Panitumumab plus 5-fluorouracil and folinic acid or 5-fluorouracil and folinic acid alone as maintenance therapy in RAS wild-type metastatic colorectal cancer (PanaMa, AIO KRK 0212... by Arndt Stahler, Meinolf Karthaus, Stefan Fruehauf, Ullrich Graeven, Lothar Müller, Ludwig Fischer von Weikersthal, Karel Caca, Eray Goekkurt, Alexej Ballhausen, Greta Sommerhäuser, Annabel H.S. Alig, Swantje Held, Armin Jarosch, David Horst, Anke Reinacher-Schick, Stefan Kasper, Volker Heinemann, Sebastian Stintzing, Tanja Trarbach, Dominik P. Modest

“…The trial is registered with ClinicalTrials.gov (NCT01991873). Findings: In 248 patients of the Full Analysis Set recruited between May 2014 and February 2021, with a median observation of 64.0 (range 12.5–86.3) months and 59.7 (range 3.7–97.3) months in the treatment arms, 230 events for PFS (92.7%) and 196 events for OS (79.0%) were recorded. …”
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Oncolytic virus OH2 extends survival in patients with PD-1 pretreated melanoma: phase Ia/Ib trial results and biomarker insights by Juan Li, Xuan Wang, Li Zhou, Jun Guo, Lu Si, Bixia Tang, Chuanliang Cui, Xiaoting Wei, Xinan Sheng, Siming Li, Zhihong Chi, Lili Mao, Bin Lian, Xieqiao Yan, Yan Kong, Caili Li, Xiangyong Gu, Binlei Liu, Hui Tian, Han Hu

“…NCT04386967 is the clinical trial identifier.Results All 44 patients were enrolled. …”
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A Systematic Review and Meta-Analysis of Mapping Biopsy for Primary Extramammary Paget’s Disease in Reducing Recurrence Following Surgical Excision by Thirrisha Murugan, Louis Choon Kit Wong, MD, Xing-Yi Sarah Ong, MD, Sze Huey Tan, PhD, Joey Wee-Shan Tan, MSc, Ying Liu, PhD, Nicholas B. Shannon, PhD, MD, Jianbang Chiang, MBBS, MRCP, MMed, Eileen Poon, MBBS, MRCP, MMED, Jason Yongsheng Chan, MBBS, MRCP, MMed, FAMS, PhD, Valerie Shiwen Yang, MB BChir, PhD, MRCP, FAMS, Nagavalli Somasundaram, MBBS, MRCP, MMED, Mohamad Farid, MBBS, MRCP, MMed, Ru Xin Wong, MBBS, FRCR, Wen Long Nei, MBBS, FRCR, Jin Wei Kwek, MBBS, FRCR, FAMS, Choon Hua Thng, MBBS, FRCR, FAMS, Tiffany Hennedige, MBBS, FRCR, MMed, MCI, Po Yin Tang, BMEDSc, MBBS, FRCPath, FRCAPA, Sathiyamoorthy Selvarajan, MBBS, PGDCP, FRCPath, MCS, FAMS, Kae Jack Tay, MBBS, MRCS, MMed, MCI, FAMS, Mohamed Rezal Abdul, MB, BCh, BAO, LRCP&SI, MSurg, Jolene Si Min Wong, MBBS, MMed, FRCS, Chin Jin Seo, MB, BCh, BAO, MMed, FRCS, Khee Chee Soo, MBBS, MD, FRACS, FACS, Claramae Shulyn Chia, MBBS, MMed, FRCS, Chin-Ann Johnny Ong, MBBS, MMed, FRCS, PhD

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Effectiveness of a universal film intervention in reducing violence against children and increasing positive parenting among migrant and displaced caregivers from Myanmar: a commun... by Amanda Sim, Khaing Zar Lwin, Stephanie Eagling-Peche, G.J. Melendez-Torres, Seema Vyas, Francisco Calderon, Tawanchai Jirapramukpitak, Jamie Lachman, Sureeporn Punpuing, Andrea Gonzalez, Mary Soan, Nway Nway Oo, Ivet Castello Mitjans, Greg Tyrosvoutis, Eve Puffer

