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https://www.readbyqxmd.com/read/28190508/navigating-the-clinical-trial-pathway-conception-design-execution-and-results-dissemination
#1
John S Sampalis, Joanne Watson, Stella Boukas, Marianna Boukas, Natalie Harvey, Sanjay Machado, Michel Bordeleau, Emmanouil Rampakakis
Dr Sampalis is founder, Chief Executive Officer, and Chief Scientific Officer of JSS Medical Research Inc, founded in 1997. He is a tenured professor of Surgery and Epidemiology & Biostatistics of McGill University, the University of Montreal and University of Laval. Recognized as a leading clinical epidemiologist and one of the top trauma researchers in Canada, he possesses extensive expertise in health services research, clinical trials, and offers services as a Research and Epidemiological Consultant for numerous pharmaceutical companies, hospitals and government organizations and agencies...
March 2017: Surgery
https://www.readbyqxmd.com/read/28185899/lurasidone-versus-treatment-as-usual-for-cognitive-impairment-in-euthymic-patients-with-bipolar-i-disorder-a-randomised-open-label-pilot-study
#2
Lakshmi N Yatham, Sylvia Mackala, Jayasree Basivireddy, Sharon Ahn, Nazlin Walji, Chen Hu, Raymond W Lam, Ivan J Torres
BACKGROUND: Cognitive impairment is present in euthymic patients with bipolar disorder and correlates with impairments in everyday functioning. We aimed to examine the efficacy of lurasidone adjunctive therapy compared with treatment as usual (TAU) in improving cognition. METHODS: For this randomised, open-label, pilot study, we recruited patients aged 19-65 years with euthymic bipolar I disorder from the Mood Disorder Centre in UBC Hospital (Vancouver, Canada)...
February 6, 2017: Lancet Psychiatry
https://www.readbyqxmd.com/read/28184150/randomized-masked-in-vitro-comparison-of-three-commercially-available-tear-film-osmometers
#3
Guillermo Rocha, Eric Gulliver, Armand Borovik, Clara C Chan
PURPOSE: The purpose of this study was to compare the precision and accuracy of commercially available tear film osmometers. METHODS: Contrived tear solution target values representing the physiological range of tear osmolarity (normal eyes 297 mOsm/L, moderately dry eyes 342 mOsm/L, and severe dry eyes 383 mOsm/L) were constructed using a mix of mono- and divalent electrolytes, metabolites, serum albumin, and pH balanced to 7.4. Solution values were randomized and masked from the investigators during testing...
2017: Clinical Ophthalmology
https://www.readbyqxmd.com/read/28178881/nanobiotech-in-big-pharma-a-business-perspective
#4
Martin Würmseher, Lea Firmin
Since the early 2000s, numerous publications have presented major scientific opportunities that can be achieved through integrating insights from the area of nanotech into biotech (nanobiotech). This paper aims to explore the economic significance that nanobiotech has gained in the established pharmaceutical industry (big pharma). The empirical investigation draws on patent data as well as product revenue data; and to put the results into perspective, the amounts are compared with the established/traditional biotech sector...
March 2017: Nanomedicine
https://www.readbyqxmd.com/read/28160585/an-evaluation-of-the-efficacy-of-a-topical-gel-with-triester-glycerol-oxide-tgo-in-the-treatment-of-minor-recurrent-aphthous-stomatitis-in-a-turkish-cohort-a-randomized-double-blind-placebo-controlled-clinical-trial
#5
D Ofluoglu, S Ergun, S Warnakulasuriya, F Namdar-Pekiner, H Tanyeri
BACKGROUND: Triester glycerol oxide gel (Protefix® Queisser Pharma, Germany) is a new topical agent that has the property of adherence to the oral mucosa by forming a lipid film which protects against mechanical trauma and may help to reduce oral tissue moisture loss and inflammation. The aim of this clinical trial was to determine the efficacy of a topical TGO gel and to also compare it with triamcinolone acetonide pomade in the treatment of minor recurrent aphthous stomatitis. MATERIAL AND METHODS: This study was a randomized, double-blind, placebo-controlled clinical trial and 180 patients with the complaint of minor aphthous ulcers were enrolled in this study...
