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Pauline T Lukey, Stephen A Harrison, Shuying Yang, Yim Man, Beverley F Holman, Alaleh Rashidnasab, Gabrielle Azzopardi, Michael Grayer, Juliet K Simpson, Philippe Bareille, Lyn Paul, Hannah V Woodcock, Richard Toshner, Peter Saunders, Philip L Molyneaux, Kris Thielemans, Frederick J Wilson, Paul F Mercer, Rachel C Chambers, Ashley M Groves, William A Fahy, Richard P Marshall, Toby M Maher
PI3 Kinases (PI3Ks) and mammalian target of rapamycin (mTOR) play a role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). Omipalisib (GSK2126458) is a potent inhibitor of PI3K/mTOR.A randomised, placebo-controlled, double-blind, repeat dose escalation, experimental medicine study of omipalisib in subjects with IPF was conducted (NCT01725139) to test safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD). Omipalisib was dosed, at 0.25 mg, 1 mg and 2 mg twice per day (BID) for approximately eight days in 4 cohorts of 4 subjects randomised 3:1 to receive omipalisib or placebo (two cohorts received 2 mg BID)...
February 14, 2019: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Eric Lawitz, Fred Poordad, Leah J Anderson, Michelle Vesay, Michelle M Kelly, Hong Liu, Wei Gao, Doreen Fernsler, Ernest Asante-Appiah, Michael N Robertson, George J Hanna, Eliav Barr, Joan Butterton, Kris V Kowdley, Tarek Hassanein, Amandeep Sahota, Stuart C Gordon, Wendy W Yeh
In clinical trials, the three-drug regimen of ruzasvir (RZR) 60 mg, uprifosbuvir (UPR) 450 mg, and grazoprevir 100 mg, with or without ribavirin has demonstrated promising efficacy and excellent tolerability across a wide range of hepatitis C virus (HCV)-infected individuals. The present study assessed the efficacy and safety of the two-drug combination of RZR 60 mg plus UPR 450 mg administered for 12 weeks in participants with HCV genotype (GT) 1-6 infection. In this open-label clinical trial, treatment-naive or -experienced and cirrhotic or noncirrhotic participants with chronic HCV GT1-6 infection received RZR 60 mg plus UPR 450 mg orally once daily for 12 weeks (NCT02759315/protocol PN035)...
February 9, 2019: Journal of Viral Hepatitis
Alyssa M Tindall, Emily A Johnston, Penny M Kris-Etherton, Kristina S Petersen
Background: Observational evidence suggests higher nut consumption is associated with better glycemic control; however, it is unclear if this association is causal. Objectives: We aimed to conduct a systematic review and meta-analysis of randomized controlled trials to examine the effect of tree nuts and peanuts on markers of glycemic control in adults. Methods: A systematic review and meta-analysis of randomized controlled trials was conducted...
February 5, 2019: American Journal of Clinical Nutrition
Michael Trauner, Aliya Gulamhusein, Bilal Hameed, Stephen Caldwell, Mitchell L Shiffman, Charles Landis, Bertus Eksteen, Kosh Agarwal, Andrew Muir, Simon Rushbrook, Xiaomin Lu, Jun Xu, Jen-Chieh Chuang, Andrew N Billin, Chuhan Chung, Georgia Li, G Mani Subramanian, Robert P Myers, Christopher L Bowlus, Kris V Kowdley
Primary sclerosing cholangitis (PSC) represents a major unmet medical need. In a Phase 2 double-blind, placebo-controlled study, we tested the safety and efficacy of cilofexor (formerly GS-9674), a nonsteroidal farnesoid X receptor (FXR) agonist in non-cirrhotic patients with large duct PSC. Patients were randomized to receive cilofexor 100 mg (n=22), 30 mg (n=20), or placebo (n=10) orally once daily for 12 weeks. All patients had serum alkaline phosphatase (ALP) >1.67xULN and total bilirubin ≤2 mg/dL at baseline...
January 19, 2019: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Jennifer R Donnan, Catherine A Grandy, Eugene Chibrikov, Carlo Marra PharmD, Kris Aubrey-Bassler, Karissa Johnston, Michelle Swab, Jenna Hache, Daniel Curnew, Hai Nguyen, John-Michael Gamble
BACKGROUND: The sodium glucose cotransporter-2 (SGLT2) inhibitors are a novel group of drugs for treatment of type 2 diabetes mellitus. We investigated whether there is a dose-response relation between SGLT2 inhibitors and urinary tract infections (UTIs) in patients with type 2 diabetes, relative to other diabetes therapies or placebo. METHODS: We conducted a systematic review and network meta-analysis of randomized controlled trials (RCTs) of SGLT2 inhibitors in patients with type 2 diabetes...