“…The trial was prospectively registered with Thai Clinical Trials Registry TCTR20230222005. Findings: Between February and June 2023, 2249 participants in 44 communities completed baseline assessments and were randomly assigned to intervention (n = 1116) and control (n = 1133). 2023 caregivers (n = 998 in intervention and n = 1025 in control) completed the four-week endline survey and 1909 caregivers (n = 961 in intervention and n = 948 in control) completed the four-month follow-up. …”
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Does pregabalin offer potential as a first-line therapy for generalized anxiety disorder? A meta-analysis of efficacy, safety, and cost-effectiveness by Narcis Cardoner, Narcis Cardoner, Narcis Cardoner, Narcis Cardoner, Luis Gutiérrez-Rojas, Luis Gutiérrez-Rojas, Pilar Saiz, Pilar Saiz, Pilar Saiz, Pilar Saiz, Pilar Saiz, Guillermo Lahera, Guillermo Lahera, Guillermo Lahera, Guillermo Lahera, Miguel Ángel Álvarez-Mon, Miguel Ángel Álvarez-Mon, Miguel Ángel Álvarez-Mon, Miguel Ángel Álvarez-Mon, Pino Alonso Ortega, Pino Alonso Ortega, Pino Alonso Ortega, Pino Alonso Ortega, María Pérez-Páramo

“…Efficacy and safety were evaluated using various scales and adverse events (AEs). Randomized clinical trials were included in the study. Four major databases were used for this study. …”
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The Multicentre Acute ischemic stroke imaGIng and Clinical data (MAGIC) repository: rationale and blueprint by Hakim Baazaoui, Stefan T. Engelter, Stefan T. Engelter, Stefan T. Engelter, Henrik Gensicke, Henrik Gensicke, Henrik Gensicke, Lukas S. Enz, Lukas S. Enz, Marios Psychogios, Marios Psychogios, Matthias Mutke, Matthias Mutke, Patrik Michel, Davide Strambo, Alexander Salerno, Henk A. Marquering, Paul J. Nederkoorn, Nabila Wali, Stephanie Tanadini-Lang, Björn Menze, Ezequiel de la Rosa, Kaiyuan Yang, Gian Marco De Marchis, Gian Marco De Marchis, Tolga D. Dittrich, Tolga D. Dittrich, Francesco Valletta, Francesco Valletta, Manon Germann, Carlo W. Cereda, João Pedro Marto, Lisa Herzog, Patrick Hirschi, Zsolt Kulcsar, Susanne Wegener, Susanne Wegener

“…This dataset reflects the current state of practice in stroke patient evaluation and management and will enable researchers to retrospectively study clinically relevant questions outside the scope of randomized controlled clinical trials. New centres are invited to join MAGIC if they meet the requirements outlined here. …”
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Clinical Utility of Combined Tissue and Plasma Next-Generation Sequencing in Patients With Advanced, Treatment-Naïve NSCLC by Helena Bote-de Cabo, MD, Marco Siringo, MD, Esther Conde, MD, PhD, Susana Hernández, PhD, Fernando López-Ríos, MD, PhD, Alicia Castelo-Loureiro, MD, Esther García-Lorenzo, MD, Javier Baena, MD-PhD, Mercedes Herrera, MD, Ana Belén Enguita, MD, Yolanda Ruano, PhD, Jon Zugazagoitia, MD, PhD, Luis Paz-Ares, MD, PhD

