Article
Pharmacology & Pharmacy
Catherine Cornu, Anne Donche, Carine Coffre, Annelie Le Gouge, Boulkedid Rym, Isabelle Vaugier, Frederic Barbot, Alain Leizorovicz, Nadine Juge, Celine Giraud, Francois Gueyffier, Alexandra Felin, Thibault Mura, Hugues Chevassus, Christine Binquet
Summary: This study presents a French version of the certified data management standards published by ECRIN. These standards provide a clear description of data management and IT requirements for clinical studies, serving as a valuable reference for academic data management structures.
Article
Computer Science, Interdisciplinary Applications
Yingcheng Sun, Alex Butler, Latoya A. Stewart, Hao Liu, Chi Yuan, Christopher T. Southard, Jae Hyun Kim, Chunhua Weng
Summary: This study used 700 COVID-19 trials to develop a semi-automatic approach to create an annotated corpus called COVIC for COVID-19 clinical trial eligibility criteria, providing a benchmark for machine learning based criteria extraction and aiding in COVID-19 trial search and analytics.
JOURNAL OF BIOMEDICAL INFORMATICS
(2021)
Article
Engineering, Industrial
Andrew Brint, Andrea Genovese, Carmela Piccolo, Gerardo J. Taboada-Perez
Summary: The recent trend of collecting large amounts of data allows organizations to discover unknown data patterns that can improve performance, but the cost of continuing this data collection can be high. This study introduces a statistical method based on PCA and TOPSIS to reduce KPIs, successfully reducing 28 KPIs to 8. The results show that having extra indicators provided little additional precision for the considered time interval, demonstrating the value of reducing a large number of KPIs to a more manageable set.
INTERNATIONAL JOURNAL OF PRODUCTION ECONOMICS
(2021)
Article
Computer Science, Interdisciplinary Applications
Amy Junghyun Lee, Kyung Won Kim, Youngbin Shin, Jiwoo Lee, Hyo Jung Park, Young Chul Cho, Yousun Ko, Yu Sub Sung, Byung Sun Yoon
Summary: To address major issues in imaging data management, a CDISC-compliant CTIMS was developed with automatic verification and transformation modules to ensure data consistency and high quality by transforming data into SDTM format.
JOURNAL OF BIOMEDICAL INFORMATICS
(2021)
Article
Cell Biology
Chantal Lechanteur, Alexandra Briquet, Virginie Bettonville, Etienne Baudoux, Yves Beguin
Summary: The study outlines the upgrade of an existing clinical-grade MSC manufacturing process to comply with GMP standards, including reorganization of key aspects and validation of a new variant for specific disease treatment. While GMP manufacturing of MSC products is feasible in academic settings, large-scale production for phase III trials would require collaboration with industrial partners.
Article
Medicine, Research & Experimental
Aynaz Nourani, Haleh Ayatollahi, Masoud Solaymani Dodaran
Summary: This study investigated the data management processes in diabetes clinical trials in three research institutes in Iran. The findings indicated a lack of clear and standard data management processes in these trials, with each research center using its own methods and processes. The study suggests the use of information technology to streamline data management processes in various clinical trials, including diabetes clinical trials.
Article
Medicine, General & Internal
Lucie Bourguignon, Bobo Tong, Fred Geisler, Martin Schubert, Frank Rohrich, Marion Saur, Norbert Weidner, Rudiger Rupp, Yorck-Bernhard B. Kalke, Rainer Abel, Doris Maier, Lukas Grassner, Harvinder S. Chhabra, Thomas Liebscher, Jacquelyn J. Cragg, John Kramer, Armin Curt, Catherine R. Jutzeler
Summary: Despite changes in the epidemiological characteristics of traumatic spinal cord injury, neurological and functional recovery has remained stable over the last two decades. This study provides an important resource for informing clinical practice and implementing new clinical trials.
Article
Medicine, General & Internal
Nina Wilson, Katie Biggs, Sarah Bowden, Julia Brown, Munyaradzi Dimairo, Laura Flight, Jamie Hall, Anna Hockaday, Thomas Jaki, Rachel Lowe, Caroline Murphy, Philip Pallmann, Mark A. Pilling, Claire Snowdon, Matthew R. Sydes, Sofia S. Villar, Christopher J. Weir, Jessica Welburn, Christina Yap, Rebecca Maier, Helen Hancock, James M. S. Wason
Summary: Adaptive designs generally require slightly more resources compared to non-adaptive trials, with the increase mostly seen in the need for statistical staff. Factors influencing resource increases include experience with adaptive trials, design complexity, and funding for core infrastructure within the CTU.