October 2018: CMAJ Open
Nathan A Pennell, Joel W Neal, Jamie E Chaft, Christopher G Azzoli, Pasi A Jänne, Ramaswamy Govindan, Tracey L Evans, Daniel B Costa, Heather A Wakelee, Rebecca S Heist, Marc A Shapiro, Alona Muzikansky, Sudish Murthy, Michael Lanuti, Valerie W Rusch, Mark G Kris, Lecia V Sequist
PURPOSE: Given the pivotal role of epidermal growth factor receptor (EGFR) inhibitors in advanced EGFR-mutant non-small-cell lung cancer (NSCLC), we tested adjuvant erlotinib in patients with EGFR-mutant early-stage NSCLC. MATERIALS AND METHODS: In this open-label phase II trial, patients with resected stage IA to IIIA (7th edition of the American Joint Committee on Cancer staging system) EGFR-mutant NSCLC were treated with erlotinib 150 mg per day for 2 years after standard adjuvant chemotherapy with or without radiotherapy...
November 16, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Maarten Everaert, Kris Dox, Julian A Steele, Dirk De Vos, Erik Smolders
Layered double hydroxides (LDH) have been proposed for phosphate (PO4 ) recovery and recycling from waste streams due to their high anion exchange capacity, good stability and high affinity towards PO4 . The high affinity towards PO4 strongly relates to the electrostatic interaction with PO4 , and thus the charge of PO4 . However, the anion speciation of intercalated PO4 , i.e. either H2 PO4 - , HPO4 2- or PO4 3- is often overlooked. This study was set up to measure solid phase PO4 speciation through ion exchange stoichiometry, X-ray diffraction (XRD), attenuated total reflection Fourier-transform infrared spectroscopy (ATR-FTIR) and modelling...
November 5, 2018: Journal of Colloid and Interface Science
Naga Chalasani, Manal F Abdelmalek, Rohit Loomba, Kris V Kowdley, Arthur J McCullough, Srinivasan Dasarathy, Brent A Neuschwander-Tetri, Norah Terrault, Beatrice Ferguson, Reshma Shringarpure, David Shapiro, Arun J Sanyal
BACKGROUND & AIMS: Non-invasive biomarkers are needed for monitoring changes in liver histology in patients with non-alcoholic steatohepatitis (NASH). Obeticholic acid (OCA) was shown to improve fibrosis in patients with NASH in the FLINT trial; a post hoc analysis of these data was performed to determine the relationship between 3 non-invasive fibrosis markers and liver fibrosis improvement. METHODS: In the Phase 2b FLINT trial, patients were randomised (1:1) to receive 25 mg OCA or placebo once daily for 72 weeks...
September 25, 2018: Liver International: Official Journal of the International Association for the Study of the Liver
Rohit Loomba, Arun J Sanyal, Kris V Kowdley, Norah Terrault, Naga P Chalasani, Manal F Abdelmalek, Arthur J McCullough, Reshma Shringarpure, Beatrice Ferguson, Lois Lee, Jianfen Chen, Alexander Liberman, David Shapiro, Brent A Neuschwander-Tetri
BACKGROUND & AIMS: Nonalcoholic steatohepatitis (NASH) is a leading cause of liver transplantation, and many trials are underway to evaluate potential therapies. The farnesoid X receptor ligand obeticholic acid in the NASH treatment trial evaluated the effects of obeticholic acid vs placebo on histologic response (defined as decrease in nonalcoholic fatty liver disease activity score [NAS] by ≥2, with no worsening of fibrosis); 45% of patients had a histologic response to obeticholic acid (25 mg), and 21% had a response to placebo (P < ...
