Extended HPV genotyping by the BD Onclarity assay: concordance with screening HPV-DNA assays, triage biomarkers, and histopathology in women from the NTCC2 study by Laura De Marco, Simonetta Bisanzi, Guglielmo Ronco, Pamela Mancuso, Francesca Carozzi, Elena Allia, Raffaella Rizzolo, Daniela Gustinucci, Helena Frayle, Jessica Viti, Anna Iossa, Elena Cesarini, Simonetta Bulletti, Basilio Passamonti, Silvia Gori, Laura Toniolo, Francesco Venturelli, Annarosa Del Mistro, Paolo Giorgi Rossi, Maria Benevolo

“…Nevertheless, the agreement is substantial for women with high-grade cytology, histologically confirmed CIN3, and p16/ki67 or mRNA positivity at triage, thus confirming a good clinical performance of all the tests used.The NTCC2 trial is registered as Clinicaltrials.gov identifier NCT01837693.IMPORTANCELarge randomized clinical trials have demonstrated that human papillomavirus (HPV) testing for high-risk types is more effective than cytology in detecting pre-cancerous lesions and preventing cervical cancer. …”
Get full text

Recommendations for the diagnosis and treatment of anti-neutrophil cytoplasmic autoantibody associated vasculitis by Enrique Morales, Iñigo Rúa-Figueroa, José Luis Callejas Rubio, Ana Ávila Bernabéu, Ricardo Blanco Alonso, María C. Cid Xutgla, Gema Fernández Juárez, Natalia Mena-Vázquez, Juan José Ríos Blanco, Joaquín Manrique Escola, F. Javier Narváez García, Bernardo Sopeña, Luis F. Quintana Porras, Susana Romero-Yuste, Roser Solans Laqué

“…The use of glucocorticoids, cyclophosphamide and other immunosupressants (such as azathioprine, mychophenolate and methotrexate) was optimised in a series of clinical trials that established the treatment of reference. …”
Get full text

Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study by Andrew Ng, Esther W Chan, Duo Huang, Cheung Chi Lam, Ning Tan, Chung Wah Siu, Jo Jo Hai, Ji-yan Chen, Chun Ka Wong, Mi Zhou, Yuk Ming LAU, Chor Cheung Frankie Tam, Yiu Tung Anthony Wong, See Yue Arthur Yung, Ki Wan Kelvin Chan, Yingqing Feng, Chi Yui Yung, Kwok Lun Lee, Chun Wai Choi, Ho Lam, Katherine Fan, Man Hong Jim, Kai Hang Yiu, Bryan P. Yan

“…Results will be published in peer-reviewed journals.Trial registration number ClinicalTrials.gov Registry (NCT04045093); pre-results.…”
Get full text

Simulation-based training program effect on pediatric nurses’ knowledge and performance regarding heel-prick during newborn blood screening test by Abdulaziz Asiri, Abeer A. Almowafy, Shimaa M. Moursy, Hanan A. Abd-Elhay, Shimaa Abdelrahim Khalaf Ahmed, Aml S. Abdelrahem, Marim T. Abo Seif, Faransa A. Ahmed

“…By improving nurses’ knowledge and performance, we can reduce the dangers caused by their training on real neonates; also, it can be an attractive way to train nurses when trained by simulators and ultimately enhance the overall quality of nursing services in the hospital. Clinical trial number This study was registered by Clinical Trials.gov Identifier: (NCT06685471|| https://www.clinicaltrials.gov/ ) with the clinical Trail registry (12-11-2024).…”
Get full text

Perinatal mortality and other severe adverse outcomes following planned birth at 39 weeks versus expectant management in low-risk women: a population based cohort studyResearch in... by Kylie Crawford, Waldemar A. Carlo, Anthony Odibo, Aris Papageorghiou, William Tarnow-Mordi, Sailesh Kumar

