mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES... by Edo Richard, Esther Van den Berg, Ron Handels, Henrike Galenkamp, Eric P Moll van Charante, Marieke P Hoevenaar-blom, Anne Roos van der Endt, Martien J H Kas

“…The study aims to evaluate the effectiveness and implementation of an mHealth intervention designed for self-managing lifestyle modifications with remote coaching to reduce dementia risk factors.Methods and analysis This prospective randomised open-label blinded end point (PROBE) trial follows a type 2 hybrid effectiveness-implementation design with a 12-month intervention period. …”
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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

“…Patients, caregivers, and outcome assessors were not blinded to group assignment. Most of the data collection took place in the patient’s home environment. …”
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The effect of sulthiame on potential biomarkers in moderate to severe obstructive sleep apnoea by Erik Hoff, Saliha Musovic, Ali M. Komai, Ding Zou, Christian Strassberger, Kaj Stenlöf, Ludger Grote, Jan Hedner

“…Methods This was an exploratory analysis of a randomised, double-blind, placebo-controlled trial of STM in OSA. Patients with moderate to severe OSA, body mass index 20–35 kg·m−2, aged 18–75 years and not accepting positive airway pressure treatment were randomised to 4 weeks with placebo, STM 200 mg or STM 400 mg. …”
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Cognitive improvement and prefrontal network interactions in individuals with remitted bipolar disorder after transcranial infrared laser stimulation by Douglas W. Barrett, Roger E. Davis, Jennifer E. Siegel-Ramsay, Amy Bichlmeier, Jorge R. C. Almeida, F. Gonzalez-Lima

“…To confirm TILS efficacy, a sham-controlled, double-blinded randomized trial is needed.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT05354895.…”
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Oral cannabidiol did not impair learning and memory in healthy adults by Hanna H. Gebregzi, Joanna S. Zeiger, Jeffrey P. Smith, Libby Stuyt, Luann Cullen, Jim Carsella, Daniel C. Rogers, Jordan Lafebre, Jennah Knalfec, Alfredo Vargas, Moussa M. Diawara

“…Method A two-arm crossover, randomized, double-blind, placebo-controlled trial was conducted at Colorado State University Pueblo (CSU Pueblo) to evaluate the effects of 246 mg oral CBD on L&M in healthy adults. …”
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Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with rese... by Orlaith Doherty, Conor White, Nanna Brix Finnerup, Eimear Smith, Mark Pollock, Nathan Kirwan, Olive Lennon, Catherine Blake

“…Methods This is a phase 2 single-blinded, randomised feasibility study. It will test the feasibility and acceptability of exoskeleton-based walking 3 times per week for 12 weeks (intervention), as a mechanistic-based intervention for NP after SCI. …”
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Safety and Intranasal Retention of a Broad-Spectrum Anti-SARS-CoV-2 Monoclonal Antibody SA55 Nasal Spray in Healthy Volunteers: A Phase I Clinical Trial by Chaoying Hu, Yibo Zhou, Xing Meng, Jianhua Li, Jinxia Chen, Zhifang Ying, Xiaoliang Sunney Xie, Yaling Hu, Yunlong Cao, Ronghua Jin

“…Methods: This phase I, dose-escalation clinical trial combined an open-label design with a randomized, controlled, double-blind design. Healthy participants aged 18–65 years were enrolled and received a single dose of the SA55 nasal spray (1 mg or 2 mg) or multiple doses of SA55 nasal spray/placebo for 7 days (1 or 2 mg/dose, 3 or 6 doses/day). …”
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Prebiotics as an adjunct therapy for posttraumatic stress disorder: a pilot randomized controlled trial by Robin M. Voigt, Robin M. Voigt, Robin M. Voigt, Phillip A. Engen, Michelle Villanueva, Simona A. Bambi, Stefan J. Green, Stefan J. Green, Ankur Naqib, Ankur Naqib, Shohreh Raeisi, Maliha Shaikh, Bruce R. Hamaker, Bruce R. Hamaker, Thaisa M. Cantu-Jungles, Thaisa M. Cantu-Jungles, Sarah A. Pridgen, Philip Held, Ali Keshavarzian, Ali Keshavarzian, Ali Keshavarzian, Ali Keshavarzian

