Analysis methods for covariate-constrained cluster randomized trials with time-to-event outcomes by Amy M. Crisp, M. Elizabeth Halloran, Matt D. T. Hitchings, Ira M. Longini, Natalie E. Dean

Subjects: “…Clinical trial design…”
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The Effectiveness of Acupuncture on Myofascial Trigger Points Versus Traditional Chinese Medicine Acupoints for Treating Plantar Fasciitis With Low Back Pain: A Study Protocol for a Randomised Clinical Trial by Huang Z, Liang X, Luo Y, Fang Z, Xu M, Xu Y, Cheng S, Li L

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Double-blind, randomized, placebo-controlled pilot clinical trial with gamma-band transcranial alternating current stimulation for the treatment of schizophrenia refractory auditory hallucinations by Xiaojuan Wang, Xiaochen Zhang, Yuan Chang, Jingmeng Liao, Shuang Liu, Dong Ming

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Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial by Xiaomei Li, Xiaoxia Wang, Jian Wu, Xiao Zhang, Chunde Bao, Shengqian Xu, Lingyun Sun, Juan Wang, Guixiu Shi, Xiaofei Wang, Qing Dai, Antao Xu, Huaxiang Wu, YongQing Wang, Yan Ye, Yongfu Wang, Huaxiang Liu, Chenyin Lv, Jun Miao, Weiqi Min, Kuanting Wang, Luan Xue, Shanhui Ye

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Impact of Preventive Intravenous Amiodarone on Reperfusion Ventricular Fibrillation in Patients With Left Ventricular Hypertrophy Undergoing Open-Heart Surgery: Randomized Controlled Clinical Trial by Chan-Juan Gong, Xiao-Kai Zhou, Zhen-Feng Zhang, Yin Fang

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Biomarkers of pembrolizumab efficacy in advanced anal squamous cell carcinoma: analysis of a phase II clinical trial and a cohort of long-term responders by Jeffrey A Meyerhardt, Sunil Kumar, Jessica A Zerillo, Aparna Parikh, James M Cleary, Scott Rodig, Benjamin Schlechter, Kimmie Ng, Stephanie K Dougan, Nora Horick, Glenn J Hanna, Andrew L Coveler, Anuj K Patel, Nadine J McCleary, Douglas A Rubinson, Jeffrey W Clark, Kent Mouw, Kathleen Pfaff, Thomas A Abrams, Matthew B Yurgelun, Eliezer M Van Allen, S Jennifer Wang, Leah H Biller, Harshabad Singh, Emma L Welsh, Brandon M Huffman, Lestat R Ali, Megan T Hoffman, Katherine A Metayer, Shayla Murray, Alexandra Bird, Jennifer A Chan, Wolfram Goessling, Jeffrey S Wisch, Brendan Reardon, Robert J Mayer, Catherine Del Vecchio Fitz, Charlotte Kuperwasser

“…Background Recent trials suggest that programmed cell death 1 (PD-1)-directed immunotherapy may be beneficial for some patients with anal squamous cell carcinoma and biomarkers predictive of response are greatly needed.Methods This multicenter phase II clinical trial (NCT02919969) enrolled patients with metastatic or locally advanced incurable anal squamous cell carcinoma (n=32). …”
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Analgesic Characteristics of Bupivacaine Alone and in Combination with Dexmedetomidine or Meperidine in Spinal Anesthesia during Cesarean Section: A Double-Blind Randomized Clinical Trial Study by Simin Azemati, Amir Zarghami, Reza Jouybar, Vida Naderi-boldaji

“…In this double-blind randomized clinical trial study, ninety pregnant women were divided into groups to receive 10 mg bupivacaine (group B), 10 mg bupivacaine with 5 μg dexmedetomidine (group BD), or 10 mg bupivacaine with 10 mg meperidine (group BM) intrathecal. …”
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Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis by Louis-Emmanuel Chriqui, Etienne Abdelnour-Berchtold, Edoardo Zanfrini, Severine Devesa-Perez, Michel Gonzalez, Thorsten Krueger, Kim Ellefsen, Alice Destaillats, David Bonnet, Martin Hübner, Hasna Bouchaab, Michal Bassani-Sternberg, Solange Peters, Sabrina Cavin, Jean Y Perentes

“…Trial registration: ClinicalTrials.gov Identifier: NCT06281860…”
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Evaluation of Clinical Effectiveness and Subjective Satisfaction of a New Toothbrush for Postsurgical Hygiene Care: A Randomized Split-Mouth Double-Blind Clinical Trial by Marco Montevecchi, Annalisa Moreschi, Maria Rosaria Gatto, Luigi Checchi, Vittorio Checchi

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Safety, Tolerability, and Pharmacokinetics of NIM‐1324 an Oral LANCL2 Agonist in a Randomized, Double‐Blind, Placebo‐Controlled Phase I Clinical Trial by Andrew Leber, Raquel Hontecillas, Nuria Tubau‐Juni, Josep Bassaganya‐Riera

