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https://www.readbyqxmd.com/read/29913438/race-age-and-gender-based-characteristics-and-toxicities-of-targeted-therapies-on-phase-i-trials
#1
Taofeek K Owonikoko, Adeniyi K Busari, Sungjin Kim, Zhengjia Chen, Adebowale Akintayo, Colleen Lewis, Bradley C Carthon, Olatunji B Alese, Bassel F El-Rayes, Suresh S Ramalingam, R Donald Harvey
BACKGROUND: The impact of age-, gender-, and race-based differences on safety and efficacy in phase I clinical trials has not been well studied. METHODS: We analyzed data from phase I clinical trials evaluating targeted biologic agents in patients with advanced solid malignancies. Race and gender distribution of enrolled patients was compared to the referral population demographics at the city, metro, and state levels. The association between age, gender, and race with type, frequency, and severity of treatment-emergent toxicities and clinical benefit was assessed using univariate and multivariable models...
June 18, 2018: Oncology
https://www.readbyqxmd.com/read/29913400/soil-sterilisation-methods-for-use-in-oecd-106-how-effective-are-they
#2
Katherine Lees, Mark Fitzsimons, Jason Snape, Alan Tappin, Sean Comber
Under many circumstances chemical risk assessments for pharmaceuticals and other substances are required to differentiate between 'loss' of a chemical from the aqueous phase as a result of abiotic (sorption or precipitation reactions) or biotic (biodegradation) processes. To distinguish only abiotic processes, it is necessary to work under sterile conditions. Reported methods include poisoning the soil with sodium azide, irradiation and autoclaving. However, a key aspect of any testing is the representativeness of the matrix and so any sterilisation procedure needs to ensure that the integrity of the sample is maintained, in particular particle size distribution, pH and organic carbon partitioning potential...
June 11, 2018: Chemosphere
https://www.readbyqxmd.com/read/29913299/pharmacological-and-toxicological-study-of-a-chemical-standardized-ethanol-extract-of-the-branches-and-leaves-from-eysenhardtia-polystachya-ortega-sarg-fabaceae
#3
Angel Josabad Alonso-Castro, Juan Ramón Zapata-Morales, Victor Arana-Argáez, Julio Cesar Torres-Romero, Eyra Ramírez-Villanueva, Sabino Eduardo Pérez-Medina, Marco Antonio Ramírez-Morales, Mario Alberto Juárez-Méndez, Yessica Paola Infante-Barrios, Fidel Martínez-Gutiérrez, Candy Carranza-Álvarez, Mario Alberto Isiordia-Espinoza, Andrés Flores-Santos
Eysenhardtia polystachya is used for the empirical treatment of cancer, infections, diarrhea, inflammation, and pain. This study identified, using GC-MS, the main chemical components in an ethanol extract of E. polystachya branches and leaves (EPE) and tested its cytotoxic, antimicrobial, anti-diarrheal, anti-inflammatory, and antinociceptive effects. The in vitro and in vivo toxicity of EPE was evaluated using the comet assay in human peripheral blood mononuclear cells (PBMC) and the acute toxicity test in mice, respectively...
June 15, 2018: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29913254/patient-reported-outcomes-in-nrg-oncology-rtog-0938-evaluating-two-ultrahypofractionated-regimens-for-prostate-cancer
#4
Himanshu R Lukka, Stephanie L Pugh, Deborah W Bruner, Jean-Paul Bahary, Colleen A F Lawton, Jason A Efstathiou, Rajat J Kudchadker, Lee E Ponsky, Samantha A Seaward, Ian S Dayes, Darindra D Gopaul, Jeff M Michalski, Guila Delouya, Irving D Kaplan, Eric M Horwitz, Mack Roach, Wayne H Pinover, David C Beyer, John O Amanie, Howard M Sandler, Lisa A Kachnic
BACKGROUND: There is considerable interest in very short (ultrahypofractionated) radiotherapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience and resource allocation benefits. OBJECTIVE: To demonstrate that detectable changes in health related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline. DESIGN, SETTING, AND PARTICIPANTS: XXXX is a non-blinded randomized phase II study of NCCN low risk prostate cancer where each arm is compared to a historical control...