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Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. by Rachel S Gross, Tanayott Thaweethai, Erika B Rosenzweig, James Chan, Lori B Chibnik, Mine S Cicek, Amy J Elliott, Valerie J Flaherman, Andrea S Foulkes, Margot Gage Witvliet, Richard Gallagher, Maria Laura Gennaro, Terry L Jernigan, Elizabeth W Karlson, Stuart D Katz, Patricia A Kinser, Lawrence C Kleinman, Michelle F Lamendola-Essel, Joshua D Milner, Sindhu Mohandas, Praveen C Mudumbi, Jane W Newburger, Kyung E Rhee, Amy L Salisbury, Jessica N Snowden, Cheryl R Stein, Melissa S Stockwell, Kelan G Tantisira, Moriah E Thomason, Dongngan T Truong, David Warburton, John C Wood, Shifa Ahmed, Almary Akerlundh, Akram N Alshawabkeh, Brett R Anderson, Judy L Aschner, Andrew M Atz, Robin L Aupperle, Fiona C Baker, Venkataraman Balaraman, Dithi Banerjee, Deanna M Barch, Arielle Baskin-Sommers, Sultana Bhuiyan, Marie-Abele C Bind, Amanda L Bogie, Tamara Bradford, Natalie C Buchbinder, Elliott Bueler, Hülya Bükülmez, B J Casey, Linda Chang, Maryanne Chrisant, Duncan B Clark, Rebecca G Clifton, Katharine N Clouser, Lesley Cottrell, Kelly Cowan, Viren D'Sa, Mirella Dapretto, Soham Dasgupta, Walter Dehority, Audrey Dionne, Kirsten B Dummer, Matthew D Elias, Shari Esquenazi-Karonika, Danielle N Evans, E Vincent S Faustino, Alexander G Fiks, Daniel Forsha, John J Foxe, Naomi P Friedman, Greta Fry, Sunanda Gaur, Dylan G Gee, Kevin M Gray, Stephanie Handler, Ashraf S Harahsheh, Keren Hasbani, Andrew C Heath, Camden Hebson, Mary M Heitzeg, Christina M Hester, Sophia Hill, Laura Hobart-Porter, Travis K F Hong, Carol R Horowitz, Daniel S Hsia, Matthew Huentelman, Kathy D Hummel, Katherine Irby, Joanna Jacobus, Vanessa L Jacoby, Pei-Ni Jone, David C Kaelber, Tyler J Kasmarcak, Matthew J Kluko, Jessica S Kosut, Angela R Laird, Jeremy Landeo-Gutierrez, Sean M Lang, Christine L Larson, Peter Paul C Lim, Krista M Lisdahl, Brian W McCrindle, Russell J McCulloh, Kimberly McHugh, Alan L Mendelsohn, Torri D Metz, Julie Miller, Elizabeth C Mitchell, Lerraughn M Morgan, Eva M Müller-Oehring, Erica R Nahin, Michael C Neale, Manette Ness-Cochinwala, Sheila M Nolan, Carlos R Oliveira, Onyekachukwu Osakwe, Matthew E Oster, R Mark Payne, Michael A Portman, Hengameh Raissy, Isabelle G Randall, Suchitra Rao, Harrison T Reeder, Johana M Rosas, Mark W Russell, Arash A Sabati, Yamuna Sanil, Alice I Sato, Michael S Schechter, Rangaraj Selvarangan, S Kristen Sexson Tejtel, Divya Shakti, Kavita Sharma, Lindsay M Squeglia, Shubika Srivastava, Michelle D Stevenson, Jacqueline Szmuszkovicz, Maria M Talavera-Barber, Ronald J Teufel, Deepika Thacker, Felicia Trachtenberg, Mmekom M Udosen, Megan R Warner, Sara E Watson, Alan Werzberger, Jordan C Weyer, Marion J Wood, H Shonna Yin, William T Zempsky, Emily Zimmerman, Benard P Dreyer, RECOVER-Pediatric Consortium

“…The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions.<h4>Clinical trials.gov identifier</h4>Clinical Trial Registration: http://www.clinicaltrials.gov. …”
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Mental health disorder symptom changes among public safety personnel after emotional resilience skills training by R.N. Carleton, S. Sauer-Zavala, T.A. Teckchandani, K.Q. Maguire, L. Jamshidi, R.E. Shields, T.O. Afifi, J. Nisbet, K.L. Andrews, S.H. Stewart, A.J. Fletcher, R. Martin, R.S. MacPhee, J.C. MacDermid, T.M. Keane, A. Brunet, M. McCarron, L.M. Lix, N.A. Jones, G.P. Krätzig, J.P. Neary, G. Anderson, R. Ricciardelli, H. Cramm, J. Sareen, G.J.G. Asmundson

“…Trial registration: ClinicalTrials.gov, NCT05530642.…”
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HELLO: a protocol for a cluster randomized controlled trial to enhance interpersonal relationships and team cohesion among ICU healthcare professionals by Elie Azoulay, Nancy Kentish Barnes, Sheila Nainan Myatra, Maria-Cruz Martin Delgado, Yaseen Arabi, Carole Boulanger, Giovanni Mistraletti, Maria Theodorakopoulou, Vernon Van Heerden, José-Artur Paiva, Oktay Demirkýran, Gabriel Heras La Calle, Abdulrahman Al Fares, Gaston Burghi, Guy Francois, Anita Barth, Jan De Waele, Samir Jaber, Michael Darmon, Maurizio Cecconi

“…Trial registration: This trial was registered on ClinicalTrials.Gov on June 18, 2024. Registration: NCT06453616.…”
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Sex differences in murine MASH induced by a fructose-palmitate-cholesterol-enriched diet by Lakshmi Arivazhagan, Sofie Delbare, Robin A. Wilson, Michaele B. Manigrasso, Boyan Zhou, Henry H. Ruiz, Kaamashri Mangar, Ryoko Higa, Emily Brown, Huilin Li, Michael J. Garabedian, Ravichandran Ramasamy, Kathryn J. Moore, Edward A. Fisher, Neil D. Theise, Ann Marie Schmidt

