Effect of reduced versus usual lipid emulsion dosing on bilirubin neurotoxicity and neurodevelopmental impairment in extremely preterm infants: study protocol for a randomized cont... by Lindsay F. Holzapfel, Cody Arnold, Jon E. Tyson, Steven M. Shapiro, Eric W. Reynolds, Claudia Pedroza, Emily K. Stephens, Alan Kleinfeld, Andrew H. Huber, Matthew A. Rysavy, Maria del Mar Romero Lopez, Amir M. Khan

“…Free fatty acids and UB will be measured daily using a novel probe. BAER testing will be performed at 34–36 weeks postmenstrual age or prior to discharge. …”
Get full text

Automated Quantification of Abnormal QRS Peaks From High‐Resolution ECGs Predicts Late Ventricular Arrhythmias in Hypertrophic Cardiomyopathy: A 5‐Year Prospective Multicenter Stud... by Adrian M. Suszko, Praloy Chakraborty, Karthik Viswanathan, Scott Barichello, John Sapp, Mario Talajic, Zachary Laksman, Raymond Yee, Anna Woo, Danna Spears, Arnon Adler, Harry Rakowski, Vijay S. Chauhan

“…QRSp <4 was associated with a <1% annual VA risk in all patients, and no VA risk among those aged <50 years. This novel ECG metric may improve patient selection for prophylactic implantable cardioverter‐defibrillator therapy by identifying those with low VA risk. …”
Get full text

Balloon Pulmonary Angioplasty in Patients with Chronic Thromboembolic Pulmonary Hypertension: Impact on Clinical and Hemodynamic Parameters, Quality of Life and Risk Profile by Pavel Jansa, Samuel Heller, Michal Svoboda, Michal Pad’our, David Ambrož, Vladimír Dytrych, Michal Širanec, Tomáš Kovárník, Marián Felšőci, Martin Hutyra, Aleš Linhart, Jaroslav Lindner, Michael Aschermann

“…Balloon pulmonary angioplasty (BPA) is a novel treatment option for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not eligible for pulmonary endarterectomy (PEA) or suffer from persistent pulmonary hypertension after PEA. …”
Get full text

Applying User-Centered Design and Implementation Science to the Early-Stage Development of a Telehealth-Enhanced Hybrid Cardiac Rehabilitation Program: Quality Improvement Study by Andrea T Duran, Adrianna Keener-DeNoia, Kimberly Stavrolakes, Adina Fraser, Luis V Blanco, Emily Fleisch, Nicole Pieszchata, Diane Cannone, Charles Keys McKay, Emma Whittman, Donald Edmondson, Rachel C Shelton, Nathalie Moise

“…MethodsAs part of a NewYork-Presbyterian Hospital (NYPH) quality improvement initiative (March 2020-February 2022), we combined UCD and IS principles and methods to design a novel home- and clinic-based telehealth-enhanced hybrid CR (THCR) program. …”
Get full text

Camrelizumab plus gemcitabine and oxaliplatin for relapsed or refractory classical Hodgkin lymphoma: a phase II trial by Yanfei Liu, Lingyan Ping, Yuqin Song, Yongjing Tang, Wen Zheng, Weiping Liu, Zhitao Ying, Chen Zhang, Meng Wu, Feier Feng, Ningjing Lin, Meifeng Tu, Jun Zhu, Yan Xie

“…Abstract Background Classical Hodgkin lymphoma (cHL) is a highly curable disease, while novel therapy is needed for refractory or relapsed (R/R) patients. …”
Get full text

Bone-Metabolism-Related Serum microRNAs to Diagnose Osteoporosis in Middle-Aged and Elderly Women by Sheng-Li Zhao, Zhen-Xing Wen, Xiao-Yi Mo, Xiao-Yan Zhang, Hao-Nan Li, Wing-Hoi Cheung, Dan Fu, Shi-Hong Zhang, Yong Wan, Bai-Ling Chen

“…<b>Methods</b>: This investigation recruited 83 eligible participants from 795 community-dwelling postmenopausal women between June 2020 and August 2021. …”
Get full text

Serious gaming and gamification education in health professions : systematic review by Gentry, Sarah Victoria, Gauthier, Andrea, Wortley, David, Lilienthal, Anneliese, Tudor Car, Lorainne, Dauwels-Okutsu, Shoko, Zary, Nabil, Campbell, James, Car, Josip, Ehrstrom, Beatrice L’Estrade, Nikolaou, Charoula K.

