Safety and efficacy of the therapeutic DNA-based vaccine VB10.16 in combination with atezolizumab in persistent, recurrent or metastatic HPV16-positive cervical cancer: a multicent... by Hannelore Denys, Frederik Marmé, Frederic Forget, Lukas Rob, Pawel Blecharz, Kristina Lindemann, Peter Hillemanns, Linn Wölber, Theresa Link, Jean-Francois Baurain, Mariusz Bidziński, Linn Woelber, Michal ZikÁN, Josef Chovanec, Christian Dannecker, Stéphanie Henry, Hannelore G Denys, Velko Minchev, Anders Rosholm, Kaja C G Berg, Roberto S Oliveri, Marchela Koleva, Bozhil Robev

“…We investigated the safety, efficacy, and immunogenicity of the therapeutic DNA-based vaccine VB10.16 combined with the immune checkpoint inhibitor atezolizumab in patients with human papillomavirus (HPV)16-positive r/m cervical cancer.Patients and methods This multicenter, single-arm, phase 2a study (NCT04405349, registered 26 May 2020) enrolled adult patients with persistent, r/m HPV16-positive cervical cancer. …”
Get full text

Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry by Elif Kaya, Jochen Senges, Matthias Hochadel, Lars Eckardt, Dietrich Andresen, Hüseyin Ince, Stefan G. Spitzer, Thomas Kleemann, Sebastian S.K. Maier, Werner Jung, Christoph Stellbrink, Tienush Rassaf, Reza Wakili

“…Median follow‐up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non‐DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non‐DM patients had a diagnosis of HF. …”
Get full text

Prevalence of potentially inappropriate prescribing in a subpopulation of older European clinical trial participants: a cross-sectional study by Manuel R Blum, Patricia M Kearney, Rose Galvin, Christine Baumgartner, Anette Van Dorland, Stephen Byrne, Nicolas Rodondi, Simon P Mooijaart, Carol Sinnott, Rosalinde K E Poortvliet, Jacobijn Gussekloo, David O Riordan, Carole Elodie Aubert, Kieran A Walsh, Robert S Du Puy, J Wouter Jukema, Vera McCarthy, Elaine K Walsh, Tinh-Hai Collet, Olaf M Dekkers

“…Objectives To estimate and compare the prevalence and type of potentially inappropriate prescribing (PIP) and potential prescribing omissions (PPOs) among community-dwelling older adults (≥65 years) enrolled to a clinical trial in three European countries.Design A secondary analysis of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial dataset.Participants A subset of 48/80 PIP and 22/34 PPOs indicators from the Screening Tool of Older Persons Prescriptions/Screening Tool to Alert doctors to Right Treatment (STOPP/START) V2 criteria were applied to prescribed medication data for 532/737 trial participants in Ireland, Switzerland and the Netherlands.Results The overall prevalence of PIP was lower in the Irish participants (8.7%) compared with the Swiss (16.7%) and Dutch (12.5%) participants (P=0.15) and was not statistically significant. …”
Get full text

Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial by Verónica V. Olavarría, Paola R. Campodónico, Valeska Vollrath, Paula von Geldern, Carolina Velásquez, Patricia Pavez, Barbara Valente, Pamela Donoso, Alexandra Ginesta, Gabriel Cavada, Enrico Mazzon, Víctor Navia, Matías Guzmán, Pablo Brinck, Andrés Gallardo, Pablo Gonzalez, Pablo M. Lavados

“…Results From August 2018 to October 2022, 200 participants were enrolled (97 randomized to the low-fat diet and 103 to the MeDi), with 189 (94.5%) completing the study. …”
Get full text

Whole lung radiomic features are associated with overall survival in patients with locally advanced non-small cell lung cancer treated with definitive radiotherapy by Meng Yan, Zhen Zhang, Jia Tian, Jiaqi Yu, Andre Dekker, Dirk de Ruysscher, Leonard Wee, Lujun Zhao

“…Methods A total of 661 patients with LA-NSCLC treated with definitive radiotherapy in combination with chemotherapy were enrolled in this study, with 292 patients in the training set, 57 patients from the same hospital from January to December 2017 as an independent test set (test-set-1), 83 patients from a multi-institutional prospective clinical trial data set (RTOG0617) as test-set-2, and 229 patients from a Dutch radiotherapy center as test-set-3. …”
Get full text