“…The identification of intrinsic, within-sex, diet-dependent disparities underscores the critical need to include both male and female individuals in MAFLD/MASH studies and clinical trials. Impact and implications:: Despite the importance of metabolic dysfunction-associated steatohepatitis (MASH) in impairment of human health, the potential for and mechanisms of sex-dependent responses have yet to be well-studied, particularly with respect to the possible influence of high-fructose corn syrup additives to the diet, which has been linked to metabolic and hepatic disturbances. …”
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Immune monitoring of trabectedin therapy in refractory soft tissue sarcoma patients - the IMMUNYON study by Paulo Rodrigues-Santos, Paulo Rodrigues-Santos, Paulo Rodrigues-Santos, Paulo Rodrigues-Santos, Paulo Rodrigues-Santos, Paulo Rodrigues-Santos, Jani Sofia Almeida, Jani Sofia Almeida, Jani Sofia Almeida, Jani Sofia Almeida, Jani Sofia Almeida, Jani Sofia Almeida, Luana Madalena Sousa, Luana Madalena Sousa, Luana Madalena Sousa, Patrícia Couceiro, Patrícia Couceiro, Patrícia Couceiro, Patrícia Couceiro, António Martinho, Joana Rodrigues, Ruben Fonseca, Manuel Santos-Rosa, Manuel Santos-Rosa, Manuel Santos-Rosa, Manuel Santos-Rosa, Manuel Santos-Rosa, Paulo Freitas-Tavares, José Manuel Casanova, José Manuel Casanova, José Manuel Casanova, José Manuel Casanova, José Manuel Casanova

“…These findings support further research into immune monitoring for future clinical trials.…”
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GWAS of CRP response to statins further supports the role of APOE in statin response: A GIST consortium study by Emma F. Magavern, Harshal Deshmukh, Geraldine Asselin, Elizabeth Theusch, Stella Trompet, Xiaohui Li, Raymond Noordam, Y.-D. Ida Chen, Teresa E. Seeman, Kent D. Taylor, Wendy S. Post, Jean-Claude Tardif, Dirk S. Paul, Emelia J. Benjamin, Nancy L. Heard-Costa, Ramachandran S. Vasan, Jerome I. Rotter, Ronald M. Krauss, J.Wouter Jukema, Paul M. Ridker, Patricia B. Munroe, Mark J. Caulfield, Daniel I. Chasman, Marie-Pierre Dubé, Graham A. Hitman, Helen R. Warren

“…GWAS meta-analysis combined results from seven cohorts and clinical trials totalling 14,070 statin-treated individuals of European ancestry within the GIST consortium. …”
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Comments on: “Early High-Titer Convalescent Plasma Therapy in Patients with Moderate and Severe COVID-19” [Transfusion and Apheresis Science 61 (2022) 103321] by Seyed Reza Hosseiniara

“…However, it is important to highlight that clinical trials adhering to the FDA's convalescent plasma treatment protocol have yielded concerning results. …”
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The in vivo metabolic pathway of Deg-AZM and in vitro investigations into the contribution of drug metabolizing enzymes and drug transporters in the drug interactions of Deg-AZM, a... by Xiaoting Gu, Xiaohe Li, Weixue Tian, Chaoyue Zheng, Chaoyue Zheng, Yutian Cai, Yutian Cai, Xiang Xu, Xiang Xu, Conglu Zhao, Conglu Zhao, Hongting Liu, Hongting Liu, Yao Sun, Yao Sun, Zhilin Luo, Zhilin Luo, Shuwen Zhu, Shuwen Zhu, Honggang Zhou, Honggang Zhou, Xiaoyu Ai, Cheng Yang, Cheng Yang

“…IntroductionDeglycosylated azithromycin (Deg-AZM), a new transgelin agonist with positive therapeutic effects on slow transit constipation, has been approved for clinical trials in 2024. This work investigated the drug metabolism and transport of Deg-AZM to provide research data for further development of Deg-AZM.MethodsA combination of UPLC-QTOF-MS was used to obtain metabolite spectra of Deg-AZM in plasma, urine, feces and bile. …”
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Comparable outcomes after busulfan- or treosulfan-based conditioning for allo-HSCT in children with ALL: results of FORUM by Krzysztof Kalwak, Laura M. Moser, Ulrike Pötschger, Peter Bader, Katharina Kleinschmidt, Roland Meisel, Jean-Hugues Dalle, Akif Yesilipek, Adriana Balduzzi, Gergely Krivan, Evgenios Goussetis, Raquel Staciuk, Petr Sedlacek, Herbert Pichler, Peter Svec, Melissa Gabriel, Tayfun Güngör, Ernest Bilic, Jochen Buechner, Marleen Renard, Kim Vettenranta, Marianne Ifversen, Cristina Diaz-de-Heredia, Jerry Stein, Jacek Toporski, Marc Bierings, Christina Peters, Marc Ansari, Franco Locatelli

