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Global blood safety

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https://www.readbyqxmd.com/read/28934376/managing-menopausal-symptoms-and-associated-clinical-issues-in-breast-cancer-survivors
#1
Richard J Santen, Cynthia A Stuenkel, Susan R Davis, JoAnn V Pinkerton, Anne Gompel, Mary Ann Lumsden
Objective: Review evidence to guide the management of menopausal signs and symptoms in women after breast cancer and make recommendations accordingly. Evidence: Randomized controlled clinical trials, observational studies, evidence- based guidelines, and expert opinion from professional societies. Background: Several symptoms and clinical problems associated with estrogen depletion -sleep disorders, vulvovaginal atrophy (VVA), vasomotor symptoms (VMS), mood changes, depressive symptoms, cardiovascular disease, osteopenia and osteoporosis- confront the estimated 9...
August 2, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28924431/occult-hepatitis-infection-in-transfusion-medicine-screening-policy-and-assessment-of-current-use-of-anti-hbc-testing
#2
REVIEW
Antonella Esposito, Chiara Sabia, Carmela Iannone, Giovanni F Nicoletti, Linda Sommese, Claudio Napoli
HBV still represents a global risk factor in transfusion medicine. The residual risk of HBV is not limited to pre-seroconversion window period but it extends to donors with occult HBV infection (OBI) characterized by the presence of HBV DNA in liver and by the absence of the virus surface antigen. Each country developed an appropriate blood screening policy according to local HBV prevalence, yields of infectious units per different screening methods and cost-effectiveness. We underline the need of maintaining a high level of attention for OBI carrier identification in all blood banks worldwide where the screening procedures are generally based on a combination of both serological markers and nucleic acid amplification test...
August 2017: Transfusion Medicine and Hemotherapy
https://www.readbyqxmd.com/read/28911936/exercise-training-in-patients-with-pulmonary-and-systemic-hypertension-a-unique-therapy-for-two-different-diseases
#3
REVIEW
Massimo Leggio, Augusto Fusco, Giorgio Limongelli, Luca Sgorbini
Pulmonary hypertension is a potentially life-threatening condition. Given its evolving definition, the incidence and prevalence of the disease is difficult to define, but registries suggest an increased global awareness. The management of patients with pulmonary arterial hypertension is highly specialised and requires multi-disciplinary input from a range of healthcare professionals, including cardiologists, respiratory physicians, rheumatologists, rehabilitation physicians and cardio-pulmonary physiotherapists...
September 11, 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/28906150/safety-and-efficacy-of-a-ttr-specific-antisense-oligonucleotide-in-patients-with-transthyretin-amyloid-cardiomyopathy
#4
Merrill D Benson, Noel R Dasgupta, Stacy M Rissing, Jessica Smith, Harvey Feigenbaum
OBJECTIVES: Cardiomyopathy is a major cause of death in both the hereditary form of transthyretin (TTR) amyloidosis and the sporadic late-age-onset transthyretin amyloidosis (ATTR wild-type (ATTRwt)). Clinically disease progression from time of diagnosis to death is usually quoted as 5- to 15-years. In prior studies, significant progression of cardiac parameters in patients with moderate to severe cardiomyopathy has been noted within a 12-month time span. METHODS: The present study was designed to prospectively monitor changes in cardiac parameters, both structural and functional, in patients with ATTR cardiomyopathy while treated with a TTR specific antisense oligonucleotide (ASO; IONIS-TTR℞) designed to lower blood levels of the amyloid fibril precursor protein...
September 14, 2017: Amyloid: the International Journal of Experimental and Clinical Investigation
https://www.readbyqxmd.com/read/28902419/reassessing-the-safety-concerns-of-utilizing-blood-donations-from-patients-with-hemochromatosis
#5
REVIEW
Adam C Winters, Douglas Tremblay, Suzanne Arinsburg, John Mascarenhas, Thomas D Schiano
Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism which may lead to iron overload. Clinical penetrance is low, however those afflicted may develop cirrhosis, hepatocellular carcinoma, diabetes mellitus and cardiomyopathy. Treatment involves regular phlebotomy to reduce the systemic iron burden. In many countries-including the United States-numerous blood centers do not accept donated blood obtained from HH patients during therapeutic phlebotomy and there are inconsistent positions regarding this globally...
