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JOURNAL ARTICLE
Arianna Bassan, Ronald Steigerwalt, Douglas Keller, Lisa Beilke, Paul M Bradley, Frank Bringezu, William J Brock, Leigh Ann Burns-Naas, Jon Chambers, Kevin Cross, Michael Dorato, Rosalie Elespuru, Douglas Fuhrer, Frances Hall, Jim Hartke, Gloria D Jahnke, Felix M Kluxen, Eric McDuffie, Friedemann Schmidt, Jean-Pierre Valentin, David Woolley, Doris Zane, Glenn J Myatt
The ICH S1B carcinogenicity global testing guideline has been recently revised with a novel addendum that describes a comprehensive integrated Weight of Evidence (WoE) approach to determine the need for a 2-year rat carcinogenicity study. In the present work, experts from different organizations have joined efforts to standardize as much as possible a procedural framework for the integration of evidence associated with the different ICH S1B(R1) WoE criteria. The framework uses a pragmatic consensus procedure for carcinogenicity hazard assessment to facilitate transparent, consistent, and documented decision-making and it discusses best-practices both for the organization of studies and presentation of data in a format suitable for regulatory review...
2024: Frontiers in toxicology
#2
JOURNAL ARTICLE
Kevin D Hall
OBJECTIVE: The objective of this study was to investigate why different weight-loss interventions result in varying durations of weight loss prior to approaching plateaus. METHODS: A validated mathematical model of energy metabolism and body composition dynamics was used to simulate mean weight- and fat-loss trajectories in response to diet restriction, semaglutide 2.4 mg, tirzepatide 10 mg, and Roux-en-Y gastric bypass (RYGB) surgery interventions...
April 22, 2024: Obesity
#3
JOURNAL ARTICLE
Ayse Bahar Ercan, Melyssa Aronson, Nicholas R Fernandez, Yuan Chang, Adrian Levine, Zhihui Amy Liu, Logine Negm, Melissa Edwards, Vanessa Bianchi, Lucie Stengs, Jiil Chung, Abeer Al-Battashi, Agnes Reschke, Alex Lion, Alia Ahmad, Alvaro Lassaletta, Alyssa T Reddy, Amir F Al-Darraji, Amish C Shah, An Van Damme, Anne Bendel, Aqeela Rashid, Ashley S Margol, Bethany L Kelly, Bojana Pencheva, Brandie Heald, Brianna Lemieux-Anglin, Bruce Crooks, Carl Koschmann, Catherine Gilpin, Christopher C Porter, David Gass, David Samuel, David S Ziegler, Deborah T Blumenthal, Dennis John Kuo, Dima Hamideh, Donald Basel, Dong-Anh Khuong-Quang, Duncan Stearns, Enrico Opocher, Fernando Carceller, Hagit Baris Feldman, Helen Toledano, Ira Winer, Isabelle Scheers, Ivana Fedorakova, Jack M Su, Jaime Vengoechea, Jaroslav Sterba, Jeffrey Knipstein, Jordan R Hansford, Julieta Rita Gonzales-Santos, Kanika Bhatia, Kevin J Bielamowicz, Khurram Minhas, Kim E Nichols, Kristina A Cole, Lynette Penney, Magnus Aasved Hjort, Magnus Sabel, Maria Joao Gil-da-Costa, Matthew J Murray, Matthew Miller, Maude L Blundell, Maura Massimino, Maysa Al-Hussaini, Mazin F Al-Jadiry, Melanie A Comito, Michael Osborn, Michael P Link, Michal Zapotocky, Mithra Ghalibafian, Najma Shaheen, Naureen Mushtaq, Nicolas Waespe, Nobuko Hijiya, Noemi Fuentes-Bolanos, Olfat Ahmad, Omar Chamdine, Paromita Roy, Pavel N Pichurin, Per Nyman, Rachel Pearlman, Rebecca C Auer, Reghu K Sukumaran, Rejin Kebudi, Rina Dvir, Robert Raphael, Ronit Elhasid, Rose B McGee, Rose Chami, Ryan Noss, Ryuma Tanaka, Salmo Raskin, Santanu Sen, Scott Lindhorst, Sebastien Perreault, Shani Caspi, Shazia Riaz, Shlomi Constantini, Sophie Albert, Stanley Chaleff, Stefan Bielack, Stefano Chiaravalli, Stuart Louis Cramer, Sumita Roy, Suzanne Cahn, Suzanne Penna, Syed Ahmer Hamid, Tariq Ghafoor, Uzma Imam, Valerie Larouche, Vanan Magimairajan Issai, William D Foulkes, Yi Yen Lee, Paul C Nathan, Yosef E Maruvka, Mary-Louise C Greer, Carol Durno, Adam Shlien, Birgit Ertl-Wagner, Anita Villani, David Malkin, Cynthia Hawkins, Eric Bouffet, Anirban Das, Uri Tabori
BACKGROUND: Constitutional mismatch repair deficiency (CMMRD) syndrome is a rare and aggressive cancer predisposition syndrome. Because a scarcity of data on this condition contributes to management challenges and poor outcomes, we aimed to describe the clinical spectrum, cancer biology, and impact of genetics on patient survival in CMMRD. METHODS: In this cohort study, we collected cross-sectional and longitudinal data on all patients with CMMRD, with no age limits, registered with the International Replication Repair Deficiency Consortium (IRRDC) across more than 50 countries...
