Anand, Om; Yu, Lawrence X; Conner, Dale P; Davit, Barbara M
In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modified-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Thus, in vitro dissolution testing plays a major role in FDA's efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products.
Schuck, Robert N; Grillo, Joseph A
Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.
... that is otherwise adulterated or misbranded. Dietary supplement advertising, including ads broadcast on radio and television, falls ... feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos ...
Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R
We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations.
U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...
U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities
U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...
... Products Radiation-Emitting Products Home Radiation-Emitting Products Mammography Quality Standards Act and Program Consumer Information (MQSA) ... it Email Print This list of FDA Certified Mammography Facilities is updated weekly. If you click on ...
U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...
On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.
Folbert, J.P.; Dagevos, J.C.
De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de
... Products For Consumers Home For Consumers Consumer Updates FDA 101: Regulating Biological Products Share Tweet Linkedin Pin ... field. back to top What biological products does FDA regulate? The Center for Biologics Evaluation and Research ( ...
Lisa M HoweDepartment of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USAAbstract: Spaying and castrating of dogs and cats has been considered for decades to be a routine standard of practice in veterinary medicine in the US for the prevention of numerous undesirable behaviors, medical conditions, and diseases. Additionally, the procedures have been promoted as a method of curbing the severe pet-over...
Full Text Available Lisa M HoweDepartment of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USAAbstract: Spaying and castrating of dogs and cats has been considered for decades to be a routine standard of practice in veterinary medicine in the US for the prevention of numerous undesirable behaviors, medical conditions, and diseases. Additionally, the procedures have been promoted as a method of curbing the severe pet-overpopulation problem in the US. Recently, however, this routine practice has come under scrutiny and become a very controversial topic. The general wisdom and safety of the procedures have been questioned by those who are concerned that the procedures may have some unintended consequences that are only recently being recognized. The purpose of this paper is to critically examine the scientific literature regarding elective spay/castration procedures and present both risks and benefits of elective gonadectomy. After the literature is examined, it becomes clear that there may not be a single absolute optimal age to spay or castrate all dogs and cats, but that the optimal age may be dependent upon several factors, including species, breed, body size, and breed-specific diseases, among others. Determining the optimal age to perform elective gonadectomy is much clearer in cats, and the literature demonstrates that the procedures can typically be safely performed at any age after 6–8 weeks of age. The optimal age to spay or castrate dogs of certain breeds (rottweiler, golden retriever, Labrador retriever, and vizsla is becoming less clear as studies are being conducted as to the health benefits and risks in those breeds. This review will examine these controversies and make recommendations as to the optimal age to spay/castrate dogs based upon the scientific literature.Keywords: gonadectomy (neuter, ovariohysterectomy (spay, castration, neoplasia, longevity, orthopedic
HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with HIV medicines is ... approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the ...
Miller, Annetta K.
The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…
Palmer, Carlysle S; Robertson, Ian D; Traub, Rebecca J; Rees, Robert; Thompson, R C Andrew
During a recent national study of intestinal parasites in dogs and cats in Australia, questionnaires were submitted to veterinarians and pet owners to evaluate from a veterinary and public health standpoint the veterinarians' perception, awareness and knowledge of gastrointestinal parasites in their locality. The study included sourcing information with regard to commonly recommended deworming protocols. The awareness of pet owners regarding parasitic zoonoses and the degree of education provided to them by veterinarians was also determined. Very few veterinarians routinely discussed the zoonotic potential of pet parasites with clients but most recommended regular prophylactic administration of anthelmintics throughout a pet's life. Some pet owners were unaware of the existence of zoonoses. It is possible that an overreliance on anthelmintics may have led to a certain complacency about the need to educate pet owners about the risks of zoonoses. Veterinarians are important educators in the community and it is important to evaluate their performance if improvements are to be made.
Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas
With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.
... does not approve cosmetics. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body ... and provide the agency with a notification before marketing a new formula. FDA conducts yearly inspections of ...
Rodolfo Oliveira Leal
Full Text Available Type I interferons (IFNs are well-known cytokines that, among their main functions, are key components of the host immune response against viral infections. Due to its immune modulation properties, they are commonly used in the therapeutic approach of various retroviral infections, namely human immunodeficiency virus (HIV and feline immunodeficiency virus (FIV. In HIV infection, it has been shown that IFN therapy limits early viral replication, particularly useful on post-exposure prophylaxis. In veterinary medicine, recombinant feline interferon omega (rFeIFN-ω was the first interferon licensed for use in cats. Several studies have recently shown that this compound seems to stimulate the innate immunity, decreasing clinical signs and co-infections in naturally FIV-infected cats. More than summarizing the main conclusions about rFeIFN-ω in cats, this review emphasizes the immune-modulation properties of IFN therapy, opening new perspectives for its use in retroviral infections. Either in FIV-infected cats or in HIV individuals, type I IFNs seem to induce an innate immune-modulation and should not be overlooked as a therapeutic option in retroviral infections.
O'Brien, Stephen J; Johnson, Warren; Driscoll, Carlos; Pontius, Joan; Pecon-Slattery, Jill; Menotti-Raymond, Marilyn
Our knowledge of cat family biology was recently expanded to include a genomics perspective with the completion of a draft whole genome sequence of an Abyssinian cat. The utility of the new genome information has been demonstrated by applications ranging from disease gene discovery and comparative genomics to species conservation. Patterns of genomic organization among cats and inbred domestic cat breeds have illuminated our view of domestication, revealing linkage disequilibrium tracks consequent of breed formation, defining chromosome exchanges that punctuated major lineages of mammals and suggesting ancestral continental migration events that led to 37 modern species of Felidae. We review these recent advances here. As the genome resources develop, the cat is poised to make a major contribution to many areas in genetics and biology.
O'Reilly, James T
Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.
Mitchel, Jules T.
Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pr...
U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...
... page: https://medlineplus.gov/news/fullstory_162726.html FDA Suggests Limits on Lead in Cosmetics Agency notes ... the authority to enforce such a limit, the FDA recommended in a draft guidance issued Thursday that ...
... Home For Consumers Consumer Updates FDA Warns About Stem Cell Claims Share Tweet Linkedin Pin it More sharing ... blood-forming system. back to top Regulation of Stem Cells FDA regulates stem cells in the U.S. to ...
The content of this bachelor thesis describes a different variety of cat parasites. This study discovers that the most infected group of the outdoor cats due to the fact that these animals are not provided with the same care as the household pets. Those cats are usually not vaccinated, not rid of worms, no one takes care of their fur and so they tend to become a host for the parasites. There are several kinds of parasites which attack cats. Among those belong the skin parasites like a cat fle...
Shanklin, D R
This communication is directed to obstetricians, to the Food and Drug Administration (FDA), and to those individuals who might want to impose possibly unnecessary external structures on the practice of medicine. It is considered a positive that the patients of today are well informed and are more actively participating in therapeutic design. There is more veto power on the part of the patient and more concern over the trained ability of the physician. In the past physicians frequently made judgements individually, applying isolated and at times random standards for their decisions. Such actions were inevitable in an era when neither pathogenesis nor treatment was well understood. Now there is no excuse for such actions. Communication is easy, journals are widely circulated, and there are numerous refresher seminars. Increased specialization of knowledge has meant more corporate or group decisions for therapy. Current trends will continue to offer both opportunities and responsibilities. The opportunities are for better diffusion of knowledge, and the responsibility is to be informed. There can be a high level national standard for medical practice. As a beginning, the medical practice laws could use some uniform decisions. The FDA needs to show more responsiveness to changing knowledge and increased willingness to reconsider indications and contraindications in the light of newer experience. There is sufficient information available now to support the revocation of the approval of the use of diuretics in the management of human pregnancy. Another role of the FDA is the approval of new substances or new uses of old substances. The prostaglandins appear in this category, and the December 1972 issue will include the recent Brook Lodge Symposium on prostaglandins. The individual physician requires journal articles, individual experience, and designed trials in order to make judgements on patients who may have some factors not accounted for by groupthink or regulations.
Kim, Soonok; Cho, Yun Sung; Bhak, Jong; O’Brian, Stephen J.; Yeo, Joo-Hong
Recent advances in genome sequencing technologies have enabled humans to generate and investigate the genomes of wild species. This includes the big cat family, such as tigers, lions, and leopards. Adding the first high quality leopard genome, we have performed an in-depth comparative analysis to identify the genomic signatures in the evolution of felid to become the top predators on land. Our study focused on how the carnivore genomes, as compared to the omnivore or herbivore genomes, shared evolutionary adaptations in genes associated with nutrient metabolism, muscle strength, agility, and other traits responsible for hunting and meat digestion. We found genetic evidence that genomes represent what animals eat through modifying genes. Highly conserved genetically relevant regions were discovered in genomes at the family level. Also, the Felidae family genomes exhibited low levels of genetic diversity associated with decreased population sizes, presumably because of their strict diet, suggesting their vulnerability and critical conservation status. Our findings can be used for human health enhancement, since we share the same genes as cats with some variation. This is an example how wildlife genomes can be a critical resource for human evolution, providing key genetic marker information for disease treatment. PMID:28042784
<正> A man takes his motionless dog to the vet."Doc,I think my dog is dead.”The vet looks the dog over, goes into a backroom,and comes out with a cat.He places the caton the table next to the dog.The cat walks aroundand sniffs at the dog.The dog does not move.The
Spurgin, Elizabeth A
Manufacturers of diabetes devices can facilitate the formal regulatory approval process through early interaction with the U.S. Food and Drug Administration (FDA). Effective planning can help manage commonly perceived risks of interaction with the Agency, introduce new technologies to regulatory reviewers, and inform the manufacturer's product development strategy. This article reviews key aspects of the FDA evaluation process and suggests strategies that may facilitate effective communication with the Agency. Integrating early communication with FDA into broader product commercialization planning can streamline regulatory review and lead to early product launch into reimbursed markets.
The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)
... Products For Consumers Home For Consumers Consumer Updates Depression: FDA-Approved Medications May Help Share Tweet Linkedin ... symptoms in some people. back to top Diagnosing Depression Diagnosis—which should be from a health care ...
U.S. Department of Health & Human Services — This dataset represents all technologies available for licensing from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Center...
基于文献研究，分析美国FDA明智监管理念的特征与作用，探讨其对医药产业发展的促进作用，为我国药品监管的提供启示。我国可以通过不断推进监管科学、重视政府信息公开、拓宽资金来源渠道等监管手段，在保障公众健康的基础上，实现促进医药产业发展的目标。%Based on the literature search, the characteristic and effect of FDA smart regulatory philosophy were analyzed, and the promoting effect of this philosophy on the development of pharmaceutical industry was discussed so as to provide enlightenment for the drug regulation of China. The goal of promoting the development of the pharmaceutical industry in China may be achieved on the basis of the protection of public health by some regulatory measures such as constantly advancing the regulatory science, paying great attention to the disclosure of government information and broadening the channels of funding sources.
... Prevention and Wellness Staying Healthy Pets and Animals Cat and Dog Bites Cat and Dog Bites Pets and AnimalsPrevention and WellnessStaying Healthy Share Cat and Dog Bites Cat and dog bites are ...
Cat scratch disease (CSD) is an illness caused by the bacterium Bartonella henselae. Almost half of all cats carry ... infection does not make cats sick. However, the scratch or bite of an infected cat can cause ...
The name of my cat is Naty. This year he is one year old. He isvery fat, but he is very nice. He has a big round white head. His mouth and nose are small. His eyes are interesting. In the day,they are small and black,but at night they are big and blue.
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Young, Kenneth A
Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.
The black cat is a masterpiece of short fiction of Poe. He successfully solved the problem of creating of the horror effect by using scene description, symbol, repetition and first-person narrative methods. And created a complete and unified mysterious terror, achieved the effect of shocking. This paper aims to discuss the mystery in-depth and to enrich the research system in Poe’s novels.
The FDA has conditionally approved atezolizumab, the first PD-L1 inhibitor, for metastatic urothelial carcinoma, along with a companion diagnostic, the Ventana PD-L1 (SP142) assay. The agency has also expanded nivolumab's indications to include classical Hodgkin lymphoma, making this PD-1 inhibitor the first to be approved for a hematologic malignancy.
There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle
A. Janet eTomiyama
Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.
... https://medlineplus.gov/news/fullstory_163464.html Screening, HPV Vaccine Can Prevent Cervical Cancer: FDA Agency recommends ... cancer, which is caused by the human papillomavirus (HPV). An FDA-approved vaccine called Gardasil 9 protects ...
... page: https://medlineplus.gov/news/fullstory_162849.html FDA to Weigh Dangers of Exploding E-Cigarettes Agency ... The Associated Press reported last month that the FDA had identified 66 instances of e-cigarette explosions ...
... page: https://medlineplus.gov/news/fullstory_162543.html FDA Issues Anesthesia Warning for Pregnant Women, Kids Under ... agency news release. She is director of the FDA's Center for Drug Evaluation and Research. "Parents and ...
... page: https://medlineplus.gov/news/fullstory_163113.html FDA Offers Guidance on Fish Intake for Kids, Pregnant ... is far less than the recommended amount, the FDA said. Fish offers nutritional benefits important for growth ...
... page: https://medlineplus.gov/news/fullstory_163882.html FDA Approves New Treatment for Dust Mite Allergies Odactra ... life," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "The approval ...
... FDA Recommends All Blood Donations Be Tested for Zika Updated guidance provides further protection for U.S. blood ... entire blood supply be routinely screened for the Zika virus. In February, the FDA recommended testing of ...
U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...
... HUMAN SERVICES Food and Drug Administration Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...
Bustamante Rojas, Carlos
La FDA y Janssen Phamaceuticals -el fabricante de cisaprida- han advertido mediante cartas a los prescriptores que el fármaco no deberá ser utilizado simultáneamente junto con macrólidos antifúngicos, algunos antidepresivos e inhibidores de las proteasas, ya que puede aparecer prolongación del intervalo QT y severos trastornos del ritmo cardiaco. Adicionalmente, el fármaco está contraindicado en los pacientes con EPOC, ICC, cáncer avanzado y en pacientes can alteraciones del equilibrio...
... of the regulations. If I see web sites advertising potassium iodide or alternative cures, should I buy ... feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos ...
... appropriate technologies that enhance the tracking and tracing of foods along the supply chain from source to... along the Food Supply System.'' FDA is announcing the opening of a docket to provide stakeholders and... submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,...
Mary Anne Opavsky
Full Text Available OBJECTIVE: To present a perspective on the current state of knowledge of cat scratch disease (CSD, including the evidence for Bartonella henselae as the etiological agent, epidemiological and clinical characteristics of the disease, available diagnostic tests and current therapeutic options.
Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.
of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...
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Silver, B E; Bean, C S
Cat scratch disease is usually benign, self-limited and without sequelae. Margileth has established four clinical criteria, three of which must be satisfied to make the diagnosis: 1) a history of animal exposure, usually kitten, with primary skin or ocular lesions; 2) regional chronic adenopathy without other apparent cause; 3) a positive cat scratch disease antigen skin test; and 4) lymph node biopsy demonstrating noncaseating granulomas and germinal center hyperplasia. Central nervous system involvement in cat scratch disease has been previously reported, although it is extremely uncommon. In a several-month period, we encountered two cases of cat scratch disease complicated by encephalopathy. The intents of this paper are twofold: 1) to briefly review the current literature on cat scratch disease, 2) to demonstrate that cat scratch disease complicated by encephalopathy presents acutely with seizures, posturing and coma and resolves rapidly with supportive care.
Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.
Flávio Munhoz Sofiati
Full Text Available O texto analisa as diferentes vertentes da Igreja Católica no Brasil, apresentando-as a partir de teóricos da própria Igreja das ciências sociais. Em seguida, discute-se a tendência ligada à Teologia da Libertação, chamada de Cristianismo da Libertação. Afirma-se que o conceito de “Tendências Internas do Catolicismo” é mais apropriado para compreender os processos internos do catolicismo e que, atualmente, a Teologia da Libertação vem perdendo espaço no cenário religioso. Isso ocorre em virtude de questões internas – como o fortalecimento do movimento carismático – e externas – como o advento do neoliberalismo. Diante dessa situação, esse segmento assume uma nova postura de atuação, que tem como idéia central a construção de mudanças “de baixo para cima” e em longo prazo. Conclui-se que houve um recuo programático dessa tendência que passa a priorizar sua ação no interior da Igreja e a valorizar temas como espiritualidade, ecologia e cultura em detrimento da dimensão política. Palavras-chaves: Sociologia da Religião. Catolicismo. Tendências católicas. Teologia da libertação. The text analyzes different aspects of the Catholic Church in Brazil, presenting them through theories of the church, from social sciences. After that there is a discussion about the tendency connected to the Theory of Freedom, so called “Freedom Cristianism”. It is said that the concept of “Inner Theories of Catholicism” is more appropriate to understand the inner processes of the Catholicism and that, nowadays, the Freedom Theory has been loosing space inside the religious scenery. This occurs due to inner reasons – such as the growing strength of the charismatic movement – and also due to external reasons – as the ascending of Neoliberalism. With that, this segment gets to a new posture of action which has as central idea the“from down to up” changes, during long terms. After all, there is the
One of the more frightening pictures in our society is one of a speaker being silenced, simply by virtue of who the speaker is; yet, the FDA engages in that type of censorship on a regular basis. The FDA censors manufacturer dissemination of truthful information concerning unapproved ("off-label") uses of prescription drugs, and does so at the expense of the First Amendment. Nor does the FDA further its mission of protecting the health and safety of the American public through its censorship....
... Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY... FDA Staff: Financial Disclosure by Clinical Investigators.'' This draft guidance is intended to assist... governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the...
... News & Events Home News & Events Newsroom Press Announcements FDA NEWS RELEASE For Immediate Release: March 22, 2013 ... Inquiries: Morgan Liscinsky, 301-796-0397, email@example.com Consumer Inquiries: 888-INFO-FDA, OCOD@ ...
... Updates FDA Facilitates Research on Earlier Stages of Alzheimer's Disease Share Tweet Linkedin Pin it More sharing ... disease.” back to top New Paths for New Alzheimer’s Drugs FDA’s draft guidance aims to encourage research ...
... Consumer Updates FDA Encourages More Participation, Diversity in Clinical Trials Share Tweet Linkedin Pin it More sharing options ... while research is conducted. back to top Do clinical trials have possible risks and benefits? Yes. Sometimes patients ...
... Home For Consumers Consumer Updates The Facts on Bipolar Disorder and FDA-Approved Treatments Share Tweet Linkedin ... to top What to Do if You Suspect Bipolar Disorder If you suspect you have a bipolar ...
... html FDA Throws Cold Water on Whole Body Cryotherapy Exposure to ultra-low temperatures shows no benefits ... evidence that a growing trend called whole body cryotherapy is effective, but it does pose a number ...
... Consumers Consumer Updates What FDA Learned About Dark Chocolate and Milk Allergies Share Tweet Linkedin Pin it ... back to top Milk Detected in Individual Dark Chocolate Products Label/Package Statement Total number of dark ...
... html FDA OKs 1st Drug to Treat Duchenne Muscular Dystrophy Exondys 51 seems to fill unmet need ... the first drug for a rare form of muscular dystrophy. Exondys 51 (eteplirsen) was granted accelerated approval ...
Rising, Joshua P.; Ben Moscovitch
When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these pr...
Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang
In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.
Collins Richard D
Full Text Available Abstract On March 11, 2004, the Food and Drug Administration (FDA pronounced that dietary supplement products containing androstenedione were adulterated new dietary ingredients under the Dietary Supplement Health and Education Act of 1994 (DSHEA. The FDA issued a press release, held a news conference, and sent warning letters to 23 companies that had manufactured, marketed or distributed the products containing androstenedione. In its warning letters, FDA threatened possible enforcement actions for noncompliance. The authors have looked at the warning letters, statutes, regulations, and media reports to analyze the legal grounds and standards upon which FDA acted against androstenedione and question the appropriateness of the action taken. They have also looked at the negative impact that FDA's lack of communication and cooperation with Industry is having upon the fitness nutrition industry and the marketing of dietary supplements containing new dietary ingredients. The authors also suggest what might be done to ameliorate this escalating problem including more cooperation between FDA and Industry and more research into the benefits and use of supplement products.
... scratch or bite from a cat, your health care provider may suspect cat-scratch disease. A physical examination may also reveal an enlarged spleen . Sometimes, an infected lymph node may form a tunnel ( fistula ) through the skin and drain (leak fluid). This ...
Zerbe, C A; Nachreiner, R F; Dunstan, R W; Dalley, J B
A diabetic cat with hyperadrenocorticism had polydipsia, polyuria, ventral abdominal alopecia, thin dry skin, and a pendulous abdomen. Results of laboratory testing indicated persistent resting hypercortisolemia, hyperresponsiveness of the adrenal glands (increased cortisol concentration) to ACTH gel, and no suppression of cortisol concentrations after administration of dexamethasone at 0.01 or 1.0 mg/kg of body weight. Necropsy revealed a pituitary gland tumor, bilateral adrenal hyperplasia, hepatic neoplasia, and demodicosis. Adrenal gland function was concurrently assessed in 2 cats with diabetes mellitus. One cat had resting hypercortisolemia, and both had hyperresponsiveness to ACTH gel (increased cortisol concentration) at one hour. After administration of dexamethasone (0.01 and 1.0 mg/kg), the diabetic cats appeared to have normal suppression of cortisol concentrations. The effects of mitotane were investigated in 4 clinically normal cats. Adrenocortical suppression of cortisol production occurred in 2 of 4 cats after dosages of 25, 37, and 50 mg/kg. Three cats remained clinically normal throughout the study. One cat experienced vomiting, diarrhea, and anorexia.
... bites and scratches well with soap and running water. Do not allow cats to lick your wounds. Contact your doctor if you develop any symptoms of cat-scratch disease or infection. CSD is caused by a bacterium called Bartonella henselae . About 40% ...
Lambert, Phyllis Gilchrist
This activity began with a picture book, Nurit Karlin's "Fat Cat On a Mat" (HarperCollins; 1998). The author and her students started their project with a 5-inch circular template for the head of their cats. They reviewed shapes as they drew the head and then added the ears and nose, which were triangles. Details to the face were added when…
Ruiz-Rebollo, M Lourdes; Velayos-Jiménez, Benito; Prieto de Paula, José María; Alvarez Quiñones, María; González Hernández, José Manuel
Over the past few years, we have read several publications regarding the term "cat scratch colon." This neologism was developed to define some bright red linear markings seen in the colonic mucosa that resemble scratches made by a cat. We would like to communicate a recent case attended at our institution.
M. Lourdes Ruiz-Rebollo
Full Text Available Over the past few years, we have read several publications regarding the term “cat scratch colon.” This neologism was developed to define some bright red linear markings seen in the colonic mucosa that resemble scratches made by a cat. We would like to communicate a recent case attended at our institution.
Pressanti, Charline; Drouet, Clémence; Cadiergues, Marie-Christine
Twenty healthy cats (group 1) with clinically normal ears, 15 cats with systemic disease (group 2) and 15 allergic cats (group 3) were included in a prospective study. The experimental unit was the ear. A clinical score was established for each ear canal after otoscopic examination. Microbial population was assessed on cytological examination of smears performed with the cotton-tipped applicator smear technique. Fungal population was significantly more prominent in allergic cats (P cats compared with healthy cats (P cats than in healthy cats (P cats suffering from systemic disease (P cats with systemic disease than healthy cats. In cats from group 2, only fungal overgrowth was associated with otitis severity. In group 3, only bacterial overgrowth was associated with otitis severity.
Hu, Yaowu; Hu, Songmei; Wang, Weilin; Wu, Xiaohong; Marshall, Fiona B; Chen, Xianglong; Hou, Liangliang; Wang, Changsui
Domestic cats are one of the most popular pets globally, but the process of their domestication is not well understood. Near Eastern wildcats are thought to have been attracted to food sources in early agricultural settlements, following a commensal pathway to domestication. Early evidence for close human-cat relationships comes from a wildcat interred near a human on Cyprus ca. 9,500 y ago, but the earliest domestic cats are known only from Egyptian art dating to 4,000 y ago. Evidence is lacking from the key period of cat domestication 9,500-4,000 y ago. We report on the presence of cats directly dated between 5560-5280 cal B.P. in the early agricultural village of Quanhucun in Shaanxi, China. These cats were outside the wild range of Near Eastern wildcats and biometrically smaller, but within the size-range of domestic cats. The δ(13)C and δ(15)N values of human and animal bone collagen revealed substantial consumption of millet-based foods by humans, rodents, and cats. Ceramic storage containers designed to exclude rodents indicated a threat to stored grain in Yangshao villages. Taken together, isotopic and archaeological data demonstrate that cats were advantageous for ancient farmers. Isotopic data also show that one cat ate less meat and consumed more millet-based foods than expected, indicating that it scavenged among or was fed by people. This study offers fresh perspectives on cat domestication, providing the earliest known evidence for commensal relationships between people and cats.
The topic of this "Perspectives" column is "Requiring a Proficiency Level as a Requirement for U.S. K-12 Teacher Licensure." In 1998, the American Council of Teachers of Foreign Languages (ACTFL) began to work with the National Council for Accreditation of Teacher Education (NCATE), which accredits teacher education programs…
Janeczko, Stephanie; Griffin, Brenda
The protozoon Giardia duodenalis is a common gastrointestinal parasite of cats. While most Giardia-infected cats are asymptomatic, acute small bowel diarrhea, occasionally with concomitant weight loss, may occur. Giardia poses a diagnostic challenge, but newer tests, including a commercially available ELISA kit, have improved clinicians' ability to obtain an accurate diagnosis. Several treatment options have been reported, and although none has been shown to be universally effective, most cases can be successfully managed with drug therapy, supportive measures, and environmental control. Current recommendations suggest that combination therapy with fenbendazole and metronidazole may be the safest, most effective treatment option for symptomatic cats.
U.S. Environmental Protection Agency — The StreamCat Dataset provides summaries of natural and anthropogenic landscape features for ~2.65 million streams, and their associated catchments, within the...
U.S. Department of Health & Human Services — IndexCat provides access to the digitized version of the printed Index-Catalogue of the Library of the Surgeon General's Office; eTK for medieval Latin texts; and...
Noel, Alexis; Martinez, Andrea; Jung, Hyewon; Tsai, Ting-Wen; Hu, David
A cat's tongue is covered in an array of spines called papillae. These spines are thought to be used in grooming and rasping meat from bones of prey, although no mechanism has been given. We use high-speed video to film a cat removing cat food deeply wedged into a 3-D printed fur mat. We show that the spines on the tongue act as Velcro for particles. The tongue itself is highly elastic. As the cat presses it against a substrate, the tongue flattens and the spines separate. When the tongue is removed from the substrate the spines come together, wedging particles between them. This elasticity-driven entrapment permits the surface of the tongue to act as a carrier for hard to reach particles, and to increase the efficacy of grooming and feeding.
Rising, Joshua P; Moscovitch, Ben
When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies--and contributing factors, such as primary outcome measures and enrollment--could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues.
Joshua P Rising
Full Text Available When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies--and contributing factors, such as primary outcome measures and enrollment--could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues.
Paradise, Jordan; Tisdale, Alison W; Hall, Ralph F; Kokkoli, Efrosini
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.
Kussmann, Martin; Morine, Melissa J; Hager, Jörg
We review here the status of human type 2 diabetes studies from a genetic, epidemiological, and clinical (intervention) perspective. Most studies limit analyses to one or a few omic technologies providing data of components of physiological processes. Since all chronic diseases are multifactorial...... of the complexity of T2DM, we propose a systems biology approach to advance the understanding of origin, onset, development, prevention, and treatment of this complex disease. This systems-based strategy is based on new study design principles and the integrated application of omics technologies: we pursue...
Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig
Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...
268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the F
The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.
An operad (this paper deals with non-symmetric operads) may be conceived as a partial algebra with a family of insertion operations, Gerstenhaber's circle-i products, which satisfy two kinds of associativity, one of them involving commutativity. A Cat-operad is an operad enriched over the category Cat of small categories, as a 2-category with small hom-categories is a category enriched over Cat. The notion of weak Cat-operad is to the notion of Cat-operad what the notion of bicategory is to the notion of 2-category. The equations of operads like associativity of insertions are replaced by isomorphisms in a category. The goal of this paper is to formulate conditions concerning these isomorphisms that ensure coherence, in the sense that all diagrams of canonical arrows commute. This is the sense in which the notions of monoidal category and bicategory are coherent. The coherence proof in the paper is much simplified by indexing the insertion operations in a context-independent way, and not in the usual manner. ...
Describes learning activities about cats for primary and intermediate grades. Primary grade activity subjects include cat behavior, needs, breeds, storybook cats, and celestial cats. Intermediate grade activity subjects include cat history, care, language, literary cats, and cats in art. (BC)
An important learning goal of Projects and Practices in Physics (P3) , the transformed introductory mechanics course at Michigan State University, is the development of scientific practices. The design team, as part of the P3 course construction, made clear attempts to assess learning goals that can often be perceived as being a part of the hidden curriculum or considered difficult to assess (e.g., learning to work productively in a group) by developing a collaborative assessment tool (CAT). The CAT is a formative assessment tool that provides students with a numerical grade for how they participated in their learning group on a weekly basis while also providing feedback in the form of written commentary and suggestions on how they might improve at a particular collaborative practice. In this presentation, we demonstrate the CAT tool from two perspectives: 1) how the CAT tool is used within the P3 context and 2) how the formative feedback has affected changes in student interactions in class. We will present the case studies of 3 students who had differing reactions to the feedback they received. We will explore the role the feedback had in their interactions over a four-week period from an in-class perspective and a reflected perspective through interviews and observations. The analysis will also be presented from a tutor and group perspective, which will highlight the affordances the CAT can have in creating a productive learning group. The research on the CAT shows promise in encouraging growth in students' collaborative skills, but this research is still in its infancy and needs to be expanded to include different contexts.
... Old Feeding Your 1- to 2-Year-Old Cat Scratch Disease KidsHealth > For Parents > Cat Scratch Disease A A A What's in this ... Doctor en español Enfermedad por arañazo de gato Cat scratch disease is a bacterial infection that a ...
Pedersen, A. S.; Berg, Lise Charlotte; Almstrup, Kristian
. Immunostaining using anti-vimentin and anti-VASA (DDX4) showed that only Sertoli cells and no germ cells were observed in the testicular tubules. As no sign of spermatogenesis was detected, we conclude that this is a classic case of a sterile, male tortoiseshell cat with a 39,XXY chromosome complement. © 2013 S...
Kis, Z.; Janszky, J.; Vinogradov, An. V.; Kobayashi, T.
The optical Schroedinger cat states are simple realizations of quantum states having nonclassical features. It is shown that vibrational analogues of such states can be realized in an experiment of double pulse excitation of vibrionic transitions. To track the evolution of the vibrational wave packet we derive a non-unitary time evolution operator so that calculations are made in a quasi Heisenberg picture.
@@ 一、故事内容 A cat goes fishing every day. He wants to eat fish, but he can't catch any fish. One day, he goes to the river as usual. Suddenly, a fish comes out. He catches the fish and putsthe fish in the basket. He's very happy, but he forgest to put the lid on the basket.
CONG Wei-hong; CHEN Ke-ji
@@ Recently, 2007, the U.S. Food and Drug Administration (FDA) issued a draft guidance for the industry, titled "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration". This is another document closely related to Chinese Medical Sciences following the issuance of the Guidance for Industry: Botanical Drug Products in June 2004. This document conforms to the dramatically increased practice of Complementary and Alternative Medicine (CAM)in the United States in recent years. It demonstrates a positive and pragmatic attitude of FDA towards new drug development. The issuance of the draft guidance, which is largely due to the appeals for emphasizing evidence-based medicine, patients' safety and care quality to a great extent meets the patient-centered medical service mode, and will undoubtedly be welcomed by customers, doctors, medical service employees, insurance companies and legislation departments of the States.
Lionberger, Robert A.
FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product de...
... page: https://medlineplus.gov/news/fullstory_162638.html FDA OKs High-Tech Diabetes Device to Help Replace ... too low, and potentially incorrect insulin dosing, the FDA said. The Dexcom G5 is the first continuous ...
The FDA algebras emerging from twisted tori compactifications of M-theory with fluxes are discussed within the general classification scheme provided by Sullivan's theorems and by Chevalley cohomology. It is shown that the generalized Maurer Cartan equations which have appeared in the literature, in spite of their complicated appearance and contrary to opposite claims, once suitably decoded within cohomology, lead to trivial FDA.s, all new p--form generators being contractible when the 4--form flux is cohomologically trivial. Non trivial D=4 FDA.s can emerge from non trivial fluxes but only if the cohomology class of the flux satisfies an additional algebraic condition which appears not to be satisfied in general and has to be studied for each algebra separately. As an illustration an exhaustive study of Chevalley cohomology for the simplest class of SS algebras is presented but a general formalism is developed, based on the structure of a double elliptic complex, which, besides providing the presented result...
The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009
... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I FDA Food Safety Modernization Act: Focus on... a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Preventive Controls for... implementation of the preventive controls for facilities provisions of the recently enacted FDA Food...
Lyons, Leslie A
Varieties of genetic tests are currently available for the domestic cat that support veterinary health care, breed management, species identification, and forensic investigations. Approximately thirty-five genes contain over fifty mutations that cause feline health problems or alterations in the cat's appearance. Specific genes, such as sweet and drug receptors, have been knocked-out of Felidae during evolution and can be used along with mtDNA markers for species identification. Both STR and SNP panels differentiate cat race, breed, and individual identity, as well as gender-specific markers to determine sex of an individual. Cat genetic tests are common offerings for commercial laboratories, allowing both the veterinary clinician and the private owner to obtain DNA test results. This article will review the genetic tests for the domestic cat, and their various applications in different fields of science. Highlighted are genetic tests specific to the individual cat, which are a part of the cat's genome.
Bozhkov, V; Madjov, R; Plachkov, I; Arnaudov, P; Chernopolsky, P; Krasnaliev, I
Approximately 24,000 people are infected with cat scratch disease (CSD) every year. CSD is caused by the bacteria Bartonella henselae, a gram-negative bacteria most often transmitted to humans through a bite or scratch from an infected cat or kitten. Although CSD is often a benign and self-limiting condition, it can affect any major organ system in the body, manifesting in different ways and sometimes leading to lifelong sequelae. It is a disease that is often overlooked in primary care because of the wide range of symptom presentation and relative rarity of serious complications. It is important for health care providers to recognize patients at risk for CSD, know what laboratory testing and treatments are available, and be aware of complications that may arise from this disease in the future.
The concept of effective field theory leads in a natural way to a construction principle for phenomenological sensible models known under the name of the Cheshire Cat Principle. We review its formulation in the chiral bag scenario and discuss its realization for the flavor singlet axial charge. Quantum effects inside the chiral bag induce a color anomaly which requires a compensating surface term to prevent breakdown of color gauge invariance. The presence of this surface term allows one to derive in a gauge-invariant way a chiral-bag version of the Shore-Veneziano two-component formula for the flavor-singlet axial charge of the proton. We show that one can obtain a striking Cheshire-Cat phenomenon with a negligibly small singlet axial charge.
Pineda Martos, Carmen María
The present Doctoral Thesis wa metabolism in the feline species. Through a series of studies, the relationship between calcium metabolism and the main hormones involved in it has been determined metabolism during the juvenile stage of growing cats effects linked to feeding calculolytic diets on feline mineral metabolism. The first part of the work was aimed the quantification of intact (I-PTH) and whole PTH) and to characterize the dynamics of PTH secretion, including ...
Schuller, S; Francey, T; Hartmann, K; Hugonnard, M; Kohn, B; Nally, J E; Sykes, J
Leptospirosis is a zoonotic disease with a worldwide distribution affecting most mammalian species. Clinical leptospirosis is common in dogs but appears to be rare in cats. Both dogs and cats, however, can shed leptospires in the urine. This is problematic as it can lead to exposure of humans. The control of leptospirosis, therefore, is important not only from an animal but also from a public health perspective. The aim of this consensus statement is to raise awareness of leptospirosis and to outline the current knowledge on the epidemiology, clinical features, diagnostic tools, prevention and treatment measures relevant to canine and feline leptospirosis in Europe.
Turner, Dennis C
This review article covers research conducted over the last three decades on cat-human and human-cat interactions and relationships, especially from an ethological point of view. It includes findings on cat-cat and cat-human communication, cat personalities and cat-owner personalities, the effects of cats on humans, and problems caused by cats.
Sawant, Satin G; Fielden, Mark R; Black, Kurt A
Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested.
Full Text Available BACKGROUND: Studies of biological shape evolution are greatly enhanced when framed in a phylogenetic perspective. Inclusion of fossils amplifies the scope of macroevolutionary research, offers a deep-time perspective on tempo and mode of radiations, and elucidates life-trait changes. We explore the evolution of skull shape in felids (cats through morphometric analyses of linear variables, phylogenetic comparative methods, and a new cladistic study of saber-toothed cats. METHODOLOGY/PRINCIPAL FINDINGS: A new phylogenetic analysis supports the monophyly of saber-toothed cats (Machairodontinae exclusive of Felinae and some basal felids, but does not support the monophyly of various saber-toothed tribes and genera. We quantified skull shape variation in 34 extant and 18 extinct species using size-adjusted linear variables. These distinguish taxonomic group membership with high accuracy. Patterns of morphospace occupation are consistent with previous analyses, for example, in showing a size gradient along the primary axis of shape variation and a separation between large and small-medium cats. By combining the new phylogeny with a molecular tree of extant Felinae, we built a chronophylomorphospace (a phylogeny superimposed onto a two-dimensional morphospace through time. The evolutionary history of cats was characterized by two major episodes of morphological divergence, one marking the separation between saber-toothed and modern cats, the other marking the split between large and small-medium cats. CONCLUSIONS/SIGNIFICANCE: Ancestors of large cats in the 'Panthera' lineage tend to occupy, at a much later stage, morphospace regions previously occupied by saber-toothed cats. The latter radiated out into new morphospace regions peripheral to those of extant large cats. The separation between large and small-medium cats was marked by considerable morphologically divergent trajectories early in feline evolution. A chronophylomorphospace has wider
埃德加•爱伦•坡（1809～1849），十九世纪美国诗人、小说家和文学评论家，同时爱伦坡也是一位恐怖小说大师。《黑猫》便是坡的代表作品之一。猫是整篇文章的线索，为什么一系列事件的发生与猫有关，到底是什么力量使男主人公最后走向毁灭。整个事件因猫而起，因猫而灭，由此作者发现故事中人物病态心理的产生，自我心灵的恐怖过程和最终走向毁灭的原因都是源于黑猫的复仇。本文通过对爱伦坡恐怖小说的背景的探索，及对原著仔细的分析，从黑猫的复仇的角度来解读《黑猫》。%Edgar Al an Poe (1809~1849), nineteenth century American poet, novelist and literary critic, while Poe was also a master of horror fiction."Black Cat"is one of the representative works of Poe. The cat is the clue of the entire article, why a series of events is related to the cat, what has lead the hero to destroy himself in the end. Al troubles rise for a cat, al troubles disappear for a cat. The author find that the producing of the characters' morbid psychology, the terror in his mind and the ultimate self-destruction are due to black cat's revenge. Then this thesis from the perspective of cat’s revenge to interpret the"Black Cat"through exploring the background of the Al enPoe' horror novel, and analyzing the original work careful y.
