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https://www.readbyqxmd.com/read/27936016/a-tool-for-investigating-asthma-and-copd-exacerbations-a-newly-manufactured-and-well-characterised-gmp-wild-type-human-rhinovirus-for-use-in-the-human-viral-challenge-model
#1
Daniel J Fullen, Bryan Murray, Julie Mori, Andrew Catchpole, Daryl W Borley, Edward J Murray, Ganesh Balaratnam, Anthony Gilbert, Alex Mann, Fiona Hughes, Rob Lambkin-Williams
BACKGROUND: Human Rhinovirus infection is an important precursor to asthma and chronic obstructive pulmonary disease exacerbations and the Human Viral Challenge model may provide a powerful tool in studying these and other chronic respiratory diseases. In this study we have reported the production and human characterisation of a new Wild-Type HRV-16 challenge virus produced specifically for this purpose. METHODS AND STOCK DEVELOPMENT: A HRV-16 isolate from an 18 year old experimentally infected healthy female volunteer (University of Virginia Children's Hospital, USA) was obtained with appropriate medical history and consent...
2016: PloS One
https://www.readbyqxmd.com/read/27935987/patient-reported-treatment-satisfaction-with-rivaroxaban-for-stroke-prevention-in-atrial-fibrillation-a-french-observational-study-the-safari-study
#2
Olivier Hanon, Edouard Chaussade, Pierre Gueranger, Elise Gruson, Sabrina Bonan, Alain Gay
BACKGROUND: For antithrombotic treatments, Patient Reported Outcomes (PRO) and patient satisfaction with treatment are essential data for physicians because of the strong relationship between patient satisfaction and adherence to treatment. The impact of rivaroxaban on patient satisfaction and quality of life was not sufficiently documented in phase III studies. There is a need for further data in this field especially in real life conditions. METHODS: The SAFARI study is composed of patients with non-valvular atrial fibrillation (AF), previously treated with vitamin K antagonist (VKA) and switched to rivaroxaban...
2016: PloS One
https://www.readbyqxmd.com/read/27934657/the-importance-of-quality-specifications-in-safety-assessments-of-amino-acids-the-cases-of-l-tryptophan-and-l-citrulline
#3
REVIEW
Hellen A Oketch-Rabah, Amy L Roe, Bill J Gurley, James C Griffiths, Gabriel I Giancaspro
The increasing consumption of amino acids from a wide variety of sources, including dietary supplements, natural health products, medical foods, infant formulas, athletic and work-out products, herbal medicines, and other national and international categories of nutritional and functional food products, increases the exposure to amino acids to amounts far beyond those normally obtained from the diet, thereby necessitating appropriate and robust safety assessments of these ingredients. Safety assessments of amino acids, similar to all food constituents, largely rely on the establishment of an upper limit [Tolerable Upper Intake Level (UL)] considered to be a guide for avoiding high intake, above which adverse or toxic effects might occur...
December 2016: Journal of Nutrition
https://www.readbyqxmd.com/read/27934656/the-safety-and-regulatory-process-for-amino-acids-in-europe-and-the-united-states
#4
REVIEW
Ashley Roberts
The safety of long-term, high-dose amino acid consumption marketed as dietary supplements or functional or medical foods requires regulatory clearance in the European Union through the novel food process or through the Dietary Supplement Health and Education Act or the GRAS (Generally Recognized As Safe) route in the United States. The safety assessment of high daily doses of amino acids for bodybuilding or other health benefits is expected to require human studies to support tolerability and safety. The need for human studies is based on the fact that there is little or no evidence of toxicity from the conduct of animal toxicity studies and because standard animal testing would be inappropriate because of the large dosages required to provide a suitable margin of safety when extrapolating from animals to humans...
December 2016: Journal of Nutrition
https://www.readbyqxmd.com/read/27934611/a-multicentre-european-registry-to-evaluate-the-direct-flow-medical-transcatheter-aortic-valve-system-for-the-treatment-of-patients-with-severe-aortic-stenosis
#5
Christoph K Naber, Stylianos A Pyxaras, Hüseyin Ince, Peter Frambach, Antonio Colombo, Christian Butter, Fernando Gatto, Ulrich Hink, Georg Nickenig, Giuseppe Bruschi, Guus Brueren, Didier Tchétché, Peter Den Heijer, Wolfgang Schillinger, Smita Scholtz, Jan Van der Heyden, Thierry Lefèvre, Martine Gilard, Karl-Heinz Kuck, Joachim Schofer, Dimitar Divchev, Helmut Baumgartner, Federico Asch, Daniel Wagner, Azeem Latib, Federico De Marco, Stephan Kische
AIMS: Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. METHODS AND RESULTS: This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee...