March 26, 2024: Lancet Oncology
#4
JOURNAL ARTICLE
Courtney M Rowan, Brenna LaBere, Cameron C Young, Laura D Zambrano, Margaret M Newhams, Suden Kucukak, Elizabeth R McNamara, Elizabeth H Mack, Julie C Fitzgerald, Katherine Irby, Aline B Maddux, Jennifer E Schuster, Michele Kong, Heda Dapul, Stephanie P Schwartz, Melania M Bembea, Laura L Loftis, Amanda R Kolmar, Christopher J Babbitt, Ryan A Nofziger, Mark W Hall, Shira J Gertz, Natalie Z Cvijanovich, Matt S Zinter, Natasha B Halasa, Tamara T Bradford, Gwenn E McLaughlin, Aalok R Singh, Charlotte V Hobbs, Kari Wellnitz, Mary A Staat, Bria M Coates, Hillary R Crandall, Mia Maamari, Kevin M Havlin, Adam J Schwarz, Christopher L Carroll, Emily R Levy, Kristin L Moffitt, Angela P Campbell, Adrienne G Randolph, Janet Chou
BACKGROUND: We aimed to determine if pre-existing immunocompromising conditions (ICCs) were associated with the presentation or outcome of patients with acute coronavirus disease 2019 (COVID-19) admitted for pediatric intensive care. METHODS: 55 hospitals in 30 U.S. states reported cases through the Overcoming COVID-19 public health surveillance registry. Patients <21 years admitted March 12, 2020-December 30, 2021 to the pediatric intensive care unit (PICU) or high acuity unit for acute COVID-19 were included...
March 11, 2024: Clinical Infectious Diseases
#5
JOURNAL ARTICLE
Azadeh C Bashi, Elizabeth A Coker, Krishna C Bulusu, Patricia Jaaks, Claire Crafter, Howard Lightfoot, Marta Milo, Katrina McCarten, David F Jenkins, Dieudonne van der Meer, James T Lynch, Syd Barthorpe, Courtney L Andersen, Simon T Barry, Alexandra Beck, Justin Cidado, Jacob A Gordon, Caitlin Hall, James Hall, Iman Mali, Tatiana Mironenko, Kevin Mongeon, James Morris, Laura Richardson, Paul D Smith, Omid Tavana, Charlotte Tolley, Frances Thomas, Brandon S Willis, Wanjuan Yang, Mark J O'Connor, Ultan McDermott, Susan E Critchlow, Lisa Drew, Stephen E Fawell, Jerome T Mettetal, Mathew J Garnett
UNLABELLED: Oncology drug combinations can improve therapeutic responses and increase treatment options for patients. The number of possible combinations is vast and responses can be context-specific. Systematic screens can identify clinically relevant, actionable combinations in defined patient subtypes. We present data for 109 anticancer drug combinations from AstraZeneca's oncology small molecule portfolio screened in 755 pan-cancer cell lines. Combinations were screened in a 7 × 7 concentration matrix, with more than 4 million measurements of sensitivity, producing an exceptionally data-rich resource...
March 8, 2024: Cancer Discovery
#6
REVIEW
Kevin D Koenig, Michelle J Hall, Caroline Gormley, Mary Kaleta, Meghan Munger, Jennifer Laine, Sara J Morgan
PURPOSE: This study aimed to identify clinical measures that have been used to evaluate function, health related quality of life (HRQoL), and/or satisfaction in children who use lower limb prostheses (LLP). The data reported on psychometric properties for children who use LLP were collected for each measure. METHODS: First, PubMed, CINAHL, and Web of Science databases were searched using broad search terms to identify standardized outcome measures of function, HRQoL, and/or satisfaction with treatment used in pediatric LLP research published in 2001 or after...