“…., dysbiosis) which can promote neuroinflammation; thus, modulation of the microbiome could be an alternative or adjunct treatment approach for PTSD.MethodsThe current study was a 12-week, double-blind, placebo-controlled trial seeking to understand if CBT combined with a microbiota-modifying, prebiotic fiber intervention would beneficially impact clinical outcomes in veterans with PTSD (n = 70). …”
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Large language models for pretreatment education in pediatric radiation oncology: A comparative evaluation study by Dominik Wawrzuta, Aleksandra Napieralska, Katarzyna Ludwikowska, Laimonas Jaruševičius, Anastasija Trofimoviča-Krasnorucka, Gints Rausis, Agata Szulc, Katarzyna Pędziwiatr, Kateřina Poláchová, Justyna Klejdysz, Marzanna Chojnacka

“…Finally, a multi-institutional group of nine pediatric radiotherapy experts conducted a blind review of responses, assessing reliability, concision, and comprehensibility. …”
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Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding by Fátima Higuera-de-la-Tijera, Alfredo I. Servín-Caamaño, Francisco Salas-Gordillo, José L. Pérez-Hernández, Juan M. Abdo-Francis, Jaime Camacho-Aguilera, Sai N. Alla, Fiacro Jiménez-Ponce

“…Methods. A randomized, double-blind, placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT02158182) which included cirrhotic patients with variceal bleeding, without minimal or clinical hepatic encephalopathy at admission. …”
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Zinc absorption from maize-based meals enriched with edible house crickets: a randomized crossover stable-isotope study in Kenyan pre-school children by Nikolin Hilaj, Tele Boit, Pauline Andang’o, Christophe Zeder, Martin N. Mwangi, Marijke Hummel, Ornella Necochea Velazco, Joop J. A. van Loon, Marcel Dicke, Michael B. Zimmermann, Alida Melse-Boonstra

“…We investigated zinc absorption from house crickets (Acheta domesticus) in a single-center and single-blinded cross-over study with children aged 24–36 months old in Kenya from September-November 2021. …”
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Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled t... by Xun Xu, Tianwei Qian, Hao Zhou, Weijun Wang, Ying Fan, Lin Xue, Xia Wu, Qiaoyun Gong, Luyao Ye

“…This study aims to evaluate the efficacy and safety of vitrectomy combined with lens capsule flap transplantation in the treatment of HMMHRD.Methods and analysis This single-centre, single-blind, prospective, randomised clinical trial will include 54 patients with HMMHRD who will first undergo phacoemulsification and intraocular lens implantation and then vitrectomy combined with lens capsule flap transplantation (experimental group) or ILM tamponade (control group). …”
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Usefulness of Magnetoinertial Wearable Devices in Neurorehabilitation of Children with Cerebral Palsy by Marco Iosa, Manuela de Sanctis, Aurora Summa, Elena Bergamini, Daniela Morelli, Giuseppe Vannozzi