“…Serious gaming and gamification education have the potential to provide a quality, cost-effective, novel approach that is flexible, portable, and enjoyable and allow interaction with tutors and peers. …”
Get full text
Get full text

‘Be on the TEAM’ Study (Teenagers Against Meningitis): protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage... by Carr, J, Plested, E, Aley, P, Camara, S, Davis, K, MacLennan, JM, Gray, S, Faust, SN, Borrow, R, Christensen, H, Trotter, C, Maiden, MCJ, Finn, A, Snape, MD

“…Whether vaccinating teenagers with the novel ‘MenB’ protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines. 4CMenB and MenB-fHbp may also impact on non-MenB disease-causing capsular groups as well as commensal Neisseria spp. …”

Molecular testing to deliver personalized chemotherapy recommendations: risking over and undertreatment by Timothée Olivier, Vinay Prasad

“…Among solutions, it should be acknowledged that clinico-pathological features, like T4 in colon cancer, may not be abandoned and replaced by novel strategies in real-life practice. Therefore, novel strategies should be tested in addition to standard of care, and not in lieu of. …”
Get full text

Once-weekly TransCon CNP (navepegritide) in children with achondroplasia (ACcomplisH): a phase 2, multicentre, randomised, double-blind, placebo-controlled, dose-escalation trialRe... by Ravi Savarirayan, Daniel G. Hoernschemeyer, Merete Ljungberg, Yuri A. Zarate, Carlos A. Bacino, Michael B. Bober, Janet M. Legare, Wolfgang Högler, Teresa Quattrin, M. Jennifer Abuzzahab, Paul L. Hofman, Klane K. White, Nina S. Ma, Dirk Schnabel, Sérgio B. Sousa, Meng Mao, Alden Smith, Mukta Chakraborty, Adebola Giwa, Bent Winding, Birgitte Volck, Aimee D. Shu, Ciara McDonnell

“…Interpretation: This phase 2 trial suggests that TransCon CNP is effective, safe, with low injection site reaction frequency, and may provide a novel, once-weekly treatment option for children with achondroplasia. …”
Get full text

Micro-Ultrasound in the Diagnosis and Staging of Prostate and Bladder Cancer: A Comprehensive Review by Francesco Paolo Calace, Luigi Napolitano, Davide Arcaniolo, Marco Stizzo, Biagio Barone, Felice Crocetto, Michelangelo Olivetta, Ugo Amicuzi, Luigi Cirillo, Andrea Rubinacci, Arturo Lecce, Savio Domenico Pandolfo, Nunzio Alberto Langella, Francesco Persico, Francesco Trama, Carmelo Quattrone, Francesco Bottone, Lorenzo Spirito, Marco De Sio, Celeste Manfredi

“…Although with less striking results, novel radiological modalities have also been proposed for bladder cancer (BCa) in recent years. …”
Get full text

Beyond 5‐year survival. A report from the Cooperative Osteosarcoma Study Group (COSS) by Julia S. Fernandes, Claudia Blattmann, Stefanie Hecker‐Nolting, Leo Kager, Matthias Kevric, Vanessa Mettmann, Benjamin Sorg, Marc Fernandes, Stefan S. Bielack

“…It argues for large disease‐oriented databases as well as for very long follow‐up periods. Novel findings will most likely require innovative statistical models to analyze such cohorts.…”
Get full text

Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Implantation in Patients with Severe Iliofemoral Calcifications: Expanding Transfemoral Indications by Matthias Linder, David Grundmann, Caroline Kellner, Till Demal, Lara Waldschmidt, Oliver Bhadra, Sebastian Ludwig, Lisa Voigtländer, Ina von der Heide, Nicole Nebel, Laura Hannen, Johannes Schirmer, Hermann Reichenspurner, Stefan Blankenberg, Lenard Conradi, Niklas Schofer, Andreas Schäfer, Moritz Seiffert

“…IVL may further expand the number of patients eligible for transfemoral TAVI and may help overcome limitations of an alternative access.…”
Get full text

A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol by Dawn Swancutt, Mark Tarrant, Wendy Ingram, Sarah Baldrey, Lorna Burns, Richard Byng, Raff Calitri, Siobhan Creanor, Sarah Dean, Lucy Evans, Laura Gill, Elizabeth Goodwin, Lily Hawkins, Chris Hayward, Sarah Hind, Laura Hollands, Joanne Hosking, Jenny Lloyd, Shokraneh Moghadam, Helen Neilens, Mary O’Kane, Steve Perry, Rod Sheaff, Anne Spencer, Adrian Taylor, Thomas Ward, Ross Watkins, John Wilding, Jonathan Pinkney

