Evaluation of efficacy of two bag-mask ventilation techniques by novice airway providers: Two-handed CE versus dominant-hand CE–non-dominant-hand thenar eminence techniques – A randomised controlled trial by Neetu Saroye, Gurpreeti Kaur, Udeyana Singh, Anju Grewal, Akshita Khanna, Rushal Nayyar

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Adherence and efficacy outcomes in young Australians with suicidal ideation using a self-management app and digital engagement strategy compared with a sham app: a three-arm randomised controlled trialResearch in context by Michelle Torok, Lauren McGillivray, Daniel Z.Q. Gan, Jin Han, Sarah Hetrick, Quincy J.J. Wong

“…Methods: This was an online double-blind, three-arm parallel randomised controlled trial in Australia. Recruitment occurred between May 30 and August 8, 2023 and eligible participants were aged 17–24 years and had suicidal ideation in the prior 30 days. …”
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Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-label, phase II, randomised controlled trial by Ying Zhu, Jianwei Zhou, Zhigang Zhang, Jiaojiao Zhang, Jing Fei, Xiaoqing Zhu

“…The NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr(NAIVE) study aims to assess the clinical efficacy and safety of NACT in combination with tislelizumab (a monoclonal antibody for programmed cell death protein 1) for advanced EOC.Methods and analysis The NAIVE study is an investigator-initiated, prospective, single-centre, open-label, randomised controlled trial for advanced EOC with the International Federation of Gynaecology and Obstetrics (FIGO) stage IIIc with a Suidan CT score of 3 or greater or a Fagotti laparoscopic score of 8 or greater; or FIGO stage IV. …”
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Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin by Anna Ugalde, Richard W. Tothill, Stephen Quinn, Hui-Li Wong, Owen Prall, Catherine Mitchell, Nilmini Wickramasinghe, Clare Fedele, Natalie Richards, Elizabeth Todio, Cindy Bryant, Louisa G. Collins, Sarah McLean, Hyun Soo Ko, Tim Akhurst, Christopher Steer, Bo Gao, Mark Wong, Chloe Georgiou, Narayan Karanth, Anna Kuchel, Louise Nott, Shamsudheen Padinharakam, Mark Shackleton, Ian M. Collins, Madhu Singh, Rachel Wong, Zee Wan Wong, Alexis Butler, Tharani Sivakumaran, Penelope Schofield, Linda Mileshkin

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Effect of different intraoperative blood pressure regulation levels on postoperative myocardial injury in patients undergoing radical mastectomy for breast cancer after receiving neoadjuvant chemotherapy: a study protocol for a randomised controlled trial by Ying Zhang, Zhou Zhou, Xinxin Wang, Xiaobao Zhang, Hongya Liu, Xiaoqiao Sang, Yingge Liu

“…MINS is defined as elevated cardiac troponin levels within 30 days after non-cardiac surgery with or without clinical and electrocardiographic signs of cardiac ischaemia.Methods and analysis The study is a single-centre, single-blind, prospective randomised controlled trial. It is expected to enrol 166 subjects receiving neoadjuvant chemotherapy with anthracyclines, between the ages of 40 and 75 years, scheduled for radical mastectomy. …”
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Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness by Jeanne Cho, Michael Hill, Corita R Grudzen, Deborah J Shim, Abigail M Schmucker, Keith S Goldfeld, Lauren Southerland, Jeffrey M Caterino, Marie-Carmelle Elie, Robert Swor, Susan E Cohen, Arum Kim, Joseph Lowy, Jennifer S Scherer, Nancy E Bael, Ellin Gafford, Joshua Lakin, Paige Barker, Angela Chmielewski, Jennifer Kapo, Audrey Tan, Rebecca Yamarik, Susan Salz, Stephen Ryan, Anne Kim, Isabel Castro, Amelia Hargrove, Laura Stuecher, Nora Daut, Juanita Booker-Vaughns, Garrett K Chan, J Nicholas Dionne-odom, Patrick Dunn, Robert Galvin, Ernest A Hopkins III, Margaret M Maguire, Neha Reddy Pidatala, Dawn Rosini, Sally Welsh, Karen Jubanyik, Ada L Rubin, Kei Ouchi, Rebecca Murray, Nicole Tang, Marie Bakitas, Abraham Brody, Caroline Blaum, Mara Flannery, Richard Tamirian, Pamela Marsack, Jennifer Bonito, Romilla Batra, Donna C Sadasivan, Eric David Isaacs, Constance L Kizzie-Gillett, William K Vaughan, Pluscedia G Williams, Angela Young-Brinn

