Human Factors Studies to Assess the Usability of the Faricimab Prefilled Syringe by Barakat MR, Kwong Jr HM, Marcon G, O'Leary OE, Paris LP, Schneider P, Tang Y, Graff JM

“…Injections were performed into single eyes of 35 patients with nAMD or DME in three US clinics and patients were followed for 7 days for safety reporting (ClinicalTrials.gov identifier: NCT05569148).Results: In the simulated-use study, most retina specialists and ophthalmic assistants completed all tasks deemed essential for PFS preparation and administration correctly and without error. …”
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Nivolumab plasma concentration and clearance associated with overall survival in patients with renal cell carcinoma by Aurélien Marabelle, Laurence Albiges, Angelo Paci, Cécile Dalban, David Combarel, Sophie Broutin, Christophe Maritaz, Louis Blondel

“…Here we describe the development of a new population pharmacokinetic (PPK) model in patients treated with nivolumab in clinical trials. Applying the model to a patient population with renal cell carcinoma identified nivolumab clearance and plasma concentration as predictors of overall survival (OS).Methods A custom liquid chromatography with tandem mass spectrometry method for quantifying nivolumab plasma concentration was developed and validated following the European Medicines Agency guidelines for bioanalytical method validation. …”
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Effects of tongue tamers and customized bonded spurs as an early treatment of anterior open bite: a randomized clinical study by Safa B. Alawy, Shaimaa S. EL-Desouky, Ibrahim A. Kabbash, Shimaa M. Hadwa

“…Trial registration ClinicalTrials.gov, NCT05792553 , “Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite”, Retrospectively registered: 31/03/2023.…”
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Blood absolute lymphocyte count and trajectory are important in understanding severe COVID-19 by Catharine I. Paules, Jacqueline A. Nordwall, Kathryn Shaw-Saliba, Judith A. Aberg, Edward M. Gardner, Anna L. Goodman, N. Kumarasamy, Shikha Vasudeva, David M. Vock, Crystal M. North, Jens Lundgren, Neil R. Aggarwal, for the STRIVE Network and TICO Trial Study Group

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Cost-utility and cost–benefit analysis of a multi-component intervention (NEXpro) for neck-related symptoms in Swiss office workers by Beatrice Brunner, Andrea Martina Aegerter, Venerina Johnston, Thomas Volken, Manja Deforth, Gisela Sjøgaard, Achim Elfering, Markus Melloh, the NEXpro Collaboration Group

“…Trial registration ClinicalTrials.gov, NCT04169646 . Registered 15 November 2019-Retrospectively registered. …”
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The proof is in the pudding: patient engagement in studying cannabidiol in mild cognitive impairment by Antonia Keck, Julia-Sophia Scheuermann, Petra Scheerbaum, Elmar Graessel, Kirsten R. Müller-Vahl

“…Abstract Background Patient engagement (PE) in clinical trials has gained importance yet remains uncommon, particularly in patients with mild cognitive impairment (MCI), a critical precursor to Alzheimer’s disease (AD). …”
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Budget Impact of Rivaroxaban for the Prevention of Thromboembolic Events after Hip or Knee Replacement in Spain by Xavier Granero Xiberta, Antonio Murcia, José Ricardo Troncoso Durán, Claudio Gómez Zubeldia, Aleix Llorac Moix, Ruth Graefenhain De Codes, Maria Giovana Ferrario, Luis Lizán

“…Rivaroxaban is an oral antithrombotic drug that has shown superior efficacy and similar safety profile compared to enoxaparin regimens in randomized clinical trials. The aim of the study was to estimate the budget impact of increasing the use of rivaroxaban with respect to enoxaparin in the prophylaxis of VTE in patients undergoing elective THR or TKR. …”
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Relationships between Serum Levels of Atazanavir and Renal Toxicity or Lithiasis by C. I. Marinescu, M. Leyes, M. A. Ribas, M. Peñaranda, J. Murillas, A. A. Campins, L. Martin-Pena, B. Barcelo, C. Barceló-Campomar, F. Grases, G. Frontera, Melchor Riera Jaume

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Evolocumab safety and efficacy in hypercholesteremia patients with or without diabetes: a retrospective real-world analysis by Sultan Ibrahim Alraddadi, Hind Almodaimegh, Abdullah Kharbosh, Hadeel Alharbi, Ahmed Ibrahim Fathelrahman, Mona Yaser Alsheikh, Lama Alfehaid

“…Conclusion The study demonstrated that the addition of evolocumab to maximally tolerated statin and ezetimibe therapy reduced LDL-C levels but with a smaller average reduction and a lower proportion of patients achieving recommended LDL-C targets than in landmark clinical trials. Additionally, there was a potential negative effect on glycemic control, warranting further investigation.…”
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Economic and relationship-strengthening intervention to reduce alcohol use in couples living with HIV in Malawi: a study protocol for a randomised controlled trial of Mlambe by Torsten B Neilands, Lynae A Darbes, James Mkandawire, Derek S Brown, Fred M Ssewamala, Judith A Hahn, Amy A Conroy, Nancy Mulauzi, Scott Tebbetts

