Comparison between 18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy and systematic biopsy for tumor detection and grading in selected patients: A prospective randomized controlled trial by Shaoxi Niu, Yachao Liu, Liyan Ao, Xiaohui Ding, Xiao Chang, Jinhang Li, Jiajin Liu, Kan Liu, Nanxing Zou, Baixuan Xu, Yong Xu, Baojun Wang, Xu Zhang

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Effect of zinc added to a daily small-quantity lipid-based nutrient supplement on diarrhoea, malaria, fever and respiratory infections in young children in rural Burkina Faso: a cluster-randomised trial by Elizabeth Yakes Jimenez, Sonja Y Hess, Souheila Abbeddou, Kenneth H Brown, Jean-Bosco Ouedraogo, Jérôme W Somé, Zinéwendé P Ouédraogo, Rosemonde M Guissou, Stephen A Vosti

“…The longitudinal prevalence of acute lower RTI (0.1%; 95% IC 0.1–0.2%) and of upper RTI (7.8%; 95% IC 7.1–8.4%) did not differ among groups (p=0.234 and p=0.501, respectively).Conclusions Inclusion of 5 or 10 mg zinc in SQ-LNS and provision of 5 mg zinc dispersible tablet along with SQ-LNS had no impact on the incidence of diarrhoea, malaria and fever or the longitudinal prevalence of RTI compared with SQ-LNS without zinc in this population.Trial registration number NCT00944281.…”
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Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol by David Williamson, Francis Bernard, Stefanie Blain-Moraes, Caroline Arbour, Virginie Williams, Louis de Beaumont, Catherine Duclos, Béatrice P De Koninck, Daphnee Brazeau, Amelie A Deshaies, Marie-Michele Briand, Charlotte Maschke

“…The findings of this two-phase study will be submitted for publication in a peer-reviewed academic journal and submitted for presentation at conferences. The trial’s results will be published on a public trial registry database (ClinicalTrials.gov).Trial registration number NCT05833568.…”
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Hypofractionated radiotherapy combined with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor, and thymosin-α1 in advanced metastatic solid tumors: a multicenter Phase II clinical trial by Jiamin Yu, Li Yin, Wenjie Guo, Qiang Wang, Juying Liu, Lansheng Zhang, Hongxun Ye, Jianhong Xia, Youyou Xia, Jianfeng Wu, Wanwei Wang, Yanguang Yang, Dan Zong, Xia He, Lijun Wang, Hong Jiang

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Correction: Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. by Laurie Zawertailo, Helena Zhang, Noreen Rahmani, Tarek K Rajji, Peter Selby

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Is It Possible to Achieve Favorable Accelerated Dental Changes with No Periodontal Complications When Retracting Upper Anterior Teeth Assisted by Flapless Corticotomy Compared to Traditional Corticotomy? A Two-Arm Randomized Controlled Trial by Hanin Nizar Khlef, Mohammad Younis Hajeer

“…The objective of this trial was to evaluate the dental changes, periodontal health, and tooth vitality in mini-screw-supported en-masse retraction with two corticotomy-based acceleration techniques. …”
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A Comparative Study between Conventional Diaphragmatic Breathing Exercise and Virtual Reality-based Diaphragmatic Breathing Exercise on Quality of Life in Chronic Obstructive Pulmonary Disease Patients: A Randomized Control Trial by Sridhar Shirodkar, Medha Deo

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Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study by Jens Kastrup, Morten Schou, Ida Gustafsson, Olav W. Nielsen, Rasmus Møgelvang, Klaus F. Kofoed, Charlotte Kragelund, Jens Dahlgaard Hove, Andreas Fabricius-Bjerre, Merete Heitman, Mandana Haack-Sørensen, Lisbeth Drozd Lund, Ellen Mønsted Johansen, Abbas Ali Qayyum, Anders Bruun Mathiasen, Annette Ekblond

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Fluoxetine for reducing postoperative cognitive dysfunction in elderly patients after total knee replacement: study protocol for a single-centre, double-blind, randomised, parallel-group, superiority, placebo-controlled trial by Yusheng Yao, Hong Ye, Yushan Wu, Daoyi Lin, Lulu Yu, Jiaxin Chen

“…Data on all the results, risk factors and adverse events will also be collected and analysed.Ethics and dissemination The Fujian Provincial Hospital Ethics Board has approved the protocol for this trial (identifier number: K2021-01-009). All participants will be required to provide written informed consent before any protocol-specific procedures.Trial registration number ChiCTR2100050424.…”
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Correction for ‘Protocol for a multisite randomised controlled trial assessing the effect of the Telehealth for early developmental Intervention in babies born very preterm (TEDI-Prem) programme on neurodevelopmental outcomes and parent well-being’

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Anti-LAG-3 antibody LBL-007 plus anti-PD-1 antibody toripalimab in advanced nasopharyngeal carcinoma and other solid tumors: an open-label, multicenter, phase Ib/II trial by Gang Chen, Dong-Chen Sun, Yi Ba, Ya-Xiong Zhang, Ting Zhou, Yuan-Yuan Zhao, Hong-Yun Zhao, Wen-Feng Fang, Yan Huang, Zhen Wang, Chao Deng, De-Sheng Hu, Wei Wang, Jin-Guan Lin, Gui-Ling Li, Su-Xia Luo, Zhi-Chao Fu, Hai-Sheng Zhu, Hui-Li Wang, Sheng-Li Cai, Xiao-Qiang Kang, Li Zhang, Yun-Peng Yang

