Articles

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

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

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

Diabetes management intervention studies: lessons learned from two studies

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

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

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

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

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

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

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

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

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

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

Authors: Tomasz Pietrzykowski and Katarzyna Smilowska

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Absolute vs. relative effects—implications for subgroup analyses

Authors: Lars W. Andersen

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

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

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

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

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

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

eRegCom—Quality Improvement Dashboard for healthcare providers and Targeted Client Communication to pregnant women using data from an electronic health registry to improve attendance and quality of antenatal care: study protocol for a multi-arm cluster randomized trial

This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targe...

Authors: Kjersti Mørkrid, Binyam Bogale, Eatimad Abbas, Khadija Abu Khader, Itimad Abu Ward, Amjad Attalh, Tamara Awwad, Mohammad Baniode, Kimberly Suzanne Frost, Michael James Frost, Buthaina Ghanem, Taghreed Hijaz, Mervett Isbeih, Sally Issawi, Zaher A. S. Nazzal, Brian O’Donnell…

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Evaluation of robotic versus open partial pancreatoduodenectomy—study protocol for a randomised controlled pilot trial (EUROPA, DRKS00020407)

Partial pancreatoduodenectomy (PD) is the indicated surgical procedure for a wide range of benign and malignant diseases of the pancreatic head and distal bile duct and offers the only potential cure for pancr...

Authors: Rosa Klotz, Colette Dörr-Harim, Thomas Bruckner, Philipp Knebel, Markus K. Diener, Thilo Hackert and André L. Mihaljevic

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial

In this cluster-randomised controlled study (CoV-Surv Study), four different “active” SARS-CoV-2 testing strategies for general population surveillance are evaluated for their effectiveness in determining and ...

Authors: Andreas Deckert, Simon Anders, Manuela de Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Kathleen Boerner, Matthias Meurer, Konrad Herbst, Matthias Sand, Lisa Koeppel, Tobias Siems, Lucia Brugnara, Stephan Brenner, Robin Burk, Dan Lou…

A platform trial in practice: adding a new experimental research arm to the ongoing confirmatory FLAIR trial in chronic lymphocytic leukaemia

The FLAIR trial in chronic lymphocytic leukaemia has a randomised, controlled, open-label, confirmatory, platform design. FLAIR was successfully amended to include an emerging promising experimental therapy to...

Authors: Dena R. Howard, Anna Hockaday, Julia M. Brown, Walter M. Gregory, Susan Todd, Tahla Munir, Jamie B. Oughton, Claire Dimbleby and Peter Hillmen

Antiplatelet therapy for the prevention of atherosclerosis in chronic kidney disease (ALTAS-CKD) patients: study protocol for a randomized clinical trial

Cardiovascular disease (CVD) is the most common complication and the leading cause of death in patients with chronic kidney disease (CKD). Accelerated atherosclerosis is a pathophysiological process that is vi...

Authors: Jiachuan Xiong, Ting He, Zhikai Yu, Ke Yang, Feng Chen, Jingbo Cheng, Yu Shi, Yinghui Huang, Yu Qiao, Haiyang Li, Yunzhu Shen and Jinghong Zhao

Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial

Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid...

Authors: Zheng Guan, Yanfeng Gao, Qiao Qiao, Qiang Wang and Jingjie Liu

Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial

Atrial fibrillation (AF) is a common arrhythmia, which is closely related to cardiovascular morbidity and mortality. Although acupuncture is used in the treatment of AF, the evidence is insufficient. The objec...

Authors: Ying Lin, Xian Wang, Xue-Bin Li, Bang-Qi Wu, Zhao-Hui Zhang, Wei-Hua Guo, Cun-Cao Wu, Xin Chen, Ming-Long Chen, Zhong Dai, Fu-Yan Chen, Rui Zhu, Chu-Xi Liang, Yun-Peng Tian, Gang Yang, Chao-Qun Yan…

Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial

Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strateg...