February 4, 2017: Medicina Oral, Patología Oral y Cirugía Bucal
https://www.readbyqxmd.com/read/28155594/pbpk-modeling-a-predictive-eco-friendly-bio-waiver-tool-for-drug-research
#6
Baishakhi De, Koushik Bhandari, Ranjan Mukherjee, Prakash Katakam, Shanta K Adiki, Rohit Gundamaraju, Analava Mitra
BACKGROUND: The world has witnessed growing complexities in disease scenario influenced by the drastic changes in host-pathogen- environment triadic relation. Pharmaceutical R&Ds are in constant search of novel therapeutic entities to hasten transition of drug molecules from lab bench to patient bedside. Extensive animal studies and human pharmacokinetics are still the "gold standard" in investigational new drug research and bio-equivalency studies. Apart from cost, time and ethical issues on animal experimentation, burning questions arise relating to ecological disturbances, environmental hazards and biodiversity issues...
February 1, 2017: Current Drug Discovery Technologies
https://www.readbyqxmd.com/read/28152896/current-landscape-of-acute-myeloid-leukemia-quality-measures-in-the-united-states
#7
Cat N Bui, Kyung Min Song, Eleanor Fitall, Kristi Mitchell, Stephanie Greenstein Braun, Erkut Bahceci, Bhavik Pandya, Dayo Jagun
: 261 Background: Acute myeloid leukemia (AML) is a rare, but deadly hematological, disease with 20,830 new cases estimated in 2015 in the United States (US). As new treatments emerge, quality measures (QMs) will become important to assess the value of care. Our aim was to evaluate the current US AML QM landscape. METHODS: We reviewed literature and online resources (eg, National Quality Measures Clearinghouse, Centers for Medicare & Medicaid Services, etc.) published within the last 5 years to identify AML-specific and AML-related QMs...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28146250/effect-of-selective-inhibition-of-reactivated-nicotine-associated-memories-with-propranolol-on-nicotine-craving
#8
Yan-Xue Xue, Jia-Hui Deng, Ya-Yun Chen, Li-Bo Zhang, Ping Wu, Geng-Di Huang, Yi-Xiao Luo, Yan-Ping Bao, Yu-Mei Wang, Yavin Shaham, Jie Shi, Lin Lu
Importance: A relapse into nicotine addiction during abstinence often occurs after the reactivation of nicotine reward memories, either by acute exposure to nicotine (a smoking episode) or by smoking-associated conditioned stimuli (CS). Preclinical studies suggest that drug reward memories can undergo memory reconsolidation after being reactivated, during which they can be weakened or erased by pharmacological or behavioral manipulations. However, translational clinical studies using CS-induced memory retrieval-reconsolidation procedures to decrease drug craving reported inconsistent results...
February 1, 2017: JAMA Psychiatry
https://www.readbyqxmd.com/read/28145075/biomarkers-designs-and-interpretations-of-resting-state-fmri-in-translational-pharmacological-research-a-review-of-state-of-the-art-challenges-and-opportunities-for-studying-brain-chemistry
#9
REVIEW
Najmeh Khalili-Mahani, Serge A R B Rombouts, Matthias J P van Osch, Eugene P Duff, Felix Carbonell, Lisa D Nickerson, Lino Becerra, Albert Dahan, Alan C Evans, Jean-Paul Soucy, Richard Wise, Alex P Zijdenbos, Joop M van Gerven
A decade of research and development in resting-state functional MRI (RSfMRI) has opened new translational and clinical research frontiers. This review aims to bridge between technical and clinical researchers who seek reliable neuroimaging biomarkers for studying drug interactions with the brain. About 85 pharma-RSfMRI studies using BOLD signal (75% of all) or arterial spin labeling (ASL) were surveyed to investigate the acute effects of psychoactive drugs. Experimental designs and objectives include drug fingerprinting dose-response evaluation, biomarker validation and calibration, and translational studies...