December 10, 2016: EuroIntervention
https://www.readbyqxmd.com/read/27933580/headache-service-quality-evaluation-of-quality-indicators-in-14-specialist-care-centres
#6
Sara Schramm, Derya Uluduz, Raquel Gil Gouveia, Rigmor Jensen, Aksel Siva, Ugur Uygunoglu, Giorgadze Gvantsa, Maka Mania, Mark Braschinsky, Elena Filatova, Nina Latysheva, Vera Osipova, Kirill Skorobogatykh, Julia Azimova, Andreas Straube, Ozan Emre Eren, Paolo Martelletti, Valerio De Angelis, Andrea Negro, Mattias Linde, Knut Hagen, Aleksandra Radojicic, Jasna Zidverc-Trajkovic, Ana Podgorac, Koen Paemeleire, Annelien De Pue, Christian Lampl, Timothy J Steiner, Zaza Katsarava
BACKGROUND: The study was a collaboration between Lifting The Burden (LTB) and the European Headache Federation (EHF). Its aim was to evaluate the implementation of quality indicators for headache care Europe-wide in specialist headache centres (level-3 according to the EHF/LTB standard). METHODS: Employing previously-developed instruments in 14 such centres, we made enquiries, in each, of health-care providers (doctors, nurses, psychologists, physiotherapists) and 50 patients, and analysed the medical records of 50 other patients...
December 2016: Journal of Headache and Pain
https://www.readbyqxmd.com/read/27933339/efficacy-and-safety-of-osteoporosis-medications-in-a-rat-model-of-late-stage-chronic-kidney-disease-accompanied-by-secondary-hyperparathyroidism-and-hyperphosphatemia
#7
M Ota, M Takahata, T Shimizu, Y Kanehira, H Kimura-Suda, Y Kameda, H Hamano, S Hiratsuka, D Sato, N Iwasaki
: This study showed that bisphosphonate was safe and effective for the treatment of bone disorders in stage 4 chronic kidney disease (CKD) rats. Intermittent teriparatide therapy showed an anabolic action on bone even under secondary hyperparathyroidism conditions without having an adverse effect on mineral metabolism in late-stage CKD. INTRODUCTION: Patients with late-stage CKD are at high risk for fragility fractures. However, there are no consensus on the efficacy and safety of osteoporosis medications for patients with late-stage CKD...
December 8, 2016: Osteoporosis International
https://www.readbyqxmd.com/read/27933145/ensuring-timely-thromboprophylaxis-on-a-medical-assessment-unit
#8
Oluwatosin Akinbobuyi, Louise Shalders, Tim Nokes
The Department of Health has defined hospital acquired venous thromboembolism (VTE) as any VTE event occurring within 90 days of hospital admission or surgery. (1) Hospital acquired thrombosis (HAT) is common during and after hospital admission and is considered a major patient safety issue. Current NICE guideline (CG 92) 2010, recommends that medical patients assessed at risk of VTE should have pharmacological prophylaxis commenced as soon as possible after risk assessment has been completed and continued until the patient is no longer at increased risk of VTE...
2016: BMJ Quality Improvement Reports
https://www.readbyqxmd.com/read/27932884/a-randomized-trial-of-aripiprazole-vs-blonanserin-for-the-treatment-of-acute-schizophrenia-and-related-disorders
#9
Taro Kishi, Yuki Matsuda, Shinji Matsunaga, Tomohiko Mukai, Masatsugu Moriwaki, Hideaki Tabuse, Kiyoshi Fujita, Nakao Iwata
OBJECTIVE: There has been no direct comparison of aripiprazole and blonanserin for schizophrenia treatment. We conducted a 24-week, rater-masked, randomized trial of aripiprazole (6-30 mg/d) vs blonanserin (4-24 mg/d) in schizophrenia patients who were not taking any antipsychotic medication for more than 2 weeks before enrollment (UMIN000011194). METHODS: The primary outcome measure for efficacy was improvement of Positive and Negative Syndrome Scale (PANSS) total score at week 24...