US Fish and Wildlife Service, Department of the Interior — The ServCat document selection guidelines were developed for selecting appropriate documents to upload into ServCat. When beginning to upload documents into ServCat,...
Weinstein, Lawrence; Alexander, Ralph
Twenty-two Siamese and 32 mixed breed cats' personalities were rated by their respective college student owners and compared. Further, the owners' self rated personality traits were correlated with the pets'; significant Siamese and Mixed differences and correlations were obtained. These are the first data to examine breed of cat on a personality…
The Contract Administrative Tracking System (CATS) was developed in response to an ORD NHEERL, Mid-Continent Ecology Division (MED)-recognized need for an automated tracking and retrieval system for Cost Reimbursable Level of Effort (CR/LOE) Contracts. CATS is an Oracle-based app...
Bock, P; Hach, V; Baumgärtner, W
Incisional biopsies from the oral cavity of 2 adult cats were submitted for histological investigation. Cat No. 1 showed a solitary well-circumscribed neoplasm in the left mandible. Cat No. 2 demonstrated a diffusely infiltrating neoplasm in the left maxilla. Both tumors consisted of medium-size epithelial cells embedded in a fibrovascular stroma. The mitotic index was 0 to 1 mitosis per high-power field. The epithelial cells showed an irregular arrangement forming nests or streams in cat No. 1, whereas a palisading growth was noted in cat No. 2. Both tumors, especially that of cat No. 1, showed multifocal accumulations of amyloid as confirmed by Congo red staining and a distinct green birefringence under polarized light, which lacked cytokeratin immunoreactivity as well as and AL and AA amyloid immunoreactivity. In addition, the amyloid in cat No. 2 was positive for the odontogenic ameloblast-associated protein, formerly termed APin. In sum, both cats suffered from an amyloid-producing odontogenic tumor, but their tumors varied with respect to morphology and type of amyloid produced.
Gabrielle C Hybki
Full Text Available Case summary Lumbosacral agenesis is a rare congenital condition reported in children. We report a 17-week-old female domestic shorthair cat with lumbosacral agenesis on whole-body radiographs. The cat was euthanized shortly thereafter presentation. A necropsy was not permitted. Relevance and novel information This is the first reported feline case of lumbosacral agenesis.
We consider the problem of generating all ideals of a poset. It is a long standing open problem, whether or not the ideals of any poset can be generated in constant amortized time, CAT for short. We refine the tree traversal, a method introduced by Pruesse and Ruskey in 1993, to obtain a CAT-generator for two large classes of posets: posets of interval dimension at most two and so called locally planar posets. This includes all posets for which a CAT-generator was known before. Posets of interval dimension at most two generalize both, interval orders and 2-dimensional posets. Locally planar posets generalize for example posets with a planar cover graph. We apply our results to CAT-generate all $c$-orientations of a planar graph. As a special case this is a CAT-generator for many combinatorial objects like domino and lozenge tilings, planar spanning trees, planar bipartite perfect matchings, Schnyder woods, and others.
Snell, Terry W; Johnston, Rachel K; Srinivasan, Bharath; Zhou, Hongyi; Gao, Mu; Skolnick, Jeffrey
There is great interest in drugs that are capable of modulating multiple aging pathways, thereby delaying the onset and progression of aging. Effective strategies for drug development include the repurposing of existing drugs already approved by the FDA for human therapy. FDA approved drugs have known mechanisms of action and have been thoroughly screened for safety. Although there has been extensive scientific activity in repurposing drugs for disease therapy, there has been little testing of these drugs for their effects on aging. The pool of FDA approved drugs therefore represents a large reservoir of drug candidates with substantial potential for anti-aging therapy. In this paper we employ FINDSITE(comb), a powerful ligand homology modeling program, to identify binding partners for proteins produced by temperature sensing genes that have been implicated in aging. This list of drugs with potential to modulate aging rates was then tested experimentally for lifespan and healthspan extension using a small invertebrate model. Three protein targets of the rotifer Brachionus manjavacas corresponding to products of the transient receptor potential gene 7, ribosomal protein S6 polypeptide 2 gene, or forkhead box C gene, were screened against a compound library consisting of DrugBank drugs including 1347 FDA approved, non-nutraceutical molecules. Twenty nine drugs ranked in the top 1 % for binding to each target were subsequently included in our experimental analysis. Continuous exposure of rotifers to 1 µM naproxen significantly extended rotifer mean lifespan by 14 %. We used three endpoints to estimate rotifer health: swimming speed (mobility proxy), reproduction (overall vitality), and mitochondria activity (cellular senescence proxy). The natural decline in swimming speed with aging was more gradual when rotifers were exposed to three drugs, so that on day 6, mean swimming speed of females was 1.19 mm/s for naproxen (P = 0.038), 1.20 for fludarabine (P = 0
James, John S
The U.S. has an apparently growing problem with fake, counterfeit drugs entering the mainstream drug supply, and being fraudulently sold at full price in regular pharmacies and hospitals; some have no active ingredient, or too little, or substitute a cheap drug for an expensive one. The FDA has asked drug manufacturers to develop technology to track all shipments electronically as they move through the distribution chain; currently, RFID (radio frequency identification) is the preferred method for doing so. This article explains what is happening, and why we do not believe that this use of RFID is a privacy threat--though other privacy issues are among the most important questions we face today.
Delorme, Yann T; Anupindi, Kameswararao; Frankel, Steven H
A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration's (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo(™) ), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows . Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al.  for the four Reynolds numbers considered.
Opposing the explosive rise in tort litigation in the last two decades has been a corresponding rise in federal preemption claims. In the FDA context, the controversy has largely surrounded the issue of whether federal law preempts state common-law “failure-to-warn” claims against drug and medical-device manufacturers. During the current Bush Administration, FDA changed its position regarding preemption of state tort law claims and for the first time asserted that that compliance with FDA-man...
Wenstrom, Katharine D
The Food and Drug Administration and Environmental Protection Agency recently issued an updated draft of advice on fish consumption for pregnant and breastfeeding women, after survey data indicated that the majority of pregnant women do not eat much fish and thus may have inadequate intake of the omega 3 fatty acids eicosapentaenoic acid [EPA] and ducosahexaenoic acid [DHA]. Omega 3 fatty acids are essential components of membranes in all cells of the body and are vitally important for normal development of the brain and retinal tissues (especially myelin and retinal photoreceptors) and for maintenance of normal neurotransmission and connectivity. They also serve as substrates for the synthesis of a variety of antiinflammatory and inflammation-resolving mediators, favorably alter the production of thromboxane and prostaglandin E2, and improve cardiovascular health by preventing fatal arrhythmias and reducing triglyceride and C-reactive protein levels. Maternal ingestion of adequate quantities of fish (defined in many studies as at least 340 g of oily fish each week) has been associated with better childhood IQ scores, fine motor coordination, and communication and social skills, along with other benefits. Although the FDA did not clarify which fish to eat, it specifically advised against eating fish with the highest mercury levels and implied that fish with high levels of EPA and DHA and low levels of mercury are ideal. The FDA draft did not recommend taking omega 3 fatty acid or fish oil supplements instead of eating fish, which is advice that may reflect the fact that randomized controlled trials of DHA and EPA or fish oil supplementation generally have been disappointing and that the ideal daily dose of DHA and EPA is unknown. It seems safe to conclude that pregnant and nursing women should be advised to eat fish to benefit from naturally occurring omega 3 fatty acids, to avoid fish with high levels of mercury and other contaminants, and, if possible, to choose
Full Text Available Acrylamide is a versatile organic compound that finds its way into many products in our everyday life. The presence of acrylamide in foods dates from 2002, when a series of studies published in Sweden, confirmed its presence in high temperatures processed foods. At EU level, first adopted measure was Commission Recommendation on the monitoring of acrylamide levels in food, on May 2007, extended then by Commission Recommendation 2010/307/EU. European Food Safety Authority (EFSA then, collected and compiled data, each year (2007-2010, and published an annual report. On January 2011 was adopted the Recommendation on the investigations into the levels of acrylamide in food and then, on November 2013 was adopted Commission Recommendation 2013/647/EU on investigation into levels of acrylamide in food. Based on these, EFSA had published, in June 2015 a comprehensive risk assessment on acrylamide in food. The FDA first published a draft regarding Detection and Quantitation of Acrylamide in Foods, in 2003 followed in 2004 by the Action Plan for Acrylamide in Food. In 2006 FDA published Survey Data on Acrylamide in food then in 2009, in August (updated in November a Federal Register Notice entitled: Acrylamide in food: Request for comments and for scientific data and information. Their findings have been materialized, in November 2013, into a powerful tool for industry: Draft Guidance for industry: Acrylamide in Foods. Despite research implications that exposure to acrylamide from food is safe, some consumers may choose to take measures to further reduce their acrylamide exposure.
Arvidson, Kirk B
Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.
Rubina Kumari Baithalu
Full Text Available Anthropozoonotic parasite Toxoplasma gondii causes widespread human and animal diseases, mostly involving central nervous system. Human acquires toxoplasmosis from cats, from consuming raw or undercooked meat and from vertical transmission to the fetus through placenta from mother during pregnancy. Socio-epidemiological as well as unique environmental factors also plays a significant role in transmission of this infection. Preventive measures should be taken into account the importance of culture, tradition, and beliefs of people in various communities more than solving poverty and giving health education. Therefore the focus of this article is to create public awareness regarding sense of responsibility of looking after pets to prevent such an important zoonotic disease. [Vet. World 2010; 3(5.000: 247-249
Defamiliarization, the core theory of Russian formalism, emphasizes specific effects in a literary work by adopting fresh perspective to change readers’automatic and practical perception to an unfamiliar one. Edgar allan poe is one of the writ-ers who applied defamiliarization in his writing The Black Cat to help improve the literariness of a literature, break the set pat-tern and attract readers attention on modern people’s twisted personality and dark inner world.
American OpenFDA is an online public health program provided by the Food and Drug Administration of USA. This article mainly introduced the background and form of the opening program and the service contents of OpenFDA so as to provide a reference for the big data opening in the future in our country.%美国 OpenFDA 是美国食品药品监督管理局开放的一项在线公众健康项目。本文主要就 OpenFDA 的开放背景、开放形式、服务内容进行介绍，旨在为我国未来大数据开放提供借鉴。
The author's cat started to develop the signs of pemphigus foliaceus one month after he returned home after six months absence. The initial signs included dry coughing and difficulty with purring and swallowing, followed by typical changes of the skin. The cat was treated by a combination of chrysotherapy and systemic glucocorticoid injections, and remained free of clinical signs for one and a half years. The cat then relapsed and showed the initial signs except that coughing was not observed. It was treated as before but after a second relapse and the same treatment it slowly developed a general weakness and was euthanased.
... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and...
Food and Drug Administration (DHHS/PHS), Rockville, MD.
This document provides information, standards, and behavioral objectives for standardization and certification of retail food inspection personnel in the Food and Drug Administration (FDA). The procedures described in the document are based on the FDA Food Code, updated to reflect current Food Code provisions and to include a more refined focus on…
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of...
McGuire, Jennifer; Kaplan, Jason; Lapolla, John; Kleiner, Rima
The U.S. Food and Drug Administration (FDA) recently released its report: A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children). By evaluating the benefits and potential concerns of eating fish during pregnancy and breastfeeding, the analysis suggests that pregnant women consuming two seafood meals (8-12 oz) per week could provide their child with an additional 3.3 IQ points by age 9. Recent insights from behavioral economics research indicate that other factors, such as concerns about price and methylmercury (MeHg) exposure, appear to reduce fish consumption in many individuals.To assess the net effects of eating commercial fish during pregnancy, we compared the consumption of select fish species necessary to achieve IQ benefits with the amount necessary to have adverse developmental effects due to MeHg exposure. For the species or market types evaluated, the number of servings necessary to reach MeHg exposure to observe an adverse effect was at least twice that the amount estimated to achieve peak developmental benefit. We then reported average costs of fresh and canned or pouched fish, and calculated the cost per week for pregnant women to achieve maximum IQ benefits for their gestating child. Canned light tuna was the least expensive option at $1.83 per week to achieve maximum IQ benefit.Due to their relatively low cost, canned and pouched fish products eaten with enough regularity are likely to provide peak cognitive benefits. Because of its popularity, canned and pouched tuna could provide some of the largest cognitive benefits from fish consumption in the U.S. Future FDA consumer advice and related educational initiatives could benefit from a broader perspective that highlights the importance of affordable and accessible fish choices. These observations underscore the importance of clear public health messaging that address both health
US Fish and Wildlife Service, Department of the Interior — This training manual for the U.S. Fish and Wildlife Service Catalog (ServCat) provides detailed instructions on searching for records, creating records, and managing...
US Fish and Wildlife Service, Department of the Interior — This document lists the Natural Resource Program Center’s priority ServCat documents. It is recommended that these documents- which include annual narrative reports,...
Medleau, L; Latimer, K S; Duncan, J R
Food hypersensitivity was diagnosed in a 4-year-old Siamese cat. Clinical signs included intense erythema, with alopecia, excoriations, erosions, and crusts involving the ventral portion of the abdomen, inguinal region, medial aspect of each thigh, and cranial and lateral aspects of all 4 limbs. The cat was intensely pruritic. Histologically, there was cutaneous mast cell hyperplasia and diffuse infiltration of eosinophils in the dermis. Blood eosinophilia also was found. Clinical signs resolved after exclusive feeding of a hypoallergenic diet.
Md Tausif Alam
Full Text Available Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing, in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.
Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar
Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing), in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.
In this note I briefly discuss the Schrodinger's cat Gedankenexperiment. By analysing the information flow in the system I show that no entanglement exists between the atom and the cat. The atom and the cat are connected only through a classical information channel (detector clicks $\\rightarrow$ poison is released $\\rightarrow$ cat is dead). No amount of local operations and classical communication can entangle the atom and the cat. Consequently, the paradox disappears.
This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.
Full Text Available Following Food and Drug Administration (FDA approval, many drugs are prescribed for non-FDA-approved ("off-label" uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs. We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children.Retrospective, segmented time-series analysis using new prescription claims during 2003-2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone. FDA approved the sNDAs for pediatric use of olanzapine and quetiapine in December 2009, but did not approve the sNDA for pediatric use of ziprasidone.During the months before FDA approval of its pediatric sNDA, new prescriptions of olanzapine decreased for both children and adults. After FDA approval, the increase in prescribing trends was similar for both age groups (P = 0.47 for schizophrenia and bipolar disorder; P = 0.37 for other indications. Comparable decreases in use of quetiapine were observed between pediatrics and adults following FDA approval of its pediatric sNDA (P = 0.88; P = 0.63. Prescribing of ziprasidone decreased similarly for pediatric and adult patients after FDA non-approval of its pediatric sNDA (P = 0.61; P = 0.79.The FDA's sNDA determinations relating to use of antipsychotics in children did not result in changes in use that favored the approved sNDAs and disfavored the unapproved sNDA. Improved communication may help translate the agency's expert judgments to clinical practice.
Full Text Available People who feed cats that they do not perceive they own (sometimes called semi-owners are thought to make a considerable contribution to unwanted cat numbers because the cats they support are generally not sterilized. Understanding people's perception of cat ownership and the psychology underlying cat semi-ownership could inform approaches to mitigate the negative effects of cat semi-ownership. The primary aims of this study were to investigate cat ownership perception and to examine its association with human-cat interactions and caretaking behaviours. A secondary aim was to evaluate a definition of cat semi-ownership (including an association time of ≥1 month and frequent feeding, revised from a previous definition proposed in the literature to distinguish cat semi-ownership from casual interactions with unowned cats. Cat owners and semi-owners displayed similar types of interactions and caretaking behaviours. Nevertheless, caretaking behaviours were more commonly displayed towards owned cats than semi-owned cats, and semi-owned cats were more likely to have produced kittens (p<0.01. All interactions and caretaking behaviours were more likely to be displayed towards cats in semi-ownership relationships compared to casual interaction relationships. Determinants of cat ownership perception were identified (p<0.05 and included association time, attachment, perceived cat friendliness and health, and feelings about unowned cats, including the acceptability of feeding unowned cats. Encouraging semi-owners to have the cats they care for sterilized may assist in reducing the number of unwanted kittens and could be a valuable alternative to trying to prevent semi-ownership entirely. Highly accessible semi-owner "gatekeepers" could help to deliver education messages and facilitate the provision of cat sterilization services to semi-owners. This research enabled semi-ownership to be distinguished from casual interaction relationships and can assist
Aaron S Coyner
Full Text Available To assess the neuroprotective effects of flibanserin (formerly BIMT-17, a dual 5-HT1A agonist and 5-HT2A antagonist, in a light-induced retinopathy model.Albino BALB/c mice were injected intraperitoneally with either vehicle or increasing doses of flibanserin ranging from 0.75 to 15 mg/kg flibanserin. To assess 5-HT1A-mediated effects, BALB/c mice were injected with 10 mg/kg WAY 100635, a 5-HT1A antagonist, prior to 6 mg/kg flibanserin and 5-HT1A knockout mice were injected with 6 mg/kg flibanserin. Injections were administered once immediately prior to light exposure or over the course of five days. Light exposure lasted for one hour at an intensity of 10,000 lux. Retinal structure was assessed using spectral domain optical coherence tomography and retinal function was assessed using electroretinography. To investigate the mechanisms of flibanserin-mediated neuroprotection, gene expression, measured by RT-qPCR, was assessed following five days of daily 15 mg/kg flibanserin injections.A five-day treatment regimen of 3 to 15 mg/kg of flibanserin significantly preserved outer retinal structure and function in a dose-dependent manner. Additionally, a single-day treatment regimen of 6 to 15 mg/kg of flibanserin still provided significant protection. The action of flibanserin was hindered by the 5-HT1A antagonist, WAY 100635, and was not effective in 5-HT1A knockout mice. Creb, c-Jun, c-Fos, Bcl-2, Cast1, Nqo1, Sod1, and Cat were significantly increased in flibanserin-injected mice versus vehicle-injected mice.Intraperitoneal delivery of flibanserin in a light-induced retinopathy mouse model provides retinal neuroprotection. Mechanistic data suggests that this effect is mediated through 5-HT1A receptors and that flibanserin augments the expression of genes capable of reducing mitochondrial dysfunction and oxidative stress. Since flibanserin is already FDA-approved for other indications, the potential to repurpose this drug for treating retinal
Full Text Available Mitral flow propagation velocity (Vp is an index used to evaluate the left ventricular diastolic function. Its influence on human and small animal cardiopathies has been studied; however there are few reports evaluating this variable in domestic felines. In addition, there is a lack of studies in non-sedated healthy cats. Therefore, the purpose of this study was to establish values for Vp and its correlation with other echocardiographic indexes in non-sedated healthy cats in order to provide new perspectives related to diastolic function in this species. Twenty-six clinically healthy cats were submitted to echocardiography to assess the animals' cardiac conditions. Variables such as age, heart rate (HR, body surface area (BSA, initial (E mitral and late (A mitral ventricular filling waves, isovolumic relaxation time (IVRT and E/IVRT relation were correlated to Vp. No proven relation between any of these variables and Vp was observed in this present study, except for HR and BSA. In the variability analysis, higher values were verified for inter-observer analysis. This study concludes that Vp proved to be an useful index for estimating left ventricular relaxation in non-sedated healthy domestic cats and provides reference ranges for this variable.
Perspectivas católicas progressistas em saúde e direitos reprodutivos: o desafio político da ortodoxia Progressive Catholic perspectives on reproductive health and rights: the political challenge of orthodoxy
Full Text Available Os católicos não seguem a doutrina Católica Romana oficial em assuntos de sexualidade e reprodução, que inclui considerar que a contracepção, mesmo para as pessoas casadas, sempre é má, e o aborto provocado, até para salvar a vida da mulher, é sempre imoral. Bem menos conhecido é o envolvimento da Igreja nas decisões políticas sobre estes mesmos assuntos. Por exemplo, a Igreja tem causado, direta ou indiretamente, o fechamento de serviços de fertilização in vitro (FIV desde a Polônia até o Uruguai. Como a Igreja nunca declarou que quaisquer das opiniões dominantes, ao longo do tempo, acerca de quando o feto se torna uma pessoa constitui uma doutrina ou dogma, não há nenhuma justificativa teológica para a condenação absoluta ao aborto. Também não há uma teoria do "aborto justo" semelhante à da "guerra justa", que permite matar em certas circunstâncias. A grande distância entre as posições da Igreja e os pontos de vista dos fiéis tem levado os católicos a desenvolvem sua própria ética sexual e reprodutiva, funcional e digna. A Igreja poderia dar uma contribuição positiva para a solução dos problemas discutidos se escolhesse estar ao lado das pessoas em sua busca em vez de por obstáculos.Catholics do not follow official Roman Catholic teachings on matters of sexuality and reproduction, including the position that contraception , even for married couples, is always evil, and that direct abortion , even to save a woman's life, is always immoral. Less well known is the extent of the Church's involvement in policy-making on these same issues. For example, it has forced the closing of in vitro fertilization (IVF services from Poland to Uruguay. As the Church has never declared any of the dominant views, over time, regarding when a fetus becomes a person as a doctrine or dogma, there is no theological justification for the absolute condemnation of abortion. Neither is there a theory on "just abortion" similar to
Bermingham, Emma N; Thomas, David G; Morris, Penelope J; Hawthorne, Amanda J
A meta-analysis was carried out in order to establish the energy requirements of adult cats. Publications that identified cat body weight (BW) were used to generate allometric relationships between energy requirements and BW of healthy adult cats, using log-log linear regression. Energy requirements were expressed in kcal/kg BW to be consistent with those reported by the National Research Council. Mean maintenance energy requirements were 55.1 (se 1.2) kcal/kg BW (115 treatment groups). Three allometric equations were identified to predict the energy requirements for maintenance of BW in the cat based on BW: light (53.7 kcal/kg BW- 1.061), normal (46.8 kcal/kg BW- 1.115) and heavy (131.8 kcal/kg BW- 0 .366). When reported on lean mass, the allometric equation revealed maintenance requirements were 58.4 kcal/kg lean mass- 1.140 (adjusted R2 0.694; thirty-six treatment groups). The present review suggests that values for maintenance energy requirements based on BW alone may not be an accurate prediction and more detailed information on the age, sex and neuter status, BW and composition would enhance the ability to interpret the maintenance energy requirements of cats.
Liu, Kassity Yefei
The U.S. Food and Drug Administration (FDA) regulates the promotion of prescription drugs. With the emergence of Web 2.0 technology and social media, the FDA faces new regulatory challenges as pharmaceutical companies have started to use social media tools to market prescription drugs to consumers. This paper first explores the history of social media, its use by the FDA, and its growing use by the pharmaceutical industry. The paper then discusses some of the actions that the agency has taken...
... Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food Safety... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...
Chaurasia, Chandra S.; Mueller, Markus; Bashaw, Edward D.; Benfeldt, Eva; Bolinder, Jan; Bullock, Ross; Bungay, Peter M.; DeLange, Elizabeth C. M.; Derendorf, Hartmut; Elmquist, William F.; Hammarlund-Udenaes, Margareta; Joukhadar, Christian; Kellogg, Dean L.; Lunte, Craig E.; Nordstrom, Carl Henrik; Rollema, Hans; Sawchuk, Ronald J.; Cheung, Belinda W. Y.; Shah, Vinod P.; Stahle, Lars; Ungerstedt, Urban; Welty, Devin F.; Yeo, Helen
Many decisions in drug development and medical practice are based on measuring blood concentrations of endogenous and exogenous molecules. Yet most biochemical and pharmacological events take place in the tissues. Also, most drugs with few notable exceptions exert their effects not within the bloods
Zito, Sarah; Vankan, Dianne; Bennett, Pauleen; Paterson, Mandy; Phillips, Clive J C
People who feed cats that they do not perceive they own (sometimes called semi-owners) are thought to make a considerable contribution to unwanted cat numbers because the cats they support are generally not sterilized. Understanding people's perception of cat ownership and the psychology underlying cat semi-ownership could inform approaches to mitigate the negative effects of cat semi-ownership. The primary aims of this study were to investigate cat ownership perception and to examine its association with human-cat interactions and caretaking behaviours. A secondary aim was to evaluate a definition of cat semi-ownership (including an association time of ≥1 month and frequent feeding), revised from a previous definition proposed in the literature to distinguish cat semi-ownership from casual interactions with unowned cats. Cat owners and semi-owners displayed similar types of interactions and caretaking behaviours. Nevertheless, caretaking behaviours were more commonly displayed towards owned cats than semi-owned cats, and semi-owned cats were more likely to have produced kittens (pcats in semi-ownership relationships compared to casual interaction relationships. Determinants of cat ownership perception were identified (pcat friendliness and health, and feelings about unowned cats, including the acceptability of feeding unowned cats. Encouraging semi-owners to have the cats they care for sterilized may assist in reducing the number of unwanted kittens and could be a valuable alternative to trying to prevent semi-ownership entirely. Highly accessible semi-owner "gatekeepers" could help to deliver education messages and facilitate the provision of cat sterilization services to semi-owners. This research enabled semi-ownership to be distinguished from casual interaction relationships and can assist welfare and government agencies to identify cat semi-owners in order to develop strategies to address this source of unwanted cats.
Luteijn, Johannes Michiel; Morris, Joan K; Garne, Ester
AIMS: Information about medication safety in pregnancy is inadequate. We aimed to develop a signal detection methodology to routinely identify unusual associations between medications and congenital anomalies using data collected by 15 European congenital anomaly registries. METHODS: EUROmediCAT......). CONCLUSIONS: Medication exposure data in the EUROmediCAT central database can be analyzed systematically to determine a manageable set of associations for validation and then testing in independent datasets. Detection of teratogens depends on frequency of exposure, level of risk and teratogenic specificity....
The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.
... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood... for Industry and FDA Staff: ] Investigational New Drug Applications for Minimally Manipulated... Investigational New Drug Application (IND) for certain hematopoietic progenitor cells from...
... Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal... Island Sea Lab (DISL). FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the...
Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn
This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.
Fehnel, Sheri; DeMuro, Carla; McLeod, Lori; Coon, Cheryl; Gnanasakthy, Ari
Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed the guidance with admirable intent, and the recommendations within this document are based on sound scientific principles. However, implementation of the guidance has been somewhat inconsistent within the Study Endpoints and Label Development (SEALD) and across the various FDA-reviewing divisions. Industry and regulatory bodies need to work toward gaining common ground to best support registration of treatments that could extend patients' lives, reduce symptoms, and/or improve health-related quality of life. PROs are valuable tools in communicating these messages, and realistic implementation of the FDA PRO Guidance may truly facilitate this process.
... Advance Science for Vaccines to Prevent Mumps and Whooping Cough Share Tweet Linkedin Pin it More sharing options ... in the FDA’s laboratories in Silver Spring, MD. Whooping Cough: Background and Key Findings The FDA is studying ...
Gross, T L; Olivry, T; Vitale, C B; Power, H T
A novel form of mural folliculitis is described in seven cats. Clinically, all cats exhibited generalized alopecia with scaling or crusting that was more pronounced over the head, neck, and shoulders. The face and muzzle of all cats was unusually thickened. Six of seven cats were progressively lethargic but did not demonstrate any other consistent systemic abnormalities. Histologically, there was severe mixed inflammation of the wall of the follicular isthmus in all cats, accompanied by some follicular destruction in five cats. Sebaceous glands were not affected. All cats had variable, but often striking, follicular mucin deposition, as well as epidermal hyperkeratosis and crusting. The cause of the severe mural folliculitis was not identified, and all cats responded poorly to immunomodulating therapy. Follicular mucinosis may be a nonspecific finding, likely reflective of the follicular lymphocytic milieu, and does not always herald follicular lymphoma.
Full Text Available The metacestode of Taenia solium, Cysticercus cellulosae, was recovered from the brain of a cat showing central nervous clinical signs ante mortem. This is the first record of cerebral cysticercosis in a cat in South Africa.
James, J S
The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.
On the basis of modern education theory and teaching technology, and social cognitive theory, with the help of CAT, a new teaching mode is founded to cultivate students' business English writing skill. The motivation to set up the mode is to satisfy the need for the development of English writing theory, the need for social development of business English writing, the need for teachers instruction reform. The mode is divided into three stages, inorganic counseling, half machine counseling, and the whole machine counseling , according to the teaching process and teaching requirement. Through the stages student's business English skills are likely to be enhanced and teachers' academic performance might be improved.%在当今教育理论和教学技术发展的基础上，以社会认知论为依据，以商务英语写作机辅教学为手段，探索一种新的培养学生商务英语写作能力的教学模式。该模式的动力基础是英语写作理论的发展需要、社会发展对商务英语写作的需要、教师教学的需要。其教学模式根据过程和教学需要分为无机辅导、半机辅导、全机辅导三个写作阶段。通过这三个阶段能够提升学生的商务英语能力和教师教学科研水平。
Jenson, Desmond; Lester, Joelle; Berman, Micah L
Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.
... a s t is O : wAnneIrmsportant What role do cats play in the spread of toxoplasmosis? Cats get Toxoplasma infection by eating infected rodents, birds ... animals, or anything contaminated with feces from another cat that is shedding the microscopic parasite in its ...
... What Happens in the Operating Room? Getting a CAT Scan (Video) KidsHealth > For Kids > Getting a CAT Scan (Video) A A A en español Obtención de una tomografía computada (video) CAT stands for "computerized axial tomography." Translated, that means ...
... the most common kind of tapeworm dogs and cats get? The most common tapeworm of dogs and cats in the United States is called Dipylidium caninum . ... infected with a tapeworm larvae. A dog or cat may swallow a flea while self-grooming. Once ...
@@ ( Dogs and cats are permanent enemies. A dog named Bubby is catnapped by the cats. The whole cats' world is shocked and alert. ) Dog Chairman: Gentlemen, a few moments ago I received word of the gravest nature. The key agent working the Brody case has been catnapped. Although he is safe, new must replace him as soon as possible.
Given, Joanne E; Loane, Maria; Luteijn, Johannes Michiel
AIMS: To evaluate congenital anomaly (CA)-medication exposure associations produced by the new EUROmediCAT signal detection system and determine which require further investigation. METHODS: Data from 15 EUROCAT registries (1995-2011) with medication exposures at the chemical substance (5th level...
Not many life stories in physics involve Nazis, illicit sex, a strange cat and the genetic code. Thus, a new biography of the great Austrian physicist Erwin Schrödinger is always of interest, and with Erwin Schrödinger and the Quantum Revolution, veteran science writer John Gribbin does not disappoint.
Full Text Available BACKGROUND: Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. METHODS AND FINDINGS: Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence
Onomatopoeia and mimicry word is one of the important features of Japanese, in newspapers, magazines, TV or fiction, prose, the use of onomatopoeia and mimicry word can be seen everywhere. Japanese onomatopoeia and mimicry word and flexible in use, strong randomness, and variety, is one of the most difficult to learn Japanese. In the process of translation of onomatopoeia and mimicry word, many things must be translated into Chinese onomatopoeia, but the number is very few, therefore, the translation of onomatopoeia and mimicry word is difficult to reach, to make the appropriate adjustments according to the context requires."I am the cat"is a representative of Japanese literary works of Natsume Soseki, works in a humorous tone, from the perspective of"cat"to view"hypocrisy"in human life, profound significance;at the same time, the use of onomatopoeia and mimicry word, and frequently works, more vivid, lively.%拟声、拟态词是日语的重要特征之一，不论在报刊、杂志、电视还是小说、散文中，拟声、拟态词的使用都随处可见。日语拟声、拟态词使用灵活，随意性强，而且种类繁多，一直是日语学习的难点之一。拟声、拟态词在汉译的过程中，很多情况都要翻译成汉语中的象声词，但汉语中的象声词数量很少，因此，拟声、拟态词的汉译很难达到一一的对应，很多时候要根据语境的要求作出适当的调整。《我是猫》是日本文学巨匠夏目漱石的代表作之一，作品以幽默诙谐的语调、以“猫”的视角来反观人类“虚伪”的生活，意义深刻；同时，作品中频繁的使用拟声、拟态词，更显得生动、活泼。
I liked cat very much. In my old opinion, cat was cute and gentle. One day, my friend asked me to feed the cat for him. So I went to his house in order to take care of his cat. His neighbor was an old woman. When I was doing some cleaning, the old woman asked me if I needed some help. Suddenly, the cat stretched out its sharp claws, and clawed me and bit me with its sharp teeth. WowA It was too abrupt. The old woman got scared. “It goes crazyA” I said and asked her to get out of the room, otherwise she woul...
This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.
KuKanich, Butch; Warner, Matt; Hahn, Kevin
OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.
Jan S Suchodolski
Full Text Available Recent studies have revealed that microbes play an important role in the pathogenesis of gastrointestinal (GI diseases in various animal species, but only limited data is available about the microbiome in cats with GI disease. The aim of this study was to evaluate the fecal microbiome in cats with diarrhea. Fecal samples were obtained from healthy cats (n = 21 and cats with acute (n = 19 or chronic diarrhea (n = 29 and analyzed by sequencing of 16S rRNA genes, and PICRUSt was used to predict the functional gene content of the microbiome. Linear discriminant analysis (LDA effect size (LEfSe revealed significant differences in bacterial groups between healthy cats and cats with diarrhea. The order Burkholderiales, the families Enterobacteriaceae, and the genera Streptococcus and Collinsella were significantly increased in diarrheic cats. In contrast the order Campylobacterales, the family Bacteroidaceae, and the genera Megamonas, Helicobacter, and Roseburia were significantly increased in healthy cats. Phylum Bacteroidetes was significantly decreased in cats with chronic diarrhea (>21 days duration, while the class Erysipelotrichi and the genus Lactobacillus were significantly decreased in cats with acute diarrhea. The observed changes in bacterial groups were accompanied by significant differences in functional gene contents: metabolism of fatty acids, biosynthesis of glycosphingolipids, metabolism of biotin, metabolism of tryptophan, and ascorbate and aldarate metabolism, were all significantly (p<0.001 altered in cats with diarrhea. In conclusion, significant differences in the fecal microbiomes between healthy cats and cats with diarrhea were identified. This dysbiosis was accompanied by changes in bacterial functional gene categories. Future studies are warranted to evaluate if these microbial changes correlate with changes in fecal concentrations of microbial metabolites in cats with diarrhea for the identification of potential diagnostic or
Yates, R.W.; Weller, R.E.; Feldman, B.F.
Myeloproliferative disorders, a complex of cytologic abnormalities arising in the bone marrow, are among domestic animals most frequently recognized in cats but are relatively uncommon. A 4-year-old female Siamese, with splenomegaly and weight loss, was listless, anorectic, pale and dehydrated. A hemogram showed severe, macrocytic normochromic anemia, leukocytosis and reticulocytosis, with abnormally high numbers of nucleated RBC and undifferentiated blast cells. Bone marrow smears contained predominantly undifferentiated blast cells, RBC precursors and myeloblasts. The fluorescent antibody test for FeLV was positive. The cat died 66 days later despite a blood transfusion and chemotherapy. Necropsy confirmed a diagnosis of myeloproliferative disease, with hepatic and splenic invasion. 15 references, 5 figures, 1 table.
Sharifi, Hassan; Nassiri, Seyed Mahdi; Esmaelli, Hossein; Khoshnegah, Javad
A 14-year-old female domestic shorthair cat was presented to Tehran University Veterinary Teaching Hospital for a persistent fever, anorexia, intermittent vomiting, weight loss and weakness. The main clinical signs were pale mucous membranes, dehydration and splenomegaly. The complete blood count and serum biochemistry tests revealed non-regenerative anaemia, thrombocytopenia and increased alkaline phosphatase (ALP) activity. An enzyme-linked immunosorbent assay (ELISA) test for feline leukaemia virus was negative. Blood film and bone marrow examination revealed a large number of immature eosinophils with variable sizes and numbers of faintly azurophilic granules. Cytochemical staining of blood film demonstrated 70% positive cells for ALP activity. Four percent CD34 positive cells were detected by flow cytometry. As eosinophilic leukaemia is difficult to identify by light microscopy, well-defined diagnostic criteria and the use of flow cytometry and cytochemical staining can improve the ability to correctly diagnose this type of leukaemia in cats.
Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen
The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications.
Rulis, Alan M; Levitt, Joseph A
Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again. This article reviews the basic components of the FDA's decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers.
Chung, Carolyn S; Yamini, Sedigheh; Trumbo, Paula R
In this review, we explain how the US Food and Drug Administration (FDA) used its evidence-based review system to evaluate the scientific evidence for a qualified health claim for 100% whey-protein partially hydrolyzed infant formula (W-PHF) and reduced risk of atopic dermatitis (AD). The labeling of health claims, including qualified health claims, on conventional foods and dietary supplements require premarket approval by the FDA. Health claims characterize the relationship between a substance (food or food component) and disease (eg, cancer or cardiovascular disease) or health-related condition (eg, hypertension). To determine whether sufficient evidence exists to support the qualified health claim, the FDA evaluated human intervention studies that evaluated the role of W-PHF in reducing the risk of AD. The FDA concluded there is little to very little evidence, respectively, to support a qualified health claim concerning the relationship between intake of W-PHF and a reduced risk of AD in partially breastfed and exclusively formula-fed infants throughout the first year after birth and up to 3 years of age. In addition, the FDA required a warning statement be displayed along with the health claim to indicate to consumers that partially hydrolyzed infant formulas are not hypoallergenic and should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.
Cannon, Claire M.
Naturally occurring tumors in dogs are well-established models for several human cancers. Domestic cats share many of the benefits of dogs as a model (spontaneous cancers developing in an immunocompetent animal sharing the same environment as humans, shorter lifespan allowing more rapid trial completion and data collection, lack of standard of care for many cancers allowing evaluation of therapies in treatment-naïve populations), but have not been utilized to the same degree in the One Medici...
Aziz, Hassan A.; Plesec, Thomas P.; Sabella, Camille; Udayasankar, Unni K.; Singh, Arun D.