February 24, 2024: Journal of Pediatric Rehabilitation Medicine
#7
JOURNAL ARTICLE
Surendra Dasari, Michael R McCarthy, Antonina A Wojcik, Beth A Pitel, Arpan Samaddar, Burak Tekin, Rumeal D Whaley, Aditya Raghunathan, Loren Herrera Hernandez, Rafael E Jimenez, Brad J Stish, R Houston Thompson, Bradley C Leibovich, Stephen A Boorjian, R Jeffrey Karnes, Daniel S Childs, J Fernando Quevedo, Eugene D Kwon, Lance C Pagliaro, Brian A Costello, Kevin C Halling, John C Cheville, Benjamin R Kipp, Sounak Gupta
Primary prostatic adenocarcinoma (pPC) undergoes genomic evolution secondary to therapy-related selection pressures as it transitions to metastatic noncastrate (mNC-PC) and castrate resistant (mCR-PC) disease. Next generation sequencing results were evaluated for pPC (n = 97), locally advanced disease (involving urinary bladder/rectum, n = 12), mNC-PC (n = 21), and mCR-PC (n = 54). We identified enrichment of TP53 alterations in high-grade pPC, TP53/RB1 alterations in HGNE disease, and AR alterations in metastatic and castrate resistant disease...
February 27, 2024: Prostate Cancer and Prostatic Diseases
#8
Verena M Link, Poorani Subramanian, Foo Cheung, Kyu Lee Han, Apollo Stacy, Liang Chi, Brian A Sellers, Galina Koroleva, Amber B Courville, Shreni Mistry, Andrew Burns, Richard Apps, Kevin D Hall, Yasmine Belkaid
No abstract text is available yet for this article.
February 27, 2024: Nature Medicine
#9
JOURNAL ARTICLE
Verena M Link, Poorani Subramanian, Foo Cheung, Kyu Lee Han, Apollo Stacy, Liang Chi, Brian A Sellers, Galina Koroleva, Amber B Courville, Shreni Mistry, Andrew Burns, Richard Apps, Kevin D Hall, Yasmine Belkaid
Nutrition has broad impacts on all physiological processes. However, how nutrition affects human immunity remains largely unknown. Here we explored the impact of a dietary intervention on both immunity and the microbiota by performing a post hoc analysis of a clinical trial in which each of the 20 participants sequentially consumed vegan or ketogenic diets for 2 weeks ( NCT03878108 ). Using a multiomics approach including multidimensional flow cytometry, transcriptomic, proteomic, metabolomic and metagenomic datasets, we assessed the impact of each diet, and dietary switch, on host immunity and the microbiota...
January 30, 2024: Nature Medicine
#10
JOURNAL ARTICLE
Bradley Hall, John N Milligan, Kevin Kelnar, Elliot Hallmark, Jacob D Ashton, Connor A Parker, Stela Filipovic-Sadic, Abigail Sharp, Samantha Eagle, Nissa Rodgers, Marco Leung, Mariam T Mathew, Luke Grissom, Rebecca Post, Nataša Teran, Gary J Latham
CONTEXT.—: Existing targeted cystic fibrosis screening assays miss important pathogenic CFTR variants in the ethnically diverse US population. OBJECTIVE.—: To evaluate the analytic performance of a multiplex polymerase chain reaction (PCR)/capillary electrophoresis (CE) CFTR assay panel that simultaneously interrogates primary pathogenic variants of different ethnic/ancestral groups. DESIGN.—: Performance characteristic assessment and variant coverage comparison of the panel with a focus on ethnicity-specific CFTR variants were performed...
January 8, 2024: Archives of Pathology & Laboratory Medicine
#11
JOURNAL ARTICLE
Christopher G Thomson, Kelly Boss, Amy Calhoun, Cary Fridrich, Kevin M Gardinier, Edward C Hall, Keith Jendza, Louise Kirman, Nancy Labbé-Giguere, Kurt Laumen, Ming Qian, Sanjit Sanyal, Michael D Shultz, Radka Snajdrova, Kian Tan, Kate Yaping Wang, Fan Yang, Feng Gao, Tao Hong, Elena Dale, Brent Kuzmiski, Danny Ortuno, Daniel S Palacios
We have developed a chiral route toward the synthesis of muscarinic M4 agonists that was enabled by the biocatalytic synthesis of the key spirocyclic diamine building blocks 10 and 12 . Using these bifunctional compounds we were able to optimize a synthetic sequence toward a collection of advanced intermediates for further elaboration. These advanced intermediates were then used as starting points for early medicinal chemistry and the identification of selective M1/M4 agonists.