2016: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/27932871/efficacy-and-safety-outcomes-of-fractional-flow-reserve-in-guiding-clinical-therapy-of-non-st-segment-elevation-myocardial-infarction-compared-with-angiography-alone-in-elderly-chinese-patients
#10
Zhao Zhang, Ke Li, Jinwen Tian
OBJECTIVE: Fractional flow reserve (FFR) is an innovative method for evaluating the physiological significance of a coronary stenosis, but its validity is less certain in patients with non-ST-segment elevation myocardial infarction (NSTEMI). It is important to assess whether FFR is effective and safe in patients, especially elderly Chinese patients, with NSTEMI. As the first one in China, the purpose of this study was to establish the efficacy and safety outcomes of FFR in guiding clinical therapy of NSTEMI compared with angiography alone in elderly Chinese patients...
2016: Clinical Interventions in Aging
https://www.readbyqxmd.com/read/27932529/effectiveness-of-first-line-pegvisomant-monotherapy-in-acromegaly-an-acrostudy-analysis
#11
Nicholas A Tritos, Philippe Chanson, Camilo Jimenez, Donna King, Peter J Jönsson, Anne Klibanski, Beverly M K Biller
OBJECTIVE: To examine the effectiveness and safety of primary pegvisomant monotherapy. DESIGN: Retrospective analysis of data extracted from ACROSTUDY (global observational outcomes study of patients with acromegaly treated with pegvisomant). METHODS: The earliest time to insulin-like growth factor 1 (IGF-1) normalization on pegvisomant monotherapy was determined. Both the proportion of patients who achieved IGF-1 normalization and the time to IGF-1 normalization on pegvisomant monotherapy were assessed...
February 2017: European Journal of Endocrinology
https://www.readbyqxmd.com/read/27932369/patient-safety-in-community-dementia-services-what-can-we-learn-from-the-experiences-of-caregivers-and-healthcare-professionals
#12
Sophie Behrman, Philip Wilkinson, Helen Lloyd, Charles Vincent
OBJECTIVES: this study aims to explore how patient safety in community dementia services is understood by caregivers, and healthcare professionals. METHODS: cross-sectional analysis of guided one-to-one interviews with 10 caregivers, and 10 healthcare professionals. RESULTS: caregivers and healthcare professionals identified a range of issues including medication errors, mis-communication between professionals, unclear service pathways and the effects of stress on caregivers' behaviour...
December 7, 2016: Age and Ageing
https://www.readbyqxmd.com/read/27932268/ten-principles-for-a-safe-surgical-treatment-of-ovarian-endometriosis
#13
M A López-de la Torre, H M Abrao, L F Fernandes, R M Kho, M S Abrao
OBJECTIVE: To demonstrate a step-by-step laparoscopic approach for excision of ovarian endometrioma following surgical principles for safety and maximal preservation of ovarian function. DESIGN: Video SETTING: Medical management of ovarian endometriomas is not recommended. Operative laparoscopic is the treatment of choice. Although considered a simple procedure, ovarian cystectomy requires precise and correct technique in order to preserve ovarian function. PATIENT: Asymptomatic, 27yo woman with ultrasound imaging suggesting a 6,2 x 5,4 cm left endometrioma...
December 5, 2016: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/27931586/observational-study-of-methotrexate-in-the-treatment-of-bronchiolitis-obliterans-syndrome
#14
S Sithamparanathan, L Thirugnanasothy, K E Morley, A J Fisher, J L Lordan, G Meachery, G Parry, P A Corris
BACKGROUND: Methotrexate (MTX) is potential change in immunosuppression after lung transplantation that may help to slow down the decline in lung function in bronchiolitis obliterans syndrome (BOS). METHODS: We sought to analyze the safety and efficacy of MTX in patients with BOS, by retrospective case review. RESULTS: Thirty lung allograft patients were treated with MTX for BOS after one bilateral lower lobe, nine single, 16 bilateral, and four heart-lung transplants...
