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Medical regulation

F Baumann, D Mahr, C Neumann, M Nerlich
BACKGROUND: New regulations of the German statutory accident insurance for inpatient treatment have been introduced. The aims of the new regulations are to improve cost-effectiveness and the quality of medical care. The introduction of the injury type catalogue and the severe injuries type procedure (SAV) has led to a concentration of resources. The purpose of these innovations is an increase in the quality of treatment of patients with complex injuries. CONCLUSION: The introduction of the new regulations resulted in a centralization of medical care in order to optimize the quality of treatment of complex injuries from occupational accidents...
October 21, 2016: Der Unfallchirurg
Jack E Henningfield, Tracy T Smith, Bethea A Kleykamp, Reginald V Fant, Eric C Donny
BACKGROUND AND RATIONALE: Steven R. Goldberg was a pioneering behavioral pharmacologist whose intravenous drug self-administration studies advanced the understanding of conditioned stimuli and schedules of reinforcement as determinants of pattern and persistence of drug-seeking behavior, and in particular, the importance of nicotine in tobacco use. His passing in 2014 led to invitations to contribute articles to psychopharmacology dedicated to his work. OBJECTIVES: The objectives of this review are to summarize and put into historical perspective Goldberg's contributions to elucidate the reinforcing effects of nicotine and to summarize the implications of his research for medication development, tobacco regulation, and potential tobacco control policy options...
October 21, 2016: Psychopharmacology
Zohar Barnett-Itzhaki, Tamar Berman, Itamar Grotto, Eyal Schwartzberg
BACKGROUND: Large amounts of expired and unused medications accumulate in households. This potentially exposes the public to hazards due to uncontrolled use of medications. Most of the expired or unused medications that accumulate in households (household medical waste) is thrown to the garbage or flushed down to the sewage, potentially contaminating waste-water, water resources and even drinking water. There is evidence that pharmaceutical active ingredients reach the environment, including food, however the risk to public health from low level exposure to pharmaceuticals in the environment is currently unknown...
2016: Israel Journal of Health Policy Research
James West, W Warren Gill
Genome editing in large animals has tremendous practical applications, from more accurate models for medical research through improved animal welfare and production efficiency. Although genetic modification in large animals has a 30 year history, until recently technical issues limited its utility. The original methods - pronuclear injection and integrating viruses - were plagued with problems associated with low efficiency, silencing, poor regulation of gene expression, and variability associated with random integration...
June 2016: Journal of Equine Veterinary Science
Raffick A R Bowen, Dorothy Adcock
Blood collection tubes (BCTs) are an often under-recognized variable in the preanalytical phase of clinical laboratory testing. Unfortunately, even the best-designed and manufactured BCTs may not work well in all clinical settings. Clinical laboratories, in collaboration with healthcare providers, should carefully evaluate BCTs prior to putting them into clinical use to determine their limitations and ensure that patients are not placed at risk because of inaccuracies due to poor tube performance. Selection of the best BCTs can be achieved through comparing advertising materials, reviewing the literature, observing the device at a scientific meeting, receiving a demonstration, evaluating the device under simulated conditions, or testing the device with patient samples...
October 17, 2016: Clinical Biochemistry
David R Holmes, Robert Califf, Andrew Farb, Dorothy Abel, Michael Mack, Tamara Syrek Jensen, Bram Zuckerman, Martin Leon, Jeff Shuren
Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients...
October 25, 2016: Journal of the American College of Cardiology
Masayuki Sano, Minoru Iijima, Manami Ohtaka, Mahito Nakanishi
Tissue-specific control of gene expression is an invaluable tool for studying various biological processes and medical applications. Efficient regulatory systems have been utilized to control transgene expression in various types of DNA viral or integrating viral vectors. However, existing regulatory systems are difficult to transfer into negative-strand RNA virus vector platforms because of significant differences in their transcriptional machineries. In this study, we developed a novel strategy for regulating transgene expression mediated by a cytoplasmic RNA vector based on a replication-defective and persistent Sendai virus (SeVdp)...
