Articles

Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial

The hypothesis of the proposed intervention is that Granulocyte-macrophage colony-stimulating factor (GM-CSF) has profound effects on antiviral immunity, and can provide the stimulus to restore immune homeosta...

Authors: Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene…

Efficacy of Parent-Infant-Psychotherapy with mothers with postpartum mental disorder: study protocol of the randomized controlled trial as part of the SKKIPPI project

After the birth of a child, many mothers and fathers experience postpartum mental disorders like depression, anxiety, obsessive-compulsive disorder, stress or other illnesses. This endangers the establishment ...

Authors: J. Mattheß, M. Eckert, K. Richter, G. Koch, T. Reinhold, P. Vienhues, A. Berghöfer, S. Roll, T. Keil, F. Schlensog-Schuster, K. von Klitzing, C. Ludwig-Körner and L. Kuchinke

Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial

Colchicine is a well-known drug, which has been used for years to treat a wide range of rheumatic and inflammatory disorders. It helps break the cycle of inflammation through diverse mechanisms including reduc...

Authors: Nooshin Dalili, Alireza Kashefizadeh, Mohsen Nafar, Fatemeh Poorrezagholi, Ahmad Firouzan, Fariba Samadian, Shiva Samavat, Shadi Ziaie and Somayeh Fatemizadeh

The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial

A variety of possible mechanisms can make the nucleic acid test of patients who meet the discharge conditions positive again, including reinfection, reactivation of the original virus, lack of strict discharge...

Authors: Jiawen Li, Chi Zhang, Zhao Wu, Guiqiang Wang and Hong Zhao

Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial

Recent studies have indicated that a ketogenic diet can be used as an adjuvant therapy to enhance sensitivity to chemotherapy and radiotherapy in cancer patients. However, there are no sufficient data and no c...

Authors: Yan Wang, Ming-Xi Jing, Lei Jiang, Yu-Feng Jia, E. Ying, Hui Cao, Xiang-Yu Guo and Tao Sun

Evidencing the impact of cancer trials: insights from the 2014 UK Research Excellence Framework

An impactful clinical trial will have real-life benefits for patients and society beyond the academic environment. This study analyses case studies of cancer trials to understand how impact is evidenced for ca...

Authors: Catherine R. Hanna, Lauren P. Gatting, Kathleen Anne Boyd, Kathryn A. Robb and Rob J. Jones

Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial

The hypothesis of the study is that treatment with hydroxychloroquine sulphate in hospitalised patients with coronavirus disease 2019 (Covid-19) is safe and will accelerate the virological clearance rate for p...

Authors: Magnus Nakrem Lyngbakken, Jan-Erik Berdal, Arne Eskesen, Dag Kvale, Inge Christoffer Olsen, Anbjørg Rangberg, Christine Monceyron Jonassen, Torbjørn Omland, Helge Røsjø and Olav Dalgard

Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics

Around 30% of post-menopausal breast cancer is related to excess body fat, alcohol intake and low levels of physical activity. Current estimates suggest that there is a 12% increased risk in post-menopausal br...

Authors: Annie S. Anderson, Angela M. Craigie, Stephanie Gallant, Chloe McAdam, E. Jane Macaskill, Jennifer McKell, Nanette Mutrie, Ronan E. O’Carroll, Naveed Sattar, Martine Stead and Shaun Treweek

The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes

The objective of this study was to investigate the effects of Anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal ...

Authors: Fatemeh Haidari, Mehrnoosh Zakerkish, Fatemeh Borazjani, Kambiz Ahmadi Angali and Golnaz Amoochi Foroushani

Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antivi...

Authors: Qing-Juan Wu, Wen-Liang Lv, Juan-Mei Li, Ting-Ting Zhang, Wen-hui Zhou, Qiang Zhang, Jiu-Chong Wang, Qing-Nan Wang, Ruo-Xuan Zhang, Xin Zhao, Si-Tong Chen, Shuang Liu, Gao-Hui Li, Zheng-Min Cao, Lei Xu and Jing Chen

Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials

The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination.

