A policy framework for leveraging generative AI to address enduring challenges in clinical trials by Johnathon Edward Liddicoat, Gabriela Lenarczyk, Mateo Aboy, Timo Minssen, Sebastian Porsdam Mann

“…Can artificial intelligence improve clinical trial design? Despite their importance in medicine, over 40% of trials involve flawed protocols. …”
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Self- versus clinician-collected swabs in anal cancer screening: A clinical trial. by Clare E F Dyer, Fengyi Jin, Jennifer M Roberts, I Mary Poynten, Annabelle Farnsworth, Leon P McNally, Philip H Cunningham, Andrew E Grulich, Richard J Hillman

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Fedratinib for the treatment of myelofibrosis: a critical appraisal of clinical trial and “real-world” data by Adrian Duek, Ilona Leviatan, Osnat Jarchowsky Dolberg, Martin H. Ellis

“…In contrast, recently published real-world data suggest that these responses may not be as robust outside clinical trials. In the context of routine clinical practice spleen responses are documented in only 13–68%, with varying degrees of symptom improvement. …”
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The Effect of Acupuncture along with Conventional Therapies on the Treatment of Allergic Rhinitis: A Clinical Trial by Sayed Mostafa Hashemi, Farhang Mokhtarinejad, Seyed Mojtaba Abtahi Forooshani, Mehran Rezvani Habibabadi

“…Materials and Methods: The present randomized, clinical trial was performed on 51 patients with AR. All patients underwent standard AR treatment under the supervision of a specialist physician. …”
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The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19 by Clara Hernández-Blanco, Karima Al-Akioui-Sanz, Lara Herrera, Cristina Aguirre-Portolés, Daniel Lozano-Ojalvo, Leticia Pérez-Rodriguez, Jordi Cano-Ochando, Pilar Guerra-García, Alejandro Martín-Quirós, José Luis Vicario, Silvia Santos, Miguel Ángel Pérez-Vaquero, Miguel Ángel Vesga, Alberto M. Borobia, Antonio J. Carcas, Antonio Balas, Miguel Ángel Moreno, Rebeca Pérez de Diego, Mercedes Gasior, Bernat Soria, Cristina Eguizabal, Antonio Pérez-Martínez

“…In 2022 a phase I, dose-escalation, single center clinical trial was conducted to evaluate the safety and feasibility of the infusion of CD3−/CD56+ NK cells against moderate/severe cases of COVID-19 (NCT04578210). …”
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The “L-Sandwich” Strategy for True Coronary Bifurcation Lesions: A Randomized Clinical Trial by Quan Guo, Liang Peng, Lixin Rao, Cao Ma, Kang Zhao, Zhenzhou Zhao, Haiyu Tang, Muwei Li

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Frequency of orthostatic hypotension in the Pooled Resource Open-Access ALS Clinical Trials database by C. Quarracino, F. Capani, F. Capani, M. Otero-Losada, G. E. Rodríguez, S. Pérez-Lloret, S. Pérez-Lloret

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Reporting and representation of participant race and ethnicity in phase III clinical trials for solid tumors by Tianyi Wang, Dinorah J Villanueva, Ambily Banerjee, Dina Gifkins

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A Criterion-based Approach for the Systematic and Transparent Extrapolation of Clinical Trial Survival Data by Gabriel Tremblay, Patrick Haines, Andrew Briggs

“…Often, significant survival effects are found beyond the time period observed in clinical trials, thus, extrapolation of trial results is required for health economic and HTA evaluations. …”
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Spontaneous intracerebral hemorrhage: Recent advances and critical thinking on future clinical trial design by Wengui Yu, Michael J. Alexander, Ting Gao

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Mesenchymal Progenitor Cells and Their Orthopedic Applications: Forging a Path towards Clinical Trials by Deana S. Shenaq, Farbod Rastegar, Djuro Petkovic, Bing-Qiang Zhang, Bai-Cheng He, Liang Chen, Guo-Wei Zuo, Qing Luo, Qiong Shi, Eric R. Wagner, Enyi Huang, Yanhong Gao, Jian-Li Gao, Stephanie H. Kim, Ke Yang, Yang Bi, Yuxi Su, Gaohui Zhu, Jinyong Luo, Xiaoji Luo, Jiaqiang Qin, Russell R. Reid, Hue H. Luu, Rex C. Haydon, Tong-Chuan He