September 13, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28880361/a-randomized-multicenter-study-safety-and-efficacy-of-mini-pool-intravenous-immunoglobulin-versus-standard-immunoglobulin-in-children-aged-1-18-years-with-immune-thrombocytopenia
#6
Mohsen Elalfy, Marwa Reda, Islam Elghamry, Omar Elalfy, Mohamed Meabed, Nada El-Ekiaby, Mahmoud A El-Hawy, Hadi Goubran, Magdy El-Ekiaby
BACKGROUND: Because there is a global shortage of intravenous immunoglobulin, there is a need for new products to fill the gap. STUDY DESIGN AND METHODS: This was a multicenter, open-label study investigating the safety and efficacy of a newly developed mini-pool intravenous immunoglobulin G for children with immune thrombocytopenia. Seventy-two patients ages 1 to 18 years with newly diagnosed (<1 month) immune thrombocytopenia who had platelet counts from 5 to 20 × 10(9) /L with no serious bleeding were recruited from four centers in Egypt...
September 6, 2017: Transfusion
https://www.readbyqxmd.com/read/28879153/implementing-slmta-in-the-kenya-national-blood-transfusion-service-lessons-learned
#7
Eric N Wakaria, Charles O Rombo, Margaret Oduor, Serah M Kambale, Kimberly Tilock, Daniel Kimani, Ernest Makokha, Peter M Mwamba, Jane Mwangi
BACKGROUND: The Kenya National Blood Transfusion Service (KNBTS) is mandated to provide safe and sufficient blood and blood components for the country. In 2013, the KNBTS National Testing Laboratory and the six regional blood transfusion centres were enrolled in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. The process was supported by Global Communities with funding from the United States Centers for Disease Control and Prevention. METHODS: The SLMTA implementation at KNBTS followed the standard three-workshop series, on-site mentorships and audits...
2017: African Journal of Laboratory Medicine
https://www.readbyqxmd.com/read/28859273/establishment-of-minimal-positive-control-conditions-to-ensure-brain-safety-during-rapid-development-of-emergency-vaccines
#8
Hyekyung Baek, Kwang Ho Kim, Min Young Park, Kyeongryun Kim, Bokyeong Ko, Hyung Seok Seo, Byoung Soo Kim, Tae-Wook Hahn, Sun Shin Yi
With the increase in international human and material exchanges, contagious and infectious epidemics are occurring. One of the effective methods of epidemic inhibition is the rapid development and supply of vaccines. Considering the safety of the brain during vaccine development is very important. However, manuals for brain safety assays for new vaccines are not uniform or effective globally. Therefore, the aim of this study is to establish a positive-control protocol for an effective brain safety test to enhance rapid vaccine development...
August 31, 2017: Journal of Veterinary Science
https://www.readbyqxmd.com/read/28858776/associations-between-alcohol-consumption-patterns-and-attitudes-towards-alcohol-interlocks
#9
Caitlin A Bishop, Sara Liu, Amanda N Stephens, Michael Fitzharris
BACKGROUND: Drink-driving and alcohol-related crashes are a significant problem globally. Alcohol interlocks are used to prevent drivers with a blood alcohol concentration above a pre-determined level from starting their vehicle, making the technology highly effective in preventing drink-drive episodes. While alcohol interlocks are commonly used in drink-drive offender groups, their broader use as a preventative road safety strategy is considered increasingly feasible. In this context it is important to understand attitudes towards the technology, and to investigate whether these attitudes vary according to alcohol consumption patterns as this influences the acceptability of a broad-based preventative alcohol interlock program...
August 28, 2017: Accident; Analysis and Prevention
https://www.readbyqxmd.com/read/28855799/review-of-lisdexamfetamine-dimesylate-in-adults-with-attention-deficit-hyperactivity-disorder
#10
REVIEW
Jadwiga Najib, Dexter Wimer, Julie Zeng, Kristina W Lam, Natalya Romanyak, Eva Paige Morgan, Anu Thadavila
Lisdexamfetamine dimesylate (LDX) is the first prodrug stimulant used for the treatment of attention-deficit/hyperactivity disorder (ADHD) dosed once daily. Due to its long-acting properties, LDX remains pharmacologically inactive until an enzymatic process predominantly associated with red blood cells converts it to the active ingredient, d-amphetamine and the amino acid lysine. The efficacy of LDX over placebo has been demonstrated in several studies in adults with moderate to severe ADHD with significant improvements noted in ADHD rating scales, Clinical Global Improvement scores, and assessments of executive function, for all doses of LDX (30-70 mg daily)...