Get full text

Impact of primary care benefits on healthcare utilisation and estimated out-of-pocket expenses in urban, rural and remote settings in the Philippines by Antonio L Dans, Arianna Maever L Amit, Leonila F Dans, Gillian Sandigan, Regine Ynez H De Mesa, Mia P Rey, Josephine T Sanchez, Cara Lois T Galingana, Nannette Bernal-Sundiang, Maria Rhodora N Aquino, Johanna Faye E Lopez, Janelle Micaela S Panganiban, Romelei Camiling-Alfonso, Jose Rafael A Marfori, Ramon Pedro Paterno, Carol Stephanie Chua Tan-Lim, Noleen Marie Fabian, Chad Lester Lastrilla, Miguel Callo

Get full text

Interaction of human gut microbiota and local immune system in progression of colorectal adenoma (MIMICA-1): a protocol for a prospective, observational cohort study by Jurate Valciukiene, Egle Lastauskiene, Aida Laurinaviciene, Aida Laurinaviciene, Matas Jakubauskas, Marius Kryzauskas, Ruta Barbora Valkiuniene, Ruta Barbora Valkiuniene, Renaldas Augulis, Renaldas Augulis, Ausra Garnelyte, Justinas Kavoliunas, Ugne Silinskaite, Tomas Poskus

“…Moreover, AI-based analysis of immune infiltrates could become additional diagnostic and prognostic tool in precancerous lesions prior to the development of colorectal cancer.RegistrationThe study is registered at the Australian New Zealand Clinical Trials Registry (ACTRN12624000976583) https://www.anzctr.org.au/.…”
Get full text

Status of cerebrovascular autoregulation relates to outcome in severe paediatric head injury: STARSHIP, a prospective multicentre validation studyResearch in context by Shruti Agrawal, Claudia Smith, Stefan Y. Bogli, Michal M. Placek, Manuel Cabeleira, Deborah White, Esther Daubney, Adam Young, Erta Beqiri, Riaz Kayani, Diarmuid O'Donnell, Nazima Pathan, Suzanna Watson, Anna Maw, Matthew Ganrett, Hari Krishan Kanthimathianathan, Harish Bangalore, Santosh Sundararajan, Gayathri Subramanian, Dusan Raffaj, Avishay Sarfatti, Simona Lampareillo, Anton Mayer, Oliver Ross, Marek Czosnyka, Peter J. Hutchinson, Peter Smielewski, Carly Tooke, Caroline Payne, Holly Belfield, Amisha Mistry, Collette Spencer, Claire Jennings, Lara Bunni, Laura Anderson, Emily Morgan, Melanie James, Rebecca Beckley, Tahnima Khatun, Hafiza Khatun, Olivia Nugent, Richard Aldridge, Ruth Morgan, Julie Morcombe, Martin Quinton, Catherine Postlethwaite, Jenny Pond, Jessica Cutler, Caitlin Oxford

“…Methods: Studying Trends of AutoRegulation in Severe Head Injury in Paediatrics (STARSHIP) (clinicalTrials.gov identifier-NCT0688462), was a prospective, multicentre, observational, research database study conducted across 10 identified UK Paediatric Intensive Care Units from 01.07.2018 till 31.04.2024. …”
Get full text

Deciphering molecular and cellular ex vivo responses to bispecific antibodies PD1-TIM3 and PD1-LAG3 in human tumors by Alfred Zippelius, Petra Herzig, Pratiksha Gulati, Christian Klein, Marta Trüb, Kirsten D Mertz, Robert Rosenberg, Viola Heinzelmann-Schwarz, Mark Wiese, Didier Lardinois, Pablo Umana, Marina Natoli, Klas Hatje, Fabian Junker, Zhiwen Jiang, Iakov I Davydov, Markus Germann, Daniel Marbach, Adrian Zwick, Patrick Weber, Stefan Seeber, Lothar Tietze, Laura Codarri-Deak, Henry Kao

“…Interestingly, LAG-3 protein upregulation was detected as a unique pharmacodynamic effect mediated by PD1-LAG3, but not by PD1-TIM3 or anti-PD-1.Conclusions Our in vitro system reliably assessed responses to bispecific antibodies co-targeting PD-1 together with LAG-3 or TIM-3 using patients’ tumor infiltrating immune cells and revealed transcriptional and phenotypic imprinting by bispecific antibody formats currently tested in early clinical trials.…”
Get full text

Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch... by Marietta Stadler, Natalie Zaremba, Amy Harrison, Jennie Brown, Divina Pillay, Jacqueline Allan, Rachael Tan, Salma Ayis, Emmanouela Konstantara, Janet Treasure, David Hopkins, Khalida Ismail

“…Analyses were conducted as intention-to-treat. ClinicalTrials.gov NCT05140564. Findings: Of the 98 screened, 40 participants with T1DE were randomised (recruitment rate: 40.81%; 95% CI: 31.60%, 50.72%): 38 women, 1 man, 1 trans man (37 White, 1 White/Asian, 1 Black; 39 ± 11 years old, diabetes duration 22 ± 15 years, HbA1c 9.1 ± 2.6%). …”
Get full text

Radiological abnormalities persist following COVID-19 and correlate with impaired health-related quality of life: a prospective cohort study of hospitalised patients by Rhian M Touyz, Ninian N Lang, Kevin G Blyth, Naveed Sattar, Patrick B Mark, Stefan Siebert, Colin Berry, Iain McInnes, Giles Roditi, Neil Basu, David Corcoran, Kenneth Mangion, Alex McConnachie, David Carrick, Jaclyn Carberry, Stuart Watkins, Paul Welsh, Sabrina Nordin, Katherine Scott, Christian Delles, Bernard Kelly, Fraser Goldie, John GF Cleland, Sharon Kean, Peter Kellman, David J Lowe, Andrew J Morrow, Antonia Ho, Rosemary Woodward, Tracey Hopkins, Ryan Wereski, Massimo Palmarini, Alasdair McIntosh, Campbell Rogers, Ammani Brown, Catherine Bagot, Kathryn Scott, Robert Sykes, Colin Church, Claire Rooney, Nicola Ryan, Clare Orange, Dirk Husmeier, Xiaoyu Luo, PETER W MACFARLANE, Heerajnarain Bulluck, Iain Findlay, Evonne McLennan, Michael Briscoe, Oliver Peck, Alastair J Rankin, Gruschen Veldtman, Varun Sharma, Kathryn McLaren, Elaine Butler, Sarah Mullen, Andrew Morrow, Patrick Mark, Daniel Doherty, Alexander Payne, Jennifer S Lees, Kaitlin J Mayne, Louise Inglis, Anna Kamdar, Hannah Bayes, Vivienne B Gibson, Lynsey Gillespie, Douglas Grieve, Pauline Hall Barrientos, Christopher McGinley, Connor Mckee, Sarah Allwood-Spiers, Sarah Weeden, Laura Knox, Lynn Abel, David Stobo, Andrew Dougherty, Liam Peng, David Barrie Stobo, Sylvia Wright, Stephen Dobbin, Keith Gillis, Sarah A Spiers, Ian Fergus, Kirsty Fallon, Lesley Gilmour, Chloe Cowan, Jurgen Van-Melckebeke, Kim Moran-Jones, Debra Stuart, Maureen Travers, Laura Dymock, Fiona Savage, Nicola Tynan, Sau Lee Chang, Mhairi Dupre, Lindsey Norton, George Bruce, Rosario Gonzalez-Lopez, Rebecca Stace, Dionne Russell, Jean Watt, Shahid Latif, Nick Hill, Amy Collinsworth, Ross McGeoch Vera Lennie, Robin P Weir

“…We present a prospective, observational, multicentre cohort study using multimodality imaging to describe the pulmonary sequelae of patients hospitalised with COVID-19, predictors of persistent abnormal radiology and implications on health status.Methods In survivors of COVID-19, we performed convalescent CT pulmonary angiogram and high-resolution CT imaging as part of the CISCO-19 study (ClinicalTrials.gov ID NCT04403607). This included serial blood biomarkers and patient-reported outcomes 28–60 days following discharge from hospital.Results Of the COVID-19 cohort, 88 (56%) patients of the COVID-19 cohort (n = 159; mean age, 55 years; 43% female) had persisting radiological abnormalities at 28–60 days postdischarge. …”
Get full text