December 14, 2023: ACS Medicinal Chemistry Letters
#12
Kevin D Hall
OBJECTIVE: To investigate why different weight loss interventions result in varying durations of weight loss prior to approaching plateaus. METHODS: A validated mathematical model of energy balance and body composition dynamics was used to simulate mean weight loss trajectories in response to intensive calorie restriction, semaglutide 2.4 mg, tirzepatide 10 mg, and Roux en-Y gastric bypass (RYGB) surgery interventions. Each intervention was simulated by varying two model parameters affecting energy intake to fit the observed mean weight loss data...
November 5, 2023: bioRxiv
#13
JOURNAL ARTICLE
Douglas A Keller, Arianna Bassan, Alexander Amberg, Leigh Ann Burns Naas, Jon Chambers, Kevin Cross, Frances Hall, Gloria D Jahnke, Amarjit Luniwal, Serena Manganelli, Jordi Mestres, Amy L Mihalchik-Burhans, David Woolley, Raymond R Tice
In silico toxicology protocols are meant to support computationally-based assessments using principles that ensure that results can be generated, recorded, communicated, archived, and then evaluated in a uniform, consistent, and reproducible manner. We investigated the availability of in silico models to predict the carcinogenic potential of pregabalin using the ten key characteristics of carcinogens as a framework for organizing mechanistic studies. Pregabalin is a single-species carcinogen producing only one type of tumor, hemangiosarcomas in mice via a nongenotoxic mechanism...
2023: Frontiers in toxicology
#14
Christina M Sciarrillo, Juen Guo, Aaron Hengist, Valerie L Darcey, Kevin D Hall
BACKGROUND: Crossover studies can induce order effects, especially when they lack a wash-out period. OBJECTIVE: To explore diet order effects on energy balance and food intake between randomized diet order groups in two inpatient crossover studies originally designed to compare within-subject differences in ad libitum energy intake between either minimally processed low carbohydrate (LC) versus low fat (LF) diets or macronutrient-matched diets composed of mostly minimally processed food (MPF) or ultra-processed food (UPF)...
October 4, 2023: medRxiv
#15
JOURNAL ARTICLE
Donghan M Yang, Qinbo Zhou, Lauren Furman-Cline, Xian Cheng, Danni Luo, Hongyin Lai, Yueqi Li, Kevin W Jin, Bo Yao, Patrick J Leavey, Dinesh Rakheja, Tammy Lo, David Hall, Donald A Barkauskas, David S Shulman, Katherine Janeway, Chand Khanna, Richard Gorlick, Christopher Menzies, Xiaowei Zhan, Guanghua Xiao, Stephen X Skapek, Lin Xu, Laura J Klesse, Brian D Crompton, Yang Xie
PURPOSE: Osteosarcoma research advancement requires enhanced data integration across different modalities and sources. Current osteosarcoma research, encompassing clinical, genomic, protein, and tissue imaging data, is hindered by the siloed landscape of data generation and storage. MATERIALS AND METHODS: Clinical, molecular profiling, and tissue imaging data for 573 patients with pediatric osteosarcoma were collected from four public and institutional sources. A common data model incorporating standardized terminology was created to facilitate the transformation, integration, and load of source data into a relational database...
September 2023: JCO Clinical Cancer Informatics
#16
Valerie L Darcey, Juen Guo, Meible Chi, Stephanie T Chung, Amber B Courville, Isabelle Gallagher, Peter Herscovitch, Rebecca Howard, Melissa LaNoire, Lauren Milley, Alex Schick, Michael Stagliano, Sara Turner, Nicholas Urbanski, Shanna Yang, Eunha Yim, Nan Zhai, Megan S Zhou, Kevin D Hall
The relationship between adiposity and dopamine type-2 receptor binding potential (D2BP) in the human brain has been repeatedly studied for >20 years with highly discrepant results, likely due to variable methodologies and differing study populations. We conducted a controlled inpatient feeding study to measure D2BP in the striatum using positron emission tomography with both [ 18 F]fallypride and [ 11 C]raclopride in pseudo-random order in 54 young adults with a wide range of body mass index (BMI 20-44 kg/m 2 )...
