US FDA best practices for initiating early feasibility studies for neurological devices in the United States

2022 ◽  
Vol 136 (1) ◽  
pp. 282-286
Keyword(s):  
Best Practices ◽  
Clinical Studies ◽  
Feasibility Studies ◽  
The United States ◽  
Clinical Testing ◽  
Physical Medicine ◽  
The Past ◽  
Regulatory Submission ◽  
The Us ◽  
Us Fda

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.

The Riddle of a Common History

2009 ◽  
Vol 1 (1) ◽  
pp. 93-116 ◽  
Author(s):  
Mauricio Tenorio-Trillo
Keyword(s):  
United States ◽  
Common Ground ◽  
The United States ◽  
History Textbooks ◽  
Recent History ◽  
History Textbook ◽  
The Past ◽  
The Us ◽  
Constant Part ◽  
Intrinsic Component

By identifying two general issues in recent history textbook controversies worldwide (oblivion and inclusion), this article examines understandings of the United States in Mexico's history textbooks (especially those of 1992) as a means to test the limits of historical imagining between U. S. and Mexican historiographies. Drawing lessons from recent European and Indian historiographical debates, the article argues that many of the historical clashes between the nationalist historiographies of Mexico and the United States could be taught as series of unsolved enigmas, ironies, and contradictions in the midst of a central enigma: the persistence of two nationalist historiographies incapable of contemplating their common ground. The article maintains that lo mexicano has been a constant part of the past and present of the US, and lo gringo an intrinsic component of Mexico's history. The di erences in their historical tracks have been made into monumental ontological oppositions, which are in fact two tracks—often overlapping—of the same and shared con ictual and complex experience.

Elotuzumab in the treatment of relapsed and refractory multiple myeloma

2021 ◽  
Author(s):  
Sebastian Grosicki ◽  
Martyna Bednarczyk ◽  
Agnieszka Barchnicka ◽  
Olga Grosicka
Keyword(s):  
Multiple Myeloma ◽  
Monoclonal Antibodies ◽  
Natural Killer Cells ◽  
Natural Killer ◽  
Clinical Studies ◽  
Mechanisms Of Action ◽  
Incurable Disease ◽  
The Us ◽  
Us Fda ◽  
Humanized Monoclonal Antibodies

Multiple myeloma (MM) is still considered an incurable disease. However, drugs with different mechanisms of action that can improve the efficiency of treatment offer hope. Still, there are concerns about an unacceptable increase in toxicity with such regimens. The results of recently published clinical studies of elotuzumab in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone confirm previous hopes to improve the effect of that treatment. Humanized monoclonal antibodies aimed at SLAMF7 stimulate natural killer cells to fight against MM cells. Elotuzumab used in combination with lenalidomide/dexamethasone or with pomalidomide/dexamethasone is approved by the US FDA to treat patients with relapsed and/or refractory MM. The article is a summary of the recent knowledge about the possibility of using elotuzumab in the treatment of relapsed and/or refractory MM and shows its potential uses in the future.

Abstract P183: 20-year Secular Trend of Cardiovascular Disease Comorbidities in the United States, 1997-2016

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Dianjianyi Sun ◽  
Tao Zhou ◽  
Xiang Li ◽  
Yoriko Heianza ◽  
Xiaoyun Shang ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Secular Trend ◽  
Adult Population ◽  
The United States ◽  
The Past ◽  
The Us ◽  
Metabolic Conditions ◽  
Respiratory Conditions ◽  
The U.S ◽  
Chronic Comorbidities

Background: Cardiovascular disease (CVD) has been the number one cause of death and disability in the US and globally for decades, and its comorbidity complicates the management of CVD. However, little is known about the secular trend of CVD comorbidities in national representative populations in the last 20 years. Methods: Prevalence of CVD and nine major chronic comorbidities was estimated using data from 1,324,214 adults aged 18 years and older in the National Health Interview Survey (NHIS) from 1997 through 2016, with age-standardized to the U.S. population in the year 2000. Results: CVD prevalence in the US adult population significantly declined in the past twenty years (from 6.6% in 1997 to 5.9% in 2016, P trend <0.01in Figure a). And such trend was shown in women and whites (P trend <0.01), but not in men and blacks (P trend >0.05). We ranked the nine major chronic comorbidities (high to low) in the CVD patients (Figure b.), including (1) hypertension, (2) respiratory conditions, (3) nervous system conditions, (4) digestive conditions, (5) diabetes, (6) cancer, (7) genitourinary conditions, (8) circulatory conditions, and (9) endocrine/nutritional/metabolic conditions. From 1997 to 2016, the prevalence of CVD comorbidities including hypertension (38.8% to 50.2%), digestive conditions (17.0% to 27.1%), diabetes (10.0% to 19.2%), cancer (9.4% to 12.8%), and genitourinary conditions (4.1% to 5.2%) continuingly increased (all P trend <0.01), while respiratory conditions declined (35.9% to 27.6%, P trend <0.01). Similar trends of CVD comorbidities were observed among subgroups stratified by gender or by race. Conclusions: CVD prevalence in the U.S. adults have declined significantly in the past two decades, but rates of CVD comorbidities including hypertension, digestive conditions, diabetes, cancer, and genitourinary conditions increased substantially.