Authors: Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven and Mihai G. Netea

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)

The prevalence of inadequate symptom control among cancer patients is quite high despite the availability of definitive care guidelines and accurate and efficient assessment tools.

Authors: Lila J. Finney Rutten, Kathryn J. Ruddy, Linda L. Chlan, Joan M. Griffin, Jeph Herrin, Aaron L. Leppin, Deirdre R. Pachman, Jennifer L. Ridgeway, Parvez A. Rahman, Curtis B. Storlie, Patrick M. Wilson and Andrea L. Cheville

Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map

Recruiting and retaining participants in randomised controlled trials (RCTs) is challenging. Digital tools, such as social media, data mining, email or text-messaging, could improve recruitment or retention, b...

Authors: Geoff K. Frampton, Jonathan Shepherd, Karen Pickett, Gareth Griffiths and Jeremy C. Wyatt

Cluster randomised trials of prescribing policy: an ethical approach to generating drug safety evidence? A discussion of the ethical application of a new research method

For most chronic medical conditions, multiple medications are available and prescribers often have limited evidence about which therapy is likely to be the most effective and safe for an individual patient. As...

Authors: Amy Rogers, Gillian Craig, Angela Flynn, Isla Mackenzie, Thomas MacDonald and Alexander Doney

Digital tools for trial recruitment and retention—plenty of tools but rigorous evaluation is in short supply

Authors: Shaun Treweek and Matthias Briel

The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol

Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to suffer renal s...

Authors: Sam McClinton, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Thomas Lam, Rodolfo Hernandez, Robert Pickard, Ken Anson, Terry Clark, Steven MacLennan, David Thomas, Daron Smith, Ben Turney, Alison McDonald, Sarah Cameron and Oliver Wiseman

Umbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: a structured summary of a study protocol for a pilot randomised controlled trial

Objective: To undertake a pilot, feasibility RCT of umbilical cord blood derived cell therapy for treatment of adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent prog...

Authors: Atul Malhotra, David Ernest, Benjamin A. Rogers, David Haylock, Ashalyn Watt, Guy Moeneclaey and Graham Jenkin

Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Primary Objective

Authors: Ruanne V. Barnabas, Elizabeth Brown, Anna Bershteyn, R. Scott Miller, Mark Wener, Connie Celum, Anna Wald, Helen Chu, David Wesche and Jared M. Baeten

Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial

We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill.

Authors: Seyed Sina Naghibi Irvani, Maryam Golmohammadi, Mohamad Amin Pourhoseingholi, Shervin Shokouhi and Ilad Alavi Darazam

Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial

SARS-CoV-2 infection presents a high transmission in the group of health professionals in Spain (12-15% infected). Currently there is no accepted chemoprophylaxis but hydroxychloroquine (HDQ) is known to inhib...

Authors: Antonio Cuadrado-Lavín, José Manuel Olmos, José Manuel Cifrian, Teresa Gimenez, Marco Antonio Gandarillas, Mar García-Saiz, Maria Henar Rebollo, Victor Martínez-Taboada, Marcos López-Hoyos, María Carmen Fariñas and Javier Crespo

Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial

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

Authors: B. Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, Shyam Varadarajulu, John J. Vargo, Field F. Willingham, Todd H. Baron, Gregory A. Coté, Joseph Romagnuolo, April Wood-Williams, Emily K. Depue, Rebecca L. Spitzer…

A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial

SARS-CoV2 infection leads to a concomitant pulmonary inflammation. This inflammation is supposed to be the main driver in the pathogenesis of lung failure (Acute Respiratory Distress Syndrome) in COVID-19. Obj...

Authors: Jonathan Rilinger, Winfried V. Kern, Daniel Duerschmied, Alexander Supady, Christoph Bode, Dawid L. Staudacher and Tobias Wengenmayer

A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial

Entertainment-education (E-E) media can improve behavioral intent toward health-related practices. In the era of COVID-19, millions of people can be reached by E-E media without requiring any physical contact....

