Hypofractionated radiotherapy combined with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor, and thymosin-α1 in advanced metastatic solid tumors: a multicenter P... by Jiamin Yu, Li Yin, Wenjie Guo, Qiang Wang, Juying Liu, Lansheng Zhang, Hongxun Ye, Jianhong Xia, Youyou Xia, Jianfeng Wu, Wanwei Wang, Yanguang Yang, Dan Zong, Xia He, Lijun Wang, Hong Jiang

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Decrease in platelet count in patients with AKI and its association with major adverse kidney events by Ramón Medina-González, Jose J. Zaragoza, Eduardo M. Hernández-Barajas, Juarez Correa-de Leon, Rolando Claure-Del Granado, Armando Vazquez-Rangel, Liliana M. Pineda-Segura, Martha K. Franco-Garcia, Gael Chávez-Alonso, Juan A. Gómez-Fregoso, Francisco G. Rodríguez-García, Guillermo Navarro-Blackaller, Luz Alcantar-Vallin, Alejandro Martínez Gallardo-González, Gabriela J. Abundis-Mora, Guillermo García-García, Jonathan S. Chávez-Iñiguez

“…The mean age was 54 years, 60% were male, and 44% had sepsis. The mean baseline platelet count was 194 x 103 cells/µL, and 65% of the KDIGO3 patients met these criteria. …”
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DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care by Stefan Neuner-Jehle, Katharina Tabea Jungo, Sven Streit, Sven Trelle, Nicolas Rodondi, Carole Elodie Aubert, Kristie Rebecca Weir, Enriqueta Vallejo-Yagüe, Samantha Chan, Marie Roumet, Pascal Juillerat, Sofia Carolina Zambrano Ramos, Jennifer Inauen, Angela Edith Schulthess-Lisibach, Renata Vidonscky Lüthold, Clémentine Tombez, Martina Zangger, Flurina Jenal, Yvonne Mattmann, Christof Bieri, Michaela Barbier

“…Data will be collected at baseline, 3-, 6-, 9- and 12-month follow-up time through online surveys or a phone call for both GPs and participants.Primary and secondary outcome measures The first co-primary endpoint is the effectiveness of the deprescribing intervention measured by the change of prescribed PPI dose. …”
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Impact of prior CAR T-cell therapy on mosunetuzumab efficacy in patients with relapsed or refractory B-cell lymphomas by Elise A. Chong, Elicia Penuel, Ellen B. Napier, Rachel K. Lundberg, Lihua E. Budde, Mazyar Shadman, Matthew J. Matasar, Nancy L. Bartlett, Ian W. Flinn, Francesc Bosch, Keith Fay, Andre Goy, Anita Kumar, Loretta J. Nastoupil, Michael C. Wei, Mei Wu, Shen Yin, Joseph A. Fraietta, Emeline R. Chong, Stephen J. Schuster

“…This is, to our knowledge, the first study to assess changes in lymphocytes, T cells, and CAR transgene levels in patients treated with BsAbs after CAR-T. …”
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The Role of Atrial Fibrillation and Oral Anticoagulation Status in Health‐Related Quality of Life 12 Months After Ischemic Stroke or TIA by Manuel C. Olma, Lena Steindorf‐Sabath, Serdar Tütüncü, Claudia Kunze, Cornelia Fiessler, Paulus Kirchhof, Joanna Dietzel, Johannes Schurig, Patrick Oschmann, Ludwig Niehaus, Christian Urbanek, Götz Thomalla, Darius G. Nabavi, Joachim Röther, Ulrich Laufs, Roland Veltkamp, Peter U. Heuschmann, Karl Georg Haeusler, Matthias Endres, for the MonDAFIS Investigators

“…HRQOL was measured using the EQ‐5D‐3L‐questionnaire (including EQ‐index/EQ‐VAS) at baseline and after 12 months using multivariable linear mixed models. …”
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Psychometric properties and meaningful change thresholds for the QOL-E instrument in patients with myelodysplastic neoplasms by Esther Natalie Oliva, Shien Guo, Jennifer Lord-Bessen, Aylin Yucel, Roberto Latagliata, Massimo Breccia, Giuseppe A. Palumbo, Grazia Sanpaolo, Marta Riva, Valeria Santini, Uwe Platzbecker, Guillermo Garcia-Manero, Pierre Fenaux, Christopher G. Pelligra

“…It contains 29 items with the first two items assessing the patient’s general well-being and the 27 remaining items grouped into six domain scores: physical well-being (QOL-FIS), functional well-being (QOL-FUN), social/family well-being (QOL-SOC), sexual well-being (QOL-SEX), fatigue (QOL-FAT), and MDS-specific disturbances (QOL-MDSS). …”
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SHoes for Adolescent PatEllofemoral pain: study protocol for the SHAPE Australian community-based, randomised clinical trial by Kim L Bennell, Kade L Paterson, Rana S Hinman, Jo-Anne Manski-Nankervis, Adam Bryant, Karen Elaine Lamb, Peixuan Li, Sam Shearer, Anurika P De Silva