Central venous oxygen saturation changes as a reliable predictor of the change of CI in septic shock: To explore potential influencing factors by Ran An, Xi-Xi Wan, Yan Chen, Run Dong, Chun-Yao Wang, Wei Jiang, Li Weng, Bin Du

“…The patients had an acute physiology and chronic health evaluation II score of 24 ± 8, a sequential organ failure assessment score of 11 ± 4, and a blood lactate level of (3.2 ± 3.1) mmol/L at enrollment. After the fluid challenge, the ΔScvO2 (mmHg) in the responders was greater than that in the non-responders (4 ± 6 vs. 1 ± 3, p = 0.019). …”
Get full text

A randomized, placebo-controlled trial of the BTK inhibitor zanubrutinib in hospitalized patients with COVID-19 respiratory distress: immune biomarker and clinical findings by Steven P. Treon, Camille N. Kotton, David J. Park, Giorgia Moranzoni, Camilla K. Lemvigh, Joseph C. Gathe, Tilly A. Varughese, Christopher F. Barnett, Johnny M. Belenchia, Nina M. Clark, Charles M. Farber, Muhammad Bilal Abid, Gulrayz Ahmed, Christopher J. Patterson, Maria L. Guerrera, Jacob D. Soumerai, Vipheaviny A. Chea, Isabel P. Carulli, Jackson Southard, Shuqiang Li, Catherine J. Wu, Kenneth J. Livak, Eric Holmgren, Pil Kim, Carrie Shi, Holly Lin, Vanitha Ramakrishnan, Ying Ou, Scott Olszewski, Lars Rønn Olsen, Derin B. Keskin, Derin B. Keskin, Zachary R. Hunter, Christopher Tankersley, Todd Zimmerman, Binod Dhakal

“…Those on mechanical ventilation ≤24 hours were enrolled in cohort 2. Patients were randomized 1:1 to zanubrutinib 320 mg once daily or placebo (cohort 1), or received zanubrutinib 320 mg once daily (cohort 2). …”
Get full text

Intratumoral pan-ErbB targeted CAR-T for head and neck squamous cell carcinoma: interim analysis of the T4 immunotherapy study by Fiona Reid, Sophie Papa, John Maher, Jean-Pierre Jeannon, James Spicer, Victoria Gibson, Selvam Thavaraj, Michael Metoudi, Christopher Fisher, Nicholas Beckley-Hoelscher, Andrew Hope, Maria Elstad, Antonella Adami, Richard Beatson, Molly Sarah George, Daniela Achkova, Evangelia Williams, Sefina Arif, Abdel Douri, Marc Delord, Mike Lyne, Dharshene Shivapatham, Sakina Gooljar, Arindam Mitra, Linda Gomm, Cienne Morton, Rhonda Henley-Smith, Alice Santambrogio, Cynthia Andoniadou, Sarah Allen, Gary J R Cook, Ana C Parente-Pereira, David M Davies, Farzin Farzaneh, Anna Schurich, Teresa Guerrero-Urbano

“…Dose of CAR T-cells was escalated in 5 cohorts from 1×107−1×109 T4+ T-cells, administered without prior lymphodepletion.Results Despite baseline lymphopenia in most enrolled subjects, the target cell dose was successfully manufactured in all cases, yielding up to 7.5 billion T-cells (67.5±11.8% transduced), without any batch failures. …”
Get full text

Safety and efficacy of PD-1 inhibitor (sintilimab) combined with transarterial chemoembolization as the initial treatment in patients with intermediate-stage hepatocellular carcino... by Lei Yu, Lan Zhang, Xin Xu, Zheng Wang, Jian Zhou, Jia Fan, Wentao Wang, Zhenggang Ren, Lixing Li, Peiran Huang

“…The study aims to evaluate the efficacy and safety of this treatment strategy for such patients.Methods In this single-arm, prospective, phase II study, we enrolled eligible patients with HCC who were treated with TACE plus programmed cell death protein 1 (PD-1) inhibitors (sintilimab) from April 2021 to February 2023. …”
Get full text

Body image and attitudes toward cosmetic surgeries among female college students in the United Arab Emirates: A cross-sectional study by Ahmad M. Al-Bashaireh, Yousef Aljawarneh, Osama Alkouri, Foad Alzoughool, Amal Alhefeiti, Amnah Aldhuhoori, Amnah Al Kaabi, Aseilah Alkaabi, Fawzia Alnaqbi

