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https://www.readbyqxmd.com/read/28340333/the-randomized-crm-an-approach-to-overcoming-the-long-memory-property-of-the-crm
#1
Joseph S Koopmeiners, Andrew Wey
The primary object of a Phase I clinical trial is to determine the maximum tolerated dose (MTD). Typically, the MTD is identified using a dose-escalation study, where initial subjects are treated at the lowest dose level and subsequent subjects are treated at progressively higher dose levels until the MTD is identified. The continual reassessment method (CRM) is a popular model-based dose-escalation design, which utilizes a formal model for the relationship between dose and toxicity to guide dose finding. Recently, it was shown that the CRM has a tendency to get "stuck" on a dose level, with little escalation or de-escalation in the late stages of the trial, due to the long-memory property of the CRM...
March 1, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28340179/open-label-pilot-study-to-compare-the-safety-and-immunogenicity-of-pentavalent-rotavirus-vaccine-rv5-administered-on-an-early-alternative-dosing-schedule-with-those-of-rv5-administered-on-the-recommended-standard-schedule
#2
Ezzeldin Saleh, Brian Eichner, Douglas W Clark, Martha E Gagliano, James M Troutman, Lynn Harrington, Monica McNeal, Dennis Clements
This study compares the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) administered on an alternative schedule (initiated at 2-5 weeks of age) with those of RV5 administered on the recommended standard schedule. Our findings support the future conduct of larger clinical trials to confirm the safety and efficacy of rotavirus vaccination in the neonatal period.
March 3, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/28339766/higher-bioavailability-of-doxycycline-in-broiler-chickens-with-a-novel-in-feed-pharmaceutical-formulation
#3
Lilia Gutiérrez, Juan Zermeño, Yazmín Alcalá, Héctor Sumano
Bioavailability of a new, long-acting (LA) pharmaceutical preparation for administering doxycycline as in-feed medication to broiler chickens was compared to the standard in-feed administration of doxycycline. A commercial poultry house harboring Ross-308 broiler chickens, weighing 450 g, was divided into 7 sections as follows: doxy-FOLA group (n = 6,000 chickens divided into 3 replicates) medicated with 10% doxycyline, long-acting pellets at a dose of 400 g of doxycycline HCl/ton of food, resulting in a calculated dose of 48 mg/kg for 5 d; doxy-ref group (n = 6,000, divided into 3 replicates) medicated as for doxy-FOLA, but using a 20% commercial preparation of doxycycline...
February 23, 2017: Poultry Science
https://www.readbyqxmd.com/read/28339648/three-dimensional-testicular-organoid-a-novel-tool-for-the-study-of-human-spermatogenesis-and-gonadotoxicity-in-vitro%C3%A2
#4
Samuel S Pendergraft, Hooman Sadri-Ardekani, Anthony Atala, Colin E Bishop
Existing methods for evaluating the potential gonadotoxicity of environmental agents and pharmaceutical compounds rely heavily on animal studies. The current gold standard in vivo functional assays in animals are limited in their human predictive capacity. In addition, existing human two-dimensional in vitro models of testicular toxicity do not accurately reflect the in vivo situation. A more reliable testicular in vitro model system is needed to better assess the gonadotoxic potential of drugs prior to progression into clinical trials...
February 17, 2017: Biology of Reproduction
https://www.readbyqxmd.com/read/28339541/vitamin-d-suppresses-oxidative-stress-induced-microparticle-release-by-human-umbilical-vein-endothelial-cells
#5
Xiuyue Jia, Jie Xu, Yang Gu, Xin Gu, Weimin Li, Yuping Wang
Endothelial microparticle (MP) release was increased in numerous cardiovascular diseases including preeclampsia. Oxidative stress is a potent inducer of endothelial dysfunction. In this study, we aimed to investigate if vitamin D could protect endothelial cells (ECs) from MP release induced by oxidative stress. Endothelial cell (from human umbilical vein) oxidative stress was induced by cultivation of cells under lowered oxygen condition (2%O2) for 48 h and cells cultured under standard condition (21%O2) served as control...
