Recomendaciones para el diagnóstico y tratamiento de las vasculitis asociadas a anticuerpos anticitoplasma de neutrófilo by Enrique Morales, Iñigo Rúa-Figueroa, José Luis Callejas Rubio, Ana Ávila Bernabéu, Ricardo Blanco Alonso, Maria 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. …”
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Reverse-sequence endoscopic versus conventional open nipple-sparing mastectomy with implant-based breast reconstruction: a single-center prospective cohort study (RECO study) by Tianyuan Li, Qing Zhang, Yanyan Xie, Huanzuo Yang, Kawun Chung, Hui Dai, Xiaoman Cao, Zhenggui Du

“…This study received approval from the Ethics Committee of Sichuan University and was registered on the China Clinical Trials Network with the trial registration number ChiCTR2100047862. …”
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Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial by Jiao Liu, Dunjin Chen, Huixia Yang, Xiaotian Li, Ka Chun Chong, Rong Zhou, Liona Poon, Hao Ying, Xiaohong Lu, Lixia Shen, Daljit Sahota, Long Nguyen-Hoang, Qiongjie Zhou, Chi Chiu Wang, Weirong Gu, Yanmin Jiang

“…The study is registered at ClinicalTrials.gov. The results of the AVERT trial will be disseminated at international academic conferences and published in high-impact factor journals.Trial registration number NCT05580523.…”
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Effectiveness and cost-effectiveness of Improving clinicians’ diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary... by Rafa Ruiz, Ana Moragas, Marta Trapero-Bertran, Antoni Sisó, Anna Berenguera, Glòria Oliva, Alícia Borràs-Santos, Ana García-Sangenís, Jaume Puig-Junoy, Josep M. Cots, Rosa Morros, Toni Mora, Anna Lanau-Roig, Ramon Monfà, Amelia Troncoso, Rosa M. Abellana, Pau Gálvez, Laura Medina-Perucha, Lars Bjerrum, Isabel Amo, Nieves Barragán, Carl Llor

“…Trial registration ClinicalTrials.gov, NCT03931577.…”
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Dendritic Cell Vaccination in Metastatic Melanoma Turns “Non-T Cell Inflamed” Into “T-Cell Inflamed” Tumors by Jenny Bulgarelli, Marcella Tazzari, Anna Maria Granato, Laura Ridolfi, Serena Maiocchi, Francesco de Rosa, Massimiliano Petrini, Elena Pancisi, Giorgia Gentili, Barbara Vergani, Filippo Piccinini, Antonella Carbonaro, Biagio Eugenio Leone, Giovanni Foschi, Valentina Ancarani, Massimo Framarini, Massimo Guidoboni

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Excluded versus included patients in a randomized controlled trial of infections caused by carbapenem-resistant Gram-negative bacteria: relevance to external validity by Vered Daitch, Mical Paul, George L. Daikos, Emanuele Durante-Mangoni, Dafna Yahav, Yehuda Carmeli, Yael Dishon Benattar, Anna Skiada, Roberto Andini, Noa Eliakim-Raz, Amir Nutman, Oren Zusman, Anastasia Antoniadou, Giusi Cavezza, Amos Adler, Yaakov Dickstein, Ioannis Pavleas, Rosa Zampino, Roni Bitterman, Hiba Zayyad, Fidi Koppel, Yael Zak-Doron, Inbar Levi, Tanya Babich, Adi Turjeman, Haim Ben-Zvi, Lena E. Friberg, Johan W. Mouton, Ursula Theuretzbacher, Leonard Leibovici

“…Trial registration The trial was registered with ClinicalTrials.gov, number NCT01732250 on November 22, 2012.…”
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Risk Adjustment In Neurocritical care (RAIN) – prospective validation of risk prediction models for adult patients with acute traumatic brain injury to use to evaluate the optimum... by DA Harrison, G Prabhu, R Grieve, SE Harvey, MZ Sadique, M Gomes, KA Griggs, E Walmsley, M Smith, P Yeoman, FE Lecky, PJA Hutchinson, DK Menon, KM Rowan

“…Of the 10 risk models selected for validation, the best discrimination overall was from the International Mission for Prognosis and Analysis of Clinical Trials in TBI Lab model (IMPACT) (c-index 0.779 for mortality, 0.713 for unfavourable outcome). …”
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Predictors of Oncologic Outcome in Patients Receiving Phase I Investigational Therapy for Recurrent or Metastatic Cervical Cancer by Ji Son, Heather Y. Lin, Siqing Fu, Amadeo B. Biter, Ecaterina E. Dumbrava, Daniel D. Karp, Aung Naing, Shubham Pant, Sarina A. Piha-Paul, Jordi Rodon, Vivek Subbiah, Apostolia M. Tsimberidou, Timothy A. Yap, Michael M. Frumovitz, Amir A. Jazaeri, Pedro T. Ramirez, Shannon N. Westin, Ying Yuan, Funda Meric-Bernstam, David S. Hong