Article
Health Care Sciences & Services
Benjamin Kinast, Hannes Ulrich, Bjoern Schreiweis
Summary: In patient care, data silos are limiting the accessibility of health data. Medical informatics is developing ways to move from siloed data to a more harmonized arrangement. This study aims to provide a catalog of functional requirements for integrating medical data into knowledge management environments and found 220 distinct requirements from 61 publications.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Article
Medical Informatics
Aynaz Nourani, Haleh Ayatollahi, Masoud Solaymani-Dodaran
Summary: This study aimed to evaluate the quality and usability of a data management system for diabetes clinical trials from the users' perspectives. The results revealed no significant differences in users' perspectives on information quality, service quality, achievements, and communication before and after using the system. However, users' expectations exceeded the system performance in terms of system quality and users' autonomy. Overall, the system usability received positive feedback from the users.
BMC MEDICAL INFORMATICS AND DECISION MAKING
(2023)
Article
Chemistry, Physical
Camila Correa-Jullian, Katrina M. Groth
Summary: During the past decade, Prognostics and Health Management (PHM) has become an important set of tools in different industries and academia to improve the safety and reliability of complex engineering systems. This paper presents a high-level approach for designing data-driven PHM applications for bulk liquid hydrogen (LH2) storage systems in hydrogen fueling stations. The focus is on improving the reliability assessment of hydrogen components and considering the challenges related to data availability, diagnostic capabilities, and integration of risk mitigation measures.
INTERNATIONAL JOURNAL OF HYDROGEN ENERGY
(2022)
Review
Medicine, General & Internal
Christian Ohmann, David Moher, Maximilian Siebert, Edith Motschall, Florian Naudet
Summary: The study found that while there is a high willingness to share IPD data from clinical trials, the actual data-sharing rates are suboptimal, and journals have poor to moderate enforcement of data-sharing policies. When data is requested, it is more often for secondary analysis and meta-analysis, rather than re-analysis. Studies on the real impact of data-sharing are rare and often use surrogate metrics like citation metrics.
Article
Nutrition & Dietetics
Kevin C. Maki, Joshua W. Miller, George P. McCabe, Gowri Raman, Penny M. Kris-Etherton
Summary: In this article, best practices for biospecimen collection, analysis, and clinical data management in human nutrition RCTs were outlined, aiming to improve data quality to support food and nutrition policies.
ADVANCES IN NUTRITION
(2021)
Article
Medicine, General & Internal
Svetlana Artemova, Ursula von Schenck, Rui Fa, Daniel Stoessel, Hadiseh Nowparast Rostami, Pierre-Ephrem Madiot, Jean-Marie Januel, Daniel Pagonis, Caroline Landelle, Meghann Gallouche, Christophe Cance, Frederic Olive, Alexandre Moreau-Gaudry, Sigurd Prieur, Jean-Luc Bosson
Summary: By analyzing big data and using machine-learning methods, we aim to identify correlations between patient characteristics and/or medical procedures during hospitalization, and build models for early identification of high-risk patients.
Article
Biochemical Research Methods
Ranjeet S. Bhamber, Andris Jankevics, Eric W. Deutsch, Andrew R. Jones, Andrew W. Dowsey
Summary: The optimized HDF5 file format mzMLb enhances read/write speed and storage efficiency of mass spectrometry data, supporting future versions of mzML and providing easy implementation.
JOURNAL OF PROTEOME RESEARCH
(2021)
Article
Gastroenterology & Hepatology
Adria Juanola, Isabel Graupera, Chiara Elia, Salvatore Piano, Cristina Sole, Marta Carol, Martina Perez-Guasch, Octavi Bassegoda, Laia Escude, Ana-Belen Rubio, Marta Cervera, Laura Napoleone, Emma Avitabile, Ann T. Ma, Nuria Fabrellas, Elisa Pose, Manuel Morales-Ruiz, Wladimiro Jimenez, Ferran Torres, Gonzalo Crespo, Elsa Sola, Pere Gines
Summary: This study found that in patients with decompensated cirrhosis, urinary L-FABP levels are independently associated with the 3-month clinical course and can predict mortality and ACLF development.
JOURNAL OF HEPATOLOGY
(2022)
Review
Gastroenterology & Hepatology
Lorenzo A. Orci, Marco Sanduzzi-Zamparelli, Berta Caballol, Victor Sapena, Nicola Colucci, Ferran Torres, Jordi Bruix, Maria Reig, Christian Toso
Summary: Nonalcoholic fatty liver disease (NAFLD) may be a risk factor for hepatocellular carcinoma (HCC), and this study used meta-analysis to analyze the incidence rates of HCC in NAFLD patients. The results showed that NAFLD patients with cirrhosis have a similar risk of developing HCC compared to cirrhosis patients with other causes. However, the incidence of HCC in nonalcoholic steatohepatitis or simple steatosis patients is lower.