December 27, 2016: Biology of Reproduction
https://www.readbyqxmd.com/read/28339358/effectiveness-and-healthcare-costs-among-stabilised-rheumatoid-arthritis-patients-with-dose-reduction-of-adalimumab-or-etanercept-in-real-world
#6
Min Yang, Philip J Galebach, James E Signorovitch, Vishvas Garg
OBJECTIVES: We assessed the level of maintained effectiveness and associated healthcare costs in stabilised rheumatoid arthritis (RA) patients who reduced doses of adalimumab or etanercept. METHODS: Eligible patients were identified from a U.S. commercial insurance database using the following criteria: adults with ≥2 RA diagnoses; effectively treated on standard dose of adalimumab or etanercept for a 6-month baseline period; and ≥3 months of dose reduction within a 6-month assessment period following the index date (date of the first reduced dose)...
March 23, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28339083/health-risk-assessment-of-environmental-selenium-emerging-evidence-and-challenges-review
#7
Marco Vinceti, Tommaso Filippini, Silvia Cilloni, Annalisa Bargellini, Anna Valeria Vergoni, Aristides Tsatsakis, Margherita Ferrante
New data have been accumulated in the scientific literature in recent years which allow a more adequate risk assessment of selenium with reference to human health. This new evidence comes from environmental studies, carried out in populations characterized by abnormally high or low selenium intakes, and from high-quality and large randomized controlled trials with selenium recently carried out in the US and in other countries. These trials have consistently shown no beneficial effect on cancer and cardiovascular risk, and have yielded indications of unexpected toxic effects of selenium exposure...
March 24, 2017: Molecular Medicine Reports
https://www.readbyqxmd.com/read/28338929/performance-tests-of-active-personal-dosemeter-developed-by-%C3%A3-nrtc-nel
#8
Dogan Yasar, Enis Kapdan, Muharrem Korkmaz
The Active personal dosemeter (APD) developed by Çekmece Nuclear Research and Training Center/Nuclear Electronic Laboratory (ÇNRTC/NEL) was calibrated at the reference radiation quality (137Cs). The performance tests were carried out with 137Cs, 60Co and X-ray beam qualities in compliance with the standards of International Organization for Standardization ISO4037-1,3 and The International Electrotechnical Commission, IEC61526:2010. Response of the personal dose equivalent was observed to be within the range from -7...
March 1, 2017: Radiation Protection Dosimetry
https://www.readbyqxmd.com/read/28338814/korean-pediatric-and-adult-head-computational-phantoms-and-application-to-photon-specific-absorbed-fractions-calculations
#9
Daphnée Villoing, Dayton McMillan, Kwang Pyo Kim, Il Park, Ae-Kyoung Lee, Hyung-do Choi, Choonsik Lee
In recent decades, applications of single photon emission computed tomography and positron emission tomography in clinical neuroimaging have markedly increased. In this study, we developed a series of Korean computational head phantoms with detailed cranial substructures for 6-, 9-, 12- and 15-year-old children and adult by non-uniformly adjusting a template head phantom to match the Korean standard head dimensions. The Korean head phantoms were coupled with a Monte Carlo transport code to calculate age-dependent specific absorbed fraction (SAF) for the combination of 10 source and target regions and mono-energetic photons ranging from 0...
February 23, 2017: Radiation Protection Dosimetry
https://www.readbyqxmd.com/read/28338490/small-volume-injections-evaluation-of-volume-administration-deviation-from-intended-injection-volumes
#10
Matthew K Muffly, Michael I Chen, Rebecca E Claure, David R Drover, Bradley Efron, William L Fitch, Gregory B Hammer
BACKGROUND: In the perioperative period, anesthesiologists and postanesthesia care unit (PACU) nurses routinely prepare and administer small-volume IV injections, yet the accuracy of delivered medication volumes in this setting has not been described. In this ex vivo study, we sought to characterize the degree to which small-volume injections (≤0.5 mL) deviated from the intended injection volumes among a group of pediatric anesthesiologists and pediatric postanesthesia care unit (PACU) nurses...
March 23, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28338441/radiosurgery-in-the-management-of-brain-metastasis-a-retrospective-single-center-study-comparing-gamma-knife-and-linac-treatment
#11
Constantin Tuleasca, Laura Negretti, Mohamed Faouzi, Vera Magaddino, Thierry Gevaert, Erik von Elm, Marc Levivier
OBJECTIVE The authors present a retrospective analysis of a single-center experience with treatment of brain metastases using Gamma Knife (GK) and linear accelerator (LINAC)-based radiosurgery and compare the results. METHODS From July 2010 to July 2012, 63 patients with brain metastases were treated with radiosurgery. Among them, 28 (with 83 lesions) were treated with a GK unit and 35 (with 47 lesions) with a LINAC. The primary outcome was local progression-free survival (LPFS), evaluated on a per-lesion basis...