“…Here, we discuss the path towards the development of clinical trials utilizing BMSCs for orthopaedic applications. …”
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Open-label randomised clinical trial investigating whether robot-assisted kidney transplantation can reduce surgical complications compared to open kidney transplantation (ORAKTx): study protocol for a randomised clinical trial by Milla Ortved, Julia Dagnæs-Hansen, Hein V. Stroomberg, Thomas Kistorp, Malene Rohrsted, Søren Schwartz Sørensen, Andreas Røder

“…Trial registration The trial was prospectively registered with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.…”
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“Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines by Sabah Attar, Carla Peacock, Mandy Wan, Erin Halil, Chloe Bickerstaff, Lionel Tan, Hafsah Bhatti, Ricardo M. Fernandes, Regis Hankard, Mark A. Turner

“…Contemporary Clinical Trials Communications…”
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Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial by Xandra García-González, Alberto M Borobia, Antonio J Carcas, Miriam Estébanez, Montserrat Carmona, Irene García García, Francisco Abad-Santos, Luis A López-Fernández, Esther Cubo, Iñaki Imaz-Iglesia, Alicia Marín-Candón, Miriam Saiz-Rodríguez, Irene Taladriz-Sender, Pedro Arias, Rocío Rosas-Alonso, Enrique Seco-Meseguer, Stefan Stewart, Elena Diago-Sempere, María del Mar García Saiz, Emilio J Laserna-Mendieta, Ana M Peiró, Magí Farré, Consuelo Rodriguez-Jimenez, Judith Sanabria-Cabrera, Lucia Pedrosa, Ignacio Bernardino, Javier Guiijarro-Eguinoa, Arturo Gómez López De Las Huertas, Susana Martín-López, Olga Hladun Alvaro, Vicente Arrate, Ana Fries, Daniel Rodriguez Díaz, Fernando Marqués García, Núria Alonso Pedrol, Modesto M Maestre Muñiz, Leticia Rodríguez Alcolado, Carlos Ortiz-Bautista, Angela Remesal-Doblado, María Isabel Lucena, Zaida Salmón González, Inmaculada Coca-Prieto

“…Trial registration of this study can be located at both the EU Clinical Trials Register available from https:// euclinicaltrials.eu/search-for-clinical-trials/?…”
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Long-Term Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: Follow-Up Data from a 3-Year Open-... by Caroline J. Stone, Geeta Ahuja, Lais Lopes Almeida Gomes, Joy Poroye, Daniella Forman Faden, Lillian Xie, Rui Feng, Barbara White, Victoria P. Werth

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Leaflet: Operative Steps for Interventional Studies in Neuroscience by Maria Meringolo, Sergio Delle Monache, Giuseppina Martella, Antonella Peppe

Subjects: “…clinical trials…”
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Artificial Intelligence in Oncology by Krzysztof Jeziorski, Robert Olszewski

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Increasing the meaningful involvement of women in HIV cure-related research: a qualitative interview study in the United States by Karine Dubé, Elizabeth Barr, Morgan Philbin, Amaya Perez-Brumer, Brian Minalga, Beth Peterson, Dawn Averitt, Bridgette Picou, Krista Martel, Cecilia Chung, María Mejía, Martha Cameron, Gail Graham, Lynda Dee, Dázon Dixon Diallo, Ebony Gordon, Anastasia Korolkova, Typhanye Dyer, Judith D. Auerbach, Eileen Scully, Krista L. Dong, Sara Gianella

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Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial by Olayinka O. Shiyanbola, Meng-Jung Wen, Martha A. Maurer

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Acupuncture Therapy in the Management of Orofacial Pain and Headaches: A Systematic Review and Meta-Analysis by Ananya Neralla, Silpiranjan Mishra, Sangamesh Ningappa Chinnannavar, S. Bhuvaneshwari, Atul A. Bajoria, Dhirendra K. Singh

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