Articles

Effects of the peripherally acting μ-opioid receptor antagonist methylnaltrexone on acute pancreatitis severity: study protocol for a multicentre double-blind randomised placebo-controlled interventional trial, the PAMORA-AP trial

Moderate to severe acute pancreatitis (AP) is associated with a high rate of complications and increased mortality, yet no targeted pharmacologic treatment currently exists. As pain is a dominant symptom in AP...

Authors: Cecilie Siggaard Knoph, Mathias Ellgaard Cook, Camilla Ann Fjelsted, Srdan Novovic, Michael Bau Mortensen, Liv Bjerre Juul Nielsen, Mark Berner Hansen, Jens Brøndum Frøkjær, Søren Schou Olesen and Asbjørn Mohr Drewes

Examining the effectiveness of Gateway—an out-of-court community-based intervention to reduce recidivism and improve the health and well-being of young adults committing low-level offences: study protocol for a randomised controlled trial

Young adult offenders represent a third of the UK prison population and are at risk of poor health outcomes including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce...

Authors: A. Cochrane, A. Booth, I. Walker, S. Morgan, A. Mitchell, M. Barlow-Pay, C. Hewitt, B. Taylor, C. Chapman, J. Raftery, J. Fleming, D. Torgerson and J. Parkes

Rationale and design of the multicentric, double-blind, double-placebo, randomized trial APrepitant versus HYdroxyzine in association with cytoreductive treatments for patients with myeloproliferative neoplasia suffering from Persistent Aquagenic Pruritus. Trial acronym: APHYPAP

Aquagenic pruritus (AP), an intense sensation of scratching induced after water contact, is the most troublesome aspect of BCR-ABL1-negative myeloproliferative neoplasms (MPNs). Mostly described in polycythemi...

Authors: C. Le Gall-Ianotto, R. Verdet, E. Nowak, L. Le Roux, A. Gasse, A. Fiedler, D. Carlhant-Kowalski, P. Marcorelles, L. Misery and J. C. Ianotto

Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions...

Authors: V. Shepherd, F. Wood, M. Robling, E. Randell and K. Hood

The influence of a supervised group exercise intervention combined with active lifestyle recommendations on breast cancer survivors’ health, physical functioning, and quality of life indices: study protocol for a randomized and controlled trial

Most cancer patients, under active treatment or not, are sedentary, despite increasing scientific and clinical understanding of the benefits of exercise and physical activity, such as improving quality of life...

Authors: Luiz Augusto Riani Costa, Raphael F. Barreto, Sarah Milani Moraes de Leandrini, Aline Rachel Bezerra Gurgel, Gabriel Toledo de Sales, Vanessa Azevedo Voltarelli, Gilberto de Castro Jr., Sally A. M. Fenton, James E. Turner, Christian Klausener, Lucas Melo Neves, Carlos Ugrinowitsch, Jose Carlos Farah, Cláudia Lúcia de Moraes Forjaz, Christina May Moran Brito and Patricia Chakur Brum

Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial

Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known tradit...

Authors: Yun Du, Yatong Li, Xianyun Fu, Chenjie Li and Luo Yanan

RENaBack: low back pain patients in rehabilitation—study protocol for a multicenter, randomized controlled trial

Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The n...

Authors: Laura Puerto Valencia, Diamantes Arampatzis, Heidrun Beck, Karsten Dreinhöfer, David Drießlein, Wilfried Mau, Julia-Marie Zimmer, Michael Schäfer, Friedemann Steinfeldt and Pia-Maria Wippert

Resource and infrastructure challenges on the RESIST-2 Trial: an implementation study of drug resistance genotype-based algorithmic ART switches in HIV-2-infected adults in Senegal

Second-line treatment of HIV-2 in resource-limited settings (RLS) is complicated by a lack of controlled trial data, limited availability of HIV-2-active antiretroviral drugs, and inadequate access to drug res...

