL (a cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study): statistical analysis plan

This a priori statistical analysis plan describes the analysis for CRISTAL.

Authors: Verinder Singh Sidhu, Thu-Lan Kelly, Nicole Pratt, Steven Graves, Rachelle Buchbinder, Justine Naylor, Richard de Steiger, Ilana Ackerman, Sam Adie, Michelle Lorimer, Durga Bastiras, Kara Cashman and Ian Harris

Transcutaneous electrical acupoint stimulation for postoperative cognitive dysfunction in geriatric patients with gastrointestinal tumor: a randomized controlled trial

This study aimed to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in older patients who were diagnosed with gastrointe...

Authors: Lijuan Xi, Fang Fang, Haijuan Yuan and Daorong Wang

Application of virtual reality on non-drug behavioral management of short-term dental procedure in children

Due to the inherent characteristics of immersion, imagination, and interactivity in virtual reality (VR), it might be suitable for non-drug behavior management of children in dental clinics. The purpose of thi...

Authors: Longkuan Ran, Nan Zhao, Lin Fan, Pinping Zhou, Chao Zhang and Cong Yu

Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2

A recently published article described the safety, tolerability, and pharmacokinetic profile of molnupiravir (Painter et al. 2021), a novel antiviral agent with potent activity against severe acute respiratory...

Authors: Wendy Holman, Wayne Holman, Stacy McIntosh, Wendy Painter, George Painter, Jim Bush and Oren Cohen

Targeting autonomic flexibility to enhance cognitive training outcomes in older adults with mild cognitive impairment: study protocol for a randomized controlled trial

Cognitive training with components that can further enhance the transferred and long-term effects and slow the progress of dementia is needed for preventing dementia.

Authors: Feng V. Lin, Kathi Heffner, Richard Gevirtz, Zhengwu Zhang, Duje Tadin and Anton Porsteinsson

Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial

The demand for care during the COVID-19 pandemic has affected the mental health of healthcare workers (HCWs), thus increasing the need for psychosocial support services. Internet-based interventions have previ...

Authors: Lina Jovarauskaite, Austeja Dumarkaite, Inga Truskauskaite-Kuneviciene, Ieva Jovaisiene, Gerhard Andersson and Evaldas Kazlauskas

Postoperative 20% albumin vs standard care and acute kidney injury after high-risk cardiac surgery (ALBICS): study protocol for a randomised trial

Acute kidney injury (AKI) is a common complication of cardiac surgery. Factors such as cardiopulmonary bypass, aortic cross-clamping and surgical stress may precipitate renal hypoperfusion and ischaemia, infla...

Authors: Mayurathan Balachandran, Piyusha Banneheke, Adrian Pakavakis, Wisam Al-Bassam, Vineet Sarode, Michael Rowland and Yahya Shehabi

Effective recruitment strategies in an exercise trial for patients with fibromyalgia

Recruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge. We evaluated the cost and randomization yields of various recruitment methods used for a ...

Authors: Michelle Park, Raveendhara R. Bannuru, Lori Lyn Price, William F. Harvey, Jeffrey B. Driban and Chenchen Wang

ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®

Colorectal cancer is a major public concern, being the second deadliest cancer in the world. Whereas survival is high for localized forms, metastatic colorectal cancer has showed poor prognosis, with a 5-year ...

Authors: Muriel Mathonnet, Mathieu Vanderstraete, Christophe Bounaix Morand du Puch, Stéphanie Giraud, Christophe Lautrette, Mehdi Ouaissi, Nicolas Tabchouri, Abdelkader Taïbi, Renaud Martin, Isabelle Herafa, Achille Tchalla and Niki Christou

Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial

Esophagogastroduodenoscopy is very useful in diagnosing and treating upper gastrointestinal mucosal disorders, but too much foam and water in stomach decrease its diagnostic efficiency. Simethicone administrat...

Authors: Xiaotian Sun, Yang Xu, Xueting Zhang, Cuiyun Ma, Aitong Li, Haiyan Yu, Weihua Zhang, Hanqing Zhang, Teng Yang, Xinfang Miao, Huiming Zhang, Yan Liu and Zheng Lu

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT

Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, lead...

Authors: Edmund Juszczak, Oliver Hewer, Christopher Partlett, Madeleine Hurd, Vasha Bari, Ursula Bowler, Louise Linsell and Jon Dorling

Efficacy and safety of Qi-Jing Hui-Xin Decoction in the treatment of coronary microvascular angina: study protocol for a randomized, controlled, multi-center clinical trial

With the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovas...

Authors: Yuanlong Sun, Chengxin Huang, Li Huo, Ying Li, Jun Chen, Zixiu Zhang, Meijun Jia, Meixian Jiang and Xiaofen Ruan

Physiological stress in safer cycling in older age (SiFAr-stress): effect of a multicomponent exercise intervention—a study protocol for a randomized controlled trial

SiFAr-Stress investigates the impact of cycling on stress levels in older adults. Uncertainty due to change to motorized bicycle or fear of falling can be perceived as stressors for cyclists. Stress activates ...

Authors: Sabine Britting, Robert Kob, Cornel Christian Sieber, Nicolas Rohleder, Ellen Freiberger and Linda Becker

Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial

After receiving breast cancer surgery or reconstruction, shoulder dysfunctions including weakness, post-operative pain, shoulder joint instability, and limited range of motion (ROM) often occur. Due to limited...

Authors: Hae-Yeon Park, Kyung Eun Nam, Jae-Young Lim, Seung Mi Yeo, Jong In Lee and Ji Hye Hwang