“…Children with CP were randomly divided in two groups: in the first group (CPI), MIMU-based parameters were used by therapists for planning patient-tailored rehabilitation programs, whereas in the second group (CPB), therapists were blind to the MIMU-based assessment results. Both CPI and CPB were tested before and after the relevant neurorehabilitation program. …”
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Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised... by Li Wang, Tamer Hudali, Shekhar Ghamande, Megan Moore, Bruno Pereira, Christopher J Lindsell, Wesley H Self, Todd W Rice, Matthew W Semler, Kate O’Connor, David B Page, Victor E Ortega, Aaron M Joffe, Swati Gulati, G Patel, Heath D White, Muhammad Ali, Jonathan D Casey, David R Janz, Derek W Russell, Derek J Vonderhaar, Kevin M Dischert, William S Stigler, Emily Adams, Kevin W Gibbs, James M Dargin, A M Joffe, Akram Khan, Simanta Dutta, Janna S Landsperger, Sarah W Robison, Itay Bentov, Joanne M Wozniak, Susan Stempek, Olivia F Krol, Matthew E Prekker, Brian E Driver, Joseph M Brewer, Christopher John Lindsell, David Janz, Stephen P Peters, Rita N Bakhru, Scott Bauer, Christina R Bellinger, Amanda M Brown, Blair Brown, Jerri Brown, Caitlin Bumgarner, Wendy Butcher, Megan Caudle, Arjun B Chatterjee, David J Chodos, Gerardo Corcino, Nathan S Cutler, Travis L Dotson, Daniel C Files, Jonathan L Forbes, John P Gaillard, Katherine A Gershner, Shannon Ginty, Kiadrick R Hood, April Hazelwood, Katherine Hendricks, Kelly Jacobus, Jonathan T Jaffe, Stacy Kay, Chad A Kloefkorn, Jennifer Krall, Margo T Lannan, Cornelia Lane, Cynthia Lanning, Jessica Lyons, William I Mariencheck, Chad R Marion, Matthew A Maslonka, Sara McClintock, Nathaniel M Meier, Matthew C Miles, Peter J Miller, Sophia Mitchell, Wendy C Moore, Katherine Moss, Andrew M Namen, Dustin L Norton, Stella B Ogake, Jill A Ohar, Jessica A Palakshappa, Rodolfo M Pascual, Sandi Pascual, Aaron Pickens, Adam R Schertz, Matt Strong, Alexander O Sy, Braghadheeswar Thyagarajan, Amy Townsend, Russell Worthen, Michael Wlodarski, Charles Yarbrough, Caroline York, Bradley Lloyd, James Dargin, Joanne Wozniak, Christopher Adler, Ahmed Agameya, Michael Colancecco, Daniel Fitelson, Joshua Giaccotto, Gena Han, Louise Kane, Ezra Miller, Timothy Noland, Jaqueline Price, Joseph Plourde, Fraser Mackay, Laura Mahoney, Avignat Patel, Michael Plourde, Zena Saadeh, Sara Shadchehr, Sandeep Somalaraju, Eleanor Summerhill, Ryan Webster, Jordan Winnicki, Ekaterina Yavarovich, Sheetal Gandotra, Anna Altz-Stamm, Cristina Bardita, Mary Clay Boone, Joe W Chiles, Kristina Collins, Abby Drescher, Kevin G Dsouza, Janna Dunn, Stacy Ejem, Josh Gautney, Nicole Harris, Savannah Herder, R Chad Wade, Rutwij Joshi, Daniel Kelmenson, Anne Merrill Mason, Scott R Merriman, Takudzwa Mkorombindo, Jada Nowak, D Sheylan, Lisa Sarratt, Tabitha Stewart, Kadambari Vijaykumar, Gina White, Micah R Whitson, Christopher Barnes, Andrew M Walters, Alejandro C Arroliga, Tasnim Lat, Stephanie Nonas, Milad K Jouzestani, Raya Adi, Chandani Anandkat, Hanae Benchbani, Matthew G Drake, Makrina N Kamel, Ramanpreet Randhawa, Jessica L Tsui

“…A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.Methods and analysis The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. …”
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Standardization and validation of a novel reverse transcriptase polymerase chain reaction method for detecting virulent strains of the infectious bursal disease virus by Vladimir Longa-Bobadilla, Phillip Ormeño-Vásquez, Manuel Criollo-Orozco, Luis Tataje-Lavanda, Katherine Huamán-Gutierrez, Ángela Montalván, Mirko Zimic, Manolo Fernández-Sanchez, Manolo Fernández-Díaz

“…Conclusion: Our novel RT-PCR procedure has been demonstrated to be helpful in selectively amplifying the consensus sequence of the VP5 gene, indicating that this novel RT-PCR procedure constitutes an important and useful tool to execute initial discrimination of field-retrieved samples containing and not containing virulent strains of this virus before deciding to execute a blindly and more costly sequencing procedure of all the samples together.…”
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Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlle... by Jan Kottner, Monira El Genedy-Kalyoncu, Alexandra Fastner, Bettina Völzer, Kathrin Raeder, Konrad Neumann, Nils Axel Lahmann