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
(2022)
Article
Medicine, General & Internal
Arturo Renu, Monica Millan, Luis San Roman, Jordi Blasco, Joan Marti-Fabregas, Mikel Terceno, Sergio Amaro, Joaquin Serena, Xabier Urra, Carlos Laredo, Roger Barranco, Pol Camps-Renom, Federico Zarco, Laura Oleaga, Pere Cardona, Carlos Castano, Juan Macho, Elisa Cuadrado-Godia, Elio Vivas, Antonio Lopez-Rueda, Leopoldo Guimaraens, Anna Ramos-Pachon, Jaume Roquer, Marian Muchada, Alejandro Tomasello, Antonio Davalos, Ferran Torres, Angel Chamorro
Summary: This study investigated whether treatment with adjunct intra-arterial alteplase after thrombectomy improves outcomes following reperfusion. The results showed that compared with placebo, the use of adjunct intra-arterial alteplase resulted in a greater likelihood of excellent neurological outcome at 90 days.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2022)
Article
Gastroenterology & Hepatology
Marco Sanduzzi-Zamparelli, Zoe Marino, Sabela Lens, Victor Sapena, Gemma Iserte, Anna Pla, Nuria Granel, Concepcio Bartres, Neus Llarch, Ramon Vilana, Isabel Nunez, Anna Darnell, Ernest Belmonte, Angeles Garcia-Criado, Alba Diaz, Sergio Munoz-Martinez, Carmen Ayuso, Luis Bianchi, Carla Fuster-Anglada, Jordi Rimola, Alejandro Forner, Ferran Torres, Jordi Bruix, Xavier Forns, Maria Reig
Summary: Research on HCV-infected patients shows that cirrhotic patients without non-characterized liver nodules at sustained virologic response still face the risk of hepatocellular carcinoma. Patients in F3 fibrosis stage have a lower cancer risk, but more prospective studies are needed for verification.
JOURNAL OF HEPATOLOGY
(2022)
Article
Oncology
Marta Espanol-Rego, Carlos Fernandez-Martos, Elena Elez, Carles Foguet, Leire Pedrosa, Nuria Rodriguez, Ana Ruiz-Casado, Estela Pineda, Joan Cid, Raquel Cabezon, Helena Oliveres, Miquel Lozano, Angels Gines, Angeles Garcia-Criado, Juan Ramon Ayuso, Mario Pages, Miriam Cuatrecasas, Ferran Torres, Timothy Thomson, Marta Cascante, Daniel Benitez-Ribas, Joan Maurel
Summary: This study investigated the potential of Avelumab combined with ADC vaccine as a treatment for MSS mCRC patients. The results showed that the combination therapy was safe and well tolerated, but had limited clinical activity. Additionally, the study found a post-therapy metabolic rewiring, which could represent novel immunotherapy-induced tumor vulnerabilities.
CANCER IMMUNOLOGY IMMUNOTHERAPY
(2023)
Article
Gastroenterology & Hepatology
Oana J. Nicoara-Farcau, Juan J. Lozano, Cristina Alonso, Julia Sidorova, Candid Villanueva, Augustin Albillos, Joan Genesca, Elba Llop, Jose L. Calleja, Carles Aracil, Rafael Banares, Rosa Morillas, Maria Poca, Beatriz Penas, Salvador Augustin, Marcel Tantau, Marcos Thompson, Valeria Perez-Campuzano, Anna Baiges, Fanny Turon, Virginia G. Hernandez-Gea, Juan G. Abraldes, Edilmar A. Tapias, Ferran Torres, Jaime Bosch, Juan Garcia-Pagan
Summary: This study aims to evaluate the role of metabolomics in predicting clinical outcomes in compensated cirrhosis patients. The results show that metabolomics can provide similar predictive capacity as invasive HVPG testing.
Article
Gastroenterology & Hepatology
Ian Rowe, Candid E. Villanueva, Jessica Shearer, Ferran Torres, Agustin Albillos, Joan C. Genesca, Joan Garcia-Pagan, Dhiraj C. Tripathi, Peter Hayes, Jaume G. Bosch, Juan Abraldes
Summary: This study conducted a Bayesian reanalysis of PREDESCI and found that beta-blocker treatment is highly likely to prevent decompensation and provides a substantial gain in decompensation-free life years at the population level.