February 1, 2017: Human Brain Mapping
https://www.readbyqxmd.com/read/28144918/a-retrospective-study-of-ranibizumab-treatment-regimens-for-neovascular-age-related-macular-degeneration-namd-in-australia-and-the-united-kingdom
#10
Robert L Johnston, Hans-Joachim Carius, Adrian Skelly, Alberto Ferreira, Fran Milnes, Paul Mitchell
INTRODUCTION: Neovascular age-related macular degeneration (nAMD) is the leading cause of vision loss among persons aged 65 years and older. Anti-vascular endothelial growth factor (anti-VEGF) treatment is the recommended standard of care. The current study compares the effectiveness of ranibizumab in routine clinical practice in two countries that generally apply two different treatment regimens, treat-and-extend (T&E) in Australia or pro re nata (PRN) in the UK. METHODS: This retrospective, comparative, non-randomised cohort study is based on patients' data from electronic medical record (EMR) databases in Australia and the UK...
January 31, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28134751/efficacy-of-urtoxazumab-tma-15-humanized-monoclonal-antibody-specific-for-shiga-toxin-2-against-post-diarrheal-neurological-sequelae-caused-by-escherichia-coli-o157-h7-infection-in-the-neonatal-gnotobiotic-piglet-model
#11
Rodney A Moxley, David H Francis, Mizuho Tamura, David B Marx, Kristina Santiago-Mateo, Mojun Zhao
Enterohemorrhagic Escherichia coli (EHEC) is the most common cause of hemorrhagic colitis and hemolytic uremic syndrome in human patients, with brain damage and dysfunction the main cause of acute death. We evaluated the efficacy of urtoxazumab (TMA-15, Teijin Pharma Limited), a humanized monoclonal antibody against Shiga toxin (Stx) 2 for the prevention of brain damage, dysfunction, and death in a piglet EHEC infection model. Forty-five neonatal gnotobiotic piglets were inoculated orally with 3 × 10⁸ colony-forming units of EHEC O157:H7 strain EDL933 (Stx1⁺, Stx2⁺) when 22-24 h old...
January 26, 2017: Toxins
https://www.readbyqxmd.com/read/28130773/identification-of-substandard-medicines-via-disproportionality-analysis-of-individual-case-safety-reports
#12
Zahra Anita Trippe, Bruno Brendani, Christoph Meier, David Lewis
INTRODUCTION: The distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the Pharmacovigilance Department at Novartis Pharma AG has been analyzing drug-associated adverse events related to 'product quality issues' with the aim of detecting defective medicines using spontaneous reporting. The method of identifying SSMs with spontaneous reporting was pioneered by the Monitoring Medicines project in 2011...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28130434/selective-progesterone-receptor-modulator-sprm-ulipristal-acetate-upa-and-its-effects-on-the-human-endometrium
#13
L H R Whitaker, A A Murray, R Matthews, G Shaw, A R W Williams, P T K Saunders, H O D Critchley
STUDY QUESTION: What is the impact of administration of the selective progesterone receptor modulator (SPRM), ulipristal acetate (UPA) on the endometrium of women with fibroids? SUMMARY ANSWER: UPA administration altered expression of sex-steroid receptors and progesterone-regulated genes and was associated with low levels of glandular and stromal cell proliferation. WHAT IS KNOWN ALREADY: Administration of all SPRM class members results in PAEC (progesterone receptor modulator associated endometrial changes)...
January 26, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28126602/the-effect-of-feed-supplementation-with-zinc-chelate-and-zinc-sulphate-on-selected-humoral-and-cell-mediated-immune-parameters-and-cytokine-concentration-in-broiler-chickens
#14
Łukasz Jarosz, Agnieszka Marek, Zbigniew Grądzki, Małgorzata Kwiecień, Marcin Kalinowski
The ability of poultry to withstand infectious disease caused by bacteria, viruses or protozoa depends upon the integrity of the immune system. Zinc is important for proper functioning of heterophils, mononuclear phagocytes and T lymphocytes. Numerous data indicate that the demand for zinc in poultry is not met in Poland due to its low content in feeds of vegetable origin. The aim of the study was to determine the effect of supplementation of inorganic (ZnSO4 and ZnSO4(+) phytase enzyme), and organic forms of zinc (Zn with glycine and Zn with glycine and phytase enzyme) on selected parameters of the cellular and humoral immune response in broiler chickens by evaluating the percentage of CD3(+)CD4(+), CD3(+)CD8(+), CD25(+), MHC Class II, and BU-1(+) lymphocytes, the phagocytic activity of monocytes and heterophils, and the concentration of IL-2, IL-10 and TNF-α in the peripheral blood...
