Stress Reduction in Perioperative Care: Feasibility Randomized Controlled Trial by Haridimos Kondylakis, Irene Alice Chicchi Giglioli, Dimitrios Katehakis, Hatice Aldemir, Paul Zikas, George Papagiannakis, Santiago Hors-Fraile, Pedro L González-Sanz, Konstantinos Apostolakis, Constantine Stephanidis, Francisco J Núñez-Benjumea, Rosa M Baños-Rivera, Luis Fernandez-Luque, Angelina Kouroubali

“…Trial RegistrationClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725 International Registered Report Identifier (IRRID)RR2-10.2196/38536…”
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Can oral caffeine decrease postoperative opioid consumption following posterior spinal fusion in adolescent idiopathic scoliosis? A randomized placebo-controlled trial by Anne Stuedemann, MSN, RN, CPNP, Richard M Schwend, MD FAAP FAOA, Kenneth A. Shaw, MD, Nicolette Saddler, MSN, APRN, FNP-C, Michon Huston, PA-C, Michael Benvenuti, MD, Julia Leamon, MSN, RN, CPN, Ashley K. Sherman, MA, John Anderson, MD

“…This trial's reported mean total oral opioid consumption range of 0.83 to 0.92 MME/kg is lower than the amounts typically observed in clinical trials. This finding could indicate a successful strategy in reducing opioid use, which aligns with current medical efforts for opioid stewardship.…”
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Prevalence and Determinants of Peripheral Microvascular Endothelial Dysfunction in Rheumatoid Arthritis Patients: A Multicenter Cross-Sectional Study by Gian Luca Erre, Matteo Piga, Anna Laura Fedele, Silvia Mura, Alessandra Piras, Maria Luisa Cadoni, Ignazio Cangemi, Martina Dessi, Gabriele Di Sante, Barbara Tolusso, Elisa Gremese, Alberto Cauli, Arduino Aleksander Mangoni, Pier Sergio Saba, Ciriaco Carru, Gianfranco Ferraccioli, Alessandro Mathieu, Giuseppe Passiu

“…Data from 874 RA patients enrolled in the EDRA study (Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis—ClinicalTrials.gov: NCT02341066) were analyzed. Log-transformed reactive hyperemia index (Ln-RHI) was evaluated by peripheral arterial tonometry (PAT) using the EndoPAT2000 device: values of Ln-RHI < 0.51 were considered indicative of peripheral ED. …”
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Adrenal aldosterone synthase (CYP11B2) histopathology and its association with disease-induced sudden death: a cross-sectional studyResearch in context by Antero Ylänen, Juhani Isojärvi, Antti Virtanen, Helena Leijon, Tiina Vesterinen, Aapo L. Aro, Heini Huhtala, Eeva Kokko, Ilkka Pörsti, Marianna Viukari, Pasi I. Nevalainen, Niina Matikainen

“…This trial was registered at ClinicalTrials.gov (NCT05446779). Findings: Adrenal histopathology revealed changes in 31 (7.7%) subjects of the cohort. …”
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Pharmacodynamic characteristics and influencing factors of tapentadol for chronic pain relief under dose titration by Liang Xin, Haoxiang Zhu, Haoxiang Zhu, Suping Niu, Xie Han, Hongxian Pang, Jiangfan Li, Ye Hu, Xuhong Wang, Lujin Li, Lujin Li, Yi Fang

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The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study by Daniel Woo, Richard Thompson, Carl D Langefeld, Nichol McBee, Daniel Hanley, Matthew L Flaherty, Lauren Sansing, Karen Lane, Lee A Gilkerson, Achala Vagal, Nathan Walborn, Wendy Ziai, Noeleen Ostapkovich, Kevin Triene, Timothy David Howard

“…The findings of the study will be published in academic peer-reviewed journals.Trial registration number NCT05611918; ClinicalTrials.gov; registered on 23 May 2023.…”
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Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Racial and Ethnic Minority Preadolescents: Randomized Controlled Trial by May May Leung, Katrina F Mateo, Marlo Dublin, Laura Harrison, Sandra Verdaguer, Katarzyna Wyka

“…Trial RegistrationClinicalTrials.gov NCT03165474; https://clinicaltrials.gov/study/NCT03165474 International Registered Report Identifier (IRRID)RR2-10.2196/10682…”
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The effect of nursing care provided to coronary intensive care patients according to their circadian rhythms on sleep quality, pain, anxiety, and delirium: a randomised controlled... by Meryem Pelin, Havva Sert