2016: PloS One
Mingyue Zhao, Jing Wu
OBJECTIVE: Examine the effects of regulated competition on the drug pricing in China. METHODS: Based on product-level data, a regression method was employed for pricing by using data from Tianjin Urban Employee Basic Medical Insurance (UEBMI) database. The market competition measures distinguished generic competition within the same molecule from therapeutic competition within the same therapeutic class. RESULTS: The increases in pricing are inversely related to the number of generic competitions...
October 20, 2016: Expert Review of Pharmacoeconomics & Outcomes Research
Jie Wu, Wei-Guang Ding, Minoru Horie
Long QT syndrome type 1 (LQT1) is a subtype of a congenital cardiac syndrome caused by mutation in the KCNQ1 gene, which encodes the α-subunit of the slow component of delayed rectifier K(+) current (IKs) channel. Arrhythmias in LQT1 are characterized by prolongation of the QT interval on ECG, as well as the occurrence of life-threatening cardiac events, frequently triggered by adrenergic stimuli (e.g., physical or emotional stress). During the past two decades, much advancement has been made in understanding the molecular pathogenesis underlying LQT1...
October 2016: Journal of Arrhythmia
Gino A Vena, Maria Concetta Fargnoli, Nicoletta Cassano, Giuseppe Argenziano
The sudden eruption of melanocytic nevi has been associated with a number of conditions, such as bullous skin diseases, immunodeficiency and immunosuppression. The exact mechanisms leading to the development of eruptive melanocytic nevi are unknown. Areas covered: The aim of this article is to review the literature concerning eruptive melanocytic nevi following the administration of immunosuppressive drugs and other medications. Expert opinion: The literature regarding the development of eruptive nevi in association with pharmacological therapies includes a relatively low number of reports...
October 19, 2016: Expert Opinion on Drug Metabolism & Toxicology
Carlo Luca Romanò, Delia Romanò, Ilaria Morelli, Lorenzo Drago
Biofilms have a tremendous impact on industrial machines working in moist environments, while in biological systems their effect is further complicated by the host's response.Implant-related infections are a complex process, starting with bacterial adhesion and biofilm formation, followed by the variable interaction between host, implant, microorganisms and their by-products. Depending on the balance of these factors, different clinical presentations are observed, which may eventually, at times, shift from one into the other...
October 19, 2016: Advances in Experimental Medicine and Biology
Stephen B Soumerai, Rachel Ceccarelli, Ross Koppel
Some medical scientists argue that only data from randomized controlled trials (RCTs) are trustworthy. They claim data from natural experiments and administrative data sets are always spurious and cannot be used to evaluate health policies and other population-wide phenomena in the real world. While many acknowledge biases caused by poor study designs, in this article we argue that several valid designs using administrative data can produce strong findings, particularly the interrupted time series (ITS) design...
October 18, 2016: Journal of General Internal Medicine
Nasrin Rafieian, Hamidreza Abdolsamadi, Aliakbar Moghadamnia, Mina Jazayeri, Mohammadali Seif-Rabiee, Mina Salmanzadeh, Shahrbanoo Radi
BACKGROUND: Recurrent aphthous stomatitis (RAS) is the most common painful ulcers of oral mucosal which can cause many sufferings. Treatment of RAS often includes administration of corticosteroids, analgesics and regulators of the immune system. However, considering the side effects of these medications, even their topical application must be done with caution. Alum is used in traditional medicine for treatment of oral ulcers without significant side effect. This study sought to assess the effect of topical application of alum on aphthous ulcers...
2016: Caspian Journal of Internal Medicine
R Soumya, Vijayalakshmi Devarashetty, C R Jayanthi, M Sushma
OBJECTIVES: Pharmacists are one of the crucial focal points for health care in the community. They have tremendous outreach to the public as pharmacies are often the first-port-of-call. With the increase of ready-to-use drugs, the main health-related activity of a pharmacist today is to assure the quality of dispensing, a key element to promote rational medicine use. MATERIALS AND METHODS: A cross-sectional study of 200 pharmacies, 100 each in various residential (R) and commercial (C) areas of Bengaluru, was conducted using a prevalidated questionnaire administered to the chief pharmacist or the person-in-charge by the investigators...