June 15, 2018: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/29913171/longitudinal-profiles-of-relaxin-and-progestagens-during-pregnancy-pregnancy-loss-and-false-pregnancy-in-the-killer-whale-orcinus-orca
#5
Todd R Robeck, Jason L Blum, Karen J Steinman, Jill R Ratner, Don R Bergfelt, Justine K O'Brien
The circulating pattern of immunoreactive relaxin and progestagens based on monthly and gestational stage (early, mid, late) profiles were determined during pregnancies that resulted in live calves (LIVE, n = 30), stillbirths (STILLB, n = 3), abortions (ABORT, n = 5) and presumptive false pregnancies (FALSE, n = 8), and during the follicular (n = 34) and luteal phases (n = 58). Monthly LIVE relaxin concentrations steadily increased during gestation, but values did not significantly exceed those of the luteal phase until 10 months prior to parturition, peaking during the final month at 2,356 ng/ml...
June 15, 2018: General and Comparative Endocrinology
https://www.readbyqxmd.com/read/29913125/effect-of-co-administration-of-two-different-phosphodiesterase-inhibitors-and-a-%C3%AE-3-adrenoceptor-agonist-in-an-experimental-model-of-detrusor-overactivity
#6
Bruno Lima Linhares, Nilberto Robson Falcão Nascimento, Lúcio Flávio Gonzaga-Silva, Cláudia Ferreira Santos, Manoel Odorico Moraes, Lucas Bernardo Marinho, Ana Patrícia Gonçalves Silva, Manassés Claudino Fonteles, Ricardo Reges
The purpose of this study was to evaluate in vitro the effect of the combination of BRL 37344 (ß3 -adrenoceptor agonist) with tadalafil (phosphodiesterase type 5 inhibitor) or rolipram (phosphodiesterase type 4 inhibitor) in an experimental model of detrusor overactivity. The experiments were carried out in two phases using bladder strips of mice. In the first phase, on the top of 40mM potassium-induced contraction, strips isolated from control mice were exposed to increasing concentrations of each study drug...
June 15, 2018: European Journal of Pharmacology
https://www.readbyqxmd.com/read/29913105/generalized-roc-methods-for-immunogenicity-data-analysis-of-vaccine-phase-i-studies-in-a-seropositive-population
#7
Li Yu, Mark T Esser, Judith Falloon, Tonya Villafana, Harry Yang
Immunogenicity data from phase 1 vaccine studies can be difficult to interpret, especially in seropositive populations and when multiple assays are used. We developed 3 statistical methods (Youden index [YI] threshold, receiver-operating characteristic relative to baseline [ROC-B], and ROC of postdose levels [ROC-P]) to characterize complex immunogenicity data by assessing the proportion of a study population that achieved values above thresholds. The YI method calculates a single threshold per assay. Both ROC methods construct ROC curves for individual assays and surfaces for assay combinations to assess degree of separation of postdose values from a reference distribution; the ROC-B method uses overall predose values as the reference distribution and the ROC-P method uses pooled postdose values...
June 18, 2018: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29913103/inhibitory-effect-of-mixture-herbs-spices-on-formation-of-heterocyclic-amines-and-mutagenic-activity-of-grilled-beef
#8
Shabnam Sepahpour, Jinap Selamat, Alfi Khatib, Mohd Yazid Abdul Manap, Ahmad Faizal Abdull Razis
Natural antioxidants in spices and herbs have attracted considerable attention as potential inhibitors against the formation of mutagenic heterocyclic amines (HCAs) in heat processed meat. In this study, the inhibitory activity of four spices/herbs and their mixtures on HCAs formation in grilled beef were examined. A simplex centroid mixture design with four components comprising turmeric, curry leaf, torch ginger and lemon grass in 19 different proportions were applied on beef samples before grilling at 240 ºC for 10 min...