Authors: Dana N. Raugi, Khardiata Diallo, Mouhamadou Baïla Diallo, Dominique Faye, Ousseynou Cisse, Robert A. Smith, Fatima Sall, El Hadji Ibrahima Sall, Khadim Faye, Jean Philippe Diatta, Binetou Diaw, Jacques Sambou, Jean Jacques Malomar, Stephen E. Hawes, Moussa Seydi and Geoffrey S. Gottlieb

SmartFeeding4Kids, an online self-guided parenting intervention to promote positive feeding practices and healthy diet in young children: study protocol for a randomized controlled trial

Caregivers’ influence on young children’s eating behaviors is widely recognized. Nutritional interventions that focus on the promotion of children’s healthy diet should actively involve parents, focusing on th...

Authors: Ana Isabel Gomes, Ana Isabel Pereira, Tiago Guerreiro, Diogo Branco, Magda Sofia Roberto, Ana Pires, Joana Sousa, Tom Baranowski and Luísa Barros

Feasibility and effectiveness of prone position ventilation technique for postoperative acute lung injury in infants with congenital heart disease: study protocol for a prospective randomized study

Prone position ventilation is a widely used lung protection ventilation strategy. The strategy is more convenient to implement in children compared to adults. Due to the precise mechanism of improving oxygenat...

Authors: Yu-lu Xu, Ya-ping Mi, Meng-xin Zhu, Yue-hong Ren, Wei-juan Gong, Wei-jia Fu, Hui-mei Wang, Lan Ye, Yin Wang, Xiao-yan Zhou, Yan Chen, Yan-yan Chen, Li-qiong Gu, Ying Gu, Bing Jia, Jing Hu…

The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial

People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalabl...

Authors: Anuradhani Kasturiratne, Khadija I. Khawaja, Sajjad Ahmad, Samreen Siddiqui, Khurram Shahzad, Lathika K. Athauda, Ranil Jayawardena, Sara Mahmood, Mirthe Muilwijk, Tayyaba Batool, Saira Burney, Matthew Glover, Saranya Palaniswamy, Vodathi Bamunuarachchi, Manju Panda, Suren Madawanarachchi…

Omega-3 mechanism of action in inflammation and endoplasmic reticulum stress in mononuclear cells from overweight non-alcoholic fatty liver disease participants: study protocol for the “Brazilian Omega Study” (BROS)—a randomized controlled trial

The low-grade inflammation is pivotal in obesity and its comorbidities; however, the inflammatory proteins are out of target for traditional drug therapy. Omega-3 (ω3) fatty acids can modulate the downstream s...

Authors: Ellencristina Silva Batista, Thaiane da Silva Rios, Vitor Rosetto Muñoz, Joyce Santos Jesus, Marcel Monteiro Vasconcelos, Diogo Thimóteo da Cunha, Jose Luis Marques-Rocha, Susana Castelo Branco Ramos Nakandakari, Roberta Lara, Adelino Sanchez Ramos da Silva, José Rodrigo Pauli, Eduardo Rochete Ropelle, Rania Angelina Mekary, Leandro Pereira de Moura, Enilton Aparecido Camargo and Dennys Esper Cintra

Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation

There is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Ye...

Authors: Mihaela S. Stefan, Penelope S. Pekow, Christopher M. Shea, Ashley M. Hughes, Nicholas S. Hill, Jay S. Steingrub, Mary Jo S. Farmer, Dean R. Hess, Karen L. Riska, Taylar A. Clark and Peter K. Lindenauer

A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial

Depression is most common among the elderly and is associated with major impairment. With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have ...

Authors: Jonas Eimontas, Vilmantė Pakalniškienė, Ieva Biliunaite and Gerhard Andersson

Correction to: A brief intervention for PTSD versus treatment as usual: Study protocol for a non-inferiority randomized controlled trial

Authors: Halvor Stavland, Camilla Refvik, Jarle Eid, Rafiq Lockhat and Åsa Hammar

Walking-adaptability therapy after stroke: results of a randomized controlled trial

The ability to adapt walking to environmental properties and hazards, a prerequisite for safe ambulation, is often impaired in persons after stroke.

Authors: C. Timmermans, M. Roerdink, C. G. M. Meskers, P. J. Beek and T. W. J. Janssen

Investigating N-3 Fatty Acids to prevent Neonatal Tobacco-related outcomeS (INFANTS): study protocol for a double-blind, randomized, placebo-controlled parallel clinical trial of n-3 polyunsaturated fatty acids in pregnant smokers

Tobacco use during pregnancy is the most important modifiable risk factor associated with adverse pregnancy outcomes, increasing the risk of preterm birth, intrauterine growth restriction and sudden infant dea...