2017: Journal of Central Nervous System Disease
https://www.readbyqxmd.com/read/28844599/generic-imatinib-therapy-among-jordanians-an-observational-assessment-of-efficacy-and-safety-in-routine-clinical-practice
#11
Abdalla Awidi, Salah Abbasi, Kamal Alrabi, Khalid A Kheirallah
INTRODUCTION: Generic imatinib therapy is being globally considered owing to cost considerations. However, evidence of its efficacy and safety in Middle Eastern clinical settings is scarce. PATIENTS AND METHODS: The efficacy and safety of generic imatinib (Cemivil) were assessed among Jordanian patients diagnosed with chronic myeloid leukemia using an observational, multicenter, prospective study design. Responses were defined using European LeukemiaNet 2009 guidelines and assessed by complete blood counts, fluorescence in situ hybridization, and real-time quantitative polymerase chain reaction...
August 5, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28816509/shp465-mixed-amphetamine-salts-in-the-treatment-of-attention-deficit-hyperactivity-disorder-in-children-and-adolescents-results-of-a-randomized-double-blind-placebo-controlled-study
#12
Matthew Brams, Ann C Childress, Michael Greenbaum, Ming Yu, Brian Yan, Margo Jaffee, Brigitte Robertson
OBJECTIVE: The aim of this study was to evaluate the efficacy, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: This randomized, double-blind dose-optimization study enrolled children and adolescents (6-17 years) meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision ADHD criteria and having baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥28...
August 17, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28814873/safety-and-efficacy-of-paliperidone-palmitate-1-month-formulation-in-chinese-patients-with-schizophrenia-a-25-week-open-label-multicenter-phase-iv-study
#13
Jingping Zhao, Lehua Li, Jianguo Shi, Yi Li, Xiufeng Xu, Keqing Li, Lili Zhang, Shangli Cai, Yu Feng, Jianmin Zhuo, Weihong Liu, Huafei Lu
RATIONALE: Long-acting injectable (LAI) paliperidone palmitate 1-month formulation (PP1M) has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest. OBJECTIVE: The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia. METHODS: In this 25-week, open-label, Phase IV study, patients (18-65 years) diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS) total score of 60-120 (inclusive) were enrolled...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28802512/cangrelor-versus-clopidogrel-on-a-background-of-unfractionated-heparin-from-champion-phoenix
#14
RANDOMIZED CONTROLLED TRIAL
Muthiah Vaduganathan, Robert A Harrington, Gregg W Stone, Ph Gabriel Steg, C Michael Gibson, Christian W Hamm, Matthew J Price, Efthymios N Deliargyris, Jayne Prats, Kenneth W Mahaffey, Harvey D White, Deepak L Bhatt
Cangrelor is approved for use during percutaneous coronary intervention (PCI) and is administered with different parenteral anticoagulants. We examined the efficacy and safety of cangrelor in the subgroup of patients who received unfractionated heparin (UFH) during PCI in the modified intention-to-treat population of the randomized CHAMPION PHOENIX trial (cangrelor vs clopidogrel; n = 10,939). The primary efficacy end point was the composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis (ST) at 48 hours...
October 1, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28800195/pharmacokinetics-safety-and-tolerability-of-glecaprevir-and-pibrentasvir-in-healthy-white-chinese-and-japanese-adult-subjects
#15
Chih-Wei Lin, Sandeep Dutta, Bifeng Ding, Tianli Wang, Neddie Zadeikis, Armen Asatryan, Jens Kort, Andrew Campbell, Thomas Podsadecki, Wei Liu
Glecaprevir and pibrentasvir are direct-acting antiviral agents being developed as combination therapy for the treatment of chronic hepatitis C virus infection. The aim of the present studies was to assess the effect of race and ethnicity (white, Han Chinese, Japanese) on the pharmacokinetics and safety of multiple oral doses of glecaprevir and pibrentasvir given alone and in combination. Two multiple-dose, single-center, phase 1 studies were conducted in healthy adult male and female subjects (n = 170) of respective Asian and white race/ethnicity...