June 18, 2018: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
https://www.readbyqxmd.com/read/29913020/effect-of-tamsulosin-on-passage-of-symptomatic-ureteral-stones-a-randomized-clinical-trial
#9
Andrew C Meltzer, Pamela Katzen Burrows, Allan B Wolfson, Judd E Hollander, Michael Kurz, Ziya Kirkali, John W Kusek, Patrick Mufarrij, Stephen V Jackman, Jeremy Brown
Importance: Urinary stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage. Objective: To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients. Design, Setting, and Participants: We conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase)...
June 18, 2018: JAMA Internal Medicine
https://www.readbyqxmd.com/read/29913017/safety-and-tolerability-of-multiple-ascending-doses-of-prx002-rg7935-an-anti-%C3%AE-synuclein-monoclonal-antibody-in-patients-with-parkinson-disease-a-randomized-clinical-trial
#10
Joseph Jankovic, Ira Goodman, Beth Safirstein, Tonya K Marmon, Dale B Schenk, Martin Koller, Wagner Zago, Daniel K Ness, Sue G Griffith, Michael Grundman, Jay Soto, Susanne Ostrowitzki, Frank G Boess, Meret Martin-Facklam, Joseph F Quinn, Stuart H Isaacson, Omid Omidvar, Aaron Ellenbogen, Gene G Kinney
Importance: Aggregated α-synuclein is believed to be central to the pathogenesis of Parkinson disease (PD). PRX002/RG7935 (PRX002) is a humanized monoclonal antibody designed to target aggregated forms of α-synuclein, thereby inhibiting neuron-to-neuron transfer of presumed pathogenic forms of α-synuclein, potentially resulting in neuronal protection and slowing disease progression. Objective: To evaluate the safety and tolerability of multiple intravenous infusions of PRX002 in patients with idiopathic PD...
June 18, 2018: JAMA Neurology
https://www.readbyqxmd.com/read/29912998/safety-of-once-weekly-glucagon-like-peptide-1-receptor-agonists-in-patients-with-type-2-diabetes
#11
Juan P Frias
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been found efficacious in the treatment of type 2 diabetes (T2D), demonstrating the ability to lower HbA1c, and having the potential for inducing weight loss and reducing the risk of hypoglycemia, compared with other antihyperglycemic agents. Currently, 4 once-weekly (OW) GLP-1 RAs are approved: albiglutide, dulaglutide, exenatide ER, and recently, semaglutide. This review compares the relative safety of OW GLP-1 RAs, as well as their safety in comparison to other antihyperglycemic agents, using safety data reported in key sponsor-led phase 3 studies of the 4 OW GLP-1 RAs...
June 2018: Journal of Family Practice
https://www.readbyqxmd.com/read/29912798/phase-iib-trial-of-an-%C3%AE-7-nicotinic-receptor-partial-agonist-with-and-without-nicotine-patch-for-withdrawal-associated-cognitive-deficits-and-tobacco-abstinence
#12
Randi Melissa Schuster, Gladys N Pachas, Luke Stoeckel, Corinne Cather, Mireya Nadal, David Mischoulon, David A Schoenfeld, Haiyue Zhang, Christine Ulysse, Elisabeth B Dodds, Sara Sobolewski, Vicenta Hudziak, Ailish Hanly, Maurizio Fava, A Eden Evins
PURPOSE/BACKGROUND: The objective of this study was to determine whether a novel α7 nicotinic acetylcholine receptor partial agonist improves cognition during nicotine withdrawal and improves abstinence rates. To do so, the effect of the α7 nicotinic acetylcholine receptor partial agonist, encenicline, on cognition and abstinence was evaluated when given as monotherapy and when combined with transdermal nicotine patch (nicotine replacement therapy [NRT]). METHODS: Adult daily smokers, n = 160, who were motivated to quit smoking completed cognitive testing at satiated baseline and after overnight abstinence and then were randomized to receive a 12-week trial of encenicline 1 mg twice daily or identical placebo the day of the overnight abstinent cognitive testing...
