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https://www.readbyqxmd.com/read/28522410/a-global-human-health-risk-assessment-for-octamethylcyclotetrasiloxane-d4
#1
Robinan Gentry, Allison Franzen, Cynthia Van Landingham, Tracy Greene, Kathy Plotzke
Octamethylcyclotetrasiloxane (D4) is a low-molecular-weight volatile cyclic siloxane, primarily used as an intermediate in the production of some widely-used industrial and consumer silicone based polymers and may be present as a component in a variety of consumer products. A global "harmonized" risk assessment was conducted to meet requirements for substance-specific risk assessments conducted by regulatory agencies such as USEPA's Integrated Risk Information System (IRIS), Health Canada's Chemical Management Program (CMP) and various independent scientific committees of the European Commission (e...
May 15, 2017: Toxicology Letters
https://www.readbyqxmd.com/read/28490267/darolutamide-odm-201-for-the-treatment-of-prostate-cancer
#2
Neal D Shore
Androgen deprivation therapy (ADT) is a mainstay initial treatment for advanced hormone-sensitive prostate cancer (HSPC), but disease progression to castration-resistant prostate cancer (CRPC) invariably occurs when patients do not succumb to another disease or comorbidity. Recognition that the androgen receptor (AR) axis continues to drive disease progression has led to the development of several AR-directed approved agents, including abiraterone acetate and enzalutamide. An investigational agent, darolutamide (ODM-201, BAY-1841788), has completed early-phase clinical trials, and two global Phase III trials are currently accruing patients...
May 11, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28488960/towards-pathogen-inactivation-of-red-blood-cells-and-whole-blood-targeting-viral-dna-rna-design-technologies-and-future-prospects-for-developing-countries
#3
REVIEW
Victor J Drew, Lassina Barro, Jerard Seghatchian, Thierry Burnouf
Over 110 million units of blood are collected yearly. The need for blood products is greater in developing countries, but so is the risk of contracting a transfusion-transmitted infection. Without efficient donor screening/viral testing and validated pathogen inactivation technology, the risk of transfusion-transmitted infections correlates with the infection rate of the donor population. The World Health Organization has published guidelines on good manufacturing practices in an effort to ensure a strong global standard of transfusion and blood product safety...
April 13, 2017: Blood Transfusion, Trasfusione del Sangue
https://www.readbyqxmd.com/read/28437352/effect-and-strategy-of-1-stage-interrupted-2-level-transpedicular-wedge-osteotomy-for-correcting-severe-kyphotic-deformities-in-ankylosing-spondylitis
#4
Yongfei Zhao, Yan Wang, Zheng Wang, Xuesong Zhang, Keya Mao, Yonggang Zhang
STUDY DESIGN: Prospective study. OBJECTIVE: To investigate the safety, outcome, and strategy of the 1-stage interrupted 2-level transpedicular wedge osteotomy for correcting the severe kyphotic deformity in ankylosing spondylitis (AS). SUMMARY OF BACKGROUND DATA: There has been a large series in the literature reporting on results of osteotomy for the correction of kyphotic deformity secondary to AS. However, few articles have reported, in detail, the plan, design, strategy, and effect of 1-stage interrupted 2-level transpedicular wedge osteotomy for the correction of severe kyphotic deformity in AS...
May 2017: Clinical Spine Surgery
https://www.readbyqxmd.com/read/28436960/amyloid-fibril-systems-reduce-stabilize-and-deliver-bioavailable-nanosized-iron
#5
Yi Shen, Lidija Posavec, Sreenath Bolisetty, Florentine M Hilty, Gustav Nyström, Joachim Kohlbrecher, Monika Hilbe, Antonella Rossi, Jeannine Baumgartner, Michael B Zimmermann, Raffaele Mezzenga
Iron-deficiency anaemia (IDA) is a major global public health problem. A sustainable and cost-effective strategy to reduce IDA is iron fortification of foods, but the most bioavailable fortificants cause adverse organoleptic changes in foods. Iron nanoparticles are a promising solution in food matrices, although their tendency to oxidize and rapidly aggregate in solution severely limits their use in fortification. Amyloid fibrils are protein aggregates initially known for their association with neurodegenerative disorders, but recently described in the context of biological functions in living organisms and emerging as unique biomaterial building blocks...