January 2019: Gastroenterology
Glenn van de Vossenberg, Selina van der Wal, Andrea Müller, Edward Tan, Kris Vissers
This case report discusses continuous epidural administration of ropivacaine 0.56 mg kg-1 h -1 for 8 days in a 7-year-old trauma patient to prevent pain, after performing a lower right and upper left leg guillotine amputation. Venous sampling after 8 days revealed bound and unbound ropivacaine concentrations of 1.1 mg/l and 0.06 mg/l in plasma, respectively. Arterial sampling for bound and unbound ropivacaine was 1.2 mg/l and 0.05 mg/l in plasma, respectively. In this case report, long-term high dose epidural infiltration of ropivacaine did not result in severe side effects or complications...
2018: Case Reports in Anesthesiology
Evelien Hilde Verstraete, Ludo Mahieu, James d'Haese, Kris De Coen, Jerina Boelens, Dirk Vogelaers, Stijn Blot
Due to potential lethality of healthcare-associated sepsis (HAS), a low threshold for blood culturing and antimicrobial therapy (ABT) initiation is accepted. We assessed variability in the trigger for blood culturing between three neonatal intensive care units. A multicenter prospective cohort study was conducted. In newborns with suspicion of HAS, 10 predefined clinical signs, nosocomial sepsis (NOSEP) score, C-reactive protein, ABT initiation, and risk factors were registered at time of culturing. Outcome was lab-confirmed HAS, defined according to the NeoKISS-criteria...
October 2018: European Journal of Pediatrics
Bob T Li, Ronglai Shen, Darren Buonocore, Zachary T Olah, Ai Ni, Michelle S Ginsberg, Gary A Ulaner, Michael Offin, Daniel Feldman, Todd Hembrough, Fabiola Cecchi, Sarit Schwartz, Nick Pavlakis, Stephen Clarke, Helen H Won, Edyta B Brzostowski, Gregory J Riely, David B Solit, David M Hyman, Alexander Drilon, Charles M Rudin, Michael F Berger, Jose Baselga, Maurizio Scaltriti, Maria E Arcila, Mark G Kris
Purpose Human epidermal growth factor receptor 2 ( HER2, ERBB2)-activating mutations occur in 2% of lung cancers. We assessed the activity of ado-trastuzumab emtansine, a HER2-targeted antibody-drug conjugate, in a cohort of patients with HER2-mutant lung cancers as part of a phase II basket trial. Patients and Methods Patients received ado-trastuzumab emtansine at 3.6 mg/kg intravenously every 3 weeks until progression. The primary end point was overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) version 1...
August 20, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
M Catherine Pietanza, Saiama N Waqar, Lee M Krug, Afshin Dowlati, Christine L Hann, Alberto Chiappori, Taofeek K Owonikoko, Kaitlin M Woo, Robert J Cardnell, Junya Fujimoto, Lihong Long, Lixia Diao, Jing Wang, Yevgeniva Bensman, Brenda Hurtado, Patricia de Groot, Erik P Sulman, Ignacio I Wistuba, Alice Chen, Martin Fleisher, John V Heymach, Mark G Kris, Charles M Rudin, Lauren Averett Byers
Purpose Both temozolomide (TMZ) and poly (ADP-ribose) polymerase (PARP) inhibitors are active in small-cell lung cancer (SCLC). This phase II, randomized, double-blind study evaluated whether addition of the PARP inhibitor veliparib to TMZ improves 4-month progression-free survival (PFS). Patients and Methods A total of 104 patients with recurrent SCLC were randomly assigned 1:1 to oral veliparib or placebo 40 mg twice daily, days 1 to 7, and oral TMZ 150 to 200 mg/m2 /day, days 1 to 5, of a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent...
August 10, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Stephanie Schelfhout, An De Schrijver, Kris Verheyen, Robbe De Beelde, Geert Haesaert, Jan Mertens
High soil P concentrations hinder ecological restoration of biological communities typical for nutrient-poor soils. Phosphorus mining, i.e., growing crops with fertilization other than P, might reduce soil P concentrations. However, crop species have different P-uptake rates and can affect subsequent P removal in crop rotation, both of which may also vary with soil P concentration. In a pot experiment with three soil-P-levels (High-P: 125-155 mg POlsen /kg; Mid-P: 51-70 mg POlsen /kg; Low-P: 6-21 mg POlsen /kg), we measured how much P was removed by five crop species (buckwheat, maize, sunflower, flax, and triticale)...