“…Introduction: We aimed to identify clinical, pathologic, and treatment factors that are predictive of response and survival in patients with cervical cancer referred to phase I clinical trials. Methods: Patients with cervical cancer who received at least one dose of a phase I investigational agent at our institution between 2014 and 2022 were included. …”
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Effect of stereotactic body radiotherapy dose escalation plus pembrolizumab and trametinib versus stereotactic body radiotherapy dose escalation plus gemcitabine for locally recurr... by Xiaofei Zhu, Wenyu Liu, Yangsen Cao, Xiaoping Ju, Xianzhi Zhao, Lingong Jiang, Yusheng Ye, Huojun Zhang

“…This study is registered with ClinicalTrials.gov, NCT02704156. Findings: Between Oct 10, 2016, and Oct 28, 2017, 147 of 170 randomly assigned participants were eligible for inclusion in this analysis. …”
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Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-l... by Ivan Foeldvari, Tamàs Constantin, Jelena Vojinović, Gerd Horneff, Vyacheslav Chasnyk, Joke Dehoorne, Violeta Panaviene, Gordana Sušić, Valda Stanevicha, Katarzyna Kobusinska, Zbigniew Zuber, Bogna Dobrzyniecka, Irina Nikishina, Brigitte Bader-Meunier, Luciana Breda, Pavla Doležalová, Chantal Job-Deslandre, Ingrida Rumba-Rozenfelde, Nico Wulffraat, Ronald D. Pedersen, Jack F. Bukowski, Bonnie Vlahos, Alberto Martini, Nicolino Ruperto, for the Paediatric Rheumatology International Trials Organisation (PRINTO)

“…Trial registration ClinicalTrials.gov: CLIPPER, NCT00962741, registered 20 August, 2009, CLIPPER2, NCT01421069, registered 22 August, 2011.…”
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Establishing Normative Values to Determine the Prevalence of Biochemical Hyperandrogenism in Premenopausal Women of Different Ethnicities from Eastern Siberia by Larisa Suturina, Daria Lizneva, Alina Atalyan, Ludmila Lazareva, Aleksey Belskikh, Tatyana Bairova, Leonid Sholokhov, Maria Rashidova, Irina Danusevich, Iana Nadeliaeva, Lilia Belenkaya, Zorikto Darzhaev, Eldar Sharifulin, Natalia Belkova, Ilia Igumnov, Tatyana Trofimova, Anastasiya Khomyakova, Kseniia Ievleva, Natalia Babaeva, Irina Egorova, Madinabonu Salimova, Bulent O. Yildiz, Richard S. Legro, Frank Z. Stanczyk, Ricardo Azziz

“…We determined the upper normal limits (UNLs) for androgens in a population-based group of premenopausal “healthy control” women, overall and by ethnicity (Caucasian and Asian), in the cross-sectional Eastern Siberia PCOS Epidemiology and Phenotype (ESPEP) Study (ClinicalTrials.gov ID: NCT05194384) conducted in 2016–2019. …”
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Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter p... by Qian Jiang, Zongru Li, Yazhen Qin, Weiming Li, Na Xu, Bingcheng Liu, Yanli Zhang, Li Meng, Huanling Zhu, Xin Du, Suning Chen, Yang Liang, Yu Hu, Xiaoli Liu, Yongping Song, Lichuang Men, Zi Chen, Qian Niu, Hengbang Wang, Ming Lu, Dajun Yang, Yifan Zhai, Xiaojun Huang

“…Trial registration: The phase 1 trial is registered at CTR20220566, and the two single-arm, open-label phase 2 studies are registered at ClinicalTrials.gov: NCT03883087 (CML-CP) and NCT03883100 (CML-AP).…”
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Effects of vitamin D, omega-3 and a simple strength exercise programme in cardiovascular disease prevention: The DO-HEALTH randomized controlled trial by Stephanie Gaengler, Angélique Sadlon, Caroline De Godoi Rezende Costa Molino, Walter C. Willett, JoAnn E. Manson, Bruno Vellas, Elisabeth Steinhagen-Thiessen, Arnold Von Eckardstein, Frank Ruschitzka, René Rizzoli, José A.P. da Silva, Reto W. Kressig, John Kanis, E. John Orav, Andreas Egli, Heike A. Bischoff-Ferrari

“…Trial registration ClinicalTrials.gov identifier: NCT01745263.…”
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Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial by Julio Vallejos, Rodrigo Zoni, María Bangher, Silvina Villamandos, Angelina Bobadilla, Fabian Plano, Claudia Campias, Evangelina Chaparro Campias, Maria Fernanda Medina, Fernando Achinelli, Hector Andres Guglielmone, Jorge Ojeda, Diego Farizano Salazar, Gerardo Andino, Pablo Kawerin, Silvana Dellamea, Antonia Cristina Aquino, Victor Flores, Carolina N. Martemucci, Silvina Maria Martinez, Juan Emanuel Segovia, Paola Itati Reynoso, Noelia Carolina Sosa, Mariana Elizabeth Robledo, Joaquina Maria Guarrochena, Maria Mercedes Vernengo, Natalia Ruiz Diaz, Elba Meza, María Gabriela Aguirre

