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Takahisa Kawamura, Hidefumi Kasai, Valentina Fermanelli, Toshiaki Takahashi, Yukinori Sakata, Toshiyuki Matsuoka, Mika Ishii, Yusuke Tanigawara
Post-marketing surveillance is useful to collect safety data in real-world clinical settings. In this study, we firstly applied the post-marketing real-world data on a mechanistic model analysis for neutropenic profiles of eribulin in patients with recurrent or metastatic breast cancer (RBC/MBC). Demographic and safety data were collected using an active surveillance method from eribulin-treated RBC/MBC patients. Changes in neutrophil counts over time were analyzed using a mechanistic pharmacodynamic model...
June 22, 2018: Cancer Science
James Wyatt Kernell, Rosalie V DePaola, Alec M Maglione, Lacey N Ahern, Naomi G Penney, David G Addiss
BACKGROUND: In areas where the prevalence of soil-transmitted helminthiasis (STH) is >20%, the World Health Organization (WHO) recommends that deworming medication be given periodically to preschool-age children. To reduce risk of choking-related deaths in children <3 years old, WHO recommends that deworming tablets be crushed and given with water. Little is known about how widely this is practiced or its effectiveness. METHODOLOGY AND PRINCIPAL FINDINGS: Albendazole distributions for STH were observed for children 1-4 years old in 65 sites in India and Haiti...
June 2018: PLoS Neglected Tropical Diseases
Ayako Shiba, Shigehiko Uchino, Tomoko Fujii, Masanori Takinami, Shoichi Uezono
BACKGROUND: Acute kidney injury (AKI) occurs in 6.1%-22.4% of patients undergoing major noncardiac surgery. Previous studies have shown no association between intraoperative urine output and postoperative acute renal failure. However, these studies used various definitions of acute renal failure. We therefore investigated the association between intraoperative oliguria and postoperative AKI defined by the serum creatinine criteria of the Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) classification...
June 20, 2018: Anesthesia and Analgesia
Elizabeth Stewart, Cathy Catroppa, Deepak Gill, Richard Webster, John Lawson, Anna Mandalis, Mark Sabaz, Belinda Barton, Suncica Lah
PURPOSE: This study aimed to examine Theory of Mind (ToM) and social competence in children and adolescents with genetic generalised epilepsy (GGE), and explore how they relate to neurocognitive and epilepsy variables. METHODS: Twenty-two children and adolescents with GGE (8-16 years old) and 22 typically developing controls completed two behavioural tasks (faux-pas, strange stories) assessing cognitive and affective ToM, and a battery of standardised neuropsychological tests...
June 18, 2018: Seizure: the Journal of the British Epilepsy Association
Yao-Ting Huang, Jan-Fang Cheng, Shi-Yu Chen, Yu-Kai Hong, Zong-Yen Wu, Po-Yu Liu
OBJECTIVES: Shewanella algae is an environmental marine bacteria and an emerging opportunistic human pathogen. Moreover, there are increasing reports of strains showing multi-drug resistance, particularly carbapenem-resistant isolates. Although S. algae have been found in bivalve shellfish aquaculture, there is very little genome-wide data on resistant determinants in S. algae from shellfish. In the study, we aimed to determine the whole genome sequence of carbapenem-resistant S. algae strain AC isolated from small abalone in Taiwan...
June 19, 2018: Journal of Global Antimicrobial Resistance
Kim Marienhagen, Frank Lehner, Jürgen Klempnauer, Hartmut Hecker, Jürgen Borlak
Post-transplant hypertension (PTH) is a common complication in cyclosporine immunosuppressed patients; however choosing the right antihypertensive medication is challenging. In a long-term observational study (≤13y) we examined different antihypertensive medications on graft/patient survival of kidney recipients with pre-existing and PTH. Altogether thirty-three co-variables were analyzed including dose and type of immunosuppressive and antihypertensive medication, co-medications, serum biochemistries and the glomerular filtration rate (GFR)...
June 19, 2018: Vascular Pharmacology
A M Quílez, M A Fernández-Arche, M D García-Giménez, R De la Puerta
ETHNO-PHARMACOLOGICAL RELEVANCE: Annona species (Annonaceae) have long been used as traditional herbal medicines by native peoples in tropical areas. In different countries they are used against a large variety of illnesses, such as parasitic and infectious diseases, cancer, diabetes, peptic ulcers, and mental disorders. AIM OF THE STUDY: This review aims to achieve a comprehensive understanding of the research conducted so far on the local and traditional uses, pharmacological activities, mechanism of actions of active compounds, toxicity, and possible interactions with other drugs of the Annona species...