“…Methods This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. …”
Get full text

Analysis of Health-Related Quality of Life Reporting in Phase III RCTs of Advanced Genitourinary Tumors by Fabrizio Di Costanzo, Fabiana Napolitano, Fabio Salomone, Anna Rita Amato, Gennaro Alberico, Fortuna Migliaccio, Giovanna Pecoraro, Annachiara Marra, Felice Crocetto, Antonio Ruffo, Sarah Scagliarini, Sabrina Rossetti, Livio Puglia, Marilena Di Napoli, Roberto Bianco, Alberto Servetto, Luigi Formisano

“…Results: We found 85 eligible trials published between 2010 and 2022. Only 1/85 RCTs (1.2%) included HRQoL among primary endpoints. …”
Get full text

Effects of GLP-1 agonists and SGLT2 inhibitors during pregnancy and lactation on offspring outcomes: a systematic review of the evidence by Dion R. P. Muller, Dion R. P. Muller, Dirk J. Stenvers, Dirk J. Stenvers, Arjan Malekzadeh, Frederik Holleman, Rebecca C. Painter, Rebecca C. Painter, Sarah E. Siegelaar, Sarah E. Siegelaar

“…Aims/hypothesisGlucagon-like peptide 1 (GLP-1) agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors are novel drugs which have recently seen rapid uptake in the treatment of type 2 diabetes and obesity. …”
Get full text

A panel of seven protein tumour markers for effective and affordable multi-cancer early detection by artificial intelligence: a large-scale and multicentre case–control studyResear... by Yi Luan, Guolin Zhong, Shiyong Li, Wei Wu, Xiaoqiang Liu, Dandan Zhu, Yumin Feng, Yixia Zhang, Chaohui Duan, Mao Mao

“…Interpretation: OncoSeek significantly outperforms the conventional clinical method, representing a novel blood-based test for MCED which is non-invasive, easy, efficient, and robust. …”
Get full text

Ki67 as a Predictor of Response to PARP Inhibitors in Platinum Sensitive BRCA Wild Type Ovarian Cancer: The MITO 37 Retrospective Study by Valentina Tuninetti, Eleonora Ghisoni, Sandro Pignata, Elisa Picardo, Francesco Raspagliesi, Claudia Andreetta, Elena Maldi, Grazia Artioli, Serafina Mammoliti, Lucia Zanchi, Angelica Sikokis, Nicoletta Biglia, Alessandro Parisi, Vincenzo Dario Mandato, Claudia Carella, Gennaro Cormio, Marco Marinaccio, Andrea Puppo, Biagio Paolini, Lucia Borsotti, Giulia Scotto, Margherita Turinetto, Dario Sangiolo, Massimo Di Maio, Giorgio Valabrega

“…Background: There is compelling need for novel biomarkers to predict response to PARP inhibitors (PARPi) in BRCA wild-type (WT) ovarian cancer (OC). …”
Get full text

Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. by Raphael J Landovitz, Sue Li, Beatriz Grinsztejn, Halima Dawood, Albert Y Liu, Manya Magnus, Mina C Hosseinipour, Ravindre Panchia, Leslie Cottle, Gordon Chau, Paul Richardson, Mark A Marzinke, Craig W Hendrix, Susan H Eshleman, Yinfeng Zhang, Elizabeth Tolley, Jeremy Sugarman, Ryan Kofron, Adeola Adeyeye, David Burns, Alex R Rinehart, David Margolis, William R Spreen, Myron S Cohen, Marybeth McCauley, Joseph J Eron

“…BACKGROUND:Cabotegravir (CAB) is a novel strand-transfer integrase inhibitor being developed for HIV treatment and prevention. …”
Get full text

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial by Debbie Tallon, Laura Thomas, Sally Brabyn, Brian Chi Fung Ching, Jane Sungmin Hahn, Berry Jude, Mekeda X Logan, Alex Burrage, Fiona Fox, Simon Gilbody, Paul Lanham, Glyn Lewis, Jinshuo Li, Stephanie J. MacNeill, Irwin Nazareth, Steve Parrott, Tim J. Peters, Roz Shafran, Katrina Turner, Chris Williams, David Kessler, Nicola Wiles

“…The INTERACT trial will evaluate this novel integration in terms of clinical and cost-effectiveness, and acceptability to therapists and clients. …”
Get full text