Initial treatment with a single capsule containing half-dose quadruple therapy vs standard-dose dual therapy in hypertensive patients (QUADUAL): a randomized, blinded, crossover tr... by Xiexiong Zhao, Tao Liu, Qiong Yang, Guoping Yang, Xingli Li, Xiaohong Tang, Jingle Li, Zhongshu Liang, Anying Li, Lixiong Zeng, Juan Wen, Xiaoyan Wang, Liping Peng, Wenjuan Wang, Jingjing Cai, Ye Chen, Miao Huang, Ruixuan Li, Ru Fu, Lin Zhao, Xiaogang Li, Weihong Jiang

“…Trial registration ClinicalTrials.gov Identifier: NCT05377203.…”
Get full text

β2-Microglobulin and Neutrophil Gelatinase-Associated Lipocalin, Potential Novel Urine Biomarkers in Periodontitis: A Cross-Sectional Study in Japanese by Mayuka Nakajima, Michihiro Hosojima, Koichi Tabeta, Sayuri Miyauchi, Miki Yamada-Hara, Naoki Takahashi, Haruna Miyazawa, Yumi Matsuda-Matsukawa, Keisuke Sato, Noriko Sugita, Yasutaka Komatsu, Tomomi Ishikawa, Kazuhiro Akiishi, Kazuhisa Yamazaki, Kiminori Kato, Akihiko Saito, Hiromasa Yoshie

“…This trial is registered with the UMIN Clinical Trials Registry UMIN000013485.…”
Get full text

Modulation of myeloid and T cells in vivo by Bruton’s tyrosine kinase inhibitor ibrutinib in patients with metastatic pancreatic ductal adenocarcinoma by Li Zhang, Matthew Crocker, Lawrence Fong, Lisa M Coussens, Charles D Lopez, Shamilene Sivagnanam, Meenal Sinha, Brandon Chen, Jaqueline Marquez, Alexander Cheung, Whitney Tamaki, Jacob Stultz, Kendra Todd, Courtney Betts, Madeline J Griffith, Isabelle Solman, Eric Liu, Denise Pener, Anne Fahlman, Erin Taber, Kimberly Lerner, Brindha Rajagopalan, Clarisha Ware, Mark Bridge, Johnson Vo, Hannah Dragomanovich, Julie Sudduth-Klinger, Gina Vaccaro, Margaret Tempero

“…This led to a phase 1b clinical trial to determine the safety, tolerability, and immunologic effects of ibrutinib treatment in patients with advanced PDAC.Methods Previously untreated patients with PDAC were enrolled in a phase 1b clinical trial (ClinicalTrials.gov) to determine the safety, toxicity, and maximal tolerated dose of ibrutinib when administered with the standard regimen of gemcitabine and nab-paclitaxel. …”
Get full text

Development and usability testing of a multifaceted intervention to reduce low-value injury care by Mélanie Bérubé, Alexandra Lapierre, Michael Sykes, Jeremy Grimshaw, Alexis F. Turgeon, François Lauzier, Monica Taljaard, Henry Thomas Stelfox, Holly Witteman, Simon Berthelot, Éric Mercier, Catherine Gonthier, Jérôme Paquet, Robert Fowler, Natalie Yanchar, Barbara Haas, Paule Lessard-Bonaventure, Patrick Archambault, Belinda Gabbe, Jason R. Guertin, Yougdong Ouyang, Lynne Moore, the Canadian Traumatic Brain Injury Research Consortium

“…Trial registration This protocol has been registered on ClinicalTrials.gov (February 24th 2023, #NCT05744154, https://clinicaltrials.gov/ct2/show/NCT05744154 ).…”
Get full text

Trifluridine-tipiracil in previously treated patients with oestrogen receptor-positive, HER2-negative metastatic breast cancer (BOOG 2019-01 TIBET trial): a single-arm, multicentre... by Niels A.D. Guchelaar, Ron H.J. Mathijssen, Maaike de Boer, Marlies L. van Bekkum, Joan B. Heijns, Birgit E.P.J. Vriens, Mandy M. van Rosmalen, Lonneke W. Kessels, Lisanne Hamming, Karin J. Beelen, Peter Nieboer, Susan M. van den Berg, Esther Oomen-de Hoop, Rhodé M. Bijlsma, Monique E.M.M. Bos

