Barriers and Facilitators in Implementing a Telemonitoring Application for Patients With Chronic Kidney Disease and Health Professionals: Ancillary Implementation Study of the NeLLY (New Health e-Link in the Lyon Region) Stepped-Wedge Randomized Controlled Trial by Marion Delvallée, Abdallah Guerraoui, Lucas Tchetgnia, Jean-Pierre Grangier, Nassira Amamra, Anne-Laure Camarroque, Julie Haesebaert, Agnès Caillette-Beaudoin

“…This study serves as a process evaluation conducted alongside the cost-effectiveness NeLLY (New Health e-Link in the Lyon Region) trial. MethodsA mixed methods approach combining a quantitative questionnaire and semistructured interviews was conducted among nurses, nephrologists, and patients with stages 3 and 4 CKD across 10 renal care centers in France that have implemented telemonitoring. …”
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Energy management education for persons living with long COVID-related fatigue (EMERGE): protocol of a two-parallel arms target trial emulation study in a multicentre outpatient intervention setting with an online control group register by Emilia Riggi, Marco Barbero, Gian Luca Di Tanna, Ruth Hersche, Andrea Weise

“…The third aim is to perform a cost-effectiveness analysis of EME.Methods and analysis Using observational data, we will emulate a prospective two-parallel arms target trial to assess whether adding EME to the standard care is associated with improved outcomes in patients with long COVID-related fatigue. …”
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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

“…Definitive conclusions are precluded as the trial stopped early for futility, and hence was underpowered.Trial registration number CTRI/2020/05/025067.…”
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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

“…Whether such a trial is technically possible is unknown; therefore, a study is necessary to inform the design and conduct of a future, definitive trial. …”
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Acceptability of donor funding for clinical trials in the UK: a qualitative empirical ethics study using focus groups to elicit the views of research patient public involvement group members, research ethics committee chairs and clinical researchers by Simon Bowman, Heather Draper, Alexander Masters, Dominic Nutt, Kirstie Shearman

“…Objectives The Plutocratic Proposal is a novel method of funding early phase clinical trials where a single donor funds the entire trial and in so doing secures a place on it. …”
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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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Reply to comments regarding ‘efficacy of analgesia using ilioinguinal-iliohypogastric (IIIH) nerve block, transversus abdominis plane (TAP) block and diclofenac after cesarean delivery under spinal anaesthesia: A non-randomised clinical trial’ by Ranju Singh, Kavita Yadav, Pooja Singh

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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

“…Results will be disseminated through peer-reviewed publications and on the project website.Trial registration number DRKS00025058.…”
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Prevalence and factors associated with uptake of pre-exposure prophylaxis amongst women vulnerable to HIV who received HIV antibodies in Antibody Mediated Prevention HVTN703/HPTN081 trial in Harare, Zimbabwe: a cross-sectional study by Bernard Ngara, Bekezela Siziba, Nyaradzo Mavis Mgodi, Tariro Dianah Chawana, Miria Chitukuta, Pamela Grace Mukwekwerere, Muchaneta Bhondai-Mhuri, Zvavahera Mike Chirenje, Felix Godwin Sivukile Mhlanga

“…Introduction There is limited evidence on pre-exposure prophylaxis (PrEP) uptake post-trial participation for women vulnerable to HIV. …”
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Comparing the Efficacy and Safety of Glucagon-Like Peptide 1 Receptor Agonists with Sodium-Glucose Cotransporter 2 Inhibitors for Obese Type 2 Diabetes Patients Uncontrolled on Metformin: A Systematic Review and Meta-Analysis of Randomized Clinical Trials by Lu Ding, Bang Sun, Xinhua Xiao

“…To conduct the first meta-analysis of randomized controlled trials (RCTs) comparing glucagon-like peptide 1 receptor agonists (GLP-1RAs) with sodium-glucose cotransporter 2 inhibitors (SGLT-2is) for obese type 2 diabetes (T2D) patients uncontrolled on metformin. …”
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Comparison of effects of volume-controlled equal inspiratory-to-expiratory ratio (1:1) ventilation with conventional ratio (1:2) ventilation on respiratory mechanics and hemodynamics in patients undergoing upper abdominal laparoscopic surgeries: A randomized clinical trial by Prathap Gunasekaran, Ramyavel Thangavelu, Sivakumar Segaran