“…This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysis This is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. …”
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FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study by Kerry Woolfall, Jamie J Kirkham, Jane Sandall, Mariana Popa, Enrico Lopriore, Mark Turner, Shakila Thangaratinam, Aris T Papageorghiou, Andrew Sharp, Lawrence Impey, Andy Healey, Jessica Mendoza, Asma Khalil, Dharmintra Pasupathy, Brigitte Vollmer, Zarko Alfirevic, Rajeswari Parasuraman, Jan Deprest, Richard Edmund Ashcroft, Kurt Hecher, Smriti Prasad, Baskaran Thilaganathan, Richard J Jackson, Tracy Karen Mitchell, Natasha Fenwick, Monique C Haak, Liesbeth Lewi, Shauna Leven, Fabricio Da Silva Costa, Odai Yaghi, Tracey Ricketts, George Attilakos, Carolyn Bailie, Christine Cornforth, Mark Denbow, Louise Hardman, Jane Harrold, Joel Marsden, Tommy Mousa, Surabhi Nanda, Michelle Watson, Karen Wilding, Dilly Anumba, Edward D Johnstone, Yoav Yinon, Ahmet Baschat

“…These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. …”
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Effect of intermittent urethral catheter clamping combined with active urination training (ICCAUT) strategy on postoperative urinary dysfunction after radical rectal cancer surgery: single-centre randomised controlled trial (ICCAUT -1) study protocol by Yuchen Guo, Quan Wang, Tingting He, Sen Liang, Yunan Guan, Jianan Sun, Haiyan Hu

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Impact of mindfulness-based tri-modal prehabilitation on functional recovery and selected surgical outcomes of patients with colorectal cancer admitted to surgical hospital wards: the first international randomised control trial for mindfulness-based tri-modal prehabilitation by Bawantha Gamage, Manori Nayanakantha Gamage, Nilushika Madushani Perera, Chadani Samararatna Kodikara, Jayamina Udhara Munasinghe Wijeratne, S M D P Seneviratne Alles, Thavendra Kumaran, J M Chandima Jeewandara, Sanath Thushara Chamakara Mahawithanage

“…This study investigates the effectiveness of mindfulness-based tri-modal prehabilitation in improving functional recovery and surgical outcomes for patients with CRC.Methods and analysis The sample size of this prospective, randomised controlled trial was calculated based on the primary outcome, which is the detection of the clinically significant difference in a 6 min walk test (6MWT). …”
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Improving the accUracy of Referrals to the emerGency departmEnt of patieNts with chesT pain using the modified HEART score in Emergency Medical Transport (URGENT 2.0): protocol for a multicentre randomised controlled trial by Joan G Meeder, Frits H M Van Osch, Robert T A Willemsen, Braim M Rahel, Lisa D S Frenk, Cees B de Vos, Fabiana G Prestigiacomo, Marcel J W Janssen, Arnoud W van 't Hof