Authors: Fang-Ting Yu, Guang-Xia Ni, Guo-Wei Cai, Wen-Jun Wan, Xiao-Qing Zhou, Xiu-Li Meng, Jin-Ling Li, Jian-Feng Tu, Li-Qiong Wang, Jing-Wen Yang, Hai-Yang Fu, Xin-Chang Zhang, Jing Li, Yan-Fu Wang, Beng Zhang, Xiao-Hui Zhang…

Continuous warfarin administration versus heparin bridging therapy in post colorectal polypectomy haemorrhage: a study protocol for a multicentre randomised controlled trial (WHICH study)

Endoscopic removal of colorectal adenoma is considered an effective treatment for reducing the mortality rates associated with colorectal cancer. Warfarin, a type of anticoagulant, is widely used for the treat...

Authors: Yasuaki Nagami, Taishi Sakai, Masafumi Yamamura, Masami Nakatani, Takayuki Katsuno, Takehisa Suekane, Hironori Uno, Hiroaki Minamino, Masatsugu Okuyama, Junichi Okamoto, Mitsutaka Kumamoto, Atsushi Noguchi, Kazuki Yamamori, Osamu Takaishi, Masahiro Ochi, Takako Miyazaki…

Improving gait adaptability in patients with hereditary spastic paraplegia (Move-HSP): study protocol for a randomized controlled trial

People with hereditary spastic paraplegia (HSP) experience difficulties adapting their gait to meet environmental demands, a skill required for safe and independent ambulation. Gait adaptability training is po...

Authors: Lotte van de Venis, Bart P. C. van de Warrenburg, Vivian Weerdesteyn, Bas J. H. van Lith, Alexander C. H. Geurts and Jorik Nonnekes

Identifying student opinion leaders to lead e-cigarette interventions: protocol for a randomized controlled pragmatic trial

After the US Surgeon General declared youth electronic cigarette (e-cigarette) use an epidemic in 2018, the number of youth e-cigarette users continued to surge, growing from 3.8 million in 2018 to over 5 mill...

Authors: Kar-Hai Chu, Sara Matheny, Alexa Furek, Jaime Sidani, Susan Radio, Elizabeth Miller, Thomas Valente and Linda Robertson

Efficacy of prophylactic methylprednisolone on reducing the risk of post-extubation stridor in patients after an emergency intubation: study protocol for a randomized controlled trial

Post-extubation stridor (PES) is one of the most common complications of invasive respiratory support, with severe cases leading to possible extubation failure (reintubation within 48 h) and increased mortalit...

Authors: Jingyi Wang, Joseph Harold Walline, Lu Yin, Yili Dai, Jiayuan Dai, Huadong Zhu, Xuezhong Yu and Jun Xu

ICan, an Internet-based intervention to reduce cannabis use: study protocol for a randomized controlled trial

Heavy cannabis use is associated with adverse physical and mental health effects. Despite available effective treatments, the majority of heavy cannabis users does not seek professional help. Web-based interve...

Authors: Marleen I. A. Olthof, Matthijs Blankers, Margriet W. van Laar and Anna E. Goudriaan

Effects of different acupuncture treatment methods on post-stroke cognitive impairment: study protocol for a multicenter randomized controlled trial

Cognitive impairment is a common dysfunction after stroke that seriously affects the overall recovery of patients. Cognitive rehabilitation training is currently the main treatment to improve cognitive functio...

Authors: Kai-Qi Su, Su-Tong Liu, Jie-Ying Li, Rui-Qing Li, Hui-Li Feng, Yang Xue and Xiao-Dong Feng

Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial

Recent experimental evidence shows that sevoflurane can reduce the inflammatory response during cardiac surgery with cardiopulmonary bypass. However, this observation so far has not been assessed in an adequat...