April 24, 2017: Nature Nanotechnology
https://www.readbyqxmd.com/read/28395659/abelmoschus-manihot-a-traditional-chinese-medicine-versus-losartan-potassium-for-treating-iga-nephropathy-study-protocol-for-a-randomized-controlled-trial
#6
Ping Li, Yi-Zhi Chen, Hong-Li Lin, Zhao-Hui Ni, Yong-Li Zhan, Rong Wang, Hong-Tao Yang, Jing-Ai Fang, Nian-Song Wang, Wen-Ge Li, Xue-Feng Sun, Xiang-Mei Chen
BACKGROUND: IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research...
April 11, 2017: Trials
https://www.readbyqxmd.com/read/28371242/oxytocin-treatment-in-children-with-prader-willi-syndrome-a-double-blind-placebo-controlled-crossover-study
#7
RANDOMIZED CONTROLLED TRIAL
Jennifer L Miller, Roy Tamura, Merlin G Butler, Virginia Kimonis, Carlos Sulsona, June-Anne Gold, Daniel J Driscoll
Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder which includes hypothalamic dysfunction, hyperphagia, cognitive and behavioral problems, increased anxiety, and compulsive behaviors. Individuals with PWS have a deficit of oxytocin producing neurons in the paraventricular nucleus of the hypothalamus. Oxytocin plays a role in regulation of feeding behaviors, social interactions, and emotional reactivity, which are all issues that significantly affect the quality of life for individuals with this syndrome...
May 2017: American Journal of Medical Genetics. Part A
https://www.readbyqxmd.com/read/28366342/pharmacokinetics-of-rotigotine-transdermal-system-in-adolescents-with-idiopathic-restless-legs-syndrome-willis-ekbom-disease
#8
Jan-Peer Elshoff, John Hudson, Daniel L Picchietti, Keith Ridel, Arthur S Walters, Kimberly Doggett, Kimberly Moran, Marga Oortgiesen, Francisco Ramirez, Erwin Schollmayer
OBJECTIVE: To investigate the pharmacokinetics (PK) of rotigotine transdermal system in adolescents with moderate-to-severe idiopathic restless legs syndrome (RLS). METHODS: This multicenter, open-label, dose-escalation study enrolled patients ≥13 to <18 years of age. Rotigotine transdermal patches were applied daily and up-titrated weekly: 0.5, 1, 2, 3 mg/24 h. Blood samples were collected on the final day of each dose step. Primary PK variables were the apparent total body clearance (CL/f; L/h) and volume of distribution at steady state (VSS/f; L) of unconjugated rotigotine for each dose step, calculated for the PK per-protocol set (PKPPS)...
April 2017: Sleep Medicine
https://www.readbyqxmd.com/read/28364864/evaluation-of-the-efficacy-and-safety-of-tribulus-terrestris-in-male-sexual-dysfunction-a-prospective-randomized-double-blind-placebo-controlled-clinical-trial
#9
Zdravko Kamenov, Svetlana Fileva, Krassimir Kalinov, Emmanuele A Jannini
OBJECTIVE: The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. PARTICIPANTS AND DESIGN: Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups...
May 2017: Maturitas
https://www.readbyqxmd.com/read/28363637/dsm265-for-plasmodium-falciparum-chemoprophylaxis-a-randomised-double-blinded-phase-1-trial-with-controlled-human-malaria-infection
#10
Mihály Sulyok, Thomas Rückle, Alexandra Roth, Raymund E Mürbeth, Stephan Chalon, Nicola Kerr, Sonia Schnieper Samec, Nathalie Gobeau, Carlos Lamsfus Calle, Javier Ibáñez, Zita Sulyok, Jana Held, Tamirat Gebru, Patricia Granados, Sina Brückner, Christian Nguetse, Juliana Mengue, Albert Lalremruata, Kim Lee Sim, Stephen L Hoffman, Jörg J Möhrle, Peter G Kremsner, Benjamin Mordmüller
BACKGROUND: A drug for causal (ie, pre-erythrocytic) prophylaxis of Plasmodium falciparum malaria with prolonged activity would substantially advance malaria control. DSM265 is an experimental antimalarial that selectively inhibits the parasite dihydroorotate dehydrogenase. DSM265 shows in vitro activity against liver and blood stages of P falciparum. We assessed the prophylactic activity of DSM265 against controlled human malaria infection (CHMI). METHODS: At the Institute of Tropical Medicine, Eberhard Karls University (Tübingen, Germany), healthy, malaria-naive adults were allocated to receive 400 mg DSM265 or placebo either 1 day (cohort 1A) or 7 days (cohort 2) before CHMI by direct venous inoculation (DVI) of 3200 aseptic, purified, cryopreserved P falciparum sporozoites (PfSPZ Challenge; Sanaria Inc, Rockville, MD, USA)...