“…Advanced risk stratification, with the help of cardiac troponin measurements, seems crucial to improve prehospital diagnostic accuracy.Methods and analysis The URGENT 2.0 trial is a randomised controlled trial in which the primary objective is to reduce the referral of non-cardiac chest pain (NCCP) patients, using a modified HEART score including a high-sensitivity capillary point-of-care high-sensitivity cardiac troponin I measurement. …”
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Hydroxychloroquine plus personal protective equipment versus personal protective equipment alone for the prevention of laboratory-confirmed COVID-19 infections among healthcare workers: a multicentre, parallel-group randomised controlled trial from India by Rohina Joshi, Sudha Vidyasagar, Niveditha Devasenapathy, Rinaldo Bellomo, Vivekanand Jha, Chirag Patel, Vijay Kumar, Lachlan Donaldson, Oommen John, Balasubramanian Venkatesh, Michael John, Naomi Hammond, Jeyaraj Pandian, Ashwani Kumar, Arpita Ghosh, S Radhakrishnan, Rajib Paul, Bharath Kumar Tirupakuzhi Vijayaraghavan, Dorrilyn Rajbhandari, Sheila Nainan Myatra, Amritendu Bhattacharya, Sumaiya Arfin, Abhinav Bassi, Lachlan Hugh Donaldson, Naomi E Hammond, Mallikarjuna Kunigari, Cynthia Amrutha, Syed Haider Mehdi Husaini, Subir Ghosh, Santosh Kumar Nag, Hari Krishnan Selvaraj, Viny Kantroo, Kamal D Shah, Sheila Myatra, Amritendu Battacharya, Pavan Kumar Vecham, Evangeline Elvira, Gomathi Parthasarathy, Archana Ragunathan, Gnanavel Rajendra Kunjurao, Pavithra Sampath Kumar, Hilda Nirmala Kumari, Jayanthi Swaminathan, Murshid Cheriyeri Peediyekkal, Arun Chander Yadav, Aarthi Venkatramanan, Cynthia Amrutha Sukumar, Dharini Prasad, Krishnanda Nayak, Ravindra Prabhu, Rohini Bilagi, Akash Bhange, Bhumika Patel, Ekta Ramchandani, Jinesh Patel, Krupa Gandhi, N Prathyusha, Rayshma Rao Bonshlay Lakshmanan, S Hari Krishnan, Abhishek George Mehta, Mousumi Pradhan, Syed Haider Mehdi Husaini, Shahid Ali Siddique, Naved-ur Rahman, Mohammad Jamalludeen, Mounika Amarneni, Suresh Sankar, Vidya Rajesh Joshi, Alka Yadav, Nikhil Modi, Rinku Dahiya, Serena Knowles, Nikita Bathla, Fatima Butt

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A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis by Ramya Bhargava, Philip A. Kalra, Paul Brenchley, Helen Hurst, Alastair Hutchison

“…This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT) of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? …”
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Cost-utility of behavioural activation for mitigating psychological impacts of COVID-19 on socially isolated older adults with depression and multiple long-term conditions compared with usual care: results from a pragmatic randomised controlled trial by Simon Gilbody, Caroline Fairhurst, Catherine Hewitt, Dean McMillan, Carolyn Chew-Graham, Della Bailey, David Ekers, Steve Parrott, Elizabeth Littlewood, Peter Coventry, Han-I Wang, Kalpita Baird

“…Behavioural activation (BA) shows promise as a remote intervention for depression during isolation, but its cost-effectiveness for depressed, socially isolated older adults remains uncertain.Objective This study aimed to assess the cost-utility of BA versus usual care for older adults with depression and MLTCs during COVID-19 restrictions.Methods A randomised controlled trial recruited and randomised individuals aged 65 and over with depressive symptoms and MLTC (n=435) to either the BA intervention or usual care. …”
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Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial by Angela Kribs, Nicole Ernstmann, Nadine Scholten, Martin Hellmich, Antje Hammer, Eva Mildenberger, Andreas Müller, Dirk Horenkamp-Sonntag, Juliane Köberlein-Neu, Tim Ohnhäuser, Katja Matthias, Jens Ulrich Rüffer, Nicola Gabriela Dymek, Julia Jaschke, Anna Katharina Stirner, Isabella Schwab, Daniel Wiesen, Till Dresbach, Friederike Eyssel, Katharina Lugani, Anne Sunder-Plaßmann, Melanie Klein, Christoph Rupprecht

“…This protocol describes the design of a study evaluating the effectiveness, implementation and economic aspects of an intervention, which aims to ensure access to MOM or HDM for VLBW infants from the first day of life in German neonatal intensive care units (NICUs).Methods and analysis The hybrid type 1 effectiveness-implementation cluster-randomised controlled trial, using a stepped-wedge design, will be conducted in 15 level I and level II NICUs across Germany over 26 months. …”
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Study protocol of a multicentre, randomised, controlled trial evaluating the effectiveness of probiotic and peanut oral immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with oral immunotherapy (OIT) alone and with placebo (the PPOIT-003 study) by Michael O’Sullivan, Michael S Gold, Francesca Orsini, Adriana Chebar Lozinsky, Paxton Loke, Susan L. Prescott, Patrick Quinn, Audrey DunnGalvin, Mimi LK Tang, Anne-Louise Ponsoby, Ee Lyn Su, Marnie Robinson, Dean Tey, Kuang-Chih Hsiao, Molly O’Sullivan, Christine Axelrad, Sigrid Pitkin, Jessica Metcalfe, Susan Fahy-Scheer, Thalayasingam Meera, Jovanka King, Fuad Abass, Abigail Cheung, Rachel Wallace, Samara Baldwin