Authors: Thiago Augusto Azevedo Maranhão Cardoso, Gudrun Kunst, Caetano Nigro Neto, José de Ribamar Costa Júnior, Carlos Gustavo Santos Silva, Gisele Medeiros Bastos, Jéssica Bassani Borges and Mario Hiroyuki Hirata

Efficacy of repetitive transcranial magnetic stimulation combined with visual scanning treatment on cognitive and behavioral symptoms of left hemispatial neglect in right hemispheric stroke patients: study protocol for a randomized controlled trial

Left hemispatial neglect (LHN) is a neuropsychological syndrome often associated with right hemispheric stroke. Patients with LHN have difficulties in attending, responding, and consciously representing the ri...

Authors: Francesco Di Gregorio, Fabio La Porta, Emanuela Casanova, Elisabetta Magni, Roberta Bonora, Maria Grazia Ercolino, Valeria Petrone, Maria Rosaria Leo and Roberto Piperno

A structured summary of a study protocol for a multi-center, randomized controlled trial (RCT) of COVID-19 prevention with Kampo medicines (Integrative Management in Japan for Epidemic Disease by prophylactic study: IMJEDI P1 study)

We aimed to test our hypothesis that traditional Japanese (Kampo) medicine, hochuekkito (Hochu-ekki-to: HET) has a preventive effect for the symptoms on COVID-19.

Authors: Takao Namiki, Shin Takayama, Ryutaro Arita, Tadashi Ishii, Mosaburo Kainuma, Toshiaki Makino, Masaru Mimura, Tetsuhiro Yoshino, Tatsuya Nogami, Makoto Arai, Juichi Sato, Koichiro Tanaka, Hajime Nakae, Hidetoshi Igari, Yoshihito Ozawa, Yuki Shiko…

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial

Recently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under...

Authors: Stacey Haukeland-Parker, Øyvind Jervan, Hege Hølmo Johannessen, Jostein Gleditsch, Knut Stavem, Kjetil Steine, Martijn A. Spruit, René Holst, Mazdak Tavoly, Frederikus A. Klok and Waleed Ghanima

Protocol for the methamphetamine approach-avoidance training (MAAT) trial, a randomised controlled trial of personalised approach bias modification for methamphetamine use disorder

Globally, methamphetamine use has increased in prevalence in recent years. In Australia, there has been a dramatic increase in numbers of people seeking treatment, including residential rehabilitation, for met...

Authors: Joshua B. B. Garfield, Hugh Piercy, Shalini Arunogiri, Dan I. Lubman, Samuel C. Campbell, Paul G. Sanfilippo, Jeff Gavin, Malcolm Hopwood, Eli Kotler, Suzanne George, Goke Okedara, Lara R. Piccoli and Victoria Manning

A comparison of approaches for combining predictive markers for personalised treatment recommendations

In the presence of heterogeneous treatment effects, it is desirable to divide patients into subgroups based on their expected response to treatment. This is formalised via a personalised treatment recommendati...

Authors: Matthias Pierce and Richard Emsley

Exercise therapy and patient education versus intra-articular saline injections in the treatment of knee osteoarthritis: an evidence-based protocol for an open-label randomised controlled trial (the DISCO trial)

Knee osteoarthritis (OA) is a highly prevalent musculoskeletal condition causing pain, physical disability, and reduced quality of life. Exercise and patient education are non-pharmacological interventions for...

Authors: Elisabeth Bandak, Anders F. Overgaard, Lars Erik Kristensen, Karen Ellegaard, Jørgen Guldberg-Møller, Cecilie Bartholdy, David J. Hunter, Roy D. Altman, Robin Christensen, Henning Bliddal and Marius Henriksen

Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China

Acupuncture is effective in symptom and quality of life improvement of chronic asthma, but the efficacy differences between different acupoints are uncertain. In terms of the theory of Meridian-viscera Associa...