August 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28790779/device-associated-healthcare-associated-infections-da-hai-and-the-caveat-of-multiresistance-in-a-multidisciplinary-intensive-care-unit
#16
Inam Danish Khan, Atoshi Basu, Sheshadri Kiran, Shaleen Trivedi, Priyanka Pandit, Anupam Chattoraj
BACKGROUND: Device-Associated Healthcare-Associated Infections (DA-HAI), including Ventilator-Associated Pneumonia (VAP), Central-Line-Associated Blood Stream Infection (CLABSI), and Catheter-Related Urinary Tract Infection (CAUTI), are considered as principal contributors to healthcare hazard and threat to patient safety as they can cause prolonged hospital stay, sepsis, and mortality in the ICU. The study intends to characterize DA-HAI in a tertiary care multidisciplinary ICU of a teaching hospital in eastern India...
July 2017: Medical Journal, Armed Forces India
https://www.readbyqxmd.com/read/28763548/effect-of-oral-methylprednisolone-on-clinical-outcomes-in-patients-with-iga-nephropathy-the-testing-randomized-clinical-trial
#17
RANDOMIZED CONTROLLED TRIAL
Jicheng Lv, Hong Zhang, Muh Geot Wong, Meg J Jardine, Michelle Hladunewich, Vivek Jha, Helen Monaghan, Minghui Zhao, Sean Barbour, Heather Reich, Daniel Cattran, Richard Glassock, Adeera Levin, David Wheeler, Mark Woodward, Laurent Billot, Tak Mao Chan, Zhi-Hong Liu, David W Johnson, Alan Cass, John Feehally, Jürgen Floege, Giuseppe Remuzzi, Yangfeng Wu, Rajiv Agarwal, Hai-Yan Wang, Vlado Perkovic
Importance: Guidelines recommend corticosteroids in patients with IgA nephropathy and persistent proteinuria, but the effects remain uncertain. Objective: To evaluate the efficacy and safety of corticosteroids in patients with IgA nephropathy at risk of progression. Design, Setting, and Participants: The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study was a multicenter, double-blind, randomized clinical trial designed to recruit 750 participants with IgA nephropathy (proteinuria greater than 1 g/d and estimated glomerular filtration rate [eGFR] of 20 to 120 mL/min/1...
August 1, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28752663/platelet-production-from-induced-pluripotent-stem-cells
#18
N Sugimoto, K Eto
Ex vivo production of human platelets has been pursued as an alternative measure to resolve limitations in the supply and safety of current platelet transfusion products. To this end, induced pluripotent stem cells (iPSCs) are considered an ideal global source, as they are not only pluripotent and self-renewing, but are also available from basically any person, have relatively few ethical issues, and are easy to manipulate. From human iPSCs, megakaryocyte (MK) lines with robust proliferation capacity have been established by the introduction of specified sets of genes...
July 28, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28740204/safety-and-tolerability-of-topically-administered-autologous-apoptotic-pbmc-secretome-aposec-in-dermal-wounds-a-randomized-phase-1-trial-marsyas-i%C3%AF
#19
Elisabeth Simader, Denise Traxler, Mohammad Mahdi Kasiri, Helmut Hofbauer, Michael Wolzt, Christoph Glogner, Angela Storka, Michael Mildner, Ghazaleh Gouya, Alexandra Geusau, Carola Fuchs, Claudia Eder, Alexandra Graf, Michaela Schaden, Bahar Golabi, Marie-Bernadette Aretin, Susanne Suessner, Christian Gabriel, Walter Klepetko, Erwin Tschachler, Hendrik Jan Ankersmit
Developing effective therapies against chronic wound healing deficiencies is a global priority. Thus we evaluated the safety of two different doses of topically administered autologous APOSEC, the secretome of apoptotic peripheral blood mononuclear cells (PBMCs), in healthy male volunteers with artificial dermal wounds. Ten healthy men were enrolled in a single-center, randomized, double-blinded, placebo-controlled phase 1 trial. Two artificial wounds at the upper arm were generated using a 4-mm punch biopsy...
July 24, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28729836/an-overview-of-herbal-products-and-secondary-metabolites-used-for-management-of-type-two-diabetes
#20
REVIEW
Ajda Ota, Nataša P Ulrih
Diabetes mellitus is a common effect of uncontrolled high blood sugar and it is associated with long-term damage, dysfunction, and failure of various organs. In the adult population, the global prevalence of diabetes has nearly doubled since 1980. Without effective prevention and management programs, the continuing significant rise in diabetes will have grave consequences on the health and lifespan of the world population, and also on the world economy. Supplements can be used to correct nutritional deficiencies or to maintain an adequate intake of certain nutrients...
2017: Frontiers in Pharmacology
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