March 24, 2017: Journal of Neurosurgery
https://www.readbyqxmd.com/read/28337774/alumina-at-50-and-13%C3%A2-nm-nanoparticle-sizes-have-potential-genotoxicity
#12
Qinli Zhang, Haiyang Wang, Cuicui Ge, Jeremy Duncan, Kaihong He, Samuel O Adeosun, Huaxin Xi, Huiting Peng, Qiao Niu
Although nanomaterials have the potential to improve human life, their sideline effects on human health seem to be inevitable and still are unknown. Some studies have investigated the genotoxicity of alumina nanoparticles (AlNPs); however, this effect is still unclear due to insufficient evaluation and conflicting results. Using a battery of standard genotoxic assays, the present study offers evidence of the genotoxicity associated with aluminum oxide (alumina) at NP sizes of 50 and 13 nm, when compared with bulk alumina (10 μm)...
March 24, 2017: Journal of Applied Toxicology: JAT
https://www.readbyqxmd.com/read/28337715/is-incremental-hemodialysis-ready-to-return-on-the-scene-from-empiricism-to-kinetic-modelling
#13
REVIEW
Carlo Basile, Francesco Gaetano Casino, Kamyar Kalantar-Zadeh
Most people who make the transition to maintenance dialysis therapy are treated with a fixed dose thrice-weekly hemodialysis regimen without considering their residual kidney function (RKF). The RKF provides effective and naturally continuous clearance of both small and middle molecules, plays a major role in metabolic homeostasis, nutritional status, and cardiovascular health, and aids in fluid management. The RKF is associated with better patient survival and greater health-related quality of life, although these effects may be confounded by patient comorbidities...
March 23, 2017: Journal of Nephrology
https://www.readbyqxmd.com/read/28337083/continuous-infusion-etomidate-in-a-patient-receiving-extracorporeal-membrane-oxygenation
#14
Joseph M LaRochelle, Bonnie Desselle, Janet L Rossi
We describe a 16-year-old, 65-kg male deployed on extracorporeal membrane oxygenation (ECMO) for refractory respiratory failure secondary to ingestion of multiple substances. During his ECMO course, standard sedative and analgesic strategies failed and alternative medications were used. The patient received various dosages of fentanyl, morphine, hydromorphone, clonidine patches, dexmedetomidine, lorazepam, methadone, pentobarbital, olanzapine, and propofol. Despite administration of multiple agents, on day 29 of ECMO the patient experienced elevated blood pressures due to agitation, and continuous infusion etomidate was started...
January 2017: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/28337078/comparison-of-the-efficacy-and-safety-of-2-acetaminophen-dosing-regimens-in-febrile-infants-and-children-a-report-on-3-legacy-studies
#15
Anthony R Temple, Brenda Zimmerman, Cathy Gelotte, Edwin K Kuffner
OBJECTIVE: Compare efficacy and safety of 10 to 15 mg/kg with 20 to 30 mg/kg acetaminophen in febrile children 6 months to ≤ 11 years from 3 double-blind, randomized, single or multiple dose studies. METHODS: Doses were compared on sum of the temperature differences (SUMDIFF), maximum temperature difference (MAXDIFF), temperature differences at each time point, and dose by time interactions. Alanine aminotransferase (ALT) was evaluated in the 72-hour duration study...
January 2017: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/28336006/influence-of-the-integral-quality-monitor-transmission-detector-on-high-energy-photon-beams-a-multi-centre-study
#16
Bozidar Casar, Marlies Pasler, Sonja Wegener, David Hoffman, Cinzia Talamonti, Jianguo Qian, Ignasi Mendez, Denis Brojan, Bruce Perrin, Martijn Kusters, Richard Canters, Stefania Pallotta, Primoz Peterlin
PURPOSE: The influence of the Integral Quality Monitor (IQM) transmission detector on photon beam properties was evaluated in a preclinical phase, using data from nine participating centres: (i) the change of beam quality (beam hardening), (ii) the influence on surface dose, and (iii) the attenuation of the IQM detector. METHODS: For 6 different nominal photon energies (4 standard, 2 FFF) and square field sizes from 1×1cm(2) to 20×20cm(2), the effect of IQM on beam quality was assessed from the PDD20,10 values obtained from the percentage dose depth (PDD) curves, measured with and without IQM in the beam path...