“…The study has been registered in ClinicalTrials.gov (Identifiers: NCT04934436). During statistical analysis, the groups were coded as Group A and Group B, ensuring blinding for the statistician. …”
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Improving Clinical Management of Diabetic Macular Edema: Insights from a Global Survey of Patients, Healthcare Providers, and Clinic Staff by Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, Jane Barratt

“…Abstract Introduction In contrast with patients receiving therapy for retinal disease during clinical trials, those treated in routine clinical practice experience various challenges (including administrative, clinic, social, and patient-related factors) that can often result in high patient and clinic burden, and contribute to suboptimal visual outcomes. …”
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Experimental evidence-based construction of electroacupuncture for ischemic stroke: a meta-analysis and systematic review by Yaoguang Guo, Sihan Hu, Sihan Hu, Shiman Luo, Lang Tu, Yao Tang, Fang Zeng, Fang Zeng, Fang Zeng

“…These findings advocate for the integration of EA into stroke rehabilitation protocols and underscore the need for clinical trials to validate its efficacy in human subjects. …”
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Comparative Effects of Glenzocimab and Eptifibatide on Bleeding Severity in 2 Mouse Models of Intracranial Hemorrhage by Sébastien Dupont, Héloïse Lebas, Sabrina Mavouna, Eloïse Pascal, Astride Perrot, Adrien Cogo, Marie‐Charlotte Bourrienne, Carine Farkh, Mialitiana Solo Nomenjanahary, Véronique Ollivier, Fatima Zemali, Bernhard Nieswandt, Stéphane Loyau, Martine Jandrot‐Perrus, Eric Camerer, Jean‐Philippe Desilles, Mikael Mazighi, Yacine Boulaftali, Benoît Ho‐Tin‐Noé

“…Here, we investigated this risk for 2 antiplatelet drugs currently being tested in clinical trials for ischemic stroke, glenzocimab and eptifibatide, in 2 mouse models of ICH. …”
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Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT) by Ashley E. Mason, Anoushka Chowdhary, Wendy Hartogensis, Chelsea J. Siwik, Osnat Lupesko-Persky, Leena S. Pandya, Stefanie Roberts, Claudine Anglo, Patricia J. Moran, J. Craig Nelson, Christopher A. Lowry, Rhonda P. Patrick, Charles L. Raison, Frederick M. Hecht

“…Results warrant future larger controlled clinical trials.Clinivaltrials.gov Registration: NCT05708976…”
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Surgical resection, radiotherapy and percutaneous thermal ablation for treatment of stage 1 non-small cell lung cancer: protocol for a systematic review and network meta-analysis by Arun Chockalingam, Menelaos Konstantinidis, Brandon Koo, John Timothy Moon, Andrew Tran, Sahar Nourouzpour, Emily Lawson, Kathleen Fox, Peiman Habibollahi, Bruno Odisio, Mohammed Loya, Ali Bassir, Nariman Nezami

“…We will conduct a meta-analysis, reviewing literature investigating these therapies in adult patients diagnosed with stage 1 NSCLC, with neither hilar nor mediastinal nodal involvement, confirmed either through cytology or histology regardless of type.Methods and analysis We will search electronic databases (MEDLINE, Embase, Web of Science, Scopus, ClinicalTrials.gov, Cochrane) from their inception to January 2021 to identify randomised controlled trials (RCTs), cluster RCTs and cohort studies comparing survival and clinical outcomes between any two interventions (lobectomy, wedge resection, video-assisted thoracoscopic surgery/robot-assisted thoracoscopic surgery, radiofrequency ablation, microwave ablation, cryoablation and consolidated radiation therapies (external beam radiation therapy, stereotactic body radiation therapy, and 3D conformal radiation therapy). …”
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A digital intervention to reduce home-office workers’ sedentary behaviour: protocol for the evaluation of the Click2Move programme, a cluster randomised controlled trial by Judit Bort-Roig, Iris Parés-Salomón, Bette Loef, Cristina Vaqué-Crusellas, Alan Coffey, Arnau Gustems-Morral, Anna M. Señé-Mir, Izabela Luznik, Maja Pajek, Kieran P. Dowd, Anna Puig-Ribera, Karin I. Proper