Background To expand the spectrum of ophthalmic manifestations in cat scratch disease. Methods Case report. Results A 7-year-old male was referred for evaluation of his left optic disc after failing vision screening test at school. His visual acuity was 20/20 OD and light perception OS. Fundus examination showed a left optic disc lesion associated with an exudative retinal detachment and vitreous seeding. Ultrasonography revealed a 7 × 7.5 × 3.8 mm lesion with a possible 6.3 mm of retrolaminar extension into the substance of the optic nerve. Brain MRI did not show evidence of optic nerve involvement but revealed a 6-mm nodule of the pineal gland suggestive of a pineoblastoma. Enucleation was performed and histopathology revealed a suppurative granulomatous inflammation suggestive of Bartonella infection. Upon further questioning, the patient had recent exposure to kittens with areas of cat scratches along both of his arms. He was subsequently referred to and treated with a 2-week course of trimethoprim-sulfamethoxazole and rifampin by the pediatric infectious disease specialist. Repeat brain MRI showed interval total resolution of enlarged pineal gland. Conclusion: Optic nerve granulomas are a rare presentation of cat scratch disease and could potentially masquerade as retinoblastoma. PMID:27843905
We introduce the `Complete Wave Function' and deduce that all living beings, not just Schroedinger's cat, are actually described by a superposition of `alive' and `dead' quantum states; otherwise they would never die. Therefore this proposal provides a quantum mechanical explanation to the world-wide observation that we all pass away. Next we consider the Measurement problem in the framework of M-theory. For this purpose, together with Schroedinger's cat we also place inside the box Rasputin's cat, which is unaffected by poisson. We analyse the system identifying its excitations (catons and catinos) and we discuss its evolution: either to a classical fight or to a quantum entanglement. We also propose the $BSV\\Psi$ scenario, which implements the Complete Wave Function as well as the Big Bang and the String Landscape in a very (super)natural way. Then we test the gravitational decoherence of the entangled system applying an experimental setting due to Galileo. We also discuss the Information Loss paradox. For ...
Full Text Available Case summary A 4-year-old male neutered domestic shorthair cat was presented to the Oregon State University cardiology service for suspected pericardial effusion. Cardiac tamponade was documented and pericardiocentesis yielded purulent fluid with cytologic results supportive of bacterial pericarditis. The microbial population consisted of Pasteurella multocida, Actinomyces canis, Fusobacterium and Bacteroides species. Conservative management was elected consisting of intravenous antibiotic therapy with ampicillin sodium/sulbactam sodium and metronidazole for 48 h followed by 4 weeks of oral antibiotics. Re-examination 3 months after the initial incident indicated no recurrence of effusion and the cat remained free of clinical signs 2 years after presentation. Relevance and novel information Bacterial pericarditis is a rare cause of pericardial effusion in cats. Growth of P multocida, A canis, Fusobacterium and Bacteroides species has not previously been documented in feline septic pericarditis. Conservative management with broad-spectrum antibiotics may be considered when further diagnostic imaging or exploratory surgery to search for a primary nidus of infection is not feasible or elected.
Full Text Available Kirsten M Hoelmkjaer, Charlotte R Bjornvad Department of Veterinary Clinical and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Frederiksberg, Denmark Abstract: Obesity is a common nutritional disorder in cats, especially when they are neutered and middle-aged. Obesity predisposes cats to several metabolic and clinical disorders, including insulin resistance, diabetes mellitus, lameness, and skin disease. Prevention and treatment of obesity is therefore of great importance in veterinary practice. Correct assessment of body composition is important for recognizing early states of obesity and for monitoring success of weight-loss programs. Various methods for assessing body composition have been proposed, of which a 9-point body-condition score has been validated in cats, and is possibly the most simple to use in the clinic; however, for extremely obese individuals, it is less useful. When calculating the appropriate daily caloric intake for a weight-loss plan, the aim is to maintain a safe weight-loss rate, increasing the chance of preserving lean body mass and decreasing the risk of developing hepatic lipidosis, while also producing a sufficient weight-loss rate to keep owners motivated. A weight-loss rate of 0.5%–2% per week is recommended, which for a cat that needs to lose 3 kg body weight results in an anticipated time for reaching the target weight of 24–60 weeks. There are several purpose-made weight-loss diets available. The optimal composition of a weight-loss diet for cats is unknown, but most of the available products have lower caloric density, an increased nutrient:energy ratio, and higher protein and fiber content. Regular follow-up visits allow the caloric intake to be adjusted based on progress, and possibly increase the chance of success. This review discusses the risk factors for and consequences of obesity, and gives directions for formulating a weight-loss plan, including daily caloric
Leonard, Elizabeth Weeks
On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.
Cassidy, K; Elyashiv-Barad, S
US FDA's continual effort to evaluate the safety of food-contact materials includes periodically re-examining our established packaging factors, such as consumption and food-type distribution factors. The use of polystyrene in food-contact and disposable food-packaging applications has expanded and is expected to continue to increase in the future. Therefore, it is important to revise the polystyrene consumption factor to account for increases in consumer exposure to substances migrating from styrenic food packaging. The currently used consumption factor for polystyrene is 0.1, which is based on market data collected around 1980. US FDA has revised the polystyrene consumption factor utilizing three different sources of market data. Using consumption and population data, US FDA calculated a new consumption factor of 0.14 for polystyrene. This consumption factor has been further subdivided to allow for the refinement of exposure estimates for uses limited to specific subcategories of polystyrene packaging.
The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery
The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.
Ahmed, Rajib; Paul, Shyamal Kumar; Hossain, Muhammad Akram; Ahmed, Salma; Mahmud, Muhammad Chand; Nasreen, Syeda Anjuman; Ferdouse, Faria; Sharmi, Rumana Hasan; Ahamed, Farid; Ghosh, Souvik; Urushibara, Noriko; Aung, Meiji Soe; Kobayashi, Nobumichi
High prevalence of Rickettsia felis in patients with fever of unknown origin was revealed in the north-central Bangladesh from 2012 to 2013. Subsequently, in this study, prevalence of R. felis in cats and cat fleas (Ctenocephalides felis), together with febrile patients, was studied by PCR detection of 17 kDa antigen gene and DNA sequencing. R. felis was detected in 28% (28/100) and 21% (14/68) of cat blood and cat flea samples, respectively, whereas 42% (21/50) of patients were positive for R. felis. R. felis-positive cat fleas were detected at significantly higher rate on R. felis-positive cats. The results suggested a potential role of cats and cat fleas for transmission of R. felis to humans in Bangladesh.
Hagman, Ragnvi; Ström Holst, Bodil; Möller, Lotta; Egenvall, Agneta
Pyometra is a clinically relevant problem in intact female cats and dogs. The etiology is similar in both animal species, with the disease caused by bacterial infection of a progesterone-sensitized uterus. Here, we studied pyometra in cats with the aim to describe the incidence and probability of developing pyometra based on age and breed. The data used were reimbursed claims for veterinary care insurance or life insurance claims or both in cats insured in a Swedish insurance database from 1999 to 2006. The mean incidence rate (IR) for pyometra was about 17 cats per 10,000 cat years at risk (CYAR). Cats with pyometra were diagnosed at a median age of 4 years and a significant breed effect was observed. The breed with the highest IR (433 cats per 10,000 CYAR) was the Sphynx, and other breeds with IR over 60 cats per 10,000 CYAR were Siberian cat, Ocicat, Korat, Siamese, Ragdoll, Maine coon, and Bengal. Pyometra was more commonly diagnosed with increasing age, with a marked increase in cats older than 7 years. The mean case fatality rate in all cats was 5.7%, which is slightly higher than corresponding reports in dogs of 3% to 4%. Geographical location (urban or rural) did not affect the risk of developing the disease. The present study provides information of incidence and probability of developing pyometra based on age, breed, and urban or rural geographical location. These data may be useful for designing cat breeding programs in high-risk breeds and for future studies of the genetic background of the disease.
Mahalski, Pauline A.; And Others
Surveyed elderly women in two New Zealand cities; one allowed pet cats, one did not. Attitudes toward pet cats were more positive in city allowing pets and among pensioners who owned, or wished to own, cats. Since positive attitudes outweighed negative ones, City Authority banning cats reversed its policy. Found conflicting evidence about cats'…
... 42 Public Health 1 2010-10-01 2010-10-01 false Dogs and cats. 71.51 Section 71.51 Public Health... QUARANTINE Importations § 71.51 Dogs and cats. (a) Definitions. As used in this section the term: Cat means all domestic cats. Confinement means restriction of a dog or cat to a building or other enclosure at...
Federal Laboratory Consortium — CATS facility is at the Construction Engineering Research Laboratory (CERL), Champaign, IL. This 1-acre test site includes a variety of subsurface features carefully...
... Dogs Farm Animals Backyard Poultry Ferrets Fish Horses Reptiles and Amphibians Turtles Kept as Pets Key Messages ... L. Feline Bartonellosis. The Veterinary Clinics of North America. Small Animal Practice. 2010 Nov;40(6):1073- ...
Taylor, Christy Marie
In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…
E. Poluzzi (Elisabetta); E. Raschi (Emanuel); A. Koci (Ariola); U. Moretti (Ugo); E. Spina (Edoardo); E.R. Behr (Elijah ); M.C.J.M. Sturkenboom (Miriam); F. de Ponti (Fabrizio)
textabstractBackground: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US FDA Adverse Event Reporting System
Pouwels, Koen B; van Grootheest, Kees
In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased risk of ischemic heart disease. It is often stated that the first signs of an increased risk of ischemic heart disease were noticed in 2004, however already in 2001 the FDA concluded, based on data available to the EMA at the time of initial approval, that rosiglitazone should not be used in combination with insulin, because this combination therapy was associated with an increased risk of cardiac failure and ischemic heart disease. Remarkably, in 2007, when the evidence against this combination therapy had increased, the EMA made a decision that encouraged the use of insulin in combination with rosiglitazone, while the FDA tried to restrict this combination therapy. Despite the publication of several studies, including a large randomized controlled study, the cardiovascular risk of rosiglitazone still has not been definitively established. The weight given to the benefits and the risks seems mainly a subjective decision. To prevent new cases like rosiglitazone, more attention should be given to evaluation of study protocols of safety trials prior to their starts. This paper gives a critical overview of the decision making process at the FDA and the EMA on the basis of public available information.
Chirba, Mary Ann; Sweetapple, Berkley; Hannon, Charles P; Anderson, John A
In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval.
Juan Carlos Martínez-Aguayo
Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.
... place during fiscal years 2008 to 2010. The resulting number of total recalls (9,303) and terminations.... Total Annual Reporting A. Recall Strategy Request firms develop a recall strategy including provision... Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION:...
Kesselheim, Aaron S; Tan, Yongtian Tina; Darrow, Jonathan J; Avorn, Jerry
Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse.
Pouwels, Koen B.; van Grootheest, Kees
In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased ris
... (CONTINUED) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL...) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be... information, including clinical data if deemed necessary by the Commissioner, that demonstrates that...
Chang, Yang; Burckart, Gilbert J; Lesko, Lawrence J; Dowling, Thomas C
Pharmacokinetic (PK) studies in patients with liver disease are an important clinical pharmacology component of drug development. In 2003, FDA released the guidance for industry on "Pharmacokinetics in Patients with Impaired Hepatic Function," which provides recommendations to sponsors on study design, data analysis, and impact on dosing and labeling. We evaluated the quality and consistency of hepatic dosing recommendations, and compared contemporary clinical practice of dosing in patients with impaired hepatic function with product labels. All new molecular entities (NME) and labels approved by the FDA during the period of January 2004 to December 2011 were reviewed. The fraction of the dose hepatically eliminated, quality of hepatic impairment PK studies reported, and any dose recommendations provided in the label and in a tertiary clinical reference (Micromedex) were reviewed. Out of 157 NMEs, 67 met the criteria for evaluation of dosing in hepatic disease. Problem areas were identified related to the lack of specific hepatic metabolism information in 90% of FDA-approved labels, inconsistent terminology, and "use with caution in liver disease" in 27% of NME. Updating the FDA guidance on PK studies in patients with impaired hepatic function could provide a standardized approach to improve the clinical usefulness of this dosing information for practitioners.
Background: Advances in microbial genomics and bioinformatics are offering greater insights into the emergence and spread of foodborne pathogens in outbreak scenarios. The Food and Drug Administration (FDA) has developed the genomics tool ArrayTrackTM, which provides extensive functionalities to man...
De Moura, Fabiana F; Lewis, Kara D; Falk, Michael C
The U.S. FDA defines whole grains as consisting of the intact, ground, cracked, or flaked fruit of the grains whose principal components, the starchy endosperm, germ, and bran, are present in the same relative proportions as they exist in the intact grain. We evaluated the effect of applying the FDA definition of whole grains to the strength of scientific evidence in support of claims for risk reduction of cardiovascular disease (CVD). We concluded that using the FDA definition for whole grains as a selection criterion is limiting, because the majority of existing studies often use a broader meaning to define whole grains. When considering only whole grain studies that met the FDA definition, we found insufficient scientific evidence to support a claim that whole grain intake reduces the risk of CVD. However, a whole grain and reduced risk of CVD health claim is supported when using a broader concept of whole grain to include studies that considered intake of fiber-rich bran and germ as well as whole grain. This type of analysis is complicated by diversity in nutrients and bioactive components among different types of whole grains.
... and Biosimilar Biological Product Sponsors or Applicants; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar... biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the...
Fukuda, Mitsuhiro; Takao, Yoshimi; Tamai, Yoshinori
The computer-aided molecular design of a rigid ring molecule has been performed. As a candidate molecule, the polyimide derived from 2,2-bis(3,4-carboxylphenyl) hexafluoropropane dianhydride (6FDA) with m-phenylenediamine (MDA) has been used. The optimized structures of the 6FDA-MDA model compounds including a precursor type amic acid model were investigated using the density functional theory (DFT) at the B3LYP/6-311G(d,p) level. Using the optimized structures of the model compounds, the probable combinations to form a flat ring polyimide are considered by taking the spatial angles between the respective aromatic groups into consideration. We selected several combinations with different conformations and the number of monomer units. We showed that the dimer, trimer and tetramer of not only the 6FDA-based ring imide but also the corresponding ring amic acid can have a stable geometry. Each of them contains a cavity of sub-nanometer size and characteristic shape. Among them, the interaction energy with some guest molecules are evaluated for the smallest ring imide constructed from two units of 6FDA-MDA using the DFT calculations.
Sage, Adam; Blalock, Susan J; Carpenter, Delesha
This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications.
Juliana Clemente Machado
Full Text Available The domestic cat has been symbolically represented over time in a very different way, with connotations sometimes positive and sometimes negative. It is also paradoxical the way that society historically interacts with this feline so, its symbolic representation and its direct interaction with the human seem to go together. In the present, the cat suffers a lot with cruelty acts, abandonment and death, including reduced rate of adoption. Thus, this paper aims to briefly describe the beliefs and ritual uses of cats in different cultures, reflecting on how the symbolism of this feline relates to ethical issues. Education programs and the proper implementation of the laws are identified as important factors to modify this anthropocentric and speciesist paradigm inconsistent with the animal ethics perspectives.
Claire M. Cannon
Full Text Available Naturally occurring tumors in dogs are well-established models for several human cancers. Domestic cats share many of the benefits of dogs as a model (spontaneous cancers developing in an immunocompetent animal sharing the same environment as humans, shorter lifespan allowing more rapid trial completion and data collection, lack of standard of care for many cancers allowing evaluation of therapies in treatment-naïve populations, but have not been utilized to the same degree in the One Medicine approach to cancer. There are both challenges and opportunities in feline compared to canine models. This review will discuss three specific tumor types where cats may offer insights into human cancers. Feline oral squamous cell carcinoma is common, shares both clinical and molecular features with human head and neck cancer and is an attractive model for evaluating new therapies. Feline mammary tumors are usually malignant and aggressive, with the ‘triple-negative’ phenotype being more common than in humans, offering an enriched population in which to examine potential targets and treatments. Finally, although there is not an exact corollary in humans, feline injection site sarcoma may be a model for inflammation-driven tumorigenesis, offering opportunities for studying variations in individual susceptibility as well as preventative and therapeutic strategies.
Chen, Chih-Mei; Gehring, Ulrike; Wickman, Magnus; Hoek, Gerard; Giovannangelo, Mariella; Nordling, Emma; Wijga, Alet; de Jongste, Johan; Pershagen, Goeran; Almqvist, Catarina; Kerkhof, Marjan; Bellander, Tom; Wichmann, H. -Erich; Brunekreef, Bert; Heinrich, Joachim
Studies have presented conflicting associations between cat allergen exposure and sensitisation and atopic disease. We therefore investigated the association between the observed domestic cat allergen level and cat sensitisation in young children in four study populations from three European countri
Raynal, Noël J-M; Da Costa, Elodie M; Lee, Justin T; Gharibyan, Vazganush; Ahmed, Saira; Zhang, Hanghang; Sato, Takahiro; Malouf, Gabriel G; Issa, Jean-Pierre J
Epigenetic drugs, such as DNA methylation inhibitors (DNMTi) or histone deacetylase inhibitors (HDACi), are approved in monotherapy for cancer treatment. These drugs reprogram gene expression profiles, reactivate tumor suppressor genes (TSG) producing cancer cell differentiation and apoptosis. Epigenetic drugs have been shown to synergize with other epigenetic drugs or various anticancer drugs. To discover new molecular entities that enhance epigenetic therapy, we performed a high-throughput screening using FDA-approved libraries in combination with DNMTi or HDACi. As a screening model, we used YB5 system, a human colon cancer cell line, which contains an epigenetically silenced CMV-GFP locus, mimicking TSG silencing in cancer. CMV-GFP reactivation is triggered by DNMTi or HDACi and responds synergistically to DNMTi/HDACi combination, which phenocopies TSG reactivation upon epigenetic therapy. GFP fluorescence was used as a quantitative readout for epigenetic activity. We discovered that 45 FDA-approved drugs (4% of all drugs tested) in our FDA-approved libraries enhanced DNMTi and HDACi activity, mainly belonging to anticancer and antiarrhythmic drug classes. Transcriptome analysis revealed that combination of decitabine (DNMTi) with the antiarrhythmic proscillaridin A produced profound gene expression reprogramming, which was associated with downregulation of 153 epigenetic regulators, including two known oncogenes in colon cancer (SYMD3 and KDM8). Also, we identified about 85 FDA-approved drugs that antagonized DNMTi and HDACi activity through cytotoxic mechanisms, suggesting detrimental drug interactions for patients undergoing epigenetic therapy. Overall, our drug screening identified new combinations of epigenetic and FDA-approved drugs, which can be rapidly implemented into clinical trials. Mol Cancer Ther; 16(2); 397-407. ©2016 AACR.
Caliendo, Angela M; Hanson, Kimberly E
Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care.
Gordon, Michal; Gordon, Goren
The quantum computer game "Schrodinger cat and hounds" is the quantum extension of the well-known classical game fox and hounds. Its main objective is to teach the unique concepts of quantum mechanics in a fun way. "Schrodinger cat and hounds" demonstrates the effects of superposition, destructive and constructive interference, measurements and…
Ordeix, Laura; Galeotti, Franca; Scarampella, Fabia; Dedola, Carla; Bardagí, Mar; Romano, Erica; Fondati, Alessandra
A series of 18 allergic cats with multifocal Malassezia spp. overgrowth is reported: atopic dermatitis was diagnosed in 16, an adverse food reaction in another and one was euthanized 2 months after diagnosis of Malassezia overgrowth. All the cats were otherwise healthy and those tested (16 out of 18) for feline leukaemia or feline immunodeficiency virus infections were all negative. At dermatological examination, multifocal alopecia, erythema, crusting and greasy adherent brownish scales were variably distributed on all cats. Cytological examination revealed Malassezia spp. overgrowth with/without bacterial infection in facial skin (n = 11), ventral neck (n = 6), abdomen (n = 6), ear canal (n = 4), chin (n = 2), ear pinnae (n = 2), interdigital (n = 1) and claw folds skin (n = 1). Moreover, in two cats Malassezia pachydermatis was isolated in fungal cultures from lesional skin. Azoles therapy alone was prescribed in seven, azoles and antibacterial therapy in eight and azoles with both antibacterial and anti-inflammatory therapy in three of the cats. After 3-4 weeks of treatment, substantial reduction of pruritus and skin lesions was observed in all 11 cats treated with a combined therapy and in five of seven treated solely with azoles. Malassezia spp. overgrowth may represent a secondary cutaneous problem in allergic cats particularly in those presented for dermatological examination displaying greasy adherent brownish scales. The favourable response to treatment with antifungal treatments alone suggests that, as in dogs, Malassezia spp. may be partly responsible for both pruritus and cutaneous lesions in allergic cats.
Full Text Available A case of cryptococcosis in a cat refferred to the Hospital Veterinário da Universidade Federal Rural de Pernambuco is described. The cat was euthanized and the microscopic examination of a firm mass observed in the nasal cavity was accomplished. Cryptococcus sp. and a chronic inflammatory process was observed throughout the tissue.
Barrs, V R; Beatty, J A; Tisdall, P L; Hunt, G B; Gunew, M; Nicoll, R G; Malik, R
Between 1997 and 1999, five domestic crossbred cats (four long haired, one short haired) presented with a palpable abdominal mass and were shown to have small intestinal trichobezoars at laparotomy or necropsy. Hair balls were associated with partial or complete intestinal obstruction and were situated in the proximal jejunum to distal ileum. In four cats obstructions were simple, while the remaining cat had a strangulating obstruction. Three of the cats were 10 years or older, and two were less than 4 years. In the three older cats abdominal neoplasia was suspected and investigations were delayed or declined in two of these cats because of a perceived poor prognosis. Predisposing factors identified in this series of cats included a long-hair coat, flea allergy dermatitis, inflammatory bowel disease and ingestion of non-digestible plant material. This report shows that the ingestion of hair is not always innocuous and that intestinal trichobezoars should be considered in the differential diagnoses of intestinal obstruction and intra-abdominal mass lesions, particularly in long-haired cats.
Li, Heng; Guan, Liang; Liu, Tao;
sensitive methods which are usually applied in aligning inter-species sequences. RESULTS: Here we present a new algorithm called CAT (for Cross-species Alignment Tool). It is designed to align mRNA sequences to mammalian-sized genomes. CAT is implemented using C scripts and is freely available on the web...
Lambert, Phyllis Gilchrist
Presents a lesson that teaches students about abstract art in a fun way. Explains that students draw cats, learn about the work of Pablo Picasso, and, in the style of Picasso, combine the parts of the cats (tail, legs, head, body) together in unconventional ways. (CMK)
... A Kid's Guide to Fever Getting a CAT Scan (Video) KidsHealth > For Kids > Getting a CAT Scan (Video) A A A en español Obtención de ... of what's going on inside your body. The scan itself is painless. All you'll need to ...
... accountability for domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table....gov/Food/FoodSafety/FSMA/default.htm . It may be viewed at the Division of Dockets Management (HFA-305... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143,...
Pouwels, Koen; Van Grootheest, Kees
The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of isch
Palmer, Peter T; Jacobs, Richard; Baker, Peter E; Ferguson, Kelly; Webber, Siri
Analytical instrumentation continues its amazing evolution, especially in regard to generating ever more sensitive, faster, and reliable measurements. Perhaps the most difficult challenges are making these instruments small enough to use in the field, equipping them with well-designed software that facilitates and simplifies their use by nonexperts while preserving enough of their analytical capabilities to render them useful for a wide variety of applications. Perhaps the most impressive and underappreciated example of instruments that meet these criteria are field-portable X-ray fluorescence (XRF) analyzers. In the past, these analyzers have been routinely used for environmental applications (lead in paint and soil, metal particulates in air samples collected onto filters), geology studies (ore and soil analysis, precious metal identification), and recycling industries (alloy identification). However, their use in the analysis of toxic elements in food, food ingredients, dietary supplements, and medicinal and herbal products, especially within the FDA and regulatory environments, has been surprisingly limited to date. Although XRF will not replace atomic spectrometry techniques such as ICP-MS for sub-parts per million level analyses, it offers a number of significant advantages including minimal sample preparation, high sample throughputs, rapid and definitive identification of many toxic elements, and accurate quantitative results. As should be obvious from many recent news reports on elevated levels of toxic elements in children's lunchboxes, toys, and supplements, field-portable XRF analyzers can fill a very important niche and are becoming increasingly popular for a wide variety of elemental analysis applications. This perspective begins with a brief review of the theory of XRF to highlight the underlying principle, instrumentation, and spectra. It includes a discussion of various analytical figures of merit of XRF to illustrate its strengths and limitations
Volta, Antonella; Manfredi, Sabrina; Gnudi, Giacomo; Gelati, Aldo; Bertoni, Giorgio
Polycystic kidney disease (PKD) is one of the most common genetic diseases in cats. It has been widely described in Persians and Persian-related cats and sporadically in other breeds. The purpose of the present paper is to describe the first reported case of PKD in a 12-year-old female Chartreux cat. The cat was referred with polyuria and polydipsia and enlarged and irregular kidneys at palpation. Multiple renal cysts and a single liver cyst were identified by ultrasound and the inherited pattern was confirmed by genetic test (polymerase chain reaction/restriction fragment length polymorphism (PCR/RFLP) assay). Chartreux cats should be included in the screening programme of PKD, and PKD should be always considered as a possible cause of chronic renal failure in this breed.
Driscoll, Carlos A; Menotti-Raymond, Marilyn; Roca, Alfred L; Hupe, Karsten; Johnson, Warren E; Geffen, Eli; Harley, Eric H; Delibes, Miguel; Pontier, Dominique; Kitchener, Andrew C; Yamaguchi, Nobuyuki; O'brien, Stephen J; Macdonald, David W
The world's domestic cats carry patterns of sequence variation in their genome that reflect a history of domestication and breed development. A genetic assessment of 979 domestic cats and their wild progenitors-Felis silvestris silvestris (European wildcat), F. s. lybica (Near Eastern wildcat), F. s. ornata (central Asian wildcat), F. s. cafra (southern African wildcat), and F. s. bieti (Chinese desert cat)-indicated that each wild group represents a distinctive subspecies of Felis silvestris. Further analysis revealed that cats were domesticated in the Near East, probably coincident with agricultural village development in the Fertile Crescent. Domestic cats derive from at least five founders from across this region, whose descendants were transported across the world by human assistance.
Beckwith-Cohen, B; Dubielzig, R R; Maggs, D J; Teixeira, L B C
Mast cell infiltration occurs in malignant, inflammatory (eg, allergic, infectious), and idiopathic disease processes in humans and animals. Here, we describe the clinical and histological features of a unique proliferative conjunctivitis occurring in 15 cats. Ocular specimens were examined histologically, and polymerase chain reaction (PCR) for feline herpesvirus 1 (FHV-1) was performed on ocular tissues obtained from 10 cats. Cats had a median age of 8 years (range: 7 months-17.5 years). The known median duration of ocular lesions prior to biopsy was 4 months (range: 1 week-3 years). Ocular disease was unilateral in 12 cats, and 9 cats had coexisting corneal disease. Clinically and histologically, proliferative or nodular conjunctival lesions were noted in 13 cats. The nictitating membrane was affected in 10 cats. Histologically, lesions were characterized by mixed inflammatory infiltrates with an abundance of Giemsa-positive and toluidine blue-positive intraepithelial and subepithelial mast cells, marked edema, and papillary epithelial hyperplasia. Feline herpesvirus 1 was demonstrated by PCR in 1 of 10 cats tested. Follow-up information was available for 14 cats: 8 had no recurrence during a median follow-up period of 17.5 months (range: 4.5-30 months), 2 underwent orbital exenteration, 3 had recurrence that was medically managed, and 1 cat had diffuse conjunctivitis at the time of biopsy and recurrence was deemed irrelevant. Various ocular medications were administered before and after surgical biopsy. This condition was designated as feline epitheliotropic mastocytic conjunctivitis, with intraepithelial mast cells being an essential feature and papillary epithelial proliferation being characteristic but not diagnostic alone. The condition appears to be uncommon and benign. Although the cause is unknown, an allergic component is possible.
Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.
Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training
Blanchard, D Caroline; Canteras, Newton S; Markham, Chris M; Pentkowski, Nathan S; Blanchard, Robert J
Exposure of rats to a cat elicits Fos activity in a number of brain areas or structures. Based on hodological relationships of these, Canteras has proposed a medial hypothalamic defense system, with input from several forebrain sites. Both electrolytic and neurotoxic lesions of the dorsal premammillary nucleus, which shows the strongest Fos response to cat exposure, produce striking decrements in a number of defensive behaviors to a cat or to cat odor stimuli, but do not have a major effect on either postshock freezing, or responsivity to the odor of a female in estrus. Neurotoxic lesions of the medial amygdala produce decrements in defensiveness to predator stimuli, particularly odor stimuli, that are consistent with a view of this structure as involved with allomonal cues. While dorsal hippocampal lesions had little effect on responsivity to predator stimuli, neurotoxic lesions of the ventral hippocampus reduced freezing and enhanced a variety of nondefensive behaviors to both cat odor and footshock, with similar reductions in defensiveness during context conditioning tests for cat odor, cat exposure and footshock. These results support the view that the dorsal premammillary nucleus is strongly and selectively involved in control of responsivity to predator stimuli. Structures with important input into the medial hypothalamic defense system appear also to be functionally involved with antipredator defensive behaviors, and these lesion studies may suggest specific hypotheses as to the particular defense functions of different areas.
The CAT gene product, catalase, occurs in the peroxisome of almost all respiring organismÃƒÆ'Ã‚Â¢ÃƒÂ¢Ã¢â‚¬Å¡Ã‚Â¬ÃƒÂ¢Ã¢â‚¬Å¾Ã‚Â¢s cells. Catalase is a heme enzyme that converts the reactive oxygen species hydrogen peroxide to water and oxygen, diminishing the toxic effects of hydrogen peroxide on the cell. Catalase promotes growth of cells including T-cells, B-cells, myeloid leukemia cells, melanoma cells, mastocytoma cells and normal and transformed fibroblast cells. Polymorphisms in this gene have been associated with decreases in catalase activity but, to date, acatalasemia is the only disease known to be caused by this gene.
Stella, Judith L.
Domestic cats (Felis silvestris catus) are the most commonly kept companion animals in the US with large populations of owned (86 million), free-roaming (70 million), research (13,000), and shelter (2-3 million) cats. Vast numbers of cats are maintained in homes and other facilities each year and are reliant on humans for all of their care. Understanding cat behavior and providing the highest quality environments possible, including positive human-cat interactions, based on research could help improve the outcomes of biomedical research, shelter adoptions, and veterinary care, as well as overall cat welfare. Often, however, cats' needs are inadequately met in homes and some aspects may also not be well met in research colonies and shelters, despite the fact that similar problems are likely to be encountered in all of these environments. This paper provides a brief overview of common welfare challenges associated with indoor housing of domestic cats. Essential considerations for cage confinement are reviewed, along with implications of poor cat coping, such as weakening of the human-animal bond and relinquishment to shelters. The important role that environmental management plays in cat behavior and welfare outcomes is explored along with the need for additional research in key areas.
O V Verkhodanov
Full Text Available We describe the current status of CATS (astrophysical CATalogs Support system, a publicly accessible tool maintained at Special Astrophysical Observatory of the Russian Academy of Sciences (SAO RAS (http://cats.sao.ru allowing one to search hundreds of catalogs of astronomical objects discovered all along the electromagnetic spectrum. Our emphasis is mainly on catalogs of radio continuum sources observed from 10 MHz to 245 GHz, and secondly on catalogs of objects such as radio and active stars, X-ray binaries, planetary nebulae, HII regions, supernova remnants, pulsars, nearby and radio galaxies, AGN and quasars. CATS also includes the catalogs from the largest extragalactic surveys with non-radio waves. In 2008 CATS comprised a total of about 109 records from over 400 catalogs in the radio, IR, optical and X-ray windows, including most source catalogs deriving from observations with the Russian radio telescope RATAN-600. CATS offers several search tools through different ways of access, e.g. via Web-interface and e-mail. Since its creation in 1997 CATS has managed about 105requests. Currently CATS is used by external users about 1500 times per day and since its opening to the public in 1997 has received about 4000 requests for its selection and matching tasks.
Zini, E; Ferro, S; Lunardi, F; Zanetti, R; Heller, R S; Coppola, L M; Guscetti, F; Osto, M; Lutz, T A; Cavicchioli, L; Reusch, C E
Pancreatitis has been described in cats with diabetes mellitus, although the number of studies currently available is very limited. In addition, ketoacidosis has been hypothesized to be associated with pancreatitis in diabetic cats. The aims of the present study were to investigate whether diabetic cats have pancreatitis and to determine if pancreatitis is more frequent with ketoacidosis. Samples of pancreas were collected postmortem from 37 diabetic cats, including 15 with ketoacidosis, and 20 control cats matched for age, sex, breed, and body weight. Sections were stained with hematoxylin and eosin, double-labeled for insulin/CD3, insulin/CD20, insulin/myeloperoxidase, insulin/PCNA, and glucagon/Ki67, and single-labeled for Iba1. A previously proposed semiquantitative score was used to characterize pancreatitis, along with counts of inflammatory cells. Scores of pancreatitis and the number of neutrophils, macrophages, and lymphocytes in the exocrine pancreas did not differ between diabetic and control cats or between diabetic cats with and without ketoacidosis. Of note, PCNA-positive acinar cells were increased (P = .002) in diabetic cats, particularly near islets (P < .001). Ki67-positive acinar cells were increased only near islets (P = .038). Ketoacidosis was not linked to proliferation. The results suggest that histopathologic evidence of pancreatitis may not be more frequent in diabetic cats and that ketoacidosis may not be associated with it at the time of death. Augmented PCNA-positive acinar cells might indicate increased proliferation due to chronic pancreatitis. The reason behind the prevalent proliferation of acinar cells surrounding pancreatic islets deserves further investigation.
Zini, E; Lunardi, F; Zanetti, R; Heller, R S; Coppola, L M; Ferro, S; Guscetti, F; Osto, M; Lutz, T A; Reusch, C E; Cavicchioli, L
Pancreatic amyloidosis and loss of α and β cells have been shown to occur in cats with diabetes mellitus, although the number of studies currently available is very limited. Furthermore, it is not known whether pancreatic islet inflammation is a common feature. The aims of the present study were to characterize islet lesions and to investigate whether diabetic cats have inflammation of the pancreatic islets. Samples of pancreas were collected postmortem from 37 diabetic and 20 control cats matched for age, sex, breed, and body weight. Histologic sections were stained with hematoxylin and eosin and Congo red; double labeled for insulin/CD3, insulin/CD20, insulin/myeloperoxidase, insulin/proliferating cell nuclear antigen, and glucagon/Ki67; and single labeled for amylin and Iba1. Mean insulin-positive cross-sectional area was approximately 65% lower in diabetic than control cats (P = .009), while that of amylin and glucagon was similar. Surprisingly, amyloid deposition was similar between groups (P = .408). Proliferation of insulin- and glucagon-positive cells and the number of neutrophils, macrophages, and T (CD3) and B (CD20) lymphocytes in the islets did not differ. The presence of T and B lymphocytes combined tended to be more frequent in diabetic cats (n = 8 of 37; 21.6%) than control cats (n = 1 of 20; 5.0%). The results confirm previous observations that loss of β cells but not α cells occurs in diabetic cats. Islet amyloidosis was present in diabetic cats but was not greater than in controls. A subset of diabetic cats had lymphocytic infiltration of the islets, which might be associated with β-cell loss.
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients
Adamama-Moraitou, K K; Paitaki, C G; Rallis, T S; Tontis, D
A Persian male cat with a history of lower urinary tract disease was presented because of polydipsia, polyuria, constipation and nasal discharge. Ten weeks before admission, the cat had been treated for lower urinary tract disease by catheterisation and flushing of the bladder. The animal was thin, dehydrated, anaemic and azotaemic. Urine culture revealed Aspergillus species cystitis. Antibodies against Aspergillus nidulans were identified in serum. Fluconazole was administered orally (7.5 mg/kg, q 12 h) for 10 consecutive weeks. The azotaemia was resolved, the kidney concentrating ability was recovered and the cat has remained healthy without similar problems.
The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. |
Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig
Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther...... to be unreliable. Although previous SMKI research was concentrated on tyrosine kinase inhibitors for cancer treatment, recent progress indicates diversification of SMKI research in terms of new targets, mechanistic types, and therapeutic indications....
Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida
The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing.
Trumbo, Paula R
The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, "This salt does not supply iodide, a necessary nutrient." If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine.
Corrigan, Kerry A.
In 1938 the Food and Drug Administration (FDA) adopted regulations which created a category of prescription drugs to be distributed only by order of a physician or other licensed medical personnel. This categorization, along with the extensive regulation of the approval, labelling and marketing of human drugs, has substantially reduced the risks which accompanied self-medication. However, the current regulatory regime does not place any limits on physician prescribing. This shortfall in regul...
The Food and Drug Administration (FDA) has approved a test to help men with elevated prostate-specific antigen (PSA) test scores decide whether to have a biopsy to test for prostate cancer. The Access Hybritech p2PSA test is approved for use in men aged 50 or older who have a PSA test score between 4 and 10 ng/ml but who show no signs of cancer during a digital rectal exam. |
Tang, Jian-yuan; Huang, Fang-hua; Zhu, Fei-peng
FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation.
The Food and Drug Administration (FDA) is publishing a guidance entitled "E9 Statistical Principles for Clinical Trials." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is intended to provide recommendations to sponsors and scientific experts regarding statistical principles and methodology which, when applied to clinical trials for marketing applications, will facilitate the general acceptance of analyses and conclusions drawn from the trials.
Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody
The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419
Blake, Kelly D; Portnoy, David B; Kaufman, Annette R; Lin, Chung-Tung Jordan; Lo, Serena C; Backlund, Eric; Cantor, David; Hicks, Lloyd; Lin, Amy; Caporaso, Andrew; Davis, Terisa; Moser, Richard P; Hesse, Bradford W
The National Cancer Institute (NCI) developed the Health Information National Trends Survey (HINTS) to monitor population trends in cancer communication practices, information preferences, health risk behaviors, attitudes, and cancer knowledge. The U.S. Food and Drug Administration (FDA) recognized HINTS as a unique data resource for informing its health communication endeavors and partnered with NCI to field HINTS-FDA 2015. HINTS-FDA 2015 was a self-administered paper instrument sent by mail May 29 to September 8, 2015, using a random probability-based sample of U.S. postal addresses stratified by county-level smoking rates, with an oversampling of high and medium-high smoking strata to increase the yield of current smokers responding to the survey. The response rate for HINTS-FDA 2015 was 33% (N = 3,738). The yield of current smokers (n = 495) was lower than expected, but the sampling strategy achieved the goal of obtaining more former smokers (n = 1,132). Public-use HINTS-FDA 2015 data and supporting documentation have been available for download and secondary data analyses since June 2016 at http://hints.cancer.gov . NCI and FDA encourage the use of HINTS-FDA for health communication research and practice related to tobacco-related communications, public knowledge, and behaviors as well as beliefs and actions related to medical products and dietary supplements.