September 14, 2016: Research in Veterinary Science
https://www.readbyqxmd.com/read/28121603/scratching-the-career-itch-leads-to-bigger-reach-in-pharma
#15
Timothy Kelley
No abstract text is available yet for this article.
November 2016: Managed Care
https://www.readbyqxmd.com/read/28121576/amcp-seeks-an-end-to-20-years-of-confusion-over-fdama-section-114
#16
Michael D Dalzell
The FDA never issued regulations to clarify the boundaries of promotion of pharmacoeconomic data, something it's been dragging its feet on for nearly 20 years. In turn, pharma companies, fearful of being penalized for off-lable promotion, have erred on the side of caution, hesitating to take advantage of Section 114.
September 2016: Managed Care
https://www.readbyqxmd.com/read/28121547/oncology-pharma-costs-to-exceed-150-billion-by-2020
#17
(no author information available yet)
Worldwide costs of oncology drugs will rise above $150 billion by 2020, according to a report by the IMS Institute for Healthcare Informatics. Many factors are in play, according to IMS, including the new wave of expensive immunotherapies. Pembrolizumab (Keytruda), priced at $150,000 per year per patient, and nivolumab (Opdivo), priced at $165,000, may be harbingers of the market for cancer immunotherapies.
October 2016: Managed Care
https://www.readbyqxmd.com/read/28117016/food-as-pharma-the-case-of-glucosinolates
#18
Edoardo Capuano, Matthijs Dekker, Ruud Verkerk, Teresa Oliviero
BACKGROUND: Glucosinolates (GLSs) are dietary plant secondary metabolites occurring in the order Brassicales with potential health effects, in particular as anti-carcinogenic compounds. GLSs are converted into a variety of breakdown products (BPs) upon plant tissue damage and by the gut microbiota. GLS biological activity is related to BPs rather than to GLSs themselves. METHODS: we have reviewed the most recent scientific literature on the metabolic fate and the biological effect of GLSs with particular emphasis on the epidemiological evidence for health effect and evidence from clinical trials...
January 20, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28114089/-non-conventional-pharmacological-agents-for-the-treatment-of-bipolar-disorder-%C3%AE-systematic-review-of-the-evidence
#19
K N Fountoulakis, D Balaris, V Nikolaou, J Νimatoudis
Bipolar disorder (BD) has a complex and variable clinical picture which is characterized by many different phacets and phases and as a result its therapeutical options are also complex and often unsatisfactory. Typically the so-called "mood stabilizers" are used in the treatment of BD and in this class lithium and specific antiepileptics are included. The present study aimed to systematically review the literature concerning the presence of randomized double blind clinical trials of 'non conventional' pharmaceutical treatment options...
October 2016: Psychiatrikē, Psychiatriki
https://www.readbyqxmd.com/read/28113163/what-lies-within-the-human-body-might-well-be-one-of-the-best-sources-for-new-antibiotics
#20
Shannon Fischer
In 1991, a group of Italian researchers announced that they had isolated a new antibiotic from a chemical soup brewed with a soil-dwelling bacteria called Planobispora rosea. The drug was a type of thiopeptide, effective against grampositive bacteria like Staphylococcus aureus, P. acnes, and C. difficile but uncooperative in terms of being harnessed for human medicines. Little came of that work until around 2012, when pharma giant Novartis reported that it had begun to experiment with the original drug's structure, ultimately creating a semisynthetic version with enough solubility that it could be effectively administered to human patients...
September 2016: IEEE Pulse
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