Before American History: Nationalist Mythmaking and Indigenous Dispossession

2021 ◽  
Author(s):  
Christen Mucher
Keyword(s):  
Knowledge Production ◽  
American History ◽  
New Spain ◽  
The United States ◽  
Material Base ◽  
Historical Knowledge ◽  
The Past ◽  
British America ◽  
The Us ◽  
Ruling Elites

Before American History examines the project of settler nationalism from the 1780s to the 1840s in two of North America’s republics—the US and Mexico—through an analysis of historical knowledge production. As the US and Mexico transformed from European colonies into independent republics—and before war scarred them both—antiquarians and historians compiled and interpreted archives meant to document America’s Indigenous pasts. Before American History approaches two iconic imaginings of the past—the carved Sun Stone and the mounded earthwork—as archives of nationalist power and Indigenous dispossession as well as objects that are, at their material base, Indigenously-produced but settler-controlled and settler-interpreted. In making the connection between earthworks built by an allegedly vanished people merely peripheral to US citizens and the literal touchstone of Mexicans’ history, Before American History details how Mexican and US nationalists created national histories out of Indigenous pasts and thereby wrote Indigenous pasts out of their national histories and out of national lands. It uncovers how the manipulation of Indigenous pasts and (mis)interpretations of “American Antiquities”—Indigenous documents, objects and monuments—served the purposes of a trans-imperial/transnational network of creole ruling elites, first in New Spain and British America, and later in Mexico and the United States, as they struggled to construct new political, geographic, and historical orders.

scholarly journals Fungicide Sensitivity of U.S. Genotypes of Phytophthora infestans to Six Oomycete-Targeted Compounds

Plant Disease ◽  
2015 ◽  
Vol 99 (5) ◽  
pp. 659-666 ◽  
Author(s):  
Amanda Saville ◽  
Kim Graham ◽  
Niklaus J. Grünwald ◽  
Kevin Myers ◽  
William E. Fry ◽  
...  
Keyword(s):  
United States ◽  
Phytophthora Infestans ◽  
The United States ◽  
Effective Concentration ◽  
Response Curves ◽  
Baseline Sensitivity ◽  
Fungicide Sensitivity ◽  
The Past ◽  
The Us

Phytophthora infestans causes potato late blight, an important and costly disease of potato and tomato crops. Seven clonal lineages of P. infestans identified recently in the United States were tested for baseline sensitivity to six oomycete-targeted fungicides. A subset of the dominant lineages (n = 45) collected between 2004 and 2012 was tested in vitro on media amended with a range of concentrations of either azoxystrobin, cyazofamid, cymoxanil, fluopicolide, mandipropamid, or mefenoxam. Dose-response curves and values for the effective concentration at which 50% of growth was suppressed were calculated for each isolate. The US-8 and US-11 clonal lineages were insensitive to mefenoxam while the US-20, US-21, US-22, US-23, and US-24 clonal lineages were sensitive to mefenoxam. Insensitivity to azoxystrobin, cyazofamid, cymoxanil, fluopicolide, or mandipropamid was not detected within any lineage. Thus, current U.S. populations of P. infestans remained sensitive to mefenoxam during the displacement of the US-22 lineage by US-23 over the past 5 years.