El-Elimat, Tamam; Zhang, Xiaoli; Jarjoura, David; Moy, Franklin J; Orjala, Jimmy; Kinghorn, A Douglas; Pearce, Cedric J; Oberlies, Nicholas H
A collaborative project has been undertaken to explore filamentous fungi, cyanobacteria, and tropical plants for anti-cancer drug leads. Through principal component analysis, the chemical space covered by compounds isolated and characterized from these three sources over the last four years was compared to each other and to the chemical space of selected FDA-approved anticancer drugs. Using literature precedence, nine molecular descriptors were examined: molecular weight, number of chiral centers, number of rotatable bonds, number of acceptor atoms for H-bonds (N,O,F), number of donor atoms for H-bonds (N and O), topological polar surface area using N,O polar contributions, Moriguchi octanol-water partition coefficient, number of nitrogen atoms, and number of oxygen atoms. Four principal components explained 87% of the variation found among 343 bioactive natural products and 96 FDA-approved anticancer drugs. Across the four dimensions, fungal, cyanobacterial and plant isolates occupied both similar and distinct areas of chemical space that collectively aligned well with FDA-approved anticancer agents. Thus, examining three separate re-sources for anticancer drug leads yields compounds that probe chemical space in a complementary fashion.
Xu, Kui; Coté, Timothy R
Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.
Linde-Sipman, J.S. van der; Inch, T.S.G.A.M. van den; Nes, J.J. van; Verhagen, H.; Kersten, J.G.T.M.; Beynen, A.C.; Plekkringa, R.
In April 1996, an outbreak of toxic polyneuropathy in cats occurred in the Netherlands. All cats had been fed one of two brands of dry cat food from one manufacturer. Chemical analyses of these foods, stomach contents, and liver and kidney of affected cats revealed contamination with the ionophor sa
Baneth, G; Thamsborg, S M; Otranto, D; Guillot, J; Blaga, R; Deplazes, P; Solano-Gallego, L
Some of the most important zoonotic infectious diseases are associated with parasites transmitted from companion animals to man. This review describes the main parasitic zoonoses in Europe related to dogs and cats, with particular emphasis on their current epidemiology. Toxoplasmosis, leishmaniosis, giardiosis, echinococcosis, dirofilariosis and toxocariosis are described from the animal, as well as from the human host perspectives, with an emphasis on parasite life cycle, transmission, pathogenicity, prevention and identification of knowledge gaps. In addition, priorities for research and intervention in order to decrease the risks and burden of these diseases are presented. Preventing zoonotic parasitic infections requires an integrated multidisciplinary 'One Health' approach involving collaboration between veterinary and medical scientists, policy makers and public health officials.
The Storm Water Management Model Climate Adjustment Tool (SWMM-CAT) is a simple to use software utility that allows future climate change projections to be incorporated into the Storm Water Management Model (SWMM).
Sivajothi, S; Sudhakara Reddy, B; Rayulu, V C; Sreedevi, C
Notoedres cati was observed in two domestic cats. Cats exhibited crust formation, hyperkeratosis, alopecia and intense pruritus. Distribution of lesions observed at the ear margins, face, and legs. Owners also had intense pruritus over the hands, small erythematic crusted papules on the wrists and both the legs. Laboratory examination of skin scrapings from the cat revealed the presence of ova, adult mites of N. cati. The infected cats were treated with weekly twice oral administration of ivermectin at 200 μg/kg body weight, oral administration of 2 ml of multi-vitamin and mineral syrup daily. Improvement was noticed by complete clinical recovery along with absence of mites in skin scrapings, after completion of four doses of oral ivermectin along with supportive therapy.
US Fish and Wildlife Service, Department of the Interior — A natural resource management plan describing the regulations and decision processes for sport hunting at Cat Island NWR. This plan has been replaced by a more...
Dimopoulou, Maria; Kirpensteijn, Jolle; Nielsen, Dorte Hald
severely affected cat, postmortem examination revealed changes consistent with nutritional secondary hyperparathyroidism and fibrous osteodystrophy, such as cortical thinning, massive connective tissue invasion in the diaphysis of long bones, and hypertrophy of the chief cells in both parathyroid glands...
Goericke-Pesch, Sandra Kathrin; Wehrend, A.; Georgiev, P.
Contents: Cats are animals with highly efficient reproduction, clearly pointing to a need for suppression of fertility. Although surgical contraception is highly effective, it is not always the method of choice. This is predominantly because it is cost-intensive, time-consuming and irreversible......, with the latter being of major importance for cat breeders. This article reviews the use of progestins, scleroting agents, immunocontraception, melatonin, GnRH antagonists and finally, GnRH agonists, in adult male and female cats in detail, according to the present state of the art. By now, various scientific...... and clinical options are available for the suppression of fertility in adult cats and the decision as to which should be chosen - independent of the legal registration of any state - depends on different facts: (i) feral or privately owned animal? (ii) temporary or permanent suppression of fertility wanted...
Rosenqvist, Maja Benedicte; Meilstrup, Ann-Katrine Helene; Larsen, Jesper
cats in different age groups. The presence was detected by a conventional polymerase chain reaction (PCR) assay on blood samples as well as by real-time PCR (RT-PCR). Results The study revealed a prevalence of 14.9% Candidatus Mycoplasma haemominutum positive cats and 1.5% Mycoplasma haemofelis...... positive cats. No cats were found positive for Candidatus Mycoplasma turicensis. The results showed a statistically significant higher prevalence in older (>8 years) cats compared to younger cats and a higher prevalence among domestic cats compared to purebred cats. As part of this study, we developed...... a cloning strategy to obtain Danish positive controls of haemoplasma 16S rRNA. Conclusion From convenience-sampled cats in Denmark, we found that 16.4% were carriers of feline haemotropic mycoplasmas. Haemoplasma was mostly found in older and domestic cats. The prevalence found in Denmark is similar...
宋成义; 周家庆; 冯晓军; 谢雨琇; 李庆平; 吴晗; 高波; 王霄燕
[目的]揭示猪CatSperB和CatSperG基因的存在、蛋白的结构特征、进化关系及时空表达特性.[方法]利用电子和分子克隆技术鉴定猪CatSperB和CatSperG基因全长cDNA,并利用定性RT-PCR和荧光定量RT-PCR进行CatSperB和CatSperG基因的时空表达研究.[结果]①分别获得了3 508 bp CatSperB和3 715 bp CatSperG电子转录子,分别包含3 3 30和3 483 bp开放阅读框,并经TA克隆测序验证,其CDS序列与人、牛、马和狗等的CatSperB和CatSperG基因的序列相似性在80％以上；②CatSperB分子质量为125.79 kD,为稳定蛋白；CatSperG分子质量为133.40 kD,为不稳定蛋白；③CatSperB和CatSperG都包含7个通道蛋白保守的跨膜结构域,CatSperG蛋白C端含一个超螺旋结构,而CatSperB蛋白无明显的超螺旋结构信号；猪CatSperB和CatSperG与牛、狗和马的CatSperB和CatSperG蛋白同源关系较近,与人和小鼠的同源关系较远；④RT-PCR分析表明,CatSperB和CatSperG基因主要在辜丸中表达,但CatSperB在其它组织也有表达信号；⑤CatSperB和CatSperG基因mRNA表达水平在猪性发育的重要阶段,精子发生(60日龄)、初情期(90日龄)和性成熟(150日龄)前后都有显著提高(P＜ 0.05).[结论]获得了猪CatSperB和CatSperG基因的cDNA克隆及其一系列生物信息学参数,揭示了CatSperB和CatSperG蛋白含7个保守的跨膜结构域及不同物种间的进化关系,证实CatSperB和CatSperG基因主要在睾丸表达,且其mRNA表达变化与公猪的性发育相一致.%[Objective] The aim of the current study is to confirm the existence of porcine CatSperB and CatSperG genes, and investigate the protein structures, evolutionary relationship and the spatial-temporal expression profiles of CatSperB and CatSperG. [Method] The in silico and molecular cloning was used to identify the full length cDNAs of porcine CatSperB and CatSperG, and the spatial-temporal expression profile was investigated by qualitative and
Reedy, L M
Severe facial pruritus in a cat was caused by food hypersensitivity to lamb. The cat had been fed an exclusive diet of lamb for 2 years after it had been diagnosed to have food hypersensitivity to fish. Signs, including erythema, alopecia, and excoriations of the head and neck, were poorly responsive to corticosteroid administration, but resolved within a few weeks after removal of the suspected allergen.
The primary malignant bone tumors are uncommon in cats. Osteosarcoma is the most frequently observed in old animals. This tumors affects the appendicular skeleton, however the axial skeleton is also affected, but the bones of the head and pelvis frequent sites of injury. This paper reports a case of a cat with a history of progressive swelling in the left mandible, with follow-up period of four months. The presumptive diagnosis of osteopathy, signed by clinical and radiographic observations w...
Antonio Rehbein Pesce
Full Text Available Este artículo es una puesta al día referente a la imagen de Martín Lutero que proyectan teólogos e historiadores católicos en el siglo XX y las líneas matrices que sigue su investigación. Además, en una segunda parte, se enfoca a Lutero desde la Iglesia católica actual, donde se destaca, como un hito importante, la celebración del año 1983, quinto centenario de su nacimiento.This article is an update of the image of Martin Luther projected by 20th Catholic historians, and the lines of research being followed. In a second part, Luther is looked at from the actual Catholic church perspective, highlighting the 5th centenary of his birth, in 1983, as an important event.
Introducing a new cat to a home with resident cats may lead to stress, aggression and even fights. In this case study 468 agonistic cat vocalisations were recorded as one cat was introduced to three resident cats in her new home. Six vocalisation types were identified: growl, howl, howl-growl, hiss, spit and snarl. Numerous other intermediate and complex vocalisations were also observed. An acoustic analysis showed differences within and between all types. Future studies include further acous...
Full Text Available Cats are obligate carnivores and under most circumstances eat only animal products. Owing to the pseudogenization of one of two subunits of the sweet receptor gene, they are indifferent to sweeteners, presumably having no need to detect plant-based sugars in their diet. Following this reasoning and a recent report of a positive correlation between the proportion of dietary plants and the number of Tas2r (bitter receptor genes in vertebrate species, we tested the hypothesis that if bitter perception exists primarily to protect animals from poisonous plant compounds, the genome of the domestic cat (Felis catus should have lost functional bitter receptors and they should also have reduced bitter receptor function. To test functionality of cat bitter receptors, we expressed cat Tas2R receptors in cell-based assays. We found that they have at least 7 functional receptors with distinct receptive ranges, showing many similarities, along with some differences, with human bitter receptors. To provide a comparative perspective, we compared the cat repertoire of intact receptors with those of a restricted number of members of the order Carnivora, with a range of dietary habits as reported in the literature. The numbers of functional bitter receptors in the terrestrial Carnivora we examined, including omnivorous and herbivorous species, were roughly comparable to that of cats thereby providing no strong support for the hypothesis that a strict meat diet influences bitter receptor number or function. Maintenance of bitter receptor function in terrestrial obligate carnivores may be due to the presence of bitter compounds in vertebrate and invertebrate prey, to the necessary role these receptors play in non-oral perception, or to other unknown factors. We also found that the two aquatic Carnivora species examined had fewer intact bitter receptors. Further comparative studies of factors driving numbers and functions of bitter taste receptors will aid in
Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.
ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...
Rubin, J Peter; D'Amico, Richard A; Rodriguez, Ricardo; Coleman, Sydney R; Cederna, Paul; Glasberg, Scot; Neumeister, Michael; Song, David H; Butler, Charles; Hume, Keith M
The Food and Drug Administration (FDA) released draft guidance documents on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the FDA by the American Society of Plastic Surgeons (ASPS).
Taylor, Joshua O; Good, Bryan C; Paterno, Anthony V; Hariharan, Prasanna; Deutsch, Steven; Malinauskas, Richard A; Manning, Keefe B
Transitional and turbulent flow through a simplified medical device model is analyzed as part of the FDA's Critical Path Initiative, designed to improve the process of bringing medical products to market. Computational predictions are often used in the development of devices and reliable in vitro data is needed to validate computational results, particularly estimations of the Reynolds stresses that could play a role in damaging blood elements. The high spatial resolution of laser Doppler velocimetry (LDV) is used to collect two component velocity data within the FDA benchmark nozzle model. Two flow conditions are used to produce flow encompassing laminar, transitional, and turbulent regimes, and viscous stresses, principal Reynolds stresses, and turbulence intensities are calculated from the measured LDV velocities. Axial velocities and viscous stresses are compared to data from a prior inter-laboratory study conducted with particle image velocimetry. Large velocity gradients are observed near the wall in the nozzle throat and in the jet shear layer located in the expansion downstream of the throat, with axial velocity changing as much as 4.5 m/s over 200 μm. Additionally, maximum Reynolds shear stresses of 1000-2000 Pa are calculated in the high shear regions, which are an order of magnitude higher than the peak viscous shear stresses (<100 Pa). It is important to consider the effects of both viscous and turbulent stresses when simulating flow through medical devices. Reynolds stresses above commonly accepted hemolysis thresholds are measured in the nozzle model, indicating that hemolysis may occur under certain flow conditions. As such, the presented turbulence quantities from LDV, which are also available for download at https://fdacfd.nci.nih.gov/ , provide an ideal validation test for computational simulations that seek to characterize the flow field and to predict hemolysis within the FDA nozzle geometry.
Davit, Barbara M; Kanfer, Isadore; Tsang, Yu Chung; Cardot, Jean-Michel
The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for industry describing how to meet criteria for requesting a waiver of in vivo bioavailability and bioequivalence studies for highly soluble, highly permeable (BCS Class I) drugs. Subsequently, the World Health Organization (WHO) and European Medicines Agency (EMA) published guidelines recommending how to obtain BCS biowaivers for BCS Class III drugs (high solubility, low permeability), in addition to Class I drugs. In 2015, the US-FDA became better harmonized with the EMA and WHO following publication of two guidances for industry outlining criteria for obtaining BCS biowaivers for both Class I and Class III drugs. A detailed review and comparison of the BCS Class I and Class III criteria currently recommended by the US-FDA, EMA, and WHO revealed good convergence of the three agencies with respect to BCS biowaiver criteria. The comparison also suggested that, by applying the most conservative of the three jurisdictional approaches, it should be possible for a sponsor to design the same set of BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach.
Siamese cats are albinos with poor visual resolution and severely impaired binocular vision. Eey muscle phyiology was studied in Siamese cats as a part of a more extensive project on eye muscle properties in cats with deficient binocular vision. Isometric contractions of the inferior oblique muscle were recorded in response to single and repetitive muscle nerve stimulation. Speed of contraction, measured as twitch contraction time, fusion frequency and rate of tetanic tension rise, was lower in Siamese than in normal cats. Eye muscles of Siamese cats fatiqued more easily to continuous activation than normal cat eye mucle. These functional changes have also been found in cats with binocular defects from monocular lid suture, but were much more marked in Siamese cats. It is suggested that the eye muscle changes represent muscular adaptations to genetically caused impairments of binocular vision and visual resolution in Siamese cats.
Worthing, Kate A; Wigney, Denise I; Dhand, Navneet K; Fawcett, Anne; McDonagh, Phillip; Malik, Richard; Norris, Jacqueline M
The objective of this study was to determine whether patient signalment (age, breed, sex and neuter status) is associated with naturally-occurring feline infectious peritonitis (FIP) in cats in Australia. A retrospective comparison of the signalment between cats with confirmed FIP and the general cat population was designed. The patient signalment of 382 FIP confirmed cases were compared with the Companion Animal Register of NSW and the general cat population of Sydney. Younger cats were significantly over-represented among FIP cases. Domestic crossbred, Persian and Himalayan cats were significantly under-represented in the FIP cohort, while several breeds were over-represented, including British Shorthair, Devon Rex and Abyssinian. A significantly higher proportion of male cats had FIP compared with female cats. This study provides further evidence that FIP is a disease primarily of young cats and that significant breed and sex predilections exist in Australia. This opens further avenues to investigate the role of genetic factors in FIP.
The amount and quality of the SPL drug knowledge which has been released so far is assessed. All published labels were loaded into a relational database and classified to create vendor-independent descriptions. While SPL labels cover only 23% of RxNorm clinical drugs, they still describe 78% of actual community pharmacy dispenses records. SPL descriptions agree well with RxNorm. SPL can be used as the primary source of drug information for e-prescribing systems once the upcoming FDA listing rule takes effect. In the interim, existing gaps can be temporarily closed with RxNorm or other sources. PMID:18693916
McGuire, Jennifer; Kaplan, Jason; Lapolla, John; Kleiner, Rima
The U.S. Food and Drug Administration (FDA) recently released its report: A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children). By evaluating the benefits and potential concerns of eating fish during pregnancy and breastfeeding, the analysis suggests that pregnant women consuming two seafood meals (8–12 oz) per week could provide their child with an additional 3.3 IQ points b...
By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.
Full Text Available Case summary This report describes the clinical and parasitological findings in a domestic shorthair cat with isolated thoracic tetrathyridiosis. The cat was a stray from Malta that had lived in Germany for several years since as an indoor-only cat. Therefore, the process of infection remains very unusual. In this case it must be considered that the cat had been infected years previously while in Malta, and had lived at least 4 years without any clinical signs. It was possible to diagnose this uncommon disease and initiate an effective treatment with fenbendazole, praziquantel and supportive care. Clinical signs, as well as radiographic findings, were regressive with this treatment. Relevance and novel information Tetrathyridiosis is a rare finding in cats, especially in Germany, but it seems to be a potential differential diagnosis of pleural effusion. Mesocestoides corti, which was the causative parasite in this case, has not previously been isolated in Germany. Because tetrathyridiosis is only diagnosed post mortem in most cases, little is known about effective therapeutic options. Furthermore, clinical signs of this disease can be absent for several years and can potentially be triggered by neoplastic conditions or immunosuppression. Tetrathyridiosis seems to be a treatable disease that can be controlled by adequate antiparasitic therapy.
Merola, I; Lazzaroni, M; Marshall-Pescini, S; Prato-Previde, E
Cats' (Felis catus) communicative behaviour towards humans was explored using a social referencing paradigm in the presence of a potentially frightening object. One group of cats observed their owner delivering a positive emotional message, whereas another group received a negative emotional message. The aim was to evaluate whether cats use the emotional information provided by their owners about a novel/unfamiliar object to guide their own behaviour towards it. We assessed the presence of social referencing, in terms of referential looking towards the owner (defined as looking to the owner immediately before or after looking at the object), the behavioural regulation based on the owner's emotional (positive vs negative) message (vocal and facial), and the observational conditioning following the owner's actions towards the object. Most cats (79 %) exhibited referential looking between the owner and the object, and also to some extent changed their behaviour in line with the emotional message given by the owner. Results are discussed in relation to social referencing in other species (dogs in particular) and cats' social organization and domestication history.
Verkhodanov, O V; Andernach, H; Chernenkov, V N
We describe the current status of CATS (astrophysical CATalogs Support system), a publicly accessible tool maintained at Special Astrophysical Observatory of the Russian Academy of Sciences (SAO RAS) (http://cats.sao.ru) allowing one to search hundreds of catalogs of astronomical objects discovered all along the electromagnetic spectrum. Our emphasis is mainly on catalogs of radio continuum sources observed from 10 MHz to 245 GHz, and secondly on catalogs of objects such as radio and active stars, X-ray binaries, planetary nebulae, HII regions, supernova remnants, pulsars, nearby and radio galaxies, AGN and quasars. CATS also includes the catalogs from the largest extragalactic surveys with non-radio waves. In 2008 CATS comprised a total of about 10e9 records from over 400 catalogs in the radio, IR, optical and X-ray windows, including most source catalogs deriving from observations with the Russian radio telescope RATAN-600. CATS offers several search tools through different ways of access, e.g. via web inte...
Smith, Brian E. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Steed, Chad A. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Shipman, Galen M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Ricciuto, Daniel M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Thornton, Peter E. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wehner, Michael [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Williams, Dean N. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)
Climate science is employing increasingly complex models and simulations to analyze the past and predict the future of Earth s climate. This growth in complexity is creating a widening gap between the data being produced and the ability to analyze the datasets. Parallel computing tools are necessary to analyze, compare, and interpret the simulation data. The Parallel Climate Analysis Toolkit (ParCAT) provides basic tools to efficiently use parallel computing techniques to make analysis of these datasets manageable. The toolkit provides the ability to compute spatio-temporal means, differences between runs or differences between averages of runs, and histograms of the values in a data set. ParCAT is implemented as a command-line utility written in C. This allows for easy integration in other tools and allows for use in scripts. This also makes it possible to run ParCAT on many platforms from laptops to supercomputers. ParCAT outputs NetCDF files so it is compatible with existing utilities such as Panoply and UV-CDAT. This paper describes ParCAT and presents results from some example runs on the Titan system at ORNL.
McLeod, Lynette J; Hine, Donald W; Bengsen, Andrew J
Free-roaming domestic cats, Felis catus, are a major public nuisance in neighbourhoods across the world, and have been linked to biodiversity loss and a host of community health problems. Owners who let their cats roam, also place their cats at risk of serious injury. One management strategy that is gaining considerable support involves encouraging cat owners to contain their pets within their property. Contemporary behaviour change models highlight the importance of identifying drivers and barriers that encourage and discourage target behaviours such as cat containment. Results from a random dial phone survey of 356 cat owners in northern Tasmania identified four distinct cat containment profiles: owners who contained their cat all the time, owners who only contained their cat at night, owners who sporadically contained their cat with no set routine, and owners who made no attempt to contain their pet. Our results indicated that cat-owners' decisions to contain or not contain their cats were guided by a range of factors including owners' beliefs about their ability to implement an effective containment strategy and their views about the physical and psychological needs of their cats. The results are discussed in terms of improving the behavioural effectiveness of cat containment interventions by selecting appropriate behavioural change tools for the identified drivers and barriers, and developing targeted engagement strategies and messaging.
We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.
Do, Kathy T; Galván, Adriana
Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers.
Rogstad, Sarah; Faustino, Anneliese; Ruth, Ashley; Keire, David; Boyne, Michael; Park, Jun
The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015 were investigated to examine the extent of the use of mass spectrometry. Mass spectrometry was found to be integral to the characterization of these biotherapeutics. Of the 80 electronically submitted monoclonal antibody and protein biotherapeutic BLAs included in this study, 79 were found to use mass spectrometric workflows for protein or impurity characterization. To further examine how MS is being used in successful BLAs, the applications were filtered based on the type and number of quality attributes characterized, the mass spectrometric workflows used (peptide mapping, intact mass analysis, and cleaved glycan analysis), the methods used to introduce the proteins into the gas phase (ESI, MALDI, or LC-ESI), and the specific types of instrumentation used. Analyses were conducted over a time course based on the FDA BLA approval to determine if any trends in utilization could be observed over time. Additionally, the different classes of protein-based biotherapeutics among the approved BLAs were clustered to determine if any trends could be attributed to the specific type of biotherapeutic.
Margot A Cousin
Full Text Available Cigarette smoking remains the most preventable cause of death and excess health care costs in the United States, and is a leading cause of death among alcoholics. Long-term tobacco abstinence rates are low, and pharmacotherapeutic options are limited. Repositioning medications approved by the U.S. Food and Drug Administration (FDA may efficiently provide clinicians with new treatment options. We developed a drug-repositioning paradigm using larval zebrafish locomotion and established predictive clinical validity using FDA-approved smoking cessation therapeutics. We evaluated 39 physician-vetted medications for nicotine-induced locomotor activation blockade. We further evaluated candidate medications for altered ethanol response, as well as in combination with varenicline for nicotine-response attenuation. Six medications specifically inhibited the nicotine response. Among this set, apomorphine and topiramate blocked both nicotine and ethanol responses. Both positively interact with varenicline in the Bliss Independence test, indicating potential synergistic interactions suggesting these are candidates for translation into Phase II clinical trials for smoking cessation.
Graham, Garry G; Day, Richard O; Graudins, Andis; Mohamudally, Anthoulla
Hepatotoxicity from paracetamol is of great concern because of the considerable number of patients who develop severe toxicity from this drug. A group of senior medical practitioners, academics and scientists were brought together on June 29 and 30, 2009 by the Food and Drug Administration of USA (FDA) with the aim of providing advice on how to limit the number of cases of hepatotoxicity due to paracetamol in USA. The most contentious recommendations were the reduction in the dose of paracetamol to 650 mg and the elimination of prescription combination products of paracetamol and opiates. The first recommendation indicates that many members of the committee consider, despite much evidence to the contrary, that therapeutic doses of paracetamol (up to 4 g daily) are associated with a significant incidence of hepatotoxicity. The second recommendation, if accepted by FDA, will require major changes in the therapeutic use of paracetamol and opiates. Adoption of these two recommendations may lead to the increased use of NSAIDs with the potential of increasing incidence of NSAIDs-related adverse reactions.
Fix Brian V
Full Text Available Abstract Background On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA. The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Method Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Results Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Conclusion Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.
This work investigates the flow in a benchmark nozzle model of an idealized medical device proposed by the FDA using computational fluid dynamics (CFD). It was in particular shown that a proper modeling of the transitional flow features is particularly challenging, leading to large discrepancies and inaccurate predictions from the different research groups using Reynolds-averaged Navier-Stokes (RANS) modeling. In spite of the relatively simple, axisymmetric computational geometry, the resulting turbulent flow is fairly complex and non-axisymmetric, in particular due to the sudden expansion. The resulting flow cannot be well predicted with simple modeling approaches. Due to the varying diameters and flow velocities encountered in the nozzle, different typical flow regions and regimes can be distinguished, from laminar to transitional and to weakly turbulent. The purpose of the present work is to re-examine the FDA-CFD benchmark nozzle model at a Reynolds number of 6500 using large eddy simulation (LES). The LES results are compared with published experimental data obtained by Particle Image Velocimetry (PIV) and an excellent agreement can be observed considering the temporally averaged flow velocities. Different flow regimes are characterized by computing the temporal energy spectra at different locations along the main axis.
Cheng, Benson Y H; Ortiz-Riaño, Emilio; de la Torre, Juan Carlos; Martínez-Sobrido, Luis
The development and implementation of arenavirus reverse genetics represents a significant breakthrough in the arenavirus field. The use of cell-based arenavirus minigenome systems together with the ability to generate recombinant infectious arenaviruses with predetermined mutations in their genomes has facilitated the investigation of the contribution of viral determinants to the different steps of the arenavirus life cycle, as well as virus-host interactions and mechanisms of arenavirus pathogenesis. In addition, the development of trisegmented arenaviruses has permitted the use of the arenavirus genome to express additional foreign genes of interest, thus opening the possibility of arenavirus-based vaccine vector applications. Likewise, the development of single-cycle infectious arenaviruses capable of expressing reporter genes provides a new experimental tool to improve the safety of research involving highly pathogenic human arenaviruses. The generation of recombinant arenaviruses using plasmid-based reverse genetics techniques has so far relied on the use of rodent cell lines, which poses some barriers for the development of Food and Drug Administration (FDA)-licensed vaccine or vaccine vectors. To overcome this obstacle, we describe here the efficient generation of recombinant arenaviruses in FDA-approved Vero cells.
Adagra, Carl; Spielman, Derek; Adagra, Angela; Foster, Darren J
Metaphyseal osteopathy, otherwise known as hypertrophic osteodystrophy, is a disease that causes pyrexia and lethargy accompanied by pain in the thoracic and pelvic limbs of rapidly growing large-breed dogs. While metaphyseal osteopathy has been descibed in association with slipped capital femoral epiphysis in cats, it has not previously been reported as a cause of limb pain and pyrexia in this species. A 7-month-old British Shorthair cat presented with a 1 month history of pyrexia, lethargy and pain in all limbs. Investigation included radiographs of the limbs and chest, abdominal ultrasound, serum biochemical analysis, haematology, bone biopsy, joint fluid aspiration and cytology. Findings were consistent with a diagnosis of metaphyseal osteopathy. The cat's clinical signs resolved following the administration of prednisolone. Symptoms recurred 1 month after the cessation of prednisolone therapy, but resolved when administration was resumed.
Di Lorenzo, Antonio
The proposal of Aharonov, Popescu, and Skrzypczyk [arXiv:1202.0631] of disembodying physical properties from particles is analyzed. It is argued that: (1) in order to state that the cat is at one location and the smile at another, one should look at correlations, not mean values; (2) a weak value of one for the presence of the cat describes the average over a large number of trials, where the detector gives in each trial outputs that are not zero nor one, and that are much larger than unity (they can be large and negative as well); (3) once these issues are addressed, the specific model proposed does not provide evidence for disembodiment of physical properties. Here, the exact probability distribution and its characteristic function are derived for arbitrary coupling strength, preparation and post-selection. This allows to successfully hunt down the quantum Cheshire cat.
McGill, Matt; Yorks, John; Scott, Stan; Palm, Stephen; Hlavka, Dennis; Hart, William; Nowottnick, Ed; Selmer, Patrick; Kupchock, Andrew; Midzak, Natalie; Trepte, Chip; Vaughan, Mark; Colarco, Peter; da Silva, Arlindo
The Cloud Aerosol Transport System (CATS), launched in January of 2015, is a lidar remote sensing instrument that will provide range-resolved profile measurements of atmospheric aerosols and clouds from the International Space Station (ISS). CATS is intended to operate on-orbit for at least six months, and up to three years. Status of CATS Level 2 and Plans for the Future:Version. 1. Aerosol Typing (ongoing): Mode 1: L1B data released later this summer; L2 data released shortly after; Identify algorithm biases (ex. striping, FOV (field of view) biases). Mode 2: Processed Released Currently working on correcting algorithm issues. Version 2 Aerosol Typing (Fall, 2016): Implementation of version 1 modifications Integrate GEOS-5 aerosols for typing guidance for non spherical aerosols. Version 3 Aerosol Typing (2017): Implementation of 1-D Var Assimilation into GEOS-5 Dynamic lidar ratio that will evolve in conjunction with simulated aerosol mixtures.
Ursin, Holger; Eriksen, Hege R
The cognitive activation theory of stress (CATS) is based on a long series of experiments on animals and on humans, in the laboratory, and in real life situations. From the common sense coping concept formulated by Seymour Levine; coping is when my "tommy" does not hurt, we have advanced to a systematic theory for what is behind the relaxed and happy coping rat (and cat). We also cover the translational leap to humans, starting with the now classic parachutist study. The bridge is based on formal and symbolic definitions, a theoretical short cut that Levine actually never really accepted. The essential pathophysiological concept is the potential pathological effects of sustained activation, which may occur in the absence of coping (positive response outcome expectancy). We review the current status of CATS in Behavioural Medicine by discussing its potential explanatory power in epidemiology, prevention and treatment of "subjective health complaints".
Howell, Tiffani J; Bowen, Jonathan; Fatjó, Jaume; Calvo, Paula; Holloway, Anna; Bennett, Pauleen C
Characteristics of the human-animal bond can be influenced by both owner-related and pet-related factors, which likely differ between species. Three studies adapted the Monash Dog-Owner Relationship Scale (MDORS) to permit assessment of human-cat interactions as perceived by the cat's owner. In Study 1293 female cat owners completed a modified version of the MDORS, where 'dog' was replaced with 'cat' for all items. Responses were compared with a matched sample of female dog owners. A partial least squares discriminant analysis revealed systematic differences between cat and dog owners in the Dog (Cat)-Owner Interaction subscale (MDORS subscale 1), but not for Perceived Emotional Closeness or Perceived Costs (Subscales 2 and 3). Study 2 involved analysis of free-text descriptions of cat-owner interactions provided by 61 female cat owners. Text mining identified key words which were used to create additional questions for a new Cat-Owner Interaction subscale. In Study 3, the resulting cat-owner relationship scale (CORS) was tested in a group of 570 cat owners. The main psychometric properties of the scale, including internal consistency and factor structure, were evaluated. We propose that this scale can be used to accurately assess owner perceptions of their relationship with their cat. A modified scale, combining items from the CORS and MDORS (a C/DORS), is also provided for when researchers would find it desirable to compare human-cat and human-dog interactions.
McDowell, Louise J; Wells, Deborah L; Hepper, Peter G; Dempster, Martin
Research points to a relationship between lateralization and emotional functioning in humans and many species of animal. The present study explored the association between paw preferences and emotional functioning, specifically temperament, in a species thus far overlooked in this area, the domestic cat. Thirty left-pawed, 30 right-pawed, and 30 ambilateral pet cats were recruited following an assessment of their paw preferences using a food-reaching challenge. The animals' temperament was subsequently assessed using the Feline Temperament Profile (FTP). Cats' owners also completed a purpose-designed cat temperament (CAT) scale. Analysis revealed a significant relationship between lateral bias and FTP and CAT scale scores. Ambilateral cats had lower positive (FTP+) scores, and were perceived as less affectionate, obedient, friendly, and more aggressive, than left or right-pawed animals. Left and right pawed cats differed significantly on 1 trait on the CAT scale, namely playfulness. The strength of the cats' paw preferences was related to the animals' FTP and CAT scores. Cats with a greater strength of paw preference had higher FTP+ scores than those with a weaker strength of paw preference. Animals with stronger paw preferences were perceived as more confident, affectionate, active, and friendly than those with weaker paw preferences. Results suggest that motor laterality in the cat is strongly related to temperament and that the presence or absence of lateralization has greater implications for the expression of emotion in this species than the direction of the lateralized bias. (PsycINFO Database Record
Full Text Available Abstract Background Research on the uptake and transport of astaxanthin is lacking in most species. We studied the uptake of astaxanthin by plasma, lipoproteins and leukocytes in domestic dogs and cats. Methods Mature female Beagle dogs (18 to 19 mo old; 11 to 14 kg BW were dosed orally with 0, 0.1, 0.5, 2.5, 10 or 40 mg astaxanthin and blood taken at 0, 3, 6, 9, 12, 18 and 24 h post-administration (n = 8/treatment. Similarly, mature domestic short hair cats (12 mo old; 3 to 3.5 kg body weight were fed a single dose of 0, 0.02, 0.08, 0.4, 2, 5, or 10 mg astaxanthin and blood taken (n = 8/treatment at the same interval. Results Both dogs and cats showed similar biokinetic profiles. Maximal astaxanthin concentration in plasma was approximately 0.14 μmol/L in both species, and was observed at 6 h post-dosing. The plasma astaxanthin elimination half-life was 9 to 18 h. Astaxanthin was still detectable by 24 h in both species. In a subsequent study, dogs and cats were fed similar doses of astaxanthin daily for 15 to 16 d and astaxanthin uptake by plasma, lipoproteins, and leukocytes studied. In both species, plasma astaxanthin concentrations generally continued to increase through d 15 or 16 of supplementation. The astaxanthin was mainly associated with high density lipoprotein (HDL. In blood leukocytes, approximately half of the total astaxanthin was found in the mitochondria, with significant amounts also associated with the microsomes and nuclei. Conclusion Dogs and cats absorb astaxanthin from the diet. In the blood, the astaxanthin is mainly associated with HDL, and is taken up by blood leukocytes, where it is distributed to all subcellular organelles. Certain aspects of the biokinetic uptake of astaxanthin in dogs and cats are similar to that in humans.
Root Kustritz, Margaret V
Average gestation length in domestic cats is 65.6 days, with a range of 52-74 days. Average reported litter size is 4.0 kittens per litter; litter size is not correlated with number of matings in a given estrus. Superfecundation is common in domestic cats; superfetation never has been definitively proven to occur. Eclampsia may occur during pregnancy in queens, with non-specific clinical signs. Ectopic pregnancy and uterine torsion have been reported. Pregnancy loss may be due to infectious causes, including bacteria, viruses or protozoa, or non-infectious causes, such as hypoluteoidism and chromosome errors.
Teshima, Takahiro; Hata, Takashi; Nezu, Yoko; Michishita, Masaki; Matsumoto, Hirotaka; Mizutani, Hisashi; Takahashi, Kimimasa; Koyama, Hidekazu
A 9-year-old spayed female domestic shorthair cat presented with a skin lesion of the left tarsus. The lesion was biopsied and, based on the microscopic appearance and immunohistochemical characteristics, histiocytic sarcoma was diagnosed. Amputation was performed with improved demeanor seen postoperatively. However, between 44 and 60 days following the surgery, relapse of skin lesions appeared in multiple locations, including at the previous amputation site, and euthanasia was elected. This is the first report of a histiocytic sarcoma treated with amputation in a cat.
Full Text Available Currently, University Technology Malaysia (UTM is engaged with a well-known private company in Malaysia to develop halal cat food for the world. A team of scientists from UTM was formed for the development of cat food from preparing palatants to producing canned cat and kibbled cat food formulation on a commercial scale to fulfil the vast market demand, as well as to act as contract manufacturer for this private company. Financial aid is made available by the university and Malaysian government. The promising market potential of cat food is estimated to be over USD27 billion with over 7 million tonnes produced in 2013 (35% of the pet food market. It is expected to grow at 5.5% in value and 2% in volume; and this had driven the project to be initiated by UTM. The idea of halal, itself is a selling point to the Muslim consumers and the world at large. The world’s Muslim population is estimated to be around 1.6 billion, while the world population is estimated to be at 4.6 billion. The demand for halal products is ever growing with emerging markets in India & China. In addition, the purchasing power of the Muslims is growing, where between 1990 and 2010, the Growth Domestic Product (GDP per capita for Muslims globally had risen from a Cumulative Annual Growth Rate (CAGR of 6.8% in comparison to global GDP per capita which is only at CAGR of 5.0%. Cat food will come in human contact during feeding, handling, cleaning of feeding utensils under the same washing basin and dishwasher. Many times cat food will engage with human food storage facilities such as in the refrigerator and May to some extent affect the human food chain if it is not halal. Most of the available cat feed produce worldwide is non halal and majority are known to contain residues of porcine, dog materials and blood meal, deem unhealthy and unclean by the Muslims community.
Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by
... page: https://medlineplus.gov/news/fullstory_162717.html Bird Flu Strain May Have Jumped From Cat to ... would be the first known transmission of this bird flu strain from cat to human, officials said. ...
... https://medlineplus.gov/news/fullstory_161086.html Cat Scratch Can Sometimes Lead to Serious Illness: CDC But ... Fluffy the cat gets out of sorts and scratches you, it's possible you could get a bacterial ...