June 19, 2018: Journal of Ethnopharmacology
Veerle Foulon, Joke Wuyts, Franciska Desplenter, Anne Spinewine, Valérie Lacour, Dominique Paulus, Jan De Lepeleire
Background and objectives Patients often experience drug-related problems at admission or after discharge from hospital. The objective of this study was to identify the main problems in medication management at transition between settings of care, as experienced by health care professionals (HCPs) and patients. Methods Focus group discussions were organised between December 2009 and February 2010; nine focus groups with primary and secondary care HCPs and patients and two with stakeholders. Focus group discussions were audiotaped and observation files were constructed...
June 22, 2018: Acta Clinica Belgica
(no author information available yet)
The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices...
February 21, 2018: Federal Register
Melissa J Palmer, Sharmani Barnard, Pablo Perel, Caroline Free
BACKGROUND: Cardiovascular disease (CVD) is a major cause of disability and mortality globally. Premature fatal and non-fatal CVD is considered to be largely preventable through the control of risk factors via lifestyle modifications and preventive medication. Lipid-lowering and antihypertensive drug therapies for primary prevention are cost-effective in reducing CVD morbidity and mortality among high-risk people and are recommended by international guidelines. However, adherence to medication prescribed for the prevention of CVD can be poor...
June 22, 2018: Cochrane Database of Systematic Reviews
Sally L Brooks, Gail Rowan, Michael Michael
AIM: Complementary medicine (CAM) use in the cancer population is higher than the general population: some studies estimate up to 70%. Our Medicines Information Centre, in a tertiary cancer institution, receives many enquiries regarding use and safety of CAM with conventional cancer therapies (chemotherapy, radiotherapy and surgery). This project aims to review the CAM most commonly enquired about with an emphasis on potential interactions with conventional cancer therapies. METHODS: An audit and review of CAM enquiries from patients or medical professionals at our center, over a 2-year period (July 2011-June 2013), was conducted...
June 22, 2018: Asia-Pacific Journal of Clinical Oncology
Ashley Suchomel, Helen Goeden, Julia Dady
Americans fill upward of four billion prescriptions for pharmaceuticals each year, and many of those pharmaceuticals eventually make their way into the environment. Hundreds of different active pharmaceutical ingredients (APIs) are detected in ambient waters and source water used for drinking water in the U.S. Very few of these drugs have health-based guidance values that suggest a safe level for individuals exposed in the ambient environment through drinking water. The Minnesota Department of Health (MDH) has developed a novel method to derive screening-level human health guidance values for APIs...
June 22, 2018: International Journal of Environmental Research and Public Health
Joaquim Aguirre-Plans, Janet Piñero, Jörg Menche, Ferran Sanz, Laura I Furlong, Harald H H W Schmidt, Baldo Oliva, Emre Guney
The past decades have witnessed a paradigm shift from the traditional drug discovery shaped around the idea of &ldquo;one target, one disease&rdquo; to polypharmacology (multiple targets, one disease). Given the lack of clear-cut boundaries across disease (endo)phenotypes and genetic heterogeneity across patients, a natural extension to the current polypharmacology paradigm is to target common biological pathways involved in diseases via endopharmacology (multiple targets, multiple diseases). In this study, we present proximal pathway enrichment analysis (PxEA) for pinpointing drugs that target common disease pathways towards network endopharmacology...
June 22, 2018: Pharmaceuticals
Chunli Chen, Sebastian G Wicha, Rikard Nordgren, Ulrika S H Simonsson
Quantitative evaluation of potential pharmacodynamic (PD) interactions is important in tuberculosis drug development in order to optimize Phase 2b drug selection and ultimately to define clinical combination regimens. In this work, we used simulations to (1) evaluate different analysis methods for detecting PD interactions between two hypothetical anti-tubercular drugs in in vitro time-kill experiments, and (2) provide design recommendations for evaluation of PD interactions. The model used for all simulations was the Multistate Tuberculosis Pharmacometric (MTP) model linked to the General Pharmacodynamic Interaction (GPDI) model...