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The Effect of an Educational Application on The Quality of Life and Treatment Adherence in Mothers of Children with Congenital Heart Disease Undergoing Cardiac Surgery: A Randomized Clinical Trial by Mohammad Rajabi, Jamalodin Begjani, Reza Negarandeh

“…This study evaluated the impact of a mobile educational application on the QoL and TA in mothers of children with CHD undergoing cardiac surgery.Methods: This randomized clinical trial was conducted on 72 mothers of children with CHD referred for cardiac surgery to Children’s Medical Center Hospital, Tehran, Iran, from September 2023 to May 2024. …”
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Extracorporeal Shock Waves Therapy for the Treatment of Acute and Chronic Wounds—A Prospective, Monocentric Clinical Trial to Examine the Effect of Shock Waves on Wound Healing by Kristina Landscheidt, Ahmed Alabdulmohsen, Markus Hübscher, Benjamin Geber, Jochen‐Frederick Hernekamp, Ole Goertz

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Peer Review of “Safety and Efficacy of Chimeric Antigen Receptor T-Cell Therapy for Recurrent Glioblastoma: An Augmented Meta-Analysis of Phase 1 Clinical Trials (Preprint)” by Vanessa Fairhurst, Randa Salah Gomaa Mahmoud, Toba Olatoye, Sylvester Sakilay

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Ultrasound-Guided Rhomboid Block versus Paravertebral Block in Postoperative Analgesia for Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Clinical Trial by Yan Wang, Xiaoping Gu, Simin Huang, Minke Shi, Xiaofeng He, Zhengliang Ma

“…It was a prospective, randomized, double-blinded clinical trial involving 132 patients with video-assisted thoracic surgery divided into three groups: the general anesthesia (GA) group, RIB group, and PVB group on T5 vertebra, using 0.4% ropivacaine at 3 mg/kg, registered in the Chinese Clinical Trial Registry (ChiCTR2100054057, “https://www.chictr.org.cn”). …”
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Effects of time restricted feeding combined with Lacto Ovo vegetarian diet on metabolic associated fatty liver disease management: a randomized clinical trial by Mahshad Shafiee, Amir Sadeghi, Fateme Ghafouri-Taleghani, Maryam Nilghaz, Maryam Ghods, Behnaz Narimani, Azita Hekmatdoost, Atoosa saidpour

“…Abstract Metabolic Associated Fatty Liver Disease (MAFLD) is becoming a major global health concern due to its links with obesity, insulin resistance, and cardiovascular risk. This randomized clinical trial assessed the effects of combining time-restricted feeding (TRF; 16/8) with a Lacto-Ovo-Vegetarian (LOV) diet on various factors in overweight and obese patients with MAFLD. …”
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Comparative Evaluation Of Postoperative Sensitivity Using Total-Etch Versus Self-Etch Bonding Techniques In Resin Composite Restorations: A Randomized Clinical Trial by Shahid Ahmad Marwat, Hassan Maqbool, Umair ul Haq, Zarnab Rizwan, Khadija Sajid, Shakeel Ur Rehman Khattak

“…Methods: A randomized clinical trial conducted at the Department of Operative Dentistry &Endodontics, from April 1st, 2022, to September 30th, 2022. …”
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Analgesic Efficacy of Intravenous Ibuprofen in the Treatment of Postoperative Acute Pain: A Phase III Multicenter Randomized Placebo-ControlledDouble-Blind Clinical Trial by Hong-Su Zhou, Ting-Ting Li, Yu Pi, Ting-Hua Wang, Fei Liu, Liu-Lin Xiong

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Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study by Tjalf Ziemssen, Ann D. Bass, Bart Van Wijmeersch, Sara Eichau, Stephan Richter, Frank Hoffmann, Nicole M. Armstrong, Magdalena Chirieac, Janete Cunha-Santos, Barry A. Singer

“…Sustained efficacy up to 9 years was observed in the phase IIIb/IV open-label TOPAZ clinical trial and assessed in the real-world retrospective and prospective study, TREAT-MS. …”
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Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss. by Elke Lathouwers, Bruno Tassignon, Alexandre Maricot, Ahmed Radwan, Maarten Naeyaert, Hubert Raeymaekers, Peter Van Schuerbeek, Stefan Sunaert, Johan De Mey, Kevin De Pauw, Kevin De Pauw

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Efficacy of Cabbage Leaf versus Cooling Gel Pad or Diclofenac Gel for Patients with Knee Osteoarthritis: A Randomized Open-Labeled Controlled Clinical Trial by Thanapon Chobpenthai, Patcharapol Arunwatthanangkul, Wiriya Mahikul

“…Patients with moderate to severe (grades 3-4) OA by the Kellgren and Lawrence grading system with a poor to good Oxford Knee Score were selected for enrollment in this clinical trial. The participants were divided into three intervention groups: the cooling gel pad group for 20 minutes duration once a day (n = 20), the diclofenac gel group for 4 times a day (n = 20) as the control group (total n = 40), and the cabbage leaf group for 1-hour duration once a day (n = 20) as the experimental group (total n = 20). …”
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