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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 AND 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 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<...
September 14, 2018: 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
Jordan G Hamilton, Jay Grosskleg, David Hilger, Kris Bradshaw, Trevor Carlson, Steven D Siciliano, Derek Peak
Adsorption and precipitation reactions often dictate the availability of phosphorus in soil environments. Tripolyphosphate (TPP) is considered a form of slow release P fertilizer in P limited soils, however, investigations of the chemical fate of TPP in soils are limited. It has been proposed that TPP rapidly hydrolyzes in the soil solution before adsorbing or precipitating with soil surfaces, but in model systems, TPP also adsorbs rapidly onto mineral surfaces. To study the adsorption behavior of TPP in calcareous soils, a short-term (48 h) TPP spike was performed under laboratory conditions...
January 8, 2018: Geochemical Transactions
H Joachim Deeg, Emily A Stevens, Rachel B Salit, Ralph P Ermoian, Min Fang, Boglarka Gyurkocza, Mohamed L Sorror, Giancarlo Fatobene, Joachim Baumgart, Lauri M Burroughs, Colleen Delaney, Kris Doney, Daniel N Egan, Mary E D Flowers, Filippo Milano, Jerry P Radich, Bart L Scott, Eileen J Sickle, Brent L Wood, Cecilia Yeung, Barry E Storer
In this prospective, randomized, phase II "pick the winner" trial we assessed the efficacy of transplant conditioning with treosulfan/fludarabine ± 2 Gy total body irradiation (TBI) in reducing post-transplant relapse in 100 patients, aged 2 to 70 years (median, 57), with myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (n = 51) or acute myeloid leukemia (AML; n = 49). Patients received i.v. treosulfan, 14 g/m2 /day on days -6 to -4 and i.v. fludarabine, 30 mg/m2 /day on days -6 to -2, alone or combined with 2 Gy TBI (day 0)...
May 2018: Biology of Blood and Marrow Transplantation
Kris van Keulen, Wilma Knol, Edmée J M Schrijver, Rob J van Marum, Astrid M van Strien, Prabath W B Nanayakkara
BACKGROUND: Treatment with antipsychotic drugs has been associated with glucose dysregulation in older outpatients, especially in the early stage of therapy. The underlying mechanism is, however, unclear. The aim of this study was to investigate changes in glucose levels during haloperidol use compared with the use of placebo among older hospitalized patients. METHODS: This substudy was part of a larger multicenter, randomized, double blind, placebo-controlled clinical trial among hospitalized patients aged 70 years and older who had an increased risk of in-hospital delirium...
February 2018: Journal of Clinical Psychopharmacology
Yujin Lee, Claire E Berryman, Sheila G West, C-Y Oliver Chen, Jeffrey B Blumberg, Karen G Lapsley, Amy G Preston, Jennifer A Fleming, Penny M Kris-Etherton
BACKGROUND: Consumption of almonds or dark chocolate and cocoa has favorable effects on markers of coronary heart disease; however, the combined effects have not been evaluated in a well-controlled feeding study. The aim of this study was to examine the individual and combined effects of consumption of dark chocolate and cocoa and almonds on markers of coronary heart disease risk. METHODS AND RESULTS: A randomized controlled, 4-period, crossover, feeding trial was conducted in overweight and obese individuals aged 30 to 70 years...
November 29, 2017: Journal of the American Heart Association
Arlyne K Thung, Charles A Elmaraghy, N'Diris Barry, Dmitry Tumin, Kris R Jatana, Julie Rice, Vidya Raman, Tarun Bhalla, David P Martin, Marco Corridore, Joseph D Tobias
OBJECTIVES: Adequate pain control is an important component in the postoperative outcome for pediatric adenotonsillectomy patients with sleep-disordered breathing (SDB). Intravenous acetaminophen appears to be a favorable analgesic adjunct owing to its predictable pharmacokinetics and opioid-sparing effects; however, its role in pediatric adenotonsillectomy pain management remains unclear. METHODS: In this prospective, randomized, double-blinded, controlled study, subjects with the diagnosis of SDB, aged 2 to 8 years, who required extended postoperative admission, received intravenous acetaminophen (15 mg/kg) or saline placebo intraoperatively in addition to morphine (0...
September 2017: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
Kris V Kowdley, Velimir Luketic, Roger Chapman, Gideon M Hirschfield, Raoul Poupon, Christoph Schramm, Catherine Vincent, Christian Rust, Albert Parés, Andrew Mason, Hanns-Ulrich Marschall, David Shapiro, Luciano Adorini, Cathi Sciacca, Tessa Beecher-Jones, Olaf Böhm, Richard Pencek, David Jones
Obeticholic acid (OCA), a potent farnesoid X receptor agonist, was studied as monotherapy in an international, randomized, double-blind, placebo-controlled phase 2 study in patients with primary biliary cholangitis who were then followed for up to 6 years. The goals of the study were to assess the benefit of OCA in the absence of ursodeoxycholic acid, which is relevant for patients who are intolerant of ursodeoxycholic acid and at higher risk of disease progression. Patients were randomized and dosed with placebo (n = 23), OCA 10 mg (n = 20), or OCA 50 mg (n = 16) given as monotherapy once daily for 3 months (1 randomized patient withdrew prior to dosing)...
May 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Tarik Asselah, Kris V Kowdley, Neddie Zadeikis, Stanley Wang, Tarek Hassanein, Yves Horsmans, Massimo Colombo, Filipe Calinas, Humberto Aguilar, Victor de Ledinghen, Parvez S Mantry, Christophe Hezode, Rui Tato Marinho, Kosh Agarwal, Frederik Nevens, Magdy Elkhashab, Jens Kort, Ran Liu, Teresa I Ng, Preethi Krishnan, Chih-Wei Lin, Federico J Mensa
BACKGROUND & AIMS: Hepatitis C virus (HCV) has high genotypic diversity and global distribution. Agents that are effective against all major HCV genotypes, with shorter treatment duration, are needed to reduce disease burden. Glecaprevir (an NS3/4A protease inhibitor) and pibrentasvir (an NS5A inhibitor) have a high barrier to resistance and synergistic antiviral activity. We evaluated the safety and efficacy of 8 and 12 weeks' treatment with glecaprevir/pibrentasvir in patients with HCV genotype 2, 4, 5, or 6 infection without cirrhosis in 3 separate phase 3 trials...
March 2018: Clinical Gastroenterology and Hepatology
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