March 28, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28363636/safety-tolerability-pharmacokinetics-and-activity-of-the-novel-long-acting-antimalarial-dsm265-a-two-part-first-in-human-phase-1a-1b-randomised-study
#11
James S McCarthy, Julie Lotharius, Thomas Rückle, Stephan Chalon, Margaret A Phillips, Suzanne Elliott, Silvana Sekuloski, Paul Griffin, Caroline L Ng, David A Fidock, Louise Marquart, Noelle S Williams, Nathalie Gobeau, Lidiya Bebrevska, Maria Rosario, Kennan Marsh, Jörg J Möhrle
BACKGROUND: DSM265 is a novel antimalarial that inhibits plasmodial dihydroorotate dehydrogenase, an enzyme essential for pyrimidine biosynthesis. We investigated the safety, tolerability, and pharmacokinetics of DSM265, and tested its antimalarial activity. METHODS: Healthy participants aged 18-55 years were enrolled in a two-part study: part 1, a single ascending dose (25-1200 mg), double-blind, randomised, placebo-controlled study, and part 2, an open-label, randomised, active-comparator controlled study, in which participants were inoculated with Plasmodium falciparum induced blood-stage malaria (IBSM) and treated with DSM265 (150 mg) or mefloquine (10 mg/kg)...
March 28, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28362135/immunogenicity-and-safety-evaluation-of-bivalent-types-1-and-3-oral-poliovirus-vaccine-by-comparing-different-poliomyelitis-vaccination-schedules-in-china-a-randomized-controlled-non-inferiority-clinical-trial
#12
Jingjun Qiu, Yunkai Yang, Lirong Huang, Ling Wang, Zhiwei Jiang, Jian Gong, Wei Wang, Hongyan Wang, Shaohong Guo, Chanjuan Li, Shuyuan Wei, Zhaojun Mo, Jielai Xia
BACKGROUND: The type 2 component of the oral poliovirus vaccine is targeted for global withdrawal through a switch from the trivalent oral poliovirus vaccine (tOPV) to a bivalent oral poliovirus vaccine (bOPV). The switch is intended to prevent paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess the immunogenicity and safety profile of 6 vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV...
March 1, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28343225/clinical-trial-of-vadadustat-in-patients-with-anemia-secondary-to-stage-3-or-4-chronic-kidney-disease
#13
Edouard R Martin, Mark T Smith, Bradley J Maroni, Qing C Zuraw, Emil M deGoma
BACKGROUND: Therapeutic options for the treatment of anemia secondary to chronic kidney disease (CKD) remain limited. Vadadustat (AKB-6548) is an oral hypoxia-inducible factor prolyl-hydroxylase domain (HIF-PHD) inhibitor that is being investigated for the treatment of anemia secondary to CKD. METHODS: A phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial (NCT01381094) was undertaken in adults with anemia secondary to CKD stage 3 or 4...
2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28325203/developing-and-evaluating-an-automated-all-cause-harm-trigger-system
#14
Christine Sammer, Susanne Miller, Cason Jones, Antoinette Nelson, Paul Garrett, David Classen, David Stockwell
BACKGROUND: From 2009 through 2012, the Adventist Health System Patient Safety Organization (AHS PSO) used the Global Trigger Tool method for harm identification and demonstrated harm reduction. Although the awareness of harm demonstrated opportunities for improvement across the system, leaders determined that the human and fiscal resources required to continue with a retrospective manual harm identification process were unsustainable. In addition, there was growing concern that the identification of harm after the patient's discharge did not allow for intervention during the hospital stay...
April 2017: Joint Commission Journal on Quality and Patient Safety
https://www.readbyqxmd.com/read/28286989/a-precision-medicine-initiative-for-alzheimer-s-disease-the-road-ahead-to-biomarker-guided-integrative-disease-modeling
#15
REVIEW
H Hampel, S E O'Bryant, S Durrleman, E Younesi, K Rojkova, V Escott-Price, J-C Corvol, K Broich, B Dubois, S Lista
After intense scientific exploration and more than a decade of failed trials, Alzheimer's disease (AD) remains a fatal global epidemic. A traditional research and drug development paradigm continues to target heterogeneous late-stage clinically phenotyped patients with single 'magic bullet' drugs. Here, we propose that it is time for a paradigm shift towards the implementation of precision medicine (PM) for enhanced risk screening, detection, treatment, and prevention of AD. The overarching structure of how PM for AD can be achieved will be provided through the convergence of breakthrough technological advances, including big data science, systems biology, genomic sequencing, blood-based biomarkers, integrated disease modeling and P4 medicine...