“…The SHoes for Adolescent PatEllofemoral pain trial will provide the first RCT evidence on the efficacy of minimalist shoes compared with motion control shoes in adolescents with patellofemoral pain. …”
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Parsing the heterogeneity of depression: a data-driven subgroup derived from cognitive function by Chenyang Xu, Yanbao Tao, Yunhan Lin, Jiahui Zhu, Zhuoran Li, Jiayi Li, Mingqia Wang, Tao Huang, Chuan Shi

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Evaluation of circulating tumor DNA as a prognostic and predictive biomarker in BRAF V600E mutated colorectal cancer—results from the FIRE‐4.5 study by Susanne Klein‐Scory, Alexander Baraniskin, Wolff Schmiegel, Thomas Mika, Roland Schroers, Swantje Held, Kathrin Heinrich, David Tougeron, Dominik P. Modest, Ingo Schwaner, Jan Eucker, Rudolf Pihusch, Martina Stauch, Florian Kaiser, Christoph Kahl, Meinolf Karthaus, Christian Müller, Christof Burkart, Sebastian Stintzing, Volker Heinemann

“…The randomized FIRE‐4.5 (AIO KRK0116) trial compared first‐line therapy with FOLFOXIRI (folinic acid, fluorouracil, oxaliplatin, and irinotecan) plus either cetuximab or bevacizumab in B‐Raf proto‐oncogene, serine/threonine kinase (BRAF) V600E‐mutant metastatic colorectal cancer (mCRC) patients. …”
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Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial by Andrea Tacchino, Michela Ponzio, Paolo Confalonieri, Letizia Leocani, Matilde Inglese, Diego Centonze, Eleonora Cocco, Paolo Gallo, Damiano Paolicelli, Marco Rovaris, Loredana Sabattini, Gioacchino Tedeschi, Luca Prosperini, Francesco Patti, Edoardo Sessa, Elisabetta Pedrazzoli, Mario Alberto Battaglia, Giampaolo Brichetto

“…MethodsThis is a 2-arm, multicenter, randomized controlled trial with 3 assessment points (baseline, 12 weeks postintervention, and 6 weeks follow-up). …”
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Tadalafil treatment for fetuses with early-onset growth restriction: a protocol for a multicentre, randomised, placebo-controlled, double-blind phase II trial (TADAFER IIb) by Hiroaki Tanaka, Yasuhiro Tanaka, Yoichi Aoki, Masayuki Endo, Tomoaki Ikeda, Shintaro Maki, Masafumi Nii, Kayo Tanaka, Satoshi Tamaru, Toru Ogura, Yuki Nishimura, Tomomi Kotani, Akihiko Sekizawa, Masahiko Nakata, Koji Nakamura, Kenji Nagao, Ichiro Yasuhi, Hiroshi Kawamura, Sho Takakura, Mayumi Kotera, Takafumi Ushida, Norihiko Kikuchi, Tadatsugu Kinjo, Mayumi Takano, Sachie Suga, Michi Kasai, Osamu Yasui, Yuka Maegawa, Shigeru Aoki, Yoshio Yoshida

“…The primary endpoint is the prolongation of gestational age at birth, defined as days from the first day of the protocol-defined treatment to birth. …”
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Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the... by Bruno Fautrel, Yoram Bouhnik, Carine Salliot, Franck Carbonnel, Mathurin Fumery, Christophe Bernardeau, Yves Maugars, Mathurin Flamant, Fabienne Coury, Ben Braithwaite, Salima Hateb, Janet Addison, the PERFUSE investigators

“…Among naïve patients, 12-month remission/low activity rates were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC, increasing significantly from baseline for all indications (p < 0.05). Switched patients’ remission rates remained stable between baseline and month 12 (M12) for all indications (p > 0.05). …”
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Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study by Michael H. McGillion, RN, PhD, Flavia K. Borges, MD, PhD, David Conen, MD, MPH, Daniel I. Sessler, MD, Brenda L. Coleman, RN, PhD, Maura Marcucci, MD, MSc, Carley Ouellette, RN, MSc, Marissa Bird, RN, PhD, Carly Whitmore, RN, PhD, Shaunattonie Henry, RN, PhD, Sandra Ofori, MD, MSc, Shirley M. Pettit, RN, Deborah M. Bedini, RN, MHS, Leslie P. Gauthier, MScT, Jennifer Lounsbury, RN(EC), MN, Nancy M. Carter, RN, PhD, Vikas Tandon, MD, Ameen Patel, MD, Teresa Cafaro, MD, MSc, Marko R. Simunovic, MD, John A. Harlock, MD, Diane Heels-Ansdell, MSc, Fadi Elias, MD, MS, Theodore Rapanos, MD, Shawn Forbes, MD, Elizabeth Peter, RN, PhD, Judy Watt-Watson, RN, PhD, Kelly Metcalfe, RN, PhD, Sandra L. Carroll, RN, PhD, Philip J. Devereaux, MD, PhD