September 28, 2023: medRxiv
#17
Marc D Ryser, Matthew A Greenwald, Inmaculada C Sorribes, Lorraine M King, Allison Hall, Joseph Geradts, Donald L Weaver, Diego Mallo, Shannon Holloway, Daniel Monyak, Graham Gumbert, Shariar Vaez-Ghaemi, Ethan Wu, Kevin Murgas, Lars J Grimm, Carlo C Maley, Jeffrey R Marks, Darryl Shibata, E Shelley Hwang
Ductal carcinoma in situ (DCIS) and invasive breast cancer share many morphologic, proteomic, and genomic alterations. Yet in contrast to invasive cancer, many DCIS tumors do not progress and may remain indolent over decades. To better understand the heterogenous nature of this disease, we reconstructed the growth dynamics of 18 DCIS tumors based on the geo-spatial distribution of their somatic mutations. The somatic mutation topographies revealed that DCIS is multiclonal and consists of spatially discontinuous subclonal lesions...
October 2, 2023: bioRxiv
#18
JOURNAL ARTICLE
Hisham Mehanna, Davy Rapozo, Sandra V von Zeidler, Kevin J Harrington, Stuart C Winter, Andrew Hartley, Paul Nankivell, Andrew G Schache, Philip Sloan, Edward W Odell, Selvam Thavaraj, Keith D Hunter, Ketan A Shah, Gareth J Thomas, Anna Long, Rasoul Amel-Kashipaz, Rachel M Brown, Brendan Conn, Gillian L Hall, Paul Matthews, Justin Weir, Yen Yeo, Miranda Pring, Catharine M L West, James McCaul, Pawel Golusinski, Alice Sitch, Rachel Spruce, Nikolaos Batis, Jennifer L Bryant, Jill M Brooks, Terence M Jones, Francesca Buffa, Syed Haider, Max Robinson
PURPOSE: Whilst there are several prognostic classifiers, to date there are no validated predictive models that inform treatment selection for oropharyngeal squamous cell carcinoma (OPSCC). Our aim was to develop clinical and/or biomarker predictive models for patient outcome and treatment escalation for OPSCC. EXPERIMENTAL DESIGN: We retrospectively collated clinical data, and samples from a consecutive cohort of OPSCC cases treated with curative intent at ten secondary care centres in UK and Poland between 1999-2012...
October 23, 2023: Clinical Cancer Research
#19
REVIEW
Emily W Flanagan, Redin Spann, Sarah E Berry, Hans-Rudolf Berthoud, Stephanie Broyles, Gary D Foster, Jonathan Krakoff, Ruth J F Loos, Michael R Lowe, Danielle M Ostendorf, Tiffany M Powell-Wiley, Leanne M Redman, Michael Rosenbaum, Philip R Schauer, Randy J Seeley, Boyd A Swinburn, Kevin Hall, Eric Ravussin
Obesity is a chronic disease that affects more than 650 million adults worldwide. Obesity not only is a significant health concern on its own, but predisposes to cardiometabolic comorbidities, including coronary heart disease, dyslipidemia, hypertension, type 2 diabetes, and some cancers. Lifestyle interventions effectively promote weight loss of 5% to 10%, and pharmacological and surgical interventions even more, with some novel approved drugs inducing up to an average of 25% weight loss. Yet, maintaining weight loss over the long-term remains extremely challenging, and subsequent weight gain is typical...
December 2023: Obesity
#20
JOURNAL ARTICLE
Johanna Junker, James Hall, Brian D Berman, Marie Vidailhet, Emmanuel Roze, Tobias Bäumer, Irene A Malaty, Aparna Wagle Shukla, Joseph Jankovic, Stephen G Reich, Alberto J Espay, Kevin R Duque, Neepa Patel, Joel S Perlmutter, H A Jinnah, Valerie Brandt, Norbert Brüggemann
OBJECTIVE: To determine longitudinal predictors of health-related quality of life (HR-QoL) in an international multicenter cohort of patients with isolated dystonia. METHODS: Out of 603 dystonia patients prospectively enrolled in the Natural History Dystonia Coalition study, 155 were assessed three times within 2 years for HR-QoL, symptoms of depression, generalized anxiety disorder (GAD), and social anxiety disorder (SAD), as well as dystonia severity and dystonic tremor...
October 15, 2023: Journal of Neurology
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