“…Therefore, the overall aim of this exploratory trial is to compare the effects of three skin protection strategies to estimate effect sizes of the recently published core outcomes in IAD research.Methods and analysis A pragmatic three-arm, assessor-blinded, randomised controlled, exploratory trial with parallel group design will be performed, comparing film-forming and lipophilic skin protecting leave-on products for IAD prevention with standard incontinence care alone. …”
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Effect of Zhan Zhuang Qigong on upper limb static tremor and aerobic exercise capacity in patients with mild-to-moderate Parkinson’s disease: study protocol for a randomised contro... by Hang Su, Xiaoyu Jiang, Limin Wang, Linlin Zhang, Qing Wang, Xihua Liu, Xiaoming Xi, Yuxiao Chen, Xinjie Qu, Haihao Cao, Wenyu Sun, Guoming Chen, Huifen Liu, Jiahui Jiang, Hongyan Bi

“…Studies have indicated that aerobic and resistance exercises alleviate PD movement disorders and improve aerobic capacity, but the effects of Qigong on PD static tremor and aerobic capacity remain unknown.Methods and analysis Objective To observe the effects of Zhan Zhuang Qigong on upper limb static tremor and aerobic capacity in patients with PD, we established a rigorous randomised, parallel-controlled, assignment hidden, evaluator-blinded protocol.Methods Seventy-two patients with PD, at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, were recruited and randomly divided into a control (n=36) and experimental group (n=36). …”
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Efficacy of the Foodbot Factory digital curriculum-based nutrition education intervention in improving children’s nutrition knowledge, attitudes and behaviours in elementary school... by Wendy Lou, Michael Farkouh, JoAnne Arcand, Jacqueline Marie Brown, Saman Tahir, Beatriz Franco-Arellano, Ann LeSage, Janette Hughes, Bill Kapralos, Ellen Vogel, Claire Tugault-Lafleur

“…Pilot data have demonstrated that Foodbot Factory can significantly improve children’s nutrition knowledge, but it has not yet been evaluated in classrooms.Methods and analysis A single-blinded cluster randomised controlled trial was designed in 2022 by a research team based at Ontario Tech University to determine the efficacy of the Foodbot Factory intervention in improving children’s nutrition knowledge, attitudes and behaviours. 32 grade 4 and 4/5 classrooms in Ontario will be randomised to receive (1) the Foodbot Factory intervention or (2) a control nutrition education intervention using conventional materials (eg, activity sheets). …”
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MAMMOTH-Subaru. II. Diverse Populations of Circumgalactic Lyα Nebulae at Cosmic Noon by Mingyu Li, Haibin Zhang, Zheng Cai, Yongming Liang, Nobunari Kashikawa, Ke Ma, Xiaohui Fan, J. Xavier Prochaska, Bjorn H. C. Emonts, Xin Wang, Yunjing Wu, Shiwu Zhang, Qiong Li, Sean D. Johnson, Minghao Yue, Fabrizio Arrigoni Battaia, Sebastiano Cantalupo, Joseph F. Hennawi, Satoshi Kikuta, Yuanhang Ning, Masami Ouchi, Rhythm Shimakawa, Ben Wang, Weichen Wang, Zheng Zheng, Zhen-Ya Zheng

“…Utilizing the wide-field capability of Hyper Suprime-Cam, we present one of the largest blind Ly α nebula selections, including QSO nebulae, Ly α blobs, and radio galaxy nebulae down to the typical 2 σ Ly α surface brightness of $(5-10)\times {10}^{-18}\,\mathrm{erg}\,{{\rm{s}}}^{-1}\,{\mathrm{cm}}^{-2}\,{\mathrm{arcsec}}^{-2}$ . …”
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Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial by Robert Clarke, Emma J Crosbie, Basil G Issa, John Belcher, Helen Clarke, Anthony Howell, Michelle Harvie, Hannah Harrison, Cheryl Lombardelli, Suzanne Krizak, Katharine Sellers, Yit Y Lim, Caroline Parkin, Shruthi Patel, Anthony J Maxwell, Julie Wisely, Sacha J Howell

“…This study aims to examine the cellular and molecular changes in breast and endometrial tissue in high-risk women following TDR-induced weight loss, as well as longer-term adherence to a 12-month TDR weight loss intervention.Methods and analysis PROBE-TDR (PRevention Of Breast and Endometrial cancer using Total Diet Replacement) is a prospective, non-blinded, randomised controlled trial of 47 women at increased risk of breast and/or endometrial cancer. …”
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