June 14, 2018: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/29912706/virus-rna-load-in-patients-with-tick-borne-encephalitis-slovenia
#13
Ana Saksida, Nina Jakopin, Mateja Jelovšek, Nataša Knap, Luka Fajs, Lara Lusa, Stanka Lotrič-Furlan, Petra Bogovič, Maja Arnež, Franc Strle, Tatjana Avšič-Županc
We determined levels of tick-borne encephalitis (TBE) virus (TBEV) RNA in serum samples obtained from 80 patients during the initial phase of TBE in Slovenia. For most samples, levels were within the range of 3-6 log10 copies RNA/mL. Levels were higher in female patients than in male patients, but we found no association between virus load and several laboratory and clinical parameters, including severity of TBE. However, a weak humoral immune response was associated with a more severe disease course, suggesting that inefficient clearance of virus results in a more serious illness...
July 2018: Emerging Infectious Diseases
https://www.readbyqxmd.com/read/29912617/is-it-possible-to-voluntarily-increase-hamstring-muscle-activation-during-landing-from-a-snow-jump-in-alpine-skiing-a-pilot-study
#14
Sebastian Färber, Dieter Heinrich, Inge Werner, Peter Federolf
Activation of the hamstrings has been discussed as a measure for reducing strain on the ACL during jump landings in alpine skiing. The current study tested the hypothesis that hamstring and quadriceps activation can be voluntarily increased by the athlete. Specifically, two different instructions - to increase hamstring activation or to increase upper-leg co-contraction - were compared to normal landings. Eight members of the German national and junior national squad in freestyle skiing (age 19.6 ± 3.8 years; weight 66...
June 18, 2018: Journal of Sports Sciences
https://www.readbyqxmd.com/read/29912555/discovery-and-evolution-of-polyoxopalladates
#15
Peng Yang, Ulrich Kortz
Noble metal catalysts, in particular palladium-containing materials, are of prime commercial interest, because of their role as oxidation catalysts in automobile emission-control systems and reforming catalysts for the production of high-octane gasoline. However, despite almost two centuries of research, the precise structure of such materials is still ill-defined on the sub-nanometer scale, which severely limits the understanding of the underlying catalytic mechanisms. As a burgeoning class of structurally well-defined noble metal oxide nanoclusters, polyoxopalladates (POPs) have been highly rated as ideal models to fully decipher the molecular mechanism of noble metal-based catalysis...
June 18, 2018: Accounts of Chemical Research
https://www.readbyqxmd.com/read/29912544/formation-of-the-conducting-filament-in-taox-resistive-switching-devices-by-thermal-gradient-induced-cation-accumulation
#16
Yuanzhi Ma, Dasheng Li, Andrew A Herzing, David A Cullen, Brian T Sneed, Karren L More, Noel T Nuhfer, James A Bain, Marek Skowronski
Distribution of tantalum and oxygen ions in electroformed and/or switched TaOx-based resistive switching devices has been assessed by high angle annular dark field microscopy, X-ray energy dispersive spectroscopy, and electron energy loss spectroscopy. The experiments have been performed in the plan view geometry on the crossbar devices producing elemental distribution maps in direction perpendicular to the electric field. The maps revealed accumulation of +20% Ta in the inner part of the filament with a 3...