“…Trial registration ClinicalTrials.gov NCT06247228. Registered 30 January 2024.…”
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Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to r... by Morgan Brown, Miriam R Elman, Jodi Lapidus, April M Young, Kathryn E Lancaster, Sarann Bielavitz, Ryan R Cook, Gillian Leichtling, Edward Freeman, Angela T Estadt, Rhonda Alexander, Caiti Barrie, Kandi Conn, Rhody Elzaghal, Lisa Maybrier, Renee McDowell, Cathy Neal, Elizabeth N Waddell, P Todd Korthuis

“…Numerous barriers impede rural PWUD trial engagement and advancing research methods to better retain rural PWUD in clinical trials is needed. This paper describes the Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2) study protocol to test the effectiveness of a peer-driven intervention to improve study retention among rural PWUD.Methods and analysis The PROUD-R2 study is being implemented in 21 rural counties in three states (Kentucky, Ohio and Oregon). …”
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Combining a WT1 Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1–Expressing Diffuse Pleural Mesothelioma: A Phase 1 Study by Prashasti Agrawal, MD, Michael Offin, MD, Victoria Lai, MD, Michelle S. Ginsberg, MD, Prasad S. Adusumilli, MD, FACS, Valerie W. Rusch, MD, Jennifer L. Sauter, MD, Teresa Ho, BS, Phillip Wong, PhD, Marjorie G. Zauderer, MD

“…Galinpepimut-S (GPS), a tetravalent, non–human leukocyte antigen–restricted, heteroclitic WT1–specific peptide vaccine was safe and effective in early phase clinical trials and upregulates T-cell suppressive programmed death-ligand 1 in the tumor microenvironment of other malignancies. …”
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Internet-Based Dementia Prevention Intervention (DementiaRisk): Protocol for a Randomized Controlled Trial and Knowledge Translation by Anthony J Levinson, Stephanie Ayers, Sandra Clark, Rebekah Woodburn, Maureen Dobbins, Dante Duarte, Roland Grad, Nick Kates, Sharon Marr, Doug Oliver, Alexandra Papaioannou, Karen Saperson, Henry Siu, Gillian Strudwick, Richard Sztramko, Sarah Neil-Sztramko

“…Trial RegistrationClinicalTrials.gov NCT05383118; https://clinicaltrials.gov/study/NCT05383118 International Registered Report Identifier (IRRID)DERR1-10.2196/64718…”
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Paracrine activity of Smurf1-silenced mesenchymal stem cells enhances bone regeneration and reduces bone loss in postmenopausal osteoporosis by Alberto González-González, Itziar Álvarez-Iglesias, Daniel García-Sánchez, Monica Dotta, Ricardo Reyes, Ana Alfonso-Fernández, Alfonso Bolado-Carrancio, Patricia Díaz-Rodríguez, María Isabel Pérez-Núñez, José Carlos Rodríguez-Rey, Jesús Delgado-Calle, Flor M. Pérez-Campo

“…These findings warrant further in vivo studies and clinical trials to validate its therapeutic efficacy and safety.…”
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Accessible model predicts response in hormone receptor positive HER2 negative breast cancer receiving neoadjuvant chemotherapy by Luca Mastrantoni, Giovanna Garufi, Giulia Giordano, Noemi Maliziola, Elena Di Monte, Giorgia Arcuri, Valentina Frescura, Angelachiara Rotondi, Armando Orlandi, Luisa Carbognin, Antonella Palazzo, Federica Miglietta, Letizia Pontolillo, Alessandra Fabi, Lorenzo Gerratana, Sergio Pannunzio, Ida Paris, Sara Pilotto, Fabio Marazzi, Antonio Franco, Gianluca Franceschini, Maria Vittoria Dieci, Roberta Mazzeo, Fabio Puglisi, Valentina Guarneri, Michele Milella, Giovanni Scambia, Diana Giannarelli, Giampaolo Tortora, Emilio Bria

“…Our model is freely available and can be used to enhance the stratification of BC patients receiving NACT, providing a framework for the development of risk-adapted clinical trials.…”
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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

“…This trial was registered at Japan Registry for Clinical Trials (jRCT2031210453). Findings: Fifty-four patients were randomised (teprotumumab, 27; placebo, 27) between February and November 2022. …”
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