“…Results: A total of 783 participants were enrolled in this study. The mean age of the participants was 20.95 years (SD = 2.149). …”
Get full text

Identification and characteristics of distressed patients with coronary heart disease and insufficiently controlled medical risk factors: baseline findings and sex differences from... by Christoph Herrmann-Lingen, Christoph Herrmann-Lingen, Monika Sadlonova, Monika Sadlonova, Monika Sadlonova, Monika Sadlonova, Monika Sadlonova, Ingrid Becker, Kristina Bersch, Franziska Geiser, Martin Hellmich, Ingrid Kindermann, Matthias Michal, Mariel Nöhre, Astrid Petersmann, Astrid Petersmann, Rolf Wachter, Rolf Wachter, Rolf Wachter, Birgit Herbeck Belnap, Birgit Herbeck Belnap, Christian Albus

“…Satisfaction with care before the trial did not differ by sex but was far lower for psychosocial care than for treatment of heart disease (p<0.001).DiscussionTEACH enrolled a patient sample with persisting distress and a typical risk factor profile. …”
Get full text

Transcriptomic Profiling and Tumor Microenvironment Classification Reveal Unique and Dynamic Immune Biology in HIV-Associated Kaposi Sarcoma by Jihua Yang, Ayse Ece Cali Daylan, Aleksei Shevkoplias, Ekaterina Postovalova, Meng Wang, Andrey Tyshevich, Matthew Lee, Hiba Narvel, Ksenia Zornikova, Nara Shin, Nikita Kotlov, Luca Paoluzzi, Changcheng Zhu, Balazs Halmos, Xingxing Zang, Haiying Cheng

“…Nine KS patients (four HIV-negative and five HIV-positive) were enrolled in the study. Longitudinally collected KS samples from three patients (one HIV-negative and two HIV-positive) allowed for the investigation of dynamic TME changes within individual patients. …”
Get full text

The association between metabolomic profiles of lifestyle and the latent phase of incident chronic kidney disease in the UK Population by Tingting Jin, Yunqi Wu, Siyi Zhang, Ya Peng, Yao Lin, Saijun Zhou, Hongyan Liu, Pei Yu

“…Therefore, we utilized the latest metabolomics data from the UK Biobank to explore the relationship between plasma metabolites and lifestyle factors, as well as to investigate the associations between various factors, including lifestyle-related metabolites, and the latent phase of CKD onset. The study enrolled approximately 500,000 participants from the UK Biobank (UKB) between 2006 and 2010, excluding 447,163 individuals with missing data for any metabolite in the NMR metabolomics, any biomarker in the blood chemistry (including eGFR, albumin, or cystatin C), any factor required for constructing the lifestyle score, or a baseline diagnosis of CKD. …”
Get full text

Fact-finding and risk factor analysis of chemotherapy-induced nausea and vomiting in children with solid tumors: a prospective observational study by Miaomiao Shao, Ying Li, Jing Qin, Yuchen Zhou, Yixin Sun, Peiyi Yang, Xisi Wang, Cheng Huang, Yan Su, Wen Zhao

“…Methods Children aged 1–18 years with solid tumors treated with HEC were enrolled. A structured diary was used to record CINV data, and the pediatric nausea assessment tool (PeNAT) was employed to assess the degree of nausea. …”
Get full text

Performance of a hybrid capture-based target enrichment next-generation sequencing for the identification of respiratory pathogens and resistance-associated genes in patients with... by Wei-Yu Hsu, Ting-Wei Kao, Hsin-Ching Cho, Sheng-Yuan Ruan, Tai-Fen Lee, Yu-Tsung Huang, Jung-Yien Chien

“…A total of 83 subjects were enrolled. The most prevalent pathogens detected by RPIP were Rothia mucilaginosa, Stenotrophomonas maltophilia, Pseudomonas aeruginosa; herpes simplex virus-1, cytomegalovirus, and Epstein-Barr virus, and Pneumocystis jirovecii. …”
Get full text

Impact of Sex on Infection Risk in Patients with Systemic Lupus Erythematosus by R. Borrelli, S. Nicola, F. Corradi, I. Badiu, L. Lo Sardo, N. Rashidy, A. Quinternetto, M. Mazzola, F. Meli, E. Saracco, I. Vitali, S. Negrini, L. Brussino