... For Consumers Consumer Updates Keep Your Dogs and Cats Safe From Holiday Hazards Share Tweet Linkedin Pin ... leave your leftover tinsel, string, and ribbons. “Your cat may find these decorations irresistible because they look ...
Ya-feng Li*, Yan Liu, Wen-yuan Gao, Jing-jing Lu
Full Text Available A unique three-dimensional metal-organic framework —— Pb(FDA (FDA = furan-2,5-dicarboxylic acid has been hydrothermally synthesized and structurally determined by single-crystal X-ray analysis. The crystal is of tetragonal system, space group I41/a, C6H2O5Pb, Mr = 361.27, a = 13.863(2 Å, b = 13.863(2 Å, c = 13.998(3 Å, V = 2690.0(8 Å3, Z = 16, Dc = 3.568 g/cm3, F(000 = 2560, ?(MuK? = 25.060 mm-1, Rint = 7.32%, R1 = 2.59% and wR1 = 5.88% for 1543 observed reflections with I > 2?(I. Pb cation is six-coordinated by oxygens of FDA, showing the hemi directed geometry. Pb cations are connected into zigzag chain along b direction in bc planar by FDA, which is furthermore linked to three-dimensional framework with very tiny aperture by bridged carboxyl oxygens of FDA. The elemental analyses, PXRD, FTIR spectra and the thermal stability have been structurally characterized.
Zito, Sarah; Paterson, Mandy; Vankan, Dianne; Morton, John; Bennett, Pauleen; Phillips, Clive
The percentage of adult cats euthanized in animal shelters is greater than that of kittens because adult cats are less likely to be adopted. This study aimed to provide evidence to inform the design of strategies to encourage adult cat adoptions. One such strategy is to discount adoption prices, but there are concerns that this may result in poor adoption outcomes. We surveyed 382 cat adopters at the time of adoption, to assess potential determinants of adopters' cat age group choice (adult or kitten) and, for adult cat adopters, the price they are willing to pay. The same respondents were surveyed again 6-12 months after the adoption to compare outcomes between cat age groups and between adult cats in two price categories. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and requirements for responsible ownership. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive for both adult cats and kittens and for adult cats adopted at low prices. The latter finding alleviates concerns about the outcomes of "low-cost" adoptions in populations, such as the study population, and lends support for the use of "low-cost" adoptions as an option for attempting to increase adoption rates. In addition, the results provide information that can be used to inform future campaigns aimed at increasing the number of adult cat adoptions, particularly in devising marketing strategies for adult cats.
Pennisi, Maria Grazia; Hartmann, Katrin; Addie, Diane D; Boucraut-Baralon, Corine; Egberink, Herman; Frymus, Tadeusz; Gruffydd-Jones, Tim; Horzinek, Marian C; Hosie, Margaret J; Lloret, Albert; Lutz, Hans; Marsilio, Fulvio; Radford, Alan D; Thiry, Etienne; Truyen, Uwe; Möstl, Karin
OVERVIEW: Cardiopulmonary nematodes are emerging parasites of cats in Europe. A number of helminth parasites may be involved. The most prevalent lungworm in domestic cats is Aelurostrongylus abstrusus. Oslerus rostratus and Troglostrongylus species are found mainly in wild cats. The trichurid Capill
Kenney, Susan Hobson
This article discusses song prompts as a way to encourage children to sing during exploratory play. A song prompt for "I Had a Cat" is included for educators to try in their own classrooms or preschools. Educators are invited to share ideas they have used that encourage children to sing during free play.
Chang, Chung-chien Karen
Satire, as a mode, is not frequently employed in Chinese narratives. "Cat Country," or "Mao Cheng Ji," written by Lao She (pen name of Shu Qing Chun, 1898--1966) has come under much attack of its literary values. Whereas most critics have no doubt that this work sets out to satirize China through the portrayal of a society of…
Lang, Linda G; Wilkinson, Thomas E; White, Tammy L; Farnsworth, Raelynn K; Potter, Kathleen A
Tooth resorption is the most common dental disease in cats and can be a source of oral pain. The current clinical gold standard for diagnosis includes a combination of oral exam and dental radiography, however early lesions are not always detected. Computed tomography (CT) of the skull, including the dental arches, is a commonly performed diagnostic procedure, however the appearance of tooth resorption on CT and the diagnostic ability of CT to detect tooth resorption have not been evaluated. The purpose of this prospective, descriptive, diagnostic accuracy study was to characterize the CT appearance of tooth resorption in a sample of affected cats and to evaluate the sensitivity and specificity of CT for tooth resorption compared to the clinical gold standard of oral exam and intraoral dental radiography. Twenty-eight cat cadaver specimens were recruited for inclusion. Each specimen was evaluated using oral exam, intraoral dental radiography, and computed tomography (four different slice thicknesses). Each tooth was evaluated for the presence or absence of tooth resorption. Teeth with lesions and a subset of normal teeth were evaluated with histopathology. On CT, tooth resorption appeared as irregularly marginated hypoattenuating defects in the mineral attenuating tooth components, most commonly involving the root or cementoenamel junction. Sensitivity for CT detection of tooth resorption was fair to poor (42.2-57.7%) and specificity was good to excellent (92.8-96.3%). Findings from this study indicated that CT has high specificity but low sensitivity for detection of tooth resorption in cats.
Pukay, B P; Stevenson, D A
A four year old ovariohysterectomized domestic short-haired cat under treatment for behavioral urine spraying and idiopathic alopecia developed mammary gland hypertrophy following treatment with megestrol acetate. Withdrawal of the progestin and treatment with androgen failed to cause regression of the hypertrophy. The affected mammary gland was surgically excised and recovery was uneventful.
Full Text Available The purpose of the study was to evaluate the effect of amlodipine on blood pressure and renal function in cats with arterial hypertension secondary to chronic renal failure. The research was conducted on 11 cats, aged between 7 and 14.5 years, diagnosed with arterial hypertension secondary to chronic renal failure. Systolic blood pressure (SBP, diastolic blood pressure (DBP, mean arterial pressure (MBP and pulse rate were determined by oscillometric method, before and after 7, 30 or 120 days of treatment with amlodipine. At the beginning of treatment, all cats were receiving 0.625 mg amlodipine once daily and after 7 days oftreatment, in five cats, the dose was increased to 1.25 mg amlodipine, once daily. Before amlodipine administration the mean values of SBP/DBP were 175 ± 13.2 mmHg/119 ± 7.2 mmHg and after 30 days of treatment, the mean values of the SBP/DBP were reduced by 27.9/25.4 mmHg (p<0,001. After 120 days of treatment with amlodipine mean values of SBP/DBP were lower with 32/31 mmHg compared with baseline values (p<0.001. The treatment with amlodipine did not significantly affect the values of blood biochemical parameters of renal profile.
Stobi'nska, M; Wodkiewicz, K; Stobi\\'nska, Magdalena; W\\'odkiewicz, Krzysztof
We present an effective method of coherent state superposition (cat state) generation using single trapped ion in a Paul trap. The method is experimentally feasible for coherent states with amplitude $\\alpha \\le 2$ using available technology. It works both in and beyond the Lamb-Dicke regime.
Over the past 30 years, a progressive increase in calcium oxalate (CaOx) urolith prevalence is reported in cats and dogs diagnosed with urolithiasis. This increase in prevalence appears to have occurred since dietary modifications were introduced to address magnesium ammonium phosphate urolithiasis.
Pedersen, N C
There is a great deal of frustration among veterinarians about the diagnosis and treatment of inflammatory diseases of the oral cavity of the cat. This frustration is due to both the high frequency of feline oral inflammatory lesions and our poor understanding of their causes. This poor understanding can be blamed on several things: (1) a rapidly emerging, but still relatively poor, understanding of feline diseases in general and nutrition in particular; (2) a tendency to lump rather than separate specific oral inflammations; (3) a tendency not to use a thorough and systematic approach to diagnosing oral cavity disease; and (4) the reluctance of veterinarians to apply what is already known about human oral cavity diseases to cats. When problems 2 through 4 are adequately addressed, it becomes apparent that we really know more about oral cavity disease in the cat than we thought we knew and that great progress has been made. The task ahead is to define, in precise medical terms, those remaining disease entities of the oral cavity that pose the greatest health risk to cats, to apply what has been already been discovered from human disease counterparts, and to study them systematically.
Berends, MJW; Tan-Sindhunata, G; Leegte, B; Van Essen, AJ
Cat-Eye syndrome (CES) is a disorder with a variable pattern of multiple congenital anomalies of which coloboma of the iris and anal atresia are the best known. CES is cyogenetically characterised by the presence of an extra bisatellited marker chromosome, which represents an inverted dicentric dupl
Lenin A Villamizar-Martinez
Full Text Available Case summary A 10-year-old castrated male domestic shorthair cat was presented for assessment of a gingival mass surrounding the left maxillary third and fourth premolar teeth. The mass was surgically removed by means of a marginal rim excision, and the tissue was submitted for histological assessment. It was identified as a benign cementoblastoma (true cementoma. There was proliferation of mineralized eosinophilic material with multiple irregularly placed lacunae and reversal lines, reminiscent of cementum. The cat recovered uneventfully from the anesthesia, and there was no evidence of tumor recurrence 6 months after surgery. Relevance and novel information Cementoblastomas (true cementomas in domestic animals are rare, with just a few reports in ruminants, monogastric herbivores and rodents. Cementoblastoma is considered a benign tumor that arises from the tooth root. The slow, expansive and constant growth that characterizes these masses may be accompanied by signs of oral discomfort and dysphagia. This case report is intended to increase knowledge regarding this tumor in cats and also highlights the importance of complete excision of the neoplasm. To our knowledge, there are no previous reports in the literature of cementoblastoma in the cat.
Full Text Available Motivated by Halpern's result, we prove strong convergence theorem of an iterative sequence in CAT(0 spaces. We apply our result to find a common fixed point of a family of nonexpansive mappings. A convergence theorem for nonself mappings is also discussed.
Abstract Since the introduction of brominated flame retardants (such as the PBDEs), increases in feline hyperthyroidism have been observed. We hypothesized that PBDE exposure was linked to the increased occurrence of hyperthyroidism in cats. Herein, PBDEs in serum of pet ...
Miranowicz, A; Wahiddin, M R B; Imoto, N
The Wehrl information entropy and its phase density, the so-called Wehrl phase distribution, are applied to describe Schr\\"odinger cat and cat-like (kitten) states. The advantages of the Wehrl phase distribution over the Wehrl entropy in a description of the superposition principle are presented. The entropic measures are compared with a conventional phase distribution from the Husimi Q-function. Compact-form formulae for the entropic measures are found for superpositions of well-separated states. Examples of Schr\\"odinger cats (including even, odd and Yurke-Stoler coherent states), as well as the cat-like states generated in Kerr medium are analyzed in detail. It is shown that, in contrast to the Wehrl entropy, the Wehrl phase distribution properly distinguishes between different superpositions of unequally-weighted states in respect to their number and phase-space configuration.
Courtney, Brooke; Bond, Katherine C; Maher, Carmen
In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats.
Ross, Joseph S; Dzara, Kristina; Downing, Nicholas S
The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients' access to new and effective therapeutics. We used qualitative methods to characterize the safety and efficacy reasons why applications for novel therapeutics approved by the FDA between 2001 and 2011 required multiple review cycles prior to approval. Among ninety-six applications approved between 2001 and 2011 that required multiple review cycles, safety concerns contributed to seventy-four (77.1 percent) and efficacy concerns to forty-three (44.8 percent). Our study suggests that multiple review cycles appear to play an important role in allowing the FDA to protect public health and in ensuring adequate understanding of clinical benefits and risks prior to approval.
J.M.A. van den Brand (Judith); K.J. Stittelaar (Koert); G. van Amerongen (Geert); M.W.G. van de Bildt (Marco); L.M.E. Leijten (Lonneke); T. Kuiken (Thijs); A.D.M.E. Osterhaus (Albert)
textabstractTo demonstrate that pandemic (H1N1) 2009 virus may cause respiratory disease in cats, we intratracheally infected cats. Diffuse alveolar damage developed. Seroconversion of sentinel cats indicated cat-to-cat virus transmission. Unlike in cats infected with highly pathogenic avian influen
M.P. Oryszczyn; R. Ree; J. Maccario; R. Nadif; F. Kauffmann
P>Background In adults, there is limited information on tolerance to cat, which may be reflected by high IgG(4) without IgE sensitization. Early exposure to cat may play a critical role. Objective The aim was to assess among adults the association of Fel d 1 IgG(4), Fel d 1 IgE, skin prick test (SPT
Su, Edwin P; Housman, Lawrence R; Masonis, John L; Noble, John W; Engh, C Anderson
A prospective, multi-center postmarket approval study has been ongoing since May 2006 to assess safety and efficacy of the first US FDA approved hip resurfacing implant. 265 patients have been enrolled at five study sites. The average age of the patients is 51.3 years. There have been 7 revisions (2.4%) in the cohort to date. K-M survival curves for the cohort are 97.6% at 5 years. There is a trend toward a gender difference in implant survivorship, with 98.6% of men and 94.7% of women free from revision. Metal ion analysis revealed median cobalt and chromium levels of 1.5 ppb and 1.7 ppb at 1 year. In this prospective US study, the Birmingham Hip Resurfacing implant is demonstrating results comparable to those in the literature.
Kinch, Michael S; Merkel, Janie
The term 'inflammation' captures a variety of disease processes linked with the immune system. An analysis of US Food and Drug Administration (FDA)-approved nuclear molecular entities (NMEs) reveals notable trends in terms of acute and chronic inflammatory indications. The number of NMEs peaked during the 1990s and has since declined by more than 50%. Whereas pharmaceutical companies have dominated the field, biotechnology companies now receive half of new approvals and academia has a relatively large role in terms of pivotal first patents. Another notable trend is that the relative number of NMEs targeting allergy has been decreasing, whereas those targeting autoimmune indications is increasing. Unlike other indications, NMEs for inflammation tend towards nuclear receptors and cytokines, and a disproportionate number of biologics target cytokine pathways.
Roth, Eli M
A new class of lipid-lowering drugs, inhibitors of PCSK9 has been generating impressive clinical trial data over the last several years, and alirocumab (Praluent) has become the first to be approved by the US FDA. Alirocumab has been shown to lower low density lipoprotein cholesterol by 45-62% with a safety profile generally comparable to placebo. Alirocumab is a monoclonal antibody to PCSK9 administered subcutaneously and has been evaluated in 16 Phase III clinical trials, the majority of which have been enrolled or completed. This article will be a review of the available Phase III safety and efficacy data of the ODYSSEY studies including a brief description of each of the 16 studies.
Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton
Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products.
Trias, Miquel; Arbona, Antonio; Massó, Joan; Miñano, Borja; Bona, Carles
Data from FDA's nozzle challenge-a study to assess the suitability of simulating fluid flow in an idealized medical device-is used to validate the simulations obtained from a numerical, finite-differences code. Various physiological indicators are computed and compared with experimental data from three different laboratories, getting a very good agreement. Special care is taken with the derivation of blood damage (hemolysis). The paper is focused on the laminar regime, in order to investigate non-Newtonian effects (non-constant fluid viscosity). The code can deal with these effects with just a small extra computational cost, improving Newtonian estimations up to a ten percent. The relevance of non-Newtonian effects for hemolysis parameters is discussed.
Barrows, Nicholas J; Campos, Rafael K; Powell, Steven T; Prasanth, K Reddisiva; Schott-Lerner, Geraldine; Soto-Acosta, Ruben; Galarza-Muñoz, Gaddiel; McGrath, Erica L; Urrabaz-Garza, Rheanna; Gao, Junling; Wu, Ping; Menon, Ramkumar; Saade, George; Fernandez-Salas, Ildefonso; Rossi, Shannan L; Vasilakis, Nikos; Routh, Andrew; Bradrick, Shelton S; Garcia-Blanco, Mariano A
Currently there are no approved vaccines or specific therapies to prevent or treat Zika virus (ZIKV) infection. We interrogated a library of FDA-approved drugs for their ability to block infection of human HuH-7 cells by a newly isolated ZIKV strain (ZIKV MEX_I_7). More than 20 out of 774 tested compounds decreased ZIKV infection in our in vitro screening assay. Selected compounds were further validated for inhibition of ZIKV infection in human cervical, placental, and neural stem cell lines, as well as primary human amnion cells. Established anti-flaviviral drugs (e.g., bortezomib and mycophenolic acid) and others that had no previously known antiviral activity (e.g., daptomycin) were identified as inhibitors of ZIKV infection. Several drugs reduced ZIKV infection across multiple cell types. This study identifies drugs that could be tested in clinical studies of ZIKV infection and provides a resource of small molecules to study ZIKV pathogenesis.
Zubair, Humza N; Beloozerova, Irina N; Sun, Hai; Marlinski, Vladimir
Knowledge of how the head moves during locomotion is essential for understanding how locomotion is controlled by sensory systems of the head. We have analyzed head movements of the cat walking along a straight flat pathway in the darkness and light. We found that cats' head left-right translations, and roll and yaw rotations oscillated once per stride, while fore-aft and vertical translations, and pitch rotations oscillated twice. The head reached its highest vertical positions during second half of each forelimb swing, following maxima of the shoulder/trunk by 20-90°. Nose-up rotation followed head upward translation by another 40-90° delay. The peak-to-peak amplitude of vertical translation was ∼1.5cm and amplitude of pitch rotation was ∼3°. Amplitudes of lateral translation and roll rotation were ∼1cm and 1.5-3°, respectively. Overall, cats' heads were neutral in roll and 10-30° nose-down, maintaining horizontal semicircular canals and utriculi within 10° of the earth horizontal. The head longitudinal velocity was 0.5-1m/s, maximal upward and downward linear velocities were ∼0.05 and ∼0.1m/s, respectively, and maximal lateral velocity was ∼0.05m/s. Maximal velocities of head pitch rotation were 20-50°/s. During walking in light, cats stood 0.3-0.5cm taller and held their head 0.5-2cm higher than in darkness. Forward acceleration was 25-100% higher and peak-to-peak amplitude of head pitch oscillations was ∼20°/s larger. We concluded that, during walking, the head of the cat is held actively. Reflexes appear to play only a partial role in determining head movement, and vision might further diminish their role.
Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.
Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.
Joseph D Planer
Full Text Available An estimated 8 million persons, mainly in Latin America, are infected with Trypanosoma cruzi, the etiologic agent of Chagas disease. Existing antiparasitic drugs for Chagas disease have significant toxicities and suboptimal effectiveness, hence new therapeutic strategies need to be devised to address this neglected tropical disease. Due to the high research and development costs of bringing new chemical entities to the clinic, we and others have investigated the strategy of repurposing existing drugs for Chagas disease. Screens of FDA-approved drugs (described in this paper have revealed a variety of chemical classes that have growth inhibitory activity against mammalian stage Trypanosoma cruzi parasites. Aside from azole antifungal drugs that have low or sub-nanomolar activity, most of the active compounds revealed in these screens have effective concentrations causing 50% inhibition (EC50's in the low micromolar or high nanomolar range. For example, we have identified an antihistamine (clemastine, EC50 of 0.4 µM, a selective serotonin reuptake inhibitor (fluoxetine, EC50 of 4.4 µM, and an antifolate drug (pyrimethamine, EC50 of 3.8 µM and others. When tested alone in the murine model of Trypanosoma cruzi infection, most compounds had insufficient efficacy to lower parasitemia thus we investigated using combinations of compounds for additive or synergistic activity. Twenty-four active compounds were screened in vitro in all possible combinations. Follow up isobologram studies showed at least 8 drug pairs to have synergistic activity on T. cruzi growth. The combination of the calcium channel blocker, amlodipine, plus the antifungal drug, posaconazole, was found to be more effective at lowering parasitemia in mice than either drug alone, as was the combination of clemastine and posaconazole. Using combinations of FDA-approved drugs is a promising strategy for developing new treatments for Chagas disease.
Lee, Seon Kyu; Chang, Kee Hyun; Goo, Jin Mo; Han, Moon Hee; Shin, Yong Moon; Choo, Sung Wook; Yu, In Kyu [Seoul National University College of Medicine, Seoul (Korea, Republic of); Cho, Seung Yull; Kong, Yoon [Chung-Ang University College of Medicine, Seoul (Korea, Republic of)
It is important to diagnosis paragonimiasis in early active because it can be dared by chemotherapy. However, it is difficult to make a correct diagnosis of cerebral paragonimiasis in the early active stage, and the radiographic findings of cerebral paragonimiasis have been rarely reported. Thus, this experimental study was designed to produce early active cerebral paragonimiasis and to demonstrate radiologic-pathologic correlations. In 8 cats, 7-8 metacercariae of Paragonimus Westermani were directly introduced into brain parenchyma of each cat's after trephination of the skull. In another 16 cats, the juvenile worms and the adult worms that had developed for varying periods (2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks) in the lunges of another cats were introduced into the brain parenchyma of each cat's with the same procedure described above. Follow -up MR images and chest radiographs were obtained at 2 days, 1 weeks, 2 weeks, 4 weeks and 8 weeks after inoculation. The autopsies and histopathological examinations of the cat's brain were undertaken in 22 cats. In 9 cats that were suspected with pulmonary lesion on chest radiograph, the soft tissue radiographs of inflated-fixed lungs were obtained. In one cat with inoculation of adult worm, acute suppurative inflammation of the brain parenchyma was demonstrated. But the other cats with inoculation of adult worm or juvenile worm and the cats with intentional of metacercaris did not reveal any evidence of acute cerebral paragonimiasis. More than half of the introduce metacercariae (5 out of 8 cats) were found in the lung parenchyma, while only 25% (4 out of 16 cats) of the adult worm inoculated cats were. Acute suppurative inflammation suggesting acute stage cerebral paragonimiasis was obtained in one case of adult worm inoculated cat. Most of the inoculated metacercariae and some of the juvenile worms or adult worms were migrated to the lungs.
Full Text Available In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available.
With bleed-curdling scenes and horrible feelings, gothic novel is just called“a novel of terror”. This article aims at analyzing the charm of the most important element of gothic novel-horror, from the two short gothic sto-ries The Black Cat and The Minister’s Black Veil separately written by Edgar Allen Poe and Nathaniel Hawthorn. By comparing the two stories from the perspective of horrible scene, image and character, the charm of the signifi-cant and ingredient element in the gothic novel-horror will be discussed.
Perego, Roberta; Proverbio, Daniela; Bagnagatti De Giorgi, Giada; Della Pepa, Alessandra; Spada, Eva
Feline otitis externa is a dermatological disorder that has not been evaluated much in stray cats. One hundred and eighty-seven stray cats were randomly selected during a trap-neuter-release programme to investigate the prevalence of otitis externa in stray cat colonies in northern Italy. Swabs for cytological examination were obtained from the external ear canal of each cat. A direct otoscopic assessment of the external ear canal was made in 86/187 cats. Cytological evidence of otitis externa was present in 55.1% of cats. The influence on otitis of age, gender, habitat and season of sampling was tested, but no risk factors were found. Otodectes cynotis (as a sole agent or in combination) was the primary cause of otitis in 53.3% of cats. Cocci and rods, either alone or in combination with other agents, were perpetuating factors in 71.8% and 29.1% of cats, respectively. Pregnancy status was a risk factor for otitis caused by coccal infections. Malassezia species, alone or in combination, was the perpetuating factor in 50.5% of cats with otitis. Urban habitat and winter season were risk factors for otitis associated with Malassezia species. Demodex cati was identified as an incidental finding in two cats. There was good agreement between otoscopy and cytology with regard to the diagnosis of otitis externa. The results of this study show a high prevalence of otitis externa in stray colony cats and provide information on causal factors for feline otitis externa.
M Nils Peterson
Full Text Available Outdoor cats represent a global threat to terrestrial vertebrate conservation, but management has been rife with conflict due to differences in views of the problem and appropriate responses to it. To evaluate these differences we conducted a survey of opinions about outdoor cats and their management with two contrasting stakeholder groups, cat colony caretakers (CCCs and bird conservation professionals (BCPs across the United States. Group opinions were polarized, for both normative statements (CCCs supported treating feral cats as protected wildlife and using trap neuter and release [TNR] and BCPs supported treating feral cats as pests and using euthanasia and empirical statements. Opinions also were related to gender, age, and education, with females and older respondents being less likely than their counterparts to support treating feral cats as pests, and females being less likely than males to support euthanasia. Most CCCs held false beliefs about the impacts of feral cats on wildlife and the impacts of TNR (e.g., 9% believed feral cats harmed bird populations, 70% believed TNR eliminates cat colonies, and 18% disagreed with the statement that feral cats filled the role of native predators. Only 6% of CCCs believed feral cats carried diseases. To the extent the beliefs held by CCCs are rooted in lack of knowledge and mistrust, rather than denial of directly observable phenomenon, the conservation community can manage these conflicts more productively by bringing CCCs into the process of defining data collection methods, defining study/management locations, and identifying common goals related to caring for animals.
Stiles, J; Weil, A B; Packer, R A; Lantz, G C
The medical records of 20 cats with post-anesthetic cortical blindness were reviewed. Information collected included signalment and health status, reason for anesthesia, anesthetic protocols and adverse events, post-anesthetic visual and neurological abnormalities, clinical outcome, and risk factors. The vascular anatomy of the cat brain was reviewed by cadaver dissections. Thirteen cats were anaesthetised for dentistry, four for endoscopy, two for neutering procedures and one for urethral obstruction. A mouth gag was used in 16/20 cats. Three cats had had cardiac arrest, whereas in the remaining 17 cases, no specific cause of blindness was identified. Seventeen cats (85%) had neurological deficits in addition to blindness. Fourteen of 20 cats (70%) had documented recovery of vision, whereas four (20%) remained blind. Two cats (10%) were lost to follow up while still blind. Ten of 17 cats (59%) with neurological deficits had full recovery from neurological disease, two (12%) had mild persistent deficits and one (6%) was euthanased as it failed to recover. Four cats (23%) without documented resolution of neurological signs were lost to follow up. Mouth gags were identified as a potential risk factor for cerebral ischemia and blindness in cats.
Wu, Yue; Noonan, Joseph P
Since the 1990s chaotic cat maps are widely used in data encryption, for their very complicated dynamics within a simple model and desired characteristics related to requirements of cryptography. The number of cat map parameters and the map period length after discretization are two major concerns in many applications for security reasons. In this paper, we propose a new family of 36 distinctive 3D cat maps with different spatial configurations taking existing 3D cat maps - as special cases. Our analysis and comparisons show that this new 3D cat maps family has more independent map parameters and much longer averaged period lengths than existing 3D cat maps. The presented cat map family can be extended to higher dimensional cases.
Hohnen, Rosemary; Tuft, Katherine; McGregor, Hugh W.; Legge, Sarah; Radford, Ian J.; Johnson, Christopher N.
The domestic cat (Felis catus) is an invasive exotic in many locations around the world and is thought to be a key factor driving recent mammal declines across northern Australia. Many mammal species native to this region now persist only in areas with high topographic complexity, provided by features such as gorges or escarpments. Do mammals persist in these habitats because cats occupy them less, or despite high cat occupancy? We show that occupancy of feral cats was lower in mammal-rich habitats of high topographic complexity. These results support the idea that predation pressure by feral cats is a factor contributing to the collapse of mammal communities across northern Australia. Managing impacts of feral cats is a global conservation challenge. Conservation actions such as choosing sites for small mammal reintroductions may be more successful if variation in cat occupancy with landscape features is taken into account. PMID:27655024
... misconduct'' is defined in 42 CFR 93.103 to mean ``fabrication, falsification, or plagiarism in proposing... that are related to biomedical or behavioral research or research training; and (5) plagiarism of... organization, or when FDA, ORI, or HHS makes a finding or takes an action potentially affecting the agency...
The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.
Romero, Klaus; Sinha, Vikram; Allerheiligen, Sandra; Danhof, Meindert; Pinheiro, Jose; Kruhlak, Naomi; Wang, Yaning; Wang, Sue-Jane; Sauer, John-Michael; Marier, J. F.; Corrigan, Brian; Rogers, James; Heerspink, H. J. Lambers; Gumbo, Tawanda; Vis, Peter; Watkins, Paul; Morrison, Tina; Gillespie, William; Gordon, Mark Forrest; Stephenson, Diane; Hanna, Debra; Pfister, Marc; Lalonde, Richard; Colatsky, Thomas
Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative . Priorities identified included the need for impro
YANG Xiang-dong; YE Hong; LI Yan-ting; LI Juan; LI Ji-ding; ZHAO Bing-qiang; LIN Yang-zheng
Polyimide (PI) is a type of important membrane material. A soluble polymer was synthesized from 4,4´-(hexalfuoroisopro-pylidene) diphthalic anhydride (6FDA) and 2,2-bis[4-(4-aminophenoxy) phenyl] hexalfuoropropane (BDAF) by the two-step polymerization method. The polymer was proved to be polyimide 6FDA-BDAF by the Fourier transform infrared (FT-IR), the1H-NMR and19F-NMR spectra. An asymmetric membrane was prepared with the synthesized polyimide 6FDA-BDAF, it was porous in the 50 μm height bulk and dense in a 3–5 μm height surface. The membrane was used to separate n-hep-tane/thiophene mixtures by pervaporation with sulfur (S) contents from 50 to 900 μg g–1. The total lfux was enlarged from 7.96 to 37.61 kg m–2 h–1 with temperature increasing from 50 to 90°C. The membrane’s enrichments factor for thiophene were about 3.13 and dependent on the experimental conditions. The experimental results demonstrated that polyimide 6FDA-BDAF would be a potential membrane material for desulfurization and controled release of the S-containing fertilizer.
Brandt, Lawrence J
The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.
Huang, Jiahao; Zhong, Honghua; Ke, Yongguan; Lee, Chaohong
We present a robust high-precision phase estimation scheme via spin cat states in the presence of particle losses. The input Greenberger-Horne-Zeilinger (GHZ) state, which may achieve the Heisenberg-limited measurement in the absence of particle losses, becomes fragile against particle losses and its achieved precision becomes even worse than the standard quantum limit (SQL). However, the input spin cat states, a kind of non-Gaussian entangled states in superposition of two spin coherent states, are of excellent robustness against particle losses and the achieved precision may still beat the SQL. For realistic measurements based upon our scheme, comparing with the population measurement, the parity measurement is more suitable for yielding higher precisions. In phase measurement with realistic dissipative systems of bosonic particles, our scheme provides a robust and realizable way to achieve high-precision measurements beyond the SQL.
GIL FILHO, Sylvio Fausto
RESUMO Este trabalho, sob o título "Igreja Católica Romana: Fronteiras do Discurso e Territorialidade do Sagrado," foi construído a partir da observação de que a Igreja mantém estratégias de expansão e preservação que configuram determinada territorialidade do sagrado. Nossa análise toma como referência o Concilio Vaticano II (1962-1965) e as repercussões no último quartel do século XX. Deste modo, partimos da desconstrução do discurso oficial da Igreja Católica Romana em quatro níveis es...
Full Text Available Dogs and cats are the animals that owners most frequently seek assistance for potential poisonings, and these species are frequently involved with toxicoses due to ingestion of poisonous food. Feeding human foodstuff to pets may prove itself dangerous for their health, similarly to what is observed in Allium species toxicosis. Allium species toxicosis is reported worldwide in several animal species, and the toxic principles present in them causes the transformation of hemoglobin into methemoglobin, consequently resulting in hemolytic anemia with Heinz body formation. The aim of this review is to analyze the clinicopathologic aspects and therapeutic approach of this serious toxicosis of dogs and cats in order to give knowledge to veterinarians about Allium species toxicosis, and subsequently allow them to correctly diagnose this disease when facing it; and to educate pet owners to not feed their animals with Allium-containg food in order to better control this particular life-threatening toxicosis.
After the big 2004 Sumatra earthquake, the tsunami threat posed by large earthquakes occurring in the Mediterranean sea was formally taken into account by many countries around the Mediterranean basin. In the past, large earthquakes that originated significant tsunamis occurred nearly once per century (Maramai et al., 2014, Annals of Geophysics). The Intergovernmental Oceanographic Commission of UNESCO (IOC-UNESCO) received a mandate from the international community to coordinate the establishment of the ICG/NEAMTWS (http://neamtic.ioc-unesco.org) through Resolution IOC-XXIII-14. Since then, several countries (France, Turkey, Greece) have started operating as candidate Tsunami Watch Provider (cTWP) in the Mediterranean. Italy started operating as cTWP on October 1st, 2014. The Italian cTWP is formed by INGV ("Istituto Nazionale di Geofisica e Vulcanologia)", DPC ("Dipartimento di Protezione Civile") and ISPRA ("Istituto Superiore per la Protezione e la Ricerca Ambientale"). INGV is in charge of issuing the alert for potentially tsunamigenic earthquakes, ISPRA provides the sea level recordings and DPC is in charge of disseminating the alert. INGV established the tsunami alert center (CAT, "Centro di Allerta Tsunami") at the end of 2013. CAT is co-located with the INGV national seismic surveillance center operated since many years. In this work, we show the technical and personnel organization of CAT, its response to recent earthquakes, and the new procedures under development for implementation. (*) INGV-CAT WG: Amato A., Basili R., Bernardi F., Bono A., Danecek P., De Martini P.M., Govoni A., Graziani L., Lauciani V., Lomax, A., Lorito S., Maramai A., Mele F., Melini D., Molinari I., Nostro C., Piatanesi A., Pintore S., Quintiliani M., Romano F., Selva J., Selvaggi G., Sorrentino D., Tonini R.
Ghermai, A K
The aetiology of chronic idiopathic intestinal inflammation is unknown. It is characterized by a diffuse infiltration with inflammatory cells into the intestinal mucosa and sometimes submucosa. Cats with chronic intermittent vomiting and diarrhoea, later on accompanied by anorexia and weight loss, are presented. Definitive diagnosis can be obtained by intestinal biopsy only. An immune pathogenesis is suspected, which is supported by the fact, that chronic inflammatory bowel disease responds to steroid therapy.
Susanna S. Nagel
Full Text Available A 10-year-old domestic short hair cat was referred for investigation of anorexia and polydipsia of 3 days’ duration. Clinically the cat was obese, pyrexic (39.8 °C, had acute abdominal pain and severe bilirubinuria. Haematology and serum biochemistry revealed severe panleukopenia, thrombocytopenia, markedly elevated alanine aminotransferase (ALT and five-fold increased pre-prandial bile acids. Ultrasonographic evaluation of the abdomen did not identify any abnormalities. Serum tests for feline immunodeficiency virus (FIV and feline leukaemia virus (FeLV were negative. Broad-spectrum antibiotic treatment for infectious hepatitis was to no avail; the cat deteriorated and died 72 h after admission. Necropsy revealed mild icterus and anaemia, severe multifocal hepatic necrosis, serofibrinous hydrothorax, pulmonary oedema and interstitial pneumonia. Histopathology confirmed the macroscopic findings and revealed multifocal microgranulomata in the brain and myocardium, as well as areas of necrosis in lymph nodes and multifocally in splenic red pulp. Long bone shaft marrow was hyperplastic with a predominance of leukocyte precursors and megakaryocytes and splenic red pulp showed mild extramedullary haemopoiesis. Immunohistochemical staining for Toxoplasma gondii was strongly positive, with scattered cysts and tachyzoites in the liver, lymph nodes, spleen, lungs, brain, salivary glands and intracellularly in round cells in occasional blood vessels. Immunohistochemical staining for corona virus on the same tissues was negative, ruling out feline infectious peritonitis (FIP. Polymerase chain reaction (PCR on formalin-fixed paraffin-wax embedded tissues was positive for Toxoplasma sp., but attempts at sequencing were unsuccessful. This was the first case report of fulminant disseminated toxoplasmosis in South Africa, in which detailed histopathology in an apparently immunocompetent cat was described.
Full Text Available The GLIMIR project at OCLC clusters and assigns an identifier to WorldCat records representing the same manifestation. These include parallel records in different languages (e.g., a record with English descriptive notes and subject headings and one for the same book with French equivalents. It also clusters records that probably represent the same manifestation, but which could not be safely merged by OCLC's Duplicate Detection and Resolution (DDR program for various reasons. As the project progressed, it became clear that it would also be useful to create content-based clusters for groups of manifestations that are generally equivalent from the end user perspective (e.g., the original print text with its microform, ebook and reprint versions, but not new editions. Lessons from the GLIMIR project have improved OCLC's duplicate detection program through the introduction of new matching techniques. GLIMIR has also had unexpected benefits for OCLC's FRBR algorithm by providing new methods for identifying outliers thus enabling more records to be included in the correct work cluster.
Menotti-Raymond, Marilyn; David, Victor A; Weir, Bruce S; O'Brien, Stephen J
A simple tandem repeat (STR) PCR-based typing system developed for the genetic individualization of domestic cat samples has been used to generate a population genetic database of domestic cat breeds. A panel of 10 tetranucleotide STR loci and a gender-identifying sequence tagged site (STS) were co-amplified in genomic DNA of 1043 individuals representing 38 cat breeds. The STR panel exhibits relatively high heterozygosity in cat breeds, with an average 10-locus heterozygosity of 0.71, which represents an average of 38 breed-specific heterozygosities for the 10-member panel. When the entire set of breed individuals was analyzed as a single population, a heterozygosity of 0.87 was observed. Heterozygosities obtained for the 10 loci range from 0.72 to 0.96. The power for genetic individualization of domestic cat samples of the multiplex is high, with a probability of match (p(m)) of 6.2E-14, using a conservative θ = 0.05.
Akhtardanesh B; Kheirandish R; Azari O
A 5-year-old neutered male domestic shorthair cat was presented for examination of a subcutaneous mass in his tail. The mass was firm, non-painful, oval, and approximately 2.5 × 3.5 cm. Surgical exploration revealed a well-circumscribed, encapsulated mass. The mass was removed and sectioned for histopathological examination. In gross section, it was filled with numerous dark hairs. Histologically the mass was consisted of haired skin with dermal cystic structures lined by stratified squamous epithelium. The cyst lumen contained squamous debris and filled with keratinous material. Numerous hair shafts were extended from the wall of the cyst. The sebaceous and apocrine gland adnexal structures were also observed which confirmed the diagnosis of dermoid cyst. No tumor recurrence was observed after surgery in fallowing checkups. Cutaneous or subcutaneous cysts of all types are considered rare in cats and to our knowledge this is the third reported case of cutaneous dermoid cyst of cats in veterinary literature which is different from the other cases because it occurred in dorsal midline in tail area whereas others occurred in flank area.