“…Trial registration ClinicalTrials.gov NCT04529525 .…”
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Post-acute COVID-19 in three doses vaccinated autoimmune rheumatic diseases patients: frequency and pattern of this condition by Clovis Artur Silva, Leonard de Vinci Kanda Kupa, Ana Cristina Medeiros-Ribeiro, Sandra Gofinet Pasoto, Carla Gonçalves Schahin Saad, Emily Figueiredo Neves Yuki, Joaquim Ivo Vasques Dantas Landim, Victor Hugo Ferreira e Léda, Luisa Sacchi de Camargo Correia, Artur Fonseca Sartori, Carolina Campagnoli Machado Freire Martins, Carolina Torres Ribeiro, Filipe Waridel, Victor Adriano de Oliveira Martins, Samuel Katsuyuki Shinjo, Danieli Castro Oliveira Andrade, Percival Degrava Sampaio-Barros, Eduardo Ferreira Borba Neto, Nadia Emi Aikawa, Eloisa Bonfa

“…Conclusion We provide novel data demonstrating that immune/inflammatory ARD disturbances after third dose vaccination do not seem to be a major determinant of post-acute COVID-19 since its pattern is very similar to that of the general population. Clinical Trials platform (NCT04754698).…”
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Durable immune responses after BNT162b2 vaccination in home-dwelling old adults by Lena Hansen, Karl Albert Brokstad, Amit Bansal, Fan Zhou, Geir Bredholt, Therese Bredholt Onyango, Helene Heitmann Sandnes, Rebecca Elyanow, Anders Madsen, Mai-Chi Trieu, Marianne Sævik, Hanne Søyland, Jan Stefan Olofsson, Juha Vahokoski, Nina Urke Ertesvåg, Elisabeth Berg Fjelltveit, Shahin Shafiani, Camilla Tøndel, Heidi Chapman, Ian Kaplan, Kristin G.I. Mohn, Nina Langeland, Rebecca Jane Cox

“…Overall, our data provide valuable insights into the kinetics of the humoral and cellular immune response in the elderly after SARS-CoV-2 vaccination or infection, highlighting the need for two doses, which can guide future vaccine design.Clinical trials.gov; NCT04706390.…”
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Synthetic lethality of combined ULK1 defection and p53 restoration induce pyroptosis by directly upregulating GSDME transcription and cleavage activation through ROS/NLRP3 signalin... by Wei Chen, Kai-Bin Yang, Yuan-Zhe Zhang, Zai-Shan Lin, Jin-Wei Chen, Si-Fan Qi, Chen-Fei Wu, Gong-Kan Feng, Da-Jun Yang, Ming Chen, Xiao-Feng Zhu, Xuan Li

“…However, MDM2 inhibitors have failed in clinical trials due to p53-induced feedback that enhances MDM2 expression. …”
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A Literature Review of Cannabis and Myocardial Infarction—What Clinicians May Not Be Aware Of by Kimesh Chetty, MBBS, BSc, Andrea Lavoie, BSc, MD, FRCPC, Payam Deghani, MD

“…Data quality is limited to that of observational studies and case report data. Therefore, more clinical trials are needed to determine a definitive cause-and-effect relationship. …”
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Adjuvant therapy for children treated by enucleation at diagnosis of retinoblastoma by Yelena Diarra, Christina Brockmeyer, Karen Fischhuber, Isabel Hülsenbeck, Saskia Ting, Madlen Reschke, Tobias Kiefer, Anna Hannbücken, Maren Wagemanns, Leyla Jabbarli, Selma Sirin, Regina Wieland, Gudrun Fleischhack, Johannes H. Schulte, Martin Ebinger, Dietmar Lohmann, Bert Müller, Daniela Süsskind, Christoph Schwab, Ines Brecht, Angelika Eggert, Stefan Schönberger, Petra Ritter-Sovinz, Nikolaos Bechrakis, Sophia Göricke, Beate Timmermann, Eva Biewald, Petra Ketteler

“…International prospective clinical trials are required to evaluate reduction of intensity of adjuvant chemotherapy in some risk groups (pT2, pT3) and intensification for pT4 retinoblastoma.…”
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A Randomized, Controlled Trial of Treat-and-Extend vs. Pro Re Nata Regimen for Neovascular Age-Related Macular Degeneration by Huixun Jia, Huixun Jia, Huixun Jia, Huixun Jia, Bing Lu, Bing Lu, Bing Lu, Yuanzhi Yuan, Fei Yuan, Lei Li, Yanping Song, Ao Rong, Minwen Zhou, Minwen Zhou, Minwen Zhou, Fenghua Wang, Fenghua Wang, Fenghua Wang, Fenghua Wang, Xiaodong Sun, Xiaodong Sun, Xiaodong Sun, Xiaodong Sun

“…The types and rates of adverse events were comparable in the two treatment groups.ConclusionThese findings suggest that the T&E regimen was not non-inferior to the PRN regimen in patients with nAMD in terms of BCVA outcomes through 24 months.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT02802657.…”
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