April 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28273997/teneligliptin-in-management-of-diabetic-kidney-disease-a-review-of-place-in-therapy
#16
REVIEW
Mohammed Abubaker, Preetesh Mishra, Onkar C Swami
Diabetes is a global health emergency of this century. Diabetic nephropathy is the most common microvascular complication associated with Type 2 Diabetes Mellitus (T2DM). T2DM has been reported as a major etiological factor in almost 45% of patients undergoing dialysis due to kidney failure. Lifestyle modifications; cessation of smoking, optimum control of blood glucose, blood pressure and lipids are required to reduce the progression of Diabetic Kidney Disease (DKD). Presently, Dipeptidyl peptidase-4 (DPP-4) inhibitors are preferred in the management of T2DM due to their established efficacy; favorable tolerability including, low risk of hypoglycaemia; weight neutrality and convenient once-a-day dosage...
January 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28263168/red-blood-cell-components-time-to-revisit-the-sources-of-variability
#17
REVIEW
Rosemary L Sparrow
Quality and safety of red blood cell (RBC) components is managed by screening of donors and strict regulatory controls of blood collection, processing and storage procedures. Despite these efforts, variations in RBC component quality exist as exemplified by the wide range in storage-induced haemolysis. This article provides a brief overview of the variables that contribute or potentially contribute to the quality of stored RBC components, including blood collection, processing, and donor-related variables. Particular focus is made on donor health and lifestyle factors that are not specifically screened and may impact on the physicobiochemical properties of RBCs and their storability...
March 2017: Blood Transfusion, Trasfusione del Sangue
https://www.readbyqxmd.com/read/28260862/sofosbuvir-velpatasvir-regimen-promises-an-effective-pan-genotypic-hepatitis-c-virus-cure
#18
REVIEW
Fazia Mir, Alp S Kahveci, Jamal A Ibdah, Veysel Tahan
Hepatitis C virus (HCV) is a global pandemic, with nearly 200 million infected patients worldwide. HCV is the most common blood-borne infection in the US with numerous health implications including liver fibrosis, cirrhosis, and hepatocellular cancer. Traditional genotype-based HCV therapies with interferon resulted in moderate success in the sustained elimination of viral genome. Recent clinical trials of the once-daily combination tablet of sofosbuvir, a nonstructural (NS) 5B polymerase inhibitor, and velpatasvir, an NS5A inhibitor, demonstrate sustained virologic response rates of about 95%, regardless of prior treatment experience or presence of cirrhosis across all HCV genotypes...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28215471/dopamine-serotonin-stabilizer-rp5063-a-randomized-double-blind-placebo-controlled-multicenter-trial-of-safety-and-efficacy-in-exacerbation-of-schizophrenia-or-schizoaffective-disorder
#19
Marc Cantillon, Arul Prakash, Ajay Alexander, Robert Ings, Dennis Sweitzer, Laxminarayan Bhat
The study objectives were to evaluate the efficacy, safety, tolerability, and pharmacokinetics of RP5063 versus placebo. The study was conducted in adults with acute exacerbation of schizophrenia or schizoaffective disorder. This 28-day, multicenter, placebo-controlled, double-blind study randomized 234 subjects to RP5063 15, 30, or 50mg; aripiprazole; or placebo (3:3:3:1:2) once daily. The aripiprazole arm was included solely to show assay sensitivity and was not powered to show efficacy. The primary endpoint was change from baseline to Day 28/EOT (End-of-Treatment) in Positive and Negative Syndrome Scale (PANSS) total score; secondary endpoints included PANSS subscales, improvement ≥1 point on the Clinical Global Impressions-Severity (CGI-S), depression and cognition scales...
February 16, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28209171/integrated-strategy-for-in-vitro-characterization-of-a-bileaflet-mechanical-aortic-valve
#20
Francesca Maria Susin, Stefania Espa, Riccardo Toninato, Stefania Fortini, Giorgio Querzoli
BACKGROUND: Haemodynamic performance of heart valve prosthesis can be defined as its ability to fully open and completely close during the cardiac cycle, neither overloading heart work nor damaging blood particles when passing through the valve. In this perspective, global and local flow parameters, valve dynamics and blood damage safety of the prosthesis, as well as their mutual interactions, have all to be accounted for when assessing the device functionality. Even though all these issues have been and continue to be widely investigated, they are not usually studied through an integrated approach yet, i...
February 16, 2017: Biomedical Engineering Online
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