“…Rates of readmission were highest in the first 7 days after discharge and declined over the follow-up period. …”
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Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol by Lan N Vuong, Rui Wang, Ben W Mol, Rong Li, Karin Hammarberg, Kate Brian, Yun Sun, Pollyanna Hardy, Anja Pinborg, Siladitya Bhattacharya, Sacha Stormlund, David J McLernon, Zi-Jiang Chen, Richard S Legro, Carlos Simon, Shimona Lai, Marian G Showell, Daimin Wei, Ze Wang, Keliang Wu, Xavier Santamaría, Christophe Blockeel, Femke Mol, Anna P Ferraretti, Bruce S Shapiro, Forest C Garner, Christos A Venetis, Abha Maheshwari, Gwenda Burns

“…The primary outcome will be live birth resulting from the first embryo transfer. All outcomes listed in the core outcome set for infertility research will be reported. …”
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MOMENT registry: Patients with advanced non-small-cell lung cancer harboring MET exon 14 skipping treated with systemic therapy by Michael Thomas, Petros Christopoulos, Wade T Iams, Julien Mazieres, Alexis B Cortot, Nir Peled, Gabriele Minuti, Egbert F Smit, Francois Audhuy, Karin Berghoff, S Peter Eggleton, Frank Fries, Maike Hildenbrand, Peter Liu, Seyed Hamidreza Mahmoudpour, Christoph Menzel, Dina Oksen

“…Data collection includes biomarker testing results, demographics, baseline clinical characteristics, treatment details and effectiveness, safety information and imaging. …”

Virtual reality-based cognitive–behavioural therapy for the treatment of anxiety in patients with acute myocardial infarction: a randomised clinical trial by Jiajun Weng, Junbo Ge, Jiajia Liu, Juying Qian, Xiao Huang, Yuanyuan Li, Juan Peng, Yan'e Lu, Dong Huang, Pingyuan Yang, Shikun Xu, Lihua Guan, Qibing Wang, Zexin Zhao, Yabin Wei

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Effectiveness of ertugliflozin during Ramadan fasting in patients with type 2 diabetes mellitus: a real-world study (ErtuRamadan study) by Md Faruque Pathan, Nazma Akter, Marufa Mustari, M. Saifuddin, Mirza Sharifuzzaman, Mohammad Motiur Rahman, Mohammed Ripon, S. M. Mohiuddin, A. B. M. Kamrul-Hasan, Mohammad Abdul Hannan, Muhammad Shah Alam, Samira Mahjabeen, Faria Afsana, Muhammed Abu Bakar, Tahniyah Haq, Afsar Ahammed, Samir Kumar Talukder, Sourav Sarkar, Shahjada Selim

“…Patients attended a baseline visit one month before the first day of Ramadan and a follow-up visit within one month after the last day of Ramadan. …”
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Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes m... by Umberto Simeoni, Antje Horsch, Arnaud Chiolero, Yvan Vial, Nicole Sekarski, Jardena J Puder, Pascal Bovet, Yvan Mivelaz, Adina Mihaela Epure, Bobby Stuijfzand, Leah Gilbert, Stefano Lanzi, Justine Gross, Didier Hans, Stefano Di Bernardo, Elena Gonzalez-rodriguez, Alain Lacroix, Jean-Benoît Rossel, Dan Yedu Quansah, Amar Arhab, Sandrine Estoppey Younes, Seyda Mayerat

“…The intervention also decreased gestational weight gain since the first gestational diabetes mellitus visit (–1.20 kg (–2.14 to –0.26)) and weekly weight gain throughout the entire pregnancy (–0.14 kg (–0.25 to –0.03)), and led to a higher proportion of women without weight retention at one year post partum (34.1% (28/82) v 20.8% (20/96), P=0.034).Conclusions Compared with active usual care based on guidelines, there was not enough evidence to conclude that the intervention led to decrease in weight or depression symptoms. …”
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Zolpidem: Efficacy and Side Effects for Insomnia by Amber N. Edinoff, Natalie Wu, Yahya T. Ghaffar, Rosemary Prejean, Rachel Gremillion, Mark Cogburn, Azem A. Chami, Adam M. Kaye, Alan D. Kaye

“…Sleep onset latency has been demonstrated to be significantly increased on the first night after stopping zolpidem (13.0 minutes; 95% CI 4.3-21.7; P\<0.01). …”
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Lesion Location and Possible Etiology of Acute Unilateral Vestibulopathy by Zhang M, Wang J, Xue S, Liu S, Li K, Zhao T, Feng Y, Sui R, Yang B, Yang X

“…Clinical data of patients including baseline data, cardiovascular risk factors, immunological test results and infection indicators were collected. …”
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