July 29, 2018: International Journal of Phytoremediation
Kris L Sorby, Mark P Green, Tim D Dempster, Tim S Jessop
Organisms increasingly encounter higher frequencies of extreme weather events as a consequence of global climate change. Currently, few strategies are available to mitigate climate change effects on animals arising from acute extreme high-temperature events. We tested the capacity of physiological engineering to influence the intra- and multi-generational upper thermal tolerance capacity of a model organism, Artemia , subjected to extreme high temperatures. Enhancement of specific physiological regulators during development could affect thermal tolerance or life-history attributes affecting subsequent fitness...
July 17, 2018: Journal of Experimental Biology
Cindy Yanfei Li, Joseph L Dempsey, Dongfang Wang, SooWan Lee, Kris M Weigel, Qiang Fei, Deepak Kumar Bhatt, Bhagwat Prasad, Daniel Raftery, Haiwei Gu, Julia Yue Cui
Polybrominated diphenyl ethers (PBDEs) are persistent environmental contaminants with well characterized toxicities in host organs. Gut microbiome is increasingly recognized as an important regulator of xenobiotic biotransformation; however, little is known about its interactions with PBDEs. Primary bile acids (BAs) are metabolized by the gut microbiome into more lipophilic secondary BAs that may be absorbed and interact with certain host receptors. The goal of this study was to test our hypothesis that PBDEs cause dysbiosis and aberrant regulation of BA homeostasis...
August 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Amy Lee Bredlau, Anjan Motamarry, Chao Chen, M A McCrackin, Kris Helke, Kent E Armeson, Katrina Bynum, Ann-Marie Broome, Dieter Haemmerich
Most drugs cannot penetrate the blood-brain barrier (BBB), greatly limiting the use of anti-cancer agents for brain cancer therapy. Temperature sensitive liposomes (TSL) are nanoparticles that rapidly release the contained drug in response to hyperthermia (>40 °C). Since hyperthermia also transiently opens the BBB, we hypothesized that localized hyperthermia can achieve drug delivery across the BBB when combined with TSL. TSL-encapsulated doxorubicin (TSL-Dox) was infused intravenously over 30 min at a dose of 0...
November 2018: Drug Delivery
Marita Stevens, Sarah Rusch, John DeVincenzo, Young-In Kim, Lisa Harrison, Elizabeth A Meals, Alison Boyers, Juin Fok-Seang, Dymphy Huntjens, Nacer Lounis, Kris Mari N, Bart Remmerie, Dirk Roymans, Anil Koul, René Verloes
Background: Respiratory syncytial virus (RSV) disease has no effective treatment. JNJ-53718678 is a fusion inhibitor with selective activity against RSV. Methods: After confirmation of RSV infection or 5 days after inoculation with RSV, participants (n = 69) were randomized to JNJ-53718678 75 mg (n = 15), 200 mg (n = 17), 500 mg (n = 18), or placebo (n = 17) orally once daily for 7 days. Antiviral effects were evaluated by assessing RSV RNA viral load (VL) area under the curve (AUC) from baseline (before the first dose) until discharge, time-to-peak VL, duration of viral shedding, clinical symptoms, and quantity of nasal secretions...
July 24, 2018: Journal of Infectious Diseases
Zhiying Zhang, Victor L Fulgoni, Penny M Kris-Etherton, Susan Hazels Mitmesser
BACKGROUND: The 2015&ndash;2020 Dietary Guidelines for Americans (DGA) recommend that the general population should consume about 8 ounces (oz.) per week of a variety of seafood, providing approximately 250 mg per day of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and that pregnant and lactating women should consume 8&ndash;12 oz. per week of seafood. METHODS: We determined the usual intakes, percentage not meeting recommendations, and trends in EPA and DHA intakes among childbearing-age and pregnant women (15&ndash;44 years of age) using the NHANES cycles 2001&ndash;2002 through 2013&ndash;2014...
March 28, 2018: Nutrients
Maarten Everaert, Kris Slenders, Kris Dox, Simon Smolders, Dirk De Vos, Erik Smolders
Layered double hydroxides (LDH) of Mg/Al are anion exchangers that are candidate materials for phosphate (PO4 ) recovery and recycling from waste streams. However, PO4 recycling in agriculture might be limited by incomplete desorption of PO4 from the minerals. This study was set up to identify the factors explaining irreversible PO4 sorption ("fixation") on LDHs by comparing the isotopic exchangeability (33 PO4 ) with the PO4 desorption from LDH materials and from boehmite as a P fixing reference mineral...
June 15, 2018: Journal of Colloid and Interface Science
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