July 2016: Indian Journal of Pharmacology
Danella Hafeman, Genna Bebko, Michele A Bertocci, Jay C Fournier, Henry W Chase, Lisa Bonar, Susan B Perlman, Michael Travis, Mary Kay Gill, Vaibhav A Diwadkar, Jeffrey L Sunshine, Scott K Holland, Robert A Kowatch, Boris Birmaher, David Axelson, Sarah M Horwitz, L Eugene Arnold, Mary A Fristad, Thomas W Frazier, Eric A Youngstrom, Robert L Findling, Mary L Phillips
OBJECTIVE: Both bipolar spectrum disorders (BPSD) and attention deficit hyperactivity disorder (ADHD) present with emotion-regulation deficits, but require different clinical management. We examined how the neurobiological underpinnings of emotion regulation might differentiate youth with BPSD versus ADHD (and healthy controls, HCs), specifically assessing functional connectivity (FxC) of amygdala-prefrontal circuitry during an implicit emotion processing task. METHODS: We scanned a subset of the Longitudinal Assessment of Manic Symptoms (LAMS) sample, a clinically recruited cohort with elevated behavioral and emotional dysregulation, and age/sex-ratio matched HCs...
October 11, 2016: Journal of Affective Disorders
Yongsan Li, Yingwei Zhang, Feng Shi, Lei Tao, Yen Wei, Xing Wang
Cell therapy has attracted wide attention among researchers in biomaterial and medical areas. As a carrier, hydrogels that could keep high viability of the embedded cells have been developed. However, few researches were conducted on 3D cell proliferation, a key factor for cell therapy, especially after injection. In this study, we demonstrated for the first time the proliferation regulation of the 3D-embedded L929 cells in a modulus-tunable and injectable self-healing hydrogel before and after injection without adding specific growth factor...
October 12, 2016: Colloids and Surfaces. B, Biointerfaces
Cees van Kooten, Ton J Rabelink, Johan W de Fijter, Marlies E J Reinders
PURPOSE OF REVIEW: Progress in the improvement of short-term and long-term outcomes of kidney transplantation seems to have reached a plateau, partially due to consequences of very efficient, but nonspecific immunosuppressive drugs. In recent years, various forms of cell therapy, including the use of mesenchymal stromal cells, have been put forward as an alternative strategy for more defined therapy. It is thought that these therapies will not only allow controlled tapering of immunosuppressive medication, but might bring us also closer to the ambition of generating donor-specific immune regulation and tolerance...
October 15, 2016: Current Opinion in Organ Transplantation
Xiaopeng Zhu, Hua Bian, Xin Gao
Nonalcoholic fatty liver disease (NAFLD) is a globally observed metabolic disease with high prevalence both in adults and children. However, there is no efficient medication available yet. Increased evidence indicates that berberine (BBR), a natural plant product, has beneficial effects on NAFLD, though the mechanisms are not completely known. In this review, we briefly summarize the pathogenesis of NAFLD and factors that influence the progression of NAFLD, and focus on the potential mechanisms of BBR in the treatment of NAFLD...
October 14, 2016: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
Marko Poglitsch, Ashraf H Ahmed, Michael Resl, Andrea Stoller, Dunja Van Oyen, Cornelia Schwager, Claudia Aigner, Oliver Domenig, Michael Krebs, Manuel Haschke, Michael Stowasser
OBJECTIVE: Primary aldosteronism (PA) is form of hypertension characterized by production of aldosterone by the adrenal that is excessive and relatively autonomous of the renin-angiotensin system. Once detected, unilateral PA can be usually cured by surgical removal of the affected adrenal, while bilateral PA can be specifically treated by medications, which antagonize aldosterone action. Clinical guidelines of Endocrine Societies in Europe and the US recommend screening for PA among most hypertensive patients...
September 2016: Journal of Hypertension
Huan Wang, Hui Chen
OBJECTIVE: Circadian rhythm disruption is shown to be the cause of various health disorders. CLOCK and BMAL1, two core circadian transcription factors, were associated with the regulation of glucose homeostasis. This study evaluated the association between single nucleotide polymorphisms in CLOCK and BMAL1 gene and insulin resistance (IR) in hypertensive patients. DESIGN AND METHOD: We collected 334 outpatients with essential hypertension (EH), who have not taken any antihypertensive agents or stopped the medications for at least a week for this case-control study...
September 2016: Journal of Hypertension
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