“…This trial was registered at www.ClinicalTrials.gov as #NCT01949129.…”
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Jet Injection of Naked mRNA Encoding the RBD of the SARS-CoV-2 Spike Protein Induces a High Level of a Specific Immune Response in Mice by Denis N. Kisakov, Larisa I. Karpenko, Lyubov A. Kisakova, Sergey V. Sharabrin, Mariya B. Borgoyakova, Ekaterina V. Starostina, Oleg S. Taranov, Elena K. Ivleva, Oleg V. Pyankov, Anna V. Zaykovskaya, Elena V. Dmitrienko, Vladimir A. Yakovlev, Elena V. Tigeeva, Irina Alekseevna Bauer, Svetlana I. Krasnikova, Nadezhda B. Rudometova, Andrey P. Rudometov, Artemiy A. Sergeev, Alexander A. Ilyichev

“…<b>Background:</b> Although mRNA vaccines encapsulated in lipid nanoparticles (LNPs) have demonstrated a safety profile with minimal serious adverse events in clinical trials, there is opportunity to further reduce mRNA reactogenicity. …”
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Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials by Myra Happe, Amelia R. Hofstetter, Jing Wang, Galina V. Yamshchikov, LaSonji A. Holman, Laura Novik, Larisa Strom, Francis Kiweewa, Salim Wakabi, Monica Millard, Colleen F. Kelley, Sarah Kabbani, Srilatha Edupuganti, Allison Beck, Florence Kaltovich, Tamar Murray, Susanna Tsukerman, Derick Carr, Carl Ashman, Daphne A. Stanley, Aurélie Ploquin, Robert T. Bailer, Richard Schwartz, Fatim Cham, Allan Tindikahwa, Zonghui Hu, Ingelise J. Gordon, Nadine Rouphael, Katherine V. Houser, Emily E. Coates, Barney S. Graham, Richard A. Koup, John R. Mascola, Nancy J. Sullivan, Merlin L. Robb, Julie A. Ake, Kirsten E. Lyke, Mark J. Mulligan, Julie E. Ledgerwood, Hannah Kibuuka, the VRC 208 and RV 422 study team

“…We investigated the safety and immunogenicity of a heterologous prime-boost regimen involving a chimpanzee adenovirus 3 vectored Ebola vaccine [either monovalent (cAd3-EBOZ) or bivalent (cAd3-EBO)] prime followed by a recombinant modified vaccinia virus Ankara EBOV vaccine (MVA-EbolaZ) boost in two phase 1/1b randomized open-label clinical trials in healthy adults in the United States (US) and Uganda (UG). …”
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Exploring the association between tissue sodium content, heart failure subtypes, and symptom burden: insights from magnetic resonance imaging by Djawid Hashemi, Djawid Hashemi, Djawid Hashemi, Djawid Hashemi, Karl Jakob Weiß, Karl Jakob Weiß, Karl Jakob Weiß, Patrick Doeblin, Patrick Doeblin, Patrick Doeblin, Moritz Blum, Radu Tanacli, Radu Tanacli, Radu Tanacli, Hana Camdzic, Hana Camdzic, Hans-Dirk Düngen, Hans-Dirk Düngen, Frank Edelmann, Frank Edelmann, Frank Edelmann, Titus Kuehne, Titus Kuehne, Titus Kuehne, Marcus Kelm, Marcus Kelm, Marcus Kelm, Sebastian Kelle, Sebastian Kelle, Sebastian Kelle

“…Trial registrationGerman Clinical Trials Register (DRKS), registration number (DRKS00015615).…”
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Characteristics of adherent and non-adherent patients with hypertension in a Norwegian cross-sectional study by Eirik Olsen, Lene V. Halvorsen, Stine Rognstad, Arleen Aune, Karl Marius Brobak, Ola Undrum Bergland, Vibeke N. Kjær, Knut Liestøl, Marit D. Solbu, Rune Mo, Eva Gerdts, Morten Rostrup, Sverre E. Kjeldsen, Aud Høieggen, Mimi S. Opdal, Anne Cecilie K. Larstorp, Camilla L. Søraas

“…Adherence was significantly and negatively related to younger age, non-European ethnicity, and increasing number of prescribed antihypertensive pills, and positively to the type of prescribed medication, especially angiotensin receptor blocker (www.ClinicalTrials.gov identifier: NCT03209154).…”
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