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Efficacy and Safety of Ergoferon in Children from 6 Months to 6 Years Old with Acute Respiratory Viral Infections in Contemporary Outpatient Practice: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial by N. A. Geppe, B. M. Blokhin, O. V. Shamsheva, S. T. Abdrakhmanova, K. A. Alikhanova, G. T. Myrzabekova

“…To evaluate the efficacy and safety of Ergoferon in combination with symptomatic therapy in children from 6 months to 6 years old with acute respiratory infections (ARI) in contemporary outpatient practice, an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial was performed. Derived by technological treatment of antibodies to interferon gamma, histamine, and CD4, Ergoferon was previously proved to modulate its molecular targets promoting effective antiviral protection. …”
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Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development. by Barbara A Friedland, Holly Gundacker, Sharon L Achilles, Beatrice A Chen, Craig Hoesley, Barbra A Richardson, Clifton W Kelly, Jeanna Piper, Sherri Johnson, Brid Devlin, John Steytler, Kyle Kleinbeck, Bindi Dangi, Chantél Friend, Mei Song, Barbara Mensch, Ariane van der Straten, Cindy Jacobson, Craig W Hendrix, Jill Brown, Diana Blithe, Sharon L Hiller, MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network

“…Addressing issues related to vaginal bleeding and expulsions early in product development will likely enhance acceptability of the DPV-LNG ring. Trial registration: Clinical Trial Registration: MTN-030/IPM 041: ClinicalTrials.gov NCT02855346; MTN-044/IPM 053/CCN019: ClinicalTrials.gov NCT03467347.…”
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Efficacy of Single-Pill Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg in Patients with Cardiovascular Disease Risk Factors: A Prospective Subgroup Analysis of a Randomized, Double-Blind, and Controlled Trial by Harold Bays, Pingjin Gao, Birgit Völker, Michaela Mattheus, Luis M. Ruilope, Dingliang Zhu

“…Report of prespecified and post hoc subgroup analyses of a randomized, controlled trial comparing telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) combination therapy with T80 monotherapy, according to the presence of cardiovascular disease (CVD) risk factors. …”
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Relative perioperative analgesic efficacy of single-shot serratus anterior plane block versus thoracic paravertebral block in breast and thoracic surgeries – A systematic review and meta-analysis of randomised controlled trials by Jeetinder K. Makkar, Narinder P. Singh, Bisman Jeet Kaur Khurana, Preet M. Singh

“…Methods: A systematic search for randomised controlled trials (RCTs) was conducted in PubMed, EMBASE and Scopus databases, covering studies from their inception to September 2023. …”
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Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations] by Pauline Frizelle, Darren Dahly, Aoife O'Shea, Aileen Murphy, Cristina McKean

“…Method The Happy Talk trial is a large scale cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, in Ireland. …”
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The Antimicrobial Effect of Pomegranate Peel Extract versus Chlorhexidine in High Caries Risk Individuals Using Quantitative Real-Time Polymerase Chain Reaction: A Randomized Triple-Blind Controlled Clinical Trial by Benoy Jacob, Nivedhitha Malli Sureshbabu, Manish Ranjan, Aishwarya Ranganath, Riluwan Siddique

“…This triple-blind randomized clinical trial involved 60 high caries risk adult patients, 19–59 years of age, randomly allocated into two groups of 30 subjects each. …”
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Effectiveness of a Web-Based Self-Guided Intervention (MINDxYOU) for Reducing Stress and Promoting Mental Health Among Health Professionals: Results From a Stepped-Wedge Cluster Randomized Trial by Yolanda López-del-Hoyo, Selene Fernández-Martínez, Adrian Perez-Aranda, Alicia Monreal-Bartolomé, Alberto Barceló-Soler, Loreto Camarero-Grados, Carilene Armas-Landaeta, José Guzmán-Parra, Vera Carbonell, Daniel Campos, Xinyuan Chen, Javier García-Campayo

“…Finding ways to promote adherence to the intervention would contribute to increasing the effectiveness of this program. Trial RegistrationClinicalTrials.gov NCT05436717; https://clinicaltrials.gov/study/NCT05436717 International Registered Report Identifier (IRRID)RR2-10.1186/s12912-022-01089-5…”
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Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China by Yang Zhang, Shiyuan Wang, Guifan Li, Jinhui Shi, Xianyun Chang, Hao Zhang, Fengcai Zhu, Jingxin Li, Hongxing Pan, Jinfang Sun

“…Vaccination with the varicella vaccine (VarV) effectively prevents chickenpox.Research design and methods In this phase III, single-center, randomized, double-blind, active-controlled trial, 1,200 healthy participants randomly assigned in a 1:1 ratio to receive two doses of either the test vaccine or the active control vaccine. …”
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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, double-blind, parallel-group clinical trial by Thibault Mura, Jean-Yves Lefrant, Remy Widehem, Camille Nicolet, Violaine Delannoy, Laurie Barthelemi, Ian Soulairol, Claire Roger

“…Secondary outcomes will include drug tolerance, mechanical ventilation duration, ICU and hospital length of stay, 28-day and 90-day mortalities and 90-day opioid consumption.Ethics and dissemination The study protocol was accepted by the Nîmes University Hospital’s research committee, the French ethics committee (Institutional Review Board OUEST IV) and the French National Agency for the Safety of Medicines and Health Products (ANSM).Trial registration number ClinicalTrials.gov: NCT05825560…”
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