Rethinking of Turkey’s Geopolitics together with Eastern Mediterranean. Turkish Perspective

2021 ◽  
Vol 705 (2) ◽  
pp. 45-66
Author(s):  
Arıboğan Deniz Ülke ◽  
Ibrahim Arslan
Keyword(s):  
Middle East ◽  
Raw Materials ◽  
Eastern Mediterranean ◽  
International System ◽  
The United States ◽  
The Past ◽  
Humanitarian Interventions ◽  
The Us ◽  
Transportation Accessibility ◽  
The Eu

In the studies carried out within the scope of geopolitical discipline, the expression "geography is destiny" is frequently used and it is claimed that geography has unchangeable, irreversible qualities and the policies implemented are shaped through this assumption. This assumption ignores the humanitarian interventions over the geography and makes it difficult to understand the results produced by these interventions at both regional and global level. Similarly, the dynamic nature of international relations reveals new actors in the international system in times of bounce and collapse, and the borders that expand or narrow with each transformation can differentiate the geopolitical view with new sovereign countries. In the historical process, transportation accessibility, trade, search for raw materials, security and alliance relations have caused the same geography to be interpreted differently in different periods. This situation also applies to the geography of Turkey had been the homeland of empires. The developments in the Middle East over the past two decades has created a sensitivity in the relations between Turkey and the West, especially the United States. Competing interests with the EU and the US in the Middle East and the Eastern Mediterranean, has necessitated a reassessment of Turkey's geography.

Population Issues and Reproductive Politics

2013 ◽  
Author(s):  
Rickie Solinger
Keyword(s):  
United States ◽  
Population Growth ◽  
The United States ◽  
The State ◽  
Reproductive Politics ◽  
The Past ◽  
United States Today ◽  
The Us

What is the state of population growth in the United States today, and how is it affected by immigration? According to the 2010 census, the US population has grown 9.7 percent (adding about 27 million people, including about 13 million immigrants) during the past...

scholarly journals An Act of War? The Interview Affair, the Sony Hack, and the Hollywood–Washington Power Nexus Today

2017 ◽  
Vol 53 (1) ◽  
pp. 1-27
Author(s):  
TONY SHAW ◽  
TRICIA JENKINS
Keyword(s):  
The United States ◽  
Global Market ◽  
Us Foreign Policy ◽  
First Century ◽  
The Other ◽  
State Security ◽  
The Past ◽  
Early Twenty ◽  
The Us ◽  
The One

Film has been an integral part of the propaganda war fought between the United States and North Korea over the past decade. The international controversy surrounding the Hollywood comedy The Interview in 2014 vividly demonstrated this and, in the process, drew attention to hidden dimensions of the US state security–entertainment complex in the early twenty-first century. Using the emails leaked courtesy of the Sony hack of late 2014, this article explores the Interview affair in detail, on the one hand revealing the close links between Sony executives and US foreign-policy advisers and on the other explaining the difficulties studios face when trying to balance commercial and political imperatives in a global market.

scholarly journals Home hours in the United States and Europe

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Lei Fang ◽  
Cara McDaniel
Keyword(s):  
United States ◽  
Time Use ◽  
Time Allocation ◽  
The United States ◽  
European Countries ◽  
The Past ◽  
The Us ◽  
The Difference ◽  
Using Data

AbstractUsing data from the Multinational Time Use Study, this paper documents the trend and level of time allocation, with a focus on home hours, for the US and European countries. Three patterns emerge. First, home hours per person have declined in both the US and European countries over the past 50 years. Second, female time allocation contributes more to the difference in time allocation per person between the US and European countries than does male time allocation. Third, the time allocation between the US and European countries is more similar for prime-age individuals than for young and old individuals.

Horizontal Mergers in the United States Health Field: Some Practical Realities

2000 ◽  
Vol 13 (3) ◽  
pp. 137-151 ◽  
Author(s):  
T. P. Weil
Keyword(s):  
The United States ◽  
Horizontal Mergers ◽  
Health Networks ◽  
General Management ◽  
The Past ◽  
Regulatory Strategies ◽  
The Us ◽  
Integration Of Services ◽  
Health Field

During the past decade, ‘merger mania’ has been a striking trend in the US health field as a strategy to improve the integration of services, to reduce expenses, and to increase the ability of providers to manage risk-based payment. However, during the past quarter of a century limited operational and fiscal evidence has been published in both the health and general management literature that strongly supports the efficacy of horizontal mergers. This article further argues that a likely scenario over the next decade, in spite of disappointments among these mergers in effecting significant cost reductions, is for the US health networks to continue acquiring additional providers and insurers. After these alliances gain significant market penetration, they are expected to behave as oligopolists. For these mergers to eventually achieve their earlier projected savings, the health field's leadership will be forced to implement cost-cutting measures such as: more vigorously coordinating the network's key clinical services to reduce competition for revenues among the partners within an alliance, closing superfluous hospitals and centralizing expensive tertiary services, encouraging surplus physicians to relocate to under-served areas, and providing direction to carefully integrate the best elements of what the competitive and regulatory strategies are able to offer to improve access, social equity, quality of care, and to reduce total health expenditures.

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