March 20, 2017: Zeitschrift Für Medizinische Physik
https://www.readbyqxmd.com/read/28335798/treatment-of-mucocutaneous-manifestations-in-beh%C3%A3-et-s-disease-with-anakinra-a-pilot-open-label-study
#17
Peter C Grayson, Yusuf Yazici, Melissa Merideth, H Nida Sen, Michael Davis, Elaine Novakovich, Elizabeth Joyal, Raphaela Goldbach-Mansky, Cailin H Sibley
BACKGROUND: The effect of IL-1 blocking therapy on mucocutaneous manifestations of Behçet's disease is incompletely understood. METHODS: Six patients with Behçet's disease and ongoing oral/genital ulcers for ≥1 month were enrolled into an adaptive, two-phase clinical trial and included in the analysis. Study duration was 6 months with extension up to 16 months. All were treated non-blinded with anakinra 100 mg subcutaneous daily with the option to escalate the dose to 200 mg in partial responders after 1 month and 300 mg after 6 months...
March 24, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28335614/therapeutic-targeting-of-protein-kinase-ck2-gene-expression-in-feline-oral-squamous-cell-carcinoma-a-naturally-occurring-large-animal-model-of-head-and-neck-cancer
#18
Claire Cannon, Janeen Trembley, Betsy Kren, Gretchen Unger, M Gerard O'Sullivan, Ingrid Cornax, Jaime Modiano, Khalil Ahmed
Protein kinase CK2 (CK2) is a highly promising target for cancer therapy and anti-CK2 gene expression therapy has shown effectiveness in rodent models of human head and neck cancer (HNC). To date, there has been no large animal model of cancer in which to further explore anti-CK2 therapies. Feline oral squamous cell carcinoma (FOSCC) has been proposed as a large animal model for human HNC and we have previously shown that CK2 is a rational target in FOSCC. We hypothesized that a novel tenfibgen coated tumor-specific nanocapsule carrying RNAi oligonucleotides targeting feline CK2α and CK2α' (TBG-RNAi-fCK2αα') would be safe in cats with FOSCC...
March 23, 2017: Human Gene Therapy. Clinical Development
https://www.readbyqxmd.com/read/28335526/oral-cyanocobalamin-is-effective-in-the-treatment-of-vitamin-b12-deficiency-in-crohn-s-disease
#19
Fernando Gomollón, Carla J Gargallo, Jose Fernando Muñoz, Raquel Vicente, Alberto Lue, Alberto Mir, Marta García-Alvarado, Marta Gracia, Santiago García-López
Cobalamin deficiency is common in patients with Crohn's disease (CD). Intramuscular cobalamin continues to be the standard therapy for the deficiency and maintenance treatment in these patients, although oral route has been demonstrated to be effective in other pathologies with impaired absorption. Our aims were to evaluate the efficacy of oral therapy in the treatment of cobalamin deficiency and in long-term maintenance in patients with Crohn's disease. We performed a multicenter retrospective cohort study that included 94 patients with Crohn's disease and cobalamin deficiency...
March 20, 2017: Nutrients
https://www.readbyqxmd.com/read/28334957/quechers-based-method-for-pesticides-analysis-in-adipose-tissue-associated-with-rat-ovaries
#20
Nathalie Zamariola, Pedro Toledo Netto, Carla Adriene da Silva Franchi, João Lauro Viana de Camargo, Mary Rosa Rodrigues de Marchi
The concomitant exposure to low doses of various pesticides is one of the most relevant issues in human toxicology today. An experimental toxicology study was developed to evaluate the effects of this type of exposure on the reproductive capacity of females of three species of rats that were exposed to mixtures of dicofol, dieldrin, endosulfan and permethrin at low doses (LOAEL and NOAEL). In this context, we have developed a method for determining pesticides in adipose tissue (0.5 g, 49% lipid) associated with the ovaries, based on the QuEChERS (quick, easy, cheap, effective, rugged and safe) strategy...
March 14, 2017: Journal of Analytical Toxicology
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