June 18, 2018: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/29912399/clinical-activity-of-ceftazidime-avibactam-against-mdr-enterobacteriaceae-and-pseudomonas-aeruginosa-pooled-data-from-the-ceftazidime-avibactam-phase-iii-clinical-trial-programme
#17
Gregory G Stone, Paul Newell, Leanne B Gasink, Helen Broadhurst, Angela Wardman, Katrina Yates, Zhangjing Chen, Jie Song, Joseph W Chow
Objectives: This analysis evaluated the clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa isolates pooled from the adult Phase III clinical trials in patients with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) or nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP). Methods: Baseline isolates from five Phase III randomized controlled trials of ceftazidime/avibactam versus predominantly carbapenem comparators in patients with cIAI (RECLAIM 1 and 2; NCT01499290 and RECLAIM 3; NCT01726023), cUTI (RECAPTURE 1 and 2; NCT01595438 and NCT01599806), NP including VAP (REPROVE; NCT01808092) and cIAI or cUTI caused by ceftazidime-non-susceptible Gram-negative pathogens (REPRISE; NCT01644643) were tested for MDR status and susceptibility to ceftazidime/avibactam and carbapenem-based comparators using CLSI broth microdilution methodology...
June 14, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29912374/luteal-phase-anovulatory-follicles-result-in-the-production-of-competent-oocytes-intra-patient-paired-case-control-study-comparing-follicular-versus-luteal-phase-stimulations-in-the-same-ovarian-cycle
#18
Danilo Cimadomo, Alberto Vaiarelli, Silvia Colamaria, Elisabetta Trabucco, Carlo Alviggi, Roberta Venturella, Erminia Alviggi, Ramona Carmelo, Laura Rienzi, Filippo Maria Ubaldi
STUDY QUESTION: Are the mean numbers of blastocysts obtained from sibling cohorts of oocytes recruited after follicular phase and luteal phase stimulations (FPS and LPS) in the same ovarian cycle similar? SUMMARY ANSWER: The cohorts of oocytes obtained after LPS are larger than their paired-FPS-derived cohorts and show a comparable competence, thus resulting in a larger mean number of blastocysts. WHAT IS KNOWN ALREADY: Three theories of follicle recruitment have been postulated to date: (i) the 'continuous recruitment' theory, (ii) the 'single recruitment episode' theory and (iii) the 'wave' theory...
June 15, 2018: Human Reproduction
https://www.readbyqxmd.com/read/29912356/effects-of-a-saccharomyces-cerevisiae-fermentation-product-in-receiving-diets-of-newly-weaned-beef-steers-ii-digestibility-and-response-to-a-vaccination-challenge
#19
E L Deters, R S Stokes, O N Genther-Schroeder, S L Hansen
Thirty-six newly weaned, crossbred beef steers (323 ± 12 kg; SD) from a single-source were used in a 56-d study to examine the effects of a Saccharomyces cerevisiae fermentation product (SCFP; Original XPC, Diamond V, Cedar Rapids, IA) on total tract nutrient digestibility and response to a vaccination challenge. Twelve d after arrival, steers were blocked by body weight (BW) and randomly assigned to treatments: SCFP at 0 (CON), 14 (SCFP14), or 28 (SCFP28) g·steer-1·d-1. Steers were fed via bunks that measured individual intake and received ear tags (CowManager, Select Sires, Plain City, OH) that recorded rumination and activity...
June 15, 2018: Journal of Animal Science
https://www.readbyqxmd.com/read/29912271/randomized-phase-3-and-extension-studies-efficacy-and-impacts-on-quality-of-life-of-naldemedine-in-subjects-with-opioid-induced-constipation-and-cancer
#20
N Katakami, T Harada, T Murata, K Shinozaki, M Tsutsumi, T Yokota, M Arai, Y Tada, M Narabayashi, N Boku
Background: The efficacy and safety of naldemedine (a peripherally-acting µ-opioid receptor antagonist) for opioid-induced constipation (OIC) in subjects with cancer was demonstrated in the primary report of a phase 3, double-blind study (COMPOSE-4) and its open-label extension (COMPOSE-5). The primary endpoint, the proportion of spontaneous bowel movement (SBM) responders, was met. Here, we report results from secondary endpoints including quality of life (QOL) assessments from these studies...
April 18, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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