“…Results will be disseminated to study participants, local health officials and HIV policy makers and through presentations at conferences and publications in peer-reviewed journals.Trial registration number ClinicalTrials.gov Protocol Registration; NCT06367348 registered on 19 April 2024; https://register.clinicaltrials.gov/. …”
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Parallel randomised trial testing community fibrosis assessment for suspected non-alcoholic fatty liver disease: outcomes from LOCATE-NAFLD by Sanjeewa Kularatna, James O'Beirne, Adrian Barnett, Patricia C Valery, Elizabeth Powell, Ingrid J Hickman, Ruth Tulleners, David Brain, Katherine Stuart, Carolyn McIvor, Elen Witness, Melanie Aikebuse

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Increasing Access to Mental Health Supports for 18- to 25-Year-Old Indigenous Youth With the JoyPop Mobile Mental Health App: Study Protocol for a Randomized Controlled Trial by Angela MacIsaac, Teagan Neufeld, Ishaq Malik, Elaine Toombs, Janine V Olthuis, Fred Schmidt, Crystal Dunning, Kristine Stasiuk, Tina Bobinski, Arto Ohinmaa, Sherry H Stewart, Amanda S Newton, Aislin R Mushquash

“…Trial RegistrationClinicalTrials.gov NCT05991154; https://clinicaltrials.gov/study/NCT05991154 International Registered Report Identifier (IRRID)DERR1-10.2196/64745…”
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A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-Partners Early After Diagnosis: Protocol for Open Pilot of Resilient Together for Dementia by Sydney McCage, Kristin Walker, Talea Cornelius, Robert A Parker, Kristen Dams-O'Connor, Brad Dickerson, Christine Ritchie, Ana-Maria Vranceanu, Sarah Bannon

“…ResultsThis study has been approved by the MSH institutional review board and is registered on ClinicalTrials.gov (NCT06421545). We anticipate that the study will be completed by late 2024. …”
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Effectiveness and safety of pembrolizumab, nivolumab, and atezolizumab as adjuvant therapy for high-risk muscle-invasive urothelial carcinoma: an indirect comparison by Wei Chen, Wei Chen, Soichiro Yoshida, Noriyoshi Miura, Shohei Fukuda, Hiroshi Fukushima, Yuma Waseda, Hajime Tanaka, Yasuhisa Fujii

“…With no direct efficacy comparisons available, we aimed to indirectly compare the efficacy and safety of pembrolizumab, nivolumab, and atezolizumab as adjuvant treatments for high-risk MIUC based on individual patient data (IPD) from clinical trials.MethodsIPD was reconstructed using the Shiny method from Kaplan–Meier curves of eligible randomized controlled trials. …”
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Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluder... by Yanxing Fang, Kai Hou, Dawei Lin, Daxin Zhou, Wenzhi Pan, Junbo Ge

“…Trial registration Trial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. …”
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From dusk to dawn: examining how adolescents engage with digital media using objective measures of screen time in a repeated measures study by Bradley Brosnan, Kim A. Meredith-Jones, Jillian J. Haszard, Shay-Ruby Wickham, Barbara C. Galland, Takiwai Russell-Camp, Rachael W. Taylor

“…Trial registration Australian New Zealand Clinical Trials Registry (anzctr.org.au), AACTRN12621000193875, Registered 23 February 2021, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?…”
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PRECIS-2 used as an implementation science tool for global environmental health: A cross-sectional evaluation of the Ecolectivos study protocol to reduce burning of household plast... by Lisa M Thompson, Annalyse Ferguson, Hina Raheel, Amy E Lovvorn, Mayari Hengstermann-Artiga, Maria Renee Lopez, Melinda Higgins, Eri Saikawa, Margaret A Handley

“…The revised Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a validated tool developed in 2015 by trialists to ensure that clinical trials are designed to fit their intended purpose, with an assessment of applicability of the trial results to specific contexts. …”
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Effectiveness of eHealth literacy interventions: a systematic review and meta-analysis of experimental studies by Chiara Barbati, Elvira Maranesi, Cinzia Giammarchi, Matteo Lenge, Manila Bonciani, Elisa Barbi, Giacomo Pietro Vigezzi, Mauro Dragoni, Tania Bailoni, Anna Odone, Roberta Bevilacqua

“…Methods Following the PRISMA guidelines, we conducted a systematic review in PubMed/Medline, Scopus, Web of Science, Embase, Cochrane Library and ClinicalTrials.gov, including original experimental studies quantifying the effectiveness of interventions aimed at increasing eHL, as assessed by the eHealth Literacy Scale (eHEALS) or other validated scales. …”
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The serum hepcidin and the hepcidin/ferritin ratio in NAFLD: a systematic review and meta-analysis by Jingmin Song, Heqing Wang, Xiaolian Gao, Fen Yang, Xinhong Zhu, Guiyuan Qiao, Ting Gan, Junxiu Tao

“…Clinical studies have identified a potential link between abnormal iron metabolism and the high incidence of NAFLD; however, the results from clinical trials remain inconsistent. This meta-analysis aims to compare serum hepcidin levels and the hepcidin/ferritin ratio between adults with NAFLD and those without to explore their potential relationship with NAFLD. …”
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Genomic analysis of the SMN1 gene region in patients with clinically diagnosed spinal muscular atrophy: a retrospective observational study by Tamaki Kato, Mamoru Yokomura, Yutaka Osawa, Kensuke Matsuo, Yuji Kubo, Taihei Homma, Kayoko Saito

“…Trial registration: University Hospital Medical Information Network Clinical Trials Registry (Number: UMIN000040095).…”
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