“…<b>Materials and Methods:</b> A retrospective study was conducted, enrolling patients and dividing them into two groups based on their biological sex. …”
Get full text

Artificial intelligence-based, non-invasive assessment of the central aortic pressure in adults after operative or interventional treatment of aortic coarctation by Renate Oberhoffer, Peter Ewert, Harald Kaemmerer, Nicole Nagdyman, Oliver Dewald, Frank Klawonn, Michael Huntgeburth, Andreas Eicken, Christian Meierhofer, Sebastian Freilinger, Martin Middeke, Pinar Bambul Heck, Annika Freiberger, Frank Harig, Manuel Lösch, Fritz Mellert, Fabian von Scheidt, Elsa Ury, Nicole Wolfrum, Ann-Sophie Kaemmerer-Suleiman, Mathieu N. Suleiman

“…This study evaluated the use of artificial intelligence-based pulse wave analysis (AI-PWA) to assess central aortic blood pressure (CABP) and related parameters in post-treatment CoA patients.Methods This exploratory, cross-sectional study enrolled 47 adults with CoA, between June 2023 and May 2024. …”
Get full text

Effect of transcranial direct current stimulation on postoperative sleep disturbance in older patients undergoing lower limb major arthroplasty: a prospective, double-blind, pilot,... by Chunyan Li, Jie Yang, He Liu, Wen Tan, Song Zhang, Hongxing Zhang, Yuan Han, Mingshu Tao, Rongguang Liu, Jiaxing Fang, Dexian Chen, Qi Wei, Xingyu Xiong, Wenxin Zhao, Junli Cao

“…The primary outcomes were the objective sleep measures on postoperative nights (N) 1 and N2.Results 116 inpatients were assessed for eligibility, and a total of 92 patients were enrolled; 47 received a-tDCS and 45 received s-tDCS. tDCS improved PSD by altering the following sleep measures in the a-tDCS and s-tDCS groups; the respective comparisons were as follows: the promotion of rapid eye movement (REM) sleep time on N1 (64.5 (33.5–105.5) vs 19.0 (0.0, 45.0) min, F=20.10, p&lt;0.001) and N2 (75.0 (36.0–120.8) vs 30.0 (1.3–59.3) min, F=12.55, p&lt;0.001); the total sleep time on N1 (506.0 (408.0–561.0) vs 392.0 (243.0–483.5) min, F=14.13, p&lt;0.001) and N2 (488.5 (455.5–548.5) vs 346.0 (286.5–517.5) min, F=7.36, p=0.007); the deep sleep time on N1 (130.0 (103.3–177.0) vs 42.5 (9.8–100.8) min, F=24.4, p&lt;0.001) and N2 (103.5 (46.0–154.8) vs 57.5 (23.3–106.5) min, F=8.4, p=0.004); and the percentages of light sleep and REM sleep on N1 and N2 (p&lt;0.05 for each). …”
Get full text

The Effect of Postoperative Tranexamic Acid and Dexamethasone on Quality of Recovery After Arthroscopic Rotator Cuff Repair: a Double-Blinded, Randomized Controlled Trial by Jiang X, Xu C, Yuan C, Gao W, Liu W, Wang Y, Wang H, Yu W, He Y

“…Our goal is to relieve the acute postoperative pain and promote fast recovery and rapid discharge for ARCR patients.Patients and Methods: Ninety-six patients who underwent ARCR from December 2023 to March 2024 were enrolled in this double-blinded, randomized control trial (Registration number, ChiCTR2300078507). …”
Get full text

Accuracy of ESAT6-CFP10 skin test compared with tuberculin skin test in a healthy population: a randomized, blind, parallel controlled phase III clinical study by Xiaoyan Ding, Weixin Du, Qiao Liu, Lifeng Tao, Yan Shao, Peng Lu, Huaiyu Yang, Xiaoxue Teng, Cheng Chen, Zhongqi Li, Jinbiao Lu, Aihua Zhao, Guozhi Wang, Miao Xu, Limei Zhu

“…Results In the first stage, 1,564 participants were enrolled in the study. The positivity rates of the T-SPOT, EC, and TB-PPD tests in all the participants were 18.89%, 10.37%, and 53.96%, respectively. …”
Get full text