Kienle, R D; Thomas, W P; Rishniw, M
Eight healthy, adult cats were examined with biplane transesophageal echocardiography (TEE). Cats were sedated with a combination of diazepam and propofol and were examined using a 5 mm x 80 cm pediatric biplane TEE probe. Consistent images were obtained at three imaging depths within the esophagus. The caudal position provided satisfactory short-axis images of the left ventricle and heart base. The middle position provided the best long-axis views of the left atrium, left ventricle, and aorta and allowed Doppler examination of transmitral left ventricular inflow. The cranial position provided satisfactory imaging of the aorta and pulmonary artery and allowed Doppler examination of right ventricular and left ventricular outflow. Biplane TEE provides an additional method of imaging the feline heart which is complimentary to other imaging techniques and the images obtained were similar to those reported for dogs. Although TEE offers a slight advantage over transthorcic imaging for Doppler examination, the quality of the images of heart base structures was not as consistently superior to transthoracic images in cats as reported in dogs.
Zimmerman, Kurt; Feldman, Bernard; Robertson, John; Herring, Erin S; Manning, Thomas
A 1-year-old spayed female Persian cat with alopecia and weight loss had numerous variably ulcerated dermal nodules. Cytologic examination of an aspirate of one of the nodules revealed pyogranulomatous inflammation along with septate hyphae and basophilic round bodies, 0.5-1.0 microm in diameter, surrounded by a thin clear halo (arthrospores). The cytologic diagnosis was dermatophytic pseudomycetoma. Histologically, there were dermal granulomas containing poorly staining, septate hyphae with bulbous spores embedded within abundant amorphous eosinophilic material (Splendore-Hoeppli reaction), and the histologic diagnosis was pseudomycetoma-associated chronic multifocal severe granulomatous dermatitis with lymphocytic perifolliculitis and furunculosis. Microsporum canis was cultured from the lesion. Pseudomycetomas are distinguished from fungal mycetomas, or eumycotic mycetomas, by the findings of multiple lesions, lack of a history of skin trauma, an association with dermatophytes, most commonly Microsporum canis, and, histologically, lack of true cement material and a more abundant Splendore-Hoeppli reaction in pseudomycetomas. Additionally, pseudomycetomas differ from dermatophytosis, in which lesions are restricted to epidermal structures. Persian cats have a high incidence of pseudomycetoma formation, suggesting a heritable predisposition. The prognosis is fair with systemic antifungal therapy. When examining cytologic specimens from Persian cats with single or multiple dermal nodules, especially if pyogranulomatous inflammation is present, a diagnosis of pseudomycetoma should be suspected and is warranted if arthrospores and refractile septate hyphae are present.
Piola, Valentina; Posch, Barbara; Aghte, Petra; Caine, Abby; Herrtage, Michael E
The os penis in the cat has not been described radiographically, as compared with the dog. However, a small linear bony radiopacity is sometimes detected in the perineal area of male cats. We hypothesized that the feline os penis might be visible on survey radiographs of the pelvis, and we aimed to investigate the frequency of its visualization using analog and computed radiography (CR) system. One hundred radiographs of the pelvis of 99 male cats were reviewed retrospectively (50 were obtained with a CR system and 50 with an analog system). Age, breed, neutering status, and reason for presentation were recorded, as well as the visualization of the os penis. An os penis was detected in 19/50 (38%) cats with CR and in eight of 50 (16%) cats with analog radiography; this difference was statistically significant. With CR, the median age of cats with a visible os penis was significantly higher than in cats where the os penis was not seen. In one cat with a visible os penis examined with CR and analog radiography, the os penis was only visible on CR images. The penile tissues were examined histopathologically in one cat and well-differentiated bone was found but there were no pathologic findings detected in surrounding tissues. Thus, the os penis can be detected on radiographs of cats and this should not be mistaken for a pathologic finding such as urolithiasis or dystrophic mineralization.
Strain, George M; McGee, Kain A
Recordings of distortion product otoacoustic emissions (DPOAEs) were taken from 15 geriatric cats (mean age ± standard deviation, SD, 13.6 ± 2.7 years; range 10.2-19.4 years) and 12 young adult control cats (mean ± SD 4.6 ± 0.5 years; range 3.4-5 years) to identify frequency-specific age-related changes in cochlear responses. Recordings were performed for primary frequencies from 2 to 12 kHz in 2 kHz increments. Cats were considered to be geriatric > 11.9 ± 1.9 years of age. Brainstem auditory evoked response (BAER) recordings were also made for subjective comparison with DPOAE responses. No differences in DPOAE response amplitudes were observed at any tested frequency in geriatric cats compared to control cats, reflecting an apparent absence of loss of cochlear outer hair cells along the length of the cochlea. No linear regression relationships were found for DPOAE response amplitude versus age in geriatric cats, despite the progressive nature of age-related hearing loss in other species. The absence of reductions in response at any of the tested frequencies in cats within the age span where cats are considered to be geriatric indicates that age-related hearing loss, if it does develop in cats, begins later in the life span of cats than in dogs or human beings.
Farrelly, John; Denman, David L; Hohenhaus, Ann E; Patnaik, Amiya K; Bergman, Philip J
Five cats with melanoma involving the oral cavity were treated with hypofractionated radiation therapy (RT). Cobalt photons were used to administer three fractions of 8.0 Gray (Gy) for a total dose of 24 Gy. Four cats received radiation on days 0, 7, and 21 and one cat received radiation on days 0, 7, and 13. One of the cats received additional irradiation following the initial treatment course. Two cats received chemotherapy. Their age ranged from 11 to 15 years with a median age of 12 years. Three cats had a response to radiation, including one complete response and two partial responses. All five cats were euthanized due to progression of disease, with one cat having evidence of metastatic disease at the time of euthanasia. The median survival time for the five cats was 146 days (range 66-224 days) from the start of RT. The results of this study suggest that oral melanoma in cats may be responsive to hypofractionated RT, but response does not seem to be durable.
Spencer, Peter B S; Yurchenko, Andrey A; David, Victor A; Scott, Rachael; Koepfli, Klaus-Peter; Driscoll, Carlos; O'Brien, Stephen J; Menotti-Raymond, Marilyn
The historical literature suggests that in Australia, the domestic cat (Felis catus) had a European origin [~200 years before present (ybp)], but it is unclear if cats arrived from across the Asian land bridge contemporaneously with the dingo (4000 ybp), or perhaps immigrated ~40000 ybp in association with Aboriginal settlement from Asia. The origin of cats in Australia is important because the continent has a complex and ancient faunal assemblage that is dominated by endemic rodents and marsupials and lacks the large placental carnivores found on other large continents. Cats are now ubiquitous across the entire Australian continent and have been implicit in the range contraction or extinction of its small to medium sized (cats using 15 short tandem repeat (STR) genomic markers. Their origin appears to come exclusively from European founders. Feral cats in continental Australia exhibit high genetic diversity in comparison with the low diversity found in populations of feral cats living on islands. The genetic structure is consistent with a rapid westerly expansion from eastern Australia and a limited expansion in coastal Western Australia. Australian cats show modest if any population structure and a close genetic alignment with European feral cats as compared to cats from Asia, the Christmas and Cocos (Keeling) Islands (Indian Ocean), and European wildcats (F. silvestris silvestris).
Analyte Specific Reagents (ASRs )for the Diagnosis of Selected Arthropod-Borne Viruses on FDA-Cleared Real - time PCR Platforms PRINCIPAL...of Analyte Specific Reagents (ASRs) for the Diagnosis of Selected Arthropod-Borne Viruses on FDA-Cleared Real - time PCR Platforms 5c. PROGRAM ELEMENT
Full Text Available BACKGROUND: The human red nucleus (Nr is comparatively less well-studied than that of cats or monkeys. Given the functional importance of reticular and midbrain structures in control of movement and locomotion as well as from an evolutionary perspective, we investigated the nature and extent of any differences in Nr projections to the olivary complex in quadrupedal and bipedal species. Using neuroanatomical tract-tracing techniques we developed a "neural sheet" hypothesis allowing us to propose how rubro-olivary relations differ among the three species. METHODS AND FINDINGS: Wheat germ agglutinin-horseradish peroxidase staining supports findings that the cat's nucleus accessories medialis of Bechtrew (NB projects mainly to the lateral bend of the principal olive. We clarified boundaries among nucleus of Darkschewitsch (ND, NB and parvicellular red nucleus (pNr of the cat's neural sheet. The macaque's ND-medial accessory olivary projection is rostro-caudally organized and the dorsomedial and ventrolateral parts of the macaque's pNr may project to the principal olive's rostral and caudal dorsal lamella; in cat it projects as well to pNr. Myelin- and Nissl-stained sections show that a well-developed dorsomedial part of the human Nr consists of densely packed cells, deriving small myelinated fibers that continue into the medial central tegmental tract. CONCLUSIONS: Based on these findings we suggest there are distinct bipedal-quadrupedal differences for Nr projections to the olivary complex. We propose the Nr of cats and monkeys comprise the ND, NB and pNr in a zonal sheet-like structure, retaining clear nuclear boundaries and an isolated, well-developed mNr. The human NB may be distinguished from its more specialised ND (ND lies alongside a well-developed pNr in the human central gray. Phylogenetically, the NB may have been translocated into a roll-shaped Nr in the reticular formation, the dorsomedial portion of which might correspond to the cat
Zito, Sarah; Paterson, Mandy; Vankan, Dianne; Morton, John; Bennett, Pauleen; Phillips, Clive
Simple Summary Commonly, more adult cats than kittens are euthanized in animal shelters. We surveyed 382 cat adopters to assess adoption outcomes and potential determinants of adopters’ choice of cat age group and price. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and responsible ownership requirements. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive in all age and adoption price groups. This study provides evidence to inform the design of strategies to encourage adult cat adoptions. Abstract The percentage of adult cats euthanized in animal shelters is greater than that of kittens because adult cats are less likely to be adopted. This study aimed to provide evidence to inform the design of strategies to encourage adult cat adoptions. One such strategy is to discount adoption prices, but there are concerns that this may result in poor adoption outcomes. We surveyed 382 cat adopters at the time of adoption, to assess potential determinants of adopters’ cat age group choice (adult or kitten) and, for adult cat adopters, the price they are willing to pay. The same respondents were surveyed again 6–12 months after the adoption to compare outcomes between cat age groups and between adult cats in two price categories. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and requirements for responsible ownership. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive for both adult cats and kittens and for adult cats adopted at low prices. The latter finding alleviates concerns about the outcomes of “low-cost” adoptions in populations, such as the study population, and lends support for the use of “low-cost” adoptions as an option for
Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B
The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.
Zawack, Kelson; Li, Min; Booth, James G; Love, Will; Lanzas, Cristina; Gröhn, Yrjö T
In response to concerning increases in antimicrobial resistance (AMR), the Food and Drug Administration (FDA) has decided to increase veterinary oversight requirements for antimicrobials and restrict their use in growth promotion. Given the high stakes of this policy for the food supply, economy, and human and veterinary health, it is important to rigorously assess the effects of this policy. We have undertaken a detailed analysis of data provided by the National Antimicrobial Resistance Monitoring System (NARMS). We examined the trends in both AMR proportion and MIC between 2004 and 2012 at slaughter and retail stages. We investigated the makeup of variation in these data and estimated the sample and effect size requirements necessary to distinguish an effect of the policy change. Finally, we applied our approach to take a detailed look at the 2005 withdrawal of approval for the fluoroquinolone enrofloxacin in poultry water. Slaughter and retail showed similar trends. Both AMR proportion and MIC were valuable in assessing AMR, capturing different information. Most variation was within years, not between years, and accounting for geographic location explained little additional variation. At current rates of data collection, a 1-fold change in MIC should be detectable in 5 years and a 6% decrease in percent resistance could be detected in 6 years following establishment of a new resistance rate. Analysis of the enrofloxacin policy change showed the complexities of the AMR policy with no statistically significant change in resistance of both Campylobacter jejuni and Campylobacter coli to ciprofloxacin, another second-generation fluoroquinolone.
Giambelli, Camilla; Fei, Dennis Liang; Han, Lu; Hang, Brian I.; Bai, Feng; Pei, Xin-Hai; Nose, Vania; Burlingame, Oname; Capobianco, Anthony J.; Orton, Darren; Lee, Ethan; Robbins, David J.
Mutations in the WNT-pathway regulator ADENOMATOUS POLYPOSIS COLI (APC) promote aberrant activation of the WNT pathway that is responsible for APC-associated diseases such as Familial Adenomatous Polyposis (FAP) and 85% of spontaneous colorectal cancers (CRC). FAP is characterized by multiple intestinal adenomas, which inexorably result in CRC. Surprisingly, given their common occurrence, there are few effective chemotherapeutic drugs for FAP. Here we show that the FDA-approved, anti-helminthic drug Pyrvinium attenuates the growth of WNT-dependent CRC cells and does so via activation of CK1α. Furthermore, we show that Pyrvinium can function as an in vivo inhibitor of WNT-signaling and polyposis in a mouse model of FAP: APCmin mice. Oral administration of Pyrvinium, a CK1α agonist, attenuated the levels of WNT-driven biomarkers and inhibited adenoma formation in APCmin mice. Considering its well-documented safe use for treating enterobiasis in humans, our findings suggest that Pyrvinium could be repurposed for the clinical treatment of APC-associated polyposes. PMID:25003333
Full Text Available Mutations in the WNT-pathway regulator ADENOMATOUS POLYPOSIS COLI (APC promote aberrant activation of the WNT pathway that is responsible for APC-associated diseases such as Familial Adenomatous Polyposis (FAP and 85% of spontaneous colorectal cancers (CRC. FAP is characterized by multiple intestinal adenomas, which inexorably result in CRC. Surprisingly, given their common occurrence, there are few effective chemotherapeutic drugs for FAP. Here we show that the FDA-approved, anti-helminthic drug Pyrvinium attenuates the growth of WNT-dependent CRC cells and does so via activation of CK1α. Furthermore, we show that Pyrvinium can function as an in vivo inhibitor of WNT-signaling and polyposis in a mouse model of FAP: APCmin mice. Oral administration of Pyrvinium, a CK1α agonist, attenuated the levels of WNT-driven biomarkers and inhibited adenoma formation in APCmin mice. Considering its well-documented safe use for treating enterobiasis in humans, our findings suggest that Pyrvinium could be repurposed for the clinical treatment of APC-associated polyposes.
Jennifer M Colón
Full Text Available Spinal cord injury (SCI is a condition without a cure, affecting sensory and/or motor functions. The physical trauma to the spinal cord initiates a cascade of molecular and cellular events that generates a non-permissive environment for cell survival and axonal regeneration. Among these complex set of events are damage of the blood-brain barrier, edema formation, inflammation, oxidative stress, demyelination, reactive gliosis and apoptosis. The multiple events activated after SCI require a multi-active drug that could target most of these events and produce a permissive environment for cell survival, regeneration, vascular reorganization and synaptic formation. Tamoxifen, a selective estrogen receptor modulator, is an FDA approved drug with several neuroprotective properties that should be considered for the treatment of this devastating condition. Various investigators using different animal models and injury parameters have demonstrated the beneficial effects of this drug to improve functional locomotor recovery after SCI. Results suggest that the mechanism of action of Tamoxifen administration is to modulate anti-oxidant, anti-inflammatory and anti-gliotic responses. A gap of knowledge exists regarding the sex differences in response to Tamoxifen and the therapeutic window available to administer this treatment. In addition, the effects of Tamoxifen in axonal outgrowth or synapse formation needs to be investigated. This review will address some of the mechanisms activated by Tamoxifen after SCI and the results recently published by investigators in the field.
Tomljenovic, Lucija; Shaw, Christopher A
There are not many public health issues where views are as extremely polarized as those concerning vaccines, and Merck's HPV vaccine Gardasil is a case in point. Ever since gaining the FDA's approval in 2006, Merck has been heavily criticized for their overly aggressive marketing strategies and lobbying campaigns aimed at promoting Gardasil as a mandatory vaccine. Subsequently, questions have been raised as to whether it was appropriate for vaccine manufacturers to partake in public health policies when their conflicts of interests are so obvious. Some of their advertising campaign slogans, such as "cervical cancer kills x women per year" and "your daughter could become one less life affected by cervical cancer," seemed more designed to promote fear rather than evidence-based decision making about the potential benefits of the vaccine. Although, conflicts of interests do not necessarily mean that the product itself is faulty, marketing claims should be carefully examined against factual science data. Currently Gardasil vaccination is strongly recommended by the U.S. and other health authorities while public concerns about safety and efficacy of the vaccine appear to be increasing. This discrepancy leads to some important questions that need to be resolved. The current review examines key issues of this debate in light of currently available research evidence.
Judith U. Cope
Full Text Available Background. Ewing sarcoma family of tumors (ESFT are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.
Ángel Gabriel Díaz-Sánchez
Full Text Available Urease is a nickel-dependent amidohydrolase that catalyses the decomposition of urea into carbamate and ammonia, a reaction that constitutes an important source of nitrogen for bacteria, fungi and plants. It is recognized as a potential antimicrobial target with an impact on medicine, agriculture, and the environment. The list of possible urease inhibitors is continuously increasing, with a special interest in those that interact with and block the flexible active site flap. We show that disulfiram inhibits urease in Citrullus vulgaris (CVU, following a non-competitive mechanism, and may be one of this kind of inhibitors. Disulfiram is a well-known thiol reagent that has been approved by the FDA for treatment of chronic alcoholism. We also found that other thiol reactive compounds (l-captopril and Bithionol and quercetin inhibits CVU. These inhibitors protect the enzyme against its full inactivation by the thiol-specific reagent Aldrithiol (2,2′-dipyridyl disulphide, DPS, suggesting that the three drugs bind to the same subsite. Enzyme kinetics, competing inhibition experiments, auto-fluorescence binding experiments, and docking suggest that the disulfiram reactive site is Cys592, which has been proposed as a “hinge” located in the flexible active site flap. This study presents the basis for the use of disulfiram as one potential inhibitor to control urease activity.
Polanski, Jaroslaw; Bogocz, Jacek; Tkocz, Aleksandra
Target-oriented drug discovery is the main research paradigm of contemporary drug discovery. In target-oriented approaches, we attempt to maximize in vitro drug potency by finding the optimal fit to the target. This can result in a higher molecular complexity, in particular, the higher molecular weight (MW) of the drugs. However, a comparison of the successful developments of pharmaceuticals with the general trends that can be observed in medicinal chemistry resulted in the conclusion that the so-called molecular obesity is an important reason for the attrition rate of drugs. When analyzing the list of top 100 drug bestsellers versus all of the FDA approvals, we discovered that on average lower-complexity (MW, ADMET score) drugs are winners of the top 100 list in terms of numbers but that, especially, up to some optimal MW value, a higher molecular complexity can pay off with higher incomes. This indicates that slim drugs are doing better but that fat drugs are bigger fishes to catch.
Jennifer M. Colón; Jorge D. Miranda
Spinal cord injury (SCI) is a condition without a cure, affecting sensory and/or motor functions. The physical trauma to the spinal cord initiates a cascade of molecular and cellular events that generates a non-permissive environment for cell survival and axonal regeneration. Among these complex set of events are damage of the blood-brain barrier, edema formation, inlfammation, oxidative stress, demyelination, reactive gliosis and apoptosis. The multiple events activated after SCI require a multi-active drug that could target most of these events and produce a permissive environment for cell survival, regeneration, vascular reorganization and syn-aptic formation. Tamoxifen, a selective estrogen receptor modulator, is an FDA approved drug with several neuroprotective properties that should be considered for the treatment of this devastating condition. Various investigators using different animal models and injury parameters have demonstrated the beneifcial effects of this drug to improve functional locomotor recovery after SCI. Results suggest that the mechanism of action of Tamoxifen administration is to modulate anti-oxidant, anti-inlfammatory and anti-gliotic responses. A gap of knowledge exists regarding the sex differences in response to Tamoxifen and the therapeutic window available to administer this treatment. In addition, the effects of Tamoxifen in axonal outgrowth or synapse formation needs to be investigated. This review will address some of the mechanisms activated by Tamoxifen after SCI and the results recently published by investigators in the ifeld.
Polanski, Jaroslaw; Bogocz, Jacek; Tkocz, Aleksandra
Target-oriented drug discovery is the main research paradigm of contemporary drug discovery. In target-oriented approaches, we attempt to maximize in vitro drug potency by finding the optimal fit to the target. This can result in a higher molecular complexity, in particular, the higher molecular weight (MW) of the drugs. However, a comparison of the successful developments of pharmaceuticals with the general trends that can be observed in medicinal chemistry resulted in the conclusion that the so-called molecular obesity is an important reason for the attrition rate of drugs. When analyzing the list of top 100 drug bestsellers versus all of the FDA approvals, we discovered that on average lower-complexity (MW, ADMET score) drugs are winners of the top 100 list in terms of numbers but that, especially, up to some optimal MW value, a higher molecular complexity can pay off with higher incomes. This indicates that slim drugs are doing better but that fat drugs are bigger fishes to catch.
Norrgran Engdahl, J; Bignert, A; Jones, B; Athanassiadis, I; Bergman, Å; Weiss, J M
Pet cats may be used as a biomarker for assessing exposures to organohalogen compounds (OHCs) adsorbed to household dust in home environments. This study explores two exposure routes of OHCs, ingestion of OHCs (i) via house dust and (ii) via cat food. House dust from 17 Swedish homes and serum from the participating families' pet cats were collected, and cat food was purchased matching the diet reported. Paired samples of cat serum, house dust, and cat food were analyzed for brominated flame retardants/natural products (polybrominated diphenyl ethers (PBDEs), decabromobiphenyl (BB-209), decabromodiphenyl ethane (DBDPE), 2,4,6-tribromophenol (2,4,6-TBP), OH-PBDEs) and organochlorines (polychlorinated biphenyls (PCBs), 1,1-bis(4,4'-dichlorodiphenyl)-2,2,2-trichloroethane (4,4'-DDT), 1,1-bis(4,4'-dichlorodiphenyl)-2,2-dichloroethene (4,4'-DDE), hexachlorobenzene (HCB), pentachlorophenol (PCP)). Significant correlations were found between serum and dust samples from the living rooms for BDE-47 (p cat serum levels and household dust has been established, a finding that supports the hypothesis that dust is a significant exposure route for cats. Serum levels were also significantly correlated with concentrations found in cat food for 6-OH-BDE47 (p cats.
Tholen, Inger; Weingart, Christiane; Kohn, Barbara
The objective of this prospective study was to measure concentrations of D-dimers in 48 cats with various diseases and in 20 healthy cats to evaluate the sensitivity and specificity for D-dimers to diagnose disseminated intravascular coagulation (DIC). The cats were classified as having DIC if an underlying disease and at least three of the following criteria were present: thrombocytopenia, prolonged activated partial thromboplastin time, prothrombin time or thrombin time, schistocytes and/or a reduced antithrombin activity. D-dimer concentrations were measured using a semi-quantitative latex agglutination (LA) test (Accuclot D-Dimer, Sigma Diagnostics). The D-dimer test was positive for 8/12 cats with DIC and for 16/36 sick cats without DIC. D-dimers were negative for all healthy control cats. The comparison of the sick cats with DIC and those without DIC revealed a specificity and sensitivity of the D-dimer test of 56% and 67%; a comparison of the results for healthy cats and cats with DIC revealed a specificity and sensitivity of 100% and 67%, respectively. The D-dimer LA test is only of limited value for the diagnosis of DIC in cats.
Full Text Available The percentage of adult cats euthanized in animal shelters is greater than that of kittens because adult cats are less likely to be adopted. This study aimed to provide evidence to inform the design of strategies to encourage adult cat adoptions. One such strategy is to discount adoption prices, but there are concerns that this may result in poor adoption outcomes. We surveyed 382 cat adopters at the time of adoption, to assess potential determinants of adopters’ cat age group choice (adult or kitten and, for adult cat adopters, the price they are willing to pay. The same respondents were surveyed again 6–12 months after the adoption to compare outcomes between cat age groups and between adult cats in two price categories. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and requirements for responsible ownership. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive for both adult cats and kittens and for adult cats adopted at low prices. The latter finding alleviates concerns about the outcomes of “low-cost” adoptions in populations, such as the study population, and lends support for the use of “low-cost” adoptions as an option for attempting to increase adoption rates. In addition, the results provide information that can be used to inform future campaigns aimed at increasing the number of adult cat adoptions, particularly in devising marketing strategies for adult cats.
Alaslai, Nasser Y.
The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.
Keller, J. L.; Haines, P. A.; Luers, J. K.
The original formulations of Roach (1970) and Oard (1974) for the calculation of clear air turbulence (CAT) potential from synoptic scale data were extended. An index which gives a measure of the specific risk of encountering CAT - the specific clear air turbulence risk (SCATR) index - was defined. This index takes into account both the locally and advected contributions to the energy necessary for CAT. The advected contribution is associated with the role of atmospheric gravity waves. The SCATR index was calculated for a number of cases where documented encounters with CAT occurred. Of particular interest were those made for cases involving severe CAT. The results for the two severe CAT cases run were quite impressive and elicited considerable interest from operational aviation meteorologists.
Christiansen, Liselotte Bruun; Prats Gavalda, Clara; Hyttel, Poul
OBJECTIVES: Hypertrophic cardiomyopathy (HCM) is the most common heart disease in cats and shares clinical and pathological characteristics with human HCM. Little is known about the pathogenic mechanisms underlying development of spontaneous feline HCM. ANIMALS: The study population consisted...... of seven cats diagnosed with HCM and eight age-matched cats with no evidence of cardiac disease. METHODS: Fresh myocardial biopsies taken from the middle of the left ventricular posterior free wall were obtained and examined with transmission electron microscopy. RESULTS: Electron microscopic examination...... showed ultrastructural aberrations of the myocardial cytoarchitecture and of the interstitium in the seven cats with HCM. In the most severely affected cats the myofibrils were disorganized and subsarcolemmal mitochondria were depleted. In control cats, contraction band artifacts were commonly seen...
根据韩礼德系统功能语言学理论，符号系统有三大元功能：概念功能、人际功能和语篇功能。语篇功能又包含主谓系统、信息系统和衔接系统。本文从功能语法理论角度分析了《雨中猫》不同译本语篇衔接系统和语篇逻辑连接功能。%Halliday proposed functional grammar theory, pointing out that a text has three metafunctions, which is ideational function, interpersonal function and textual function. And the textual function includes theme system, information system and cohesion system. This discourse focuses on textual cohesion of Cat in The Rain
Filgueira, Kilder Dantas; Reche Junior,Archivaldo
Background: In the feline species, 80% to 93% of neoplasias in the mammary gland are malignant, being the majority carcinomas. Among them, there is the mammary squamous cell carcinoma, which amounts to a very rare neoplasm in the domestic cat, with considerable potential for malignancy. This study aimed to report a case of squamous cell mammary carcinoma in the feline species. Case: A female cat, mixed breed, ten years old, presented history of skin lesion. The cat had been spayed two years b...
Bell, Erin T; Suchodolski, Jan S; Isaiah, Anitha; Fleeman, Linda M; Cook, Audrey K; Steiner, Jörg M; Mansfield, Caroline S
Microorganisms within the gastrointestinal tract significantly influence metabolic processes within their mammalian host, and recently several groups have sought to characterise the gastrointestinal microbiota of individuals affected by metabolic disease. Differences in the composition of the gastrointestinal microbiota have been reported in mouse models of type 2 diabetes mellitus, as well as in human patients. Diabetes mellitus in cats has many similarities to type 2 diabetes in humans. No studies of the gastrointestinal microbiota of diabetic cats have been previously published. The objectives of this study were to compare the composition of the faecal microbiota of diabetic and non-diabetic cats, and secondarily to determine if host signalment and dietary factors influence the composition of the faecal microbiota in cats. Faecal samples were collected from insulin-treated diabetic and non-diabetic cats, and Illumina sequencing of the 16S rRNA gene and quantitative PCR were performed on each sample. ANOSIM based on the unweighted UniFrac distance metric identified no difference in the composition of the faecal microbiota between diabetic and non-diabetic cats, and no significant differences in the proportions of dominant bacteria by phylum, class, order, family or genus as determined by 16S rRNA gene sequencing were identified between diabetic and non-diabetic cats. qPCR identified a decrease in Faecalibacterium spp. in cats aged over ten years. Cat breed or gender, dietary carbohydrate, protein or fat content, and dietary formulation (wet versus dry food) did not affect the composition of the faecal microbiota. In conclusion, the composition of the faecal microbiota was not altered by the presence of diabetes mellitus in cats. Additional studies that compare the functional products of the microbiota in diabetic and non-diabetic cats are warranted to further investigate the potential impact of the gastrointestinal microbiota on metabolic diseases such as
Osborn, Douglas.; Weiner, Ruth F.; Mills, George Scott; Hamp, Steve C.; O' Donnell, Brandon, M.; Orcutt, David J.; Heames, Terence J.; Hinojosa, Daniel
This document provides a detailed discussion and a guide for the use of the RadCat 2.0 Graphical User Interface input file generator for the RADTRAN 5.5 code. The differences between RadCat 2.0 and RadCat 1.0 can be attributed to the differences between RADTRAN 5 and RADTRAN 5.5 as well as clarification for some of the input parameters. 3
Booij-Vrieling, H E; van der Reijden, W A; Houwers, D J; de Wit, W E A J; Bosch-Tijhof, C J; Penning, L C; van Winkelhoff, A J; Hazewinkel, H A W
The periodontal pathogens Porphyromonas gingivalis and Tannerella forsythia are strongly associated with periodontal disease and are highly prevalent in humans with periodontitis. Porphyromonas and Tannerella spp. have also been isolated from the oral cavity of cats. The oral microflora in animals was compared with those in humans in earlier studies, but no studies are available on the comparison of the oral microflora from pets and their respective owners. The aim of this study was to determine the presence of these bacteria in the oral microflora of cats and their owners, since animal to human transmission, or vice versa, of oral pathogens could have public health implications. This study investigated the prevalence of Porphyromonas gulae, P. gingivalis, and T. forsythia in the oral microflora of cats and their owners, using culture and polymerase chain reaction (PCR). All Porphyromonas isolates from cats (n=64) were catalase positive, whereas the Porphyromonas isolates from owners (n=7) were catalase negative, suggesting that the isolates from cats were P. gulae whereas those from the owners were P. gingivalis. T. forsythia was recovered from both cats (n=63) and owners (n=31); the proportion of T. forsythia relative to the total CFU was higher in cats with periodontitis than in cats without periodontal disease. Genotyping of T. forsythia isolates (n=54) in six cat/owner couples showed that in one cat/owner couple the T. forsythia isolates (n=6) were identical. These T. forsythia isolates were all catalase positive, which led us to hypothesize that transmission from cats to owners had occurred and that cats may be a reservoir of T. forsythia.
Wilcox, Rebbecca S; Bowman, Dwight D; Barr, Stephen C; Euclid, James M
An adult domestic shorthair (DSH) cat was presented with acute vomiting, anorexia, lethargy, and dyspnea. The cat's clinical status worsened over 24 hours with conservative medical management. An exploratory celiotomy was performed. Acute intestinal obstruction resulting from infection with Taenia (T.) taeniaeformis was diagnosed. Surgical removal of the cestodes via multiple enterotomies resolved the obstruction. This paper reports, for the first time, small intestinal obstruction caused by T. taeniaeformis infection in a cat.
Park, Eui Ju; Lee, Joon Seong; Lee, Tae Hee; Choi, Dae Han; Kim, Eui Bae; Jeon, Seong Ran; Hong, Su Jin; Kim, Jin-Oh
"Cat scratch colon" is a gross finding characterized by hemorrhagic mucosal scratches on colonoscopy. It is usually associated with a normal colon and is rarely associated with collagenous colitis. In a previous report, cat scratch colon was noted in the cecum and ascending colon, but has also been observed in the distal transverse colon. The patient in this study was also diagnosed with ischemic colitis that may have played a role in the development of cat scratch colon.
Weniger, B G; Warren, A J; Forseth, V; Shipps, G W; Creelman, T; Gorton, J; Barnes, A M
Bubonic plague was transmitted to a 10-year-old girl in Oregon by a scratch wound inflicted by a domestic cat. The cat probably was infected by contact with infected wild rodents or their fleas. Yersinia pestis was identified in Diamanus montanus fleas collected from an abandoned burrow near the patient's home. Domestic cats may infect humans with Y pestis by inoculation from a scratch.
Girod, M; Vandenheede, M; Farnir, F; Gommeren, K
Rectal temperature measurement (RTM) can promote stress and defensive behaviour in hospitalised cats. The aim of this study was to assess if axillary temperature measurement (ATM) could be a reliable and less stressful alternative for these animals. In this prospective study, paired rectal and axillary temperatures were measured in 42 cats, either by a veterinarian or a student. To assess the impact of these procedures on the cat's stress state, their heart rate was checked and a cat stress score (CSS) was defined and graded from 1 (relaxed) to 5 (terrified). A moderate correlation was found between RTM and ATM (r=0.52; Pcats.
Peterson, J L; Willard, M D; Lees, G E; Lappin, M R; Dieringer, T; Floyd, E
Lymphocytic-plasmacytic enteritis, a chronic inflammatory intestinal disease, was diagnosed in 2 cats. In 1 cat, recurrence of clinical signs after initiating treatment was attributed to relapse of the inflammatory intestinal disease, but was found to be attributable to relapsing toxoplasmosis secondary to immunosuppressive drug therapy. Treatment with clindamycin resolved the recurrent toxoplasmosis. In the second cat, clinical signs of toxoplasmosis did not develop, but serologic testing yielded evidence of active toxoplasmosis. Treatment with clindamycin caused the titers to decrease. Relapsing toxoplasmosis may be responsible for apparent resistance to treatment in cats for inflammatory intestinal disease being treated with immunosuppressive drugs.
WorldCat Local是OCLC于2008年推出的一站式发现与传递服务。本文通过分析WorldCat在40年里的四个发展阶段辨析WorldCat Local的发展路径，再从内容建设、功能开发、用户规模等方面介绍WorldCat Local逐步完善的过程，最后分析WorldCat Local的主要功能及其与其他发现平台的异同点。
Robertson, S A; Taylor, P M; Sear, J W
The plasma concentration of buprenorphine was measured by radioimmunoassay in six female cats after the administration of 0.01 mg/kg (0.033 ml/kg) buprenorphine hydrochloride solution into the side of the cat's mouth. Blood samples were taken through a preplaced jugular catheter before and one, two, four, six, 10, 15, 30, 45 and 60 minutes, and two, four, six, 12 and 24 hours after the dose was administered. The buprenorphine was accepted well by all the cats and did not cause salivation or vomiting. Its median peak plasma concentration was 7.5 ng/ml and was reached after 15 minutes. The pharmacokinetic data were similar to the pharmacokinetic data obtained after the intramuscular and intravenous administration of buprenorphine to cats from the same colony, suggesting that the mucosal route of administration should be as effective as intravenous and intramuscular injections. In addition, the pH of the oral cavity of 26 cats was measured with pH paper, and 100 cat owners were asked their preferred method of administering drugs to cats. The pH of the cats' mouths was between 8 and 9, and the technique preferred by the cat owners was the use of drops placed in the mouth.
Ibarrola, Patricia; German, Alexander J; Stell, Anneliese J; Fox, Richard; Summerfield, Nuala J; Blackwood, Laura
A 13-year-old neutered male Persian cat and an 11-year-old neutered female Persian cat were examined because of an acute onset of lameness. In both cats, conscious proprioception and reflexes were diminished in the affected limb. In 1 cat, no blood flow was detected in the left brachial artery with a Doppler ultrasonic flow detector, whereas blood flow in the right brachial artery was easily documented. In the other cat, the right femoral pulse was not palpable. Neither cat had any echocardiographic evidence of cardiac disease. In both cats, treatment was primarily supportive. One cat died, and the other was euthanatized. At necropsy, lung lobe consolidation was seen. Microscopically, there was multifocal infiltration of the lung parenchyma with cuboidal to columnar neoplastic epithelial cells. Neoplastic epithelial cells of similar morphology were identified in nodular masses in sections of muscle, and intravascular tumor emboli were identified obliterating small and large arterioles. Immunohistochemical staining of pulmonary and muscular tissue for pan-cytokeratin antigen revealed intense cytoplasmic staining of neoplastic cells. Staining for factor VIII-related antigen confirmed that clusters of neoplastic cells represented intravascular emboli. Clinical signs in the cats were attributed to arterial occlusion by tumor emboli.
Diabetes mellitus is a common disease in cats and dogs. Its incidence is increasing, possibly due to an increase in obesity in both species. Different types of diabetes have been identified in pet animals. The classification of diabetic dogs and cats is modeled after the human classification but especially in the diabetic dogs, many aspects are different. The diabetic cat, however, resembles type 2 diabetic human patients more closely. The clinical presentation, pathophysiology, and histologic findings are described for both dog and cat and possible etiological mechanisms are discussed.
Full Text Available Case summary A 7-year-old male castrated domestic short-haired cat was evaluated for a 4 week history of intermittent vomiting, ptyalism, lethargy and weight loss. Serum biochemistry revealed mild mixed hepatopathy. Abdominal ultrasonography identified multiple heterogeneous hepatic masses and a linear, hyperechoic focus with associated reverberation artifact in the wall of the stomach consistent with a gastric ulcer. Serum gastrin concentrations were markedly increased. Cytologic interpretation of a fine-needle aspirate of the hepatic masses was consistent with neuroendocrine neoplasia, and a diagnosis of gastrinoma was established. Deterioration of the cat’s condition, despite at-home acid-suppressant therapy, led to hospitalization. The cat was initially stabilized with intravenous crystalloid fluid therapy, maropitant, pantoprazole and octreotide. A continuous radiotelemetric intragastric pH monitoring system was used to monitor the response of intragastric pH to therapy. Long-term therapy was continued with omeprazole (orally q12h, octreotide (subcutaneously q8h and thrice-weekly toceranib administered orally. Toceranib therapy led to gastrointestinal upset and was discontinued. Gastric ulceration resolved within 8 weeks, and palliation of clinical signs was achieved for approximately 5 months. Relevance and novel information Including this report, only six cases of feline gastrinoma have been reported in the veterinary literature. Little is known regarding non-surgical therapy, and octreotide has not been previously reported for medical management of feline gastrinoma. Results of intragastric pH monitoring and clinical improvement suggest that medical therapy using octreotide and proton pump inhibitors represents a novel therapeutic option for cats with gastrinoma where surgical excision is not feasible.
In this paper we show that an iterative sequence generated by the Halpern algorithm converges to a fixed point in the case of complete CAT(κ) spaces. Similar results for Hadamard manifolds were obtained in[Li,C.,López, G., Martín-Márquez, V.:Iterative algorithms for nonexpansive mappings on Hadamard manifolds. Taiwanese J. Math., 14, 541-559 (2010)], but we study a much more general case. Moreover, we discuss the Halpern iteration procedure for set-valued mappings.