Authors: Harvey J. Murff, Robert A. Greevy, Reesha S. Sanghani, Katherine E. Hartmann, Tina V. Hartert, Cornelia R. Graves, Scott S. Lee and Hilary A. Tindle

Effect of electro-acupuncture on ovarian function of women with diminished ovarian reserve: study protocol for a randomized controlled trial

Diminished ovarian reserve (DOR) is the precursor state of ovarian failure and can cause the decline of women’s reproductive function. DOR also leads to poor outcome of in vitro fertilization and embryo transf...

Authors: Le Yang, Hanwang Zhang, Li Zhou, Ying Gao, Lijuan Yang, Yajun Hu, Lu Xu and Dongmei Huang

Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS): study protocol for a randomized controlled trial

Emotional dysregulation (ED) constitutes a relevant factor involved in the onset and maintenance of many mental disorders. Targeting ED during adolescence could be a determinant both to identify high-risk indi...

Authors: Laura Pedrini, Roberta Rossi, Laura Rosa Magni, Mariangela Lanfredi, Serena Meloni, Clarissa Ferrari, Ambra Macis, Nicola Lopizzo, Valentina Zonca and Annamaria Cattaneo

Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial

It is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce health...

Authors: Céline K. Stäuble, Markus L. Lampert, Samuel Allemann, Martin Hatzinger, Kurt E. Hersberger, Henriette E. Meyer zu Schwabedissen, Christian Imboden and Thorsten Mikoteit

Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia

Schizophrenia is a persistent psychotic disorder often accompanied by severe disability and premature mortality. New pharmacological treatments are urgently needed. Sodium benzoate, a common food preservative ...

Authors: Andrea Baker, Lachlan Clarke, Peter Donovan, Jacobus P. J. Ungerer, Gunter Hartel, George Bruxner, Luca Cocchi, Anne Gordon, Vikas Moudgil, Gail Robinson, Digant Roy, Ravinder Sohal, Emma Whittle and James G. Scott

Effect of traditional Chinese medicine formula Guilu Xian on in vitro fertilization and embryo transfer outcome in older women with low prognosis: study protocol for a prospective, multicenter, randomized double-blind study

In recent years, the prevalence of infertility has significantly increased and has become a global reproductive health problem. The female ovarian reserves have been shown to decrease progressively with an inc...

Authors: Yingjie Ma, Xianling Cao, Jingyan Song, Dandan Gao, Xinlei Wang, Li Li and Zhengao Sun

Does virtual reality increase the efficacy of psychotherapy for young adults with mild-to-moderate depression? A study protocol for a multicenter randomized clinical trial

The improvement of psychological treatments for depression in young adults is a pressing issue highlighted in the literature. Its relevance is determined not only because young adults are underrepresented in r...

Authors: Adrián Montesano, Joan C. Medina, Clara Paz, Helena García-Mieres, Noelia Niño-Robles, Eugeni García-Grau, Josep Cañete Crespillo, Alejandro García-Gutiérrez, Miquel Alabèrnia-Segura and Guillem Feixas

Safety and efficacy of the new CryoPop® cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls

Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally ...

Authors: S. Yogeshkumar, Jean Anderson, Enriquito Lu, Edward Kenyi, Margaret Mensa, Katrina Thaler, Ramalingappa Antartani, Kasturi Donimath, Basavaraj Patil, Santosh Chikaraddi, Shailaja Bidri, Aruna Biradar, Muttappa R. Gudadinni, Laxmikant Lokare, Gayane Yenokyan, Mrutyunjaya B. Bellad…

An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial

The combination of poverty, HIV and depression in the perinatal period represents a major public health challenge in many Southern African countries. In some areas, up to a third of HIV-positive women experien...

Authors: Tamsen J. Rochat, Samukelisiwe Dube, Kobus Herbst, Cecilia A. Hoegfeldt, Stephanie Redinger, Thandeka Khoza, Ruth Margret Bland, Linda Richter, Louise Linsell, Chris Desmond, Aisha K. Yousafzai, Michelle Craske, Ed Juszczak, Melanie Abas, Taygen Edwards, David Ekers…

Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic in self-reported good and poor sleepers (Sleep COVID-19): study protocol for a randomised controlled trial

Theoretical models of insomnia suggest that stressful life events, such as the COVID-19 pandemic, can cause acute insomnia (short-term disruptions to sleep). Early interventions may prevent short-term sleep pr...