Authors: Shirui Cheng, Xiaohui Dong, Lei Lan, Zhaoxuan He, Siyi Yu, Yi Yang, Chuantao Zhang, Mei Chen, Jun Yang, Haoran Chu, Yalan Liu, Menglin Wang, Qingsong Huang and Fang Zeng

The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan

Procedural sedation and analgesia (PSA) is frequently required to perform closed reductions for fractures and dislocations in children. Intravenous (IV) ketamine is the most commonly used sedative agent for cl...

Authors: Anna Heath, Juan David Rios, Eleanor Pullenayegum, Petros Pechlivanoglou, Martin Offringa, Maryna Yaskina, Rick Watts, Shana Rimmer, Terry P. Klassen, Kamary Coriolano and Naveen Poonai

Efficacy of simultaneous aerobic exercise and cognitive training in subjective cognitive decline: study protocol for randomized controlled trial of the Exergames Study

Subjective cognitive decline (SCD) is an early manifestation of Alzheimer’s disease (AD) and offers a therapeutic window where interventions have strong potential to prevent or delay the progression of AD. Aer...

Authors: Dereck Salisbury, Tom Plocher and Fang Yu

Adapting the randomised controlled trial (RCT) for precision medicine: introducing the nested-precision RCT (npRCT)

Adaptations to the gold standard randomised controlled trial (RCT) have been introduced to decrease trial costs and avoid high sample sizes. To facilitate development of precision medicine algorithms that aim ...

Authors: Nils Kappelmann, Bertram Müller-Myhsok and Johannes Kopf-Beck

Partnering with general practitioners to optimize survivorship for patients with lymphoma: a phase II randomized controlled trial (the GOSPEL I trial)

Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high ...

Authors: Raymond Javan Chan, Stephanie Buhagiar, Laisa Teleni, Camilla Simonsen, Jane Turner, Courtney Rawson, Nicolas H. Hart, Lee Jones, Louisa Gordon, Ria Joseph, Oluwaseyifunmi Andi Agbejule, Fiona Henderson, Joel Rhee, Marissa Ryan, Christine Carrington and Sally Mapp

Reporting guidelines for clinical trials of artificial intelligence interventions: the SPIRIT-AI and CONSORT-AI guidelines

The application of artificial intelligence (AI) in healthcare is an area of immense interest. The high profile of ‘AI in health’ means that there are unusually strong drivers to accelerate the introduction and...

Authors: Hussein Ibrahim, Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, An-Wen Chan, Matthew R. Sydes, Melanie J. Calvert and Alastair K. Denniston

Safety and clinical efficacy of the secretome of stressed peripheral blood mononuclear cells in patients with diabetic foot ulcer—study protocol of the randomized, placebo-controlled, double-blind, multicenter, international phase II clinical trial MARSYAS II

Diabetes and its sequelae such as diabetic foot ulcer are rising health hazards not only in western countries but all over the world. Effective, yet safe treatments are desperately sought for by physicians, he...

Authors: Alfred Gugerell, Ghazaleh Gouya-Lechner, Helmut Hofbauer, Maria Laggner, Franz Trautinger, Gabriele Almer, Anja Peterbauer-Scherb, Marcus Seibold, Wolfram Hoetzenecker, Christiane Dreschl, Michael Mildner and Hendrik Jan Ankersmit

Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial

1. To assess the efficacy of Mesenchymal Stromal Cells (MSC) versus a control arm as described in the primary endpoint.

Authors: Concepción Payares-Herrera, María E. Martínez-Muñoz, Inés Lipperheide Vallhonrat, Rosa Malo de Molina, Manuel Pérez Torres, Andrea Trisan, Isabel Salcedo de Diego, Rosalía Alonso, Rocío Zafra, Trinidad Donaire, Rocío Sánchez, Juan José Rubio, Rafael F. Duarte Palomino and Cristina Avendaño Solá

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial

The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practi...

Authors: Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Jessica Smith, Chen Ji, Elaine Fairbrother, Stuart Ennis, Peter Heine, Sharisse Alleyne, Jonathan Guck, Emma Padfield…