Gold, Michael H
This manuscript is intended to give one an international perspective on the use of fillers around the world-what makes some of them special and what is the need and what is the purpose of having so many fillers in this global dermatologic community we live in. In the US, we have a finite number of fillers and only a handful more currently going through FDA testing. We demand much from our fillers in terms of safety and efficacy, and for all of us in the US, this is a very good reason to keep the numbers of fillers available to a reasonable number.
Full Text Available Lyme disease is a leading vector-borne disease in the United States. Although the majority of Lyme patients can be cured with standard 2–4 week antibiotic treatment, 10%–20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS. While the cause for this is unclear, persisting organisms not killed by current Lyme antibiotics may be involved. In our previous study, we screened an FDA drug library and reported 27 top hits that showed high activity against Borrelia persisters. In this study, we present the results of an additional 113 active hits that have higher activity against the stationary phase B. burgdorferi than the currently used Lyme antibiotics. Many antimicrobial agents (antibiotics, antivirals, antifungals, anthelmintics or antiparasitics used for treating other infections were found to have better activity than the current Lyme antibiotics. These include antibacterials such as rifamycins (3-formal-rifamycin, rifaximin, rifamycin SV, thiostrepton, quinolone drugs (sarafloxacin, clinafloxacin, tosufloxacin, and cell wall inhibitors carbenicillin, tazobactam, aztreonam; antifungal agents such as fluconazole, mepartricin, bifonazole, climbazole, oxiconazole, nystatin; antiviral agents zanamivir, nevirapine, tilorone; antimalarial agents artemisinin, methylene blue, and quidaldine blue; antihelmintic and antiparasitic agents toltrazuril, tartar emetic, potassium antimonyl tartrate trihydrate, oxantel, closantel, hycanthone, pyrimethamine, and tetramisole. Interestingly, drugs used for treating other non-infectious conditions including verteporfin, oltipraz, pyroglutamic acid, pidolic acid, and dextrorphan tartrate, that act on the glutathione/γ-glutamyl pathway involved in protection against free radical damage, and also the antidepressant drug indatraline, were found to have high activity against stationary phase B. burgdorferi. Among the active hits, agents that affect cell membranes, energy
Daniel B Kramer
Full Text Available BACKGROUND: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. METHODS: We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA to evaluate recalls and adverse events related to security and privacy risks of medical devices. RESULTS: Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8% of these included computers, 35 (1.9% stored patient data, and 31 (1.7% were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8% mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. CONCLUSIONS: Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.
Madrid, Peter B.; Chopra, Sidharth; Manger, Ian D.; Gilfillan, Lynne; Keepers, Tiffany R.; Shurtleff, Amy C.; Green, Carol E.; Iyer, Lalitha V.; Dilks, Holli Hutcheson; Davey, Robert A.; Kolokoltsov, Andrey A.; Carrion, Ricardo; Patterson, Jean L.; Bavari, Sina; Panchal, Rekha G.; Warren, Travis K.; Wells, Jay B.; Moos, Walter H.; Burke, RaeLyn L.; Tanga, Mary J.
Background The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. Methodology/Principal Findings A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. Conclusions/Significance The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses. PMID:23577127
Peter B Madrid
Full Text Available BACKGROUND: The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. METHODOLOGY/PRINCIPAL FINDINGS: A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. CONCLUSIONS/SIGNIFICANCE: The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses.
The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.
This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.
Full Text Available Este trabajo analiza el posicionamiento político de la Juventud Obrera Católica (JOC y el proceso de configuración de identidades políticas de sus miembros entre 1943 y 1955. Así, se propone un abordaje desde dos perspectivas complementarias: a través del discurso y el accionar de la JOC a nivel institucional y a partir de la mirada de sus militantes, una visión forjada al calor de un proceso de conformación de la identidad peronista. Las fuentes utilizadas fueron el periódico de la JOC, Juventud Obrera, y la interpretación de testimonios orales de antiguos dirigentes de la asociación.This paper deals with the political positioning of the Juventud Obrera Católica (JOC and the configuration process of the political identities of their members between 1943 an 1955. So, we propose an approach from two complementary perspectives: through the speech and actions at the institutional level and from the look of its members, a vision forged in the heat of the forming process of the Peronist identity. The sources used were the news paper of the JOC, Juventud Obrera, and several oral testimonies from formers leaders of the association.
Yang Jianzhou; Xie Rihua; Daniel Krewski; Wang Yongjin; Mark Walker; Cao Wenjun; Shi Wu Wen
Background Changing health care providers frequently breaks the continuity of care,which is associated with many health care problems.The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C,D and X drugs.Methods A 50％ random sample of women who gave a birth in Saskatchewan between January 1,1997 and December 31,2000 were chosen for this study.The association between the number of changes in health care providers and with pregnancy exposure to category C,D,and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression,with adjusted odds ratios (ORs) and its 95％ confidence intervals (C/s) as the association measures.Results A total of 18 568 women were included in this study.Rates of FDA C,D,and X drug uses were 14.35％,17.07％,21.72％,and 31.14％,in women with no change of provider,1-2 changes,3-5 changes,and more than 5 changes of health care providers.An association between the number of changes of health care providers and pregnancy exposure to FDA C,D,and X drugs existed in women without chronic diseases but not in women with chronic disease.Conclusion Change of health care providers is associated with pregnancy exposure to FDA category C,D and X drugs in women without chronic diseases.
Pinkerton, JoAnn V; Pickar, James H.
Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug...
The Food and Drug Administration (FDA) is publishing a guidance entitled "E5 Ethnic Factors in the Acceptability of Foreign Clinical Data". The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance recommends regulatory and development strategies to permit clinical data collected in one region to be used for the support of drug and biologic registrations in another region while allowing for the influence of ethnic factors.
Mueller, Robert; Kanungo, Rohit; Kiyono-Shimobe, Mayumi; Koros, William J.; Vasenkov, Sergey
In this paper, we demonstrate the potential of pulsed field gradient (PFG) NMR spectroscopy to reveal detailed knowledge of self-diffusion of light gases and light gas mixtures in carbon molecular sieve membranes on small length scales. PFG NMR is used to investigate intra-membrane diffusion of carbon dioxide and methane for a broad range of temperatures and mean square displacements in a carbon molecular sieve membrane derived from a 6FDA/BPDA-DAM polyimide film. Diffusion is investigated...
Farris, April L
As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.
Tucker, Samuel; Penninck, Dominique G; Keating, John H; Webster, Cynthia R L
Eosinophilic enteritis (EE) in cats is poorly characterized. The aim of the current study was to retrospectively evaluate the clinical and ultrasonographic findings in cats with histologic evidence of eosinophilic inflammation on gastrointestinal biopsy. Twenty-five cats with tissue eosinophilia on surgical (10) or endoscopic (15) biopsy of the gastrointestinal tract, having an abdominal ultrasound performed within 48 h of biopsy acquisition, were enrolled. History, clinical presentation, clinical pathology and abdominal ultrasound findings were reviewed. Intestinal biopsies were evaluated by a single pathologist and separated into two groups based on the degree of eosinophilic infiltrate: mild (eosinophils/high-power field [HPF], 11/25 cats), or moderate/marked (>10 eosinophils/HPF, 14/25 cats). The former were considered primary lymphoplasmacytic or lymphocytic inflammatory bowel disease (LPE) with subtle eosinophilic infiltrates, and the latter to have EE. Signalment, history and clinical signs were similar in all cats. Only cats with EE (6/14) had palpably thickened intestines. The only distinguishing clinicopathological feature of cats with EE was the presence of peripheral eosinophilia (6/14). On ultrasound, when compared with cats with LPE, cats with EE had a greater mean jejunal wall thickness (3.34 mm ± 0.72 mm vs 4.07 mm ± 0.58 mm, respectively) and an increased incidence of thickening of the muscularis layer (1/11 and 11/14, respectively). In conclusion, ultrasonographic evidence of a prominent intestinal muscularis layer, palpably thickened intestines and peripheral eosinophilia can serve as biomarkers for the presence of EE in cats with chronic intestinal signs.
Full Text Available Abstract FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.
O'Donoghue, Amie C; Sullivan, Helen W; Williams, Pamela A; Squire, Claudia; Betts, Kevin R; Fitts Willoughby, Jessica; Parvanta, Sarah
In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed.
Full Text Available Case summary A 14-year-old, neutered male European shorthair cat was evaluated for a routine health check. The owner did not report any clinical signs except for respiratory stridor. On physical examination the main findings were broad facial features and increased interdental spaces. On haematology, a mild, non-regenerative anaemia was detected, whereas the serum biochemistry profile and urinalysis were unremarkable. The serum glucose concentration was within the reference interval. Serum insulin-like growth factor-1 concentration was markedly elevated (>1600 ng/ml. The basal serum growth hormone concentration was elevated and decreased only mildly after somatostatin administration. Basal serum insulin concentration was high, and the insulin concentration increased considerably after glucose loading, consistent with insulin resistance. CT scanning of the skull showed an enlarged pituitary gland and increased skull bone thickness. The final diagnosis was acromegaly. Relevance and novel information These findings demonstrate that acromegaly should be pursued and suspected in cats other than those with diabetes mellitus.
Comercio, E A; Monachesi, N E; Loza, M E; Gambarotta, M; Wanke, M M
The hypo-osmotic (HOS) test has been used in other species as an indicator of the fertilising capacity of spermatozoa. The aims of this study were to assess the response of domestic cat spermatozoa to the hypo-osmotic test, to determine the type of solution, concentration and time of incubation needed to obtain a maximum percentage of swelling, to correlate the selected combination with the percentages of progressive motility and to evaluate whether dilution of the ejaculate alters the results. Incubation for 30 and 45 min in solutions of fructose and of citrate of 50 and 100 mOsmol kg⁻¹ was evaluated. The highest percentage of swelling was obtained using the 50 mOsmol kg⁻¹ solution, and no significant differences were observed between the times of exposure to the solutions. A positive correlation was observed between the percentage of individual progressive motility and the percentage of sperm swelling in a 50 mOsmol kg⁻¹ fructose solution, with no significant differences being observed between raw and diluted semen samples. The results of this study suggest that the HOS test could be useful for evaluating membrane function in domestic cat spermatozoa, both in raw semen and in samples diluted in the EZ Mixin® commercial extender, and thus could be incorporated into routine semen evaluation protocols.
ESO has just released a stunning new image of the vast cloud known as the Cat's Paw Nebula or NGC 6334. This complex region of gas and dust, where numerous massive stars are born, lies near the heart of the Milky Way galaxy, and is heavily obscured by intervening dust clouds. Few objects in the sky have been as well named as the Cat's Paw Nebula, a glowing gas cloud resembling the gigantic pawprint of a celestial cat out on an errand across the Universe. British astronomer John Herschel first recorded NGC 6334 in 1837 during his stay in South Africa. Despite using one of the largest telescopes in the world at the time, Herschel seems to have only noted the brightest part of the cloud, seen here towards the lower left. NGC 6334 lies about 5500 light-years away in the direction of the constellation Scorpius (the Scorpion) and covers an area on the sky slightly larger than the full Moon. The whole gas cloud is about 50 light-years across. The nebula appears red because its blue and green light are scattered and absorbed more efficiently by material between the nebula and Earth. The red light comes predominantly from hydrogen gas glowing under the intense glare of hot young stars. NGC 6334 is one of the most active nurseries of massive stars in our galaxy and has been extensively studied by astronomers. The nebula conceals freshly minted brilliant blue stars - each nearly ten times the mass of our Sun and born in the last few million years. The region is also home to many baby stars that are buried deep in the dust, making them difficult to study. In total, the Cat's Paw Nebula could contain several tens of thousands of stars. Particularly striking is the red, intricate bubble in the lower right part of the image. This is most likely either a star expelling large amount of matter at high speed as it nears the end of its life or the remnant of a star that already has exploded. This new portrait of the Cat's Paw Nebula was created from images taken with the Wide Field
Chen, I.-Hsuan; Hu, Jiajia; Wang, Fengen; Horikawa, Shin; Barbaree, James M.; Chin, Bryan A.
Efforts were made to incorporate the phage Magnetoelastic (ME) biosensor in FDA's Spinach Soaking procedures according to FDA 2015 BAM method. Three soaking materials (Lactose broth, LB broth, and Peptone water) and various soaking times were investigated. Using merely 100 Salmonella cells spiked on the produce surfaces, the phage biosensors detected Salmonella within 5 hours when soaking tomatoes in LB broth as opposed to taking up to 24 hours. Salmonella was detected on spinach leaves within 7 hours. These phage ME biosensors provide a promising rapid detection platform using LB broth in FDA's soaking procedures while shortening the incubation period.
Adamovich, Ashley; Park, Susie; Siskin, Gary P; Englander, Meridith J; Mandato, Kenneth D; Herr, Allen; Keating, Lawrence J
The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.
Moriello, K A; Kunkle, G; Miller, L M; Crowley, A
Autologous tissue transmission of spontaneously developing feline eosinophilic plaques was attempted in 5 cats. Macerated tissue from the plaque was vigorously rubbed onto 2 scarified skin sites in each cat. The inoculated areas were observed daily for 30 days. During that time, no clinical or histologic evidence of transmission was found.
Daignault, D.; Chouinard, L.; Møller, Kristian
Actinobacillus suis has been isolated from the lungs of a 9-month-old cat. The bacterium was characterized biochemically as well as genetically, and its sensitivity profile to different antimicrobial agents was established. The role of this isolate in the cat's condition is discussed....
Kinnear, Judith F.
Focuses on genetic concepts that form key components of transmission genetics and illustrates how the domestic cat can be used in the teaching of these concepts. Offers examples of how laboratory experiences with the cat can enhance student learning of genetics. (ML)
Hagen-Plantinga, E.A.; Bosch, G.; Hendriks, W.H.
The aim of this study was to determine possible differences in felinine excretion between domesticated cat breeds. For this purpose, urine was collected from a total of 83 privately owned entire male cats from eight different breeds in the Netherlands during the period of November 2010 till November
Hagen - Plantinga, Esther; Hendriks, Wouter; Bosch, Guido
The aim of this study was to determine possible differences in felinine excretion between domesticated cat breeds. For this purpose, urine was collected from a total of 83 privately owned entire male cats from eight different breeds in the Netherlands during the period of November 2010 till November
Antila, Johanna M; Jeserevics, Janis; Rakauskas, Mindaugas; Anttila, Marjukka; Cizinauskas, Sigitas
A six-year-old Ragdoll cat underwent examination due to a six-month history of slowly progressive gait abnormalities. The cat presented with an ambulatory tetraparesis with a neurological examination indicating a C1-T2 myelopathy. Radiographs of the spine showed a radiopaque irregular line ventrally in the vertebral canal dorsal to vertebral bodies C3-C5. In this area, magnetic resonance imaging revealed an intradural extramedullary/extradural lesion compressing the spinal cord. The spinal cord was surgically decompressed. The cause of the spinal cord compression was dural ossification, a diagnosis confirmed by histopathological examination of the surgically dissected sample of dura mater. The cat gradually improved after the procedure and was ambulating better than prior to the surgery. The cat's locomotion later worsened again due to ossified plaques in the dura causing spinal cord compression on the same cervical area as before. Oral prednisolone treatment provided temporary remission. Ten months after surgery, the cat was euthanized due to severe worsening of gait abnormalities, non-ambulatory tetraparesis. Necropsy confirmed spinal cord compression and secondary degenerative changes in the spinal cord on cervical and lumbar areas caused by dural ossification. To our knowledge, this is the first report of spinal dural ossification in a cat. The reported cat showed neurological signs associated with these dural changes. Dural ossification should be considered in the differential diagnosis of compressive spinal cord disorders in cats.
... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Destruction of dogs and cats. 28.43 Section 28.43 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR... VIOLATIONS OF PARTS 25, 26, AND 27 Impoundment Procedures § 28.43 Destruction of dogs and cats. Dogs and...
Leptospirosis is a zoonotic disease of worldwide distribution affecting most mammalian species. Clinical leptospirosis is common in dogs but seems to be rare in cats. Both dogs and cats however, can shed leptospires in the urine. This is problematic as it can lead to exposure of humans. The control ...
Pommerich, Mary; Segall, Daniel O.
The accuracy of CAT scores can be negatively affected by local dependence if the CAT utilizes parameters that are misspecified due to the presence of local dependence and/or fails to control for local dependence in responses during the administration stage. This article evaluates the existence and effect of local dependence in a test of…
Full Text Available Whole blood samples from 211 stray cats from Algiers, Algeria, were cultured to detect the presence of Bartonella species and to evaluate the genetic diversity of B. henselae strains by multiple locus VNTR analysis (MLVA. Bartonella henselae was the only species isolated from 36 (17% of 211 cats. B. henselae genotype I was the predominant genotype (64%. MLVA typing of 259 strains from 30 bacteremic cats revealed 52 different profiles as compared to only 3 profiles using MLST. Of these 52 profiles, 48 (92.3% were identified for the first time. One-third of the cats harbored one MLVA profile only. As there was a correlation between the age of cats and the number of MLVA profiles, we hypothesized that the single profile in these cats was the profile of the initial infecting strain. Two-third of the cats harbored 2 to 6 MLVA profiles simultaneously. The similarity of MLVA profiles obtained from the same cat, neighbor-joining clustering and structure-neighbor clustering indicate that such a diversity likely results from two different mechanisms occurring either independently or simultaneously: independent infections and genetic drift from a primary strain.
Gerhold, R W; Jessup, D A
Free-roaming cat populations have been identified as a significant public health threat and are a source for several zoonotic diseases including rabies, toxoplasmosis, cutaneous larval migrans because of various nematode parasites, plague, tularemia and murine typhus. Several of these diseases are reported to cause mortality in humans and can cause other important health issues including abortion, blindness, pruritic skin rashes and other various symptoms. A recent case of rabies in a young girl from California that likely was transmitted by a free-roaming cat underscores that free-roaming cats can be a source of zoonotic diseases. Increased attention has been placed on trap-neuter-release (TNR) programmes as a viable tool to manage cat populations. However, some studies have shown that TNR leads to increased immigration of unneutered cats into neutered populations as well as increased kitten survival in neutered groups. These compensatory mechanisms in neutered groups leading to increased kitten survival and immigration would confound rabies vaccination campaigns and produce naïve populations of cats that can serve as source of zoonotic disease agents owing to lack of immunity. This manuscript is a review of the various diseases of free-roaming cats and the public health implications associated with the cat populations.
Tooth resorption in cats Tooth resorption affecting several teeth is a painful disease with a prevalence of up to 75% in household cats and is often accompanied by periodontitis. Tooth resorption is caused by an increased number and activity of tooth-resorbing odontoclasts, cells that share function
F. Tozzini; D. Matteucci; P. Bandecchi; F. Baldinotti; C.H.J. Siebelink (Kees); A.D.M.E. Osterhaus (Albert); M. Bendinelli
textabstractSera from cats experimentally infected with five isolates of feline immunodeficiency virus (FIV) from various geographical regions and from FIV enzyme-linked immunosorbent assay-seropositive field cats from four European countries neutralized the Petaluma strain of FIV (FIV-P), originall
Apfelbacher, Christian Joachim; Ollert, Markus; Ring, Johannes; Behrendt, Heidrun; Krämer, Ursula
Whether or not associations between animal contact and allergy/atopy are homogeneous across social strata has not yet been investigated. The aim of this study was to estimate the association between animal contact (cat, dog) and allergy/atopy in 6-yr-old school beginners, stratified by parental educational level. A total of 30794, 6-yr old children participated in cross-sectional studies between 1991 and 2000 in Germany. Allergic sensitization to common aeroallergens and symptoms and diagnoses of atopic diseases (asthma, eczema, hay fever) were the dependent variables. Contact with dog/cat were the independent variables. Logistic regression was used to adjust for confounding. Analyses were stratified for parental education. Prevalences of hay fever, eczema, specific sensitization to pollen and house dust mite increased, while the prevalence of contact to cat and dog decreased with parental educational level. Globally significant positive associations between cat contact and sensitization to cat (interaction significant) and between dog contact and wheezing remained significant in the highest and medium/highest educational strata respectively. A globally significant inverse association between cat contact and hay fever remained significant in the highest educational stratum only. The inverse association of contact to dog with eczema was globally significant, but not in the strata. When estimating the associations between animal contact and allergy/atopy in children, effect modification by social status should be considered. Cat contact seems to increase the odds of sensitization to cat only in children whose parents have a high level of education.
Other tests that use a CAT include the GRE [e.g., Syvum 2006] and GMAT [e.g., Princeton Review 2006]. The CAT estimates an examinee’s ability...correspondence, September 2005. The Princeton Review, 2006, GMAT : A Computer-Adaptive Test, http://www.princetonreview.com, 19, May 2006, New York, NY. Sands
Before the discovery of Toxoplasma gondii as a coccidium of the cat in 1970, cat and dog coccidia were classified in the genus Isospora and considered of little clinical or zoonotic significance. Since 1970, several new (Hammondia sp., Neospora sp.) and previously described species, including Sarcoc...
Roosje, Pieternella Janna
The term atopic dermatitis (AD) is commonly used in cats. At present, however, there is little known about the pathogenesis of feline AD. The aim was to investigate various aspects of the immunopathogenesis in a defined group of cats with signs and symptoms of atopic dermatitis and compare our findi
Lommer, M J; Verstraete, F J M
Oral mucosal salivary samples were collected from 25 cats with chronic gingivostomatitis and 24 cats with periodontal disease. Viral culture and isolation of feline calicivirus and feline herpesvirus 1 were performed. Eighty-eight per cent of cats with chronic gingivostomatitis were shedding both viruses, compared to 21% of cats without chronic oral inflammatory disease. Cats with chronic gingivostomatitis are significantly more likely to concurrently shed both feline calicivirus and feline herpesvirus 1 than are cats with classical periodontal disease.
Stella, Judi; Croney, Candace; Buffington, Tony
Feline interstitial cystitis (FIC) is a chronic pain syndrome of domestic cats. Cats with FIC have chronic, recurrent lower urinary tract signs (LUTS) and other comorbid disorders that are exacerbated by stressors. The aim of this study was to evaluate behavioral and physiological responses of healthy cats and cats diagnosed with FIC after exposure to a five day stressor. Ten healthy cats and 18 cats with FIC were housed at The Ohio State University Veterinary Medical Center (OSUVMC) vivarium...
运用可能世界理论,具体分析了《雨里的猫》中所建构的四个情景,推导出主人公愿望世界的形成和落空,解读出小说主人公力求改变现状、改变自我的强烈愿望,以及此种愿望注定无法实现的悲剧结局,进而揭露和批判了美国社会的男女之间的不平等。%The paper analyzes the four circumstances constructed in Cat in Rain to narrate the formation of heroine＇s mental world and frustration from possible world theory. It can be analyzed that the heroine tried her best to change the current situation and her strong wish, together with the tragic ending doomed so as to expose and criticize the social inequality between men and women in the United States.
Mason, K V; Evans, A G
Eight cats had lesions on the nasal bridge, ears, and footpads, with histologic and hematologic features of a recently described seasonal form of eosinophilic granuloma complex. Four cats were examined in detail, and it was established that 2 of the 4 reacted to mosquito extract on intradermal skin testing read at 20 minutes. Neither of the 2 cats tested had deposits of immunoglobulins in lesional or perilesional skin. Lesions on all 4 cats resolved when kept at home behind insect screening, but flared up if the screening was removed. Mosquitoes that were observed to be biting and causing lesions were collected and identified. Other species of laboratory-reared mosquitoes were allowed to bite nonlesional skin of 1 affected cat, causing pruritus, erythematous crusting, and ulcerative lesions at the bite site, which was characterized histologically as eosinophilic dermatitis.
Wang, Chen; Gao, Yvonne Y.; Reinhold, Philip; Heeres, R. W.; Ofek, Nissim; Chou, Kevin; Axline, Christopher; Reagor, Matthew; Blumoff, Jacob; Sliwa, K. M.; Frunzio, L.; Girvin, S. M.; Jiang, Liang; Mirrahimi, M.; Devoret, M. H.; Schoelkopf, R. J.
Quantum superpositions of distinct coherent states in a single-mode harmonic oscillator, known as “cat states,” have been an elegant demonstration of Schrödinger’s famous cat paradox. Here, we realize a two-mode cat state of electromagnetic fields in two microwave cavities bridged by a superconducting artificial atom, which can also be viewed as an entangled pair of single-cavity cat states. We present full quantum state tomography of this complex cat state over a Hilbert space exceeding 100 dimensions via quantum nondemolition measurements of the joint photon number parity. The ability to manipulate such multicavity quantum states paves the way for logical operations between redundantly encoded qubits for fault-tolerant quantum computation and communication.
Easley, R B; Cooperstock, M S; Tobias, J D
Status epilepticus from cat-scratch encephalopathy is often recalcitrant to usual therapies, causing treatment to focus on critical care management of the patient that may require aggressive interventions, such as continuous pentobarbital administration. We describe two children whose initial clinical presentation of cat-scratch disease was status epilepticus with normal cerebrospinal fluid studies. A history of cat exposure (specifically, kitten and/or fleas), regional lymphadenopathy, and a papule or inoculation site should be sought, but are not essential for diagnosis. The presumptive diagnosis of cat-scratch disease can be made by serology alone even in the absence of classic diagnostic criteria. Our two cases and other reports in the literature show a favorable prognosis in most cases, despite the occurrence of status epilepticus. The diagnosis of cat-scratch disease should be strongly considered in all children with unexplained status epilepticus or encephalopathy and serologic testing for Bartonella henselae should be done.
McGregor, Hugh W; Legge, Sarah; Jones, Menna E; Johnson, Christopher N
Feral cats are normally territorial in Australia's tropical savannahs, and hunt intensively with home-ranges only two to three kilometres across. Here we report that they also undertake expeditions of up to 12.5 km from their home ranges to hunt for short periods over recently burned areas. Cats are especially likely to travel to areas burned at high intensity, probably in response to vulnerability of prey soon after such fires. The movements of journeying cats are highly directed to specific destinations. We argue that the effect of this behaviour is to increase the aggregate impact of cats on vulnerable prey. This has profound implications for conservation, considering the ubiquity of feral cats and global trends of intensified fire regimes.
McGregor, Hugh W.; Legge, Sarah; Jones, Menna E.; Johnson, Christopher N.
Feral cats are normally territorial in Australia’s tropical savannahs, and hunt intensively with home-ranges only two to three kilometres across. Here we report that they also undertake expeditions of up to 12.5 km from their home ranges to hunt for short periods over recently burned areas. Cats are especially likely to travel to areas burned at high intensity, probably in response to vulnerability of prey soon after such fires. The movements of journeying cats are highly directed to specific destinations. We argue that the effect of this behaviour is to increase the aggregate impact of cats on vulnerable prey. This has profound implications for conservation, considering the ubiquity of feral cats and global trends of intensified fire regimes.
Olsen, Caroline Salling; Willesen, Jakob; Pipper, Christian Bressen
As Aelurostrongylus abstrusus has not previously received any attention in Denmark, the study investigated the occurrence of A. abstrusus amongst outdoor cats from three regions (Zealand, Møn and Falster). Faeces and lungs were collected from a total of 147 feral (n=125) and domesticated cats (n=22......) that were euthanized for reasons outside of this project. Using a modified Baermann technique 13.6% of the cats was found to be positive. A new lung digestion technique was developed to isolate eggs, L1 and adult worms from the lungs and this revealed a prevalence of 15.6% although with regional differences....... There was no difference between feral and domesticated cats just as sex and age did not appear to influence prevalence and worm burden. Lungs from 87% of the positive cats had the gross appearance compatible with A. abstrusus and the severity of lung damage was proportional to LPG and number of adult worms. Within...
... for Exhibition Determinations: ``Balthus: Cats and Girls--Paintings and Provocations'' SUMMARY: Notice..., I hereby determine that the objects to be included in the exhibition ``Balthus: Cats and...
Levy, Julie K
Free-roaming unowned stray and feral cats exist throughout the world, creating concerns regarding their welfare as well as their impact on the environment and on public health. Millions of healthy cats are culled each year in an attempt to control their numbers. Surgical sterilization followed by return to the environment is an effective non-lethal population control method but is limited in scope because of expense and logistical impediments. Immunocontraception has the potential to be a more practical and cost-effective method of control. This is a review of current research in immunocontraception in domestic cats. Functional characteristics of an ideal immunocontraceptive for community cats would include a wide margin of safety for target animals and the environment, rapid onset and long duration of activity following a single treatment in males and females of all ages, and sex hormone inhibition. In addition, product characteristics should include stability and ease of use under field conditions, efficient manufacturing process, and low cost to the user. Two reproductive antigens, zona pellucida and GnRH, have been identified as possible targets for fertility control in cats. Zona pellucida, which is used successfully in multiple wildlife species, has achieved little success in cats. In contrast, immunization against GnRH has resulted in long-term contraception in both male and female cats following a single dose. GnRH is an ideal contraceptive target because it regulates pituitary and gonadal hormone responses in both males and females, thus suppressing nuisance behaviors associated with sex hormones in addition to preventing pregnancy. The responsiveness of cats to fertility control via GnRH suppression should encourage researchers and cat control stakeholders to continue efforts to optimize vaccines that induce multiyear contraception following a single dose in a high proportion of treated cats.
Maria Mercedes Nogueras
Full Text Available BACKGROUND: Rickettsiatyphi is the etiological agent of murine typhus (MT, a disease transmitted by two cycles: rat-flea-rat, and peridomestic cycle. Murine typhus is often misdiagnosed and underreported. A correct diagnosis is important because MT can cause severe illness and death. Our previous seroprevalence results pointed to presence of human R. typhi infection in our region; however, no clinical case has been reported. Although cats have been related to MT, no naturally infected cat has been described. The aim of the study is to confirm the existence of R. typhi in our location analyzing its presence in cats and fleas. METHODOLOGY/PRINCIPAL FINDINGS: 221 cats and 80 fleas were collected from Veterinary clinics, shelters, and the street (2001-2009. Variables surveyed were: date of collection, age, sex, municipality, living place, outdoor activities, demographic area, healthy status, contact with animals, and ectoparasite infestation. IgG against R. typhi were evaluated by indirect immunofluorescence assay. Molecular detection in cats and fleas was performed by real-time PCR. Cultures were performed in those cats with positive molecular detection. Statistical analysis was carried out using SPSS. A p < 0.05 was considered significant. Thirty-five (15.8% cats were seropositive. There were no significant associations among seropositivity and any variables. R. typhi was detected in 5 blood and 2 cultures. High titres and molecular detection were observed in stray cats and pets, as well as in spring and winter. All fleas were Ctenocephalides felis. R. typhi was detected in 44 fleas (55%, from shelters and pets. Co-infection with R. felis was observed. CONCLUSIONS: Although no clinical case has been described in this area, the presence of R. typhi in cats and fleas is demonstrated. Moreover, a considerable percentage of those animals lived in households. To our knowledge, this is the first time R. typhi is detected in naturally infected cats.
Gutiérrez, Ricardo; Nachum-Biala, Yaarit; Harrus, Shimon
Cats are considered the main reservoir of three zoonotic Bartonella species: Bartonella henselae, Bartonella clarridgeiae, and Bartonella koehlerae. Cat fleas (Ctenocephalides felis) have been experimentally demonstrated to be a competent vector of B. henselae and have been proposed as the potential vector of the two other Bartonella species. Previous studies have reported a lack of association between the Bartonella species infection status (infected or uninfected) and/or bacteremia levels of cats and the infection status of the fleas they host. Nevertheless, to date, no study has compared the quantitative distributions of these bacteria in both cats and their fleas under natural conditions. Thus, the present study explored these relationships by identifying and quantifying the different Bartonella species in both cats and their fleas. Therefore, EDTA-blood samples and fleas collected from stray cats were screened for Bartonella bacteria. Bacterial loads were quantified by high-resolution melt real-time quantitative PCR assays. The results indicated a moderate correlation between the Bartonella bacterial loads in the cats and their fleas when both were infected with the same Bartonella species. Moreover, a positive effect of the host infection status on the Bartonella bacterial loads of the fleas was observed. Conversely, the cat bacterial loads were not affected by the infection status of their fleas. Our results suggest that the Bartonella bacterial loads of fleas are positively affected by the presence of the bacteria in their feline host, probably by multiple acquisitions/accumulation and/or multiplication events.
Hosie, Margaret J; Addie, Diane D; Boucraut-Baralon, Corine; Egberink, Herman; Frymus, Tadeusz; Gruffydd-Jones, Tim; Hartmann, Katrin; Horzinek, Marian C; Lloret, Albert; Lutz, Hans; Marsilio, Fulvio; Pennisi, Maria Grazia; Radford, Alan D; Thiry, Etienne; Truyen, Uwe; Möstl, Karin
OVERVIEW: In 2013, the ABCD published 'Matrix vaccination guidelines: ABCD recommendations for indoor/outdoor cats, rescue shelter cats and breeding catteries' in a Special Issue of the Journal of Feline Medicine and Surgery (Volume 15, Issue 7, pages 540-544). The ABCD's vaccination recommendations
Matzke, Gary R; Dowling, Thomas C; Marks, Samantha A; Murphy, John E
In 1998, the United States Food and Drug Administration (FDA) released the first guidance for industry regarding pharmacokinetic (PK) studies in renally impaired patients. This study aimed to determine if the FDA renal PK guidance influenced the frequency and rigor of renal studies conducted for new chemical entities (NCEs). FDA-approved package inserts (APIs) and clinical pharmacology review documents were analyzed for 194 NCEs approved from 1999 to 2010. Renal studies were conducted in 71.6% of NCEs approved from 1999 to 2010, a significant increase over the 56.3% conducted from 1996 to 1997 (P = .0242). Renal studies were more likely to be completed in highly renally excreted drugs (fe ≥ 30%) compared with drugs with low renal excretion, fe FDA guidance has resulted in improved availability of PK and drug-dosing recommendations, particularly for high fe drugs.
In the quest for cognitive computing, we have built a massively parallel cortical simulator, C2, that incorporates a number of innovations in computation, memory, and communication. Using C2 on LLNL\\'s Dawn Blue Gene/P supercomputer with 147, 456 CPUs and 144 TB of main memory, we report two cortical simulations - at unprecedented scale - that effectively saturate the entire memory capacity and refresh it at least every simulated second. The first simulation consists of 1.6 billion neurons and 8.87 trillion synapses with experimentally-measured gray matter thalamocortical connectivity. The second simulation has 900 million neurons and 9 trillion synapses with probabilistic connectivity. We demonstrate nearly perfect weak scaling and attractive strong scaling. The simulations, which incorporate phenomenological spiking neurons, individual learning synapses, axonal delays, and dynamic synaptic channels, exceed the scale of the cat cortex, marking the dawn of a new era in the scale of cortical simulations. Copyright 2009 ACM.
Full Text Available WorldCat records are clustered into works, and within works, into content and manifestation clusters. A recent project revisited the clustering of collected works that had been previously sidelined because of the challenges posed by their complexity. Attention was given to both the identification of collected works and to the determination of the component works within them. By extensively analysing cast-list information, performance notes, contents notes, titles, uniform titles and added entries, the contents of collected works could be identified and differentiated so that correct clustering was achieved. Further work is envisaged in the form of refining the tests and weights and also in the creation and use of name/title authority records and other knowledge cards in clustering. There is a requirement to link collected works with their component works for use in search and retrieval.
Very little is known regarding the epidemiology, etiology, and mechanisms of spontaneous intrathoracic neoplasia in companion animals. Much of what we know or suspect about thoracic neoplasia in animals has been extrapolated from experimentally-induced neoplasms. Most studies of thoracic neoplasia have focused on the pathology of primary and metastatic neoplasms of the lung with little attention given to diagnostic and therapeutic considerations. Although the cited incidence rate for primary respiratory tract neoplasia is low, 8.5 cases per 100,000 dogs and 5.5 cases per 100,000 cats, intrathoracic masses often attract attention out of proportion to their actual importance since they are often readily visualized on routine thoracic radiographs.
Alexander J LoPinto
Full Text Available Case summary A 2-month-old, male kitten was presented for evaluation of unilateral blepharospasm and epiphora involving the right eye. Ocular examination revealed conjunctivitis, a superficial corneal ulcer, reflex anterior uveitis and a haired mass within the dorsal cornea of the right eye. The mass was subsequently removed surgically via a lamellar keratectomy. Histologic evaluation of the mass via light microscopy revealed it to be comprised of normal-haired skin with mild inflammation. One week after surgical removal and medical management of the corneal ulcer, all ocular clinical signs had resolved with minimal corneal scarring. On re-examination 6 months following surgical excision of the mass, the kitten was noted to be comfortable with no significant corneal scarring. Relevance and novel information To our knowledge, this is the first case report of a dorsally located corneal dermoid in a cat.
Klishko, Alexander N; Farrell, Bradley J; Beloozerova, Irina N; Latash, Mark L; Prilutsky, Boris I
We investigated which of cat limb kinematic variables during swing of regular walking and accurate stepping along a horizontal ladder are stabilized by coordinated changes of limb segment angles. Three hypotheses were tested: 1) animals stabilize the entire swing trajectory of specific kinematic variables (performance variables); and 2) the level of trajectory stabilization is similar between regular and ladder walking and 3) is higher for forelimbs compared with hindlimbs. We used the framework of the uncontrolled manifold (UCM) hypothesis to quantify the structure of variance of limb kinematics in the limb segment orientation space across steps. Two components of variance were quantified for each potential performance variable, one of which affected it ("bad variance," variance orthogonal to the UCM, VORT) while the other one did not ("good variance," variance within the UCM, VUCM). The analysis of five candidate performance variables revealed that cats during both locomotor behaviors stabilize 1) paw vertical position during the entire swing (VUCM > VORT, except in mid-hindpaw swing of ladder walking) and 2) horizontal paw position in initial and terminal swing (except for the entire forepaw swing of regular walking). We also found that the limb length was typically stabilized in midswing, whereas limb orientation was not (VUCM ≤ VORT) for both limbs and behaviors during entire swing. We conclude that stabilization of paw position in early and terminal swing enables accurate and stable locomotion, while stabilization of vertical paw position in midswing helps paw clearance. This study is the first to demonstrate the applicability of the UCM-based analysis to nonhuman movement.
Miller, Jennifer E.; Korn, David; Ross, Joseph S
Objective: To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design: Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrial...
