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 concept of KOPAL could serve as a blueprint for other regions and meet the challenges of geographical equity in end-of-life care.Trial registration number DRKS00017795; German Clinical Trials Register.…”
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A phase III, randomized, controlled noninferiority trial to study the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) vs piperacillin/tazobactam (PIP/TAZ) in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) by Junjie Li, Feng Wei, Peng Xiang, Zhengang Tang, Lianshu Ding, Luke Francis Chen, Maria Losada, Zlatka Iamboliyska, Fang Sun, Mingfen Zhu, Xiaodan Guo, Xiaoling Du, Chang Chen, Christopher Bruno, Sandra Koseoglu, Katherine Young, Min Zhou, Jieming Qu

“…Methods: In this phase III, double-blind, multinational, randomized trial (NCT03583333), adults with HABP/VABP were randomized 1:1 to receive intravenous IMI/REL (500 mg/250 mg) or piperacillin/tazobactam (PIP/TAZ; 4000 mg/500 mg) every 6 h for 7-14 days. …”
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Efficacy and safety of glycyrrhizic acid and essential phospholipids (Phosphogliv) combination for alcoholic liver disease: results of the double-blind randomized placebo-controlled multicenter post-registration (phase IV) clinical trial «Jaguar» (PHG-M2/P03-12) by I. G. Bakulin, N. A. Bokhan, P. O. Bogomolov, N. I. Geyvandova, M. V. Matsiyevich, M. A. Vinnikova, V. G. Morozov, O. M. Khromtsova, G. S. Soldatova, O. Yu. Shiryayev, R. D. Ilyuk, K. V. Rybakova, A. G. Katkovskaya, S. V. Teplykh, A. A. Bagretsova, M. V. Krasnova, Ye. V. Alekseyeva, A. V. Anipchenko, Ye. V. Baskakov

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Treating common mental disorder including psychotic experiences in the primary care improving access to psychological therapies programme (the TYPPEX study): protocol for a stepped wedge cluster randomised controlled trial with nested economic and process evaluation of a training package for therapists by David Fowler, Jesus Perez, Peter B Jones, Debra Russo, Clare Knight, Mary Dixon-Woods, Allan B Clark, Margaret Heslin, Sarah Byford, Paul French, Thomas Kabir, Jan Stochl, Mona Kanaan, James Clarke, Nick Grey, Ann Marie Swart, Polly-Anna Ashford, Ushma Patel, Freya Stuart, Hannah Murray, J Hodgekins, Nesta Reeve, Nicola Marshall, Michelle Painter, Maria Leathersich, Martin Pond

“…Results will be made available to patients and the public, the funders, stakeholders in the IAPT services and other researchers.Trial registration number ISRCTN93895792.…”
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Study protocol for virtual leisure investigating the effect of virtual reality-delivered stress reduction, entertainment and distraction on the use of coercion and need-based medication and patient satisfaction at a closed psychiatric intensive care unit - a mixed-methods pilot clinical trial by Julie Midtgaard, Lars Clemmensen, Louise Birkedal Glenthøj, Gry Jørgensen, Kristina Ballestad Gundersen, Lisa Charlotte Smith, Stephane Bouchard, Christina Plambøck Thomsen, Louise Turgut

“…Results from this study will be disseminated via peer-reviewed journals and congress/consortium presentations.Trial registration number NCT05654740.…”
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Holistic health and social care outreach for people experiencing homelessness with recent non-fatal overdose in Glasgow, Scotland: the Pharmacist and third sector Homeless charity worker Outreach Engagement Non-medical Independent prescriber Rx (PHOENIx) pilot randomised controlled trial by Vibhu Paudyal, Nicola Greenlaw, Frances S Mair, Kate Stock, Andrew McPherson, Andrea E Williamson, Richard Lowrie, Donogh Maguire, Steven Ross, James Roy Robertson, Alison Boyle, Clare Duncan, Rebecca Blair, Cian Lombard, Fiona Hughes, Jane Moir, Ailsa Scott, Frank Reilly, Laura Sills, Jennifer Hislop, Stephen Wishart, David Brannan, Rebekah Ramage