Authors: Olivia L. Sawdon, Greg J. Elder, Nayantara Santhi, Pamela Alfonso-Miller and Jason G. Ellis

Effect of preoperative CT angiography examination on the clinical outcome of patients with BMI ≥ 25.0 kg/m² undergoing laparoscopic gastrectomy: study protocol for a multicentre randomized controlled trial

Gastric cancer, which is the fifth most common malignancy and the third most common cause of cancer-related death, is particularly predominant in East Asian countries, such as China, Japan and Korea. It is a s...

Authors: Cheng Meng, Shougen Cao, Xiaodong Liu, Leping Li, Qingsi He, Lijian Xia, Lixin Jiang, Xianqun Chu, Xinjian Wang, Hao Wang, Xizeng Hui, Zuocheng Sun, Shusheng Huang, Quanhong Duan, Daogui Yang, Huanhu Zhang…

A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond

Prior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery w...

Authors: Jane A. H. Masoli, Kim Down, Gary Nestor, Sharon Hudson, John T. O’Brien, James D. Williamson, Carolyn A. Young and Camille Carroll

Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study

The COVID-19 pandemic poses challenges for timely outcome assessment in randomized clinical trials (RCT). Our aim was to describe our remote neurocognitive testing (NCT) protocol administered by telephone in p...

Authors: Annie C. Lajoie, Joelle Crane, Ann R. Robinson, Anne-Louise Lafontaine, Andrea Benedetti, R. John Kimoff and Marta Kaminska

Evaluation of the Intensive Treatment and Rehabilitation Program for Residential Treatment and Rehabilitation Centers (INTREPRET) in the Philippines: a study protocol for a randomized controlled trial

The Philippines has been severely affected by the methamphetamine crisis. The government has launched a policy war against drug use, although the severe sanctions imposed on drug users have been criticized int...

Authors: Takayuki Harada, Toshiaki Baba, Tomohiro Shirasaka and Shogo Kanamori

Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial

A clinical pattern of damage to the auditory, visual, and vestibular sensorimotor systems, known as multi-sensory impairment, affects roughly 2% of the US population each year. Within the population of US mili...

Authors: Ann-Margret Ervin, Michael C. Schubert, Americo A. Migliaccio, Jamie Perin, Hamadou Coulibaly, Jennifer L. Millar, Dale Roberts, Mark Shelhamer, Daniel Gold, Stephanie Beauregard, Robin Pinto, Douglas Brungart and Bryan K. Ward

Online supervised versus workplace corrective exercises for upper crossed syndrome: a protocol for a randomized controlled trial

Musculoskeletal disorders (MSDs) including upper crossed syndrome (UCS) are considered as the leading cause of work-related issues worldwide among office workers. Therefore, the present study aims to evaluate ...

Authors: Zohreh Yaghoubitajani, Mehdi Gheitasi, Mohammad Bayattork and Lars Louis Andersen

Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology

Electroconvulsive therapy (ECT) is the most effective treatment for treatment-resistant depression (TRD), especially for acute suicidal ideation, but the associated cognitive adverse effects and negative stigm...

Authors: Zafiris J. Daskalakis, Shawn M. McClintock, Itay Hadas, Elisa Kallioniemi, Reza Zomorrodi, Alanah Throop, Lucy Palmer, Faranak Farzan, Kevin E. Thorpe, Carol Tamminga and Daniel M. Blumberger

Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH II): study protocol for a randomized controlled trial

Chronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve ou...

Authors: Rong Cai Jiang, Dong Wang, Shi Guang Zhao, Ren Zhi Wang, De Zhi Kang, Xin Gen Zhu, Zong Mao Zhao, Jun Ji Wei, Ying Huang, Yan Qu, Xiao Chuan Sun, Hong Ming Ji, Xiao Chun Jiang, Jin Fang Liu, Xi De Zhu, Jian Jun Wang…

TIMELAPSE study—efficacy of low-dose amitriptyline versus cognitive behavioral therapy for chronic insomnia in patients with medical comorbidity: study protocol of a randomized controlled multicenter non-inferiority trial

Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for...