“…The study was registered within ClinicalTrials.gov (NCT04489173) and is closed for inclusion. …”
Get full text

PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the emergency department (PRONTO): protocol for a multicentre, open-label,... by David Taylor-Robinson, Steve Goodacre, Neil French, Richard Body, Kerenza Hood, Emma Thomas-Jones, Jane Daniels, Sarah Walker, Ingeborg Welters, Mike Bradburn, Paul Schmidt, Enitan Carrol, Lucy Brookes-Howell, Sarah Milosevic, Andrew Tabner, Philip Pallmann, Stephen Aston, Gavin Barlow, Emma Richards, Emmanuel Nsutebu, Philip Howard, Matthew Inada-Kim, Stacy Todd, Fiona McGill, Martin Llewelyn, Louis Wihelmus Niessen, Joanne Euden, Julie Carman, Stephanie Gilbert, Sam Clarkstone, Jacqui Hughes, Lena Meister, Angela Brain, Matthew Scarborough, Sian O'Shea, Claire James

Get full text

Neoadjuvant apatinib addition to sintilimab and carboplatin-taxane based chemotherapy in patients with early triple-negative breast cancer: the phase 2 NeoSAC trial by Guoshuang Shen, Zhilin Liu, Miaozhou Wang, Yi Zhao, Xinlan Liu, Yujin Hou, Wenbiao Ma, Jingqi Han, Xiaofeng Zhou, Dengfeng Ren, Fuxing Zhao, Zitao Li, Shifen Huang, Yongzhi Chen, Yingjian He, Yan Liu, Zijun Zhu, Yongxin Li, Jinming Li, Mengting Da, Hongnan Mo, Feng Du, Liang Cui, Jing Bai, Zhen Liu, Fei Ma, Jiuda Zhao

“…Our study suggests that apatinib, sintilimab combined with carboplatin and nab-paclitaxel chemotherapy showed a promising clinical activity and manageable safety profile in early TNBC and merits further study. ClinicalTrials.gov registration: NCT04722718.…”
Get full text

Adherence to a digital therapeutic mediates the relationship between momentary self-regulation and health risk behaviors by Enzo G. Plaitano, Enzo G. Plaitano, Daniel McNeish, Sophia M. Bartels, Sophia M. Bartels, Kathleen Bell, Jesse Dallery, Michael Grabinski, Michaela Kiernan, Hannah A. Lavoie, Hannah A. Lavoie, Shea M. Lemley, Michael R. Lowe, David P. MacKinnon, Stephen A. Metcalf, Stephen A. Metcalf, Lisa Onken, Judith J. Prochaska, Cady Lauren Sand, Cady Lauren Sand, Emily A. Scherer, Luke E. Stoeckel, Haiyi Xie, Lisa A. Marsch

“…Together, this work demonstrated the ability to digitally assess the transdiagnostic mediating effect of momentary self-regulation on medical regimen adherence and pro-health behavioral outcomes. Clinical Trial RegistrationClinicalTrials.gov, identifier (NCT03774433).…”
Get full text

Genetic Mutations of Tim-3 Ligand and Exhausted Tim-3+ CD8+ T Cells and Survival in Diffuse Large B Cell Lymphoma by Tingting Zhang, Tianyuan Ren, Zheng Song, Jing Zhao, Lei Jiao, Zhenzhen Zhang, Jin He, Xianming Liu, Lihua Qiu, Lanfang Li, Shiyong Zhou, Bin Meng, Qiongli Zhai, Xiubao Ren, Zhengzi Qian, Xianhuo Wang, Huilai Zhang

“…Tim-3 is a promising target for antitumor immunotherapy. A number of clinical trials are evaluating the efficacy of anti-Tim-3 therapies as a single agent or combinations in solid tumors and haematologic malignancies. …”
Get full text