A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors by Mingchuan Zhao, Xichun Hu, Pengpeng Zhuang, Aiping Zeng, Yan Yu, Zhendong Chen, Hongmei Sun, Weihua Yang, Lili Sheng, Peijian Peng, Jingfen Wang, Tienan Yi, Minghong Bi, Huaqiu Shi, Mingli Ni, Xiumei Dai, Changlu Hu, Hongjie Xu, Dongqing Lv, Qingshan Li, Kaijian Lei, Xia Yuan, Ou Jiang, Xicheng Wang, Baihui Hu, Zhe Hou, Zhaoping Su, Song Zheng, Ming Zhou, Changlin Dou

“…Introduction: Denosumab (Xgeva®) is a standard treatment for the prevention of skeletal-related events (SREs) in patients with bone metastases (BM). This trial was designed to assess the equivalence of LY01011 to denosumab in terms of efficacy and safety. …”
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Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]) by A. DeMichele, A. C. Dueck, D. Hlauschek, M. Martin, H. Burstein, G. Pfeiler, N. Zdenkowski, A. Wolff, M. Bellet-Ezquerra, E. Winer, M. Balic, K. Miller, M. Colleoni, D. Lake, G. Rubovsky, D. Cameron, J. Balko, C. F. Singer, Z. Nowecki, H. Iwata, N. Wolmark, K. A. Parraga, H. Rugo, G. G. Steger, T. Traina, G. Werutsky, D. Czajkowska, O. Metzger, S. El-Abed, K. P. Theall, R. D. Lu, P. O’Brien, C. Fesl, E. Mayer, M. Gnant

“…Abstract Background The PALLAS trial investigated the addition of palbociclib to standard adjuvant endocrine therapy to reduce breast cancer recurrence. …”
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Comparative evaluation of conventional and socket-shield techniques on maxillary esthetics following immediate implant placement in fresh extraction sockets: A randomized controlled trial by Farhan Durrani, Aishwarya Pandey, Shweta Ahlawat, Ekta Kumari, S. U. Gokila Vani, Sakshi Agarwal, P. G. Naveen Kumar

“…Materials and Methods: Twenty-four patients with type 1 extraction sockets were included in this randomized trial and assigned to either conventional immediate implant placement or the socket-shield technique. …”
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Comparison of local minocycline hydrochloride delivery and antimicrobial photodynamic therapy as adjuncts to mechanical debridement for the treatment of peri‑implant mucositis: A randomized controlled trial by Abdulrahman M. AlMubarak

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A randomised, double-masked, placebo-controlled trial evaluating the efficacy and safety of teprotumumab for active thyroid eye disease in Japanese patientsResearch in context by Yuji Hiromatsu, Eri Ishikawa, Ai Kozaki, Yasuhiro Takahashi, Mika Tanabe, Ken Hayashi, Yukihiro Imagawa, Kazutoyo Kaneda, Masashi Mimura, Xiaoxian Dai, Tomoko Hayashida, Takashi Akamizu

“…Adverse events were assessed in all patients. This trial was registered at Japan Registry for Clinical Trials (jRCT2031210453). …”
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Effects of Cinnamomum zeylanicum (Ceylon cinnamon) extract on lipid profile, glucose levels and its safety in adults: A randomized, double-blind, controlled trial. by Dimuthu Muthukuda, Chamini Kanatiwela de Silva, Saumiyah Ajanthan, Namal Wijesinghe, Anuradha Dahanayaka, Arunasalam Pathmeswaran

“…However, there are no well-conducted randomized controlled trials that can accurately measure the lipid and glucose-lowering effects of Cinnamomum zeylanicum (C. zeylanicum) extract. …”
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Comparing the safety and efficacy of remimazolam-based total intravenous anesthesia versus volatile agent-based anesthesia: a meta-analysis of randomized controlled trials by Ji-In Park, Hyo-Seok Na, Keum-O Lee, Jung-Hee Ryu, Hyun-Jung Shin