Authors: Nynke L. Rauwerda, Hans Knoop, Irene Pot, Annemieke van Straten, Marian E. Rikkert, Anouk Zondervan, Thom P. J. Timmerhuis, Annemarie M. J. Braamse and H. Myrthe Boss

The ELSA trial: single versus combinatory effects of non-prohibited beta-2 agonists on skeletal muscle metabolism, cardio-pulmonary function and endurance performance—study protocol for a randomized 4-way balanced cross-over trial

Asthma and/or airway hyper-responsiveness (AHR) are common in elite endurance athletes with a high prevalence rate of beta-2 adrenoreceptor (beta-2) agonists use. Nevertheless, there are data on dose-dependent...

Authors: Martina Zügel, Daniel A. Bizjak, Dorle Nussbaumer, Kay Winkert, Kensuke Takabayashi, Johannes Kirsten, Mickel Washington, Gunnar Treff, Jens Dreyhaupt, Luise Steeb, Patrick Diel, Maria Kristina Parr, Jürgen M. Steinacker and Hasema Persch

The effectiveness of antibacterial therapeutic clothing based on silver or chitosan as compared with non-antibacterial therapeutic clothing in patients with moderate to severe atopic dermatitis (ABC trial): study protocol for a pragmatic randomized controlled trial

Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10 to 20% of children and between 2 and 15% of the adults in Western Europe. Since 2000, therapeutic clothing or functional textiles b...

Authors: Aviël Ragamin, Karin B. Fieten, Ron A. Tupker, Jill de Wit, Minke M. F. van Mierlo, Marieke S. Jansen, Madelon B. Bronner, Renske Schappin, Frank H. J. Schuren, Margreet L. E. Romeijn, Bernd W. M. Arents, Suzanne Polinder, Marlies de Graaf, Thomas Rustemeyer, Marie L. A. Schuttelaar and Suzanne G. M. A. Pasmans

Clinical efficacy of Tailin formulation combined with continuous low-dose antimicrobial therapy for recurrent urinary tract infection: study protocol for a multicenter, double-blind, randomized, controlled clinical trial

Given the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic ther...

Authors: Tonglu Li, Yingru Xu and Xuezhong Gong

Treatment of urinary incontinence in women with chronic obstructive pulmonary disease—a randomised controlled study

Little is known regarding treatment of urinary incontinence (UI) in women with chronic obstructive pulmonary disease (COPD). The aim of the study was to explore the efficacy of pelvic floor muscle training (PF...

Authors: Stacey Haukeland-Parker, Bente Frisk, Martijn A. Spruit, Signe Nilssen Stafne and Hege Hølmo Johannessen

The Moo’D Study: protocol for a randomised controlled trial of A2 beta-casein only versus conventional dairy products in women with low mood

Beta-casein is a major protein in cow’s milk, of which A1 and A2 are the most frequent variants. Recent evidence implicates A1 beta-casein consumption in mechanisms that are of potential importance to mental h...

Authors: Meghan Hockey, Hajara Aslam, Michael Berk, Julie A. Pasco, Anu Ruusunen, Mohammadreza Mohebbi, Helen Macpherson, Mary Lou Chatterton, Wolfgang Marx, Adrienne O’Neil, Tetyana Rocks, Amelia J. McGuinness, Lauren M. Young and Felice N. Jacka

Effects of immunoglobulin plus prednisolone in reducing coronary artery lesions in patients with Kawasaki disease: study protocol for a phase III multicenter, open-label, blinded-endpoints randomized controlled trial

Kawasaki disease (KD) is an acute systemic vasculitis of unclear etiology that mainly affects infants and young children. Strategies to reduce the incidence and severity of coronary artery lesions (CALs), the ...

Authors: Si-Yuan Lin, Lan He, Li-Ping Xie, Yin Wang, Yi-Xiang Lin, Yin-Yin Cao, Wei-Li Yan, Fang Liu and Guo-Ying Huang

Participants’ characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa

HIV is one of the greatest public health challenges in South Africa. Potential HIV vaccines and antibodies are thought to be cost-effective biomedical HIV prevention methods and are currently under investigati...