“…QoL and treatment uptake appeared to be higher in PHOENIx versus UC at 6 and 9 months.Conclusions A definitive RCT is merited, to assess the impact of PHOENIx on people with multiple, severe disadvantages.Trial registration number ISRCTN10585019.…”
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Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research by Morgan Brown, Miriam R Elman, Jodi Lapidus, April M Young, Kathryn E Lancaster, Sarann Bielavitz, Ryan R Cook, Gillian Leichtling, Edward Freeman, Angela T Estadt, Rhonda Alexander, Caiti Barrie, Kandi Conn, Rhody Elzaghal, Lisa Maybrier, Renee McDowell, Cathy Neal, Elizabeth N Waddell, P Todd Korthuis

“…Numerous barriers impede rural PWUD trial engagement and advancing research methods to better retain rural PWUD in clinical trials is needed. …”
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AVRUPA İNSAN HAKLARI SÖZLEŞMESİ ÇERÇEVESİNDE TERCÜMAN YARDIMINDAN YARARLANMA HAKKI by Uğur Kaynakçıoğlu

Subjects: “…right to fair trial…”
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Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China by Li Zhang, Jiong Wu, Guangyu Liu, Shuang Hao, Jianjing Hou, Changming Zhou, Yifeng Hou, Keda Yu, Zhen Hu, Genhong Di, Zhi Min Shao, Xiaoli Yu

“…Further evaluation in a randomised trial comparing preoperative radiotherapy versus conventional PMRT in breast reconstruction is required to assess both oncological and patient-reported outcomes (PROs).Methods and analysis The CAPPELLA trial is a prospective, multicentre, open-label, randomised controlled trial across nine centres comparing PROs and safety outcomes between preoperative and postoperative radiotherapy in patients with locally advanced breast cancer requiring immediate DIEP flap reconstruction. …”
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Comment on “Graft Inflow Modulation by Splenic Artery Ligation for Portal Hyper Perfusion Does Not Decrease Rates of Early Allograft Dysfunction in Adult Live Donor Liver Transplantation: A Randomized Control Trial”: Can We Really Write Off Graft Inflow Modulation by Niteen Kumar, MBBS, MS, MCh, Abhideep Chaudhary, MBBS, MS, FACS, FAIS, FRCS (Glasgow)

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Qualitative methods: the missing link in orthopaedic research by Samantha Jones, Sarah Tyson

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Peculiarities of criminal proceedings materials preservation in conditions of martial law by T. H. Fomina

Subjects: “…information and telecommunication system of pre-trial investigation.…”
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Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial by Ying Cheng, Panpan Zhang, Ming Lu, Zhendong Chen, Lijie Song, Si Shi, Feng Ye, Xing Zhang, Baorui Liu, Dongmei Ji, Yanqiao Zhang, Weiguo Su, Michael Shi, Songhua Fan, Panfeng Tan, Chen Zhong

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Protocol for a phase IV double-blind randomised controlled trial to investigate the effect of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine on pneumococcal colonisation using the experimental human pneumococcal challenge model in healthy adults (PREVENTING PNEUMO 2) by Tao Chen, Duolao Wang, Konstantinos Liatsikos, Stephen B Gordon, Hassan Burhan, Ben Morton, Tinashe K Nyazika, Bradford D Gessner, Helen Hill, Andrea Collins, Josh Hamilton, Kelly Davies, Fred Fyles, Phoebe Hazenberg, Elizabeth Begier, Angela Hyder-Wright, Sherin Pojar, Christopher Myerscough, Jesus Reine, Ryan E Robinson, Britta Urban, Elena Mitsi, Carla Solorzano, Angela Quinn, Kaijie Pan, Annaliesa S Anderson, Christian Theilacker, Daniela M Ferreira, Kelly Convey, James Court, Madlen Farrar, Lisa Hitchins, Ashleigh Howard, Lauren Kerruish, Samuel Latham, Annabel Murphy, Elissavet Nikolaou, Angelina Peterson

“…Findings will be published in peer-reviewed journals.Trial registration number ISRCTN15728847, NCT04974294.…”
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Investigation of the effects of combined exercises and self-management education, with and without functional exercises, on pain and functional outcomes in patients with avascular necrosis of the femoral head: a protocol for a single-blind, randomised controlled trial with a parallel design and a 4 month follow-up by Zohreh Gholami, Seyedeh Tahereh Faezi, Elham Madreseh, Raghad Mimar

“…Data will be collected at baseline (preintervention), postintervention at 12 weeks and at a 4 month follow-up. Trial registration number: IRCT20220510054814N2.…”
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Safety and tumour-specific immunological responses of combined dendritic cell vaccination and anti-CD40 agonistic antibody treatment for patients with metastatic pancreatic cancer: protocol for a phase I, open-label, single-arm, dose-escalation study (REACtiVe-2 trial) by Joachim G J V Aerts, Sjoerd H van der Burg, Martijn P Lolkema, Sai Ping Lau, Freek R van ’t Land, Marjolein Y V Homs, Casper H J van Eijck

“…The results of the trial will be submitted for publication in a peer-reviewed scientific journal.Trial registration number NL9723.…”
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Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context by Raymond J. Chan, Fiona Crawford-Williams, Chad Yixian Han, Lee Jones, Alexandre Chan, Daniel McKavanagh, Marissa Ryan, Christine Carrington, Rebecca L. Packer, Megan Crichton, Nicolas H. Hart, Emma McKinnell, Melissa Gosper, Juanita Ryan, Bethany Crowe, Ria Joseph, Carolyn Ee, Jane Lee, Steven M. McPhail, Katharine Cuff, Laisa Teleni, Jon Emery

“…GPs can meet the survivorship care needs identified breast cancer survivors. This trial can inform a large, pragmatic, hybrid effectiveness-implementation trial. …”
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Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2): study protocol for a phase 2, prospective, multicentre, open-label, multiarm, biomarker-directed, signal-seeking, umbrella, clinical trial for recurrent IDH mutant, grade 2/3 glioma by Marshall Pitz, Eng-Siew Koh, Elizabeth H Barnes, Lucille Sebastian, Mandy L Ballinger, David M Thomas, Christopher O'Callaghan, John Simes, Hui K Gan, Sonia Yip, Hao-Wen Sim, Desma Spyridopoulos, Richard De Abreu Lourenco, Cynthia Hawkins, Kristen McParland, Benjamin Kong, Subotheni Thavaneswaran, Patrick J Wheeler

“…A report describing the results of the study will be submitted to international meetings and peer-reviewed journals.Trial registration number ACTRN12623000096651.…”
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Panitumumab plus 5-fluorouracil and folinic acid or 5-fluorouracil and folinic acid alone as maintenance therapy in RAS wild-type metastatic colorectal cancer (PanaMa, AIO KRK 0212): final efficacy analysis of a randomised, open-label, phase 2 trialResearch in context by Arndt Stahler, Meinolf Karthaus, Stefan Fruehauf, Ullrich Graeven, Lothar Müller, Ludwig Fischer von Weikersthal, Karel Caca, Eray Goekkurt, Alexej Ballhausen, Greta Sommerhäuser, Annabel H.S. Alig, Swantje Held, Armin Jarosch, David Horst, Anke Reinacher-Schick, Stefan Kasper, Volker Heinemann, Sebastian Stintzing, Tanja Trarbach, Dominik P. Modest

“…Secondary endpoints included PFS of re-induction (PFS re-ind.), time to failure of strategy (TFS) and overall survival (OS). The trial is registered with ClinicalTrials.gov (NCT01991873). …”
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