“…Here we describe the protocol for a Phase IIb multicentre, double-blind, randomised, controlled trial (PPOIT-003) with dual primary objectives to evaluate the effectiveness of PPOIT at inducing SU (assessed at 8 weeks after treatment cessation) compared with placebo treatment and peanut OIT alone, in children with peanut allergy.Methods and analysis 200 children 1 to 10 years of age with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited from three tertiary paediatric hospitals in Australia. …”
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Protocol for a multicentre randomised controlled trial examining the effects of temporarily pausing Bruton tyrosine kinase inhibitor therapy to coincide with SARS-CoV-2 vaccination and its impact on immune responses in patients with chronic lymphocytic leukaemia by Abhishek Abhishek, Jonathan A Cook, Helen M Parry, Anne Francis, Lelia Duley, Vicki S Barber, Paul Moss, Nicholas Peckham

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NIFTy: near-infrared fluorescence (NIRF) imaging to prevent postsurgical hypoparathyroidism (PoSH) after thyroid surgery—a phase II/III pragmatic, multicentre randomised controlled trial protocol in patients undergoing a total or completion thyroidectomy by Deborah D Stocken, Maureen Twiddy, Hisham Mehanna, Jonathan Wadsley, Neil Corrigan, Katie Gordon, Julie Croft, Neil Sharma, Anna Perry, Mark Strachan, Gemma Ainsworth, Elizabeth Glenister, Sabapathy Prakash P Balasubramanian

“…Some studies have shown promising results using near-infrared fluorescence (NIRF) imaging in reducing the risk of PoSH which has the potential to significantly reduce morbidity and costs associated with monitoring and treatment.Methods and analysis NIFTy is an unblinded, parallel group, multicentre, seamless phase II/III randomised controlled trial in patients undergoing total or completion thyroidectomy. …”
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Comparison of carbon dioxide control during pressure controlled versus pressure-regulated volume controlled ventilation in children (CoCO2): protocol for a pilot digital randomised controlled trial in a quaternary paediatric intensive care unit by Luregn J Schlapbach, Barbara Brotschi, Kristen S Gibbons, Florian Zapf, Rebeca Mozun, Daphné Chopard, Philipp Baumann, Anika Adam, Vera Jaeggi, Beat Bangerter, Juerg Burren

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Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial by Judith Dams, Hans-Helmut König, Tim Friede, Nils Schneider, Stephanie Stiel, Martin Scherer, Silke Böttcher, Gabriella Marx, Ingmar Schäfer, Nadine Janis Pohontsch, Hendrik van den Bussche, Friedemann Nauck, Michael Freitag, Eva Hummers, Tina Mallon, Franziska Schade, Manuel Zimansky, Thomas Asendorf, Christiane A Mueller

“…The KOPAL study (a concept for strenghtening interprofessional collaboration for patients with palliative care needs) will test the effectiveness of a SPHC nurse–patient consultation followed by an interprofessional telephone case conference.Methods and analysis Multicentre two-arm cluster randomised controlled trial KOPAL with usual care as control arm. …”
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Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial by Ernest Choy, Kerenza Hood, Emma Thomas-Jones, Eleanor Barnes, Keith Wilson, Christian H Ottensmeier, Debbie Harris, Adrian Hill, Mark Tuthill, Richard Adams, Catherine Porter, Katie Ewer, Sian Griffin, Rebecca Tangney, Joanne Euden, Shirley Pringle, Lawrence Raisanen, Ruby Ray, Lisette Sheena Nixon, Melanie Varley, Craig Bodman, Paola Cicconi, Vivien Dagley, Steven Knapper

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