Article
Pharmacology & Pharmacy
Stella Pesiou, Rafel Barcelo, Marc Fradera, Ferran Torres, Caridad Pontes
Summary: Psychotropic use in pediatrics, especially off-label use, is common and carries potential risks. A retrospective study in Catalonia, Spain found that the prevalence of psychotropic use in pediatric patients was high, with hydroxyzine as the most commonly dispensed drug. Adolescents and boys were more likely to receive psychotropics, particularly psychostimulants like methylphenidate. About 12% of subjects had received off-label prescriptions, highlighting the need for further research on efficacy and safety in pediatric populations where extrapolation from adult data is unreliable.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Pharmacology & Pharmacy
Dan Ouchi, Carles Vilaplana-Carnerero, Ramon Monfa, Maria Giner-Soriano, Ana Garcia-Sangenis, Ferran Torres, Rosa Morros
Summary: This study aims to describe the impact of initiating a combination treatment to reduce glycated hemoglobin in patients with type 2 diabetes. The study found that combination therapy with insulin and glucagon-like peptide-1 achieved the goal faster, while combinations with sulfonylureas had poorer results. Medication adherence played an important role in glycated hemoglobin control.
DRUGS-REAL WORLD OUTCOMES
(2023)
Article
Endocrinology & Metabolism
Dan Ouchi, Maria Giner-Soriano, Carles Vilaplana-Carnerero, Ramon Monfa, Ferran Torres, Rosa Morros
Summary: The aim of this study was to analyze the initial and subsequent treatments prescribed to newly diagnosed type 2 diabetes mellitus patients. The majority of patients started treatment with a single metformin medication, while a smaller percentage began with combination therapy. Metformin was the most commonly used first and third-line therapy, while metformin with DPP4i or sulfonylurea combination therapy was more prevalent as second-line therapy.
DIABETES RESEARCH AND CLINICAL PRACTICE
(2023)
Letter
Gastroenterology & Hepatology
Candid Villanueva, Ferran Torres, Dhiraj Tripathi, Jaume Bosch
JOURNAL OF HEPATOLOGY
(2023)
Review
Psychiatry
Sarah Grube Jakobsen, Torben Nielsen, Christina Petrea Larsen, Pernille Tanggaard Andersen, Jens Lauritsen, Elsebeth Stenager, Erik Christiansen
Summary: European countries use different terminologies for self-harm and attempted suicide, making it difficult to compare incidence rates. This scoping review examined the definitions used and the possibilities for comparison in Europe. The results showed a lack of comparability due to different reporting traditions and approaches. International agreement on definitions and registration practices is needed for better understanding of suicidal behavior.
JOURNAL OF PSYCHIATRIC RESEARCH
(2023)
Article
Public, Environmental & Occupational Health
David Elvira, Ferran Torres, Roser Vives, Gemma Puig, Merce Obach, Daniel Gay, Daniel Varon, Thais de Pando, Josep Tabernero, Caridad Pontes
Summary: This study evaluates the relationship between oncology and hematology drug prices and structured value parameters at the time of reimbursement decision in Spain. The results show that factors such as the type of standard of care, references to long-lasting responders, the convenience of drug use, and the impact of treatment on patient autonomy are associated with drug prices. The study suggests that implementing MCDA-EVIDEM methodologies may capture the influence of additional factors on pricing decisions.
FRONTIERS IN PUBLIC HEALTH
(2023)
Article
Clinical Neurology
Peter Birkeland, Victoria Hansen, Vinosha Tharmabalan, Jens Lauritsen, Troels Nielsen, Thomas Truelsen, Sverre Rosenbaum, Paul von Weitzel-Mudersbach
Summary: This study provides data on the extent of the risk of recurrent stroke in MMD. Bypass surgery patients had fewer stroke events than those treated conservatively. There was a trend toward a higher stroke risk in females.
INTERNATIONAL JOURNAL OF STROKE
(2023)
Meeting Abstract
Gastroenterology & Hepatology
Elisa Pose, Cesar Jimenez, Giacomo Zaccherini, Daniela Campion, Salvatore Piano, Frank Erhard Uschner, Koos de Wit, Olivier Roux, Kohilan Gananandan, Wim Laleman, Cristina Sole, Sonia Alonso, Berta Cuyas, Xavier Ariza, Adria Juanola, Ann T. Ma, Laura Napoleone, Jordi Gratacos, Marta Tonon, Enrico Pompili, Jordi Sanchez-Delgado, Marta Carol, Martina Perez, Nuria Fabrellas, Judit Pich, Claudia Martell, Georgina Casanovas, Gemma Domenech, Ferran Torres, Victor Manuel, Vargas Blasco, Paolo Caraceni, Carlo Alessandria, Paolo Angeli, Jonel Trebicka, Ulrich Beuers, Claire Francoz, Raj Mookerjee, Rafael Banares, German Soriano, Ruben Hernaez, Andrew S. Allegretti, Manuel Morales-Ruiz, Miquel Serra, Hugh Watson, Juan G. Abraldes, Patrick S. Kamath, Pere Gines
JOURNAL OF HEPATOLOGY
(2023)