June 21, 2018: AAPS Journal
Miguel R Ossandon, Lokesh Agrawal, Eric J Bernhard, Barbara A Conley, Sumana M Dey, Rao L Divi, Ping Guan, Tracy G Lively, Tawnya C McKee, Brian S Sorg, James V Tricoli
The importance of circulating free DNA (cfDNA) in cancer clinical research was recognized in 1994 when a mutated RAS gene fragment was detected in a patient's blood sample. Up to 1% of the total circulating DNA in patients with cancer is circulating tumor DNA (ctDNA) that originates from tumor cells. As ctDNA is rapidly cleared from the blood stream and can be obtained by minimally invasive methods, it can be used as a dynamic cancer biomarker for cancer early detection, diagnosis, and treatment monitoring...
June 20, 2018: Journal of the National Cancer Institute
Paul D Wesson, Ali Mirzazadeh, Willi McFarland
Background: The multiplier method is one of the most frequently used population size estimation (PSE) methods for key populations, yet estimates from this method are often inconsistent with each other, other PSE methods and local knowledge. We developed a novel Bayesian approach, the 'Anchored Multiplier', which synthesizes estimates from multipliers coupled to an a priori estimate to arrive at a single consensus estimate and credible range. Methods: Data for size estimation were collected from three cross-sectional bio-behavioural surveillance studies of people who inject drugs (PWID) in San Francisco, CA, USA (2005, 2009 and 2012)...
June 21, 2018: International Journal of Epidemiology
Elisabetta Giorgini, Simona Sabbatini, Romina Rocchetti, Valentina Notarstefano, Corrado Rubini, Carla Conti, Giulia Orilisi, Elisa Mitri, Diana E Bedolla, Lisa Vaccari
In the present study, human primary oral squamous carcinoma cells treated with cisplatin and 5-fluorouracil were analyzed, for the first time, by in vitro FTIR Microspectroscopy (FTIRM), to improve the knowledge on the biochemical pathways activated by these two chemotherapy drugs. To date, most of the studies regarding FTIRM cellular analysis have been executed on fixed cells from immortalized cell lines. FTIRM analysis performed on primary tumor cells under controlled hydrated conditions provides more reliable information on the biochemical processes occurring in in vivo tumor cells...
June 22, 2018: Analyst
Ramesh Sharma Poudel, Shakti Shrestha, Santosh Thapa, Bhupendra Kumar Poudel, Muniraj Chhetri
Background: Appropriate labeling of marketed medicines is necessary to fulfill the regulatory provisions and ensure patient medication safety. This study aimed to assess the primary labeling of medicines manufactured and marketed by Nepalese pharmaceutical industries. Methods: We assessed the primary labeling of all medicines available at the pharmacy of Chitwan Medical College Teaching Hospital (CMCTH), Chitwan, Nepal, between November 2017 to December 2017. Medicines were assessed as required by Drug Standard Regulation, 2043 (1986 AD) of Nepal...
2018: Journal of Pharmaceutical Policy and Practice
Sumit Gaur, Rupali Agnihotri
Background: Amlodipine, a dihydropyridine calcium channel blocker (CCB) is commonly prescribed for cardiovascular conditions. Its administration may produce an uncommon adverse oral manifestation, the gingival overgrowth (GO). Lately, there has been an increase in the rate of GO in patients on amlodipine therapy. The current systematic review was undertaken to evaluate the evidence on plausible risk factors involved in amlodipine induced gingival overgrowth (AIGO). Material and Methods: Literature search was conducted in the databases like Pubmed (Medline), Scopus and Google Scholar to include the original research articles related to etio-pathogenesis of AIGO...
June 2018: Journal of Clinical and Experimental Dentistry
Chen Xu, Jie Gao, Hai-Feng Zhang, Na Gao, Yuan-Yuan Guo, Yan Fang, Qiang Wen, Hai-Ling Qiao
UDP-glucuronosyltransferase 2B7 (UGT2B7) is one of the most significant isoforms of UGTs in human liver. This research measured UGT2B7 protein content and activities including Vmax and CLint in human liver at isoform, microsomal, liver tissue, and liver levels and identified the factors that influence expression. We determined absolute protein content by LC-MS/MS and activities using the probe drug Zidovudine in 82 normal human liver microsomes. Using a bottom-up method for derivation, we showed UGT2B7 content at the microsomal, liver tissue, and liver levels, as well as activities at the isoform, microsomal, liver tissue, and liver levels in vitro, and predicted hepatic clearance in vivo, with median, range, variation, and 95 and 50% prediction intervals...
June 21, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
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