“…Results A total of 969 patients from 12 randomized controlled trials were included. The incidence of hypotension was 14% and 34% in the remimazolam and volatile agent groups, respectively. …”
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Efficacy of the ECHOMANTRA online intervention to support recovery from anorexia nervosa in adult patients: study protocol of a randomized controlled multi-center trial by Yolanda Quiles, Álvaro Ruiz, Eva León-Zarceño, Javier Manchón, Marie-Carmen Neipp, Sofía Payá-López, Katina Kovacheva, Valentina Cardi

“…Methods In a multi − center pilot randomized controlled trial (RCT), 148 adult AN patients, and their carers, will be randomized to receive treatment as usual (TAU) or TAU plus ECHOMANTRA. …”
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Intravenous nicardipine and labetalol use in hypertensive patients with signs or symptoms suggestive of end-organ damage in the emergency department: a subgroup analysis of the CLUE trial by Brian Hiestand, Phillip Levy, W Frank Peacock, Brigitte M Baumann, Richard M Nowak, Amy Hsu, Joseph Varon, Chad M Cannon, David M Cline, Pierre Borczuk, Abhinav Chandra, Deborah B Diercks, Preeti Jois, Brian Kaminski, Jon W Schrock

“…On multivariable modelling with adjustment for gender and clinical site, nicardipine patients were more likely to be in TR by 30 min than patients receiving labetalol (OR 3.65, 95% CI 1.31 to 10.18, C statistic=0.72).Conclusions In the setting of hypertension with suspected EOD, patients treated with nicardipine are more likely to reach prespecified SBP targets within 30 min than patients receiving labetalol.Clinical Trial Registration NCT00765648, clinicaltrials.gov…”
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Accelerated symptom improvement in Parkinson’s disease via remote internet-based optimization of deep brain stimulation therapy: a randomized controlled multicenter trial by Alireza Gharabaghi, Sergiu Groppa, Marta Navas-Garcia, Alfons Schnitzler, Laura Muñoz-Delgado, Vicky L. Marshall, Jessica Karl, Lin Zhang, Ramiro Alvarez, Mary S. Feldman, Michael J. Soileau, Lan Luo, S. Elizabeth Zauber, Benjamin L. Walter, Chengyuan Wu, Hong Lei, Damian M. Herz, Ming-Hua Chung, Yagna Pathak, Bram Blomme, Binith Cheeran, Corneliu Luca, Daniel Weiss

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Response to Letter to Editor on “Tuina versus physiotherapy or a combination of both for the management of chronic nonspecific low back pain: A randomized controlled trial” by Qinqyu Ma, Jiaxu Chen

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Day before late regimen vs standard split dose of low-volume PEG-CS for early morning colonoscopy: Multicenter randomized controlled trial by Luigi Pasquale, Giuseppe Grande, Rocco Maurizio Zagari, Paolo Biancheri, Antonio Pisani, Paola Da Massa Carrara, Bastianello Germanà, Enrico Ciliberto, Gianpaolo Cengia, Antonietta Lamazza, Patrizia Lorenzini, Mariavittoria V Carati, Liboria Laterza, Flavia Pigò, Desiree Picascia, Carmelo Stillitano, Matteo Pollastro, Elisabetta Dal Pont, Stefania Maraggi, Rita Conigliaro, Giuseppe Galloro

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Effects of Meaningful Action Observation Therapy on Occupational Performance, Upper Limb Function, and Corticospinal Excitability Poststroke: A Double-Blind Randomized Control Trial by Aryan Shamili, Afsoon Hassani Mehraban, Akram Azad, Gholam Reza Raissi, Mohsen Shati

“…Method. A randomized control trial was designed to compare between experimental (n=13) and control groups (n=14). …”
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Adapting MOVED as a web-based moral elevation intervention for veterans with PTSD: Using feedback from a pilot trial and subject matter experts by Adam P. McGuire, Alexander Riera, Xrystyan Lascano