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Corrigendum to “The Threshold of the Severity of Diabetic Retinopathy below Which Intensive Glycemic Control Is Beneficial in Diabetic Patients: Estimation Using Data from Large Randomized Clinical Trials” by Yuqi Liu,Juan Li, Jinfang Ma, Nanwei Tong by Yuqi Liu, Juan Li, Jinfang Ma, Nanwei Tong

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Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes by Ian A Harris, Samuel J MacDessi, Aziz Bhimani, Darren B Chen, Ian Harris, Michelle Lorimer, David Parker, Tamara Hooper, Richard Boyle, Jonathan Mulford, Daniel Franks, Gregory C Wernecke, Durga Bastiras, Emma Heath, Anthony Leong, Brett Fristch, David Penn, George Kirsh, John Limbers, Julian Yu, Maurice Guzman, Peter McEwen

“…Results will be submitted for publication in a peer-reviewed journal and presented in national, state and international meetings.Trial registration number ACTRN12621000205831.…”
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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

“…Results will be communicated to participants, the CLL patient and clinical communities and health policy-makers.Trial registration number ISRCTN14197181.…”
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Building a diverse national research advisory board by Gayle Valensky, Jeff B. Pawelek, Lauren Serpico, David Rodriguez, Maribel Pieters, Yulissa Perez, Julia Moore Vogel

Subjects: “…diversity and inclusion in clinical trials…”
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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

“…The trial incorporates a process evaluation (IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up framework) 2a) to inform the trial protocol, a phase II (IDEAL 2b) analysis using a surrogate primary outcome of 1 day transient hypocalcaemia to determine early futility and phase III (IDEAL 3) assessment of the primary outcome of PoSH at 6 months after surgery. 454 participants will be randomised on a 1:1 basis to evaluate thyroid surgery with NIRF and indocyanine green against standard thyroid surgery in reducing PoSH at 6 months after surgery, with the phase II analysis occurring once data are available for 200 participants. …”
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Transradial versus Transfemoral Access and the Risk of Acute Kidney Injury following Primary Percutaneous Coronary Intervention in Patients with ST-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Propensity-Score-Matched Studies by Gaspar Del Rio-Pertuz, Michel Juarez, Poemlarp Mekraksakit, Kanak Parmar, Mohammad M. Ansari

“…Studies included were randomized controlled trials (RCTs) and propensity-score-matched (PSM) studies evaluating the association of TRA versus TFA access with AKI in patients undergoing primary PCI for STEMI. …”
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Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOke Subjects with mOtor deficits (MAESTOSO) study protocol by Narayanaswamy Venketasubramanian, Deidre Anne De Silva, Christopher P L H Chen, Cyrus G Escabillas, John Harold Hiyadan, Johnny K Lokin, Romulo U Esagunde, Joel M Advincula, Christian Oliver C Co, Maria Epifania V Collantes, Annabelle Y Lao, Yeow-Hoay Koh, Carol Huilian Tham

“…The results of this study will provide objective level B evidence on the efficacy of MLC1501 on long-term recovery and safety of 24 weeks of treatment among patients with IS.Trial registration number NCT05289947.…”
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Protocol of the TransformUs SecondaryTeachers’ perceptions of the program reach, effectiveness,adoption, implementation and maintenance schools program: a type II hybrid implementation-effectiveness trial to increase adolescents’ physical activity and reduce sedentary time in secondary schools by Harriet Koorts, Anna Timperio, Jo Salmon, David Revalds Lubans, Gavin Abbott, Nicola D Ridgers, Natalie Lander, Ana María Contardo Ayala, Emiliano Mazzoli

“…Results from this study will be disseminated through peer-reviewed journal articles, scientific conferences, summary reports to students and schools and stakeholder meetings.Trial registration number Australian Clinical Trials Registration Registry (ACTRN12622000600741).…”
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Phase II trial of nab-paclitaxel plus ramucirumab in combination with nivolumab for unresectable advanced or recurrent gastric cancer after progression on first-line treatment including fluoropyrimidine, platinum, and anti-PD-1/PD-L1 antibody (PADDLE) by Hidekazu Hirano, Naoki Takahashi, Yusuke Amanuma, Nobumi Suzuki, Daisuke Takahari, Takeshi Kawakami, Chie Kudo-Saito, Kengo Nagashima, Narikazu Boku, Ken Kato, Hirokazu Shoji

“…Trial registration jRCT2031220448…”
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