Authors: Jill Hanass-Hancock, Bradley Carpenter, Tarylee Reddy, Ayanda Nzuza, Zakir Gaffoor, Ameena Goga and Michele Andrasik

Clinical validation of a combinatorial PharmAcogeNomic approach in major Depressive disorder: an Observational prospective RAndomized, participant and rater-blinded, controlled trial (PANDORA trial)

Major depressive disorder (MDD) is a common, chronic, debilitating mood disorder that causes serious functional impairment and significantly decreased quality of life. Pharmacotherapy represents the first-line...

Authors: Alessandra Minelli, Stefano Barlati, Erika Vitali, Stefano Bignotti, Vincenzo Dattilo, Giovanni Battista Tura, Elisabetta Maffioletti, Edoardo Giacopuzzi, Vincenza Santoro, Giulia Perusi, Chiara Cobelli, Chiara Magri, Silvia Bonizzato, Luisella Bocchio-Chiavetto, Edoardo Spina, Antonio Vita…

Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial

In order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. T...

Authors: Saad Jwair, Ralf A. Boerboom, Huib Versnel, Robert J. Stokroos and Hans G. X. M. Thomeer

Development of a core outcome set (COS) for studies relating to awareness and clinical management of reduced fetal movement: study protocol

Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aim...

Authors: Dexter J. L. Hayes, Declan Devane, Jo C. Dumville, Valerie Smith, Tanya Walsh and Alexander E. P. Heazell

Correction to: Establishing a core outcome set for mucopolysaccharidoses (MPS) in children: study protocol for a rapid literature review, candidate outcomes survey, and Delphi surveys

Authors: Alison H. Howie, Kylie Tingley, Michal Inbar-Feigenberg, John J. Mitchell, Nancy J. Butcher, Martin Offringa, Maureen Smith, Kim Angel, Jenifer Gentle, Alexandra Wyatt, Philippe M. Campeau, Alicia Chan, Pranesh Chakraborty, Farah El Turk, Eva Mamak, Aizeddin Mhanni…

The Selah study protocol of three interventions to manage stress among clergy: a preference-based randomized waitlist control trial

Like many helping professionals in emotional labor occupations, clergy experience high rates of mental and physical comorbidities. Regular stress management practices may reduce stress-related symptoms and mor...

Authors: Logan C. Tice, David E. Eagle, Joshua A. Rash, Jessie S. Larkins, Sofia M. Labrecque, Alyssa Platt, Jia Yao and Rae Jean Proeschold-Bell

Autologous full-thickness skin graft as reinforcement in parastomal hernia repair: a randomised controlled trial

Parastomal hernia is a common complication of an enterostomy and can have a significant impact on health-related quality of life. Currently used methods of repair have high recurrence rates and considerable ri...

Authors: Viktor Holmdahl, Ulf Gunnarsson and Karin Strigård

Beta blocker use in traumatic brain injury based on the high-sensitive troponin status (BBTBBT): methodology and protocol implementation of a double-blind randomized controlled clinical trial

Beta-adrenergic receptor blockers (BB) play an important role in the protection of organs that are susceptible for secondary injury due to stress-induced adrenergic surge. However, the use of BB in traumatic b...

Authors: Ayman El-Menyar, Mohammad Asim, Ahmed Abdel-Aziz Bahey, Talat Chughtai, Abdulnasser Alyafai, Husham Abdelrahman, Sandro Rizoli, Ruben Peralta and Hassan Al-Thani

Investigator-Driven Randomised Controlled Trial of Cefiderocol versus Standard Therapy for Healthcare-Associated and Hospital-Acquired Gram-negative Bloodstream Infection: Study protocol (the GAME CHANGER trial): study protocol for an open-label, randomised controlled trial

Increasing rates of antibiotic resistance in Gram-negative organisms due to the presence of extended-spectrum beta-lactamases (ESBL), hyperproduction of AmpC enzymes, carbapenemases and other mechanisms of res...

Authors: Hugh Wright, Patrick N. A. Harris, Mark D. Chatfield, David Lye, Andrew Henderson, Tiffany Harris-Brown, Anna Donaldson and David L. Paterson