Full Text Available BACKGROUND: Comparative phylogeography links historical population processes to current/ecological processes through congruent/incongruent patterns of genetic variation among species/lineages. Despite high biodiversity, India lacks a phylogeographic paradigm due to limited comparative studies. We compared the phylogenetic patterns of Indian populations of jungle cat (Felis chaus and leopard cat (Prionailurus bengalensis. Given similarities in their distribution within India, evolutionary histories, body size and habits, congruent patterns of genetic variation were expected. METHODOLOGY/PRINCIPAL FINDINGS: We collected scats from various biogeographic zones in India and analyzed mtDNA from 55 jungle cats (460 bp NADH5, 141 bp cytochrome b and 40 leopard cats (362 bp NADH5, 202 bp cytochrome b. Jungle cats revealed high genetic variation, relatively low population structure and demographic expansion around the mid-Pleistocene. In contrast, leopard cats revealed lower genetic variation and high population structure with a F(ST of 0.86 between North and South Indian populations. Niche-model analyses using two approaches (BIOCLIM and MaxEnt support absence of leopard cats from Central India, indicating a climate associated barrier. We hypothesize that high summer temperatures limit leopard cat distribution and that a rise in temperature in the peninsular region of India during the LGM caused the split in leopard cat population in India. CONCLUSIONS/SIGNIFICANCE: Our results indicate that ecological variables describing a species range can predict genetic patterns. Our study has also resolved the confusion over the distribution of the leopard cat in India. The reciprocally monophyletic island population in the South mandates conservation attention.
Menotti-Raymond, Marilyn; David, Victor A; Pflueger, Solveig M; Lindblad-Toh, Kerstin; Wade, Claire M; O'Brien, Stephen J; Johnson, Warren E
Genetic variation in cat breeds was assessed utilizing a panel of short tandem repeat (STR) loci genotyped in 38 cat breeds and 284 single-nucleotide polymorphisms (SNPs) genotyped in 24 breeds. Population structure in cat breeds generally reflects their recent ancestry and absence of strong breed barriers between some breeds. There is a wide range in the robustness of population definition, from breeds demonstrating high definition to breeds with as little as a third of their genetic variation partitioning into a single population. Utilizing the STRUCTURE algorithm, there was no clear demarcation of the number of population subdivisions; 16 breeds could not be resolved into independent populations, the consequence of outcrossing in established breeds to recently developed breeds with common ancestry. These 16 breeds were divided into 6 populations. Ninety-six percent of cats in a sample set of 1040 were correctly assigned to their classified breed or breed group/population. Average breed STR heterozygosities ranged from moderate (0.53; Havana, Korat) to high (0.85; Norwegian Forest Cat, Manx). Most of the variation in cat breeds was observed within a breed population (83.7%), versus 16.3% of the variation observed between populations. The hierarchical relationships of cat breeds is poorly defined as demonstrated by phylogenetic trees generated from both STR and SNP data, though phylogeographic grouping of breeds derived completely or in part from Southeast Asian ancestors was apparent.
Schnabl, E; Bockstahler, B
Although orthopaedic abnormalities in cats are frequently observed radiographically, they remain clinically underdiagnosed, and kinetic motion analysis, a fundamental aspect of orthopaedic research in dogs and horses, is not commonly performed. More information obtained with non-invasive measurement techniques to assess normal and abnormal gait in cats would provide a greater insight into their locomotion and biomechanics and improve the objective measurement of disease alterations and treatment modalities. In this systematic review, 12 previously performed studies that investigated ground reaction force measurements in cats during locomotion were evaluated. The aims of these studies, the measurement methods and equipment used, and the outcomes of parameters used to assess both sound and diseased cats are summarised and discussed. All reviewed studies used pressure sensitive walkways to gain data and all provided an acclimatisation period as a prerequisite for measurements. In sound cats during walking, the forelimb peak vertical force was greater than in the hindlimb and the peak vertical force in the hindlimb was greater in cats than in dogs. This review confirms that ground reaction forces can be used to evaluate lameness and treatment effects in the cat.
O'Neill, K E; Labato, M A; Court, M H
Fenoldopam is a selective dopamine-1 receptor agonist that improves diuresis by increasing renal blood flow and perfusion and causing peripheral vasodilation. Fenoldopam has been shown to induce diuresis and be well-tolerated in healthy cats. It is used clinically in cats with oliguric kidney injury at doses extrapolated from human medicine and canine studies. The pharmacokinetics in healthy beagle dogs has been reported; however, pharmacokinetic data in cats are lacking. The goal of this study was to determine pharmacokinetic data for healthy, awake cats receiving an infusion of fenoldopam. Six healthy, awake, client-owned cats aged 2-6 years old received a 120-min constant rate infusion of fenoldopam at 0.8 μg/kg/min followed by a 20-min washout period. Ascorbate stabilized plasma samples were collected during and after the infusion for the measurement of fenoldopam concentration by HPLC with mass spectrometry detection. This study showed that the geometric mean of the volume of distribution, clearance, and half-life (198 mL/kg, 46 mL/kg/min, and 3.0 mins) is similar to pharmacokinetic parameters for humans. No adverse events were noted. Fenoldopam at a constant rate infusion of 0.8 μg/kg per min was well tolerated in healthy cats. Based on the results, further evaluation of fenoldopam in cats with kidney disease is recommended.
Middleton, S M; Kubier, A; Dirikolu, L; Papich, M G; Mitchell, M A; Rubin, S I
The current available formulations of itraconazole are not ideal for dosing in cats. The capsular preparation often does not allow for accurate dosing, the oral solution is difficult to administer and poorly tolerated, and the bioavailability of compounded formulations has been shown to be poor in other species. The aim of this study was to evaluate every other day dosing of 100 mg itraconazole capsule in healthy adult cats. Ten healthy adult cats received a 100 mg capsule of itraconazole orally every 48 h for 8 weeks. Peak and trough serum concentrations of itraconazole were measured weekly using high-performance liquid chromatography (HPLC). Physical examination, complete blood count (CBC), and chemistry profiles were performed weekly. The dosage regimen achieved average therapeutic trough concentrations (>0.5 μg/mL) within 3 weeks. The protocol yielded no adverse effects in 8 of the 10 study cats, with affected cats recovering fully with discontinuation of the drug and supportive care. At 8 weeks, an average peak concentration of 1.79 ± 0.952 μg/mL (95% CI: 0.996-2.588) and an average trough concentration of 0.761 ± 0.540 μg/mL (95% CI: 0.314-1.216) were achieved. Overall, a 100 mg every other day oral dosage regimen for itraconazole in cats yielded serum concentrations with minimal fluctuation and with careful monitoring may be considered for treatment of cats with systemic fungal disease.
Williams, J F; Shearer, A M
The longevity and productivity of Taenia taeniaeformis were studied in experimentally infected cats. Nineteen of 20 cats became infected after they were given 8 to 12 strobilocerci. In 8 cats, mean prepatent period was 47.1 days +/- 5.9 SEM (34 to 80 days). Patent periods in the infected cats were 7 to 34 months. In 11 cats in which the infections were allowed to terminate naturally (spontaneous recovery), mean patient period was 17.4 months +/- 2.3. Two of these cats were then given a 2nd dose of strobilocerci and both became reinfected. The mean daily proglottid output in 6 cats followed throughout the patent period was 4.3 +/- 0.5. Destrobilization occurred spontaneously and sporadically throughout the infection, but did not always increase at the time of natural termination. Usually, proglottid productivity began to decrease after the 1st year of infection. Shed proglottids contained 0 to 12,180 eggs, with a mean of 1,606 +/- 402, but more than 60% of the segments contained 500 or less. Taenia taeniaeformis appeared to be as persistent as other taeniids, such as T ovis and T hydatigena in the dog, but it was far less prolific as an egg producer.
Ibarrola, Patricia; Blackwood, Laura; Graham, Peter A; Evans, Helen; German, Alexander J
Recent work has highlighted the importance of cobalamin deficiency in cats with a range of alimentary tract diseases. The primary aim of our study was to determine the incidence of subnormal cobalamin concentrations in sick cats with and without alimentary system disorders. Firstly, serum cobalamin concentrations were measured in a population of cats, with and without gastrointestinal (GI) disease, evaluated at a referral hospital. In the second part of the study, the incidence of cobalamin deficiency was assessed in samples submitted to a commercial laboratory specifically for cobalamin measurement. For both studies, a validated radioimmunoassay was used to measure serum cobalamin concentrations (reference range: > 150 pg/ml). In the first part of the study, 132 cats were included and none of these cats had subnormal cobalamin concentrations (median=1,172; range: 278 to >2,000). There were no differences in cobalamin concentrations between cats with alimentary system disorders, and those with diseases of other organs. In the second part, 682 samples were submitted for cobalamin assay over a period of 3 years, and only one cat had a result below the reference range (median=794; range: 147 to >2,000). Cobalamin deficiency was rare in the population tested and this may suggest that the incidence of this biochemical abnormality is less common than reported in the USA.
Full Text Available Abstract Background Feline coronavirus is comprised of two pathogenic biotypes consisting of feline infectious peritonitis virus (FIPV and feline enteric coronavirus (FECV, which are both divided into two serotypes. To examine the prevalence of Korean cats infected with feline coronavirus (FCoV type I and II, fecal samples were obtained from 212 cats (107 pet and 105 feral in 2009. Results Fourteen cats were FCoV-positive, including infections with type I FCoV (n = 8, type II FCoV (n = 4, and types I and II co-infection (n = 2. Low seroprevalences (13.7%, 29/212 of FCoV were identified in chronically ill cats (19.3%, 16/83 and healthy cats (10.1%, 13/129. Conclusions Although the prevalence of FCoV infection was not high in comparison to other countries, there was a higher prevalence of type I FCoV in Korean felines. The prevalence of FCoV antigen and antibody in Korean cats are expected to gradually increase due to the rising numbers of stray and companion cats.
Golovko, Lyudmila; Lyons, Leslie A; Liu, Hongwei; Sørensen, Anne; Wehnert, Suzanne; Pedersen, Niels C
Genetic factors are presumed to influence the incidence of feline infectious peritonitis (FIP), especially among pedigreed cats. However, proof for the existence of such factors has been limited and mainly anecdotal. Therefore, we sought evidence for genetic susceptibility to FIP using feline high density single nucleotide polymorphism (SNP) arrays in a genome-wide association study (GWAS). Birman cats were chosen for GWAS because they are highly inbred and suffer a high incidence of FIP. DNA from 38 Birman cats that died of FIP and 161 healthy cats from breeders in Denmark and USA were selected for genotyping using 63K SNPs distributed across the feline genome. Danish and American Birman cats were closely related and the populations were therefore combined and analyzed in two manners: (1) all cases (FIP) vs. all controls (healthy) regardless of age, and (2) cases 1½ years of age and younger (most susceptible) vs. controls 2 years of age and older (most resistant). GWAS of the second cohort was most productive in identifying significant genome-wide associations between case and control cats. Four peaks of association with FIP susceptibility were identified, with two being identified on both analyses. Five candidate genes ELMO1, RRAGA, TNFSF10, ERAP1 and ERAP2, all relevant to what is known about FIP virus pathogenesis, were identified but no single association was fully concordant with the disease phenotype. Difficulties in doing GWAS in cats and interrogating complex genetic traits were discussed.
Sicuto de Oliveira, Adriana; Terçariol, César Augusto Sangaletti; Genaro, Gelson
Simple Summary Captive domestic cats frequently suffer from the lack of physical space and opportunities to perform species-typical behaviors, such as climbing or hiding. Environmental enrichment is a technique that helps transform the space available to animals into a more appropriate habitat. In this study, we tested horizontal and vertical refuge boxes as environmental enrichment for cats living communally in a cat rescue shelter. The provision of boxes in the environment increases the use of available space by the cats. We suggest this improves the cats’ welfare while in communally-housed rescue shelters. Abstract The increase of domestic animals kept in shelters highlights the need to ensure animal welfare. Environmental enrichment can improve animal welfare in many ways, such as encouraging captive animals to use all the space available to them. The effects of physical environmental enrichment on the spatial distribution and behavioral repertoire of 35 neutered domestic cats housed communally were analyzed. The provision of boxes in the environment increases the use of available space by the cats. We suggest this improves the cats’ welfare while in communally-housed rescue shelters. The frequencies of active and especially inactive behaviors also increased in the enriched condition. In a test with vertical environmental enrichment, the animals showed an increased length of stay in refuges located at a height of 0.5 m compared to those on the ground (0.0 m). However, the entry frequency was higher in refuges at 0.0 m. Both horizontal and vertical environmental enrichment increased the use of available space, demonstrating that box refuges as enrichment are effective in providing a refuge when at a height, or a place to explore at ground level. We suggest it enhances the welfare of cats in communally housed shelters. This information adds to the body of evidence relating to cat enrichment and can be useful in designing cat housing in veterinary clinics
Full Text Available Vitamin D insufficiency, defined as low serum concentrations of the major circulating form of vitamin D, 25 hydroxyvitamin D (25(OHD, has been associated with the development of numerous infectious, inflammatory, and neoplastic disorders in humans. In addition, vitamin D insufficiency has been found to be predictive of mortality for many disorders. However, interpretation of human studies is difficult since vitamin D status is influenced by many factors, including diet, season, latitude, and exposure to UV radiation. In contrast, domesticated cats do not produce vitamin D cutaneously, and most cats are fed a commercial diet containing a relatively standard amount of vitamin D. Consequently, domesticated cats are an attractive model system in which to examine the relationship between serum 25(OHD and health outcomes. The hypothesis of this study was that vitamin D status would predict short term, all-cause mortality in domesticated cats. Serum concentrations of 25(OHD, together with a wide range of other clinical, hematological, and biochemical parameters, were measured in 99 consecutively hospitalised cats. Cats which died within 30 days of initial assessment had significantly lower serum 25(OHD concentrations than cats which survived. In a linear regression model including 12 clinical variables, serum 25(OHD concentration in the lower tertile was significantly predictive of mortality. The odds ratio of mortality within 30 days was 8.27 (95% confidence interval 2.54-31.52 for cats with a serum 25(OHD concentration in the lower tertile. In conclusion, this study demonstrates that low serum 25(OHD concentration status is an independent predictor of short term mortality in cats.
Slovak, Jennifer E; Villarino, Nicolas F
Objectives The aim of this study was to evaluate the safety and clinical effects of intravenous (IV) and oral mycophenolate mofetil (MMF) in healthy cats. Methods A total of 24 healthy adult cats weighing >3.5 kg were either administered IV MMF (over a 2 h infusion) or oral MMF. The dosages used were as follows: 5 mg/kg IV once (n = 2), 10 mg/kg q12h IV for 1 day (n = 1), 20 mg/kg q12h IV for 1 day (n = 6) and 10 mg/kg q12h IV for 3 days (n = 5). Blood was collected from each cat at intervals of up to 12 h from the last dose for analysis purposes. Oral MMF was given at 10 mg/kg q12h for 7 days (n = 3), 15 mg/kg q12h for 7 days (n = 3) and 15 mg/kg q8h for 7 days (n = 4). Results Side effects to MMF were minimal. There was no anorexia or vomiting noted in any of the cats during or after IV medication administration. Only 4/14 cats had diarrhea from 12-48 h after IV administration. There was hyporexia in 1/10 cats given oral MMF and no vomiting noted. In 5/10 cats given oral MMF, there was diarrhea between days 2 and 7 of the study. Conclusions and relevance Cats tolerate MMF at an IV dose of 10 mg/kg q12h for 3 days and an oral dose ⩽15 mg/kg q12h for up to 7 days. There seems to be a dose-dependent incidence of gastrointestinal side effects. MMF may be a useful alternative immunosuppressant to be considered for use in some cats.
Spillmann, Thomas; Willard, Michael D; Ruhnke, Isabelle; Suchodolski, Jan S; Steiner, Jörg M
Cats are predisposed to diseases of the biliary tract and the exocrine pancreas and these can be challenging to diagnose. In humans and dogs > 10 kg, endoscopic retrograde cholangiopancreatography (ERCP) has been successfully used to diagnose some of these disorders. The purpose of our study was to determine whether ERCP would also be feasible in cats using a pediatric duodenoscope. Four purpose-bred, clinically healthy, castrated domestic shorthair cats participated in two studies. Study 1 compared standard white light endoscopy with chromoendoscopy for localizing the major duodenal papilla. In Study 2 ERCP was performed. Repeated clinical examinations and measurements of serum feline pancreatic lipase immunoreactivity (fPLI) were performed before and up to 18 hours after interventions on all cats. Chromoendoscopy was subjectively judged to be superior for localizing the major papilla. Insertion of the ERCP catheter was best accomplished when cats were in dorsal recumbency. Complete ERCP was successful in two cats. In the other cats, either retrograde cholangiography or pancreatography was possible. Serum fPLI concentrations increased temporarily in two cats during Study 2 when measured immediately, 2, 4, and 18 h after ERCP. Peak fPLI concentrations were detected either immediately after ERCP or 2 h later. No clinical signs of complications were observed within 18 h after the procedures. Findings indicated that ERCP is technically demanding but feasible in healthy cats. Future studies need to determine whether the temporary increases in serum fPLI concentrations are clinically important and to investigate the utility of ERCP in feline patients.
Guérin, Annie; Mody, Reema; Carter, Valerie; Ayas, Charles; Patel, Haridarshan; Lasch, Karen; Wu, Eric
Objectives In 2009, the FDA issued a warning that omeprazole–a proton pump inhibitor (PPI)–reduces the antithrombotic effect of clopidogrel by almost half when taken concomitantly. This study aims to analyze the impact of the FDA Safety Communications on prescribing clopidogrel together with PPIs. Methods This retrospective study identified clopidogrel users from the Truven Health Analytics MarketScan Databases (01/2006–12/2012). Rates of clopidogrel-PPI combination therapy were estimated in 6-month intervals for patients with ≥1 clopidogrel prescription fill, then were analyzed pre- and post-safety communication (11/17/2009). Analyses were also conducted by grouping PPIs into CYP2C19 inhibitors (omeprazole and esomeprazole) and CYP2C19 non-inhibitors (pantoprazole, lansoprazole, dexlansoprazole, and rabeprazole). Results Overall, 483,074 patients met the selection criteria; of these, 157,248 used a clopidogrel-PPI combination. On average, 30.5% of patients in the pre- and 19.9% in the post-communication period used a clopidogrel-PPI combination therapy. Among clopidogrel users, the probability of using clopidogrel-PPI combinations fell by over 40% in the post-communication period (OR = 0.57; pomeprazole fell from 10.1% to 6.3%. Among combination therapy users, the probability of patients using a combination with a CYP2C19 inhibitor decreased by 53% (OR = 0.47; p<0.001); however, 31.5% of patients were still prescribed a clopidogrel-PPI combination therapy. Trends were similar for all and newly treated patients, regardless of clopidogrel indication and physician specialty. Conclusions The FDA Safety Communication resulted in a reduction in the number of patients undergoing combination therapy; however approximately one-third of patients still used combination therapy post-communication. PMID:26727382
Maxey, Dawn M; Ivy, D Dunbar; Ogawa, Michelle T; Feinstein, Jeffrey A
Because most medications for pediatric pulmonary hypertension (PH) are used off label and based on adult trials, little information is available on pediatric-specific adverse events (AEs). Although drug manufacturers are required to submit postmarket AE reports to the Food and Drug Administration (FDA), this information is rarely transmitted to practitioners. In the setting of a recent FDA warning for sildenafil, the authors sought to give a better description of the AEs associated with current therapies in pediatric PH. In January 2010, a written request was made to the Food and Drug Administration for AE records of commonly used PH medications. Reports were screened for pediatric patients, analyzed in terms of AEs, and compared with the medical literature. Arbitrarily, AEs that could be attributed to concomitant medications were not attributed to the PH medication in question. Adverse events occurring in more than 5 % of events for each drug were assumed to be associated with the targeted PH medication. Between November 1997 and December 2009, 588 pediatric AE reports (death in 257 cases) were reported for the three most commonly used therapies: bosentan, epoprostenol, and sildenafil. Many of the AEs were similar to those reported previously. However, 27 AEs not previously reported in the literature (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA postmarket records for PH medications in pediatric patients show a significant number of AEs. The discovery of AEs not previously reported will better inform those caring for these complex and critically ill children, and the large number of deaths suggest they may be underreported in current literature.
Roosje, Pieternella Janna
The term atopic dermatitis (AD) is commonly used in cats. At present, however, there is little known about the pathogenesis of feline AD. The aim was to investigate various aspects of the immunopathogenesis in a defined group of cats with signs and symptoms of atopic dermatitis and compare our findings with the immunoregulation of atopic dermatitis in humans. The presence of antigen-specific IgE in serum of AD cats was investigated by means of the Prausnitz-Küstner (PK) test and the passive c...
Fox, J G; Claps, M; Beaucage, C M
Campylobacter jejuni was isolated from a cat with chronic diarrhea. The diarrheic cat and another cat (which previously had diarrhea) in the same household had bactericidal antibody titers to the C jejuni. Clinical response to antibiotic therapy and not recovering Campylobacter sp from normal feces after treatment also supported the diagnosis of Campylobacter-associated diarrhea. Although the owner had a protracted episode of diarrhea, C jejuni was not isolated from the owner's feces, nor was a bactericidal antibody detected in the owner's serum.
Serafini, A [Dipartimento di Fisica ' E R Caianiello' , Universita di Salerno, INFM UdR Salerno, INFN Sezione Napoli, G C Salerno, Via S Allende, 84081 Baronissi, SA (Italy); De Siena, S [Dipartimento di Fisica ' E R Caianiello' , Universita di Salerno, INFM UdR Salerno, INFN Sezione Napoli, G C Salerno, Via S Allende, 84081 Baronissi, SA (Italy); Illuminati, F [Dipartimento di Fisica ' E R Caianiello' , Universita di Salerno, INFM UdR Salerno, INFN Sezione Napoli, G C Salerno, Via S Allende, 84081 Baronissi, SA (Italy); Paris, M G A [ISIS ' A Sorbelli' , I-41026 Pavullo nel Frignano, MO (Italy)
We address the evolution of cat-like states in general Gaussian noisy channels, by considering superpositions of coherent and squeezed coherent states coupled to an arbitrarily squeezed bath. The phase space dynamics is solved and decoherence is studied, keeping track of the purity of the evolving state. The influence of the choice of the state and channel parameters on purity is discussed and optimal working regimes that minimize the decoherence rate are determined. In particular, we show that squeezing the bath to protect a non-squeezed cat state against decoherence is equivalent to orthogonally squeezing the initial cat state while letting the bath be phase insensitive.
Serafini, A; Illuminati, F; Paris, M G A
We address the evolution of cat-like states in general Gaussian noisy channels, by considering superpositions of coherent and squeezed-coherent states coupled to an arbitrarily squeezed bath. The phase space dynamics is solved and decoherence is studied keeping track of the purity of the evolving state. The influence of the choice of the state and channel parameters on purity is discussed and optimal working regimes that minimize the decoherence rate are determined. In particular, we show that squeezing the bath to protect a non squeezed cat state against decoherence is equivalent to orthogonally squeezing the initial cat state while letting the bath be phase insensitive.
Bohling, Mark W; Henderson, Ralph A
Regardless of the species involved, wound healing follows a predictable course of overlapping phases. In spite of these commonalities, significant species differences in cutaneous wound healing have been uncovered in the Equidae and, more recently, between the dog and cat. It has also recently been shown that the subcutaneous tissues play an important supporting role in cutaneous wound healing, which may help to ex-plain healing differences between cats and dogs. These discoveries may improve veterinarians' understanding of problem wound healing in the cat and, hopefully, lead to better strategies for wound management in this sometimes troublesome species.
Pettersson, A; Mannerfelt, T
Ninety-six, randomly selected Swedish cats were evaluated for the presence of dental resorptive lesions. All cats were examined while receiving general anesthesia. Diagnosis was based on oral examination and full-mouth, intraoral dental radiographs. Information concerning age, sex, vaccination status, eating habits, food type, environment (indoor or outdoor housing), oral, discomfort, dental care, and medical treatment was recorded. Hematologic samples included analysis for FeLV, FIV, and calcivirus. Of the cats examined in this study, 32% had gross or radiographic signs of dental resorptive lesions. There was a positive relationship between the occurrence of dental resorptive lesions and increasing age.
McKenzie, R A; Connole, M D; McGinnis, M R; Lepelaar, R
Moniliella suaveolens was isolated in pure culture from histologically typical phaeohyphomycotic granulomas containing dematiaceous fungi in two cats. One cat had several slow-growing black lesions up to 2 cm in diameter in the abdominal subcutis. These lesions recurred after surgical excision was attempted. The second cat had a single black subcutaneous 0.5 X 1.5-cm lesion near one dewclaw. This lesion was successfully removed surgically without recurrence. M. suaveolens has not been isolated previously from lesions in animals including man.
Li, Yuanyuan; Xie, Yanming
The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.
Sivén, M; Savolainen, S; Räntilä, S; Männikkö, S; Vainionpää, M; Airaksinen, S; Raekallio, M; Vainio, O; Juppo, A M
The purpose here was to determine the problems cat owners encounter in medicating their cats with orally administered drugs at home. The study was carried out as an open e-questionnaire survey addressed to cat owners in which the authors focused on the oral administration route. A total of 46 completed questionnaires were included in the survey. In the study, 46 cats received 67 orally administered drugs. Approximately half of the drugs were registered for use in cats by the European Medicines Agency (54 per cent), and there were also off-label drugs registered for human (36 per cent) and canine medication (7.4 per cent) and an ex tempore drug (3.0 per cent). The owners were unable to give the doses as prescribed for their cats for one-fourth of the medications (16/67). Drugs that were registered for feline medication were significantly more palatable than drugs registered for other species (odds ratio (OR) 4.9), and liquid formulations were significantly more palatable than solid formulations (OR 4.8). However, most of the owners (22/38) preferred a solid dosage form, while few (4/38) chose a liquid formulation. The results indicate that there is still a need for more palatable and easily administered oral drugs for cats.
Brunetti, E; Fabbi, M; Ferraioli, G; Prati, P; Filice, C; Sassera, D; Dalla Valle, C; Bandi, C; Vicari, N; Marone, P
In this paper, we report an investigation on cat-scratch disease (CSD) in Northern Italy. Seventy-four cases of CSD were diagnosed at the San Matteo hospital, Pavia, during the period 2005-2010. Of these 74 patients, 18 (24.3 %) reported atypical clinical manifestations such as ocular papillitis, maculopapular eruptions, vertebral infection, pulmonary infiltrates, and granulomatous hepatitis. Contact with cats was documented for 61 patients (82.4 %), while cat-related trauma was reported for 49 patients (66.2 %). We subsequently investigated the presence of Bartonella infection in cats belonging to the above patients and in other domestic and stray cats from three provinces of Northern Italy. Among the 27 domestic cats tested, nine of the 11 belonging to the CSD patients and two of the remaining 16 were infected by B. henselae (81.8 % vs. 12.5 %). Out of over 1,300 stray cats examined, 23.1 % were seropositive for B. henselae; after culturing and genotyping, 17 % were found to be infected by B. henselae (15.5 %) or B. clarridgeiae (1.5 %).
Guitton, D; Douglas, R M; Volle, M
Gaze is the position of the visual axis in space and is the sum of the eye movement relative to the head plus head movement relative to space. In monkeys, a gaze shift is programmed with a single saccade that will, by itself, take the eye to a target, irrespective of whether the head moves. If the head turns simultaneously, the saccade is correctly reduced in size (to prevent gaze overshoot) by the vestibuloocular reflex (VOR). Cats have an oculomotor range (OMR) of only about +/- 25 degrees, but their field of view extends to about +/- 70 degrees. The use of the monkey's motor strategy to acquire targets lying beyond +/- 25 degrees requires the programming of saccades that cannot be physically made. We have studied, in cats, rapid horizontal gaze shifts to visual targets within and beyond the OMR. Heads were either totally unrestrained or attached to an apparatus that permitted short unexpected perturbations of the head trajectory. Qualitatively, similar rapid gaze shifts of all sizes up to at least 70 degrees could be accomplished with the classic single-eye saccade and a saccade-like head movement. For gaze shifts greater than 30 degrees, this classic pattern frequently was not observed, and gaze shifts were accomplished with a series of rapid eye movements whose time separation decreased, frequently until they blended into each other, as head velocity increased. Between discrete rapid eye movements, gaze continued in constant velocity ramps, controlled by signals added to the VOR-induced compensatory phase that followed a saccade. When the head was braked just prior to its onset in a 10 degrees gaze shift, the eye attained the target. This motor strategy is the same as that reported for monkeys. However, for larger target eccentricities (e.g., 50 degrees), the gaze shift was interrupted by the brake and the average saccade amplitude was 12-15 degrees, well short of the target and the OMR. Gaze shifts were completed by vestibularly driven eye movements when the
Gershony, L C; Penedo, M C T; Davis, B W; Murphy, W J; Helps, C R; Lyons, L A
Coat colours and patterns are highly variable in cats and are determined mainly by several genes with Mendelian inheritance. A 2-bp deletion in agouti signalling protein (ASIP) is associated with melanism in domestic cats. Bengal cats are hybrids between domestic cats and Asian leopard cats (Prionailurus bengalensis), and the charcoal coat colouration/pattern in Bengals presents as a possible incomplete melanism. The complete coding region of ASIP was directly sequenced in Asian leopard, domestic and Bengal cats. Twenty-seven variants were identified between domestic and leopard cats and were investigated in Bengals and Savannahs, a hybrid with servals (Leptailurus serval). The leopard cat ASIP haplotype was distinguished from domestic cat by four synonymous and four non-synonymous exonic SNPs, as well as 19 intronic variants, including a 42-bp deletion in intron 4. Fifty-six of 64 reported charcoal cats were compound heterozygotes at ASIP, with leopard cat agouti (A(P) (be) ) and domestic cat non-agouti (a) haplotypes. Twenty-four Bengals had an additional unique haplotype (A2) for exon 2 that was not identified in leopard cats, servals or jungle cats (Felis chaus). The compound heterozygote state suggests the leopard cat allele, in combination with the recessive non-agouti allele, influences Bengal markings, producing a darker, yet not completely melanistic coat. This is the first validation of a leopard cat allele segregating in the Bengal breed and likely affecting their overall pelage phenotype. Genetic testing services need to be aware of the possible segregation of wild felid alleles in all assays performed on hybrid cats.
Levy, J K; Isaza, N M; Scott, K C
Approximately 2-3 million cats enter animal shelters annually in the United States. A large proportion of these are unowned community cats that have no one to reclaim them and may be too unsocialized for adoption. More than half of impounded cats are euthanased due to shelter crowding, shelter-acquired disease or feral behavior. Trap-neuter-return (TNR), an alternative to shelter impoundment, improves cat welfare and reduces the size of cat colonies, but has been regarded as too impractical to reduce cat populations on a larger scale or to limit shelter cat intake. The aim of this study was to assess the effect of TNR concentrated in a region of historically high cat impoundments in a Florida community. A 2-year program was implemented to capture and neuter at least 50% of the estimated community cats in a single 11.9 km(2) zip code area, followed by return to the neighborhood or adoption. Trends in shelter cat intake from the target zip code were compared to the rest of the county. A total of 2366 cats, representing approximately 54% of the projected community cat population in the targeted area, were captured for the TNR program over the 2-year study period. After 2 years, per capita shelter intake was 3.5-fold higher and per capita shelter euthanasia was 17.5-fold higher in the non-target area than in the target area. Shelter cat impoundment from the target area where 60 cats/1000 residents were neutered annually decreased by 66% during the 2-year study period, compared to a decrease of 12% in the non-target area, where only 12 cats/1000 residents were neutered annually. High-impact TNR combined with the adoption of socialized cats and nuisance resolution counseling for residents is an effective tool for reducing shelter cat intake.
Lyons, Leslie A; Grahn, Robert A; Kun, Teri J; Netzel, Linda R; Wictum, Elizabeth E; Halverson, Joy L
Shed hair from domestic animals readily adheres to clothing and other contact items, providing a source of transfer evidence for criminal investigations. Mitochondrial DNA is often the only option for DNA analysis of shed hair. Human mitochondrial DNA analysis has been accepted in the US court system since 1996. The murder trial of the State of Missouri versus Henry L. Polk, Jr. represents the first legal proceeding where cat mitochondrial DNA analysis was introduced into evidence. The mitochondrial DNA evidence was initially considered inadmissible due to concerns about the cat dataset and the scientific acceptance of the marker. Those concerns were subsequently addressed, and the evidence was deemed admissible. This report reviews the case in regards to the cat biological evidence and its ultimate admission as generally accepted and reliable. Expansion and saturation analysis of the cat mitochondrial DNA control region dataset supported the initial interpretation of the evidence.
National Labor Relations Board — NLRB C-Case (Unfair Labor Practice) data from CATS (Case Activity Tracking System) for the period of 01/01/2006 through 12/31/2006. This dataset represents all data...
Mucha, S; Wolc, A; Gradowska, A; Szwaczkowski, T
The objective of the study was to analyze effective population size and inbreeding level in populations of cat breeds registered in the Polish Studbook. The Association of Purebred Cat Breeders in Poland provided access to pedigrees of 26725 cats from seven breeds. The most frequent breed was Persian, however increasing tendency in numbers of registered animals from other breeds was recorded in later years. Although the percentage of inbred individuals was increasing over time, mating of close relatives was avoided by most of the breeders, and the average inbreeding coefficient exceeded 5% only for Siberian and Russian breeds. Current analysis suggests that the Polish pedigree cat populations are not threatened by negative effects of inbreeding.
We study several classical-like properties of q -deformed nonlinear coherent states as well as nonclassical behaviors of q -deformed version of the Schrödinger cat states in noncommutative space. Coherent states in q -deformed space are found to be minimum uncertainty states together with the squeezed photon distributions unlike the ordinary systems, where the photon distributions are always Poissonian. Several advantages of utilizing cat states in noncommutative space over the standard quantum mechanical spaces have been reported here. For instance, the q -deformed parameter has been utilized to improve the squeezing of the quadrature beyond the ordinary case. Most importantly, the parameter provides an extra degree of freedom by which we achieve both quadrature squeezed and number squeezed cat states at the same time in a single system, which is impossible to achieve from ordinary cat states.
We study several classical like properties of q-deformed nonlinear coherent states as well as nonclassical behaviours of q-deformed version of the Schrodinger cat states in noncommutative space. Coherent states in q-deformed space are found to be minimum uncertainty states together with the squeezed photon distributions unlike the ordinary systems, where the photon distributions are always Poissonian. Several advantages of utilising cat states in noncommutative space over the standard quantum mechanical spaces have been reported here. For instance, the q-deformed parameter has been utilised to improve the squeezing of the quadrature beyond the ordinary case. Most importantly, the parameter provides an extra degree of freedom by which we achieve both quadrature squeezed and number squeezed cat states at the same time in a single system, which is impossible to achieve from ordinary cat states.
Summarized are clinical findings (including chromosome analysis and dermatoglyphics, as well as cytogenic findings in relatives) on five female and three male patients (age 15 years or older) with the cat cry or cri du chat syndrome. (KW)
Tallinna Ülikooli teadlaste poolt merikilpkonna eeskujul konstrueeritud allveerobotist U-Cat. Konstrueerimisel on peetud silmas sukeldumist laevavrakkidesse. Robot konstrueeriti projekti Arrows (Archaeological Robot Systems for the World's Seas) raames
Declercq, Jan; De Bosschere, Hendrik
Two cats were presented for acute onset of rapidly progressive, bilaterally symmetrical hair loss of the ventrum and limbs. Alopecia occurred within 2 weeks after accidental skin exposure to diesel oil. The remaining hair epilated easily in affected areas. Denuded skin was strikingly dry and had adherent scale. Erythema and demarcation between affected and normal skin by a liquid-line were present in one case. Above this line, the hair could not be removed. The head and the footpads were not involved. Systemic signs were not observed. Both cats made a complete recovery without treatment. Histological examination in one cat revealed severe orthokeratotic hyperkeratosis, mild to moderate acanthosis, follicular keratosis, a moderate dermal infiltrate of mast cells and an almost complete absence of sebaceous glands. If skin contact with diesel oil occurs in a cat, thorough washing of skin and haircoat after soaking in prue vegetable oil is recommended.
Lyons, Leslie A.; Grahn, Robert A.; Kun, Teri J.; Netzel, Linda R.; Wictum, Elizabeth E.; Halverson, Joy L.
Shed hair from domestic animals readily adheres to clothing and other contact items, providing a source of transfer evidence for criminal investigations. Mitochondrial DNA is often the only option for DNA analysis of shed hair. Human mitochondrial DNA analysis has been accepted in the US court system since 1996. The murder trial of the State of Missouri versus Henry L. Polk, Jr. represents the first legal proceeding where cat mitochondrial DNA analysis was introduced into evidence. The mitochondrial DNA evidence was initially considered inadmissible due to concerns about the cat dataset and the scientific acceptance of the marker. Those concerns were subsequently addressed, and the evidence was deemed admissible. This report reviews the case in regards to the cat biological evidence and its ultimate admission as generally accepted and reliable. Expansion and saturation analysis of the cat mitochondrial DNA control region dataset supported the initial interpretation of the evidence. PMID:25086413
Minganti, F; Lolli, J; Casteels, W; Ciuti, C
Since their conception, Schr\\"odinger's cats have captured the collective imagination. Photonic cat states are superpositions of two coherent states with opposite phases and with a significant number of photons. Recently, these states have been observed in the transient dynamics of a driven-dissipative resonator subject to engineered two-photon processes. Here we present an exact analytical solution of the steady-state density matrix for this class of systems by including one-photon losses, that are considered detrimental for the achievement of cat states. We demonstrate that the unique steady state is a statistical mixture of two cat-like states with opposite parity, in spite of significant one-photon losses. The transient dynamics to the steady-state depends dramatically on the initial state and can pass through a metastable regime lasting orders of magnitudes longer than the photon lifetime. By considering individual quantum trajectories in photon counting configuration, we find that the system intermitten...
National Labor Relations Board — NLRB C-Case (Unfair Labor Practice) data from CATS (Case Activity Tracking System) for the period of 01/01/2003 through 12/31/2003. This dataset represents all data...
National Labor Relations Board — NLRB C-Case (Unfair Labor Practice) data from CATS (Case Activity Tracking System) for the period of 01/01/2005 through 12/31/2005. This dataset represents all data...
National Labor Relations Board — NLRB C-Case (Unfair Labor Practice) data from CATS (Case Activity Tracking System) for the period of 01/01/2011 through 12/31/2011. This dataset represents all data...
National Labor Relations Board — NLRB C-Case (Unfair Labor Practice) data from CATS (Case Activity Tracking System) for the period of 01/01/2007 through 12/31/2007. This dataset represents all data...