Authors: Alain Vandormael, Maya Adam, Merlin Greuel and Till Bärnighausen

Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial

The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care on blood oxygenation and systemic cytokine rele...

Authors: Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene…

Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial

Comparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionals

Authors: Reihaneh Pirjani, Tahereh Soori, Ahmad Reza Dehpour, Mahdi Sepidarkish, Ashraf Moini, Arshia Shizarpour and Razieh Mohammad Jafari

A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial

Primary objective: to evaluate the efficacy of melatonin as a prophylactic treatment on prevention of symptomatic SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure.

Authors: Irene García García, Miguel Rodriguez-Rubio, Amelia Rodríguez Mariblanca, Lucía Martínez de Soto, Lucía Díaz García, Jaime Monserrat Villatoro, Javier Queiruga Parada, Enrique Seco Meseguer, María J. Rosales, Juan González, José R. Arribas, Antonio J. Carcas, Pedro de la Oliva and Alberto M. Borobia

Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial

Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have

Authors: Z. Q. Ren, Y. F. Wang, G. F. Ao, H. X. Chen, M. Huang, M. X. Lai, H. D. Zhao and R. Zhao

The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial

Dentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms ca...

Authors: Takashi Matsuura, Megumi Mae, Masayuki Ohira, Yasunori Yamashita, Ayako Nakazono, Kouji Sugimoto, Kajiro Yanagiguchi and Shizuka Yamada

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol

Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general prac...

Authors: Kathryn Curtis, Michael Moore, Christie Cabral, Vasa Curcin, Jeremey Horwood, Richard Morris, Vibhore Prasad, Anne Schilder, Nicholas Turner, Scott Wilkes, Alastair D. Hay and Jodi Taylor

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial

The primary objective of the study is to assess the safety of a single intravenous infusion of Mesenchymal Stromal Cells (MSCs) in patients with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. Seco...

Authors: Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S. Tunnicliffe, Gavin D. Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran, Cliona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams…

Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial

Transcranial direct current stimulation (tDCS) is promising for improving motor and cognitive performance. Nevertheless, its mechanisms of action are unclear and need to be better characterised according to th...

Authors: Yohan Grandperrin, Sidney Grosprêtre, Magali Nicolier, Philippe Gimenez, Chrystelle Vidal, Emmanuel Haffen and Djamila Bennabi

CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins

Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablat...

Authors: Sungsin Cho, Hyung Sub Park, Taeseung Lee, Seung Jae Byun, Woo-Sung Yun, Shin-Seok Yang, Hyangkyoung Kim, Woo-Shik Kim, Jin Hyun Joh and In Mok Jung

Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan

The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to...

Authors: Alysha M. De Livera, Anne Reutens, Mark Cooper, Merlin Thomas, Karin Jandeleit-Dahm, Jonathan E. Shaw and Agus Salim

MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial

In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis a...

Authors: Anne-Laure Philippon, Margaux Dumont, Sonia Jimenez, Sarah Salhi, Marine Cachanado, Isabelle Durand-Zaleski, Tabassome Simon and Yonathan Freund

Changes to aspects of ongoing randomised controlled trials with fixed designs

Despite careful planning, changes to some aspects of an ongoing randomised clinical trial (RCT), with a fixed design, may be warranted. We sought to elucidate the distinction between legitimate versus illegiti...

Authors: Xanthi Coskinas, John Simes, Manjula Schou and Andrew James Martin

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial

Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to im...

Authors: William J. Meurer, Mackenzie Dinh, Kelley M. Kidwell, Adam Flood, Emily Champoux, Candace Whitfield, Deborah Trimble, Joan Cowdery, Dominic Borgialli, Sacha Montas, Rebecca Cunningham, Lorraine R. Buis, Devin Brown and Lesli Skolarus

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. ...

Authors: Caroline Trang-Poisson, Elise Kerdreux, Alexandra Poinas, Lucie Planche, Harry Sokol, Pascale Bemer, Karine Cabanas, Eliane Hivernaud, Laetitia Biron, Laurent Flet, Emmanuel Montassier, Ghislaine Le Garcasson, Anne Chiffoleau, Alexandra Jobert, Didier Lepelletier, Jocelyne Caillon…

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study)

Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and...