December 2016: Transplantation Proceedings
https://www.readbyqxmd.com/read/27931515/autologous-adipose-derived-mesenchymal-stromal-cells-for-the-treatment-of-psoriasis-vulgaris-and-psoriatic-arthritis-a-case-report
#15
Miguel M De Jesus, Jayson S Santiago, Camille V Trinidad, Melvin E See, Kimberly R Semon, Manuel O Fernandez, Francisco S Chung
Psoriasis is a dermatologic disease of immune origins with no definitive cure. We report the Makati Medical Center experience of utilizing autologous mesenchymal stromal cells (MSCs) for one patient with psoriasis vulgaris (PV) and another with psoriatic arthritis (PA). Patients were educated and gave informed consent, according to the principles of the Declaration of Helsinki. The protocol was approved by the Cellular Transplantation Ethics Committee of the Makati Medical Center. Autologous MSCs were cultured from lipoaspirate and expanded in a clean room class 100 facility (Cellular Therapeutics Center, Makati Medical Center)...
November 2016: Cell Transplantation
https://www.readbyqxmd.com/read/27931463/guideline-for-monitoring-and-management-of-pediatric-patients-before-during-and-after-sedation-for-diagnostic-and-therapeutic-procedures-update-2016
#16
(no author information available yet)
The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase thepotential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions...
October 2016: Pediatric Dentistry
https://www.readbyqxmd.com/read/27931277/american-academy-of-allergy-asthma-immunology-membership-experience-with-allergen-immunotherapy-safety-in-patients-with-specific-medical-conditions
#17
Dsire E S Larenas-Linnemann, David W Hauswirth, Christopher W Calabria, Lawrence D Sher, Matthew A Rank
BACKGROUND: Little data in the literature exist concerning patients with certain underlying medical conditions who receive allergen subcutaneous immunotherapy (SCIT). OBJECTIVE: To survey allergists' experience with SCIT in patients with medical conditions considered to impose an elevated risk for untoward outcomes. METHODS: A Web-based survey was conducted among members of the American Academy of Allergy, Asthma Immunology to query about their experience with SCIT in patients with certain medical conditions...
September 2016: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/27930499/prevalence-and-risk-factors-of-prolonged-corrected-qt-interval-among-children-and-adolescents-treated-with-antipsychotic-medications-a-long-term-follow-up-in-a-real-world-population
#18
Inmaculada Palanca-Maresca, Belén Ruiz-Antorán, Gustavo Adolfo Centeno-Soto, Maria Azul Forti-Buratti, Ana Siles, Ana Usano, Cristina Avendaño-Solá
PURPOSE: This study aimed to describe the prevalence of corrected QT (QTc) interval disorders and the possible predisposing factors in children and adolescents treated with antipsychotic (AP) medications in a real-world population with a long-term follow-up. METHODS: Data were obtained from the SafEty of NeurolepTics in Infancy and Adolescence (SENTIA) registry (https://sentia.es). The SENTIA includes patients younger than 18 years who are currently taking or initiating treatment with AP medications and have agreed to participate in the registry...
December 7, 2016: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/27930486/being-called-to-safety-occupational-callings-and-safety-climate-in-the-emergency-medical-services
#19
Stephanie A Andel, Shani Pindek, Paul E Spector
OBJECTIVE: The aim of this study was to investigate the importance of safety climate in the Emergency Medical Services (EMS) and to assess occupational callings as a boundary condition for the effect of safety climate on safety behaviors. METHODS: EMS professionals (n = 132) participated in a three-wave survey study. Hierarchical linear regressions were conducted to test the moderating effects of occupational callings. RESULTS: Safety climate was significantly related to safety behavior, and occupational callings moderated this direct relationship (ΔR = 0...
December 2016: Journal of Occupational and Environmental Medicine
https://www.readbyqxmd.com/read/27929477/production-review-and-impact-of-technical-quality-control-guidelines-in-a-national-context
#20
Michelle K Nielsen, Kyle E Malkoske, Erika Brown, Kevin Diamond, Normand Frenière, John Grant, Natalie Pomerleau-Dalcourt, Jason Schella, L John Schreiner, Laurent Tantôt, J Eduardo Villareal-Barajas, Jean-Pierre Bissonnette
A close partnership between the Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist's (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) has resulted in the development of a suite of Technical Quality Control (TQC) guidelines for radiation treatment equipment; they outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. The adopted framework for the development and maintenance of the TQCs ensures the guidelines incorporate input from the medical physics com-munity during development, measures the workload required to perform the QC tests outlined in each TQC, and remain relevant (i...
November 8, 2016: Journal of Applied Clinical Medical Physics
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