“…Contemporary Clinical Trials Communications…”
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Effectiveness of couple-based violence prevention education in reducing intimate partner violence during pregnancy in rural Ethiopia: A cluster randomized controlled trial. by Zeleke Dutamo Agde, Jeanette H Magnus, Nega Assefa, Muluemebet Abera Wordofa

“…Scale-up and adaptation to similar settings are recommended.<h4>Trial registration</h4>The trial is registered on ClinicalTrials.gov under the identifier NCT05856214 on May 4, 2023.…”
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Longitudinal impact of cross-clamp duration on postoperative sleep disturbance and quality of life in elderly cardiac surgery patients: a secondary analysis of the MINDDS trial by Grace E. Namirembe, Jamie Sparling, Alexis Novak, Ariel Mueller, Julia Bertsch, Kwame Wiredu, Jason Z. Qu, M. Brandon Westover, Timothy T. Houle, Oluwaseun Akeju

“…ObjectivesThis study aimed to assess the enduring impact of cross-clamp duration on postoperative sleep disturbance and functional outcomes (up to 180 days) in cardiac surgery patients.DesignThis is a secondary analysis of data from a randomized, double-blind trial comparing dexmedetomidine to placebo for delirium prevention (Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep).SettingData from patients recruited at a tertiary medical center in Boston, Massachusetts, between March 2017 and February 2022 were analyzed in January 2024.ParticipantsThe study included 394 patients aged ≥60 who underwent cardiac surgery with cardiopulmonary bypass.InterventionsThe primary exposure was cross-clamp time, while secondary exposures included surgical type [isolated coronary artery bypass graft (CABG) or not] and dexmedetomidine randomization.Measurements and main resultsThe primary outcome was sleep quality, assessed using the PROMIS Sleep Disturbance questionnaire at 30, 90, and 180 days postoperatively. …”
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Risk of Candida Infection and Serious Infections in Patients with Moderate-to-Severe Psoriasis Receiving Biologics: A Systematic Review and Meta-Analysis of Randomized Controlled Trials by Yue Feng, Baosen Zhou, Zhen Wang, Guijuan Xu, Lili Wang, Tingting Zhang, Yanping Zhang

“…PubMed, EMBASE, and Cochrane Library were searched for eligible randomized controlled trials (RCTs) from their inception to December 2021. …”
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Improvement of Mouth Functional Disability in Systemic Sclerosis Patients over One Year in a Trial of Fat Transplantation versus Adipose-Derived Stromal Cells by Maria Giuseppina Onesti, Paolo Fioramonti, Sara Carella, Pasquale Fino, Cinzia Marchese, Nicolò Scuderi

“…The present clinical experimentation should be regarded as a starting point for further experimental research and clinical trials.…”
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Associated adverse outcomes with tumor treating fields when combined to temozolomide versus temozolomide alone for the treatment of glioblastoma: a meta-analysis of randomized trials by Yuanyuan Chen, Yan Chen, Hong Zhen, Danhua Lou

“…All the studies were randomized trials. The majority of the participants were males (68.0–75.0%) with a mean age of the varying from 54.0 to 69.0 years. …”
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Development and feasibility of an mHealth intervention for psychoeducational support of Nigerian women diagnosed with breast cancer undergoing chemotherapy: A pilot randomized controlled trial. by Oluwadamilare Akingbade, Ka Yi Hong, Oluwabukola Sharon Ayo, Adetutu Sefinat Alade, Moshood Akinwumi Lawal, Ibironke Elizabeth Somoye, Victoria Adediran, Olamide Sado, Ka Ming Chow

“…These findings suggest that the CENBA programme could be a valuable tool in addressing the psychoeducational needs of this population, warranting further investigation in a full-scale RCT.<h4>Trial registration</h4>This manuscript reports a feasibility study preceding the full trial, which was registered with the United States Clinical Trials registry (number NCT05489354).…”
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