Authors: Caroline Gronnier, Cécile Chambrier, Alain Duhamel, Benoît Dervaux, Denis Collet, Delphine Vaudoyer, Jean-Marc Régimbeau, Jacques Jougon, Jérémie Théréaux, Gil Lebreton, Julie Veziant, Alain Valverde, Pablo Ortega-Deballon, François Pattou, Muriel Mathonnet, Julie Perinel…

Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial

In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women’s physical and mental health, IPV also incr...

Authors: Roxanne C. Keynejad, Tesera Bitew, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Negussie Deyessa, Nick Sevdalis, Wietse A. Tol, Louise Howard and Charlotte Hanlon

Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study

Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is ...

Authors: Anna Ozaki, Takaomi Kessoku, Michihiro Iwaki, Takashi Kobayashi, Tsutomu Yoshihara, Takayuki Kato, Yasushi Honda, Yuji Ogawa, Kento Imajo, Takuma Higurashi, Masato Yoneda, Masataka Taguri, Takeharu Yamanaka, Hiroto Ishiki, Noritoshi Kobayashi, Satoru Saito…

Genetic basis for prediction of non-responders to dietary plant sterol intervention (GenePredict-PS): a study protocol for a double-blind, placebo-controlled, randomized two-period crossover study

Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases...

Authors: Maryam Shamloo, Matthew J. Granger, Elke A. Trautwein, James D. House and Dylan MacKay

The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study)

Approximately 30% of appendectomies are for complicated acute appendicitis (CAA). With laparoscopy, the main post-operative complication is deep abscesses (12% of cases of CAA, versus 4% for open surgery). A r...

Authors: C. Sabbagh, N. Siembida, H. Dupont, M. Diouf, J. L. Schmit, S. Boddaert and J. M. Regimbeau

Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial

Rhizarthrosis (trapeziometacarpal osteoarthritis) is the second most common site of osteoarthritis in the hand affecting 10–30% of adults over the age of 50. Up to four times as many women as men have rhizarth...

Authors: Markus Bock, Andreas Eisenschenk, Heiko Lorenzen and Martin Lautenbach

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population

Smartphone-based support can reach thousands of smokers and help those who would otherwise try to quit smoking by themselves with little chance of success. Nicotine medications double the chances of quitting s...

Authors: Jean-François Etter and Yasser Khazaal

Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial

Coronary artery diseases (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in progressive replacement of contractile myocardium w...

Authors: Leo Pölzl, Felix Nägele, Michael Graber, Jakob Hirsch, Daniela Lobenwein, Martina Mitrovic, Agnes Mayr, Markus Theurl, Michael Schreinlechner, Matthias Pamminger, Christian Dorfmüller, Michael Grimm, Can Gollmann-Tepeköylü and Johannes Holfeld

Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial

Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could...

Authors: Sanmy Rocha Nóbrega, Silvana Gama Florencio Chachá and Cleiton Augusto Libardi

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide infor...

Authors: Victoria Shepherd

High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial

Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly common intervention in the treatment of pancreaticobiliary disorders. Patients are often elderly with complex co-morbidities. While moni...

Authors: Venkatesan Thiruvenkatarajan, Ashok Dharmalingam, Gilberto Arenas, Medhat Wahba, Reinhard Steiner, Vasanth Rao Kadam, Andre Tran, John Currie, Roelof Van Wijk, Anthony Quail and Guy Ludbrook

Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial

Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not y...

Authors: Tony Kendrick, Michael Moore, Geraldine Leydon, Beth Stuart, Adam W. A. Geraghty, Guiqing Yao, Glyn Lewis, Gareth Griffiths, Carl May, Rachel Dewar-Haggart, Samantha Williams, Shihua Zhu and Christopher Dowrick

Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study

Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharm...

Authors: Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Linda Birt, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris…