Efficacy of systemic lidocaine in postoperative delirium in elderly patients undergoing laparoscopic colorectal surgery: study protocol for a multicentre, prospective, double-blind... by Yusheng Yao, Xincheng Liao, Bingbing Fu, Jia Yun, Huifen Lin, Bin Qian

“…This study will be presented at scientific conferences and submitted to international journals.Trial registration number ChiCTR2100050314.…”
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Effect of a multimodal analgesia strategy on remifentanil daily consumption in mechanically ventilated adult ICU patients: study protocol for a randomised, placebo-controlled, doub... by Thibault Mura, Jean-Yves Lefrant, Remy Widehem, Camille Nicolet, Violaine Delannoy, Laurie Barthelemi, Ian Soulairol, Claire Roger

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An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol f... by Ana Paula Taboada Sobral, Elaine Marcilio Santos, Marcela Leticia Leal Gonçalves, Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Sandra Kalil Bussadori, Elza Padilha Ferri, Juliana Maria Altavista Sagretti Gallo, Thais Gimenez, José Carlos Pettorossi Imparato

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Study protocol for a 1-year, randomized, single-blind, parallel group trial of stand-alone indoor air filtration in the homes of US military Veterans with moderate to severe COPD i... by Brent Stephens, Insung Kang, Kaveeta Jagota, Zane Elfessi, Nancy Karpen, Saeed Farhoodi, Mohammad Heidarinejad, Israel Rubinstein

“…This trial also offers the potential for providing novel data on associations between housing conditions and COPD outcomes and providing novel insight into air cleaner operation in this vulnerable population. Trial registration ClinicalTrials.gov: NCT05913765. Registered on June 22, 2023.…”
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Study protocol of a German multi-center, observer-blind, randomized, and actively controlled parallel-group trial comparing maintenance electroconvulsive therapy to treatment as us... by Anton Deicher, Sebastian Karl, Marie-Luise Otte, Johannes Knabbe, Bernadette Wendel, Maria Gose, R. Christian Wolf, Alexander Sartorius

“…Methods Here, we present the protocol of the MECT-RESIST trial, a German multi-center, observer-blind, randomized, and actively controlled parallel-group clinical trial. The scientific aim of the study is to test the hypothesis that mECT plus treatment as usual (TAU) (intervention group) is superior to TAU alone (control group) for relapse prevention in CRS. …”
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Rationale and design for the thoracic Paravertebral Adjunctive Dexamethasone Palmitate Reducing chronic pain After cardiac surgery (PANDORA) trial: a parallel-group, double-blinded... by Jing Zhao, Hui Zhang, Ziyu Zheng, Baobao Gao, Lini Wang, Chong Lei, Hailong Dong, Taoyuan Zhang, Jiao Gao, Lihong Hou

“…Results will be submitted for publication in peer-reviewed journals and presented at academic meetings.Trial registration number ClinicalTrials.gov, NCT05920967.…”
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Investigation of the combined effects of cannabidiol plus naltrexone on alcohol craving in alcohol dependence: study protocol of a phase II randomised, double-blind, placebo-contro... by Falk Kiefer, Christina Klose, Bettina C Thomas, Sabine Vollstaedt-Klein, Marietta Kirchner, Anne Koopmann, Bernd Lenz, Patrick Bach, Sina Vetter, Julia Weinberg, Paul Thalmann, Marlen Pfisterer, Torsten Kölsch, Selma Oesterle, Tobias Link

“…Preclinical studies suggest that CBD may enhance NTX’s therapeutic effects.Methods and analysis This is a three-armed, randomised, double-blind, placebo-controlled parallel group, multicentre phase II clinical trial. …”
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AVATAR Virtual Reality Social therapy (AVATAR_VRSocial) for distressing voices and their interference in social everyday life in early psychosis: protocol of a single-blind paralle... by Tom K J Craig, Silvia Schneider, Philippa Garety, Thomas Ward, Mar Rus-Calafell, Melina Luker, Maren Marzinzik, Phuong-Mi Nguyen, Tobias Teismann, Nils Ehrbar, Ekincan Tas, Xiao Chi Zhang, Clementine Edwards, Mark Huckvale

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Preclinical study and parallel phase II trial evaluating antisense STAT3 oligonucleotide and checkpoint blockade for advanced pancreatic, non-small cell lung cancer and mismatch re... by Heather Lin, Vivek Subbiah, Siqing Fu, Aung Naing, Courtney Nicholas, Shubham Pant, Chad Tang, Michael A Curran, David S Hong, Ying Yuan, Sarina A Piha-Paul, Jordi Rodon Ahnert, Timonthy A Yap, Apostolia M Tsimberidou, Daniel D Karp, Anupallavi Srinivasamani, Coline Couillault, Genevieve P Hartley, James Dai, Ecaterina E Ileana Dumbrava, Paola Guerrero, Sarah Dhebat, Theresa Proia

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Tislelizumab plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy for elderly patients with inoperable locally advanced esophageal squamous cell carcinoma: a multi... by Ke Zhang, Qifeng Wang, Jianzhong Cao, Chengcheng Fan, Wenbin Shen, Qin Xiao, Xiaolin Ge, Tian Zhang, Xiao Liu, Xi Chen, Jie Dong, Zewei Li, Zhunhao Zheng, Cihui Yan, Ping Wang, Qingsong Pang, Wencheng Zhang

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Effect of a moderately carbohydrate-restricted diet on liver enzymes, steatosis and fibrosis in normal-weight individuals with non-alcoholic fatty liver disease: study protocol for... by Ahmad Esmaillzadeh, Amir Ali Sohrabpour, Seyed Moayed Alavian, Fatemeh Dashti, Sara Ebrahimi Mousavi, Seyed-Ali Keshavarz

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Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric... by Elsa Tavernier, Elise Launay, Christèle Gras Le Guen, Gaelle Hubert, Cécile Feildel Fournial, Anne Chauvire-Drouard, Fleur Lorton

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Effects of liposomal bupivacaine in preoperative fascia iliac block on postoperative pain and delirium in elderly patients undergoing hip fracture surgery: a study protocol for a r... by Xiang Li, Jinbao Li, Hongjiao Xu, Weiwen Li, Zhuang Yu, Yingxiang Hao, Minjia Zheng, Xinwan Wu, Shen Liu

“…However, whether regional nerve block analgesia can decrease the occurrence of POD in elderly patients undergoing hip fracture surgery has not been reported.Methods and analysis This is a single-blinded, randomised, parallel-controlled prospective clinical study. Participants will be randomly assigned preoperatively to either the liposomal bupivacaine (ie, Exparel) or ropivacaine groups by block randomisation. …”
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Efficacy of brain-computer interface training with motor imagery-contingent feedback in improving upper limb function and neuroplasticity among persons with chronic stroke: a doubl... by Myeong Sun Kim, Hyunju Park, Ilho Kwon, Kwang-Ok An, Hayeon Kim, Gyulee Park, Wooseok Hyung, Chang-Hwan Im, Joon-Ho Shin

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EFfects of Y-6 SUblingual Tablets for PaTients with AcUte Ischemic StRokE (FUTURE): a phase II, randomised, double-blind, double-dummy, placebo-controlled, parallel trial by Liping Liu, Yongjun Wang, Yilong Wang, Zhongrong Miao, Lei Wang, Zixiao Li, Xingquan Zhao, Xiaochuan Huo, Xiaoling Liao, Yuesong Pan, Ling Guan, Shuya Li, Hui Qu, Yicong Wang, Baoshan Qiu

“…The primary outcome is the percentage of patients achieving the modified Rankin Scale score of 0–1 at 90 days.Discussion The EFfects of Y-6 SUblingual Tablets for PaTients with AcUte Ischemic StRokE trial assesses whether Y-6 sublingual tablets are effective and safe in improving the clinical outcomes of patients with acute ischaemic stroke caused by large vessel occlusion.Trial registration number NCT06138834.…”
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Effects of switching from dipeptidyl peptidase 4 inhibitors to oral semaglutide on oxidative stress and glycemic variability in patients with type 2 diabetes: an open-label, prospe... by Makoto Ohara, Hiroki Yokoyama, Hiroaki Seino, Tomoki Fujikawa, Yo Kohata, Noriyuki Takahashi, Shunichiro Irie, Michishige Terasaki, Yusaku Mori, Tomoyasu Fukui, Sho-ichi Yamagishi

“…Methods This was an open-label, prospective, randomized, multicenter, parallel-group comparison study conducted over 24 weeks. …”
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Effectiveness of the GRACE risk score according to troponin elevation in patients admitted with non-ST elevation acute coronary syndrome: a post hoc analysis of the UKGRIS parallel... by Chris P Gale, Derek P Chew, Andrew T Yan, David B Brieger, Ramesh Nadarajah, Catherine Reynolds, Catherine Fernandez, Linda Sharples, Kathryn Carruthers, Keith A A Fox, Rachael Gilberts, Shaun Goodman, Deborah Stocken, Suleman Aktaa

“…However, this did not translate into a reduction in the composite primary or secondary outcomes at 24 months.Trial registration number ISRCTN29731761.…”
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Treating nightmares in post-traumatic stress disorder with the α-adrenergic agents clonidine and doxazosin: protocol for a phase II randomised, double-blind, placebo-controlled par... by Christian Schmahl, Jürgen Gallinat, Andreas J Fallgatter, Christian Otte, Stefan Roepke, Robert Roehle, Nikola Schoofs, Kathlen Priebe, Felix Wuelfing, Tolou Maslahati, Katharina Stieglbauer, Sarah Biedermann, Ingo Schaefer, Thomas Ethofer, Bernd Hanewald, Christoph Mulert, Stefanie Koglin

“…The study results will be published in peer-reviewed journals and presented at both national and international conferences.Trial registration number NCT05360953, EudraCT 2021-000319-21.…”
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Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Suppor... by Annie S Anderson, Frank Kee, Stephan U Dombrowski, Jayne V Woodside, Pat Hoddinott, Emma McIntosh, Caroline Free, Clíona McDowell, Michelle C McKinley, Christopher R Cardwell, Elinor Coulman, Eleni Spyreli, Suzie Heaney, Sally Bridges, Dunla Gallagher

“…Results will be published via a range of outputs and audiences.Trial registration number ISRCTN16299220.…”
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School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group clus... by Jessica Deighton, Emily Stapley, Neil Humphrey, João Santos, Praveetha Patalay, Jan Rasmus Boehnke, Anna Moore, Paul Stallard, Daniel Hayes, Rosie Mansfield, Emma Ashworth, Eva Bonin, Sara Evans-Lacko, Bettina Moltrecht, Abigail Thompson, Kirsty Nisbet, Emma Thornton, Aurelie Lange

“…This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.Method A three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. …”
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